Insulet Corporation

Good afternoon, ladies and gentlemen, and welcome to the Insolent Corporation second quarter 2022 earnings conference call. At this time, all participants are on a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. 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 of Investor Relations.

Thank you, Dylan. Good afternoon and thank you for joining us for Insula's second quarter 2022 earnings call. With me today are Jim Hollingshead, President and Chief Executive Officer, and Wade McMillan, Executive Vice President and Chief Financial Officer. Brett 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 2022 second quarter results and 2022 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 INFLIT 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 operating margin, 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're 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. I'm excited to be here with you today on my first earnings call as CEO of Insulet. This past quarter, we exceeded our revenue expectations, resulting from sustained momentum across our business. We are halfway through the year, and the entire Insula team is executing at a high level. We increased our four-year outlook for U.S. Omnipod, delivered record U.S. and global new customer starts, had our second highest new customer starts quarter internationally, and meaningfully advanced each of our strategic imperatives. Accomplishing this was no easy task, given the challenging global macro environment that we and other companies are facing. We are incredibly excited to have recently entered full market release for Omnipod 5, and now our differentiated transformative technology is available broadly through retail pharmacies. The results to date have been amazing. Omnipod 5 is proving to be the game changer we thought it would be. Customer and healthcare provider feedback has been overwhelmingly positive, and our teams are doing a remarkable job executing the launch. Our CE mark submission review is progressing very well, and we are in the final stretch toward approval. This represents a key milestone in our plan to bring Omnipod 5 to people with diabetes around the world. This approval is one step in our strategy to participate in the international AID market, which is being driven largely by CGM reimbursement. We have also advanced our clinical efforts. Our FDA submission for an expanded indication for Omnipod 5 in the U.S. down to age 2 is progressing very well, and we are confident in the near-term clearance. The value that Omnipod 5 can deliver to young children and their families is abundantly clear, and we're thrilled to soon bring Omnipod 5 to this highly vulnerable population. We shared compelling data at ADA demonstrating how powerful Omnipod 5 can be for the Type 2 insulin requirement population, a market segment that is further adopting Omnipod due to our unique value proposition. And in the Type 1 population, we are currently enrolling for a 200-patient, three-month randomized controlled trial in France and the U.S. to demonstrate superior efficacy for Omnipod 5 compared to non-AID pumps and CGM alone. Lastly, we broke ground at our future Malaysian manufacturing facility, which will strengthen our global manufacturing capabilities and redundancy as well as support our international expansion strategy. Before moving into a broader view of the quarter and our progress, I want to take a step back and reflect on my first two months as CEO. I was aware of the strength and commitment of the entire Insulet team from my three years on the board of directors. Now that I'm CEO, I'm even more impressed. Our global teams are exceptional. The shared commitment to our mission of improving the lives of people with diabetes is inspiring and it's pervasive throughout our organization. Diabetes is a growing global epidemic, and Insulet's ability to serve unmet needs and provide improved outcomes has never been more important. It is clear that we have the team, the product portfolio, the innovation roadmap, and most importantly, the passion to improve millions of lots, and I'm excited and privileged to lead Insulet on that journey. Expanding access and awareness are keys to driving our business forward. Despite improvements over the last few years, only a small percentage of people with type 1 diabetes globally benefit from insulin delivery technology. Access and awareness are important levers that will significantly drive increased penetration over the coming years. We are making terrific progress building awareness and securing coverage globally, including broad coverage for OmniFOD5 in the U.S. We've built a unique leadership position in the U.S. pharmacy channel, which improves functional access for both the Type 1 and Type 2 populations. The vast majority of our U.S. customers continue to pay less than $50 each month through the pharmacy for Omnipod Dash and now Omnipod 5, with many paying nothing. We've eliminated lengthy lock-in periods and upfront costs that are common in the DME channel, and our pay-as-you-go model provides easier and more affordable access for our customers and removes risk for payers. And we are delivering this easier access combined with lower costs while also delivering an improved customer experience and better outcomes. That's a winning combination and one that resonates with people using multiple daily injections, a population from which we continue to capture approximately 80% of our new customers. Our pharmacy channel and pay-as-you-go business models also connect with people with type 2 diabetes. We are acutely focused on making access simple and more affordable. providing an unmatched form factor, and generating clinical evidence that supports what Omnipod can do for the Type 2 population. Because the Omnipod offering is so compelling, during the second quarter, Type 2 users represented almost 30% of our U.S. new customer starts. As expected, this is a percentage reduction from prior quarters because Omnipod 5 is indicated for use with people with Type 1 diabetes, as is the case with all AID systems. Therefore, we expect the mixed percentage of new customers to change as more people with Type 1 adopt Omnipod 5. We saw this begin in Q2, and we're excited to see it continue now that we are in full market release. Nevertheless, we continue to see a strong number of new customers with Type 2 adopting Omnipod Dash, and we remain confident in our ability to further penetrate this underserved population. A major component of our awareness efforts is our direct-to-consumer advertising campaign. We ramped our DTC program ahead of the full market release of Omnipod 5 and have since accelerated our spend. This has resulted in more people wanting to learn about Omnipod 5 and the impact it can have on their lives and those they care about. We expect our DTC efforts for Omnipod 5 will be even more effective than what we have experienced for Omnipod Dash. We are also using DTC to drive awareness for Omnipod in select international markets. Customers love Omnipod 5. That's because of the number of firsts it brings to the market. It's the first pod-based AID system, the first fully compatible phone-controlled AID system, the first system no one has to plug in to access data, and the first with a smart bolus calculator to directly incorporate trends. We've heard humbling and inspiring stories from countless customers, and we're just getting started. I want to share a couple of stories we've heard from individuals adopting Omnipod 5 and how impactful it's been for their lives. An individual who had been using an insulin pump for over a decade and recently switched to Omnipod 5 told us that after 10 years of worrying about visible tubes, getting caught on doorknobs, and dealing with the nuisances of being tethered to his pump, he now spends more time focusing on life. His outcomes have