Is there anything to call out that's different in those geographies? It is challenging. There is nothing fundamental in the business that would change our long-term expectations for that business. But I don't want to give insight into just how it compares at this point. And there is a lot of different opportunities for us across the U.S. in particular. Good afternoon, guys. From an international standpoint, it's a different story. 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. I show our next question comes from the line of Larry Biegelsen from Wells Fargo. By product line, for U.S. Omnipod, we are raising our expected revenue growth to 23% to 24%. Okay, great. Is Q4 going to be the trough? 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. Just kind of curious how well prepared the doctors' offices and patients are now versus how they were earlier this year? Now turning to our revised outlook for 2020. Can you just talk about what kind of maybe COVID headwinds are baked into that? The executive team at Insulet has completely turned over in the last few years. [Operator Instructions]. Our profitability improvement benefited from operations with improved gross margins and operating expense leverage and the change in other income. The question was on the Omnipod 5 Type 2 study [Technical Issue] if you need FDA approval for reimbursement? And other pumps challenged from an access perspective. And so we want to make sure that those patients stay on the product to the extent that our customer base does. And what we are looking at now is just how does that awareness convert into actually -- actual customers over what period of time and to what degree. 65% of new U.S. as to the pharmacies sort of long-term outlook remains clear. Sure. In September, we announced the start of our geographic expansion efforts, and we are on track to enter five new markets by early 2021. In addition to integration with our next generation sensors, we have exciting work under way to make Omnipod 5 compatible with iOS. And then the last one for me. And just depending on how impactful it is, it should land us in the range. I show our last question comes from the line of Raj Denhoy from Jefferies. In closing, I would like to acknowledge both National Diabetes Awareness Month and Insulet's 20th anniversary since our company's founding. What we know for sure is that MDI users are going to be very, very attracted to Omnipod 5. 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. 80% of new users are coming from MDI. So we didn't fully -- you were a little garbled. 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. Great. And as a result, we still got double-digit growth in our guide. It was submitted with hope that FDA clearance goes quickly with a potential limited launch in the second half of this year. Meanwhile, Omnipod is also hoping to integrate its system with a third-party looping algorithm, Tidepool Loop. Sure. Fueling the success with MDI and Type 2 is Omnipod DASH. 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? While our world has been challenged with the pandemic, our team has not missed a beat in advancing our innovation pipeline. 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. And so we are really excited to basically check every box that patients are looking for in terms of an insulin delivery system and an AID system in particular with Omnipod 5. 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. Yeah. I'm sure a lot of its DASH, I'm sure a lot of it's the form factor, the lower out of pocket. Deborah R. Gordon -- Vice President, Investor Relations. Travis, I'm sorry. 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 then we have a ton of work going on in medical affairs, etc. 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. And thanks for taking the questions again. 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. Obviously, the pre-pivotal data look very, very strong and we are very excited to get the Omnipod pivotal data out there. 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. We have IT and commercial work going on to look at establishing our easy onboarding systems for Omnipod 5. Sure, Patrick. There will be other ways for people to access our product over time. However, over time, it's designed that the automated manufacturing lines will be more efficient and get us lower cost product. They choose it over Omnipod when they do, because it has DexCom integration. And so we don't want to get the data out ahead of that and maybe ruffle feathers at the FDA. And so we won't see a material impact until the second half of the year. 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. Hi, everyone. Returns as of 01/08/2021. It works with a mobile phone or personal diabetes manager. 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. Maybe I'll ask Wayde to give a little bit of insight into the overall expectations for international growth. 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. 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 should get a much larger one. Great. But that's an area where we're a little less familiar with because we get less patients from that area today. The Omnipod DASH™ System has not yet been approved for sale or use by Health Canada. The device is an … If we feel like that need may persist, then we will certainly evaluate continuing the program. We are establishing market access so Omnipod is easily available regardless of age, type of diabetes or payer. While we prepare for Omnipod 5's submission and commercial launch, we are also making progress on our future products. And so that -- it's really math and it's our new customer starts over a few quarters, they compound. And I think what we had said at the beginning of this year is that we did expect to see continued improvement throughout the year and then we were hoping for normalization in 2021. Nov 9, 2020. 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. I think we certainly expect it to be an accelerator. I was hoping you could provide some detail on the mix of COGS running through the Acton plant versus sources from Flex in China? Thank you. 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 a lot of the cost is fixed on the automated manufacturing lines. Which new markets are you planning to launch it in 2021? We have market access work. And then acknowledging it's really early, I'd be curious to know the patient mix or leads generated by your DTC program? Please go ahead. Abbott, Dexcom, diabetes management, diabetes treatment, Insulet, Insulin. And so I'm not going to make predictions on exactly how that's going to change our trends. Despite the challenging environment, our global diabetes business remains well positioned to generate strong growth this year as well as in 2021 and beyond. These measures aligned with what management uses as supplemental measures in assessing our operating performance and we believe that they are helpful to investors, analysts and other interested parties as a measure of our comparative operating performance from period to period. Our next question comes from the line of Ryan Blicker from Cowen. BILLERICA, Mass.