德康醫療 (DXCM) 2021 Q1 法說會逐字稿

Welcome to the DexCom First Quarter 2021 Earnings Release Conference Call. My name is Adrian, and I'll be your operator for today's call. (Operator Instructions) Please note this conference is being recorded.

I'll now turn the call over to Sean Christensen. Sean, you may begin.

Thank you, operator, and good afternoon, everyone. Welcome to DexCom's First Quarter 2021 Earnings Call. Our agenda begins with Kevin Sayer, DexCom's Chairman, President and CEO, who will provide a summary of our progress; followed by a financial review and outlook from Jereme Sylvain, our Chief Financial Officer; and then an update from Quentin Blackford, our Chief Operating Officer, on the company's strategic initiatives and scaling progress. (Operator Instructions) 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 total revenue growth of 25% over the first quarter of 2020. As I often tell our employees, our ability to thrive as a company ultimately comes down to solving significant problems with a great product. And that is what we continue to see with G6. We hear incredible stories of improved glucose control, reduced disease burden and people being empowered, and those responses have only increased as we've enhanced tools to better drive our customer experiences. These stories are coming from multiple sources as well, whether it is coming from G6 users or their family members who are gaining better control of their glucose levels to real-time data or clinicians who are empowered by the ability to gather unique insights into the diabetes treatment of their type 1 or type 2 patients and optimize therapy accordingly, and even new settings like nurses and doctors in the inpatient setting who are deploying CGM and learning about its potential to optimize workflows and benefit from our remote monitoring technology.

New customer additions are off to a great start in 2021, especially in the U.S., as we continue to see growth across all channels, building from the increased access that we've gained over the past several years. This includes continued traction for people with type 1 diabetes and type 2 intensively managed diabetes, both of which have continued the strong growth momentum that we've seen over the past couple of years. We're also seeing a growing number of type 2 nonintensive customers on G6, not only through our partnerships like UnitedHealthcare's Level2 program, but also including the other innovative programs and providers that are establishing early access to DexCom CGM.

We're also progressing our strategic commercial efforts, with the remainder of our commercial sales force expansion completed in the first quarter and our direct-to-consumer marketing efforts generating new levels of brand awareness. The Super Bowl commercial featuring Nick Jonas was a highlight for the company in the first quarter. We were able to generate significant excitement for our employees and customers, many of whom have sent us pictures and stories of their pride and feeling represented during one of the biggest annual events in the world. We also contribute to a broader conversation in the diabetes community that we hope will help facilitate broader access to CGM in the future. The ad drove a record number of visitors to our website, a record for single-day new customer leads and significantly more media impressions than we generated in all of 2020.

And we are confident that there will be ongoing benefits that will come from the ad. In fact, according to the independent Harris Poll, DexCom led all Super Bowl advertisers in brand equity growth. Overall, it was a great investment for the company, and I'm really proud of our team for pulling it together. Our commercial efforts also include a strong push from our teams to expand access to DexCom CGM technology internationally, both deeper in existing markets as well into new geographies. With DexCom in the strongest inventory position in the company's history as a result of our scaling initiatives, we are aggressively advocating for broader access to our G6 systems for people with type 1 diabetes and intensively managed type 2 diabetes, similar to what we have done here in the United States.

Since we last reported in February, we have received confirmation from 3 additional Canadian provinces that they will begin covering DexCom CGM. This is a great step forward in expanding access for people with diabetes. There is significant demand from customers and clinicians, and we are optimistic that we will continue this positive momentum in Canada with both the public and private payers over the coming months.

In certain reimbursed markets, we are proactively lowering price to significantly expand access to incremental customer populations. This positions us well to continue to grow sensor volume significantly now and into the future, and we believe the incremental volumes will more than offset the impact of price in the near term.

In conjunction with our commercial initiatives and the growing CGM category awareness, we are advancing the clinical and regulatory path for our next-generation G7 CGM system. As a reminder, we expect G7 to improve all aspects of the current customer experience offered with G6 in a disposable wearable that is less than half the size. We are working to prepare the submission for CE Mark in accordance with the new medical device reporting standard in the EU. At this point, we remain on track for our target launch of G7 in the second half of 2021.

We also plan to present preliminary data on G7 performance at the upcoming ATTD conference in early June. Our trial that will support our U.S. iCGM filing is also well underway. And we have received outstanding feedback from the investigators and patients involved. We expect to complete that trial in the current quarter, and we'll keep you updated as we progress towards regulatory approvals and launch.

Even as we advance our strategic plans and have seen continued customer growth over the past year, the evidence of the global pandemic remains with us. We continue to navigate certain closures in territories that have seen cases spike, and our team remains focused on the 3 priorities that we have emphasized throughout the past year: the health and safety of our employees, continued supply of our customers and service to our communities. Towards this end, we were pleased to recently work with the state of Arizona to open the first indoor mass vaccination facility in Arizona to help the community as it transitions to the heat of the summer months. This facility rests within our Mesa distribution facility and has the capacity to support several thousand appointments per day. I am proud to lead a company whose employees are so dedicated to the service of our customers and willing to think creatively about what it means to be a leader in the communities that we serve.