improved, including his overnight blood sugar, and he no longer has to live his life with diabetes top of mind. We also heard from a physician who has lived with type 1 diabetes for 43 years. He noted that during that time he's seen treatment options evolve and change, but Omnipod 5 is the largest leap in improvement he has ever seen. This very experienced physician called our system, quote, remarkable. These two stories are just a small representation of the amazing testimonials we continue to receive from Omnipod 5 users. There's a common thread that connects all the stories we hear from users. Omnipod 5 is redefining how people manage their disease, and it's making their lives simpler. The impact Omnipod 5 is having is clear and it's powerful. In Q2, the first full quarter of limited market release, Omnipod 5 already represented over 25% of our U.S. new customer starts. We expect that percentage to accelerate with the U.S. full market release as we now sell through a broader distribution channel, including all of our wholesalers that supply products to approximately 88,000 retail pharmacies. We are also having outstanding success securing coverage for Omnipod 5. Today, we have over 55% covered lives for Omnipod 5, which is well ahead of where we were when launching Omnipod Dash, and represents a significant increase from Q1. Our team has done an amazing job, and we expect to make meaningful progress the rest of this year and into the next. Omnipod 5 is now fully available through retail, specialty, and mail order pharmacies to anyone with a prescription and coverage in line with our expected timing. Our limited market release provided key learnings about how healthcare professionals and customers interact with our product, onboard, and virtually trained, all of which are dramatically easier than ever before. Already, the small improvements we have implemented are resonating with users, especially those coming from a tubed pump who transition to a more simplified experience. In fact, One of the key learnings is that physicians and patients can rely on the automation of the system to do the work for them during the first few days. Omnipod 5 works with the first pod out of the box, and then it learns and adapts to personalized care for each individual user, typically within the first or second pod change. This ability to automatically personalize therapy clearly differentiates Omnipod 5 from all other systems on the market. Quite simply, Omnipod 5 eliminates significant burden and shared work between patients and their physicians. Although our target market continues to be MDI, not surprisingly, many of our Omnipod 5 new customers come from competitive pumps, and people are loving the experience. The clinical benefits of Omnipod 5 were clearly demonstrated by the preschool pivotal extension data we shared at ADA that built on the strong results we saw during the study's initial phase. which were recently published in the peer-reviewed journal Diabetes Care. During the first three-month phase of the study, as well as through the end of the extension phase, patients achieved an average A1C of 6.9% compared to 7.4% at baseline. The data clearly demonstrated these individuals maintained their improved levels through the extension phase. Time and range and percent time in hypoglycemia also showed sustained improvements during the extension phase, demonstrating the durability and power of Omnipod 5 for this critical population. We look forward to receiving our preschool indication for Omnipod 5 this year. The engagement around Omnipod 5 at ADA was really something to see. We met with hundreds of attendees at our booth and held a product theater that was standing room only. It was here where we shared patient case studies and the real-world experience of HCPs who have had remarkable success with Omnipod 5. The overwhelming feedback was that Omnipod 5 clearly stood out as the most robust AID offering, and many of the MDI and tube to pump users in attendance have since adopted our technology. Overall, ADA marked another opportunity to highlight our products and clinical accomplishments that demonstrate how Omnipod can change the lives of people with diabetes around the globe and how important and meaningful our mission is. We are also advancing our innovation pipeline. We're developing the next generations of Omnipod 5, furthering our iOS development, and working closely with our CGM partners, Dexcom and Abbott. Our innovation priorities are focused on growing our addressable market, building our next generation AID technology, and creating digital and data-driven products to make diabetes management easier for our customers and their physicians. Moving on to our international operations. Our Omnipod 5 CE Mark submission is moving swiftly through review and we expect approval over the next couple of months. This is an important milestone for our international business as we work to bring Omnipod 5 to people around the world. CE Mark clears the way for us to focus on completing a cloud-based infrastructure that is compatible with local data protection regulations, developing country-specific launch plans, channel and customer experience approaches, and seeking reimbursement. Omnipod 5 is a transformative platform and we look forward to entering our first international markets in mid 2023. We will take a staged approach to entering markets so we can ensure successful launches in each country in which we operate. In addition to bringing Omnipod 5 to global markets, we continue working to enter new markets and recently launched Omnipod Dash in the United Arab Emirates and Saudi Arabia. Omnipod is now available in 24 countries and we're building local teams and advancing our regulatory and reimbursement goals. These efforts will serve us well as we bring Omnipod 5 to our international markets and strengthen our competitive position. Lastly, the global supply chain and inflation each present significant challenges to Insulet as they do for most manufacturers across a range of industries. However, we continue to navigate these headwinds and increase our resiliency. ensuring ample product supply, including supporting the Omnipod 5 launch and the needs of our growing global customer base. We are mitigating supply risks by securing components well ahead of our capacity needs. While this comes at an increased cost that will have a near-term impact on margins, we are taking the appropriate steps in these turbulent times to ensure uninterrupted supply for our current and future customers. The footprint of our global manufacturing operations is one of our many competitive advantages. and we advanced our efforts to further strengthen our capabilities. We recently broke ground at a new manufacturing location in Malaysia. The future facility, located in Johor Bahru, represents an investment of approximately $200 million over the next five years, will provide approximately 400,000 square feet of manufacturing space, and house more than 500 full-time employees at capacity. Our regional sourcing strategy includes the use of local suppliers for components and we have already outlined our plans to utilize environmentally responsible and resource efficient materials in our building design. We expect to begin production at this new facility by the end of 2024. This facility supports our operational strategy to increase our global manufacturing redundancy, build our global talent base, and support future international market expansion efforts. In closing, the second quarter marked a number of financial, commercial, and operational milestones. our entire Insula team continues to execute with an unwavering commitment to our mission and to our customers. We are proud of all the work and accomplishments we achieved this quarter and know we are setting the stage for sustainable long-term growth. I'll now turn the call over to Wade.

