Yeah. Please go ahead. Thanks for taking the question. And I don't want to sort of predict what's going to happen in 2021, but I think it's great to see where we are now predicting to close this year, because it means we're ahead of what we expected in terms of the potential impact of COVID. We are steadily advancing our strategic imperatives and delivering on our mission to improve the lives of people with diabetes. And our initial launch of Omnipod 5 for Type 1 diabetes users aged seven plus, marks our first step. We always give our guide at our Q4 call. It certainly is driving increased awareness. Omnipod ranks number one within this demographic, and we are delighted to have kicked off our pivotal study to make Omnipod 5 available down to age two. Insulet just launched the Omnipod Dash about nine months ago in the U.S. and two months ago in Europe, but the company spent much of its J.P. Morgan Healthcare presentation focused not on the recent launch, but on the next-gen product that’s expected to come out during the second half of 2020. This market opportunity will grow significantly as we move into new geographies, expand awareness and access to our technologies and bring our game-changing consumer-oriented innovations to market. But I would say that momentum is very strong in the pharmacy channel, access continues to increase and we do expect that Omnipod 5 should be a catalyst in terms of pharmacy conversions because it really is going to be a pharmacy product. Good afternoon, guys. So we haven't seen that many people on the program. This includes the headwind of $9 million to $10 million or approximately 100 basis points of estimated one-time costs related to COVID safety and mitigation efforts versus our prior guide of $7 million to $10 million. And then the last one for me. And despite the headwind, it's been on the low end of our stated new customer starts headwind. This speaks to the power of our differentiated market position through product innovation and durable recurring revenue model. Hi, Brianna. Please go ahead. I think I asked you this last question and you far outstated your guidance range, but I'm going to ask you again on this call. We ended the third quarter with $897 million in cash and investments. And so we'll have a much better feel I think for what -- at least the early part of 2021 will look like in the U.S. Outside the U.S., international, we're seeing more and more lockdowns already here in the quarter. We are focused on finishing the year strong and building momentum as we enter 2021. The Omnipod Horizon System is anticipated for commercial release in the second half of 2020 and will expand upon the current Omnipod DASH System platform. Our investments are primarily to scale manufacturing and supply chain operations capacity as well as for R&D programs, global commercial and sales force expansion and international product and geographic expansion. Patrick, it's funny, you're asking the questions that we're asking ourselves internally. Those -- that's really what's driving access and availability of Omnipod to the Type 2 population. And so we won't see a material impact until the second half of the year. We had a great forum with ATTD and our clinical investigators being invited to share the data. If we get there, then it really is about how does COVID impact us in 2021. It's Wayde. Good afternoon, everyone, and thank you for joining us. So that to me is probably the biggest opportunity. Is there anything to call out that's different in those geographies? Good afternoon. And David, on your question on Omnipod 5, I think it's a great question and one we are looking forward to sort of seeing the answer in 2021. Together, our team has cared for our users who need our support, advanced our innovation pipeline and delivered another remarkable quarter on all aspects of our business. In terms of milestones for Omnipod 5, there is a tremendous amount of activity going on in the company as we think about our ramping toward the Omnipod launch. Medtronic Diabetes Closed Loop Okay. DASH is still a primary driver for us. Patrick Allen -- Piper Sandler -- Analyst. Medtronic Minimed 780G ACTON, Mass. Please go ahead. Q3 revenue included a headwind of an approximate 4 million decrease in distributor channel inventory levels, partially offsetting estimated channel inventory built in the first half of the year, mainly due to the pandemic. Pivotal trial is expected to start in December, US launch planned for second half of 2020. That's great. And then our teams have done a great job ramping the virtual training. What was once a clunky pager looking device now resembles a sleek smartphone. So we've always been strategically focused on the young pediatric population. 