DexCom Q2 2022 Earnings Call Transcript

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Provided by Quartr
July 27, 2022

Key Takeaways

  • Strong Q2 performance: Organic revenue rose 16% YoY to $696M with record global new customer starts and an all-time US Net Promoter Score.
  • Software-led innovation: R&D spending now favors software over hardware, enabling new experiences like Dexcom ONE, expanded real-time API partnerships, and future metabolic health ventures.
  • International market expansion: Launched Dexcom ONE in Spain and the UK, partnered with Roche in Italy, and secured subsidized G6 access for all type 1 diabetics in Australia.
  • G7 approval update: FDA requested software tweaks to alarms and alerts, delaying US limited launch to Q4 2022 with a full rollout in Q1 2023, while payer discussions remain positive.
  • Financial outlook and capital return: Raised FY 2022 revenue guidance to $2.86–2.91B with ~65% gross margin and announced a $700M share repurchase to offset 2023 note dilution.
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Earnings Conference Call
DexCom Q2 2022
00:00 / 00:00

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Operator

Welcome to the Dexcom Q2 2022 earnings release conference call. My name is Daryl, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press zero one on your touch-tone phone. As a reminder, this conference is being recorded. I will now turn the call over to Sean Christensen. Sean, you may begin.

Sean Christensen
Sean Christensen
VP of Finance and Investor Relations at Dexcom

Thank you, operator, and welcome to Dexcom's Q2 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 Q2 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.

Sean Christensen
Sean Christensen
VP of Finance and Investor Relations at Dexcom

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.

Sean Christensen
Sean Christensen
VP of Finance and Investor Relations at Dexcom

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 Q2 earnings presentation for a reconciliation of these measures to their most directly comparable GAAP financial measure. Now, I will turn it over to Kevin.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

Thank you, Sean, and thank you everyone for joining us. Today, we reported another strong quarter for Dexcom with Q2 organic revenue growth of 16% compared to the Q2 of 2021. Momentum for global CGM adoption remains high, and we once again achieved worldwide record new customer starts in the Q2. Following some disruption early in the year related to the Omicron wave, office access has continued to improve, and we experienced a return to a more normalized customer journey, which helped us deliver this record. Customer satisfaction also continues to reach new levels as our U.S. Net Promoter Score hit another all-time record in the Q2. Our customers value the differentiated experience that Dexcom provides with consistent praise for our real-world accuracy, connectivity, actionable features, and customer support. Product performance has been a hallmark for Dexcom throughout our history.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

Customers and caretakers alike rely upon the accuracy of Dexcom CGM and can be confident in performance across all aspects of glucose management, backed by numerous clinical trials and borne out by real-world experience. We have long viewed software as an avenue to differentiate, enabling unique user experiences, supporting greater connectivity, and enhancing our ability to move more seamlessly into new markets. In support of this vision, we have invested significantly in building our software infrastructure in recent years and now spend more of our R&D budget on software than hardware. A tangible example of this can be found in our rollout of Dexcom One. This product leverages our G6 hardware and will use our G7 platform in the future, but uses software to provide a different experience than our G-Series systems.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

This has allowed us to meaningfully expand our market presence in recent months, entering new markets and winning tenders internationally that were previously not available to our G-Series product. This is just the beginning of our journey on leveraging software to create products that meet the needs of our end users. Our software infrastructure has also positioned us to be the partner of choice for technology companies looking to build new and innovative experiences around CGM data. Our list of real-time API partners continues to grow as we're the only company that can provide partners real-time CGM data in an FDA-regulated solution. Our software capabilities are also laying the foundation for our success beyond the intensively managed population. For example, two partners focused on the use of CGM for weight management and metabolic health, Signos and Levels Health, have clinical trials underway that are leveraging our real-time API capabilities.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

We are excited to see the outcome from these trials as they provide a glimpse into the future for CGM technology that could serve as a much broader end market than today. The Q2 saw a number of strategic accomplishments in international markets that continue to strengthen our competitive position. The excitement continues to grow for our portfolio of CGM systems, G6, G7, and Dexcom One, and we've made significant strides in both direct and distributor markets to broaden access to our technology. We launched Dexcom One in both Spain and the UK and have secured reimbursement for key segments of the population, opening large parts of these markets that previously lacked reimbursement for Dexcom CGM. We also announced a partnership with Roche to distribute Dexcom One in Italy. This relationship will allow us to leverage Roche's well-established commercial infrastructure to bring Dexcom One to a much larger Italian market.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