Thanks, Jim. We've made great progress in Q2 as we delivered another quarter of record U.S. and global new customer starts and achieved a number of notable milestones, including the US full commercial launch of Omnipod 5 within the time range we expected. We are advancing each of our strategic imperatives, navigating supply chain and inflation challenges, and maintaining our focus on fulfilling our mission. We generated 18% revenue growth in the second quarter, finishing above the high end of our guidance range. On a reported basis, for total revenue, Foreign currency was a 390 basis point headwind compared to Q2 of last year. U.S. Omnipod revenue growth was 31%, exceeding our guidance range. Revenue growth continues to be driven by the compounding benefit from record new customer starts and increasing volume through the U.S. pharmacy channel, including initial contributions from Omnipod 5. Q2 revenue included an estimated $7 million of net channel inventory build, which consisted of Omnipod 5 inventory build, partially offset by a reduction of classic Omnipod and Omnipod Dash inventory at our distributors. Additionally, as a reminder, Q2 of the prior year included a favorable comparison for an approximate $2 million catch-up in rebates from earlier periods. Omnipod 5 and Omnipod Dash new customer starts combined were up sequentially to over 90% of our total U.S. new customer starts, comprised of Omnipod Dash at approximately 65% and Omnipod 5 over 25%. In addition, pharmacy channel volume increased to approximately 65% of our total U.S. volume. International Omnipod revenue increased 9%. at the low end of our guidance range, driven by Omnipod Dash adoption, partially offset by AID competition headwinds, and the pandemic's compounding impact over the past year. On a reported basis, foreign currency was a 1,130 basis point headwind over prior year. During Q2, both our estimated global attrition and pod utilization remained consistent. Drug delivery revenue declined 36% in line with our guidance range. Gross margin was 63.6%, representing a 580 basis point decrease or 640 basis points on a constant currency basis. The primary drivers were the expected higher mix of costs and manufacturing inefficiencies as we ramp our U.S. manufacturing operations. A higher warranty accrual for costs related to Omnipod Dash PDMs for battery lives as they age, as well as higher costs given the mixed impact of Omnipod 5 ramping, all partially offset by growing volume through the U.S. pharmacy channel. As a reminder, the higher mix of volume at our U.S. manufacturing facility, growing Omnipod 5 volume, and the higher component costs included in our inventory balance will continue to pressure gross margin for the remainder of this year as we sell the product out of inventory. Operating expenses were above our expectations due to 27.3 million of legal costs, as well as 3.4 million of costs associated with the retirement and advisory services of the former CEO. Excluding these charges, operating expenses were higher than Q2 of last year due to continued investments in sales and marketing, such as our Omnipod 5 launch efforts, international expansion, continued investments in innovation, and scaling our global business to support our growth. Adjusted operating margin and adjusted EBITDA in Q2, which exclude the legal and CEO transition costs, were 1.3% and 9.2% respectively. Both were impacted by the gross margin pressures and increase in operating expenses and unfavorable foreign currency. Turning to cash and liquidity. During the quarter, we secured an additional $10 million of availability under our revolving credit facility. We ended the quarter with over $700 million in cash and the full $70 million available under our credit facility. Overall, our financial position is strong and provides flexibility to invest across our business to fuel sustainable long-term growth. Now, turning to 2022 guidance. We are raising full year revenue to a range of 14% to 17%. For U.S. Omnipod, we are increasing our revenue range to 23% to 26%. Revenue growth will be driven primarily by increased Omnipod Dash volume through the pharmacy channel, the benefit of our pay-as-you-go model, which should expand both our Type 1 and Type 2 customer base, and increasing volume for Omnipod 5 following our full market release. As a reminder, significant revenue from the Omnipod 5 launch and adoption ramp will take time given our annuity-based business model. For international Omnipod, we are reducing our full-year revenue guidance to 9% to 12% related to the impact of AID competition in our international markets. Revenue growth will be driven by ongoing Omnipod Dash adoption which is sold in all of our markets. We expect international revenue growth will be the highest in the fourth quarter of the year due to an easier comparison, as well as an expected improvement in COVID conditions. Lastly, for our drug delivery revenue range, we are lowering full year guidance to a decline of 35% to 40%. As a reminder, 2021 levels were elevated as a result of the pandemic. Turning to 2022 gross margin, we now expect a range of 65% to 66%, representing a decline of 200 basis points from our previous expectation as we continue to encounter higher costs associated with ramping U.S. manufacturing and Omnipod 5 volumes, higher warranty costs, and the ongoing inflationary and supply chain pressures in the broader macro environments. We continue to execute strategies to partially offset these headwinds while also ensuring we have more than enough capacity to meet expected demand. On a year-over-year basis, our gross margin will be impacted by product line mix from lower drug delivery revenue, higher costs associated with our U.S. manufacturing ramp, product mix, including ramping Omnipod 5, manufacturing components due to inflation, and warranty costs. We expect these headwinds to be partially offset by the benefit of increasing volume in the U.S. pharmacy channel. We expect unfavorable product mix, the U.S. manufacturing ramp, as well as inflation and supply chain macro-related headwinds to continue to impact our results for the next couple of years. We expect operating expenses to rise year over year, driven by ongoing investments in our sales and marketing efforts, including the launch of Omnipod 5 in increasing DTC advertising, as well as expanding our innovation pipeline and clinical efforts and scaling our support functions. Excluding the legal and CEO transition costs, we now expect operating margin to be in the high single digits as a result of the gross margin reduction and the macro environment creating inflationary and foreign exchange pressures. Lastly, we continue to expect capital expenditures to increase slightly due to ongoing investments in key areas of our business. Turning to our third quarter 2022 revenue guidance, we expect total company growth of 17% to 20%, including OmniFi growth of 18% to 21%. Based on current foreign currency exchange rates, we estimate the impact will be approximately 500 basis points on a reported basis for total revenue. For U.S. Omnipod, we expect growth of 24% to 27%, driven by the benefits of our recurring revenue model, growing Omnipod Dash volume through the U.S. pharmacy channel, and ramping contributions from Omnipod 5. We expect Q3 international Omnipod growth of 7% to 10%, driven by the ongoing Omnipod Dash adoption partially offset by competitive AID headwinds on the compounding impact on new customer starts in 2021 and into 2022, largely due to the pandemic. We estimate the unfavorable foreign exchange impact will be approximately 1,300 basis points on a reported basis. Finally, we expect Q3 drug delivery revenue to decline 14% to 5% as revenue is normalizing to pre-pandemic levels. In conclusion, we've achieved a number of critical milestones that further position Insulet for growth. While there continues to be macro-related challenges, these are exciting times, with the full market release of Omnipod 5 now fully available through retail pharmacies, and soon CE Mark approval for Omnipod 5 internationally. We're on track to deliver another strong year of revenue growth and new customer growth while also investing in key areas throughout our global business in order to drive future growth and sustain long-term value creation. With that, Dilem, please open the call for questions.

