Thank you for taking our questions. So obviously we will start to build reimbursement in the pharmacy channel for Omnipod 5. We are steadily advancing our strategic imperatives and delivering on our mission to improve the lives of people with diabetes. Insulet, makers of the Omnipod insulin pump, recently submitted its update to the PDM, the Omnipod Dash Touchscreen Handheld, to the FDA.. 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 executive team at Insulet has completely turned over in the last few years. Like, how are you thinking about the broader rollout for that DTC campaign as you round the corner of '20 into '21? If we can get to the high end of our guide or even above, then new customer starts are going to be pretty strong for us in Q4. 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. 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. We now expect 2020 capital expenditures will be below prior year levels due to projects coming in favorable to estimated spend and due to timing. 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. Good afternoon, and thank you for joining us for Insulet's third quarter 2020 earnings call. With me today are Shacey Petrovic, President and Chief Executive Officer and Wayde McMillan, Executive Vice President and Chief Financial Officer. Larry Biegelsen -- Wells Fargo -- Analyst. Please go ahead. And we're testing a bunch of different messages in DTC. Deborah R. Gordon -- Vice President, Investor Relations. This feasibility study will include 30 to 40 participants, each wearing Omnipod 5 for approximately two months. We are focused on finishing the year strong and building momentum as we enter 2021. Our profitability improvement benefited from operations with improved gross margins and operating expense leverage and the change in other income. I was hoping you could provide some detail on the mix of COGS running through the Acton plant versus sources from Flex in China? And we don't -- our practice is not to notify or become public when we submit. And that really sets us up for the 67% to 70% next year. 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. But how should we think about when you have Horizon 5? And the new third-party manufacturer in China is not an impact on our gross margins today. We always give our guide at our Q4 call. Thank you. This Laser Can Monitor Your Blood Sugar, ADA issues new diabetes guidelines for 2016, Dexcom’s G6 Sensor Shines in Early Accuracy Study, Diabetic Retinopathy Can Reveal Heart Risk, Dexamethasone Less Effective for COVID-19 with Diabetes, Effect of Empagliflozin on Kidney Disease, Metabolic Syndrome Increases Risk for Complications of Type 1, The Link Between Diabetes and Death from COVID-19. We know that the technology adoption curve for CGM is helping to drive this. Before we begin, I would like to inform you that certain statements made by Insulet during the course of this call may be forward-looking and could materially differ from current expectations. And so in speaking with our field teams there, they do anticipate it's going to be more challenging. We have to see what the pandemic impact is in Q4 and then what Q1 looks like. We delivered 65%, up 80 basis points, exceeding our expectations. ACTON, Mass. I guess, I get most excited about the MDI users that are converting. In terms of reimbursement, we're fortunate. Our total Omnipod growth rates are now back in line with our original guidance set at the start of the year pre-COVID, which is a testament to the resilience of our durable annuity model and the execution of our Insulet team. 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. We are thrilled to be knocking down barriers and enabling Omnipod to bring improved quality of life and outcomes to more people with diabetes. Not producing sellable product yet, but we do have them producing product. We're not done moving customers from the DME and direct side of the business into the pharmacy and ramping up DASH. While it will take time to broaden our presence, over the longer term, our expanded global footprint will significantly increase our total addressable market. So we will get 30 to 40 users on the product. And thanks for taking the questions again. And over that time, we've brought advanced innovation to the diabetes community and helped people spend more time living their best life and less time managing their chronic condition. In Q3, we exceeded our guidance for new customer starts. Yeah, you've actually touched on a couple of key drivers there. As a result of third quarter revenue that exceeded expectations, we are raising our total company full year 2020 revenue guidance to growth of 20% to 21%, up from our previous expectations of 17% to 19% and above our beginning of year estimate. Looking by product line, U.S. Omnipod revenue grew 21%, exceeding our guidance range of 14% to 16%. And the premium that we get for the pay-as-you-go model because we're giving the PDM for no charge, those are dynamics today, but they're are far outweighed by the volume increases in the business. While this isn’t a closed loop system (that’s their Omnipod Horizon, which is slated to launch in late 2019/2020), it is a HUGE update to their current system. We will also discuss non-GAAP financial measures with respect to our performance, namely, adjusted EBITDA and constant currency revenue, which is revenue growth excluding the effect of foreign exchange. We will look to see does the algorithm perform as we would expect it to for this segment or do we need to tweak the algorithm. Sure. 