And so even as certain areas experience more challenges with the pandemic, we're able to continue to bring new patients on to the product. Maybe just starting with the pharmacy channel transitions, you noted greater than 30% of U.S. volume is going to the pharmacy, which is similar to last quarter. It's just simply that we're in the midst of a pandemic and that there has been a slower recovery in particularly Europe and other parts of the world and particularly the United States. In conclusion, we achieved strong growth year-to-date despite the impact from the global pandemic. 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. With that, we'll turn the call over to the operator for Q&A. It will then map out for us how much clinical work do we have. In our total Omnipod business, the pandemic was a smaller headwind than expected. About DexCom, Inc. Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Obviously the most important thing is that we get FDA clearance and get to launch in the first half of next year. And we therefore expect capital expenditures to grow again next year to support scaling manufacturing and supply chain operations capacity as well as advancements in our innovation pipeline and commercial and international expansion. And so those will start to factor into our COGS either later this year or in early 2021. And just a reminder, Q4 in the prior year was our all-time highest new customer starts. Stock Advisor launched in February of 2002. So I think four obviously has three quarters of compounded impact to it, and that's factored into our guidance. Thanks, Shacey. Thank you. And it's also a population where Omnipod is heavily, heavily differentiated for a variety of reasons. So Wayde, these third quarter momentums slowdown in the U.S., I'm sort of assuming because you guided to momentums slowed in the fourth quarter that just reflects probably the peak COVID new patient start impact in the third quarter and there is kind of no change in underlying U.S. fundamentals. So we're excited about getting everybody enrolled in our clinical trial and getting that label expansion ideally before the end of next year. First of all, glad you brought guidance because we're very happy that we chose to issue guidance back in Q2 at the front end of this pandemic. 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. Gross margins. And then just for Shacey. Now, turning to our progress in our international markets. But like you said, a major consideration for us is getting us out to our customers as fast as possible. Hey, Robbie. We are confident an Omnipod AID system will provide great value for the type 2 population, and we expect our early clinical work will result in important learnings. 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. You broke up there. Good afternoon, guys. And that's why I mentioned in my remarks that we're really starting in earnest our expansion in early 2021. Patrick, it's funny, you're asking the questions that we're asking ourselves internally. So when we launch in the first half of 2021, we will launch into a limited market release. Congrats on a really good quarter. So we are very fortunate to be in the pharmacy channel providing the pay-as-you-go model. And virtual training is quick and effective. That came from just a lot of tweaking of the algorithm. This really is a step in the eventual label expansion, and it's an early stuff. Super helpful. We didn't give the five markets, so we'll lay those out for you as we enter into them. I was hoping you could provide some detail on the mix of COGS running through the Acton plant versus sources from Flex in China? We are excited about the impact it will make in the market and on the lives of people with diabetes. The Omnipod Horizon closed loop system , also developed in partnership with Dexcom, is being tested pre-release in the USA - it is not expected in Canada until late 2020. tidepool.org is working on getting the Loop app (see below) approved by the US FDA and using it … And for international Omnipod, we are raising our expectations to 18% to 19%. I show our next question comes from the line of Larry Biegelsen from Wells Fargo. 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. Turning to the third quarter financial results. Okay, great. And that's being driven by Omnipod's form factor, by pharmacy access in both Type 1 and Type 2 MDI users. The identified anomaly could result in the system using an incorrect glucose value which has the potential to impact insulin delivery. I guess, I get most excited about the MDI users that are converting. Although COVID to create uncertainties and it is difficult to predict the progression of the pandemic or the probability of a resurgence, we now expect the global new customer starts for the full year of 2020 will improve to approximately 75% of our beginning of the year estimate. So definitely becomes a volume business. Adjusted EBITDA as a percentage of revenue was 18.1% in the third quarter, up from 15.4% in the prior year. And it sounds like, Jeff, you're close. So we do have actually messaging that is geared toward the Type 2 population. We are thrilled to be knocking down barriers and enabling Omnipod to bring improved quality of life and outcomes to more people with diabetes. We are thrilled to have recently completed our Omnipod 5 pivotal trial and remain on track to launch in the first half of this coming year. The device is an … Shacey Petrovic -- Director, President and Chief Executive Officer of Insulet Corporation and Director, Exact Sciences. 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. As I think about Omnipod 5 next year and some of the different things you've talked about these last couple of calls, you always talk about MDI, you've talked about Type 1 as well. 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%. Depending on the volume and depending on how fast we ramp, we could be at the low end or we could just as easily be at the high end. Good afternoon, and thank you for joining us for Insulet's third quarter 2020 earnings call. Yeah. So we're going to live with that for four quarters. Meanwhile, Omnipod is also hoping to integrate its system with a third-party looping algorithm, Tidepool Loop. We've made investments in our commercial business and expanding the sales force. And the investments that we've been making in manufacturing, both in the U.S. and in China, really build a critical mass of expertise and know-how and how to do this. And so with label expansion that should pave the way for access in the pharmacy channel for Type 2. This is very much about ensuring that while COVID is negatively impacting in an outsized fashion our partners that they can remain on product. But as Shacey said, we're really happy to have it in place. And then acknowledging it's really early, I'd be curious to know the patient mix or leads generated by your DTC program? 