Thank you, sir. At this time, if you have a question, please press star 11 on your touch-tone telephone. We are limiting each participant's questions to one. However, please feel free to go back into the queue, and if time permits, we'll be more than happy to take your follow-up questions. Aisha, our first question comes from the line of Larry Bivelson from Wells Fargo. Please go ahead.

Good afternoon. Thanks for taking the question, and congratulations on a nice quarter and, you know, the full market release of Omnipod 5. Wade, I actually wanted to start with the margins, given that that was a pretty big change here. So totally understandable what's happening this year to the gross margin and the OpEx. I'd like some color on how you're thinking about gross margin and operating margin in Q3 and Q4. And when do you think you can get back to that 70% gross margin that you recently had? And how are you thinking about leverage beyond 2022? Thanks for taking the question.

Hi, Larry. So for our margins, as you mentioned, we stepped them down this quarter for both some micro and macro issues. You know, I think as has been well publicized across many companies, the macro environment is tough, both from an inflationary and foreign exchange, and we've felt that as well. We also have a couple things that impacted us in the quarter. You saw us talk about our warranty increase on our PDMs, as well as some of the volume that we're increasing in our Acton facility. And then just to highlight for folks, you saw us take down our gross margin guidance for drug delivery. That's a higher margin product line, and so when we reduce revenue guidance there, that's a headwind for us. And then we've increased our volume for Omnipod 5. Our expectations for Omnipod 5 are growing even above what we originally thought, and cost of goods sold are slightly higher for Omnipod 5 as well. So although that's a good thing that we're growing volumes with Omnipod 5, it is a headwind to our cost of goods sold. So that creates about a 2% impact to gross margins, and that really is what drops through to operating margins. We also have other inflationary headwinds throughout operating expenses, given the wage environment, as well as services and other increased costs out there that most companies are dealing with. So that's the reason that we changed our guidance. It's a little too early to tell what expectations will be beyond 2022. We have to monitor closely the macro environment here. What we do know is that we are paying higher cost for inputs, raw materials, and components to build capacity. And you can see it in our inventory as we continue to grow inventory. Our operations teams are doing a great job of identifying capacity and growing inventory in this environment, but it is coming at a higher cost. And with the inventory that we've built, a lot of that is deferred over a six-month period of time. And so that's already starting to impact what our gross margins will be next year. So although we're very happy to be building inventory and developing extra capacity, it does come at a higher cost. And so that's going to impact us for some time. But we're not going to look out beyond that at this point, Larry. I think we've got to monitor the macro environment and see what it looks like. What we are going to commit to is that over time, we will continue to expand gross margins and operating margins. It's a key focus for us. It may not be in any particular year, especially with the macro headwinds that we're dealing with today, but you can count on us to continue to expand margins over time.

Thank you. And I see our next question comes from the line of Robbie Marcus from JPMorgan. Please go ahead.

