Good day, and thank you for standing by. Welcome to the Insulet Corporation Q3 2021 Earnings Conference Call. At this time, all participants are on a listen only mode. After the speaker presentation, there will be a Q&A session. To ask a question during the session, you will need to press star one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your first speaker today, to Deborah Gordon, Vice President, Investor Relations. Please go ahead. Thank you, Dalam. Good afternoon, and thank you for joining Insulet's Q3 2021 earnings call. With me today are Shacey Petrovic, President and Chief Executive Officer, and Wayde McMillan, Executive Vice President and Chief Financial Officer. Bret Christensen, our Executive Vice President and Chief Commercial Officer, is also with us today for the Q&A portion of our call. Both the replay of this call and the press release discussing our 2021 Q3 results and guidance will be available on the investor relations section of our website. Before we begin, I would like to inform you that certain statements made by Insulet during the course of this call may be forward-looking and could materially differ from current expectations. Please refer to the cautionary statements in our SEC filings for a detailed explanation of the inherent limitations of such statements. We will also discuss non-GAAP financial measures with respect to our performance, namely adjusted EBITDA and constant currency revenue, which is revenue growth excluding the effect of foreign exchange. 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 Shacey. Thanks, Deb. Good afternoon, everyone, and thank you for joining us. Our Q3 results reflect outstanding execution by our Insulet team and momentum across our global business. We delivered 17% revenue growth, driven by total Omnipod growth of 22%. While we are experiencing headwinds related to the ongoing impact of the global pandemic, revenue growth was near the high end of our expectations. We achieved these strong results thanks to our annuity model, which is a competitive differentiator that provides insulation from market disruption. We continue to achieve strong new customer additions, and we celebrated another record-setting quarter in the United States. We are seeing more impact from COVID internationally and expect this to continue over the short term. We are also seeing increasing preference for automated insulin delivery systems among people with type 1 diabetes, setting us up for an exciting launch of our first AID system, Omnipod 5. Until then, we expect these factors to affect our top-line results in Q4 and for a portion of 2022. Nevertheless, we continue to expect double-digit revenue growth in Q4 of this year, including high teens to low 20% for total Omnipod, with positive momentum entering 2022. Wayde will elaborate on this in his remarks. Our team has done a remarkable job navigating this dynamic time in the market, and 2021 will mark not only another year of strong revenue growth, but also tremendous advancement of our strategic priorities. Diabetes is becoming more prevalent, and pump penetration in both the type 1 and type 2 markets is low. In fact, we believe the U.S. type 1 market can double over the coming years from its current penetration rate of approximately 1/3. Additionally, the type 2 market, with a U.S. penetration rate in the low single digits, offers significant room for growth. We already see people with diabetes adopting technology at accelerated rates, driven by pod therapy and automated insulin delivery. Internationally, both the type 1 and type 2 insulin-intensive markets are even less penetrated, with sizable runways for expansion. We continue to disrupt the old market paradigm with a leading technology and differentiated business model that deliver an improved customer experience and improved outcomes. Our success in the type 1 and type 2 markets demonstrates the power of Omnipod and the value it delivers compared to MDI and legacy pump therapies. While not having a commercialized AID system presents some competitive headwinds in the near term, our performance without Omnipod 5 highlights the incredible growth opportunities that we will begin to unlock in 2022 and beyond. We expect AID adoption and our highly differentiated platform to provide years of exciting growth as we advance our mission to improve the lives of people with diabetes. Our journey will take a major step forward with the expected upcoming FDA clearance of Omnipod 5, which remains on track to occur later this quarter. As we recently shared, we submitted our responses to the FDA's request for additional information in September. We are pleased to have that part of the process complete and can't wait to bring Omnipod 5 to market, as we are confident it will be a transformative product for people living with diabetes. We are in the final stages of the review, and our team is working closely with the FDA, who has been a great partner in the process. Advancing toward Omnipod 5 clearance is not the only strategic progress we made this quarter. We continue to drive growing Omnipod DASH coverage and volume through the U.S. pharmacy channel and further penetrate the type two market, where we are uniquely positioned with our product innovation and differentiated business model. Omnipod DASH has proven to be a terrific solution for people living with type 2 insulin-requiring diabetes, where today we have established a leadership position. Additionally, we continue to amass compelling clinical evidence that supports Omnipod's many benefits. This includes impressive new Omnipod 5 data we shared in September at EASD. Taken together, we are on track to deliver another year of strong financial and operational performance and outstanding strategic progress. I will now speak to each of our strategic imperatives, including expanding access and awareness, delivering consumer-focused innovation, growing our global addressable market, and driving operational excellence. Access and awareness both remain critically low throughout the global diabetes market, despite millions of newly diagnosed people each year. Awareness of advanced technologies like Omnipod needs to increase, especially awareness of its many benefits, such as its simplicity, discretion, improved quality of life, and better outcomes. In addition, access to technology is still far too complicated. We have broken down barriers through our innovative pay-as-you-go business model in the U.S. pharmacy and raised awareness through our direct-to-consumer campaigns. We are pleased with the impact both efforts have had on improving access for many who require care. Even with our successes to date, however, many opportunities remain to improve access and awareness in order to empower more people with diabetes to live healthier, easier lives. In the United States, our pay-as-you-go business model in the pharmacy channel provides benefits for everyone. It's more efficient for Insulet and provides an improved experience and lower out-of-pocket costs for consumers, with the vast majority paying less than $50 per month through the pharmacy. Additionally, it's easier for physicians to prescribe and offers numerous benefits to payers. In the Q3, we expanded Omnipod DASH U.S. covered lives to over 80%, which in turn drove increased volume through the pharmacy channel. Payers are increasingly recognizing the economic benefits of offering Omnipod DASH in the pharmacy. In the U.S., our new customer starts once again reflected the value Omnipod offers compared to MDI, as well as our growing strength in the type 2 market. MDI conversions represented over 80% of our U.S. new customer starts, and the percentage that were type 2 remains in the 35% to 40% range, even with the strong new customer growth within the type 1 population. Our MDI conversion rate continues to trend upward as we successfully drive adoption among people living with type 2 diabetes, the majority of whom come from MDI. In addition to expanding affordability, we