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. The move into Type 2 is still early. Our U.S. and international Omnipod product lines, each achieved another record revenue quarter. 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. While delivering strong performance, we are also building a foundation to drive adoption in our enormous and growing market over the long-term. We expect these newly developed capabilities to continue to provide value as we scale our business. That's great. 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. Yeah. 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. 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. So we've always been strategically focused on the young pediatric population. International Omnipod revenue grew 12% compared to our guidance range of 9% to 11%, primarily due to better than expected new customer starts. 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. We have obviously the clinical data analysis and presentation and publication of the data, so that will be a milestone as we move forward. And so that we are committed to. 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. So in the past, I think you guys have talked about international growth being in the high-teens, low 20% range. And maybe I'll let Wayde talk about the specific numbers in terms of the pharmacy channel. Yeah. 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. Brandon Vazquez -- William Blair -- Analyst. So it's not like it was in Q2. And then you had also asked, Larry, about Omnipod 5 in international. It's obviously a really important population for us, not necessarily because of the size of the population, but because we know that when people adopt Omnipod they stay with us. Please go ahead. -- … And as we scale and bring more volumes into it, those volumes help us drive gross margins significantly as well. Turning to fourth quarter 2020 guidance. And so we want to make sure that those patients stay on the product to the extent that our customer base does. And then we have a ton of work going on in medical affairs, etc. This is Brianna on the Raj. If you could repeat your question that would be great? Thank you. Just kind of curious how well prepared the doctors' offices and patients are now versus how they were earlier this year? With Omnipod 5, we will give our customers freedom, simplicity and integration with personal consumer technology like no other system on the market today. 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. 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. Our profitability improvement benefited from operations with improved gross margins and operating expense leverage and the change in other income. Our automated insulin delivery platform is transformative technology with potential applications in a variety of segments. We've just got those two lines up and running and producing. 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. We should get a much larger one. In terms of new customers, we now expect global new customer starts to improve in the fourth quarter to a range of 15% to 25%, less than our beginning of the year expectations. We now expect total company revenue growth of 7% to 11%. And then internationally, a little higher again than the estimates you put out there. Abbott, Dexcom, diabetes management, diabetes treatment, Insulet, Insulin. Turning to gross margin. We had a great forum with ATTD and our clinical investigators being invited to share the data. In September, we announced the start of our geographic expansion efforts, and we are on track to enter five new markets by early 2021. Good afternoon, everyone, and thank you for joining us. The question was on the Omnipod 5 Type 2 study [Technical Issue] if you need FDA approval for reimbursement? The DASH’s most noticeable update is in their PDM (personal diabetes manager). So we know we've got a really appealing product. It's very attractive in terms of form factor and the access channel. And despite the headwind, it's been on the low end of our stated new customer starts headwind. And my quick follow-up. I think we certainly expect it to be an accelerator. Drug delivery revenue increased 47% compared to our guidance range of 23% to 28%. Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes: Actual Study Start Date : December 30, 2019: Actual Primary Completion Date : September 22, 2020: Estimated Study Completion Date : December 2021 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? Thanks so much. We delivered 20% revenue growth ahead of our expectations and $9 million above our guidance range. You can see it in our growth rates. In terms of the data, I really don't have much insight to offer there. 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. 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. And so we don't want to get the data out ahead of that and maybe ruffle feathers at the FDA. So in terms of overall pump utilization in Type 2s, it's still pretty low penetration and there is just a massive opportunity to go get with the Type 2s. So this feasibility study will give us those learnings. While our team prepares for FDA submission, virtually all of the trial participants have transitioned into a pivotal extension phase. 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. 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. Lastly, for drug delivery, we are updating our expected revenue growth to 4% to 6%, resulting from the increased forecast from our business partner. And maybe one for Wayde. Thanks, Larry. Thanks all, and have a great evening. So we're looking to see are there other appropriate forums for us to get it out there. Attrition and utilization for total Omnipod were stable sequentially. Fueling the success with MDI and Type 2 is Omnipod DASH. However, over time, it's designed that the automated manufacturing lines will be more efficient and get us lower cost product. Also, starting July 1, 2018, Insulet will distribute its Omnipod Insulin Management System in Europe. So with COVID, obviously, that's a question mark. And is that going to be materially different in fourth quarter? I think we are building significant critical mass in the business here as we accumulate more and more customers with our patch pump disposable design. Thank you. 