Oh, great. Thanks for taking the question, and congrats on a nice quarter. As it relates to the U.S. new patient starts, I'm surprised Omnipod 5 was already over 25%. I would imagine the exit rate is even higher than that. Maybe you could just talk about the types of patients you're seeing. Are these new to therapy? Are these switching from other therapies? How high a percentage of new patient mix do you think Omnipod 5 will settle out as And is this, in the short term at all, changing your type 1 and type 2 mix? Thanks a lot.

Thanks, Ravi. Thanks for the congratulations, too. I think it's a little bit early to say about how the rates are going to settle out. We're very happy with adoption of Omnipod 5 across the board. As we said, more than 80% of our new customers are patients coming from MDI. And so that's our target market. We are seeing a high percentage of patients converting from Omnipod Dash. And to me, that's a great sign of demand because what it shows is that patients who are already on the Omnipod experience, we know they've been waiting for Omnipod 5. And so we're actually, I think, getting a somewhat higher percentage of conversions already. And if you remember, during limited market release, what we've been telling the market is the fastest way to get an Omnipod 5 is to get an Omnipod Dash and then convert. So we're seeing that very well. And we are seeing conversions from other tubed pump offerings. And so So we're getting a mix across the board, and we're really happy with that.

Hey, Robbie, it's Brett. Just to draft in here a little bit, you asked about the exit rate. So yeah, good pick up there. 25% was our mix for the entire quarter. So remember, we just entered a full market release. And so as you can imagine, the ramp throughout the quarter, really, the exit rate was quite a bit higher than 25%. So We're in a great spot going into Q3. You should expect that Q3 is going to be a much higher mix of our new starts as Omnipod 5. The other thing to remember is I know many of you look at IQVIA data to sort of understand what new starts are. There's a component there called NRX, which is usually a really good way to take a look at new prescriptions on a product. For Omnipod 5, it's pretty high, and there's just some things to keep in mind there. One, Jim called out the percent of conversion. So we have a very large percentage of new to Omnipod 5 that are conversions from our legacy products. The other thing to remember is that Omnipod 5 requires two prescriptions. So it requires a prescription for a starter kit and a refill of pods. And so as you look at IQVIA data, you're just going to want to make sure that you're only viewing one of those and that you remember that the majority of new to Omnipod is conversions. But we're thrilled to be in full market release and the team's excited to just be in full promotion mode starting Q3.

Thank you. And I show our next question comes from the line of Travis Thede from Bank of America. Please go ahead.

Hey, congrats, and thanks for taking the question. Wade, I was looking at the guidance for U.S. Omnipod growth specifically in the U.S., The first half was about 26%, and the guide for the full year, 23% to 26%. So it seems a little bit of a step down in the second half, but you do have the COVID comps going away and Omnipod 5 launching. So we wanted to get some color on the second half specifically. And then on the $7 million of stocking, our inventory bill with Omnipod 5 this quarter, how much of that was assumed in the Q2 guidance? Thank you.

Hi, Travis. Glad you asked this question. We get to provide a little more color here. So first of all, you called out the 7 million of channel inventory build and that's something that you have to factor into the first half, second half as you're thinking about the guidance. The other thing to normalize for is we had an incredibly strong Q4 last year and so that creates a tough comp for us. So if you include normalization for the channel build and think about the tough comp, the second half is actually a stronger percentage growth rate and certainly on an absolute dollar basis, so much higher than the first half. So we've got a really strong U.S. guide into the second half of the year. And on the channel inventory build, we don't factor in any major channel build into our guidance. We do factor some trends and some normal order patterns and some normal stocking. But whenever we see a large material or significant channel build or channel destock, we call them out, just like we have in the past. And so, as we talked about in the prepared remarks here, we're going to continue to see Omnipod 5 inventory ramp. That will be offset by reductions of our classic Omnipod and Omnipod Dash at our distributors. And depending on how that matches up or is mismatched, it could result in a inventory channel build. And so again, when we see it material, we'll factor that in and let you guys know in our prepared remarks. But from here, we typically don't build in large stocking or destocking into our guidance.

Thank you. And I show our next question comes from the line of Steve Lichtman from Oppenheimer. Please go ahead.

Thank you. Hi, guys. Just on your clinical programs, what is the latest outlook for a type 2 pivotal study? And on the clinical study you mentioned versus non-AID, are you hoping to use that for enhanced reimbursement? Have you received feedback from payers that that is possible? Thanks a lot.

Thanks, Steve. On the type 2 program, we've launched, obviously we have first two patients very successfully with Omni pod dash where we have an indication for use and as we as we said in our prepared comments we had roughly 30% of our new customers starts were people with type 2 diabetes and we continue to grow that year over year so we were very confident that we have a great experience for people with type 2 diabetes already fantastic form factor great pay-as-you-go model and access to the pharmacy all which are differentiated but we are working on type 2 pipeline and as you know we published a We're people with type 2 diabetes, and we continue to grow that year over year, so we're very confident that we have a great experience for people with type 2 diabetes already. Fantastic form factor, great pay-as-you-go model, and access to the pharmacy, all of which are differentiated. But we are working on type 2 pipeline, and as you know, we published fantastic feasibility data with Omnipod 5 for patients with type 2. We published that earlier in the year at ATTD in Barcelona. And based on that study, we're in conversation with the FDA about the protocol for a pivotal trial, and as we get closer on that, we'll tell the market more about it. And I'm gonna turn to Deb to talk about the randomized control trial.