are also driving access to Omnipod in a number of other ways in order to provide more options for people living with diabetes. We recently received FDA clearance for use of Lilly's Lyumjev with Omnipod. We are the only insulin pump manufacturer in the United States to obtain this indication, which we pursued to provide more alternatives and flexibility for customers. A key component of our awareness strategy remains our DTC advertising. Our efforts in the U.S. and select international markets continue to generate a highly positive response. The feedback has been enthusiastic and the increased awareness, interest, and leads are contributing to our new customer growth. Our efforts are attracting MDI users and competitive pumpers as both face unmet needs that Omnipod helps address. Additionally, our DTC efforts are driving increased interest from individuals with type 2 diabetes as more primary care physicians learn about the benefits of Omnipod for this underserved population. DTC will remain a core component of our awareness efforts, and we are encouraged by the early results. We are a consumer-centric company, and our innovation efforts are focused on delivering the best experience to our consumers. To that end, we are confident Omnipod 5 will mark an enormous step forward and drive accelerated adoption. Today, we offer a tubeless, on-body experience that is unique compared to anything else in the market and an access model in the U.S. that has eliminated needless barriers and burdensome costs. The experience that Omnipod DASH provides is unparalleled, and Omnipod 5 will mark another breakthrough in diabetes care that builds upon our existing competitive advantages. Omnipod 5 will deliver groundbreaking technology first, including fully compatible smartphone control with an algorithm residing on the pod and SIM cards in each handheld controller. Omnipod 5 is a transformative innovation and will remain highly accessible and affordable through the pharmacy channel. It will be priced at parity with Omnipod DASH despite the increased value and advanced technology the system offers. In turn, we believe this will drive faster coverage of Omnipod 5, and we are already off to a great start. While we eagerly await Omnipod 5 clearance, our efforts to prepare for a successful launch have been moving at full speed, including securing coverage. Payers are generally reluctant to negotiate coverage terms prior to product clearance. However, given excitement around Omnipod 5, we already have secured substantial coverage. We expect this head start on access to position us for a highly successful launch of Omnipod 5. We cannot wait to receive clearance as we know the incredible impact our advanced technology will have on people living with diabetes. The power of Omnipod is clearly demonstrated by the compelling clinical data we have shared over the course of 2021. One recent highlight was our new pivotal study extension results for Omnipod 5, presented at EASD. This study marked a total of one year of Omnipod 5 use in ages six through seventy years old. We were thrilled to find that the outstanding safety and improved glycemic outcomes first observed in the three-month Omnipod 5 pivotal study were maintained over 12 months of home use. The data demonstrated the trifecta of insulin management, a sustained reduction in A1C, improved time in range, and minimal hypoglycemia. This long-term data demonstrates the durable benefits that Omnipod 5 offers. We are also close to submitting to the FDA our preschool expanded indication down to age two and expect to do so shortly following Omnipod 5 clearance. We continue to plan for an expanded indication in 2022. Additionally, we advanced our type 2 clinical efforts and remain in the six-month extension phase of our Omnipod 5 type 2 feasibility study. The early data is very promising, and we expect to share the results at a future conference. Following clearance for Omnipod 5, we will begin discussions with the FDA on pivotal trial requirements for an expanded indication in this patient population. We are excited to be pioneers in bringing the benefits of automated insulin delivery to people living with type 2 insulin-dependent diabetes. In addition to Omnipod 5, we also presented results from our largest cohort study of people living with type 1 diabetes who use Omnipod DASH. Across approximately 4,800 people, the results demonstrated low time in hypoglycemia and a significant decrease in A1C after 90 days of use for children, adolescents, and adults. For adults, the decrease in A1C was achieved while also demonstrating a 20% reduction in total daily dose of insulin used. As we build a portfolio of clinical evidence for our near-term innovations, we are also investing in the technologies required to position Omnipod for long-term growth. Our teams are diligently working on an iOS version of the Omnipod 5 mobile app, globalizing our AID system to bring it to international markets, and integrating Omnipod 5 with both Abbott's FreeStyle Libre and Dexcom's G7. We're excited to continue collaborating with these two great partners and, in time, offer CGM choice to our customers. We are also leveraging our significant digital capabilities to expand the ecosystem around Omnipod. Our Omnipod VIEW app was built for caregivers. Today, it allows caregivers of Omnipod DASH users to see real-time insulin data remotely. Omnipod 5 enhances the power of Omnipod VIEW because of the incorporation of SIM cards in every controller. SIM cards mean every user will have the unique experience of constant connectivity and being able to share real-time insulin and CGM data with caregivers and loved ones. SIM cards also mean no Omnipod 5 customer will need to manually upload data when visiting with his or her care team, thanks to cloud-to-cloud data transfer. Looking to the future, our algorithm and data science teams have already processed the data from our pivotal studies and type 2 feasibility study and are hard at work on our next-generation AID system. We believe we've built a blockbuster with Omnipod 5, and we are excited to continue to innovate on the extraordinary technology platforms it provides us. Now, turning to global expansion, where we are growing our global addressable market across attractive international regions. Our international expansion unlocks the power of Omnipod for people across the world and will further increase our global addressable market beyond the 11 to 12 million people we estimate are living with insulin-dependent diabetes throughout the global markets we currently serve. During the last 12 months, we expanded our global presence in seven new countries within Europe, the Middle East, and Asia Pacific. While it takes time for new markets to meaningfully contribute to our results, given the nature of our business model, we see strong long-term growth potential through our growing presence in multiple regions. The work to bring Omnipod 5 to our international markets is ongoing, and we are making great progress. Omnipod DASH has been a major global growth driver, and we believe adding our game-changing AID system to our product offering will further strengthen our competitive position across our international markets. Moving forward, we see a number of attractive opportunities to expand our global presence, to further penetrate our existing markets, and to introduce advanced technology to underserved regions. We continue to assess many markets throughout the globe where we know people with diabetes can greatly benefit from Omnipod and where we are confident we can drive strong adoption and growth. Our near-term focus is on growing our global presence throughout the Middle East and Europe. Over the medium term, we plan to expand further within the Asia Pac region. Lastly, we continue to invest in our global manufacturing operations, which will further strengthen our production capabilities, efficiency, and scale. Today, we are producing tens of millions of pods a year and