And in September, we announced the full commercial rollout of Omnipod DASH. So we remain very bullish on our expansion strategy over the long-term. We simply share the news when we're cleared. Fueling the success with MDI and Type 2 is Omnipod DASH. We've obviously seen a lot of resurgence of COVID globally. And so there's just so many good things that this compounding new customer starts is offsetting for us. Insulet Corporation – the company that brought us the tubeless insulin pump, the OmniPod, released some exciting news a couple weeks ago which could drastically shift the future of Type 1 diabetes management as we know it. Thanks, Larry. 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. Thanks. 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. And just depending on how impactful it is, it should land us in the range. 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. With Omnipod DASH in the pharmacy, MDI users no longer pay large upfront costs or get locked into a four year contract to try an insulin pump. There will be other ways for people to access our product over time. I think those are great questions, and I think really highlight why we're so excited about Omnipod 5. Thank you. 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. And then you had also asked, Larry, about Omnipod 5 in international. Thank you. Joanne, I don't have the total population of two to six year olds in the market. Larry Biegelsen -- Wells Fargo -- Analyst. 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. In our guidance we said greater than 30%. And on the numbers, Patrick, they have been quite small actually. 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. 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. When we check that box, we should get a much larger -- already today, we get a very large percent of MDI conversions. That's really helpful color, guys. 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 like you said, a major consideration for us is getting us out to our customers as fast as possible. Omnipod 5 Type 2 feasibility study. And my quick follow-up. From an international standpoint, it's a different story. While COVID-19 has presented challenges, it also has pushed us to embrace virtual training, which is now preferred by users and providers. We are thrilled to be knocking down barriers and enabling Omnipod to bring improved quality of life and outcomes to more people with diabetes. And so in speaking with our field teams there, they do anticipate it's going to be more challenging. We know that the technology adoption curve for CGM is helping to drive this. Thanks. We have obviously the clinical data analysis and presentation and publication of the data, so that will be a milestone as we move forward. New customer starts were stronger than expected, and we now expect to deliver our fifth consecutive year of 20% revenue growth despite the pandemic. And so it's really our job to build the momentum here, come out the other side stronger. While we prepare for Omnipod 5's submission and commercial launch, we are also making progress on our future products. 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. ACTON, Mass. 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. Yeah. We are focused on finishing the year strong and building momentum as we enter 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. So we didn't fully -- you were a little garbled. Drug delivery revenue increased 47% compared to our guidance range of 23% to 28%. I have two questions. By product line, we expect U.S. and international Omnipod revenue each to grow 10% to 14% and drug delivery to decline 17% to 23%. Also contributing was favorable product line mix. Good evening, and thank you for taking the question. Hi, Brianna. We do have a lot of programs going. The question was on the Omnipod 5 Type 2 study [Technical Issue] if you need FDA approval for reimbursement? Not producing sellable product yet, but we do have them producing product. Yeah. So yeah, that one's still a jump off for us. And regardless of what happens with the vaccine and the macro environment, our teams are getting great at managing and making an impact in this environment, and that's because of some of the things that Wayde just mentioned, our virtual training tools and various capabilities that we've built. Our U.S. and international Omnipod product lines, each achieved another record revenue quarter. We expect these newly developed capabilities to continue to provide value as we scale our business. I show our next question comes from the line of Larry Biegelsen from Wells Fargo. Thanks, Ryan. I'll just put them all upfront. Great. So we are very fortunate to be in the pharmacy channel providing the pay-as-you-go model. 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? It really just depends on how we want to approach the market. Stock Advisor launched in February of 2002. Travis, I'm sorry. Thank you for taking our questions. But in the U.S., the momentum has been building. So we're excited about getting everybody enrolled in our clinical trial and getting that label expansion ideally before the end of next year. Insulet’s Omnipod Horizon 2020 is looking to be the year for a commercial version of a closed-loop system with a patch pump. Finally, turning to operational excellence. Actually in the pharmacy channel, the vast majority of our patients are accessing Omnipod for less than a $50 co-pay. Please go ahead. 