8 Diabetes Products on the Horizon. We ask that you please refer to the cautionary statements contained in our SEC filings for a detailed explanation of the inherent limitations of such forward-looking statements. And just maybe the follow-up then is, this cumulative math that we talked to a lot of investors about and it seems to confuse them at times and the way you guide to new patient starts relative to your pre-COVID expectations. And it's clear from the early numbers that we've made an impact on awareness. Just wondering, thus far in 2020, have you seen any evidence of pump penetration increasing among that Type 2 patient population or do you believe the increase in your Type 2 mix is being more driven by share gains of new patients? And so there's just so many good things that this compounding new customer starts is offsetting for us. ... are still delivered manually. So there's just a lot of positives that are somewhat offsetting those headwinds from new customer starts. I mentioned, DASH newly launched internationally, but we've made sales force expansion there and we're also expanding into new countries. But in combination with that is scale. Thank you. Just trying to get a sense of some of the underlying trends here and how much of it is conservatism versus just a downward move in the numbers? While our world has been challenged with the pandemic, our team has not missed a beat in advancing our innovation pipeline. Tidepool Loop also announced last November that Omnipod would be the first official pump partner for the company as they seek FDA approval for their app. Meanwhile, Omnipod is also hoping to integrate its system with a third-party looping algorithm, Tidepool Loop. As a result of our outperformance in the third quarter and stronger revenue outlook, we are raising our full year 2020 gross margin guidance to approximately 64%, up from approximately 63%. Assuming market conditions stabilize next year, we remain on track to deliver our 2021 targets of $1 billion in revenue, gross margin in the range of 67% to 70% and operating income as a percentage of revenue at the low end of mid-teens. From a mix standpoint, we'll continue to see the mix benefit in the U.S. from the pharmacy channel. And I had one follow-up. And as we scale and bring more volumes into it, those volumes help us drive gross margins significantly as well. The Omnipod Horizon system should debut in the second half of 2020. We've just got those two lines up and running and producing. And I think it will be interesting to see in that population what happens in terms of adoption for Omnipod 5. I mean, you see the growth that we're driving. We achieved third quarter revenue growth of 20%. Our innovation pipeline is strong and our financial position is sound. We didn't give the five markets, so we'll lay those out for you as we enter into them. And we grew volume through the pharmacy channel to over 30% of our total U.S. volume. Remember, when we did our early feasibility studies with Omnipod 5 in the Type 1 population, we did a lot of work on the algorithm, a tremendous amount of work on the algorithm to deliver the performance that we saw in the pre-pivotal. I show our last question comes from the line of Raj Denhoy from Jefferies. Obviously the most important thing is that we get FDA clearance and get to launch in the first half of next year. And then acknowledging it's really early, I'd be curious to know the patient mix or leads generated by your DTC program? And on the numbers, Patrick, they have been quite small actually. And really, our goal here is to come out of the other side of the pandemic with as much momentum as we can around our new product innovations, around our business model strategies with Type 2 and the pharmacy as well as the investments we've made in the sales force, in the commercial business including virtual training as well as, Shacey mentioned, the end-to-end customer process. So this feasibility study will give us those learnings. Is Q4 going to be the trough? We've maintained a solid track record of performance, largely due to our loyal customers and the commitment and execution of our global Insulet team. We did get one checked off the box this quarter in Belgium. It works with a mobile phone or personal diabetes manager. And you mentioned, is it a limited market release, is it a full market release. If we have current customers that can't afford the product given the current situation they're in, we're more than happy to backstop them and help them continue with their therapy until they can access it through normal channels again. But in the U.S., the momentum has been building. However, the compelling benefits of Omnipod, the uniqueness and durability of our recurring revenue model and the outstanding execution of our team provide significant insulation for Insulet. Wayde, you've clearly demonstrated a conservative approach to guidance since you've come in at CFO, and particularly I'd say a very conservative stance to guidance during COVID-19, and I understand with good reason all the unpredictability, especially with the cases starting to rise again. So we're seeing a great recovery. So we're looking at our options and we certainly understand and we are enthusiastic to get it out there as soon as possible, but I don't have specifics to provide today. We now expect total company revenue growth of 7% to 11%. And we continue to advance our algorithm to expand our lead in simplicity and ease-of-use. Yeah. How long that will be, I think remains to be seen, because it depends upon when we're meeting our endpoints and our objectives for a limited market release. We have also made an investment in another contract manufacturer in China, allowing us to leverage our local supplier base and highly experienced team to quickly scale. Travis Steed -- BoFA Securities, Inc. -- Analyst, Hey, thanks for taking the question. I show our next question comes from the line of David Lewis from Morgan Stanley. Hi, everyone. Our results were favorable in both the U.S. and international regions with the combined impact slightly less than 30%. This includes raising total Omnipod revenue to a range of 21% to 22%. We've always maintained that we will do a limited market release. So actually, one of the five we just entered. But how should we think about when you have Horizon 5? There is just incredible enthusiasm in the market and