As we come back to first quarter results, I want to welcome a new voice to our earnings call, those familiar to many of you already. Last month, we announced the promotion of Jereme Sylvain to the role of Chief Financial Officer. And I'm pleased to have Jereme joined Quentin and I for his first DexCom earnings call this afternoon. Jereme?

Thank you, Kevin. I'm excited to be with you today and in the new role as we advance our work together for people with diabetes. 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 on today's earnings release as well as on our IR website.

For the first quarter of 2021, we reported worldwide revenue of $505 million compared to $405 million for the first quarter of 2020, representing growth of 25% on a reported basis and 23% on a constant currency basis. This is our seventh consecutive quarter of revenue growth of $100 million or more. Impressively, our revenue performance came against our toughest quarterly comparison in 2020 for both our U.S. and international businesses as the first quarter of 2020 was largely unaffected by the COVID-19 pandemic. We also saw nearly 40% global unit volume growth in the quarter, demonstrating the continued customer growth in the business.

U.S. revenue totaled $381 million for the first quarter compared to $292 million for the first quarter in 2020, representing growth of 30%. Our U.S. business was the primary driver of growth in the first quarter, with our commercial efforts in rising CGM awareness driving solid volumes and an acceleration from our fourth quarter growth percentage. We believe that we are well positioned to continue this momentum. Our DTC efforts are driving awareness of DexCom CGM. We have new connected systems coming to market that build from years of collaborative work with our partners, and we have an expanded field sales force equipped with the products that our customers love.

Our international business reached another quarterly high watermark with a revenue of $124 million or 10% growth on a reported basis compared to the first quarter of 2020. As we saw in the final 3 quarters of 2020, the impact of COVID-19 lockdowns has had a greater impact on new customer growth in certain international markets, which has a compounding effect on our reoccurring revenue model. Nevertheless, we delivered growth against our toughest quarterly comp of 2020, where international revenue grew 61% before the pandemic.

We continue to see strong growth across a number of our markets, particularly in countries where the administrative requirements to access CGM are minimized via our e-commerce channel or via broad reimbursement. As many of you have seen, we've successfully reduced our manufacturing costs and intentionally increased sensor production capacity. Through these manufacturing efficiencies and increased capacity, we are no longer restricted to focusing on high-risk, high-reimbursement populations. With this increased commercial flexibility, we are executing on our strategy to broaden access to our CGM technology by pushing deeper into existing markets we previously could not address. Through the incremental volumes generated by these efforts, we believe we will offset any near-term price impact while better positioning the company for long-term growth.

Our first quarter gross profit was $343.9 million or 68.1% of revenue compared to 63.9% of revenue in the first quarter of 2020. The fact that we are driving margin expansion, despite absorbing the channel mix impact associated with the acceleration of our U.S. business to the pharmacy channel, is a testament to the work of our teams to drive down material and production costs. Operating expenses were $297.5 million for the first quarter of 2021 compared to $215.4 million for the first quarter of 2020. The increase in operating expenses as a percentage of sales in the first quarter of 2021 is a result of several of the key initiatives that we outlined in our original 2021 guidance in February. This includes our expanded commercial efforts with the doubling of our U.S. sales force and increased global DTC marketing efforts, both reflected in the quarterly results.

In addition, the first quarter research and development expense includes costs associated with our large U.S. iCGM trial for G7, which will continue into the second quarter as we generate the data necessary to support our regulatory filing. Offsetting those strategic investments, we continue to gain leverage in our general and administrative expenses in the quarter, demonstrating the benefits of our scaling initiatives. To that end, as we've previously indicated, we have launched a global business services facility in Lithuania, which is now officially live in servicing our customers.

Operating income was $46.4 million or 9.2% of revenue in the first quarter of 2021 compared to $43.3 million or 10.7% of revenue in the same quarter of 2020, with 150 basis point decrease resulting from our strategic investments offset by our gross margin improvement. Adjusted EBITDA was $94.4 million or 18.7% of revenue for the fourth quarter compared to $77.8 million or 19.2% of revenue for the first quarter of 2020. Net income for the first quarter was $32.8 million or $0.33 per share. We remain in a great financial position, closing the first quarter with more than $2.6 billion in cash and cash equivalents and well positioned to continue our G7 scale-up and remain opportunistic as we look to expand our growth opportunities.

Turning to guidance. We expect some impact to new customer starts to continue during the ongoing global vaccine rollout, particularly in certain international markets as well as continued higher-than-usual volumes in our U.S. Medicaid channel as the economy recovers. With the strong first quarter performance as well as the currency benefit that we saw in the first quarter and continue to anticipate, we are pleased to be in a position to raise our full year 2021 revenue guidance. We now expect 2021 revenue to be between $2.26 billion to $2.36 billion, representing growth of 17% to 22% over 2020. This growth continues to factor in strong unit growth volumes, which are offsetting the impact of lower revenue per customer channels and our recent efforts to broaden access to G6 in international markets as well as the impact of currency.

Turning to margins. We are affirming the full year 2021 targets previously established on our fourth quarter call. This includes non-GAAP results to be approximately at the following levels: gross profit margins of approximately 65%, operating margins of approximately 13%. We continue to expect that adjusted EBITDA margins to be approximately 23%. And finally, as you may have noticed, from a tax perspective, we have transitioned to profitability and we'll have a tax rate applicable to earnings going forward. Our expectation

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the call over to Quentin for a scale and strategy update.