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. And you mentioned, is it a limited market release, is it a full market release. Thanks, guys. We delivered 20% revenue growth ahead of our expectations and $9 million above our guidance range. So definitely becomes a volume business. We are evaluating that. Insulet collaboration with Tidepool Loop Program Insulet announced it will be working with Tidepool, a non-profit organization that is working on an open-source, iOS based app and algorithm. Insulet to Present at Upcoming Investor Conferences. 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? I can start with that one. Obviously, the pre-pivotal data look very, very strong and we are very excited to get the Omnipod pivotal data out there. BILLERICA, Mass.--(BUSINESS WIRE)--Jun. Wayde will discuss our financial results and outlook for the rest of this year, and then we'll open the call to your questions. So I don't anticipate that COVID is going to slow us down. The pharmacy model with pay-as-you-go is working well. On today's call, I'll update you on our progress with our strategic imperatives, and then many reasons we are excited about the future. And then internationally, a little higher again than the estimates you put out there. I show our next question comes from the line of Travis Steed from Bank of America. Lastly, for drug delivery, we are updating our expected revenue growth to 4% to 6%, resulting from the increased forecast from our business partner. The move into Type 2 is still early. Maybe I'll ask Wayde to give a little bit of insight into the overall expectations for international growth. Those -- that's really what's driving access and availability of Omnipod to the Type 2 population. Great. 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. And so there is a lot of momentum building in behind this pandemic. The device is an … [Operator Instructions] Our first question comes from the line of Margaret Kaczor from William Blair. Just [Technical Issue]. First, Shacey, I was hoping you could give us your thoughts on the status of new patients and where they're coming from? But how should we think about the DTC efforts into next year with some of the COVID impacts still kind of percolating and Omnipod 5 coming out? This data will also help inform our future innovations beyond Omnipod 5. Yeah. Hi. From a mix standpoint, we'll continue to see the mix benefit in the U.S. from the pharmacy channel. So just -- is there being -- is there a reconsideration happening that maybe you could get a premium for O5 or how to think about that? We've seen significant improvement from Q2 into Q3. It's a high stakes product for us. And so there's just so many good things that this compounding new customer starts is offsetting for us. Brandon Vazquez -- William Blair -- Analyst. Our innovation pipeline is strong and our financial position is sound. Hey, Brandon. 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. The question was on the Omnipod 5 Type 2 study [Technical Issue] if you need FDA approval for reimbursement? The Omnipod 5 Horizon System is a hybrid closed loop automated insulin delivery device. 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. 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. I'll start with expanding access and awareness. 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 . Omnipod 5 Type 2 feasibility study. When we check that box, we should get a much larger -- already today, we get a very large percent of MDI conversions. Hi, everyone. Sure, Patrick. We do have a lot of programs going. And we still see that our virtual tools and the capabilities that we've built our certainly helping to ensure that we can continue to bring patients on. The goal: FDA approval and a release of the device in 2019. I don't know yet. And is that going to be materially different in fourth quarter? Yeah. Turning to the rest of the P&L. Our goal is to have the expanded indication by the end of 2021 for this young population and their caregivers. The Omnipod 5 Horizon System is a hybrid closed loop automated insulin delivery device. But again, next year, it makes it a much more challenging thing. We achieved third quarter revenue growth of 20%. 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. And so that's -- those are the things to look for kind of publicly externally. International Omnipod revenue grew 12% compared to our guidance range of 9% to 11%, primarily due to better than expected new customer starts. Additionally, approximately one-third of our U.S. new customers were Type 2, up from last quarter. Sure. 