PODD - NASDAQ

Good afternoon, ladies and gentlemen, and welcome to the Insulet Corporation Third Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder this conference call is being recorded. I would now like to turn the conference over to your host Deborah Gordon, Vice President Investor Relations.

Thank you. Good afternoon and thank you for joining us for Insulet's third quarter 2023 earnings call. With me today are Jim Hollingshead, President and Chief Executive Officer; and Lauren Budden, our Interim Chief Financial Officer and Treasurer. Both the replay of this call and the press release discussing our quarterly results and our guidance will be available on the Investor Relations section of our website. Also on our website is our third quarter supplemental earnings presentation. We encourage you to reference that document for a summary of key metrics and business updates. Before we begin, we 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. Please refer to the cautionary statements in our SEC filings for a detailed explanation of the inherent limitations of such statements. We'll also discuss non-GAAP financial measures with respect to our performance, namely adjusted gross and operating margins, adjusted EBITDA and constant currency revenue, which is revenue growth excluding the effect of foreign exchange. These measures align with what management uses as supplemental measures in assessing our operating performance and we believe they are helpful to investors, analysts and other interested parties as measures of our operating performance from period to period. Additionally, unless otherwise stated all financial commentary regarding dollar and percentage changes will be on a year-over-year reported basis with the exception of revenue growth rates, which will be on a year-over-year constant currency basis. With that, I'll turn the call over to Jim.