doing so at the highest quality. Our manufacturing expertise is a competitive advantage, and the investments we have made over the last several years to expand our operational excellence and establish redundant manufacturing capabilities while securing strong partnerships with key suppliers are critical. This positions us to support growing global demand for Omnipod DASH, the upcoming launch of Omnipod 5, our international expansion, and our innovation pipeline. It has also helped to mitigate global supply chain issues throughout the pandemic and represents an important long-term driver of sustainable revenue growth and gross margin expansion. In closing, we remain on track to deliver another year of double-digit revenue growth and have made significant progress across each of our strategic imperatives. The clearance and limited market release of Omnipod 5 are just around the corner, and we could not be more excited for just how transformative this innovation will be for people living with diabetes. Our passionate and hardworking global team is our greatest strength, and we are focused on finishing the year strong and carrying the underlying momentum in our business into 2022 and well beyond. I'll now turn the call over to Wayde. Thank you, Shacey. The Q3 marked a continuation of our strong financial performance and strategic progress. We generated strong new customer starts despite continuing to feel the pandemic's impact, which speaks to the durable power of Omnipod and our success driving expanded awareness and eliminating access barriers. We remain incredibly excited about the upcoming launch of Omnipod 5 and what it can do for people living with diabetes. We generated 17% revenue growth in the Q3, finishing near the high end of our guidance range, driven by total Omnipod growth of 22%. In Q3, we delivered U.S. Omnipod revenue growth of 26% within the range of our expectations. As a reminder, our Q3 growth rate benefited from the net impact of the estimated $4 million distributor channel destocking last year. The trend of record U.S. new customer starts continued in the Q3, falling within our expected range. We continue to execute and drive strong top-line growth and expect to finish the year with continued momentum. Also in Q3, we once again increased our volume through the U.S. pharmacy channel and drove strong Omnipod DASH adoption globally among both Type 1 and Type 2 customers. During Q3, Omnipod DASH drove 80% of our U.S. new customer starts, and we increased pharmacy channel volume to almost 50% of our total U.S. volume. In Q3, international Omnipod revenue grew 14% at the high end of our guidance range. As a reminder, Q3 growth was impacted by the estimated $4 million to $5 million of distributor channel stocking that we experienced in the Q3 of last year ahead of the international full market release of Omnipod DASH. Today, all our new customers start on Omnipod DASH, which continues to drive adoption across our markets and our expanding customer base. That said, we continue to experience pandemic-related headwinds with a lagging revenue effect due to the compounding impact of our annuity model. During Q3, we saw the biggest impact from COVID in several of our international markets due to increased restrictions implemented in the H1 of the year. As a result of the virtual training and onboarding capabilities we built at the start of 2020, as well as the team's adaptability and execution, we have successfully mitigated much of these short-term headwinds. Nevertheless, we will continue to feel the effects on our top line over the next few quarters. Additionally, we expect Omnipod DASH will drive continued solid adoption. We're seeing increased competition in some markets from AID systems. As Shacey mentioned, we are excited to advance our Omnipod 5 innovation efforts as we look to bring what we believe to be a transformative and unmatched AID system to all of our markets. The fundamentals of our international business remain strong, and we continue to grow our existing markets and expand our global footprint. We also continue to augment our team and capabilities to drive sustainable growth over the long term. I'll touch on our near-term expectations in a moment. Lastly, our estimated global attrition in the high single digits and pod utilization remained stable during Q3. While we saw a slight impact on attrition in a few international markets where AID systems have been launched, the changes are not material overall. Drug delivery revenue declined 30% during the Q3, finishing around the high end of our expectations. As a reminder, order volumes were elevated in the prior year as a result of the pandemic. Gross margin was 68.5% in the Q3, representing a 360 basis point increase or a 330 basis point increase on a constant currency basis. This performance was in line with our expectations. The primary drivers of our gross margin performance were our improved manufacturing operations and the mixed benefit of growing volume through the U.S. pharmacy channel. These drivers were partially offset by the expected higher mix of costs as we continued to ramp U.S. manufacturing. Operating expenses were in line with our expectations as we continue to invest in our robust innovation pipeline, our clinical initiatives, our commercial efforts to support the expected upcoming launch of Omnipod 5, and also our continued international expansion. Operating margin was 12.2%, up 200 basis points, and adjusted EBITDA margin was 20.2%, up 210 basis points. Operating income was in line with our expectations as we invest throughout our global business to fuel our long-term growth trajectory. Turning to cash and liquidity, we finished Q3 with $857 million in cash and short-term investments and the full $60 million available under our revolving credit facility. We're in a strong financial position with no near-term obligations, and we have opportunities to further invest across key areas of our business. We continue to take measured steps to strengthen our overall capital structure. As we noted on our Q2, we used the proceeds from our Term Loan B financing to repurchase 92% of our convertible notes due 2024. In July, an additional 5% of the outstanding balance was converted, which resulted in a $1.5 million loss on extinguishment during Q3 that is excluded from adjusted EBITDA. Also in July, we raised an additional $43 million of cash through an equipment financing, which further helps to reduce our overall cost of capital. Now turning to our outlook for the remainder of this year. We are updating our full-year revenue guidance and now expect 18% to 20% growth, including Omnipod revenue growth of 18% to 20%. We now expect full-year U.S. Omnipod revenue growth in the range of 22% to 24%, driven by increased access and awareness, our strong U.S. new customer starts throughout this year, the benefits of our annuity-based model, and our growing volume in the Type 1 and Type 2 markets, and through the pharmacy channel. For international Omnipod, we now expect full year 2021 revenue growth in the range of 12% to 14%. The ongoing adoption of Omnipod DASH and expansion of our customer base continue to fuel our international growth. We expect the tailwinds in both our U.S. and international product lines will be partially offset by the lagging impact of the pandemic, which has a cumulative impact on our results, as well as some competitive pressure from AID systems in the market. Lastly, we now expect revenue growth of 11% to 6% for drug delivery based on our partners' increased forecast. Turning to gross margin. Looking at Q4 specifically, we continue to expect a sequential decline, largely due to higher production costs as we ramp our automated manufacturing lines. While this causes some anticipated fluctuation in our quarter-to-quarter performance, we remain on track for full year gross margin in the range of 68% to 69%, likely closer to the low end of the range. Our gross margin performance represents a notable year-over-year