internally with all of us to get that product on to the market, and we're going to make that happen regardless of what's happening in the macro environment. The additional cash further strengthens our position and allows us to continue to invest in our strategic imperatives. And that's being driven by Omnipod's form factor, by pharmacy access in both Type 1 and Type 2 MDI users. I show our next question comes from the line of Joanne Wuensch from Citibank. Thank you. Good afternoon, everyone. This has been eagerly awaited by those who use Omnipod, as an update to the handheld device has not happened in several years. And I would be surprised if other pumps are seeing the level of conversion that we're seeing in Type 2s. The Omnipod Horizon system is expected to launch in the second half of 2020. And we're testing a bunch of different messages in DTC. technology with its Omnipod ® Insulin Management System, today announced that it plans to pause the pivotal study of the Omnipod Horizon Automated Glucose Control System to correct a software anomaly. Turning to the rest of the P&L. And on Omnipod 5, do you guys typically announce when you have filed or submitted something like that? I would now like to turn the conference back to Shacey Petrovic. Our strong growth was driven by further expansion of our customer base, increased Omnipod DASH adoption and the mix benefit from the shift to the pharmacy channel, including the premium on DASH where we provide the PDM to customers at no charge. Lots of benefits, obviously, to pricing it at a premium, but there are just as many benefits and a very compelling one from a customer standpoint to get it into the hands of our current customers and new customers. Cumulative Growth of a $10,000 Investment in Stock Advisor, Insulet Corp (PODD) Q3 2020 Earnings Call Transcript @themotleyfool #stocks $PODD, Insulet Corp (PODD) Q2 2020 Earnings Call Transcript, 3 Diabetes Monitoring Companies That Are Recession-Proof, This Diabetes Company's Q1 Earnings Reflect the Resiliency of Its Business Model, 4 Promising Stocks to Own That You Probably Forgot About, Copyright, Trademark and Patent Information. Read more, Click to share on Twitter (Opens in new window), Click to share on Facebook (Opens in new window), Diabetes Medications May Help Ward Off Alzheimer’s, FDA Approves First ‘Artificial Pancreas’ for Type 1 Diabetes, No More Needles? Insulet’s Omnipod Horizon 2020 is looking to be the year for a commercial version of a closed-loop system with a patch pump. And then we'll be able to determine what's the path for label expansion. I think you mentioned COBRA, but there has been many other options for people including Medicaid in the states or alternative insurance in the household. I think we'll continue to see that segment adopt Omnipod based on its form factor and based on the out of pocket economics. We've heard limited launch, we've heard full launch, but you've got a very successful DASH product that's already out there. We delivered strong financial and operational performance, and we are taking the appropriate steps to expand our innovation pipeline, grow our addressable markets and enhance our global manufacturing capabilities. They choose it over Omnipod when they do, because it has DexCom integration. Q4 ends up with three quarters, including Q2, which was the lowest in it. Brandon Vazquez -- William Blair -- Analyst. Yeah. I know you started a limited national DTC that seems to be doing well, and you'll have more KPIs to kind of gauge how successful that program is. And so for the U.S., it's going to be pretty close. In just the markets we currently serve, there are approximately 10 million people living with insulin-dependent diabetes, who could benefit from improved quality of life and better outcomes with Omnipod. For the other drivers that you mentioned, Omnipod 5, that one comes first half of the year will be our limited market release. But we are in a unique position in terms of our channel and in terms of our form factor and Omnipod's discretion and ease-of-use to be able to win in that market. What we know for sure is that MDI users are going to be very, very attracted to Omnipod 5. We've been expanding our DTC over the last couple of years through digital channels, but this is the first time that we've really stuck our toe into television. And that's why I mentioned in my remarks that we're really starting in earnest our expansion in early 2021. Just kind of curious how well prepared the doctors' offices and patients are now versus how they were earlier this year? Deborah R. Gordon -- Vice President, Investor Relations. Our Omnipod 5 pre-school pivotal study with two to six year olds is under way with all 80 participants on product. BILLERICA, Mass.