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%. And it's a good place to start actually because this is obviously a major driver in the business today, and it's really different in the U.S. and international, as you said. And on the numbers, Patrick, they have been quite small actually. We remain in challenging unprecedented times. We've always maintained that we will do a limited market release. And how far behind is Omnipod 5 outside the U.S. compared to the U.S.? And the key for us today is Acton manufacturing is a more expensive product because it's fairly low volumes on two lines in a plant that's designed for four automated lines. The DASH’s most noticeable update is in their PDM (personal diabetes manager). And just one very quick clarification. And then I'm trying to get my head around how Omnipod 5 ramps next year? 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. Robert Marcus -- J.P. Morgan Securities -- Analyst. Thanks for taking the questions here. And on an absolute basis, OUS maybe down marginally 5% or 10% year-over-year, but not dramatically down. And that is, as you mentioned, the single largest driver of improved gross margins for us over time. A new study examined its effectiveness for children with type 1 diabetes. Operating expenses in the third quarter were largely in line with our expectations on a dollar basis and slightly lower as a percentage of revenue given our strong top-line performance. Thanks for sneaking me in. We've heard limited launch, we've heard full launch, but you've got a very successful DASH product that's already out there. But we really don't annualize out that tough Q2 until we get to Q1 next year. 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 don't want to preview it. That recovery is being driven, as it frankly always has been, off of Omnipod's form factor. 24, 2018-- Insulet Corporation (NASDAQ:PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced that positive results from the most recent clinical trial of the Omnipod® Horizon™ Automated Glucose Control System (Omnipod Horizon … And so this is really an enhancement to that program, and we haven't met the number of people that we had on our original program yet. I think what you're highlighting is why we can't -- we're so excited about Omnipod 5 is that you can really see the power of integration with a DexCom sensor and AID. 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. In summary, the world remains challenged with the impact of the global pandemic. We know increased awareness is key to growing adoption, and we are delighted to be in such a strong position to invest and explore this area. 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. Can you help us understand some of the underlying metrics that get you to a range that I would say, people would say, seems fairly conservative? The next thing that we'll really announce is probably the data and then the clearance of the system. Hi, Brianna. In the third quarter, Omnipod DASH drove approximately 65% of our U.S. new customer starts. ... are still delivered manually. 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. A unique feature of the device is that it uses custom-built glucose control, modifiable based on the time of day; it can also prevent the patient from experiencing a hypoglycemia episode. So we're anticipating pretty strong recovery in the U.S. 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. This speaks to the power of our differentiated market position through product innovation and durable recurring revenue model. I'm sure a lot of its DASH, I'm sure a lot of it's the form factor, the lower out of pocket. And we've put the infrastructure in place, we've built up our access teams, we've built up our wholesalers and distributors and we've learned a lot through the ramp of DASH. 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. Abbott, Dexcom, diabetes management, diabetes treatment, Insulet, Insulin. Actually in the pharmacy channel, the vast majority of our patients are accessing Omnipod for less than a $50 co-pay. 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. So we've always been strategically focused on the young pediatric population. And maybe I'll let Wayde talk about the specific numbers in terms of the pharmacy channel. By Ava Runge and Adam BrownExpected in 2017. Thanks for taking the questions. Stock Advisor launched in February of 2002. 