Thanks Deb. Good afternoon and thank you for joining us. Q3 was another strong quarter for Insulet with rapid growth and achievement of many strategic milestones. Thanks to our global team's execution, dedication and focus we are on track to complete another transformational year and enter 2024 with significant momentum. On today's call, I want to do three things; discuss our financial results and market traction provide an update on our continuing progress in clinical and market access work, and review key developments in our innovation pipeline. Our third quarter revenue exceeded our expectations with total Omnipod growth of over 27% including US growth of 35%. We also achieved total company growth of 25%. These are remarkable results especially coming in the context of our strong prior year comparables. As a result, we raised guidance once again for the full year. Performance was driven primarily by the huge success of Omnipod 5, our revolutionary automated insulin delivery system. It is gratifying to see the positive impact Omnipod 5 is having as it continues to simplify and improve the lives of people with diabetes and we are only in the early innings. Q3 represented the anniversary of the US launch of our Omnipod 5 platform. Omnipod 5 is the only FDA-cleared fully disposable pod-based AID system and it continues to transform diabetes management. Its simplicity, ease of use, widespread and affordable access and improved real-world outcomes have made Omnipod 5, the leading AID offering on the market. With the added benefits of US pharmacy channel access pay-as-you-go model and an easy onboarding pathway, Omnipod 5 makes it simple and efficient for health care practitioners, patients and payers to conveniently prescribe access and afford our breakthrough technology. We are now also beginning the global rollout of Omnipod 5 in our international markets starting with the UK this past June. With one full quarter under our belts in the UK we are seeing very strong early adoption. In Q3, Omnipod 5 drove accelerated new customer starts in the UK taking revenue growth to almost 45% year-over-year and driving approximately 70% sequential growth in new customer starts. It's a strong early sign of the global power of Omnipod 5 to transform diabetes care. During Q3, we also commenced the rollout of Omnipod 5 in Germany in August and early momentum is exciting. Based on these results, we are confident that Omnipod 5 will emerge as the market-leading offer everywhere it is available. The success of Omnipod 5 led to another outstanding quarter of new customer starts both in the US and globally. In the US, Omnipod 5 continue to represent the vast majority of our new customer starts in Q3 and customer retention remains strong. In the US in Q3, Omnipod new customer starts coming from multiple daily injections and legacy tubed pumps was an estimated 80-20 percentage split which is in line with our historical mix. Omnipod was specifically designed for individuals on MDI and as expected, we are driving pump penetration across all age groups in both the Type 1 and Type 2 markets, while also growing our share positioning Insulet as a leader in these markets. We estimate that we are the clear leader bringing customers into the market from MDI. In addition to growing awareness of Omnipod and high product demand among patients, a growing number of HCPs are writing scripts for it. In Q3, we saw another increase in prescribers growing to over 17,000 up from over 15,000 in Q2. In a market where there are 7,000 to 8,000 endocrinologists this shows the broad appeal and ease of prescription of Omnipod 5. Importantly, this extensive reach is critical to access patients who are not seen at the high-volume pump-prescribing clinics that historically defines the pump market. Omnipod 5's broad appeal is also evidenced by the growing number of scripts that these HCPs write for our system. Omnipod loyalty amongst Podders has been a hallmark of our brand for many years and it is great to see the growing demand and confidence amongst the prescribing HCPs. In fact an increasing number tell us that when given the choice their patients overwhelmingly choose Omnipod. Our results in Q3 also strengthen our conviction that we'll be able to reach the millions of people with Type 2 diabetes who need insulin therapy as a part of their care. In the quarter, Omnipod adoption in the Type 2 market continued at a steady pace with Type 2 patients representing approximately 20% of our US new customer starts. These new customer starts come from across our Omnipod portfolio of products, demonstrating the clear benefits that our products offer the Type 2 population. Omnipod DASH continues to be the leading insulin pump offer with an indication for use in the Type 2 market. While we can't yet market Omnipod 5 for Type 2, the obvious underlying demand for AID in the Type 2 market is encouraging. And we look forward to bringing Omnipod 5 to these customers once we complete our pivotal trial and secure an extension to our existing indication for use. And to that end, we are very excited to announce that we have reached our enrollment goal this week in our US Type 2 pivotal study. As a reminder, this is a study of up to 400 participants with a 13-week protocol comparing Omnipod 5 to participants' previous therapy. The feedback from HCPs and study participants continues to be very strong and strengthens our confidence that Omnipod 5 will have a big impact in the critically underserved population of Type 2 patients who require insulin. We will provide further updates as the trial progresses. I'd like to make a few comments about the ongoing debate about the impact of GLP-1s on our markets. As we've made clear, we regard the GLP-1 class of drugs as an important innovation for people with Type 2 diabetes and they have been indicated for use in Type 2 diabetes for several years. These drugs help many of the same patients we aim to help and we applaud their innovation. Further as a reminder, we believe GLP-1s do not materially impact our end markets. They are not indicated for use in Type 1 diabetes which is an autoimmune disorder and there is no apparent mechanism for them to impact the course of type one as a condition. Likewise, there is no apparent mechanism for GLP-1 drugs to alter the underlying progression of beta cell decline that is characteristic of Type 2 diabetes. Last month we published a short slide presentation going into these issues in more detail. This week we published an update to those slides based upon data that was recently presented at EASD. In a large retrospective study of 23,000 users of semaglutide, the evidence presented suggests three important conclusions. First, semaglutide has almost identical impact on glycemic control as liraglutide in terms of the magnitude and duration of A1c reduction. Second, this real-world evidence shows a very clear relationship between dose adherence and glycemic control such that only the most adherent users receive the level of benefit that has been demonstrated in more controlled clinical settings. Finally and importantly, weight loss and the persistence of weight loss for semaglutide users in this study was demonstrated to be independent of glycemic control. In short, real-world evidence shows that patients using semaglutide continue to have their diabetes progress with limited or no incremental duration of effect over previous drugs and type 2 diabetes continues to progress even with weight loss. For those who are interested in more detail, we refer you to our updated presentation which is available on the Insulet Investor page. These data reinforce our existing view. Because the underlying disease continues to progress most people with type 2 diabetes will eventually need to incorporate insulin into their therapy. Insulet is incredibly well-positioned to serve these customers as they progress in their condition and need to add first basal and then intensive insulin into their treatment. We are already winning in this market and we continue to have strong conviction that people with type 2 diabetes represent a large and underserved population. We are continuing our efforts to bring the full power of a broad portfolio of insulin delivery options including Omnipod DASH, Omnipod 5, and Omnipod GO, which I will come back to in a few moments. In addition to our type 2 pivotal trial, we are progressing several additional clinical initiatives. We are pleased to have completed the protocol with the last participant in our randomized controlled trial using Omnipod 5 with Dexcom's G6. We're in the process of analyzing and preparing the data, which we expect to show the clear benefits of Omnipod 5 therapy over non-AID systems. We are also making great progress with the RADIANT study which is our Libre 2 Integration trial, for which we began enrollment in September. Clinicians have remarked about the simplicity and ease of transition for MDI users to Omnipod 5 in the outpatient setting including in regions where it is often the norm for AID therapy to occur in the hospital for days due to the complexity of existing tubed pump offerings. We are excited that our integration with Abbott's Libre 2 sensor has advanced to the point where study participants are using the system. Both of these studies will provide the evidence we need to drive pricing and market access initiatives as we launch Omnipod 5 across our international markets. I'd now like to turn to three key areas of innovation for us; expanding the Omnipod 5 platform, moving upstream in the type 2 market with Omnipod GO, and driving the future of AID with our advanced algorithm program. The widespread success of Omnipod 5 makes it easy to forget that the current version of our offering is in some ways our minimum viable product. In order to achieve the full promise of the platform, our aim is to expand on customer choice, both for phone control and for CGM use. In that context, we are excited to have received FDA clearance for our 510(k) for the Omnipod iOS app. This is another major innovation milestone for Insulet and iOS is one of the most requested features from our customers. We are thrilled to have the opportunity to provide the iOS option to our existing Omnipod 5 customer base as well as future customers. Because the iOS app represents a completely new software platform we expect to begin a US limited market release in early 2024. And upon successful completion, we will make iOS for Omnipod 5 broadly available as soon as possible. With regard to CGM, our efforts to expand our sensor integrations with our partners, Dexcom and Abbott, continue to steadily progress. I've already mentioned our progress with Libre sensor integration in the context of our European trial. We are also hard at work to complete our integration with Dexcom's G7 sensor and we are excited to announce that we are planning for a limited market release of Omnipod 5 plus G7 also in early 2024. Omnipod 5 is the market-leading offer and with these coming innovations, we are confident we will be able to maintain and extend that leadership. A key innovation effort that moves us upstream from AID is Omnipod GO, which is designed to radically simplify the initiation of basal insulin therapy for people who need to start insulin as their type 2 diabetes progresses. Even small penetration into this market will meaningfully contribute to our long-term growth trajectory. We have commenced the commercial pilot for Omnipod GO in the US, which includes HCPs that we don't typically call on who are new to Omnipod most of whom who are primary care physicians. Our commercial pilot is providing us with the opportunity to present Omnipod GO and also to educate PCPs on all of our Omnipod offerings. Although early in our pilot, PCPs are telling us that Pod therapy is much easier than pump therapy. As a result these HCPs want to learn about the entire Omnipod portfolio. We expect both Omnipod GO and Omnipod DASH to make the treatment pathway far easier for these type 2 patients. Learnings from our ongoing Omnipod GO commercial, pilot will help us to refine our plans for commercialization in 2024. We are continuing to progress work on our next-generation AID algorithm with our Evolution feasibility trial which we began earlier in the year and which is being conducted in New

