Hi, everyone, welcome to the J.P. Morgan Healthcare Conference, day three. My name is Caroline Borowski , and I'm an associate here at the J.P. Morgan Healthcare Group. It is my pleasure to introduce Dev Kurdikar, President and CEO of Embecta.
Thank you, Caroline. Yeah, it's an absolute pleasure for us to be here. This is our first J.P. Morgan Healthcare Conference as our own independent company, and it's truly a thrill, especially because in our first year we are back in person now after being virtual for a number of years. With me today, I have Jake Elguicze, our Chief Financial Officer. Pravesh Khandelwal is sitting there. He's our Head of Investor Relations. Our plan is to take about 20 minutes just to give you a strategy and business update, and then I'm sure we'll have time for questions. This is our forward-looking statements language. Given that we are a new company, let me just first start by sort of emphasizing who we are.
Our mission is to develop and provide solutions for people living with diabetes. That is our sole focus. That is all we do. We are global leaders in insulin injection devices. We've been making these devices now for almost 100 years. Our manufacturing strength, I would argue, is unmatched. Our global distribution capabilities and commercial capabilities allow us to get these products that we manufacture from our plants into the hands of an estimated 30 million people in over 100 countries. Since our spin, we've been hard at work. We carved out a business, as I mentioned, that was part of BD, Becton Dickinson, for over 100 years.
We've been hard at work bringing on talent, standing up our own systems and processes, so that we can continue to progress towards our vision of a life unlimited by diabetes for people who suffer from diabetes. Turning to this page, let me first just describe the landscape, right? The global diabetes landscape. It's a growing space where people with diabetes need chronic treatment. The prevalence of diabetes globally is steadily and consistently rising. Maybe more so even in emerging markets, where demographics, the improvements in economies are leading to different lifestyles, leading to different dietary habits. The incidence of diabetes is rising.
If you do get diagnosed with diabetes, and say Type 2 diabetes, it's likely you'll start with conservative treatment, diet and lifestyle modifications, maybe some oral drugs, maybe some injectable drugs, but then eventually maybe on insulin. Once you're on insulin, you generally will remain on insulin for the rest of your life. There have been a lot of advances in diabetes treatment over the years, but insulin injections we believe will remain the standard of care. Even with all the technological advancements that have occurred, with adoption rates mostly in the U.S. and maybe some developed markets, there is still a lot of unmet need in this space. This map, emphasizes the point I made about the prevalence and cost of diabetes growing consistently around the world.
If you just take a look at the map, you'll see every region of the world, there's an increase in the number of people with diabetes. If you look at the total, which is on the top right-hand side of this page more than 500 million people with diabetes rising to almost 800 million over the next 25 years. 10% prevalence rate, three out of four people with diabetes live in low and middle-income countries. Cost is high, almost $1 trillion. That number has gone up by more than 300% over the last 15 years. Clearly a big global issue. As I mentioned, even with all the advances in diabetes treatments, there is still a lot of unmet need, even with the most advanced treatments if you're using them.
If you're insulin dependent, you truly have to juggle your life every day. You have to serve as your own healthcare provider, right? Let me just sort of describe to you what a person with diabetes goes through. You have to self-monitor your blood glucose level several times a day. You have to consider the implications of the readings you get on your diet, on your medications. You have to take your medications, you have to adhere to them. Sometimes those medications are based on calculations you have to do based on what you ate and what your blood glucose reading was. You have to make daily decisions on what you're gonna eat, whether you're gonna exercise, when are you gonna take your medications. Finally, there's a chance you have to change your lifestyle, right? Including exercise and diet.
You can imagine you're a person trying to live your daily life, but you're constantly doing this juggle, mental sort of gymnastics in your life every day. It has a high burden on society, both on physical health, certainly the financial cost that you have to pay for all these medications and treatments, and then certainly your emotional well-being. In this large market with unmet needs, now here we are, an independent company with a leadership strength that's really based on a few core strengths. We have scale, we have a reputation for quality, and we have efficiency that create competitive advantages. If you think about the fact that insulin was first used to treat diabetes in 1922, we made the first specialized insulin syringe in 1924, just 2 years after insulin was used. We have a 100-year history now, almost.