Thank you, Jereme. It's been a pleasure to work alongside Jereme for the last 7 years of our careers, and I am thrilled for him as he now steps into the CFO role. I look forward to watching you and take this next step in his career and look forward to the many contributions that he'll make in his new role while also excited by the opportunity to turn my attention much more broadly to our strategic and scaling efforts across the organization.

Our teams remain incredibly focused on our strategic initiatives and are making great progress on several fronts. As Kevin mentioned, we are advancing our regulatory and clinical efforts for G7 and will present the first set of G7 data at the upcoming ATTD conference in early June. As we press forward toward our G7 goals, we are making steady progress in our effort to scale G7 manufacturing to support our launches and the continued growth of our global customer base. In the near term, this includes the lines that we are building in our San Diego and Mesa, Arizona facilities. We've also broken ground on our manufacturing site in Malaysia, which we expect to enable us to significantly scale our G7 production capacity to serve meaningfully more customers as we continue to grow our business in the years to come.

Even with G7 on the horizon, we remain committed to building on the leading customer experience that we have established for users of our G6 system. Following the December regulatory approval in the U.S., we rolled out an update to the G6 algorithm in the first quarter. We believe this update will drive further reductions to times in which data is temporarily unavailable and have seen excellent results from the initial launch of this updated algorithm in Canada in 2020. These are the kinds of incremental improvements that we are always looking to provide, and they are contributing to our strong customer retention and satisfaction levels reflected in our industry-leading Net Promoter Scores.

On the insulin delivery front, we were encouraged to see the great results from the Omnipod 5 pivotal trial presented at ENDO 2021, and look forward to the upcoming launch of that system for our DexCom customers using the Omnipod pump. With this launch in Omnipod's differentiated patch pump form factor as well as Tandem's continued market traction with their DexCom-connected Control-IQ, we believe that we are very well positioned to continue to benefit from the growing appreciation for these automated insulin delivery systems.

Similarly, we continue to advance our development with Eli Lilly, Novo Nordisk, and more recently, Ypsomed, leaving us in a strong position in future years as people with diabetes stand to benefit from greater variety in their choices for Bluetooth-connected insulin delivery options that integrate DexCom CGM.

We've discussed the excellent first quarter performance in our U.S. IIT market as well as some of the key strategic initiatives that we are undertaking to expand access in our international markets. We are also making excellent progress in our effort to drive the third pillar of near-term growth that we highlighted at our 2020 Investor Day, the nonintensive type 2 market.

As we've mentioned before, we are taking multichannel approach to enabling access to DexCom CGM in the absence of widespread reimbursement. This involves direct work with payers, digital health programs, health care providers, and integrated networks as well as the patients themselves. The early rollout of Level2 is progressing well as we continue to see that program expand and our teams are working well with the UnitedHealthcare team to optimize the experience for members using our G6 system as part of that program.

We also worked with several partners to expand their use of G6 in their respective type 2 populations in the first quarter. This includes the initiation of commercial pilots with Teladoc Health's Livongo for Diabetes platform as well as with WellDoc. Everside Health also announced that it will offer G6 to its members with type 2 diabetes in its Healthstat business unit, and we are proceeding there now in a pilot phase. This relationship builds from our initial work with Healthstat over the previous 2 years, including the use of DexCom CGM in a pilot for health screenings at on-site clinics. Each of these relationships is expanding the pool of customers who can access our technology while generating evidence of the utility of DexCom CGM for the broader type 2 market that we believe will drive access and awareness in the future.

Beyond these core growth initiatives, our teams continue to advance innovative research and product development that we feel will contribute to long-term growth for DexCom. This includes the hospital market, where we are generating data via our patient registry and receiving great feedback as many hospitals across America continue to take advantage of the FDA's temporary allowance to use DexCom CGM in the inpatient setting during the pandemic. This also includes several clinical studies assessing the use of DexCom CGM for better management of gestational diabetes, a solution that we believe can enhance the outcomes for both the mother and the child. And finally, we continue to access next-generation technologies that we believe can build from the sensor platform that we've established with G6 and G7. We look forward to updating you as we progress.

With that, I will pass it back to Kevin.

Thanks, Quentin. As you can see, we're off to a great start to the year and working hard to execute on the strategic pathway that we've laid out for 2021. I would now like to open up the call for Q&A. Sean?

Thank you, Kevin. (Operator Instructions) Operator, please provide the Q&A instructions.

(Operator Instructions) And our first question comes from Jeff Johnson from Baird.

Let me -- I'll put it into a multipart question, I guess. But Kevin, I think it's officially one question. But on the channel mix headwinds that we've been talking about here in the last 6 to 8 quarters or so, is it still fair to be thinking around $200 million, plus or minus, this year? And given the exit rate from 4Q of '20, still fair to think a little bit of that as front-end loaded? And then when I look at your 30% U.S. growth, it would seem like if I ex out the channel headwinds, the pricing headwinds there, volumes must have grown well north of 40%. So if you could just kind of confirm that from a pricing versus volume mix in 1Q U.S. number, that would be helpful as well.

Jereme will take that one, Jeff.