In Australia, the government recently committed to providing subsidized access to our G6 system for all people living with type 1 diabetes, which is a significant improvement in coverage and a great win for Australians deserving access to CGM technology. Our limited launch of G7 in the U.K. continues to be met with significant enthusiasm from our customers, who have provided consistently positive feedback on product size, ease of use, the shorter warm up time, the app experience, and more. Many customers shared that they would often forget they were even wearing the G7 during their session and indicated they can't wait to continue wearing the product full-time in the future.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

The period has proven to be incredibly valuable, allowing us to assess the functionality of the sensor and app in a real world setting and providing feedback on ways to refine our support system to make the broader rollout as streamlined as possible. We are excited to get G7 in the hands of more customers and plan to expand our launch in the Q3 starting in the U.K. In the U.S., our 510(k) submission for G7 remains under review with the FDA. As part of this process, we are making a subtle change to the G7 software based on feedback from the FDA, slightly delaying our expected timelines for clearance and U.S. launch. We expect FDA clearance and a limited launch later this year and a large commercial launch in the U.S. in the Q1 of 2023.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

Encouragingly, our preliminary discussions with payers have progressed very well. They understand what this product will mean for our customers and people with diabetes broadly, giving us increasing confidence in the ability to ramp up commercial coverage quickly. Finally, we were very proud to showcase our expanded CGM portfolio at two of the largest diabetes conferences of the year, ATTD in Barcelona and ADA in New Orleans. These events provide us an opportunity to connect with thought leaders across the diabetes space, and we continue to see a clear consensus on real-time CGM being the standard of care in diabetes management and a growing appreciation of the health and economic benefits of extending the use of this technology beyond the intensively managed population, including the broader type two population in use in the hospital.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

Between these two events, there were dozens of presentations, abstracts, and posters highlighting success stories of CGM to date and what the future could hold for this technology. I started attending diabetes conferences almost 30 years ago. As I look back even 2 or 3 years ago, these types of conversations around the broad potential of CGM were nonexistent. Now it's become very apparent that CGM data will become the basis of where diabetes management and glucose control in the future is headed. We're very excited about the opportunities ahead for Dexcom. With that, I'll turn it over to Jereme for review of the Q2 financials. Jereme?

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

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 Q2 of 2022, we reported worldwide revenue of $696 million, which included $12 million of unfavorable foreign currency impact. This is compared to $595 million for the Q2 of 2021, which represents growth of 16% on an organic basis. We have slightly changed our definition of organic revenue based on feedback from our stakeholders to exclude currency and acquisition-related revenue in the trailing twelve-month period. Volume growth for the Q2 came in around the mid-30% range on a global basis.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

U.S. revenue totaled $511 million for the Q2, compared to $462 million in the Q2 of 2021, representing growth of 11%. Customer demand remains strong in the U.S., and our unit volume growth continued to grow at a very healthy clip this quarter, relatively in line with recent quarters. We have been launching a number of new tools for our sales force in the U.S. that leverage technology to make each physician visit more efficient and effective. These tools inform our team what each doctor is prescribing, the makeup of their payer mix, and even comparative out-of-pocket costs for each customer. This data can make each visit more impactful and help us continue to address the competitive myths that still exist in the market.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

We continue to see an ongoing impact from revenue growth from our strategic shift to the pharmacy channel. As discussed previously, we believe this will ultimately set us up to serve meaningfully more customers over time. International revenue grew 39%, totaling $185 million in the Q2. Organic revenue growth was 34% for the Q2. Our positive momentum continued this quarter as the number of global initiatives we implemented in the past year has significantly improved our competitive position in international markets. In addition to the Dexcom ONE new market wins Kevin highlighted before, we also continued to drive greater reimbursement in our initial launch countries in Eastern Europe this quarter. While we previously announced that patient reimbursement in Bulgaria and Estonia, Latvia and Lithuania have now established full or partial reimbursement for individuals with type one diabetes.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