--(BUSINESS WIRE)--Jun. But what's different than Q2 when this really caught everybody by surprise is our teams are much more effective now, it's still staying in contact with their customers, finding ways to connect with them, and DASH is a great -- it's just great timing for us to be launching DASH because it gives our teams an opportunity to still get those meetings with physicians and with customers. So today, our production out of our Flex China facility is lower cost than Acton. They can start on Omnipod with a free trial and no lock-in period. Our team is focused on finishing the year strong and sustaining our momentum as we move toward launch of Omnipod 5 in the first half of 2021. So does that kind of bake in things getting worse or does it kind of assume that things stay the same as we go through the fourth quarter? Despite the challenging environment, our global diabetes business remains well positioned to generate strong growth this year as well as in 2021 and beyond. Wayde will discuss our financial results and outlook for the rest of this year, and then we'll open the call to your questions. And it's also a population where Omnipod is heavily, heavily differentiated for a variety of reasons. And CGM adoption is paving the way for generations of Omnipod products to meet these needs. Expenses increased on a dollar basis, primarily due to the marketing costs as well as R&D and clinical spend for Omnipod 5. And that's the unknown and we'll obviously know more after we get through Q4 and we're setup to give our 2021 guide. Thanks for taking the questions here. Okay, great. I mean, that was a quarter where we had significantly lower new customer starts. What is the size of the two to six year old population that you were looking to go after with that incremental study? And then if I could ask a two part follow-up on the Type 2 opportunity. Plus, the latest in the pipeline, including concentrated insulin systems and the Horizon Automated Glucose Control SystemDuring its first-ever Investor Day, Insulet shared timing and new details on its key products in development. This agreement builds on Dexcom and Insulet’s previously announced integration efforts and formalizes plans to commercially launch the Omnipod Horizon System, expected to occur in the second half of 2020. Drug delivery revenue also finished ahead of our expectations with growth of 47%, which was $3 million above our guidance range. Sure. I show our next question comes from the line of Robbie Marcus from J.P. Morgan. A new study examined its effectiveness for children with type 1 diabetes. Obviously 4Q '19 was even stronger, but 3Q '19, it seems like your U.S. new patient starts almost at parity with last year. Thanks, Shacey. Market data powered by FactSet and Web Financial Group. I mean, one of the reasons why we wanted to do DTC this year before launching Omnipod 5 is that we really wanted to learn about the impact, learn about the messaging that's most effective, the channels that are most effective. Insulet to Present at Upcoming Investor Conferences. And then looking 2021, do you believe the Omnipod 5 launch will be a catalyst to convert a large portion of your existing installed base to the pharmacy? Is there anything sort of high level we should be thinking about as we think about the models next year in terms of new patient starts margins, mix of business? And over time, this adds significant addressable market to us over the coming years. This data will also help inform our future innovations beyond Omnipod 5. Which new markets are you planning to launch it in 2021? And so for us, mix plays an important component today as it moves -- as we move customers from our traditional DME and direct channels into the pharmacy. And just to clarify, it is growing a couple of percentage points in our number. [Operator Instructions]. And we certainly take into consideration the current environment that we're in other AID systems that are in the marketplace and we also know that there is a significant opportunity for us to get there faster. But as Shacey said, we're really happy to have it in place. And so we want to get it right, and a limited market release is part of doing that. Outside of the U.S., it's a more fragmented and more challenged environment right now. We are establishing market access so Omnipod is easily available regardless of age, type of diabetes or payer. So it's very economic. Thank you. About DexCom, Inc. Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. And so I think from a modeling standpoint, gross margin is just right in that 67% to 70% range. The timing of launch of the Horizon AP on the slide shows late 2019, however, in the presentation late 2018 was also mentioned. Strong results show potential for Horizon to improve clinical outcomes in pediatric and adolescent age groups with type 1 diabetes. The executive team at Insulet has completely turned over in the last few years. And on the same token, does COVID potentially slow the rollout of Omnipod 5 given that may be needs a little bit more hands on training given it's a closed loop or perhaps that's an incorrect assumption? Insulet Omnipod Horizon – expected in second half of 2020. Six additional abstracts with data on Insulet’s Omnipod Insulin Management System were selected for presentation at the ADA scientific sessions during June 7-11, 2019 . So we didn't fully -- you were a little garbled. But that's an area where we're a little less familiar with because we get less patients from that area today. And other pumps challenged from an access perspective. However, the trial run will be an important factor in getting this groundbreaking technology on track for a full commercial launch in 2021. Adjusted EBITDA as a percentage of revenue was 18.1% in the third quarter, up from 15.4% in the prior year. Insulet said it plans to deliver a software update to correct the problem by the end of April. Thank you. Because remember, they can adopt Omnipod 5 without an upfront cost and without a four year lock-in period. And so I'm not going to make predictions on exactly how that's going to change our trends. And I know it runs till December of this year, but as some people may have roll off their COBRA insurance plan, do you envision this dynamic to further the utilization of that program or any color there would be really appreciated? Just one more in it