Yeah, hi, how are you? We're excited about the randomized control trial, and you're right, we're doing that in order to grow our clinical body of evidence, but also it's really focused on driving access and reimbursement in our international markets. As you're aware, we consider ourselves our own category with a tubeless AID system, and what we want to do is chart out reimbursements specific for our offering that we know will be well received internationally, and it will help, we believe, with the strength of the data from the RCT, should help us with negotiating pricing, and setting reimbursement in countries where there either is not reimbursement today with AID, or certainly we want to get higher reimbursement for our offering. So really excited about doing the study. We are in the United States and France because they're two of our largest markets. And in fact, we actually, very early on in the enrollment process, but we already have almost 50 people enrolled in seven sites. in our U.S. market, and we'll be soon enrolling our new first patients in France. So really excited. It's just one of the many levers that we are pulling in order to get ourselves ready to launch next year in our international markets with Omnipod 5.

Thank you. And I show our next question comes from the line of Chris Pasquale from Nefron Research. Please go ahead.

Thanks, and that's in the quarter, guys. Wade, I want to circle back on margins. You talked about a lot of the puts and takes on gross margins, but SG&A was up meaningfully year over year, even if you back out some of the one-time stuff. I'm just curious, was there anything to call out there, and how do you think about that moving forward? And then one just detail on 05, are you getting a price premium there versus Dash? Some of the prescription data suggests that it might be priced a little higher. Thank you.

Hey, Chris, I'll start it, and then I'll pass over to Brett on the questions on Omnipod 5. So regarding SG&A, you may have caught it in the prepared remarks. We talked about increasing our investment in direct-to-consumer advertising on the front end of Omnipod 5, and we certainly have a lot of investment for Omnipod 5, both here in the U.S. as we prepared for the full market release and worked our way through the limited market release, And then internationally, we've got a significant amount of work going across many functions, marketing, and in particular in IT. And we've got a significant amount of work to do country by country from the infrastructure that needs to be built to support our cloud infrastructure. And what we have to bring with our Omnifod 5 system is really this differentiated system that works in the cloud and brings a lot of benefits to both the HCPs and the customers. And so we're working on that. It's different in every country outside the U.S. We have to be aware of the privacy laws and other things. So a lot of investment there. And that's what you're seeing show up in our SG&A today. And I'll pass over to Brett on Omnipod 5. Yeah. Hi, Chris.

The pricing of Omnipod 5 versus Dash, remember, we said we would price it at parity to Dash, and we're sticking to that. So we are offering payers the exact same rebates for Omnipod 5 that we offered for Dash. The exception to that, and the reason you might see some discrepancies in pricing, are mainly around mix. And remember, Omnipod 5 is a pharmacy-only product, so we did have a few payers that were in DME that we are not offering Omnipod 5 in DME, and so they do have to move to the pharmacy channel. So that will cause a little bit of price lift, frankly, in the pharmacy channel for the average pod pricing, but prepare this pricing at parity with just a few exceptions.

Thank you. And I show our next question comes from the line of Joanne Wish from Citi. Please go ahead.

Thank you for taking the question. A nice quarter. As you prepare for the international launch of OmniCloud 5, what have you learned so far in the limited version here in the U.S. that you can take over there? And should we think of a limited launch in the international market arena also?

Thanks. Yeah. Hi, Joanne. This is Brett. Yeah. You know, most of the learnings from the U S we can translate to a European launch. And so remember there's, there's a lot to learn from Omnipod 5. It's, um, there's self-service, there's different training. Uh, we've, we've learned a lot with training and support and coordination with, with Dexcom, our CGM partner. So all of those will serve us well when we launch in Europe. There's still work to do. And Jim mentioned, you know, we are well on our way to CE Mark in Europe and we've still got work to do even after CE Mark. So, you know, we're targeting middle of 23 for the first markets in Europe to come on board. And that will, that effort will move into 24 because they are going to be staggered launches. So there's work to do with the cloud. And remember, we're pioneering here. We are going to be the first company that's getting real-time data on every single user. So we're putting a SIM card in PDMs. We're building a cloud that meets the requirements of every country. And then we're assessing the reimbursement environment. We've got to establish reimbursement for an AID system that is Omnipod. And we're looking at the potential for different pricing in those markets. So Oh, and there's work to be done even after CE Mark, and you can expect those launches to come in a staggered fashion starting in the middle of 23.

I'll just tag on the back of that, Brett, that one thing to bear in mind is as we launch Omnipod 5 and we go market by market, with all of that work we're doing to pioneer cloud-based offerings, we're also digging a huge moat. We're going to do it sequentially, we're going to do it right, and we're going to do it to win. It will be very difficult for anybody to follow.

Thank you. And I show our next question comes from the line of Cecilia Folong from Morgan Stanley. Please go ahead.

Great. Good afternoon, and thank you for taking the question. I wanted to ask if you could just provide a bit more color just in terms of takeaways from your limited distribution period, what was incorporated or adjustments that you made as you transitioned to full market launch, and then kind of on the heels of that, too, just your free trial period with Omnipod 5, really the rationale shifting from 30-day to 10-day. And thank you for taking the question.

Yeah, Cecilia, this is Brett. So, you know, the list is long of what we learned in the LMR. And, you know, we're thrilled, again, to be moving to full market release. But we've commented on some of what we've learned. A lot has to do with the onboarding experience. We adjusted the training protocols, some of the self-service options. some of the expectation setting for those that might be coming from an AID system versus MDI. There's a lot to learn there, and we got really comfortable with that, which is why we're moving to full market release. And the second part was, I think, around the free trials. Oh, the free trials. Yeah, so the 10 days is a great question because we are committed to free trial with OmniPy5. And, you know, it was a 30-day free trial with DASH. And while we wanted to do that same trial with Omnipod 5, Omnipod 5 is a system that includes Dexcom CGM. So that was really in coordination with our partner there at Dexcom as they offer a free 10-day trial. We want to make sure that we're not offering a trial that doesn't include a CGM. So a lot of work there and a lot of coordination that went into that. But we're committed to doing free trials for Omnipod 5, and it's something you will see us continue to offer.