increase and reflects both our enhanced manufacturing capabilities as well as the benefits of our growing volume through the U.S. pharmacy channel. We continue to expect operating expenses for the full year to rise in line with revenue as we have been investing in our innovation pipeline, sales and marketing capabilities, global manufacturing, and international expansion. We believe these investments are critical to sustaining the momentum in our business and building upon our foundation for long-term sustainable growth. We are reaffirming full year operating margin in the low double digits range. The key drivers of our growth include our strong top-line revenue growth and gross margin expansion. We continue to expect an approximate 100 basis points improvement in our operating margin on an annual basis going forward. Finally, we expect capital expenditures in 2021 will slightly decrease from 2020 compared to our previous expectations of an increase, primarily due to timing. We continue to invest throughout our global manufacturing operations as well as our strategic initiatives. Turning to our Q4, 2021 guidance. We expect total company revenue growth of 19% to 25%. This includes total Omnipod revenue growth of 17% to 22%. For U.S. Omnipod, we expect Q4 revenue growth of 22% to 27%. The core drivers of this growth are the cumulative impact from our record new customer starts during 2021, the benefits of our annuity model, and increased Omnipod DASH volume through the U.S. pharmacy channel. We expect Q4 international Omnipod revenue growth of 7% to 13%, driven by continued Omnipod DASH adoption across our international markets. We expect the tailwinds in both product lines will be partially offset by the same headwinds mentioned for the full year guide. Lastly, we expect Q4 drug delivery revenue to increase 45% to 65% based on our partners' current forecast. In conclusion, we're on track for another successful year as we continue to deliver solid financial performance and broad strategic progress. We're focusing on finishing the year strong and are excited for the expected upcoming clearance of Omnipod 5. We're investing in the critical areas of our business that will build on our current competitive advantages and drive further differentiation in the near and long term. There are significant growth opportunities ahead, and we remain well positioned to continue to drive meaningful value to all of our stakeholders. With that, we'll turn the call over to Dalam to open up for questions. Thank you, sir. If you have a question at this time, please press star one on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. We ask that you please keep your questions to no more than one, but please feel free to go back into the queue, and if time permits, we will be more than happy to take your follow-up questions at that time. Please stand by while we populate the Q&A roster. I show our first question comes from the line of Margaret Kaczor from William Blair. Please go ahead. Hey, good afternoon, everyone. Thanks for taking the question. I wanted to start with type two. You guys mentioned a few updates on the call, specifically kind of on the algorithm side, and you know, trying to make progress on o5. I was curious, you know, what kind of pivotal study could look like. As you think about the types of patients that could benefit from, you know, Omnipod and o5 specifically, would it be intensely managed, or could you actually kind of accelerate some of the efforts into other types of type twos and why? Thanks, guys. Yeah. Thanks, Margaret, for the question. Yes. Maybe I'll take us back a few months. If you remember, we shared really compelling data at ENDO back in March that demonstrated the impact of Omnipod 5 that it can have on people living with type 2 insulin-dependent diabetes. That data demonstrated early data, but it demonstrated more than a doubling of time and range from 27% to 59%. We do believe that the technology has tremendous potential to you know, to make a positive impact on outcomes for people living with insulin-dependent type 2 diabetes. We are looking at the intensively managed group for this technology. As you know, one trend we see, macro trend in the market that we see is that there is growing utilization of CGM among type 2 users, particularly intensively managed type 2 users. Our belief is that as more CGM use happens, that will drive more seeking of these patients for tools to manage their disease, and that Omnipod 5 will be right there with, you know, the best wearable AID system for this population. In terms of what the pivotal study could look like, I think that's a great question. You know, this is uncharted territory for people living with type 2 diabetes, and so we are really proud to be doing the work to bring this technology to this population and to be pioneers. You know, the feasibility data looked promising, and we still need to really have the discussion with the FDA on what a pivotal could look like. I think we could see a lot of range here. You know, it might be that we can use some real-world data because it's clear that there will be type 2 users of Omnipod 5 upon launch because of the access position that we're in. Or it could look like a full-blown pivotal like we did in the type one population. That will remain to be seen once we've had the conversation with the FDA, and we'll certainly keep everybody posted because we do view this as a really exciting opportunity for that segment. Thank you. Our next question comes from the line of Robbie Marcus from JPMorgan. Please go ahead. Yeah. Thanks for taking the question. Wayde, I wanted to ask on U.S. and international Omnipod for fourth quarter, and I was hoping you could just sort of walk us through some of the puts and takes here. You know, it looks like in the international market that the midpoint of the guide is down sequentially on a dollar basis. So just wondering what would drive that. Are people using less pods? I would imagine with the annuity model, if utilization was the same, it'd probably increase. And then also in the U.S., you know, you're still seeing record new patients start. So was just sort of wondering, you know, what brought you down off the top end of the guidance range there, and walk us through some of the dynamics there. Thanks. Sure, Robbie. Yep, happy to. Overall, we're still holding the high end of our total company beginning of year guide at 20%, so no change there. We've raised the low end up to 18%. We're 18% to 20% now for both total company and total Omnipod. As you mentioned, you know, we've tightened the guidance ranges for each product line for the year, you know, although still really strong growth, especially in the United States. What are we factoring in? We're factoring in the lagging impact of the pandemic, as well as some competition from AID systems in the market, as we mentioned in our prepared remarks. You know, overall, our Q4 guide is very strong. At the high end, it is our highest growth rate for the year, for both Omnipod and total company, with 17% to 22% for total Omnipod, and then 19% to 25% for total company. You know, as is our annual guide, still 18% to 20%. We keep an eye on the annual guide as we think about Q4 as well. You know, despite some COVID-19 headwinds, and the pandemic's impact on new customer starts last year that factored into the growth rate this year, as well as the delayed clearance here for the launch of Omnipod 5, you know, we're still at that high end for the full year. You know, if we hit the high end, we'll have now grown 20% for the last two years through COVID and with increasing AID competition here. You know, a couple specifics. You know, Robbie, international down sequential at the midpoint. You know, we don't really think about the midpoint. We factor in our total puts and takes, and, you know, it's sequential growth at the high end, sequential decline at the low end. One of the things we have to watch for, internationally, is some order