This is a great example of how our CGM portfolio strategy can help us enter completely new markets and be a catalyst for access. Through new product launches and reimbursement efforts over the past 18 months, we are happy to share that we have increased the reimbursed access to our product by more than 3 million customers and look forward to getting this much-needed technology in the hands of as many people as possible. Our Q2 gross profit was $449.5 million, or 64.6% of revenue, compared to 70.1% of revenue in the Q2 of 2021. Given the initial launch of G7 in the UK, this is the Q1 where G7 development costs started to flow through COGS, accounting for some of the expected year-over-year step-down in gross margin.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

Additionally, there were greater than 50 basis points of impact from currency in the quarter. Our Q2 gross margin was a nice step up from the Q1 and leaves us on track to hit our margin targets for the full year. Operating expenses were $347.6 million for Q2 of 2022, compared to $315 million in Q2 of 2021. Similar to last quarter, we generated meaningful operating expense leverage despite incremental investment to support the G7 launch. We saw OpEx as a percentage of sales this quarter drop by 310 basis points year-over-year as we continue to leverage our R&D and G&A expense lines.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

Operating income was $101.9 million or 14.6% of revenue in the Q2 of 2022, compared to $101.5 million or 17.1% of revenue in the same quarter of 2021 as a tough year-over-year gross margin comp was partially offset by operating leverage in the quarter. Adjusted EBITDA was $175.5 million or 25.2% of revenue for the Q2, compared to $156.6 million or 26.3% of revenue for the Q2 of 2021. Net income for the Q2 was $69.5 million or $0.17 per share. We remain in a great financial position, closing the quarter with approximately $2.8 billion worth of cash and cash equivalents.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

This provides us the flexibility to continue to invest in our organic growth opportunities, including the ongoing build-out this year of our Malaysia manufacturing facility, and to assess any compelling strategic investments that present themselves. Along those lines, we announced today a $700 million share repurchase program, which will allow us to offset the dilutive impact from our 2023 convertible notes. We are always assessing the best uses of our capital, and given the recent market pressure, we view this as a great time to invest in our own business as we remain incredibly bullish on the sizable opportunity ahead for Dexcom. Turning to guidance, we are updating our full year 2022 revenue guidance to a range of $2.86 billion-$2.91 billion.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

For margins, we are reaffirming our prior full year guidance of gross profit margins of approximately 65%, operating margins of approximately 16%, and adjusted EBITDA margins of approximately 25%. This guidance factors in a significant uptick in currency headwinds relative to the expectations we shared a quarter ago. We now expect around $40 million of foreign currency headwinds for the full year relative to our prior estimate of around $15 million-$20 million. With that, I will pass it back to Kevin.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

Thanks, Jereme. As I look at this quarter, our underlying fundamentals remain incredibly strong. We experienced another quarter of solid volume growth, achieved worldwide record new customer starts, recorded our highest-ever customer satisfaction rating. These results were before any material contribution from G7, which we expect to improve the customer experience in every way. We advanced our CGM portfolio outside the United States with a wider rollout of Dexcom One, helping us reach more reimbursed lives and serving more new customers. For G7, the feedback from our limited launch in the UK has been fantastic, leaving us incredibly excited for a broader global launch in the coming weeks. In the US, we now have clear visibility to the finish line on G7 clearance, and our preliminary payer discussions are setting the stage for a big launch early next year.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

Despite all the macroeconomic challenges that exist today, runaway inflation, supply chain challenges, FX headwinds, we reiterated our margin guidance, continue to have no delivery delays across our business, and remain committed to driving additional operating leverage in the coming years. Finally, we announced a $700 million share repurchase plan today. This will allow us to offset the dilutive impact of our 2023 convertible notes and also provides us an opportunity to send a clear message: we're betting on ourselves and the massive opportunity ahead of us. We're optimistic as we've ever been about our future. With that, I'd now like to open up the call for Q&A. Sean?

Sean Christensen
Sean Christensen
VP of Finance and Investor Relations at Dexcom

Thank you, Kevin. As a reminder, we ask our audience to limit themselves to only one question at this time and then re-enter the queue if necessary. Operator, please provide the Q&A instructions.

Operator

If anyone has a question, you can press zero one on your touch-tone phone. Once again, if you have a question, it's zero one on your touch-tone phone. Our first question comes from Robbie Marcus from JPMorgan. Go ahead, Robbie.