Thanks so much, Jim. It's an honor to serve as interim CFO. As Jim shared, Insulin achieved another quarter of robust growth financial performance and strategic progress. We once again delivered strong global new customer starts fueled by huge demand for Omnipod 5 in the US. And we are seeing a very nice uptick in new customer starts in the international markets where we launched Omnipod 5. As a result of our growing customer base, we delivered 25% revenue growth in Q3, finishing above the high end of our guidance range. Our outperformance was driven by global Omnipod growth of over 27%. On a reported basis, for total revenue, foreign currency was a 180 basis point tailwind compared to Q3 last year. US Omnipod revenue growth was 35% and exceeded our guidance range. Revenue growth continues to be driven by our annuity-based model and growing US pharmacy volume. This includes an increase in volume contribution from Omnipod 5 and Omnipod DASH and the related premium for Pods in the US pharmacy. Pharmacy channel access continues to be a competitive advantage and we remain focused on driving increased volume through this channel, which in Q3 represented between 90% and 95% of our total US volume. Omnipod 5 ramp dynamics resulted in an estimated net tailwind of approximately $10 million, which is in line with what we expected for Q3 guidance. As a reminder, since our launch, we have realized a recurring net volume benefit from new customers as well as from Omnipod customers converting to Omnipod 5, many of whom received their starter kits and first refill orders in the quarter plus some initial stocking in retail pharmacies. Our estimates have been net of those Omnipod 5 customers who skipped an order in the period. In Q3, as we expected, the volume benefit from conversions has been normalizing and was therefore immaterial as the majority of our existing customers already switched to Omnipod 5. Going forward, we expect continued benefit from the two script dynamics, as we drive Omnipod 5 new customer starts. In Q3, US attrition and global utilization remained stable. International Omnipod revenue increased 8%, which was above our expectations. Growth was primarily driven by continued strong adoption of Omnipod DASH and to a smaller degree incremental benefit from our Omnipod 5 launch in the UK, which drove a notable increase in new customer starts. These benefits were partially offset by slightly higher attrition as we continue to be impacted by AID competition including lower distributor orders. On a reported basis, foreign currency was a 720 basis point tailwind over the prior year. Drug Delivery revenue declined 27%, which was slightly below our guidance range, due to a lower forecast from our partners. Gross margin was 67.8%, up over 1,200 basis points and included income of $1.9 million due to lower estimated costs associated with the medical device corrections we announced last year when we took a charge of approximately $37 million in Q3 last year. Excluding both, gross margin increased 120 basis points to 67.3% in Q3 of this year. This exceeded our expectations due to favorable manufacturing costs and higher-than-expected revenue. The year-over-year increase in adjusted gross margin was primarily driven by improved manufacturing efficiency and a premium from volume growth in the pharmacy channel. These increases were partially offset by expected higher production costs as US manufacturing continues to ramp and become a larger portion of our total production. Operating expenses were up year-over-year in line with our expectations as we invested in our business to support our strong growth trajectory. Adjusted operating margin was 12.2% and adjusted EBITDA was 19.1%. Both exclude the favorable medical device correction adjustment of $1.9 million and were above our expectations due to higher-than-anticipated revenue and gross margin. Turning to cash and liquidity. We ended the quarter with $685 million in cash and the full $300 million available under our credit facility. This strong financial position gives us the flexibility to invest in our innovation pipeline and other key areas of our organization in order to build on our foundation for long-term sustainable growth. Now turning to our 2023 outlook. For the full year, we are raising our expectations for total Omnipod revenue growth to a range of 29% to 30% and total company revenue growth to a range of 26% to 27%. For US Omnipod, we are increasing our revenue growth outlook to a range of 37% to 38%. This increase is primarily driven by continued strong Omnipod 5 adoption stemming from consecutive strong new customer starts and to a lesser extent ongoing conversions from other Omnipod products as well as from recurring revenue from Omnipod DASH and the benefits of our pay-as-you-go model in the pharmacy channel. As a reminder, Q4 of last year was the first full quarter of Omnipod 5 sales contributing to a tougher comparison in the fourth quarter of this year. The prior year included the two-script benefit, which was in large part due to the accelerated pace of customer conversions in the second half of 2022. It also included retail channel stocking. For International Omnipod, we are raising the low end of our guidance range and now expect 9% to 10% growth. On a reported basis we estimate a favorable foreign currency impact of approximately 100 basis points. We expect growth will be driven by ongoing Omnipod DASH adoption as well as the benefit from our Omnipod 5 launches in the UK and Germany partially offset by AID competitive headwinds. As a reminder, given the nature of our annuity model we expect Omnipod 5 to more meaningfully contribute to our growth rate in the second half of 2024. For Drug Delivery, we are reaffirming our guidance range of a 45% to 50% decline. Turning to 2023 gross margin. We are raising our adjusted gross margin expectations to a range of 66% to 67% and expect to achieve the midpoint of this range. The increase from our prior guide is driven by improved manufacturing costs as well as higher-than-expected revenue including favorable mix. Although certain headwinds that we experienced during 2023 will carry over into next year, we expect to see further gross margin improvement in 2024. We now expect adjusted operating margin in the range of 9% to 10% given our revenue and gross margin outperformance. We remain committed to margin expansion and anticipate leveraging our investments in 2024 and beyond. Turning to our fourth quarter 2023 revenue guidance. We expect total Omnipod and total company growth of 22% to 25%. For US Omnipod, we expect growth of 28% to 31%. Even with the challenging comp due to the Omnipod 5 full market release in August of last year our new customers start momentum and the benefits of our annuity model continue to fuel our revenue growth, including strong expected sequential dollar growth in Q4. For International Omnipod, we expect growth of 5% to 8%. On a reported basis, we estimate a favorable foreign exchange impact of approximately 300 basis points. Finally, we expect Q4 Drug Delivery revenue to be approximately $3 million to $5 million due to timing of production and orders. We have sustained momentum across our business and we are poised for another strong year in 2024. While we will provide formal 2024 guidance on our Q4 call in February, I will provide some color now on how we are thinking about 2024 given the strong momentum we see in the business. We anticipate another year of large dollar growth in 2024, even with the significant volume benefits realized in 2023 from our Omnipod 5 ramp. For US Omnipod, we expect a growth rate within the mid-20% range, fueled by Omnipod 5 and its strong pace of new customer starts as well as our annuity model and pharmacy channel access. For International, we expect continued growth with Omnipod DASH and more meaningful growth towards the second half of the year from our recent Omnipod 5 launches in the UK and Germany. We expect continued headwinds in the countries where we do not yet have Omnipod 5 to partially offset this growth. All in, that puts us somewhere in the high single digits for the year with the second half of the year accelerating to a range of high single digits to low double-digits. For Drug Delivery, we expect to see a decline and at the high end of the forecast, we expect the decline to be lower than in 2023. In conclusion, we delivered another quarter of solid financial performance and we further positioned Insulet for continued momentum through the end of this year and beyond. As we continue to capitalize on the global market opportunity and invest in innovation, we're poised for another strong year of customer base growth and revenue growth. Opportunities of this magnitude are few and far between, and we are very well positioned to drive long-term value creation for our shareholders. With that, operator, please open the call for questions.

