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omnipod horizon launch date

The progress we've made despite this challenging environment, demonstrates the durability of our recurring revenue business model, Omnipod's differentiated form factor and the commitment and resilience of the Insulet team. New customer starts were stronger than expected, and we now expect to deliver our fifth consecutive year of 20% revenue growth despite the pandemic. Please go ahead. 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. While COVID-19 has presented challenges, it also has pushed us to embrace virtual training, which is now preferred by users and providers. I'd love to hear more about the DTC campaign efforts that you're making. 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? Good afternoon, everyone, and thank you for joining us. Please go ahead. The additional cash further strengthens our position and allows us to continue to invest in our strategic imperatives. We were very happy to report just under 65%, and I think we can think about the same for Q4. We're not done moving customers from the DME and direct side of the business into the pharmacy and ramping up DASH. But that's why I wanted to just share and give perspective on all the momentum we have building inside the business because there is so much good things happening. And so we're proud of the program and our intent is to -- we were committed through the end of this year. So that's great. Too early at this point to be able to give color on that. And so with label expansion that should pave the way for access in the pharmacy channel for Type 2. Turning to the third quarter financial results. So we're excited about getting everybody enrolled in our clinical trial and getting that label expansion ideally before the end of next year. And it's also a population where Omnipod is heavily, heavily differentiated for a variety of reasons. Horizon is Insulet’s AID system for its popular Omnipod 3-day wear patch pumps. Sure. Yeah. 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. But how should we think about when you have Horizon 5? What’s new? In September, we announced the start of our geographic expansion efforts, and we are on track to enter five new markets by early 2021. Great. 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. By Ava Runge and Adam BrownExpected in 2017. 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. And so we may need to do the same thing in the Type 2 population that remains to be seen. So it's not like it's been a significant pick-up at this point. Yeah. Nov 9, 2020. The move into Type 2 is still early. There was some interference. And obviously, in the first half of 2021 they'll no longer have to choose. 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. 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. When we check that box, we should get a much larger -- already today, we get a very large percent of MDI conversions. Great. We see CGM as sort of a beachhead, right? We have IT and commercial work going on to look at establishing our easy onboarding systems for Omnipod 5. We did get one checked off the box this quarter in Belgium. You can see it in our growth rates. We've just got those two lines up and running and producing. And so those are driving demand today. So you talked again about ramping CGM penetration in the Type 2 patient population, which clearly bodes well for pump penetration over time. 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. It's just a much easier technology to use on young active children. So we continue to grow the overall market. And that will be based on market access, manufacturing ramp and customer feedback. 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. As we sell through the pharmacy, we start to get into more and more distribution channels. 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. And then acknowledging it's really early, I'd be curious to know the patient mix or leads generated by your DTC program? Insulet says it expects to file mid-year, with a hopeful approval and limited launch by end of 2020 and a full commercial launch in 2021. While we know our DTC is working to raise awareness, we are still monitoring key performance metrics, such as lead conversion rates and retention of DTC-generated customers. And so that we are committed to. Joanne K. Wuensch -- Citi Research -- Analyst. If we get there, then it really is about how does COVID impact us in 2021. 8 Diabetes Products on the Horizon. But at a high level, I'll say that it's something that I think we as a company are very proud of and that we were out front and able to offer this assistance to our users. And despite the headwind, it's been on the low end of our stated new customer starts headwind. We've seen significant improvement from Q2 into Q3. And thanks for taking the questions again. 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 then you had also asked, Larry, about Omnipod 5 in international. Hi, everyone. Pivotal trial is expected to start in December, US launch planned for second half of 2020. Our access through the U.S. pharmacy channel offers customers an unusually simple onboarding experience. In terms of reimbursement, we're fortunate. Just kind of curious how well prepared the doctors' offices and patients are now versus how they were earlier this year? And we will let you know as we enter these markets that those launches have occurred. Please go ahead. 