Robbie Marcus
Robbie Marcus
Analyst at JPMorgan

Great. Thanks for taking the question. You know, it was when you filed G7 last year, you had a pretty high degree of confidence in the completeness of the filing. Wondering if we could get a little more on what it is with the software, what you have to change, and how different it's gonna be from the European version. What gives you that level of confidence, and how to think about U.S. sales growth until we get a G7 launch? Thanks.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

You know, Robbie, this is Kevin. I'll take the G7 questions. The software revisions relate to the management of the alerts and alarms in the U.S. app. FDA had some questions about some of the things that we had done and put in it. We discussed several options that we had. We decided the best option at this time was to revise the software and file it differently, and we've added a few other features to it as well, based on our discussions with them. We're in the middle of revising the software for that and have to run it through the complete validation verification process and resubmit. We're not done with it yet, but we're working very quickly to get done with that, and that's really our big major issue. We've talked through everything else.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

We did have a strong level of confidence, and we still do in our relationships and our discussions with the FDA on G7. The one thing we've figured out as we've been through this process is we changed absolutely everything. We changed the algorithm, we changed the insertion techniques, we changed every manufacturing, you know, procedure that we have and completely rewrote the entire app and the software experience, which is a lot for them to digest and a lot for us to submit. You know, if I look at learnings for us over time, I think we'll probably do things a little more incrementally, going forward rather as big as this one was, and we can get things through faster. We're, you know, in a good spot.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

We have a lot of clarity as to where we need to go going forward, and I'll let Robbie handle the growth issues regarding G6 'cause we're still doing extremely well with that product. Or not Robbie, Jereme, go ahead.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

Yeah. Hey, how you doing, Robbie? Thanks for the question. In the US, you know, look, the quarter here, we had about 11% growth. You know, that's generally due to some of what we talked about in prior quarters, us getting into physicians' offices. You know, as those new patients didn't hit those record levels, you ultimately see that recur in a recurring business model such as ours, it plays through. What gives us a lot of confidence for the back half of the year is Q2 was a record, and we're back on that record track, and we do expect strength for the rest of the year to the point where we expect US growth rates to accelerate in Q3 and Q4 as we come off of this quarter where we see these record new patient starts.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

Quite frankly, we expect to have record new patient starts going forward for the balance of the year, even without G7. Hope that gives you that question. We're very confident in G6, and obviously, we're even more confident in G7 once that launches.

Operator

Our next question comes from Jeff Johnson from Baird. Go ahead, Jeff.

Jeff Johnson
Jeff Johnson
Senior Medical Technology Analyst at Baird

Thank you. Kevin, I just wanna go back on your comments about revising some of the software on the alerts and alarms on the G7 product. It sounds like to me you're still in the process of that, but I think you also said in your prepared remarks that you were comfortable that you would still have a limited launch in the Q4 and a fuller launch in the Q1 of 2023 in the U.S. You know, one, can I just confirm that's what you said? Two, do you have some better certainty on all the other aspects of the filing from the FDA that gives you that ability to draw that line in the sand? Or at least where's your confidence on that timeline? Thank you.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

We do have great certainty on the other components of the filing with the FDA. We've talked through all the other questions and things that we've discussed, and we're very, very comfortable with that. Really the outstanding major item is revision and filing of the revised software after we validate and verify all that. We are very, very comfortable with that. Yes, what I did say is we are anticipating a limited launch in the Q4 in the U.S. and then a full-on rollout in early in the year in 2023. You know, one of the things I also said in my prepared remarks is we're very bullish about the progress we've made with the payers as far as getting the G7 reimbursed because they can see how important it's gonna be for our patient base.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

On the one hand, while we have the delay in the approval and the launch. Look, none of us, we'd all like to be faster. The other thing we're seeing on the other side is a lot of cooperation in the payer community and just in the channel in getting this thing positioned for reimbursement very quickly after approval, so we can get the launch out in not too different of a timeframe on a reimbursed basis from what we expected in the beginning. Those two factors together, again, add to where we think we are.

Operator

Our next question comes from Margaret Kaczor from William Blair. Go ahead, Margaret.