Yes, Jeff. So to your question on what the channel mix headwinds are, we'll just tell you what the numbers were for the quarter. It was about $50 million for the quarter. And if you recall, we talked about it being a little bit more straight-lined over the course of 2021 due to comps. The one thing we have talked about, and Kevin referred to it on the call as did I, is that we are going to be a little more aggressive in international markets. And so because of that, we're raising what we call channel mix/pricing headwinds to about $250 million on the year. And that obviously takes into account the aggressive steps we've taken outside the U.S.

In terms of your question in terms of growth and unit volume, we talked about unit volume approaching 40% on a global basis. When you take the channel mix headwinds we talked about, you are correct. The U.S. unit volume growth was well in excess of that, obviously, being the stronger point of the quarter from a growth perspective. So you are seeing that performance on the quarter.

And our next question comes from Joanne Wuensch from Citibank.

Can I go back to what you just said, please? To be clear, the $50 million in the quarter, how much of that was U.S. versus OUS?

Yes. So Joanne, we generally don't break down the two. What we did talk about was $50 million is the global now. A majority of that has traditionally been the channel mix from pharmacy or from DME into pharmacy. But when we give that number, we give a global number. So that was $50 million globally on the quarter, again, heavily weighted U.S.

Okay. I'm going to sneak one more because that was a clarification. Is there any reason that it's not possible for G7 to be in the U.S. by the end of this year?

We're not giving any G7 timelines other than we will launch it by the end of the year. As I said in the earlier portion of our remarks, our U.S. pivotal study will conclude this quarter, and then we'll file. We're working on our filing in Europe under MDR rules for CE Mark, and we'll go from there. Time will tell, but everything is going well. We're happy with the progress of the product. We're extremely happy with the feedback we've gotten from clinicians and patients. In fact, one clinician called me this morning in between our prep for this call to tell me how great the product was. So we're very happy with it, but we're not going to give any other timelines on what we have so far.

And our next question comes from Robbie Marcus from JPMorgan.

Great. Congrats on nice quarter. I wanted to talk about the guidance raise. It was more than the beat you had in the first quarter. So maybe walk us through your new patient assumptions and what's driving that U.S. versus OUS. And if you could comment at all on how the early trends of the Super Bowl and increased DTC spend and sales force doubling has benefited the company so far and what to expect in 2021.

Sure. Yes. So we can walk you through it. The guidance raise was approximately $25 million of it was currency. So we referenced some of the foreign currency tailwinds associated with the other half was related to volume growth, expected both in the first quarter and on the balance of the year. In terms of what we saw in terms of new patient adds in the first quarter, new patient adds were slightly ahead of expectations. And so that's really -- as we look to the balance of the year, certainly, those repeat customers obviously play through in the balance of revenue for the year. And so we've added that to the guidance.

We still are bullish on the year. We still expect to have a very strong year. I don't think there was any question there. And I think if you see the performance in the U.S. result, I think you're obviously seeing a lot of, to your second question, a lot of the DTC, a lot of the Super Bowl ads as well as the new sales force ads starting to really play through, not to mention the fact that we have a sampling program that's out there that is starting to allow folks to trial the product, which we think is garnering interest as well.

So that's all been contemplated in the guidance as we lay it out. And I think what you'd say is for the balance of the year, I do think you are seeing the momentum continue to support raising what we raised it by.

And Robbie, I would just -- the one thing I'd add to that is, as Jereme laid out in the prepared remarks, our decision on the international markets with respect to opening up access, I do expect you're going to see that new patient number continue to perform very nicely in the back half of the year as we're accessing markets that are 5 to 6x larger than what we had coming into the year in some of these markets. So very excited about where that new patient number potentially goes to.

And our next question comes from Matthew O'Brien from Piper Sandler.

Just a follow-up on the pricing commentary. The $200 million to $250 million is obviously a pretty meaningful increase. We've got Libre 3 over in Germany now. You're talking about being more aggressive in terms of lowering pricing OUS, I think, for more access. I mean does that -- is it a function of Libre 3? You're trying to be aggressive in front of a more broad launch there with G6 over there. Is that a reason why you're increasing the pricing concessions right now? And then what does that say about when 3 comes to the U.S.? And how can G7 kind of offset that?

We've not made our decisions based on Libre 3, Matt. We've looked at what we accomplished in the U.S. here. What we've done is we've increased access by going to the pharmacy channel by looking at Medicare approval, for example, which came in at a lower price than what our DME price was before as we've set up Medicaid pricing structures in the U.S. that are yet once again a pricing structure lower than what we had before, but to increase access to a number of patients.

We then have looked at our OUS business in several of our key geographies and said, you know what, our access is not broad enough. Our access is very much focused on very intensively managed type 1s, oftentimes just children or adults with pumps or adults with an incredibly bad hypoglycemia awareness or something along those lines. And it's more important to us to reach more patients. So we've taken the strategy we've used in the U.S., and we're deploying it in other places as well to increase our access. We won't let Libre 3 drive our decisions. We'll drive our own.

I think one important thing to note there is the pricing point. It's always been part of our global pricing strategy and the level that we're going to is still very much in line with where we're at in the U.S. pharmacy channel, to be honest with you. So we're just stepping down as we've had inventory availability now. We're in the best position we've ever been in from that perspective. We know we got to reduce the burdens to get on the product. We're in a position now to continue to execute against that global pricing strategy. So this is very much part of where we were heading. It doesn't create risk elsewhere globally. Like I mentioned, it's right in line with our U.S. pharmacy pricing if you get into the comps. So excited about what this has a potential to create for us.