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? Are you willing to give us maybe what volume versus mix price was in third quarter? Which new markets are you planning to launch it in 2021? But I don't want to give insight into just how it compares at this point. Please go ahead. So that's why we have a bigger headwind in new customer starts in Q4 than we've seen. And I would be surprised if other pumps are seeing the level of conversion that we're seeing in Type 2s. I'll start with expanding access and awareness. Similar to Q2, the overachievement was due to our partners' increased forecast related to the current environment. We've always maintained that we will do a limited market release. Super helpful. 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. I would now like to turn the conference back to Shacey Petrovic. Returns as of 01/08/2021. This creates a compounding impact on our revenue, which we began to see in the third quarter and we'll continue to see an impact into the fourth quarter and first half of 2021. What was once a clunky pager looking device now resembles a sleek smartphone. Maybe I'll ask Wayde to give a little bit of insight into the overall expectations for international growth. Thanks all, and have a great evening. There is nothing fundamental in the business that would change our long-term expectations for that business. 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. 80% of new users are coming from MDI. The replay of this call will be archived on our website and the press release discussing our third quarter 2020 results and fourth quarter and full year 2020 guidance is also available in the IR section of our website. And so we want to get it right, and a limited market release is part of doing that. Thank you. Plans for the next generation OmniPod have also changed and appear to be a very intentional first step toward the Horizon AP system. We now expect total company revenue growth of 7% to 11%. And that's being driven by Omnipod's form factor, by pharmacy access in both Type 1 and Type 2 MDI users. So we're anticipating pretty strong recovery in the U.S. This data will also help inform our future innovations beyond Omnipod 5. Got it. We achieved third quarter revenue growth of 20%. 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. The timing of launch of the Horizon AP on the slide shows late 2019, however, in the presentation late 2018 was also mentioned. First if I could just focus on the Q4 guide. Thank you. I think you just checked off the major ones, David. 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. I mentioned, DASH newly launched internationally, but we've made sales force expansion there and we're also expanding into new countries. And so we don't want to get the data out ahead of that and maybe ruffle feathers at the FDA. And whether or not it's driving a disproportionate level of interest among Type 2s? Yeah. Omnipod 5 is the world's first tubeless wearable AID system and the only one fully controlled by a user's mobile phone. And then I'm trying to get my head around how Omnipod 5 ramps next year? Insulet Corp (NASDAQ:PODD)Q3 2020 Earnings CallNov 4, 2020, 4:30 p.m. When I put all that in the blender, it does seem to create maybe a little confusion. Since launched 18 months ago, awareness of Omnipod DASH's unparalleled simplicity has grown and we have built a broad pharmacy access in the United States. 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. So that to me is probably the biggest opportunity. And then how does the new manufacturing contract in China play into that mix? It will then map out for us how much clinical work do we have. CGM is helping users recognize that they need better insulin delivery solutions. What I would say is the U.S. was a little stronger headwind than you laid out there, but Q4 is going to be getting pretty close against a really tough comp in Q4. And then we'll be able to determine what's the path for label expansion. Is that still intact? You implemented your financial assistance program in April, can you give us a sense for the participation within that program? Nov 9, 2020. Gross margins. 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 … 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. The U.S. business has been performing really well. I'll ask Wayde to give a little bit more color on utilization of the program. It negatively impacted global new customer starts in both the second and third quarters. We are excited to share our clinical results. 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 virtual training is quick and effective. 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. 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. 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 maybe I'll let Wayde talk about the specific numbers in terms of the pharmacy channel. So we're going to live with that for four quarters. While our world has been challenged with the pandemic, our team has not missed a beat in advancing our innovation pipeline. 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. So when we launch in the first half of 2021, we will launch into a limited market release. Our long-term financial strategy and capital deployment plans remain unchanged. BILLERICA, Mass.--(BUSINESS WIRE)-- 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 additional … Market data powered by FactSet and Web Financial Group. 