Thank you. Yeah. And I show our next question comes from the line of Margaret from William Blair. Please go ahead.

Hey, good afternoon, guys. Thanks for taking the question. So I wanted to follow up a little bit on the inventory build and kind of what that means for domestic patient ads. Just as I was going with our model quickly, you know, even if you take out that $7 million, it still seems like those domestic patient ads grew at a faster clip than expected. So You know, can you give us any sense of whether new patient ads domestically, for example, grew faster than overall domestic revenue growth? Or, you know, that's too strong to say. And then, you know, on the inventory side, were you able to talk to distributors in terms of why they wanted to build up so much demand? You know, is it because they're seeing it, you know, fear around lack of supply, or they're hearing from patients already that they need to be ready?

Sure. Hey, Margaret. It's Wade. Why don't I start with the inventory, maybe a little on the new product ads. I'll pass it over to Brett because he's got the insights from the team. So on the inventory build, some of this is just timing and the way it happened as we shifted from limited market release into full market release. And limited market release, as you recall, we stepped into it by adding in mail order pharmacies, specialty pharmacies, but held back on the large bolus of retail pharmacies. And when we then moved to the retail pharmacies, that's when we had significant inventory to move into the channel so that those wholesalers and distributors can feed, as Jim said in his prepared remarks, the 88,000 retail pharmacies across the country. And so that's just timing. And we'll continue to build inventory with Omnipod 5, and it just depends on the end of the quarter where we're at with the reductions on the Dash and Classic if we have more inventory builds in the future. But you're right, it does speak to the excitement out there and the demand that's building out there. And that's why we're trying to get as much channel inventory out there as soon as we can now. Because of the access, as Jim mentioned as well in his prepared remarks, we're well ahead on access. That was one of the other major metrics that we were managing. in order to go to full market release. And now that we're over 50% access out there, there are many people that can get prescriptions and now get OmniPod 5. So it's pretty exciting to see the inventory stocking in the channel and all the pharmacies across the country that people be able to access the product in. And from a domestics ad standpoint, you're right. That is one of the reasons that we exceeded the high end of our guidance this quarter. We don't get a significant amount of revenue from new customer starts in any particular quarter. just because of the annuity-based model that we're in that I know you're familiar with. But Brett, any color you want to add on the domestic ads?

Yeah, Margaret, I mean, this inventory build is almost something that's just unavoidable with a product launch like Omnipod 5. I mean, ideally, you'd love to see the Dash inventory drop at the same rate that Omnipod 5 is going up. But look, we try to project this as well as we can and communicate with our distributors. And I think it's fair to say demand just exceeded our expectations here. especially with conversions. So the one thing we have to point to was when we launched Dash, we did see conversions from our legacy product, but demand for Omnipod 5 is just much different. And we have potters who have been waiting for Omnipod 5 for a long time. And that is, we just saw a lot more conversions, a lot more demand, and that resulted in a little bit of inventory build. But again, it's healthy and we try to keep it to a minimum.

Thank you. And I show our next question comes from the line of Jason Bedford from Raymond James. Please go ahead.

Good afternoon and congrats on the progress. Jim, you've set a high bar for yourself with the quarter here, at least in the U.S. Wanted to ask on international, it was down quarter on quarter. The model typically doesn't lend itself to sequential declines. And I realize FX is probably a bit of a factor here, but Why was 2Q international revenue down quarter on quarter? And it looks like the implied 3Q is kind of flat to down slightly as well. So a little detail there. Thanks.

Sure, Jason Swade, I can take that one. And this is what we've seen historically as well. So we do get this question from time to time. It's typically when we see that sequential down. And it's certainly an understandable question because it's an annuity model. But what we see happening across our international business, and this is the case in prior years as well, because we sell a lot of our revenue through the distribution channel, we have ebbs and flows in the distributor inventory patterns and order patterns and depends at the end and beginning of quarters where we're at in fulfilling those orders. So it lends itself to be a little bit more difficult to understand because it is an annuity model. But that's it. You've also seen us call out internationally whenever we've had stocking or destocking of a material nature, you've seen us call that out as well. So when we don't and we see a couple million dollar swings between the quarters, it's really just an order trend and nothing that we're concerned about or think we should be calling out as well. And as we move into the second half of the year, you're right, Q3 goes up, but we typically see a seasonal trend. decline in Q4s as well. And that's some of the distributors, I think, managing their inventory at the calendar year ends. And so really nothing to talk about here, Jason, other than just some normal inventory trends. And, you know, again, we'll call it out when we see anything material.

Thank you. And I show next question comes from the line of Joshua Jennings from Cali. Please go ahead.

Hi, this is Brian for Josh. Thank you for taking my question. On the cost of therapy, a competitor cited patients delaying pump purchases specifically because of the upfront cost. How big of a factor do you judge cost to be as a driver for Omnipod 5 adoption and Do you have an ability to or I guess an interest in lowering current co-pays further should pump manufacturers introduce payment plans that match the typical co-pay?