And our next question comes from Bob Hopkins from Bank of America.

I just wanted to ask a question on G7. I was wondering if you could comment on 2 things. First thing, I just want to clarify, when do you expect to file CE Mark in Europe? I thought that was something that was going to happen or might have happened already. And then secondly, I was wondering if you just could comment on the upcoming data that we're going to see on G7, just maybe help give us a sense of just what we're going to see and how meaningful it might be? And just a little bit more detail there would be great.

Well, G7, we have not filed yet. We will file it in the not-too-distant future. We want to -- we need all our ducks in a row. For example, we want to file both the Android and the iOS app at the same time, not file one and then do another filing. So making sure our software is validated and verified is really one of the bigger tasks. The clinical data is in, and we're ready with that part of the filing, and we've had direct discussions with our authorities over there, and we feel we're in good shape. But we'll file when we're ready. We don't want to do it twice and spend a lot of time answering questions.

With respect to the data that we'll present here in the summer, it will be on some of the smaller studies that we've done. It will not be on any of the U.S. pivotal data, obviously, but you'll see how the product performs and how consistent and how happy we are with it. Obviously, I'm happy with the data and as is our team. I've made the comment on several times when all said and done, everything you love about G6, you're going to love more about G7. And when that product comes to market, that's exactly how we're going to feel about it not only from the smaller wearable and the easier insertion and all the other wonderful patient ease of use features we're putting in there, but the software, the app and the performance of the system, we believe, is going to be spectacular and again, set a real standard for people to go over.

And our next question comes from Kyle Rose from Canaccord.

Great. Wanted to talk about a few of the commercial initiatives in the U.S. I mean, obviously, still early in the sampling program. You've just completed the doubling of the sales force and kind of shifting some of the focus to more on the primary care. So maybe just help us understand how some of those initiatives have played out in the early days with respect to the Q1 and early into Q2. And just, are there any metrics? Or is there any sort of goalpost you can help me frame the early execution on those initiatives for us? And how do we think about that as we move through '21?

Sure. I'll take a quick shot at the sampling and then hand it over to Kevin here. There aren't any metrics that we're going to disclose, particularly to sampling, in and of itself, although I will tell you, the early response to this program has been beyond our expectations, both from a physician's perspective of just how easy we've enabled these PCPs to get products into the hands of our patients and then also from a patient perspective when they realize just how easy it is to use the DexCom product. So the sampling program has been beyond what we imagined coming out of the gate. It will continue to be a big part of what we do into the future. But in terms of giving specific metrics around it, that's not something we will do. I will tell you, it's one of the better investments that we look to make at this point.

Yes, I'd agree with that. With respect to the sales force, we've added everybody we were going to add. Everybody's in place. And everybody is getting up to speed. And some of the people came from a diabetes background, so they get it to speed easier because they have relationships already established in these offices, possibly from another company. Others, it's going to take a little while longer, and we plan for that as we do this expansion. But as far as calling on more voices, we are learning that, in all fairness, we've been underserved with respect to our ability to call on people.

There's a great story we heard from down in Texas. One of our reps called on a physician or -- and talked to them about our product and the doctor said, I know nothing about your product. I've put people on your competitors' product because they come and ask me for it. So again, using the sample program that Quentin described with Hello Dexcom, we put this patient on the system, introduce the physician to it, and now he's prescribing DexCom all the time because of the experience that patient had. We needed a deeper reach. We'll get that deeper reach with what we've done, and we'll continue to evaluate over time. And we've got tremendous metrics on our salespeople. We have an incredible commercial organization that monitors that. But we also very much understand it takes a while to get up to speed.

The other great thing I can tell you about this expansion, we literally have thousands of people apply for these jobs. And a lot of very, very qualified people that we did not hire. This is a place that people want to work and a product that they really want to represent, and we want to continue that culture and maintain that.

And our next question comes from Mathew Blackman from Stifel.

I wanted to follow-up on the OUS pricing strategy and sort of a multipart question here. But is the incremental $50 million headwind you called out isolated to 2021? Or will these price headwinds continue beyond 2021 outside the U.S.? And then if I think about the full year guidance range -- raise of about $50 million, I think about half of that you said is underlying outperformance. But that's also in the face of another $50 million headwind on price. So is it fair to say that the guidance rate is actually closer to, call it, $75 million ex FX on an underlying basis?

Yes. So good question. So let's go step by step. So in terms of your question on the international pricing, a majority of the raise is our strategy outside the U.S. And so what you are seeing is we are taking an incremental $50 million of, call it, mix headwinds as a result of going into there. And we still -- yes, you're right. We did raise guidance in the face of that by $50 million, of which $25 million was currency. So absent that incremental, yes, you would have seen a $75 million. Now we are going to be taking those pricing headwinds, and we're going to be taking those pricing headwinds and making up for an incremental volume. So it's obviously net neutral to the full year guide. But you are correct. Absent taking on that strategy -- or because of that strategy, we expect to add new patients to the point where it increases our full year outlook.