patterns. We sell a lot of our product through distributors internationally, and sometimes there's order patterns. We have to account for that, in addition to the other factors I just mentioned. In the US, you know, again, we have the strongest guide for the year at 27% for Q4. Although we've tightened the ranges somewhat, we're still looking at a very strong quarter for Q4. Thank you. I show our next question comes from the line of Danielle Antalffy from SVB Leerink. Please go ahead. Yeah. Hi, good afternoon, guys. Thanks so much for taking the question. Apologies if I missed this, but my first question, Shacey, is for you on your confidence in Omnipod 5 approval by the end of the year. Just trying to push a little bit, make sure, you know, this isn't gonna slip again. Just curious, what gives you the confidence? Are we just waiting now for FDA, or have you had more back and forth? Is there still more back and forth happening with FDA? Then I have one quick follow-up. Okay, Danielle, we may need your follow-up now, or you might not fit it in. Do you wanna ask it now? Oh, sure. Sorry. Just as it relates to the Omnipod 5 launch as well, I'm curious if you guys think about, you know, what you could learn early on in the launch? Or do you think launching an integrated system is not gonna be all that different from, you know, sort of how you've launched the Omnipod in the past? Just curious if there's anything different about launching an integrated system versus launching just a standard Omnipod. Should we be thinking about this launch differently than sort of how you've been present in the market in the past? That's it for me. Great. Okay. Thank you for your questions, Danielle. Yeah. I'll take the one on Omnipod, confidence in Omnipod 5, and then I'll let Bret talk to just what we expect to learn with an integrated system launch. The interactions have been frequent and very collaborative with the FDA. As I mentioned in my prepared remarks, obviously, we had submitted the update to the app back in September, and since then, we've had multiple back and forth with the FDA. Frankly, it's that back and forth that gives us the confidence that the system will be cleared before the end of the year. We are down to the final mile, and we're really appreciative of the FDA's responsiveness and engagement. You know, it is a breakthrough device-designated technology, and it is a breakthrough device because of so much breakthrough technology in the system with, you know, full phone control with the algorithm on the pod. No one has ever done this before, including the FDA. We are plowing new ground here, which we're excited about, but we feel very confident in the quality of the submission, and very positive about the interactions that we've had with the FDA. I would just say, before I pass it off to Bret, that the teams are doing a terrific job. Bret is leading a lot of this effort. You know, just an outstanding job preparing for our limited market release. That includes all of the, you know, testing of the training systems, the support, the benefits investigations, obviously establishing coverage, which I spoke to, manufacturing the product, you know, all of that stuff. We are ready to go and couldn't be more excited. I'll let Bret answer your second question. Yeah. Hi, Danielle. It's Bret. There's a lot that we can build upon from the learnings of DASH. Chasey highlighted some of what we anticipate in the LMR. The reason we're doing a limited release is so we can, you know, test some of these things and establish access early. We're well ahead of the game on access, as well as the user experience, which is some of what I think you're getting at with the integrated systems. There's a lot to understand there. You know, with the introduction of Omnipod 5, the onboarding experience will be unique and different from anything we've ever done, which is part of what we'll be testing in the LMR. Some of that depends on their experience with both Dexcom and with Omnipod. Depending on their experience, each onboarding experience is unique to the individual, and in some cases, they'll be able to completely self-serve and onboard. That's going to be really exciting. It's gonna establish tremendous commercial scale for us, enable us to onboard many of our existing Podders that are so excited about Omnipod 5. You know, all of that, the cooperation between Dexcom and Insulet on customer support will also be unique as we've sort of worked through all of the different use cases and scenarios where there'll be warm transfers going back and forth to the companies depending on what the potential issue could be. All that stuff is when we talk about the customer experience, what we'll be testing in the limited release before we move to a full market release. We're well prepared for all of those things. Thank you. Our next question comes from the line of Larry Biegelsen from Wells Fargo. Please go ahead. Hey, guys. Good afternoon. Thanks for taking the question. Shacey, you know, one big picture question on international. You know, we've seen it slow the last couple of years, and the midpoint of the guidance is 13% this year. How should we think about international growth before Omnipod 5 launches outside the U.S.? And any color on, you know, whether that could start happening in 2022, or should we be thinking about international Omnipod 5 launches more like 2023? Thanks for taking the question. Yep. Thanks, Larry. You know, I think our international business has been performing well, as Wayde said, in the face of some challenges related to COVID and some market dynamics around AID adoption. You know, DASH has really been helping us to drive that growth. I think ultimately we are seeing double-digit growth despite the fact that the, you know, environment is changing in terms of CGM access, in terms of AID, access and awareness. That's great. We expect that to continue. We expect new patient adds to continue in our international markets, and it's one of the reasons why we're working so hard to bring Omnipod 5 to our international markets. We're not gonna give a timeline on that yet. You know, we really wanted to wait to get Omnipod 5 into the market before we give guidance. You can expect that sometime next year. I can tell you that the work is underway, fully committed to bringing our system to our global markets, and we will do that as quickly as we can. I think ultimately these trends, while they present some near-term headwinds, they are very favorable trends for us, both in the U.S. and internationally. As we think about, you know, increasing awareness and adoption of AID in the U.S., as we think about increasing access for Dexcom CGM, and increasing access and adoption of AID in our international markets, that paves the way for successful launch of Omnipod 5. While it presents some near-term challenges, really medium-term, it should be a great trend for us. Thank you. I show our next question comes from the line of Jeff Johnson from Baird. Please go ahead. Thank you. Good evening, guys. Wayde, you've mentioned the competitive impact of AID systems a couple times. Every time you do, it seems like it's focused on the international market. One, we've got, you know, at least one of those AID systems here in the U.S. You're not mentioning it as much from a U.S. perspective. Is that just given the pharmacy access, the T2 access, things like that that's covering that up, or is there something, you know, specific in the international markets relative to the U.S. that is causing, you know, some of that issue, number one? And number two, Shacey, just to push you on that OUS-05 timeline and commentary you had. You know, regulatory-wise, what would you have to do? Can you use U.S. pivotal data to get a CE mark and launched in Europe, maybe in Canada, things like that? Or would you have to go through trials there that you haven't yet contemplated or started? Thanks. Hey, Jeff, I can certainly start that, and appreciate the question on this evolving