for you and then a quick one for Shacey. And then just for Shacey. And so it's really our job to build the momentum here, come out the other side stronger. Because if you think about the capital equipment model, some of those folks or most of those folks are locked into a four year contract. First, Shacey, I was hoping you could give us your thoughts on the status of new patients and where they're coming from? It was a big decision. What is the Omnipod DASH? And we don't -- our practice is not to notify or become public when we submit. Stock Advisor launched in February of 2002. And in September, we announced the full commercial rollout of Omnipod DASH. And so we're working our first two lines there to get sellable product. Wayde, I wonder if next year is an interesting year when we think about Omnipod 5 launching certain margin considerations that you've talked about fair amount this year, and of course COVID impacting new patient starts, which could sort of bleed into early part of 2021. But as I said, as we lay out our expectations for 2021, we'll be able to give insight into our DTC and what we expect that that's going to drive for us. And so we do think that new customer starts will continue to be more of a headwind above or at the high end of this range for us, but our teams are doing a better job, and there is lots of momentum. Insulet’s hybrid closed loop — Omnipod Horizon — is gearing up to enter Phase 3 clinical trials later this year and aiming for a public release in the second half of 2020. We've obviously seen a lot of resurgence of COVID globally. In terms of reimbursement, we're fortunate. If we feel like that need may persist, then we will certainly evaluate continuing the program. We remain in a strong position with our earliest debt maturing in 2024 and low cash interest expense. So how should we think about as we set our models to benefit from DASH, but also the benefit that's coming once you have a competitive AID solution? Thank you. But at the end of the day, the anticipated headwinds to the extent we can, I mean, it's obviously very difficult to predict how much impact the pandemic will have, but we've built the assumption into the high end and low end of our guidance ranges. And there's just a lot of moving pieces. Thank you. And that will be based on market access, manufacturing ramp and customer feedback. We expect these newly developed capabilities to continue to provide value as we scale our business. ... waterproof pump system, Insulet is developing the Omnipod Dash. While positive foreign exchange was a 60 basis point tailwind, it was offset by a 60 basis point headwind from one-time COVID-related costs of $1.1 million. So give us an opportunity to share more about it and to provide enough data points. The DASH’s most noticeable update is in their PDM (personal diabetes manager). But having said that, we've always had financial assistance program and we've had several -- quite a few people on that over the years. In conclusion, we achieved strong growth year-to-date despite the impact from the global pandemic. And virtual training is quick and effective. In our progress on establishing broad market access through the pharmacy channel, the time was right to launch a small-scale direct-to-consumer advertising pilot. As -- I appreciate it's probably too early to get into specific numbers for 2021, but maybe it might be helpful if you just kind of -- how are you thinking about '21 internally about what kind of COVID catalyst, whether it'd be a vaccine, whether a widespread available vaccine, what kinds of catalysts are you looking forward to kind of get back to normal pre-COVID levels? The move into Type 2 is still early. And you're right. Total Omnipod growth was 18%, which was the major driver of our outperformance at $6 million above our guidance range. Thank you. Thank you. In the third quarter, Omnipod DASH drove approximately 65% of our U.S. new customer starts. We have to see what the pandemic impact is in Q4 and then what Q1 looks like. And our plan is to give a bit more color on the next call when we're bringing [Technical Issue] and we should have learned more by then and have a better point of view in terms of expanding [Technical Issue] But I think what's exciting is that now that we have the position that we have in the pharmacy channel, we actually have the scale and the position to kind of support increased demand. Thank you. So in the past, I think you guys have talked about international growth being in the high-teens, low 20% range. Ryan, you're correct. As CGM adoption happens, which is happening, it's very maturely happening in Type 1, but just really getting going in Type 2, and we see that as a trend that then, as you said, bodes well for pump adoption. I was hoping you could provide some detail on the mix of COGS running through the Acton plant versus sources from Flex in China? Channel inventory growth in the quarter of an estimated 4 million to 5 million was primarily driven by stocking shipments of Omnipod DASH and with similar to the amount of estimated increased distributor orders we experienced in Q3 2019. And then internationally, a little higher again than the estimates you put out there. Because if you think about what's happening today, nobody chooses, at least our data would indicate that, nobody chooses a tubed pump because it has tubes. I thought that was kind of settled at this point that you probably were going to go after access more than pricing just to try to get it out there faster and even more broadly across accounts in that.