And our next question comes from Matt Taylor from UBS.

Okay. So I'd like to ask one just about the U.S. momentum improvement. That was impressive, and you called out the factors. Is it possible for you to say which of the DTC, sampling and sales force, you think, contributed more to that? And which of those is still more to come? Or is it just all equal?

I think there are all more to come, and I think they're relatively equal. As I called out on the call, the effect of the Super Bowl, the ad was more than just short-term sales growth, in our minds. The awareness we generated, the text messages I was getting during the Super Bowl from industry and technology executives that I've met over the years made it all worth it. I'm just sitting on the couch saying, "hey, this is really cool." It really created a lot of awareness for our company, awareness we hadn't had before, and that was really the goal, as we talked about. We developed more brand equity from our ad than anybody else. So that was important to us. The DTC remains important.

As you watch our ads, you'll see certainly more with Nick and certainly other campaigns as well. And then on top of that, having more feet on the Street is good. We needed it. But it will take time to develop those relationships. I think of the 3, I couldn't quantify one of them, but I think, ultimately, the sales force expansion will be extremely helpful in this. We probably got less bang out of that just because we were ramping it up in the first quarter, but the DTC work and the Super Bowl ad, that was probably the biggest. And then Hello Dexcom and the reps will come more throughout the rest of the year.

And our next question comes from Jayson Bedford from Raymond James.

Somewhat similar to the last question. The first quarter strength in the U.S., much better than historical seasonality. I'm just wondering, is this more a function of just channel shifts that gone on the business? Or a function of the new momentum that you've seen kind of perhaps from some of these new initiatives? I know it's a tough question, but if there's any way to parse that out, that would be helpful.

Sure. Yes. So good question. Some of that is a bit of a change in shift in dynamics, and you're absolutely right, as more and more goes to the pharmacy. I think you are seeing that neutralization, if you will, of the Q4, Q1 dynamic. One thing we did see this quarter, and we thought it was certainly a testament to the work that our customer experience team is doing is we saw a slight decline in attrition -- a slight decline in attrition and a slight increase in utilization. And so as you think about the customer experience that we're trying to create here, we've been talking about increases in Net Promoter Scores. That's starting to play through and customer utilization have it. So that's certainly something we saw a little bit of.

And then I think what we also saw is just a little bit of incremental performance. We saw some of the performance outpaced expectations. I think what we talked about is an expectation of new patient growth, slightly outpacing it as a result of increased awareness as a result of DTC. So I think it's all 3 of those coming together.

And our next question comes from Christopher Pasquale from Guggenheim.

Two quick questions for Jereme on the margin front. First, just given how strong gross margin was in 1Q, I was hoping you could talk about why 65% is the right number for the full year. And then your audio cut out a little bit when you were talking about the tax rate. If you could just go back to that and what you're expecting for an overall tax rate this year, that would be great.

Sure. I'll start with the latter first. We expect the tax rate for the year to be between -- the non-GAAP tax rate between 23% and 25%. Back to your question on margins, we did have a great quarter in Q1. Certainly, we're very proud of the 68%. The one thing we do want to do is, first off, is the first quarter. So we think about it from a first quarter and really thinking about before, taking a look at changing anything, being mindful that we won't see things play out over time. But there's really 2 components you have to be aware of. We do expect to take on incremental channel mix headwinds in our international markets for the back half of the year. So we have to contemplate that in light of some of the efficiencies you're starting to see.

And then getting back to the -- our previous discussions about the drivers when we set guidance is, in the back half of the year, it's when we're going to launch G7. And when we launched G7, the yield that you get on some of these lines generally is a little lower. You saw it also happen with our launch of G6. There's a little bit of step back as you start to work out the kinks of these lines and the yields start to play out. So as those play out in the back half of the year, that's why we don't -- we feel comfortable, very comfortable with our guidance, but we didn't feel any need to raise it at this point and let the year play out.

And our next question comes from Cecilia Furlong from Morgan Stanley.

Great. I guess I just wanted to go back to the pricing headwinds, but just in light of increasing ex-U.S. headwinds. Should we expect your 2Q ex-U.S. results to look more like they did in 2019, just in terms of relatively flat sequential performance? Or can you really still grow ex-U.S. revenues quarter-over-quarter before G7?

Yes. I don't think we're going to get into details of providing specific guidance around U.S. versus OUS, particularly at a quarterly level. I think we're incredibly bullish on where the international business can go. There's so much runway that continues to sit in front of us. A big part of that is continuing to step into this global pricing strategy that we've laid out over a multiyear basis. And really, what you're seeing with the pricing decisions today is that we're in a position now where we can pull some of those decisions forward where we couldn't have historically.

And a lot of that comes down to having inventory available to us, being highly confident in the ability to continue to grow and scale the levels of production as we go into the future. So I'm confident you're going to see terrific results coming out of that international business over time. And with some of these decisions that we've made, we're now opening up access to patient volumes that are 5 or 6x larger than what we were really addressing historically. So I think all of that sets up very well for a very strong international business here into the future.

And our next question comes from Danielle Antalffy from SVB Leerink.

I was just wondering if you could talk a little bit about the potential impact from doubling the sales force and specifically as it relates to the primary care physician. I'm curious if you guys have this detail as to what percentage of your prescribing physicians are coming from primary care today so we can sort of have a sense of with the sales force doubling and better calling on the primary care, how many more physicians you could potentially capture.