Margaret Kaczor
Margaret Kaczor
Analyst at William Blair

Hey, good afternoon, guys. Thanks for taking the question. Yeah. I wanted to maybe dive a little bit further into kind of this new patient add growth, just because it's important as we get into 2023 as well. Any details that you can give in terms of how it looks like within T1s, T2 intensives, and others, and if there have been any changes, I guess, in the last 6-12 months? You know, are things getting harder, easier? You know, and you know, what kind of efforts can you guys put in place to reaccelerate more meaningfully those new patient adds? Thanks.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

Sure. Yeah, I can answer that, and thank you for the question. What we saw, I think we've really talked about it, is we found our folks are most effective when they're able to get into physicians' offices. That's always been the case, and it's continued to show itself time and time again. What we've found is it rises all tides once we're able to do so. But the predominance of where our new patient adds are coming, if you wanna kind of see what the acceleration is, it's really in the Type 2 intensive space. As we get into more primary care physicians' offices, these are folks we've called on really for the first time as we've expanded our sales force in 2021.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

Getting there in person has really unlocked that market, and that's what you continue to see. Now our focus is, and we talked about it a little bit in the prepared remarks, now that we're in these offices, a record new patient quarter this quarter, certainly, that's encouraging. We're also seeing that all of these tools that have been put in place means every call, every visit, every time we're in the office, we're able to be more effective about what might be the prescriber's decision-making around that particular patient.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

Through doing that, whether it's debunking myths around co-pays and what the out-of-pocket is and making sure folks understand the cost, whether it's the ease of use and showing folks that a majority of our patients are able to put it on and use either training online or simple training in the box to ultimately put it on their body. What we're really finding is we're breaking down all of those myths out there, and our sales force continues to get more and more effective. We're gonna continue to do that over time, and we're seeing that continue to play out as better prescriber patterns, more prescriptions per provider, and more providers coming over to prescribing Dexcom. All of those are playing out, which is what gives us confidence for acceleration in the U.S. in the back half of the year.

Operator

Our next question comes from Joanne Wuensch from Citigroup. Go ahead, Joanne.

Joanne Wuensch
Joanne Wuensch
Analyst at Citigroup

Good evening or afternoon, and thank you. I'm a little bit curious about some of the reimbursement landscape and things which may or may not have changed. Where do you think reimbursement is for bolus? And are you seeing any other changes as it relates to prior authorization or one product versus or another, or anything else that we really should be aware of? Thank you.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

Thanks, Joanne. Yeah, I can take the question. In terms of basal, we continue to make progress there. You know, as you think about where we're having the conversations, the conversations are both with the government and the U.S. CMS, as well as the U.S. commercial providers. We're having conversations with both, and our access team has submitted the data. They've submitted both clinical data, economic data, as well as clinician recommendations. We are going through those conversations. It's been submitted. Discussions are ongoing. Timing is hard to peg in all of these, but we are continuing to advance it forward in terms of conversations. That's basal. As that progresses forward, we'll continue to give you line of sight as to how that goes.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

In terms of other areas, existing coverage in areas around prior authorizations or otherwise, we haven't seen a lot of that. Now, there are occasionally plans that have a prior authorization pop up or pullout. Our goal is through all of the renegotiations that take place to limit those prior authorizations. As we continue to show how CGM can improve patient outcomes, it's becoming very, very clear that prior authorizations, we see payers starting to pull those down over time. Better way to put it. We continue to expect to see and keep pushing that. We have not seen a material change in any form or fashion. In fact, for the most part, we see them coming down, and we'll expect to see that over time in the intensive space.

Operator

Our next question comes from Matthew O'Brien. Go ahead, Matt.

Matthew O'Brien
Matthew O'Brien
Managing Director and Senior Research Analyst at Piper Sandler

Great. Thanks for taking the question. Can we just you know, as I look at the stock down 18% in the aftermarket, that's $6 billion-ish in lost market cap, maybe a little bit more than that. You know, I think it'd be helpful. I don't know if the reduction of the top line guidance from 20 down to 19 or maybe it's a little bit more is largely because of G7, but I'm thinking it's like a $60 million headwind, maybe something like that this year versus not getting the approval. Is it about a $100 million of incremental pressure you're gonna see next year in not having the approval earlier this year that you can't you know, get all the marketing activities up and going next year?