Thank you. [Operator Instructions] Our first question comes from Robbie Marcus from JPMorgan. Please go ahead. Your line is open.

Hi. This is Rohan [ph] on for Robbie. Congrats on a really nice quarter. So there are several exciting developments you outlined on deck for 2024 just between CGM integration iOS launch and continued international expansion. And thanks for providing that color on those preliminary targets for next year as well. But my question is more related to how we should think about the growth contribution from each of these tailwinds next year and the puts and takes and what's assumed in those preliminary targets that you outlined? Thanks.

Thanks Rohan. We're really excited about the growth catalysts that we have coming. We've obviously got great momentum continuing to drive really strong demand and new customer starts in the market really well positioned. And we're very excited about getting into the limited market releases for both iOS and G7 early in the year and also really excited about continuing progress with the Libre integration. So we think they do drive continued growth for us. And in terms of the guide we haven't really guided on the number for that. It's really in our color. But we do think it opens up a lot of potential growth for us across the board. They're all important. And I wouldn't want to necessarily weigh one over the other so we think they all drive catalyst. But I'll ask Lauren and Deb if they want to add any color to that.

Sure. Thanks, Jim. So yes we have factored them in. But given our annuity model as Jim said it's not expected to be a meaningful contribution. And we're just entering in LMR in the beginning of the year.

Our next question comes from Larry Biegelsen from Wells Fargo. Please go ahead. Your line is open.

Hi. This is Charles [ph] on for Larry. First congrats on the nice quarter. And I just wanted to ask I don't know if you said this already. Did you say new patient starts were a record worldwide? Did I hear that right? And then I got a quick follow-up.

New customer starts were really strong not quite a record. And so second we're not we don't want to get in the table ranking all of our quarters all the time, but it was our second-highest quarter ever of new customer starts just coming in behind. Q2 was kind of a blowout quarter for us in new customer starts where everything hit on every cylinder. So really happy with the new customer starts, but not quite a record.

Okay. Thank you. And just a quick follow-up. Wondering if you might be able to give an update on the search for a new CFO. What exactly are you looking for there? And I wonder if you could give a possible time line you might hope to have an announcement there.

Sure Charles. First of all we're really happy to have Lauren in the chair. She's been with us for a long time. She's such a great contributor to the company and to our senior finance team and really blessed to have somebody of Lauren's caliber to step in in this interim. And we're conducting a search. We're just out of the market now with the search. We've written the spec. And I don't really want to talk about the characteristics and so on that we're looking for. We think that the CFO job here is a really fun job. We have internal candidates who are really strong including Lauren and early look at the market looks really promising. We want to move as quickly as we can because we want to get to some stability there. But we're very confident we'll get the right person in the role.

Our next question comes from Stephanie Piazzola from Bank of America. Please go ahead. Your line is open.

Hi. Congrats on a good quarter. I wanted to ask more about margins, which were really strong in the quarter and throughout the year have been showing improvement each quarter. So appreciate the revenue color you gave on 2024. But if there's any color you could share on margins for next year that would be helpful, maybe any of the puts and takes to consider there? Thank you.

Yeah. So…

Thanks Stephanie. I'll turn to Lauren on that. Go ahead. Sorry Lauren. Go ahead, go ahead.

So we're not providing guidance today. But just a little colour we are committed to expanding our margins. We're thrilled that we increased gross margins for the full year of 2023 to 66% to 67%. And we are also very thrilled that we increased the high-end of our operating margin guidance range as well. So we're very focused on increasing those and we would expect that trend to continue going forward as well.

Our next question comes from Jayson Bedford from Raymond James. Please go ahead. Your line is open.

Hi. Good afternoon. This is Jayson on for Jayson. So big picture have the physician or user discussions changed with greater GLP adoption? I'm just wondering, if you changed your marketing strategy in any way? And then just quickly as a related follow-up can we assume that the year-over-year growth in new Type 2 users was higher than your overall U.S. Omnipod growth? Thanks.

Hi Jayson. [Indiscernible] So yeah, no we haven't changed our marketing message at all. The Omnipod 5 Pod and Omnipod DASH are so effective in insulin delivery. The pilot with The Omnipod 5 Pod though is -- we're learning a lot. It's going well. And GLP-1s are out there. GLP-1 has been indicated for some time in the market. And so we haven't changed our messaging. I think that we continue to learn about GLP-1s. And if we need to adapt our messaging we will. But we haven't had to change our messaging and we continue to obviously have a lot of success. Can you remind me of the second part of your question there, Jayson?