Well, this is Kevin. I'll take that. Very little comes from that channel right now. That's why we added them, and that's why we've expanded. If you take a look at the type 2 intensive insulin users, most of them are found in those offices. And that's why we needed to get out there. Over time, this will certainly increase. We expect it to, and those are the expectations of the team we brought on board.

We're hearing good anecdotal stories and things are starting to heat up and all reality. And with a large book of business we already have and the recurring orders from our current patients, it's -- we got a ways to go. We think they'll do great, and we'll monitor it. If we see great returns, we'll just keep giving them tools to get great returns is the best way to describe it. And I think Hello Dexcom is going to be the best one that we have for that group.

And our next question comes from Ravi Misra from Berenberg Capital.

Congrats, Jereme and Quentin on the moves. A lot of management changes over at DexCom -- or rotations, I guess, over the last year or so. The question I had, I guess I wanted to go after the gross margin and pricing commentary from maybe a different angle. When you had the similar type of pricing impact in the U.S. when you started going into pharma channel, we really saw a pretty strong level of uptake through that to that arena, albeit the pricing headwind continues. So I guess what I'm trying to ask is, do you -- does guidance factor in that type of kind of immediate impact from the price cut, I guess, in Europe? And do you think that $50 million is the kind of extent of it as we kind of go forward here?

Yes. Sure. I can take that. So our gross margin certainly contemplates the impact of pricing impacts in our international markets. And so I wouldn't expect any changes there. In terms of the extent of it, as we go after these incremental markets and open up access, we almost look at that as new patients. And so when we go after new patients and new markets, certainly, pricing is going to change over time. So there could be impacts that drag out over time in the future years as a result of just going after incremental pockets of patients and any sort of knock along impact, certainly not anything that we would expect to be significant. But that will always be contemplated in our guidance, and it will all be something that we certainly talk to on these calls. I wouldn't expect anything that we provide hasn't been thought through and contemplated in any of the targets that we provide to you guys.

And our next question comes from Marie Thibault from BTIG.

Congrats to you as well, Jereme. I wanted to ask a question on OUS. I understand that the impact of COVID last year, obviously, having an impact on revenue this year. But curious if you're still seeing a COVID impact in this Q1 quarter as well as the existing quarter here in terms of that still affecting new patient starts. We certainly heard from other companies that Europe is lagging on the vaccine rollout. So would love to hear if that's been contemplated in guidance. And if so, how you expect that to change over the year?

Yes. I think from our perspective, all that we know right now is kind of the environment we operate within with respect to COVID, which we know from an international perspective has certainly created some incremental pressure in pockets of that business, particularly those that require in clinic visit to get onto the product or some of those administrative hurdles that have been put there. In other channels where we have e-commerce, for example, we're seeing incredible results. And so I think one thing to point out on that first quarter international result is that when you look at it from a 2-year growth perspective, it's an incredibly strong number. Last year was an absolute record growth for us in that first quarter from an international perspective. So I think you got to normalize that when you're looking at that first quarter growth.

But in terms of the remainder of the year, on an international basis and patient adoption, a big part of stepping price down in line with kind of our global pricing strategy was the fact that we had to see administrative requirements reduced or eliminated altogether to get patients onto the product. And so in these markets where we've done that, the hurdle to get onto the product has been removed. And so we absolutely would expect to see patient -- new patient acquisition become much easier for us and see that start to take off in a very positive way. So I do think you're going to see that uptick over the course of the year, even in the COVID environment with, of course, the caveat being that it kind of stays stable to where it's at today. If we were to get worse in some case, then we might have to think about that differently. But we're trying to look at the future based upon what we see today and how it's impacted the markets here in the moment.

And our next question comes from Larry Biegelsen from Wells Fargo.

So on pricing, once G7 and Libre 3 are competing with each other, how much of a price premium do you think is sustainable? And how close do you think you are to that premium today in the U.S. and outside the U.S.? And do you see the opportunity to price G6 as a value brand?

Larry, thanks for your question. We have numerous opportunities here, but I'm not going to give our pricing strategy on earnings call. We -- we're very thoughtful about this. We run several models. We know what our technology is worth, and we know what great benefit we provide. We'll price it accordingly, but we're also going to price our products in a manner to whereby our patients have access to it as well. And I think our commercial team combined with our finance team and everybody who's done a wonderful job balancing that, we'll continue to balance, but we'll continue to grow as well. I mean look at the volume growth versus our dollar growth this quarter, and we already said our U.S. volumes were in excess of the overall volume growth. We've managed it extremely well, and we'll continue to do so.

And our next question comes from Anthony Petrone from Jefferies.

A couple of questions, one on G7 and one on margins as well. Just on G7, trying to get a sense when you look at U.S. timing to entry and efforts to get iCGM, do you think the market actually behaves differently? In other words, new patient starts potentially slow a bit as the new form factor is coming to market. And then on margins, taking the other side, the COGS side, specifically, breaking down -- breaking ground in Malaysia. Maybe just an update on timing as to when FDA inspections will take place for that facility and just a recap of what that can do on the COGS side for sensors on a per unit basis.