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. 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. So today, our production out of our Flex China facility is lower cost than Acton. Okay, that's great. 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. Yeah. And I would be surprised if other pumps are seeing the level of conversion that we're seeing in Type 2s. 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. We launched the pilot in September and have been learning a ton. We're taking a deliberate approach to our international expansion as we build our capabilities in each market and leverage our existing teams and strong distributor relationships. Is there anything to call out that's different in those geographies? 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. We are establishing market access so Omnipod is easily available regardless of age, type of diabetes or payer. It was a big decision. I mean, you see the growth that we're driving. And so I'm trying to just -- if you could walk us through any milestones or milepost we should think about? I'm sure a lot of its DASH, I'm sure a lot of it's the form factor, the lower out of pocket. First if I could just focus on the Q4 guide. We remain in challenging unprecedented times. And on Omnipod 5, do you guys typically announce when you have filed or submitted something like that? 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? 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. Our results were favorable in both the U.S. and international regions with the combined impact slightly less than 30%. And we're testing a bunch of different messages in DTC. And the new third-party manufacturer in China is not an impact on our gross margins today. Sure. Great. I think it's a good point. And so I think we are winning -- I know we're winning primarily with MDI conversions not other pumps. Please go ahead. So that's great. They can start on Omnipod with a free trial and no lock-in period. 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. And so 25% of them will come up. So yeah, that one's still a jump off for us. Great. Yeah. We are focused on finishing the year strong and building momentum as we enter 2021. I have two questions. Thank you. First, Shacey, I was hoping you could give us your thoughts on the status of new patients and where they're coming from? 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. 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. And a lot of the cost is fixed on the automated manufacturing lines. In Q3, we exceeded our guidance for new customer starts. In order to meet the growing demand for Omnipod, we are increasing capacity in both the United States and China. But in combination with that is scale. This is Brandon on for Margaret. I heard five new markets in the prepared remarks. I think you just checked off the major ones, David. One of your competitors with an integrated solution is outpacing you in terms of new patient growth, and a lot of it has to do with the AID solution. We delivered 65%, up 80 basis points, exceeding our expectations. We're not done moving customers from the DME and direct side of the business into the pharmacy and ramping up DASH. Is that the fair way to be thinking about what they were on an absolute basis in the quarter itself? While COVID-19 has presented challenges, it also has pushed us to embrace virtual training, which is now preferred by users and providers. This study was the first feasibility study on the automated blood sugar control algorithm and researchers report “beneficial” results in adults with type 1 diabetes. Thanks, Deb. And our initial launch of Omnipod 5 for Type 1 diabetes users aged seven plus, marks our first step. Over time, we will be investing in clinical studies to first explore and then prove Omnipod 5's utility in more market segments. So we didn't fully -- you were a little garbled. So that's why we have a bigger headwind in new customer starts in Q4 than we've seen. And so that's -- so far, we feel comfortable we'll be in the range that we've provided for Q4 for international. This includes total Omnipod revenue growth of 10% to 14%, which as a reminder, reflects the compounding of lower new customer starts from the prior two quarters related to the pandemic. Insulet Resumes Pivotal Study of its Next-Generation Product - Omnipod, Powered by Horizon™ Business Wire ACTON, Mass. And so we're proud of the program and our intent is to -- we were committed through the end of this year. And so that is the first step in terms of our clinical exploration for Type 2s on Omnipod 5. If we get there, then it really is about how does COVID impact us in 2021. I can start with that one. We know it's the most anticipated innovation in the pipeline of all diabetes products. Wayde will discuss our financial results and outlook for the rest of this year, and then we'll open the call to your questions. *The Omnipod HORIZON™ System is an investigational device, limited by United States Law to Investigational Use. Wayde McMillan -- Executive Vice President, Chief Financial Officer and Treasurer. Omnipod 5 is the world's first tubeless wearable AID system and the only one fully controlled by a user's mobile phone. So it's not like it's been a significant pick-up at this point. So we will get 30 to 40 users on the product. And just to clarify, it is growing a couple of percentage points in our number. So of course, we've talked a lot about the virtual tools for training and support that we've rolled out. 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. Now turning to our revised outlook for 2020. And so that is really exciting to us in the DME channel, getting patients through the process and on to the product is a bit more cumbersome. Insulet Corp (NASDAQ:PODD)Q3 2020 Earnings CallNov 4, 2020, 4:30 p.m. And so those are driving demand today. 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