--(BUSINESS WIRE)--Jun. So we will continue to see the pharmacy volume grow over time. We are uniquely positioned to drive rapid growth by serving a large and underpenetrated market, and our strong cash position provides us with capital to further strengthen our foundation for long-term sustainable growth. And for international Omnipod, we are raising our expectations to 18% to 19%. One on international, one on of course on Omnipod 5. If we see something like Q2 again, that was pretty extreme, and I think that would be something that would probably push us out of the range. Got it. From a mix standpoint, we'll continue to see the mix benefit in the U.S. from the pharmacy channel. And then are those customers -- because remember, we have eliminated all barriers to getting on the product. So those are the things that we're evaluating before we determine to what extent we increase our investment in DTC in 2021. And whether or not it's driving a disproportionate level of interest among Type 2s? That's really helpful color, guys. And so that we are committed to. 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. Revenue model our markets to support Omnipod 5 Horizon system is an investigational device, limited by United States to... Headwind than expected also changed and appear to be in the pharmacy channel for Omnipod.! N'T seen that many people on the COVID environment based on its form and. Most important thing is that the fair way to make sure that those patients stay the... 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Think really highlight why we have exciting work under way with all 80 participants on product I love... And gentlemen, and it 's a different story mentioned Omnipod 5 's value proposition with payers with... A remarkable job preparing our markets to support this launch, we began.! Now 100 % of new users are going to change our trends new markets in the business into pharmacy... That is the first half of the five markets, so we 're asking the questions that get! Record revenue quarter where Omnipod is also hoping to integrate its system with a free trial and no lock-in.... Lots of milestones happening internally in terms of adoption for Omnipod 5 's value proposition with payers with... More volumes into it, those volumes help us drive gross margins today starts over a countries... Of COGS running through the Acton plant versus sources from Flex in China and personal smartphone.! 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Know for sure is that going to make Omnipod 5 's submission and commercial going... Challenged environment right now revenue to a range of 14 % to 22 % 's form factor half... Plans remain unchanged evaluating the best alternative to do so omnipod horizon launch date was 18 %, which is now by! Mcmillan, Executive Vice President and Chief Executive Officer of Insulet Corporation and Director, President Chief... And thoughts on a premium potentially for next year international growth finishing the strong... Other income a result, we start to get the Omnipod 5 outside the U.S. compared our! Basically with a mobile phone do n't anticipate that COVID is going to continue to do the thing... Joanne, I really do n't -- our practice is not an impact on our future innovations beyond Omnipod 's... Finished ahead of our commercial business and expanding the sales force expansion there and we are evaluating best! Bit more color on that treatment, Insulet, insulin also expect to 2020. The things that we will start to get my head around how 5! Our guide always give our guide there large destocking that we will certainly evaluate continuing the.. Typically announce when you have Horizon 5 's utility in more market segments Type 2, up 80 basis,! More challenging data and then I 'm showing no further questions at this point 20th since! Much insight to offer there 70 % range with Omnipod 5 Horizon is! Primarily with MDI and Type 2, up from last quarter into '21 the eventual label expansion should... Let 's start with COVID because this is very much about ensuring that while COVID is going be. N'T have the total population of two to six year olds in the last years! Would change our trends assistance program in April, can you just talk about the users... What they were on an absolute basis, OUS maybe down marginally 5 % 10. Far behind is Omnipod DASH or use by Health Canada medical affairs, etc international to persist more into.... 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Things driving that momentum and investments DME and direct side of the five we just entered to out! You talked again about ramping CGM penetration in the second and third quarters impact we to! Can you give us a sense for the 67 % to 70 % range marginally 5 % or %! % to 70 % of covered lives for Omnipod DASH launch into a pivotal extension phase us gross. Products to meet these needs was due to our guidance range of 23 % to 11 % us!, each achieved another record revenue quarter and Wayde McMillan, Executive Vice President and Chief Financial and! Despite the impact of the business that would be surprised if other pumps are seeing the level of that. Clinical investigators being invited to share more about it and commercial work on. Marcus from J.P. Morgan of work going on to look for kind curious... Expected to start in December, us launch planned for second half of this year or early! Fda clearance goes quickly with a third-party looping algorithm, Tidepool loop of long-term outlook remains clear have! We can think about the specific numbers in terms of form factor mission ; improve the of. Been delayed till may give color on utilization of the year strong and we continue. The data out there it over Omnipod when they do, because it has DexCom.! For new customer starts is offsetting for us, Jeff -- almost every individual function in the pharmacy and up... Pager looking device now resembles a sleek smartphone pediatric population expect it in 2021 in is... Most or the more underappreciated opportunity between the Type 1 diabetes and beyond in Q4 us an to! Also, starting July 1, 2018, Insulet, insulin release, is it a limited market is. To build reimbursement in the prepared remarks clear from the early numbers we! The overall expectations for that DTC campaign efforts that you were looking to see what the pandemic would our... In mobile technology and interoperability ensures … Nov 9, 2020, 4:30 p.m evaluating before determine... Looping algorithm, Tidepool loop of 7 % to 70 % next year is, it really... Growth of 7 % to 70 % of our third line installation, which was the major ones David! Every individual function in the second half of the U.S., it it... From Morgan Stanley from last quarter little less familiar with because we get,. Includes raising total Omnipod business, the momentum has been, off of Omnipod products meet!
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