dynamic that Shacey just highlighted, you know, eventually becomes a positive for us. We do think the dynamic is different between the U.S. and international. You know, in the U.S., certainly, we've got AID systems to contend with. But as you mentioned, we have done a great job with other significant growth drivers, DTC, our business model in the pharmacy channel with pay-as-you-go. Certainly DASH has performed well in the U.S. We have a lot of momentum behind it. In international, we've just launched DASH over the last year and have good momentum there, you know, growing in the mid-teens, internationally. As we mentioned in the prepared remarks, we have seen a couple countries start to see some more stronger AID competition. As Shacey mentioned, as CGM adoption ramps, certainly that brings AID systems with it. We do think the headwind is stronger internationally. Jeff, to your question regarding Omnipod 5 internationally, there is not a clinical trial requirement to get CE mark to be able to sell and market Omnipod 5 in our international markets. It is a regulatory pathway, the MDR pathway that we will submit through for CE mark, and there will be clinical work that is done to establish increased adoption and increased access and coverage of the technology. But we don't actually require any type of clinical to get clearance to be able to sell and market the technology in our international markets. So the work that is underway is the technical work around translations, unit of measure, that stuff for the system, internationalizing the label and the system. Of course, you know, we've got some regulatory work and then some clinical commercial work, really for more of the commercial elements of the launch. Thank you. I see our next question comes from the line of Matt Taylor from UBS. Please go ahead. Hi, thanks for taking the question. So I actually wanna ask one about international, just as a educational question. You talk a lot about pharmacy and pay as you go in the U.S., and I just wanted to characterize how much of those types of channel and trialing advantages were translatable in the international markets given their, you know, heterogeneous and you have a different go-to-market strategy there. Could you talk a little bit about that? Yeah, Matt, it's such a great question. I'll kick us off, and then I'll ask Bret to weigh in as well. You know, I think it is. Most of the dynamics that are driving our success in the U.S., you highlighted them, pay-as-you-go and type 2, for example. Those are opportunities outside of the U.S. It's just a matter of time. As you note, the OUS markets are fragmented and complex, so it will be more fragmented in terms of how we deliver on those opportunities outside the U.S. For type 2, there really is less coverage. One of the reasons why we've had so much success in the United States in the pharmacy with type 2 is because of the differentiated access position. It is much easier to access Omnipod through the pharmacy than it is to access pump therapy through the DME channel. That is, you know, what is fueling part of our growth and why we've got 35% to 40% of our new starts type 2. The same value proposition exists in terms of the clinical impact, the improvement in A1C, and the reduction in total daily dose of insulin. We've got more work to do clinically to demonstrate that healthcare economic argument outside of the U.S. and to establish reimbursement and coverage access really for type 2 outside of the U.S. Then Brett, I know we've had some progress on pay-as-you-go. If you wanna talk a bit about that. Yeah, sure. Matt, it's a great question because the growth drivers today are a little bit different in the U.S. than they are internationally. We see those as opportunities, and Shacey highlighted that, you know, we can move to pay-as-you-go, the pharmacy channel type 2. You know, those are related because remember, the reason why we have such great type 2 access in the U.S. is because we don't bill that upfront fee. Pay-as-you-go really is more key than the pharmacy channel is. We'll be looking at all these opportunities internationally. Certainly, we see lots of opportunity to move to a pay-as-you-go reimbursement model in the markets that we're in and in future markets. That could open up the door for type 2 access. We think that's a good start because when you don't charge that upfront fee, you eliminate that risk for the payer. All these things that are carrying us today in the U.S. that really make the growth rates different than they are internationally, as headwinds are fairly similar, those are all opportunities for us in the international markets. Thank you. I show our next question comes from the line of Travis Steed from Barclays. Please go ahead. Hey, thanks for taking the question. I just curious, Wayce, if you could give a little more color on kinda what you're seeing with COVID, vacations, and are you seeing staffing issues at endo offices? A little color on kind of how you see some of the puts and takes on 2022. Like, obviously, Omnipod 5 is a big unknown at this point when that actually comes. But just curious if you could give some puts and takes on next year, and especially given some of the unusual seasonality we saw this year with COVID. Sure. We're lucky enough to have Bret on. Bret, do you wanna touch on, you know, what we're seeing internationally and around, you know, vacations and staffing and things? Then, I can pick up on some thoughts on 2022. Yeah, sure. I can touch on both of those. You know, I guess the vacations and staffing are both real. I think the staffing is actually more of a real issue within some of the endocrinology offices. That becomes an issue for companies like ours only if we rely on those staff to do some of the work for onboarding. You know, that's an effort that we've had underway for a long time now to take that work away from healthcare providers, to do more of the trainings, to do more of the onboarding. We believe that we are the easiest product to train and onboard on because of the ease of use of Omnipod. We don't see that as a real headwind, although those are real issues for our customers and endocrinology offices. It's not slowing us down in any way. Great. Just picking up on 2022. You know, regarding how we're thinking about our outlook there, you know, at this point, we don't issue formal 2022 guidance until Q4 call in February, per usual. However, happy to give you some of our thinking here. We do think that we're in a good position to start strong again in the 15% to 20% range for total diabetes. You know, it's a good place to start. We do have some differences between the regions, given the different dynamics. Some of them we talked about here. You know, I think we see U.S. Omnipod with really strong momentum, and we're thinking again, it's probably a high teens, low 20s kind of a start to the year. International, more in the low double digits, you know, at the lower end of that, 15% to 20% or even below. It's looking like, you know, 15% to 20% for total Omnipod, which is strong growth off a growing base, and we have opportunities to exceed that, but certainly some risks to consider. For drug delivery, you can expect it to decline year-over-year, coming off a very strong year elevated by the pandemic year. Overall, you know, we're thinking about our total company revenue growth in the mid-teens. You know, this can change as we close out Q4 and plan our official guidance here. But that's how we're thinking about it today. Maybe some color on the U.S. You know, regarding the U.S., we need to keep in mind that Omnipod 5 will be in a limited market release for some time and ramping during the year, with access growing, and it takes time for our annuity model to build momentum and accelerate revenue. We'll get some benefit from Omnipod 5 in 2022, but there are many factors to determine how much, and, you know, we'll certainly provide updates as we go through the year. We won't see a full year impact from