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, Ryan. 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 order to meet the growing demand for Omnipod, we are increasing capacity in both the United States and China. Obviously the most important thing is that we get FDA clearance and get to launch in the first half of next year. Thank you. The next thing that we'll really announce is probably the data and then the clearance of the system. Yeah. We have to see what the pandemic impact is in Q4 and then what Q1 looks like. Wayde McMillan -- Executive Vice President, Chief Financial Officer and Treasurer. If we get there, then it really is about how does COVID impact us in 2021. Thank you so much for taking the questions. Hi, everyone. So obviously we will start to build reimbursement in the pharmacy channel for Omnipod 5. And our initial launch of Omnipod 5 for Type 1 diabetes users aged seven plus, marks our first step. I show our last question comes from the line of Raj Denhoy from Jefferies. However, the trial run will be an important factor in getting this groundbreaking technology on track for a full commercial launch in 2021. Please go ahead. So with COVID, obviously, that's a question mark. 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. 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. But that's an area where we're a little less familiar with because we get less patients from that area today. So it's very economic. And is there any reason why the pivotal Omnipod 5 data would look much different from the pre-pivotal data we saw at ADA this year. Key drivers of our gross margin expansion included improving performance of our U.S. manufacturing as we ramp our newly implemented automated lines as well as the favorable revenue mix from the shift to higher volume through the pharmacy channel. And so those are driving demand today. Expanded commercialization will continue on a market by market basis throughout 2020 and beyond. Good afternoon, and thank you for joining us for Insulet's third quarter 2020 earnings call. This speaks to the power of our differentiated market position through product innovation and durable recurring revenue model. And when we check the box of integration and automation with DexCom, that's going to be a very differentiated and appealing product. Q2 is the problem quarter. Good afternoon. Patrick Allen -- Piper Sandler -- Analyst. Thanks for taking the question. [Operator Instructions] Our first question comes from the line of Margaret Kaczor from William Blair. Insulet Omnipod Horizon – expected in second half of 2020. So you talked again about ramping CGM penetration in the Type 2 patient population, which clearly bodes well for pump penetration over time. So we're looking to see are there other appropriate forums for us to get it out there. Are there any major conferences to present the pivotal data now that ATTD has been postponed or should we expect it in the label? We should get a much larger one. So we will get 30 to 40 users on the product. 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. And then internationally, a little higher again than the estimates you put out there. We've seen significant improvement from Q2 into Q3. This is Patrick on for Matt. 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%. 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. 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. And despite the headwind, it's been on the low end of our stated new customer starts headwind. 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. Those -- that's really what's driving access and availability of Omnipod to the Type 2 population. We are excited about the impact it will make in the market and on the lives of people with diabetes. 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. *The Omnipod HORIZON™ System is an investigational device, limited by United States Law to Investigational Use. The one thing that's still a question mark for us there is, what we'll be pricing Omnipod 5 at and whether we'll have a premium price or price parity there. 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. Additionally, unless otherwise stated, all financial commentary regarding dollar and percentage changes will be on a year-over-year basis, and all revenue growth rates will be on a constant currency basis. I guess, I get most excited about the MDI users that are converting. We delivered 65%, up 80 basis points, exceeding our expectations. In terms of reimbursement, we're fortunate. In the pharmacy channel, there really isn't a distinction between the Type 1 and Type 2 user. Our teams have done a remarkable job preparing our markets to support this launch, and our customers are loving the product. And we are nearing completion of our third line installation, which we expect will produce sellable product next year. Shacey Petrovic -- Director, President and Chief Executive Officer of Insulet Corporation and Director, Exact Sciences. 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. I can start with that one. This is Brandon on for Margaret. And so 25% of them will come up. And so those will start to factor into our COGS either later this year or in early 2021. So it's not like it's been a significant pick-up at this point. 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. 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