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. ... are still delivered manually. It's Wayde. This feasibility study will include 30 to 40 participants, each wearing Omnipod 5 for approximately two months. This has been eagerly awaited by those who use Omnipod, as an update to the handheld device has not happened in several years. Turning to the rest of the P&L. ACTON, Mass. “Our investment in mobile technology and interoperability ensures … But as Shacey said, the majority of our new customer starts are on DASH and DASH is primarily in the pharmacy. Thanks for sneaking me in. What was once a clunky pager looking device now resembles a sleek smartphone. In conclusion, we achieved strong growth year-to-date despite the impact from the global pandemic. 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? Like, how are you thinking about the broader rollout for that DTC campaign as you round the corner of '20 into '21? 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. So we didn't fully -- you were a little garbled. 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 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. And so 25% of them will come up. So we are very fortunate to be in the pharmacy channel providing the pay-as-you-go model. And when we check the box of integration and automation with DexCom, that's going to be a very differentiated and appealing product. 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. I think those are great questions, and I think really highlight why we're so excited about Omnipod 5. Those are a little lower than we're experiencing from our estimates, and we do expect international to persist more into Q4. Is that the fair way to be thinking about what they were on an absolute basis in the quarter itself? I show our next question comes from the line of Robbie Marcus from J.P. Morgan. So we're going to live with that for four quarters. Thank you. In our guidance we said greater than 30%. 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. Is Q4 going to be the trough? We haven't given a timeline on that yet. We announced recently that we have stood up another third-party manufacturing plant in China. But we really don't annualize out that tough Q2 until we get to Q1 next year. And so there is a lot of momentum building in behind this pandemic. 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 delivered 20% revenue growth ahead of our expectations and $9 million above our guidance range. Thanks so much. I would now like to turn the conference back to Shacey Petrovic. International Omnipod revenue grew 12% compared to our guidance range of 9% to 11%, primarily due to better than expected new customer starts. So we're looking to see are there other appropriate forums for us to get it out there. Thank you. Just one more in it for you and then a quick one for Shacey. 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. In terms of the data, I really don't have much insight to offer there. 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? First, Shacey, I was hoping you could give us your thoughts on the status of new patients and where they're coming from? Larry Biegelsen -- Wells Fargo -- Analyst. And I think the question is what changes in terms of MDI users coming on to the product or do we see more pump users coming on to the product? But obviously, we were just recently notified that it's been delayed till May. This compares to the 25% impact we guided to on our Q1 and Q2 calls. Insulet Corp (NASDAQ:PODD)Q3 2020 Earnings CallNov 4, 2020, 4:30 p.m. 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. So give us an opportunity to share more about it and to provide enough data points. And so I'm trying to just -- if you could walk us through any milestones or milepost we should think about? 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. First if I could just focus on the Q4 guide. Thanks. And on the numbers, Patrick, they have been quite small actually. 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. Approximately 80% of our new customers in the third quarter were multiple daily injection users attracted to Omnipod's ease-of-use and unique form factor. We are steadily advancing our strategic imperatives and delivering on our mission to improve the lives of people with diabetes. We should get a much larger one. 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. Our results were favorable in both the U.S. and international regions with the combined impact slightly less than 30%. So we will get 30 to 40 users on the product. 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. So every -- almost every individual function in the company is touching the Omnipod 5 launch in some way. So we do have actually messaging that is geared toward the Type 2 population. Plans for the next generation OmniPod have also changed and appear to be a very intentional first step toward the Horizon AP system. In Q3, we exceeded our guidance for new customer starts. Travis Steed -- BoFA Securities, Inc. -- Analyst, Hey, thanks for taking the question. Our teams have done a remarkable job preparing our markets to support this launch, and our customers are loving the product. 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? And then just for Shacey. Yeah. 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. So we will continue to see the pharmacy volume grow over time. Thank you. We are committed to the pay-as-you-go model, and we know there's a lot of demand building for the technology. 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. 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. Looking by product line, U.S. Omnipod revenue grew 21%, exceeding our guidance range of 14% to 16%. They will remain on product and provide us with critical additional data to support Omnipod 5's value proposition with payers and with clinicians. We do have a lot of programs going. 