Matthew O'Brien
Matthew O'Brien
Managing Director and Senior Research Analyst at Piper Sandler

Just how do we frame up, you know, some of this modest delay? It seems like on the payer side, things are better. Just frame up, you know, what this modest delay may do to the top line as we look forward.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

Sure. I can talk about at least for 2022 and how it operates. You know, we can maybe not get too much into 2023, but it can help that conversation. A lot of the guidance and the pull-down of guidance is related to currency. It's not necessarily related to the G7 and the timing associated with that. As you look at where we're going and where we've pulled that down, currency has, especially outside the U.S., played a large impact on reported growth rates, and that's one of the reasons why we've shifted in how we talk about organic growth. As you zoom back into the U.S., the G7 delay does have a little bit of an impact on guidance. Certainly we would recognize that we had some impact in there and assumed it would launch.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

The longer term impact is really determined on how fast we get commercial coverage and how fast we can roll it out. What we believe is by working alongside our coverage teams and trying to get access as fast as possible, and while we're working through getting formal approvals, partnering with folks to get quicker access and quicker coverage, we believe we can work on getting those patients back in quicker and faster to where we don't believe it's going to be a material impact on 2023 and beyond. A little bit in 2022. Certainly, it could have a little bit of tick in 2023. For the most part, we're doing all the work now to make sure that we have a major launch where it doesn't impact longer term growth rates.

Operator

Our next question comes from Jayson Bedford from Raymond James. Go ahead, Jayson.

Jayson Bedford
Jayson Bedford
Analyst at Raymond James

Good afternoon. Just two questions that require quick answers. Just a clarification. I get the sense that it was a record for new patient starts in both the U.S. and worldwide, if you could just confirm that. The second question is, you mentioned expanding the G7 launch in Europe over the coming weeks, and I wasn't clear whether you're going into new countries or is this just more expansive in the U.K.? Thanks.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

This is Kevin. I'll start. Yes, it was record new patients, OUS and in our U.S. markets as well. Both teams had new patient add records during this quarter. With respect to the roll out of G7 in Europe, what we had indicated was our first rollout will be in the U.K., and we expect to roll out in other geographies before the end of the year.

Operator

Our next question comes from Travis Steed from Bank of America. Go ahead, Travis.

Travis Steed
Travis Steed
Analyst at Bank of America

Hey, thanks for taking the question. One quick clarification, the pricing mix versus volume growth this quarter. Then as you look ahead to next year, will we start to see volume and revenue growth start to match up a bit more? I'm thinking about the basal opportunity. Is that an opportunity where you're gonna have to lower price to get the volume? Or is the basal pricing probably pretty similar to the intensive market? Thank you.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

Sure. I can take those questions. You know, in terms of pricing and what I would say is more channel mix, but the delta between the two, it was about the same this quarter as it was in prior quarter, which is what we had signaled at the start of the year. We still expect to migrate in the U.S. channel as we move more DME to pharmacy. That continues as expected. We had the OUS pricing where we took down pricing in exchange for access. We expected that to run through the end of Q2 before we lapped our strategy. It's all gone in line with expectations. It was right around $70 million on the quarter. In terms of basal and beyond, look, basal coverage, we believe is out there.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

In terms of what the pricing is, you know, at this point, a lot of the conversations are about category coverage. And currently category coverage is already relatively defined in pricing today. What that means is it could be the same, but would we be willing to talk to folks about increasing access in exchange for price? We'd absolutely entertain the conversation. Have to make sense for us for both, you know, the returns that we would expect on our performance as well as for our shareholders. But nothing to this point has indicated it would be lower. However, we understand that as more and more folks get access, we will be having those conversations.

Operator

Our next question comes from Marie Thibault from BTIG. Go ahead, Marie.

Marie Thibault
Marie Thibault
Managing Director and Medical Technology and Digital Health Analyst at BTIG

Hi. Good evening. Thanks for taking the questions. I wanted to go back to something Kevin said earlier about the new software and app experience for the patient with G7 in the U.S. Can you give us a hint of how meaningful that new app experience might be for patient willingness to try the G7, to switch to the G7, and what it might do for patient demand? Thank you.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

One of the best features of the limited launch in the UK has been getting feedback on the software, and people absolutely love the app. From the very beginning, when you start, it's much easier to fire it up and get on the system and understand what CGM is gonna do for you and how it's gonna work. For a new user, this is a much easier experience and much easier start. The other thing that's very obvious in the software is another feature that our patients love. It's a 30-minute warm up that actually ends up being about 25 minutes once you put the sensor on.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