Type 2 -- it looked like Type 2 was strong just in terms of Type 2 adoption. Can I assume that it grew faster? If I just look at the number of type two added in 3Q this year versus last year it feels like, it's faster than overall Omnipod growth, if there's a way to bless that assumption that would be great.

I'm not sure I would jump to that split. Go ahead. Go ahead, Lauren.

I was just going to say it grew about the same.

Our next question comes from Patrick Wood from Morgan Stanley. Please go ahead. Your line is open.

I was going to make a joke about it. I think somebody else put the accent kind of gives me a way I am afraid. Thanks for taking my question. I'm just curious like big picture not about 2024 just slightly longer term how the launch in the U.K. and I mean, I guess, some of what's around Germany, how you're thinking the time line to returning to double-digit growth OUS [ph] could look. And is there anything you're seeing in those markets that would sort of prohibit you from reaccelerating as Omnipod 5 pushes through that region? Thanks.

Thanks. Yeah, we're so excited about getting Omnipod 5 into multiple markets in Europe. As we said -- as we detailed in the prepared remarks the U.K. launch is going really well. Germany is strong out of the gate. In direct answer to your question we don't see any barriers to driving really strong and robust growth where we launch Omnipod 5. And as I think I said in the prepared remarks we're very confident it's going to be a leading offer wherever we're able to put it in the market. So it's such a great solution it's so easy for customers to use. It drives such great real-world results. And as we get more evidence and we can drive access conversations we're also confident we can get a price premium for the value that Omnipod 5 creates. And so we're all systems -- full speed ahead in getting into our international markets with Omnipod 5.

Our next question comes from Jeff Johnson from Baird. Please go ahead. Your line is open.

Thank you. Good afternoon guys. Nice quarter. Jim maybe if I could pin you down on a little bit more detail on the Sensor Integration side. So in LMR on G7 integration in the U.S. early in the year I know it's going to depend on what you see in the field what the feedback is and all that. But just generally do we tend to think of LMRs I could go back and check my notes I guess in O5. Is that like a three-month LMR and then a full launch or just how to think about that? And then on the L2 front obviously you gave some updates internationally. How should we think about the time line L2 in the U.S.? And L3 OUS and U.S. any updates there at all, just once L2 comes out integration is it a 6-month or is it a year? How far down the road might we see L3? Thanks.

Yes. Thanks Jeff. I'll go in reverse order. We're not providing additional guidance on timing for the Libre family of sensors at this point. We do feel good about the integration we have going with our RADIANT trial. And the customer experience on the RADIANT -- which is the Libre 2 integration that we're doing in Europe. The customer experience on the RADIANT trial has been terrific. And so, we're very bullish on that. And obviously to be in trial with that system we have to have a working integration. So, we're bullish on that, but we're not ready to provide timing on Libre for any specific markets at this moment. On the LMR question, it's a great question. We don't -- we think of LMR as exercises to test hypotheses and make sure the system is working the way we want it to. So we don't actually put a time line on it. We put a set of conditions on it. And so, as we get into market with LMR, we'll see what we see. Obviously, we wouldn't be going into LMR with the G7 integration, if we weren't confident that the system was working as expected. But with all of these things, you have to get the product out in a while to see how it performs. And so we'll get the LMR out there and we'll move as quickly as we can and we're really excited about bringing that G7 integration to market.

Our next question comes from Matt Taylor from Jefferies. Please go ahead. Your line is now open.

Hey, thanks for taking the question. I guess I wanted to ask you more about your efforts in type 2. Obviously, you're having some good success there today with 20% coming into the fold and that being a consistent level over time a healthy level. But I guess my question is, as you get the hopefully additional indications that are able to market, do you expect the proportion of type 2s to increase in the future? Maybe offer some thoughts on where that could go to. And also, could that even further broaden the prescriber base once you have that?

Thanks, Matt. Those are both great questions. First thing I'll say is, we're so strong in type 1, all right? So our offering in type 1 is bringing so many customers into the market from MDI that we expect to continue to drive penetration to the type one market and bring those customers who are currently not on a technology-based solution onto Pod therapy. And so -- and therefore that portion of the growth will continue. We're very bullish on growing MDI in type 1. Type two is a massively underpenetrated market. And we've been through the numbers on this a couple of times. And it's in our deck that we put up our investor deck that shows the market size for type two -- the progression of type two disease. But we've got 30-some-odd million people diagnosed with type 2 in the US who then progress on the basal and then on to intensive insulin therapy. Right now, there are about 2.5 million people in the US market who need intensive insulin as a part of their type two diabetes care. And they're just really underpenetrated as a market for pump therapy overall and therefore for Pod therapy. And we're very, very bullish on that. So if you think about -- we'll continue to penetrate type 1. Type two is actually a larger end market for intensive insulin therapy than type 1. So the proportion -- I do think to your point, the proportion will probably swing as we're able to get the indication for use and drive adoption in the market, but the numbers will go up. The total adoption number of customers will go up on both fronts.

Our next question comes from Matthew O'Brien from Piper Sandler. Please go ahead. Your line is open.

Hey this is Phil on for Matt. Thanks for taking our questions and congrats on the quarter. Just wait Jim, as we think about the key growth factors for the business being on the volume side of things, the ratio of MDI to conversions has marched from 50-40 to now 80-20 in the US. Are you seeing any kind of slowdown in your ability to convert competitive pumpers? Also, if you could provide that same ratio in OUS given the launch there, what does that MDI-to-conversion ratio look like in Europe?