Omnipod 5 until 2023 and beyond. That really sets us up for multiple years of strong growth from there. I think, Travis, Wayde, that was very well articulated. Travis, I would just point out, you know, to what Wayde is saying, that Omnipod 5 will be an accelerator. It's just a matter of when we can get into full market release in the U.S., and then when we can get it into market in our international markets. Obviously, the work is underway, and the teams are very focused on making that happen. As we look beyond 2022, we couldn't be more excited because we're launching what we think is going to be the most differentiated technology in the AID space. We see follow-on indications pretty rapidly with pediatrics. We see international expansion, we see iOS, and we see additional CGM integrations over the coming couple of years. Really exciting trajectory of innovation and growth over the next few years. Thank you. Our next question comes from the line of Jayson Bedford from Raymond James. Please go ahead. Good afternoon. Geez, Wayde, after that last answer, I'm kind of tempted to ask about 2023 guidance, but I won't. So I have a couple of pharmacy questions. Pharmacy access, it's now near 50% of your U.S. volume. Can we assume that the majority of these folks will have access to Omnipod 5 upon launch? Then my second question is, for the other half of folks that are not accessing Omnipod through the pharmacy, it looks like 2/3 may have coverage but are not yet going through the pharmacy. I'm just wondering why those folks are not choosing to go through what seems like a better access point? Hi, Jayson, it's Bret. I can take those questions. I think what you're referencing is 50% of our volume is now in the pharmacy channel. Our access is actually quite higher than that, as DASH access is 80% now, which is the bulk of that is all in the pharmacy channel. Very strong access in the pharmacy channel. Your question as to what we can expect at launch. You know, we're well ahead of DASH at this time and didn't think we'd have any access with Omnipod 5 until we got clearance from the FDA. We're quite pleased with where we're at. The conversations with payers are going very nicely as we've talked about AID systems, the pivotal data. I think they're just waiting for clearance to start that process to contract and then add us to formulary. There's really no reason at all why we wouldn't expect Omnipod 5 access to very quickly reach the access that we have today with DASH in the pharmacy channel. It's just a process and a little bit of time. Your question about, you know, why wouldn't somebody start in the pharmacy channel, knowing that it's a better product and a better experience. You know, while the vast majority of co-pays are less than $50 in the pharmacy channel, it doesn't mean all of them are. In some cases, our legacy access is different than DASH. There are situations, most probably access related, why somebody may not choose to go into the pharmacy channel right up front. that access we're continuing to get stronger and build every day. That's why the percentage of new starts that are Dash into the pharmacy channel continues to rise. Thank you. I show our next question comes from the line of Cecilia Furlong from Morgan Stanley. Please go ahead. Great. Thanks for taking the questions. I wanted to ask about just the percentage of patients coming from MDI. It sounded like it ticked up slightly this quarter, but just as you think about Omnipod 5 launch, going forward, how do you think about the ability of Omnipod 5 to really expand pump utilization, versus driving competitive conversions going forward relative to Omnipod DASH? Thank you. Thanks, Cecilia. It's a great question. What we know is those percentages will change. It's a little hard to predict. But when I think about Omnipod 5, I think about it as a additive growth driver. All the exciting growth that we're driving, because of the pharmacy and because of type two adoption, which is primarily multiple daily injections today in the type two users, that will continue. We know we've got a leadership position there, and we have a differentiated technology for the type two user. Omnipod 5 will be additive in terms of the, growth eventually when we get into full market release and in terms of the patients that it's bringing in. It should make us more competitive, for those, users that are choosing AID over pump therapy. We know that that's the primary reason why somebody doesn't choose Omnipod when they come on to pump therapy. We would guess that our pump conversions will increase with the launch of Omnipod 5. Thank you. Our next question comes from the line of Anthony Petrone from Jefferies. Please go ahead. Thanks and congratulations on a good quarter. I have three quick ones. Just a quick update on DTC. Continue to see the TV ads, and so just wondering, you know, if there's any update on return on investment there on DTC. What are the plans as you get into Omnipod 5? Just on supply chain constraints, as we look into 2022, do you see any potential impacts to the working capital cycle as we get into next year? Thanks. Hi, Anthony. I can start that one with an update on DTC. You know, it continues to be a really strong growth driver for us in the U.S. We know that awareness is one of the problems we need to solve for, not just in the U.S., but internationally. Our spend has been pretty constant for DTC. We started this, remember, in September, about a year ago, and it continues to be a real growth driver for us. We're getting better at it. We're getting better at converting leads into new starts. We're getting really creative with our messaging too. We launched different campaigns over the summer called the Summer of Omnipod, which highlights the form factor of Omnipod, some of the benefits that we have and the freedom that Omnipod offers. It We've also dabbled a little bit internationally. We've run some TV commercials in the U.K., some in Germany, some in Canada. We're trying to learn, you know, the ROI in those specific countries too, because we just see it as a really massive opportunity to increase awareness. The ROI's been positive. I won't throw out any numbers there, but we know it's a good investment for us and something that you can expect that we'll continue to do. On the supply chain question, I can maybe start us off and then ask Wayde to comment about the impact on working capital. What I can tell you is that our teams are doing a marvelous job managing these dynamics. That investment has really helped us to manage through, you know, some of the challenges that we've seen, in all environments, all industries in terms of the supply chain around, freight, around, certain components, et cetera. Our team, while we may have incurred some additional costs, they've also done a terrific job offsetting those costs. Ultimately, you know, there's been no impact at all to customer supply. That's a testament to how hard our teams are working to support the growth and also manage through these very real challenges that exist today. Yeah. I could just add, you know, to the redundancy and supply chain improvements and investments that Shacey just talked about, we have been very successfully growing our inventory ahead of revenue. Our inventories have grown significantly over the last year. We feel very good about that given, you know, where we were in the pandemic. Our teams did a fantastic job managing through that. We actually built inventory through the pandemic. Then, you know, with the more recent supply chain challenges globally, team's done a really nice job managing that. I think what you'll continue to see us do is continue to build capacity and build inventory ahead of our operational performance. We do that to make sure we're in the best position possible to serve our customers and for new customers coming on board. I don't see a major change to our working capital cycle just given that we've increased inventory so much to this point. You will see us