I'll take the latter part of that with respect to Malaysia. We're clearly well into that project, making great progress. We'll have a building in place as we exit the year, with plans in place to have a clean room up and ready for validation, either at the turn of the year into the first quarter -- sorry, first quarter of next year. So the expectation is we'll be producing product out of that in the first half of next year there in Malaysia. So very excited about what we're seeing there.

Yes. And I'll take the G6, G7 and the cutover question. Again, with respect to U.S. timing, we've not disclosed anything. One of our great learnings on G6 was have enough product ready to go when you go and really be fully ready for launch, and we've made that commitment to our customers that we will be ready when we do launch this product, that we will be able to literally flip the switch and go over.

As far as patients slowing their purchases of G6, in particular, in the pharmacy channel, you're buying 1 month of product at a time. So it's not like you're going in there and loading up with 3 to 6 months as we did in the past in the DME channel. And even in the DME channel today, there's less of that loading up by patients with G6 than there was in G5 and G4 prior to that.

We don't view that, that people will quit purchasing their G6 is when G7 is announced because in all fairness, our customers can't live without it. And when we have the opportunity to take care of them all, what we'll do is organize but as rapid a migration as we possibly can. And as far as G6 future plans, we do see a lot of opportunity here, but we really haven't disclosed anything.

And our next question comes from Steven Lichtman from Oppenheimer.

Just had a question on your international expansion efforts. What are some of the key countries and focus for you here over the near term? And are you anticipating any contribution from these new regions in this year's guidance? Or is that more -- really more of a driver for 2022?

Yes, I think that will be more of a driver for future years. We've talked about our launch in Japan with Terumo, and that's scheduled to happen in the second half of the year. We got reimbursement in France, as many of you know. So we do expect France to be a bigger part of our business than it has in the past. But a lot of large numbers in our businesses, things have gotten so big, they can't give us a whole lot that moves the needle when we start.

Hence, the discussion we've had about increasing access in our more mature markets and looking at how we follow similar paths in these other geographies. With the operating capability we have now, there's no sense in going through and selling just the top end of this market. We want to get more aggressive and be more broad. So I think you'll see as we go into these geographies, over time, we'll start as we started in the past, but we are going to get more reimbursement and try to get more patients more rapidly.

And our next question comes from Brandon Vazquez from William Blair.

I just wanted to go back to one of the comments made during the prepared remarks. And it sounded like there was maybe a little hinting at new connected systems coming this year. Just curious if you could talk about those and specifically, what those kind of products. I'm thinking, is there something outside of the regular hardware upgrades that we see maybe somewhere on the software side that could be a catalyst maybe for growth within maybe some of the TAM expansion opportunities like the type 2 non-intensives or gestational diabetes or anything like that. So is there anything we're kind of not thinking out of the box here from the normal hardware that will be important in the coming 12 months or so?

No, I don't think that there's anything that you guys are missing in terms of the prepared remarks and speaking to some of those systems. The one thing that we certainly are excited about has to be the Omnipod 5 product in the back half of the year. And we'll let Insulet speak to the exact timing of when we're ready to put that product into the marketplace. But having connectivity into a product like that is something that we're very excited about and believe that they'll have success with, and we'll have success with as well.

I think with respect to the whole type 2 population and the opportunity there, we couldn't be more bullish on the opportunity that sits in front of us. And I think by the day, we learn more and more that increases that bullishness for us and the confidence that there's going to be some real opportunity there to create value coming from it. And you're going to see a study a little bit later this year, midyear, at some of the midyear society meetings that's going to start to really lay out the benefit of using CGM relative to BGM in this type 2 population, particularly the nonintensive population that just demonstrates the sort of impact we can have on patients who say they're on basal only. And that's a 4 million patient population in the U.S.

So I think that sort of data starts to really accumulate in favor of opening up a whole another market segment that doubles the existing core U.S. intensive market today that we're very excited about. So you'll see that data here midyear. But I think all of it starts to point to the fact that this type 2 space is going to open up in a significant way, and we're well positioned to take advantage of it.

And that concludes our question-and-answer session. I'll turn the call back over to Kevin Sayer for final remarks.

Thank you, and thanks, everybody, for participating. As we wrap up our call today, I want to take a minute to acknowledge some very important recognition that DexCom received this week. Forbes recently published their 100 company list of America's Best Employers for Diversity. DexCom was honored to be #66 on that list. While we consider this a perpetual journey, we're very happy to have been recognized for some of the work that we've done so far.

As far as our outlook on the business going forward, our great quarter fuels our continued belief that best is yet to come. I recently caught up with a friend who's a long-time health care industry executive and the gist of his message to me was very simple. Everything important in diabetes care is going to revolve around CGM. For example, there are numerous instant delivery devices and algorithms available for automated insulin delivery. But there's only one CGM commercially capable of delivering the patient experience and outcomes that we've all envisioned for a very long time. And that's only the beginning.

There are incredible new compounds, treatments and programs stepping forward for the treatment of type 2 diabetes, and we are very confident that the right CGM experience will become an integral part of all these solutions, and we haven't even started talking about the difference we can make as part of our pre-diabetes program. We've never been more excited and engaged in our opportunity than we are today. Thank you again, everyone, and have a great day.

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating, and you may now disconnect.