Thanks, Phil. The Q3 doesn't look hugely different from Q2 in terms of the mix of components of where customers are coming from. The only difference was -- and if I just back up, I'll go into the weeds for a second I apologize for going into the weeds. When we talk about sources of customers, whether it's type 1, type 2, MDI competitive conversion, we have different sources of data that allow us to estimate that including voluntary -- so when a customer enrolls on Omnipod, they will tell us where they're coming from usually. So it's voluntary information. It's not 100% data capture and what that means is there's a little bit of an estimation kind of range on those things. And so, Q3 compared to Q2 didn't look all that different. The only thing that looks different enough for us to change the number was competitive conversions went -- as you said, last quarter, we said it was 75-25. In this quarter, we said 80-20. But even that in terms of total number and range of estimate was not that huge a change. And we've been really happy with competitive conversions over the course of the launch of Omnipod 5. We're really clear at launch that the number, the volume of people converting from tubed pumps was a pleasant surprise for us. And we sustained that for a long time and probably a little longer on balance above historical trends of 80/20 sustained it for a little bit longer than we thought. So it's not really a surprise for us to get back to this 80/20 mix. And what it means is we continue to bring we're the clear market leader in bringing customers from MDI on to -- you could talk about again the broad category of AID but on to AID Pod therapy on Omnipod 5. We're the clear market leader in bringing MDI into the market and we're still taking share out of the installed base of tubed pumps. And so we don't really see anything in the data. And out in the market we see a lot of promotional activity. But we haven't -- our field is not really reporting any move that's making it harder for us in any way to convert people off of their tubed pump experience because Omnipod 5 and for that matter Omnipod DASH are so compelling. So that's maybe a long more in-the-weeds answer than you're looking for but that's how we see it. On the European side of the question, it's -- I think we're going to see that different market by market. And in fact in the UK what we see is different hospital by hospital. So in some instances, the NHS trust hospitals are tilting more towards new customer starts with Omnipod 5. And in some cases, they're tilting more towards upgrading from Omnipod DASH as a mix on balance more conversion than new customers start. A little bit of that is driven by physician preference and a little bit of that is driven by the hospital budget for the year. And so I think we'll see -- and I think it will look a little different in Germany and I think they'll look a little different as we get into other countries. As a reminder, the contracting in Europe locks everybody into a contract. So in the US we're in the pharmacy channel. It's easy to convert from a tubed pump on to Omnipod 5. In most of the European markets whether you're on an Omnipod DASH or you're on a tubed pump, you're locked into a contract for a period of time. And so for example in the UK it's at the discretion of the hospital to upgrade somebody to an Omnipod 5. And so that market behavior will look a little bit different market by market. What we do know is that Omnipod 5 is just -- the pent-up demand for Omnipod 5 in our European markets is really strong and you can see the results already in the UK.

Our next question comes from Margaret Kaczor from William Blair. Please go ahead. Your line is open.

Hey, good afternoon. Thanks for taking the question. I wanted to talk a little bit about Omnipod GO. I think you had mentioned that you're maybe seeing some pull-through in sales for the whole Omnipod family even early on. So is there any more detail around what you're seeing and how that relates maybe to the long-term commercial opportunity of a patient per account basis or however you look at it? And then as a follow-up, which I'll sneak through as you think about 2024 guidance, are you assuming any of that benefit from that pull-through direct sales from Omnipod 5? Thanks.

Thanks Margaret. I'll do them in reverse order. We haven't put anything formally into the guide out of the Omnipod GO pilot and we're still planning -- so this is not even yet a limited market release. It's a commercial pilot. And so we haven't tried to quantify that or include any of it into the color that Lauren provided or the guide. The pilot the -- I'm really pleased that we're piloting it in the way we are because we are doing exactly what we wanted, which is we're learning a lot. And it's I would say a pleasant surprise as we get into these PCP practices and talk to them about the offering that not only do they recognize the target patient profile for Omnipod GO as we characterize it. But as we explain Omnipod GO and they see the ease of use of Omnipod GO they ask us about the broader product portfolio. And I don't think we anticipated that that would be happening. And so it's -- and what it tells us is that Omnipod therapy genuinely is so simple to use that it should open up the conversation in primary care. What we're using the pilot for is to figure out what are the mechanics of that. So what does it look like? How many reps? What's the call pattern? What's in the bag? And we're testing things like the target patient profiles and things like that. And so I continue to think of it as early days but the learnings from the pilot have been really, really productive for us as we think about how to approach type 2 patients in the primary channel.

Our next question comes from Joanne Wuensch from Citigroup. Please go ahead. Your line is open.

Good afternoon. This is actually Anthony [ph] on for Joanne. Thanks for taking our question. Just a quick easy one here. I just want to confirm the $10 million this quarter that was associated with the Omnipod 5 ramp dynamics. I just want to confirm that was the tailwind. And then are you providing any guidance on what this number could be next year whether it's a tailwind or a headwind? Thank you.

Yes. So the $10 million is the double script phenomenon. And what's different now is that conversions is really a small component of that. So it's really immaterial. So going forward we expect the double script phenomenon to continue, but it's really just part of our normal growth rate going forward on new customer starts.

Our next question comes from William Plovanic from Canaccord Genuity. Please go ahead. Your line is open.

Hi. This is Caitlin Cronin on for Bill and congrats on a great quarter. Just to dig into US competition a little bit more it seems like there's been a few new entrants into the market this year and updates and potentially some early next year. How are you thinking about kind of the competitive landscape for tubed pumps and then also kind of for patch pumps in development going forward? Thank you.