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. Total Omnipod growth was 18%, which was the major driver of our outperformance at $6 million above our guidance range. I show our next question comes from the line of Robbie Marcus from J.P. Morgan. Is there large destocking that we should think about? These investments strengthen our global manufacturing and supply chain operations and ensure that over the long-term we have the capacity and redundancy to meet increased global demand for our products. Very simplistically in the 3Q when I take kind of all the data points you were providing, it seems to me your new patient starts in the U.S. were probably closed on par with what they were last year in the 3Q, which was a pretty good quarter. So we didn't fully -- you were a little garbled. Any considerations at all that could be helpful as we think about '21 modeling? So those are the things that we're evaluating before we determine to what extent we increase our investment in DTC in 2021. By product line, for U.S. Omnipod, we are raising our expected revenue growth to 23% to 24%. In terms of Omnipod 5, that is a product that we have spent so much design work and thinking and organizational focus on simplicity and ensuring that everything from the onboarding experience through to the use experience of the system is simple. We are excited about the impact it will make in the market and on the lives of people with diabetes. Yeah. And then you had also asked, Larry, about Omnipod 5 in international. Now, turning to our progress in our international markets. In conclusion, we achieved strong growth year-to-date despite the impact from the global pandemic. And that's the big one that we will annualize out of the business in Q1 next year and adding new customers starts from Q2 into Q3 and Q4. I think we certainly expect it to be an accelerator. 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. Just to let everybody know that that work is under way and we are fully committed to bringing Omnipod 5 to our European markets and to all of our international markets. What is the size of the two to six year old population that you were looking to go after with that incremental study? Turning to gross margin. And when we check the box of integration and automation with DexCom, that's going to be a very differentiated and appealing product. And just a reminder, Q4 in the prior year was our all-time highest new customer starts. 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. So as the quarters go quarter-to-quarter, we're probably not going to see major step-ups just given that our overall business grows as well. Turning to fourth quarter 2020 guidance. But when we looked at the recurring revenue model that we're in and how that really defends against a one quarter impact like the pandemic happened in Q2 and that we were going to see a potential new customer starts impacting us for a few quarters, it compounds. Thank you. Thanks so much. And that's being driven by Omnipod's form factor, by pharmacy access in both Type 1 and Type 2 MDI users. 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. As we learn more from our growing Type 2 user base, we know there is a large market for an appropriate Type 2 AIG system. And you're right. And up until the next few months when we get -- or next several months when we get Omnipod 5 out into the market, patients have had to choose between what we know is a preferred form factor and integration with a DexCom sensor. Attrition and utilization for total Omnipod were stable sequentially. Insulet Corp (NASDAQ:PODD)Q3 2020 Earnings CallNov 4, 2020, 4:30 p.m. Thank you. As you think about the impact to Omni 5 in the market next year, is it much more about for you Type 1 conversions, Type 1 share, which has not been necessarily a significant driver of the business? And for patients to be able to walk into the pharmacy, get the product, have no upfront cost and have that sort of easy onboarding experience is the right time to start to learn more about DTC, and we're encouraged and stay tuned. Wayde said, in Q4, in the U.S., we could be back to a all-time record quarter at the high end of our guidance for new patients. And obviously, in the first half of 2021 they'll no longer have to choose. And then we have a ton of work going on in medical affairs, etc. Just kind of curious how well prepared the doctors' offices and patients are now versus how they were earlier this year? So we know we've got a really appealing product. And in September, we announced the full commercial rollout of Omnipod DASH. But can you provide any additional color on why the pace of quarterly increases for total U.S. volumes in the pharmacy has slowed a bit over the past couple of quarters? For full year 2020 adjusted EBITDA, as a percentage of revenue, we continue to expect to come in at the low end of our previously stated 13% to 17% range. And so I'm trying to just -- if you could walk us through any milestones or milepost we should think about? We remain in a strong position with our earliest debt maturing in 2024 and low cash interest expense. And then acknowledging it's really early, I'd be curious to know the patient mix or leads generated by your DTC program? 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. Great. Thank you. Yeah. It negatively impacted global new customer starts in both the second and third quarters. Patient mix or leads generated by your DTC program Mass. -- ( WIRE! Had significantly lower new customer starts is offsetting for us the overall expectations for pathway. 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