I was speaking with a patient just last week, and I asked her, "What is your favorite and what is your worst thing about G6?" The 2-hour warm up is very frequently comes up, was what came up. This half hour warm up is gonna be a feature. The software itself, in addition to the typical graph and the and, you know, and the sensor reading and the arrows, we also have Clarity data built into the app that gives you feedback about how you're doing over 1 day, 3 days, 7 days or even a month. Someone can go down and look and see exactly how they're doing and what their trends are, you know, how much time they are spending in range.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

It's much more of a full experience for somebody in their diabetes care, and our patients liked it tremendously. We'll be ready to go on Android and iOS in launch. We're not gonna hold either of them back. You know, the other thing with the app, and it's not really on the app, but it's a feature of this product that's been very well accepted as well I didn't talk much about, we have a new receiver coming, that patients absolutely have loved and are using it very well. While I, you know, I figured when we went to the phone in the beginning, everybody would immediately migrate to the phone, there's a very large percentage of our customers who use that receiver. They will be greatly enhanced in their experience by going to the next receiver with us.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

On the good news front as well, that new receiver, while a better experience, is a much lower cost offering. All good stuff there on the app.

Operator

Our next question comes from Mathew Blackman. Go ahead, Mathew.

Mathew Blackman
Mathew Blackman
Managing Director at Stifel

Good afternoon, everybody. Thanks for taking my question. International growth did step up even though you had a tougher comp. Is that the broader G7 rollout, Dexcom ONE, some combination of those two? I'm also really curious about Germany in particular, where I think you are going head to head versus the newest sensor from your competitor. Just any commentary about sort of geographic performance within that international number. Thanks.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

Sure. Yeah, we can absolutely answer that. You know, it's interesting. Dexcom ONE and G7 really haven't contributed all that much to this point. Certainly it's an exciting future contributor, and we're very, very bullish on both G7 and the opportunity in Dexcom ONE. Dexcom ONE really is in the Benelux countries and hasn't contributed all that much. G7 was a limited launch, and what you're seeing is G7 with a more meaningful launch and Dexcom ONE with a more meaningful launch in bigger countries in Q3 and beyond. What you saw in Q2 was really a continuation of our access and going deeper into countries where we had our G-Series.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

Really it was broad-based, and it's a continuation of broad-based performance outside the U.S., really across all of our countries, including Germany, where we do go head to head with Libre 3. I think what you can say is that business is doing incredibly well, and there's new catalysts to ultimately support it for upcoming periods. We are very excited about that international business. Like I said, in countries where we're going up head to head with our competitor's most recent product, we continue to do very well and take share. Very, very bullish on our opportunity going forward.

Operator

Our next question comes from Josh Jennings from Cowen. Go ahead, Josh.

Analyst at Cowen

Hi, this is Brian here for Josh. Are you currently seeking or planning to seek CE mark approval for the software changes you're making in the U.S.? If so, could you share the projected timeline there? Thanks for taking the question.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

We already have the software approved for CE mark in Europe, and we do not plan immediately on implementing the changes that we're putting into the U.S. app. We'll consider that over time. We have the app and the software configured to whereby we can launch the product with what we're doing in Europe, sell it, and support it there. If we feel the need to in some period of time, we can implement those changes into the other software and upgrade patients' apps on the phone. But not immediately, no.

Operator

Our next question comes from Steven Lichtman from Oppenheimer. Go ahead, Steven.

Steven Lichtman
Steven Lichtman
Managing Director and Senior Analyst at Oppenheimer

Thank you. Hi, guys. As you're moving G7 to full launch in the UK, where you now also have Dexcom ONE, just wondering how will those two offerings be marketed relative to each other? Should we assume that over time, they sort of merge, and with G7 becoming the primary hardware there? Obviously, that's gonna happen in more and more countries over time. Wondering if, you know, if you could talk to your thoughts on that. Thanks.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

No, I appreciate that question. You know, we launched Dexcom ONE in Europe, and we're launching in the U.K. because there are many reimbursement opportunities we've not been able to participate in. Our G-Series or our G6 and G7 products are regarded as very high-end sensors for intensive insulin management, integration with insulin pumps, a lot of pediatrics, the share, the follow, the other features that have made our products so endeared to our users. The Dexcom ONE app doesn't have many of those features. It's much more simple, and it falls into a different reimbursement category in many of these geographies. In the U.K., for example, our Dexcom ONE system will literally go through the pharmacy channel for broad-based distribution and broad-based accessibility for everybody, whereas our G-Series requires more documentation, more approval in very specific conditions.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