Hi, Caitlin. We're very confident in our competitive position. Omnipod 5 with G6 sensor is the best AID offering on the market. And what we see coming in competitor pipelines -- we think nothing in competitive pipeline is as good as Omnipod 5 with G6. And so -- and it doesn't mean that there won't be competition. As I said earlier, we see our competitors out there's a lot of promotional activity around from some of our competitors. So we see that out in the world. We haven't really seen it impact our results at this point. Now competition always -- I think -- first of all, I think, competition is great for business. It helps everybody learn and develop better products and it helps customers have better experience, which is what we're all trying to do. And so we know there's going to be competition. We know our competitors continue to try to innovate, but we're very, very confident in our competitive position and our growth profile. And that's why we're so excited about the growth catalysts we have coming in 2024. As to patch pump companies there's patch pumps -- we're the leader in patch pump. There's not really a viable patch pump competitor that we see on the horizon. And so that's another reason that we're very, very bullish on our position and expect to continue to lead the market.

Our next question comes from Mike Kratky from Leerink Partners. Please go ahead. Your line is open.

Hi, everyone. Thanks for taking our question. So regarding the ongoing SECURE pivotal trial for Omnipod 5. How are you thinking about how that could impact the commercial opportunity for this product over the next few years? And what are the other main drivers that you expect to increase penetration within the insulin-intensive Type 2 patients that remain so underpenetrated?

Thanks for the question. We're very excited about the SECURE trial. And as I said in our prepared comments, we've completed the goal for recruitment. And so just to be clear what that means that trial is designed to be up to 400 patients, but it has a minimum number of patients that are required. And so we crossed over the hurdle for the minimum number of patients. And the way to think about that is that it derisks the trial from an enrollment point of view. So we now are certain to have enough patients to successfully complete the trial. Enrollment is still open. So we'll continue to enroll some patients for the next little while because it's always better to have more patients in the trial rather than fewer. But -- so the trial is derisked operationally now with enough patients in to get a powered results that we need. And we'll continue the trial. And then it's a 13-week protocol. Once the last patient is in they'll complete the 13-week protocol. We'll gather the data, we'll clean the data, we'll prepare submission and so on. And then it will be in the hands of the FDA. And that will be a huge unlock for us in the Type 2 space. We're already the market leader in Type 2 with Omnipod DASH. Omnipod DASH has had an indication for use in Type 2 for some time. And we've been promoting Omnipod DASH for Type 2 this year. And you can see the results already. So if you saw quarter-over-quarter DASH actually did really well in the quarter, a little bit better than last quarter in terms of percent of revenue. And that's clearly because as we're out talking to physicians about Type 2 patients and Pod therapy we're driving growth in Type 2. We also know -- even though we cannot promote Omnipod 5 because it does not yet have an indication for use we do know that AID for people with Type 2 and specifically Omnipod 5 AID for people with Type 2 has very high appeal and physicians are writing it off label even though we're not promoting it. And so when you take those two things together the success of Omnipod DASH in the Type 2 market, the obvious pent-up demand for Omnipod 5 in the type two market once we get the indication for use with a successful result from the SECURE trial we think it will unlock massive growth for us. That will come in the endocrinology channel. That's what we also think type 2 growth can come out of the PCP channel which is why we are piloting Omnipod GO in the PCP channel because it extends our reach upstream for type 2 patients, as they initiate insulin therapy with a basal offering. And then as they progress, they will already be on an Omnipod offering and they should pretty seamlessly progress onto either Omnipod DASH or Omnipod 5.

Our next question comes from Steven Lichtman from Oppenheimer. Please go ahead. Your line is open.

Thank you. So you mentioned earlier you're clearly moving your prescriber base past high-volume endos. Do you need to expand sort of your feet on the street meaningfully as this prescriber base continues to grow? Or are you seeing leverage opportunities from your current team?

Great question, Steve. And I would say two things on that front. The first one is, we are considering expanding feet on the street and that's part of the Omnipod GO commercial pilot to figure out how many feet on the street we need to get the reach that we want. The other thing is we get a lot of leverage out of DTP. And so a lot of the physicians that are writing for us, don't necessarily have a rep calling on them right now. And what's happening is our DTP advertising often reaches physicians by the way. So they often see the product through our online media or maybe on the TV ad, but patients go in and ask for Omnipod into those practices that we don't necessarily have a call routine with. So we're getting leverage in that way already. And then we will consider adding feet on the street as you say as appropriate over the coming quarters.

Our next question comes from Chris Pasquale from Nephron. Please go ahead. Your line is open.

Thanks. I just want to follow-up on the O5 type 2 opportunity. How are you thinking about the time line for FDA approval? And then also for presentation of that data - because it sounds like there's also already a fair amount of off-label interest. And it would seem like perhaps the data presentation itself could be a catalyst to spur even more interest before you actually get the labeling?

Great questions, Chris. First on timing, we haven't announced a formal time line on getting to an FDA clearance out of SECURE trial, but it's fairly easy to do the math. I think the last patient will probably be in no later than the end of the calendar year a 13-week protocol analyze the data to do a filing. So I think it's safe to say that, we'll be filing with the FDA in 2024 for sure for clearance. And then we'll see what happens in terms of -- each of those steps can have a plus or minus on the time line on them. But we expect to file next year for that. In between now and then there's a couple of things that are in terms of data on the study. We have published data out of our type 2 feasibility trial. And as we've referred to that in the context of the GLP-1 news that what we do see in -- out of our feasibility data is that the patients in that smallest trial who were also on GLP-1s actually did better on Omnipod 5 than patients not on GLP-1s and for reasons that we explained in the slides that we posted last quarter and that we've updated this week. And so GLP-1s make the body more sensitive to insulin and they reduced the required dose. And so the combination of the 2 actually ends up with a better outcome for patients which is interesting. And along those lines we anticipate that we will have a large number just about half plus or minus of the current enrollees in that trial are already on either an SGLT2 or a GLP-1. And so we anticipate being able to report out on subsets of the trial. That may happen -- it may happen before the FDA filing it may happen after but we anticipate being able to do some kind of scientific reporting on that as well during 2024.