continue to invest in a growing inventory number to make sure that we've got more than ample supply for our existing customers and for our future growth plans. Thank you. I show our next question comes from the line of Matt O'Brien from Piper Sandler. Please go ahead. Hi, good afternoon. This is Drew on for Matt. Thank you for taking questions and congrats on the solid quarter here. I appreciate the color on next year. I just wanna follow up a little bit so I can understand it better. Obviously, your U.S. business is growing 20% plus the last couple years, even despite the pandemic. I hear that should fade a bit next year. You know, definitely still room on DASH penetration then obviously the Omnipod 5 launch at some point next year. Is the 15% to 20% really a function of your U.S. business more towards the higher end of that range and OUS more towards the lower, or is that, you know, more a function of your, you know, expecting that ramp of Omnipod 5 to not kick off in a meaningful way to the business until more later in the year? Yeah, Drew, I can start that, and then, Bret may wanna add some color as well. Specific to the numbers, yeah, 15% to 20%, I think you have it right in the sense that the U.S. will be at the high end of that range. You know, we're, you know, calling it high teens, low 20s, just to give ourselves some room there. As you said, the U.S. has lots of momentum, and, you know, you'll certainly see low 20s in that range. International at the other end of the guidance, as we said, you know, low double digits because of the dynamics we've just talked about on the call today. Although, you know, double-digit growth internationally, still good growth, strong growth on the back of DASH, we don't have an AID system there, and we haven't announced when we will yet. You know, we always put a thoughtfully appropriate guide in place for the year. We think diabetes at 15% to 20% on what's now a billion-dollar base of business is a good place to start. Again, we haven't given formal guidance yet, just trying to help people understand some of the major puts and takes heading into 2022. As you mentioned, Omnipod 5, you know, that has a lot of variability to it. We've talked about here the limited market release and how long that takes. You know, we've said publicly before, it's usually a three to nine month timeframe. Depending on how fast that can be will dictate how fast we move to full market release. Access is also another gating factor. We're starting really strong in a good position here, but it may take some time to build enough access. So there's just lots of things to consider around Omnipod 5. What we said is that, you know, we'll start somewhere in this range, and we'll update as we go through the year and as we progress with Omnipod 5. I don't know, Bret, if you wanna add anything else there. Yeah. Well said, Wayde. Drew, I would just say, you know, your question is right. It really is a stronger U.S. growth next year that's really driven by the current growth drivers. DTC, our Type 2 access, the pharmacy model, all those things will continue to drive the U.S. growth. We did build in some growth for Omnipod 5, as Wayde suggested. But, you know, again, with the annuity model, it takes a little bit of time. There's still some uncertainty of the length of the LMR, the time to get to full market release. Then once we get to full market release, the annuity model doesn't really represent growth right away. It takes some time to build that into the rates and revenue. Thank you. I show our last question comes from the line of Joanne Wuensch from Citi. Please go ahead. Thank you so much for squeezing me in. I really appreciate it. I'm trying to get my head around something, which is when Omnipod 5 comes out, what does it do in terms of the portion of the market that you're most likely to address? What I'm also trying to do is cross-reference that with increasing new patient starts in type 2. Do you see your market splintering? Maybe splintering is the wrong word, or expanding, or just help me understand when it arrives, and as it arrives, what happens? Sure. Joanne, I will start, and perhaps Bret will have some additional thoughts to offer. We believe that Omnipod 5 will be additive to our growth. As you think about the momentum that exists today in our business, we'll focus on the U.S. because that's where we're gonna launch first. You know, there's a lot of momentum being driven today by DTC, so increasing awareness. There's a lot of momentum being driven today by type 2 users of DASH, the increasing use in the pharmacy, and then the benefits of the pharmacy for all users, and then of course our differentiated form factor. That's what's driving our growth today. All of that remains, and then Omnipod 5 comes and is additive, and we believe will make us more competitive in the type 1 space. There's also likely to be type 2 users of the technology, although we will not, you know, market directly to them until we have an expanded label. We do think the technology has value there, to offer. I think it, you know, we know, for all of the people that are coming out of MDI and onto pump therapy, the primary reason that someone doesn't choose Omnipod, which is clearly, tests and market research should be a preferred form factor, is AID. With Omnipod 5, obviously we check that box, and we believe we check that box with the very best system, that will be on the market. We think we get a lot more competitive, which is why I said earlier that the numbers will change, the ratios will change. Today, we get, you know, 80% of our users from multiple daily injections. We're gonna continue to get those people, and we will get more. You know, we will get more competitive switchers as a result of Omnipod 5. Yeah. I think those two percentages that we often speak to, 80% of our new starts coming from MDI and 40% of our new starts being type two. I think we're okay with those percentages going down with the introduction of Omnipod 5 as long as new starts go up, which they will for sure. The other thing to think about, Joanne, is, you know, all these tailwinds that we've spoken about, that Shacey mentioned are still going to be there with Omnipod 5, and we remove really one of the biggest headwinds that we have today, which is AID competition. Omnipod 5 does check all the boxes. It's why we think it's going to be a best-in-class product offering, and we're so excited about what it does to growth once we get to full market release. Thank you. That concludes our Q&A session. At this time, I'd like to turn the call back over to Shacey Petrovic for closing remarks. Please go ahead. Thank you, Dalam. Thanks to everyone for your participation and questions today. As part of a company-wide event last week, we hosted several Omnipod users, including a few Omnipod 5 trial participants still using the system. It was incredible to hear the impact Omnipod 5 has had on this diverse group of customers. Dwight, a grandfather living with late onset type one diabetes, said that because of Omnipod 5's simplicity, he truly trusted the system right away when he walked out of the clinic. Morgan, a young woman living with type one diabetes for 19 years, told us, quote, "Omnipod 5 is magic. It's unreal. I don't ever have to think about my diabetes. I want everyone to know about it. It has changed my life." Valentino, a first-generation American who has participated in other AID system trials, said of Omnipod 5, "All I can say is wow. I'm waking up normal. I don't ever have to think about my diabetes. It brings peace." I want Dwight, Morgan, Valentino, and others in the community to know that we hear you. We are working hard to get Omnipod 5 into your hands and to make sure that everybody knows about and can benefit from this remarkable technology. Thanks again for joining us today, and have a great evening. Thank you. This concludes today's conference call. Thank you for your participation, and have a wonderful day. You may all disconnect.