Hi, Josh. It's Brian. We think cost is very important, and it's one of the reasons why years ago we decided to move to the pharmacy channel, more importantly move to a pay-as-you-go model because It is, the upfront fee is very disruptive and very difficult for patients, especially if they have not met their deductible. So, you know, for us, we don't see these type of headwinds and these fluctuations because the co-pays in the pharmacy are predictable and they're low. And remember, the majority, the vast majority of our patients pay something less than $50, so the average is much lower than that. As Jim said, many pay zero. So, you know, the pay-as-you-go model is really important. We top that off with a free trial, you know, and you can try Omnipod for free if you want to. And then I think the final part of your question is about lowering copays. And that's just an effort we're always making. And we talk about that as functional access. So we want to do a few things. We want to remove prior offs. We want to remove high copays. And in some cases, we're willing to give up a little bit on the rebate percentage with payers if we can get that accomplished, because we want to remove every obstacle we can to get it on Omnipod.

Thank you. And I show our next question comes from the line of Matthew O'Brien from Piper Sandler. Please go ahead.

Afternoon. Thanks for taking the question. So wait, I think you kind of started talking about this, but if you adjust for that inventory build in Q2, you know, you grew on a stack to your basis, you know, low, low 20%, you know, in Q2, low 20% in Q1. Now you're expecting this big bump in Q3, Q4. kind of more of the mid-20s on a two-year stack basis. So where is that growth specifically expected to come from? Is it an acceleration in the type 1 patient population? Is it more conversion from existing pump users? I mean, where is that really coming from here in the U.S.? Thanks.

Yeah, Matt, I'm not sure I quite followed all that math, but I think if I followed you right, what you're saying is first half, strong growth rates, and if you do normalize for that $7 million channel inventory build, we have about a 26% growth rate in the U.S. in Q2. And so then you take that and you look at the second half guide, where, as you said, we're in the mid-20s, and that's a strong guide for us, especially given that tough competitive comp we have in Q4 of last year with such a strong quarter. And then where's the growth going to come from? It's all the above, Matt. It's pretty exciting. As you know, all of the drivers that we've had in the business before Omnipod 5 are really what are continuing to drive the business here. The pay-as-you-go model, the Dash product itself, all the economic benefits that Brett just mentioned, and so as well as the differentiated opportunity we have in Type 2 in the pharmacy channel. So a lot of drivers, and that is going to be what continues to drive the business. And then Omnipod 5, at 25% of the new customer starts here in Q2, will continue to be a driver as that continues to ramp. So we've got a lot of growth momentum in the U.S., and I think the guidance reflects that.

Thank you. And I show our last question comes from the line of Dane Reinhart from Baird. Please go ahead.

Thank you. Good afternoon, guys. This is actually Jeff on for Dane. I apologize. I'm having some phone issues today. But two questions, I guess. One, Wade, just clarifying, we keep talking about this $7 million stocking tailwind in the second quarter. I thought you said some of that was netted out between old Omnipod inventory coming out. Should we be thinking about that as a one-timer of $7 million, or is it a little less than that? And then, Jim, just wanted to ask you, you know, this is your first full quarter now as CEO or first quarter as CEO. Spending is going way up. Is this conceptually how we should think about you? You're a revenue guy. You're going to drive revenue and cost be damned or at least cost don't matter in the near term. We are going to push the top line into competitive mode as much as possible. Just trying to understand your style here maybe. Thanks.

Sure. Hey, Jeff, I was a little disappointed, actually, if you weren't going to be on, so it was great to hear your voice. And I'll just answer the first part really quickly. The $7 million is net, so that is the net impact of Omnipod 5 inventory ramping and classic Omnipod and Dash coming down.

Jeff, thanks for your question, and I actually love your question. And by the way, it's great to be here. on my first quarter and I'm loving this and we have a great team and a great strategy and we have incredibly talented people and so much passion. But in answer to your question, I don't think you should think of me as somebody who's going to, you know, cost be damned. We have massive growth opportunities in front of us. You know, our investment thesis remains the same, which is we're going to drive Omnipod 5. We're going to drive successful launch and successful growth with Omnipod 5. We're going to continue to drive international growth with Dash. We're going to continue to drive type 2 growth with Dash, and we're going to fund all of our great innovations that are coming to market, but we're going to be very prudent with cost and how we do that. We're obviously in a macro environment that presents a lot of challenges. We're not immune to that. That's happening across industries. It's happening in our industry, so we're going to be very prudent with costs, and we're very mindful of that, but we have fantastic growth in front of us, and we're going to capture it.

Thank you. This concludes our Q&A session. I'd like to turn the call back to Jim Hollinshead, President and CEO, for closing remarks. Please go ahead, sir.

Thanks, Dilem, and thanks, everyone, for joining us today. We've made terrific progress in the second quarter, and we're on track for another successful year, despite having to navigate through the challenging macro environment. The full market release of OmniPod 5 is an exciting milestone, and we're really thrilled to be in full market release with that offering. And our goal is to drive that growth and to finish the year strong and sustain our growth for the long term. I've been really inspired, just on a personal note, I've been truly inspired in my first two months here as CEO. We're making great progress. We are changing people's lives. We've got great and talented people. We have one of the best management teams in MedTech, and we've got phenomenal offerings. Insulet has never been in a better position to deliver on our mission to simplify and improve the lives of people with diabetes. Thanks, everyone, and have a great day.

Ladies and gentlemen, this concludes today's session, and have a wonderful day. Email Disconnect.