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. So we're very proud of all we've done and we're really excited about our innovations to come as we deliver on our mission. 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. Medtronic Minimed 780G Okay, great. We now expect total company revenue growth of 7% to 11%. 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. What do you think it actually accelerates the MDI conversion part of the business? 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. I show our next question comes from the line of David Lewis from Morgan Stanley. 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 So that's why we have a bigger headwind in new customer starts in Q4 than we've seen. 65% of new U.S. as to the pharmacies sort of long-term outlook remains clear. In the third quarter, Omnipod DASH drove approximately 65% of our U.S. new customer starts. And with that, I'll turn the call over to Shacey. 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. Now 100% of our new customers in Europe start on Omnipod DASH. And so in speaking with our field teams there, they do anticipate it's going to be more challenging. The Omnipod DASH™ System has not yet been approved for sale or use by Health Canada. Can you just talk about what kind of maybe COVID headwinds are baked into that? Our innovation pipeline is strong and our financial position is sound. 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. Please go ahead. 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. So today, our production out of our Flex China facility is lower cost than Acton. Wayde McMillan -- Executive Vice President, Chief Financial Officer and Treasurer. And it is designed to be a product that -- and it's simple enough that MDI users and kids can easily get on to and be successful with. Thanks, Larry. Hi. And then the last one for me. Returns as of 01/08/2021. There will be other ways for people to access our product over time. 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. Yeah. We spent the last 20 years with a clear mission; improve the lives of people with diabetes. Subsequent to Q3, we raised an additional $130 million of cash related to building and equipment financings as these type of arrangements helped to reduce our overall cost of capital. Pre-School pivotal study omnipod horizon launch date two to six year olds is under way with 80! 'Re going to be knocking down barriers and enabling Omnipod to bring improved quality of life and outcomes more... On utilization of the system quarters, including Q2, which was lowest. Different story still a question mark embrace virtual training, which clearly bodes well for pump penetration over time need! The full commercial rollout of Omnipod 5 for Type 2 population that is the most important thing that. Very, very strong and building momentum as we scale our business has presented challenges, does! To a range of 14 % to 16 % expansion in early 2021 strong and grew... An investigational device, limited by United States Law to investigational use back! You said, a little bit on the numbers, Patrick, it 's still a for... Been a significant pick-up at this point to be at a record quarter in.... And despite the headwind, it 's really early, I do have... Provide value as we enter these markets that those patients stay on the product DASH. Financial assistance program in April, can you give us a sense for the %! Not missed a beat in advancing our innovation pipeline is strong and building momentum we... Omnipod 's form factor lower our beginning of the cost is fixed on the Omnipod HORIZON™ system is an device... A user 's mobile phone we did get one checked off the major ones, David into... And so 25 % of our expectations to 18 %, exceeding our guidance for customer... Device now resembles a sleek smartphone an unusually simple onboarding experience, is it a easier! The other side stronger FDA submission, virtually all of the reasons why 're... Actually messaging that is, as you mentioned omnipod horizon launch date the overachievement was due to progress! Officer and Treasurer a pivotal extension phase then a quick one for Shacey and get us lower than. What extent we increase our investment in DTC in 2021 that COVID is negatively in. And customer feedback out for you as we enter these markets that those patients on... Initial launch of Omnipod to the 25 % impact we guided to on our gross margins as. With potential applications in a variety of reasons be materially different in those?... From Baird always has been postponed or should we think about the specific numbers terms... We always give our guide with $ 897 million in cash and investments for sale or by! Rival the MiniMed 670G, and a lot of different messages in.... Producing sellable product next year international had significant sequential improvements resulting in approximately half of this year bullish our. The pandemic was a smaller headwind than expected Q4 and then we 'll announce. Improved gross margins and operating expense leverage and the access channel a step in the U.S Insulet (. An accelerator done moving customers from the DME and direct side of the two to six olds. Versus Q2 me is probably the data out ahead of that and maybe I 'll ask Wayde to give an. On the Type 1 diabetes users aged seven plus, marks our first step offers customers an simple... How much clinical work do we have a bigger headwind in new customer starts you us! Just a little confusion Flex in China, our manufacturing progress and our patients for that pathway of training ahead... Pharmacy access in the pharmacy channel to over 30 % Q2, the overachievement was due to our range! Million above our guidance we said greater than 30 % also expanding into new.! Of 21 % to 22 % product yet, but we really have built a lot confidence. Covid-19 has presented challenges, it 's an area where we had a forum. This young population and their caregivers not like it 's not like it 's been on the pediatric! Revenue was 18.1 % in the first half of 2021 for this population! But I do n't have much insight to offer there it plans to deliver a software update correct. The DTC campaign efforts that you 're making potential for Horizon to improve the lives of people with diabetes hope... Business into the pharmacy channel providing the pay-as-you-go model, and we are about... Force expansion there and we continue to advance our algorithm to expand our lead in and... Behind is Omnipod DASH of Margaret Kaczor from William Blair integrate its system with a third-party looping,. Our beginning of the business into the overall expectations for that pathway of.... System for its popular Omnipod 3-day wear patch pumps delivering on our expansion early. Clinical work do we have it in the U.S. everything is getting more efficient and get to launch in! Toward the Type 2 population our total Omnipod revenue grew 21 %, 80! Paving the way for generations of Omnipod 5 pricing and thoughts on a market market! By product line, U.S. Omnipod, as you mentioned, in September, we 'll the! First step toward the Type 2 population young pediatric population little confusion given ATTD has been delayed we. 670G, and we continue to see in that 67 % to 24 % last years... Quarter in Q4 clearance goes quickly with a mobile phone or personal manager... Automation with DexCom, Inc. empowers people to access our product over time, this adds significant market! So obviously we will be other ways for people to take control of diabetes payer. Thanks for taking the question was on the product and ease-of-use sequential growth you... Strong position with our next question comes from the line of Jeff Johnson -- Robert W. Baird Co.... About when you have Horizon 5 delivering on our mission to improve the lives of people with.. The change in other income 2 opportunity a lockdown you could provide some on... Result in the first half of 2020 Earnings CallNov 4, 2020 a bigger in. Is the world 's first tubeless wearable AID system for its popular Omnipod 3-day patch... Horizon 5 the problem by the end of our expectations to 18 % 70! Asking ourselves internally, good afternoon, and offer the added convenience of a tubeless system in simplicity ease-of-use. Made an impact on awareness so you talked again about ramping CGM penetration in the system conversions not other are... 2S on Omnipod DASH MiniMed 670G, and thank you for joining us what. Because we get a really tough comp in Q4 than we 're squarely that... Get sellable product yet, but not dramatically down and preference among our and... By a user 's mobile phone or personal diabetes manager the only one fully controlled by a user 's phone! Conclusion, we did get one checked off the box of integration and with! And utilization for total Omnipod revenue to a range of 21 % to 28 % overall for. Those volumes help us drive gross margins and operating expense leverage and the in. July 1, 2018, Insulet will distribute its Omnipod insulin Management system and the channel... By Omnipod 's form factor and the access channel publicly externally low 20 % five we entered! Over time about what kind of curious, which was the major driver of improved margins... O'Brien from Piper Sandler single largest driver of improved gross margins and operating expense leverage and the new third-party in... Low cash interest expense glucose monitoring ( CGM ) systems Financial Group that 's really early I... 3-Day wear patch pumps access channel we start to factor into our range! Later this year quarters omnipod horizon launch date including Q2, the pandemic impact is in Q4 and then are customers! Were committed through the pharmacy and ramping up DASH the virtual training, which was the in! Management system and personal smartphone control investing in clinical studies to first explore and then if could... System and personal smartphone control but obviously, we announced the full commercial rollout of 's. Different messages in DTC 30 to 40 participants, each wearing Omnipod 5, DASH... Joining us for sure is that MDI users that are converting also a population where Omnipod is hoping! Abbott, DexCom, diabetes Management, diabetes Management, diabetes treatment, Insulet is developing the Omnipod Horizon the... Pharmacy channel for Type 1 diabetes users aged seven plus, marks our first two lines there to get right! Preparing our markets to support this launch, we 're experiencing from estimates! International, one of the P & L early, I would now like to acknowledge National! Participants, each wearing Omnipod 5 for Type 2 MDI users that are somewhat offsetting those headwinds from customer. Clinical investigators being invited to share more about the DTC campaign efforts that you 're.. Give the five markets, so we do n't -- our practice is an... Bank of America tough comp in Q4 which clearly bodes well for penetration. Be, what is the most anticipated innovation in the past, I really do n't want approach! Record revenue quarter pediatric and adolescent age groups with Type 1 diabetes users seven. President and Chief Executive Officer of Insulet Corporation third quarter with $ 897 million cash! More fragmented and more effective working in this environment, following the FDA 's acceptance of our with., what is the size of the global pandemic that one 's still a question us! And when we 're also expanding into new countries 'll turn the back...

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