As we look at these geographies, we think we have an opportunity with Dexcom One to sell a different product in a different system with different features that really won't step over onto our G series that is fully integrated with other systems and offers all these other features. Ultimately, as I said on the call, we want our Dexcom One product to be on the G7 platform as well as simplify our operating structure over time, but that'll take a little while. G6 for Dexcom One platform, we think will do very well, and our initial user feedback has been very good. The software for Dexcom One, I would also add, has been designed on the same platform as the G7 software, so it looks and feels much more like G7 than it does G6.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

Our users will have a great experience there. As long as there are two reimbursement categories, we do not see these two products coming together from a reimbursement perspective. They might look more alike physically, and be on the same platform once we get G7 and enough capacity to transfer to the other, Dexcom onto that platform, but they won't be the same experience. It won't be reimbursed at the same rates.

Operator

Our next question comes from Larry Biegelsen from Wells Fargo. Go ahead, Larry.

Analyst at Wells Fargo

Hi, this is Nathan on for Larry. Can you comment on what drives the margin improvement in the second half, given the launch of G7, and how should we think about margins into 2023? Thanks.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

Sure. Let me talk about the second half, and we won't get too much into 2023 specifically other than with our long-range plan is 65%, and so that's the way we generally think about things. In terms of the back half of the year, typically what happens is, as we go typical seasonality, as we go through the course of the year, and a part of this has to do with who's ultimately purchasing the product, margins typically get better. Now that was thrown on its head a little bit as we were launching G7, and we had some timing things about when that would launch and in what countries that would go into.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

What you're finding is for the first half of the year, we obviously had a few different unique items that impacted margins. What you're really finding is the run rate for our margin for the first half of the year, absent these, was just below 65%. Back half of the year, we expect it to be just the opposite, just north of 65% as we hit that typical seasonality. We will have a little bit of pressure from the launch of G7 outside the U.S. However, that'll clearly be offset through the G6 throughput that you ultimately see.

Jereme Sylvain
Jereme Sylvain
EVP and CFO at Dexcom

The reason the tick up in the back half of the year, but in some ways is due to, with the G7 launch in a meaningful way outside inside the U.S. sliding into Q1 of next year, you do see that performance on that G6 platform, which continues to have nice margins play through over the course of the rest of the year. We have a lot of confidence, 65% for the year, even despite all of the macroeconomic conditions.

Operator

We have no more questions at this time. I'll turn it back to the speakers for closing comments.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

Well, again, thanks everybody for participating on the call. One of the great things that's happened in the Q2 has been my own ability to get out and talk and meet with people, going to ADA and also some other conferences where I've spoken. I've never seen Dexcom more respected and more visible than we are now. Our customer satisfaction scores, as I talked earlier, have never been higher, and that's what you hear in real life. People are absolutely thrilled with the performance of our product and the problem that we solve for them. It's never been a better time here. We have a number of Dexcom One launches coming out over the next few quarters on top of that with G7 as well, both presenting great revenue and growth opportunities for us, and our operations are running very efficiently and smoothly.

Kevin Sayer
Kevin Sayer
Chairman, President, and CEO at Dexcom

Everybody have a great day and thanks for participating on the call.

Operator

Thank you. Ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now disconnect.

Executives
Analysts
    • Jayson Bedford
      Analyst at Raymond James
    • Jeff Johnson
      Senior Medical Technology Analyst at Baird
    • Joanne Wuensch
      Analyst at Citigroup
    • Margaret Kaczor
      Analyst at William Blair
    • Marie Thibault
      Managing Director and Medical Technology and Digital Health Analyst at BTIG
    • Mathew Blackman
      Managing Director at Stifel
    • Matthew O'Brien
      Managing Director and Senior Research Analyst at Piper Sandler
    • Robbie Marcus
      Analyst at JPMorgan
    • Sean Christensen
      VP of Finance and Investor Relations at Dexcom
    • Steven Lichtman
      Managing Director and Senior Analyst at Oppenheimer
    • Travis Steed
      Analyst at Bank of America
    • Analyst at Cowen
    • Analyst at Wells Fargo
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