Our next question comes from Marie Thibault from BTIG. Please go ahead. Your line is open.

Thanks for squeezing me in. Congrats on the iOS clearance. Just a quick one here on that. When might we see the G7 Omnipod five integrated with iOS as well just all the latest generation? Thanks.

We haven't guided the timing on that Marie. You can imagine that that's a very urgent matter for us to get to. But we'll do first things first. And so we'll get an LMR with iOS which will be a G6 offering initially. And we'll get into LMR G7 and then the two systems will come together after that.

Thanks, Josh. I'll provide -- we don't have perfect data on the specifics of your question, but we're very well penetrated with endocrinologists. We know that some of those prescribers are nurse practitioners and other care extenders, in endo practices. And then we know that some of the writers are PCPs or PAs attached to nonspecialist practices as well. But, I don't think -- I mean I'll turn to Lauren and/or Deb, to see if we have other color than that. That's the color I think we have.

No. This is Deb. That's the color that we have, Jim. It's great because, what we are seeing is we're seeing increases from all aspects. We're seeing increasing prescribers from endos, increasing prescribers from HCPs. And it's great that we also have PCPs, that are becoming aware of the system and prescribing it. So, we look at the trend data and we see it increasing over the last quarter and it's been great. So, we'll see where it goes from there.

Thanks, Danielle. Primary care physicians are really important in the Type 2 patient journey absolutely. And a couple of things, that we're doing there. One is, that's a main -- that's one of the main objectives of our Omnipod GO commercial pilot. We really want to understand better than we do right now, kind of in person what's going on in the primary care channel. And so the Omnipod GO commercial pilot has allowed us to get into a number of primary practices, present a target patient population of them, which we're finding is ringing true for them for the GO offering. And as I said earlier, it's really allowing us to see that -- primary practices, don't know much often about our portfolio products. And once we get in there they're very interested in our full portfolio including Omnipod DASH. And of course, we're not indicated for Omnipod 5, so we're not promoting it there. But it's giving us an opportunity to talk about the whole portfolio. And out of the pilot, we'll develop a better approach or find approach for how to commercialize into primary care. And there are several other options. The other thing, that that we see is that our DTP advertising or sorry direct-to-patient direct-to-consumer-type advertising, and our social media does tend to reach into the primary channel. So physicians, often see that media and patients often see the medium walk into their position and ask about it. So, we're getting leverage in that way as well. And I agree with you we need to really service type 2 patients. We need to find them where they are and very often where they are as in the primary channel.

Our last question today will come from Matt Miksic from Barclays. Please go ahead, your line is open.

Great. Thanks so much for fitting me in. So, maybe just if you could with sort of the thinking of entering the basal market potentially on the other side of this, just give us a sense of your expectations there in terms of is this sort of attaching with relationships with patients potentially as they move into a more insulin-intensive clinical needs. Or is this a portion of that market that you feel -- I'm speaking beyond the sort of out-of-pocket interest that you've seen so far. But -- is there a portion of that market that you think is particularly attractive and maybe the size around that? Just sort of an update on your view as to what is that opportunity in addition of course being very large compared to the insulin-intensive opportunity? Thanks.

Yes. Thanks Matt. There are at least 3 million patients in the US who are on basal-only therapy. Some people say 4 million, so let's call it 3 million to 4 million people on basal-only insulin therapy who have type 2 diabetes in the US. Really only a small penetration in that market helps meaningful with our growth trajectory because our aim is to not only serve those patients but to introduce the Omnipod family of products to them such that when their disease progresses, which is essentially inevitable, as their disease progresses, we have a relationship with them. We're helping with the therapy early and then we stay -- they stay with us, we stay with them as their disease progresses. The target patient population there is -- there's a lot of people there and there's a lot of offerings in there. There's people on MDI. We've been asked before and we're conscious of the fact that the insulin companies are looking to launch once-a-week insulin, which will be a type of therapy in that market. We think there's a lot of room in that market for different offerings. And for us there's some clear benefits that we bring to market with Omnipod GO, which include there's no needles. So, there's a very significant percentage of patients don't want to do an injectable therapy because they don't like needles. And then the other thing is people forget to take their care. They forget to take their insulin. And so we think that we solve both of these problems for both patients and their physicians and that's what we're testing out in our commercial pilot. So, we think there is a meaningful market there for us for Omnipod GO with basal-only therapy. And importantly, we think when we get to those patients and help them early in their patient journey, we can help them throughout their patient journey. And eventually many of them will end up on Omnipod DASH or Omnipod 5. And so that's the theory of the case. It's both end. It's a meaningful market for us is a basal market. And it's early customer acquisition if you think about it that way early in the patient lifecycle, which helps us to acquire those patients much further upstream.

I'm showing no further questions at this time. I would like to turn the conference back to Jim Hollingshead for closing remarks.

Thank you everybody for joining us today. We're really excited to have delivered another outstanding quarter for Insulet with our Omnipod family of products, clearly driving growth and have great momentum in the type 1 market, both in the US and now excited internationally, as we've launched Omnipod 5 in the UK and Germany and are on track to deliver in other international markets. Clearly, leading the market in type 2, which is a very exciting development for us. I want to thank all of our Insulet employees for their dedication and for their focus on mission because it's helped us to get out and continue to reach all the people out there that we've reached helping them simplify their lives with diabetes. There are millions of people around the world that we intend to help and we're well on track to do that. Thanks everybody for joining us today and have a good evening.