Over that time, we've built trust in our brand. We are, I said before, the number one producer of pen needle syringes and safety devices, touching almost 30 million people. Over that 100-year history, we now have established relationships with customers and key stakeholders. Manufacturing is a core strength of ours. We have 3 plants producing almost 8 billion units a year. They're highly automated plants. Again, because we've been producing these products for as long as we have, we have stable, strong supply base with long-standing relationships. Also, over the decades that we've been producing these devices, you can imagine we've gone down the learning curve. A lot of what we have learned in terms of manufacturing, we protect as trade secrets, and it's sort of the IP is buried in our manufacturing line and processes.
The products that we produce are then distributed, and we have vast commercial capabilities. They go into global distribution centers where more than 600 commercial employees around the world, slightly over half of them are in emerging markets, allow those products to be accessible to people with diabetes in over 100 countries. On the manufacturing side, we have three plants, one in Dún Laoghaire, where we are the largest global producer of pen needles. In Holdrege, Nebraska, where we are the largest manufacturer of specialized insulin syringes, and our newest plant is in Suzhou, China, where we make pen needles, and we supply those products for markets in Asia, including China. As I mentioned, these are highly automated lines, they run 24/7. Our commercial capabilities are also quite strong. Almost half of our revenue comes from outside the United States.
What we've done is that we've tailored our go-to-market strategies depending upon the needs of the region so that we can manage reimbursement and take into account local market dynamics. In North America, notably in the US, which is our single largest market, we have ongoing collaboration with retail pharmacies, long-term care centers, integrated delivery networks. Our reimbursement landscape in the US has been stable, and we have strong reimbursement both from private payers as well as from Medicare. In EMEA, obviously, a conglomeration of almost 70 countries, we have direct teams. We also use distributors. The reimbursement landscape generally is stable in most countries. Then in Asia and Latin America, we have some tender markets, we have some direct presence, and we use distributors as well.
There, the reimbursement landscape is a mix of payer reimbursement, sometimes government reimbursement, but also self-pay. What we try to do, regardless of our go-to-market strategy in each of these countries that we are in, we try to differentiate our product based on quality, clinical outcomes, price, and very importantly, our demonstrated ability to supply the market. This is a source of competitive advantage because if you think about a person with diabetes wanting to walk into their corner drugstore and pick up a box of needles and syringes, that product needs to be available so that they can administer insulin to themselves. We've demonstrated that we can provide that product and keep those shelves stocked. Certainly, we've demonstrated that ably over the last couple years where there's just been so much turmoil in the manufacturing and sort of the operational landscape.
Big market, we have a strong leadership position, but now we are an independent company. We are beginning to think about where we are going to invest to change the long-term growth profile of this company. Those investments fall into three buckets: commercial investments, investing greater in R&D, and then thinking about M&A. If you look at our core markets, we think that there is potential to continue to get some growth in the core. It's gonna come in a couple different ways, right? We have leadership share positions in most markets we are in. E-commerce is a growing channel, notably in Asia, so we are investing behind that. The other thing we've learned is that even in markets where there is strong reimbursement, people tend to reuse these needles. These needles are supposed to be single-use disposable products.
We are looking at ways to collaborate with retailers, use digital marketing techniques to remind people that they should be using a fresh needle for every injection. Small changes in reuse rate can have a notable impact on our business. The second thing we are doing is we are investing more in R&D, notably behind a patch pump for the Type 2 market that I'll speak to in a second here. Finally, we wanna seek partnerships and look for business development opportunities where we can add value through one of our strengths, right? Our strengths are this high volume manufacturing expertise and distribution capabilities. We have a unique channel, especially for a med tech company, right? Our products are available through the retail channel. Finally, certainly again for a company of our size, we have strong emerging market infrastructure.
That point is particularly important because if you think about where the growth is gonna occur in the number of people with diabetes, that's disproportionately in emerging markets because of the reasons we spoke about earlier. I mentioned we are working on a patch pump. Our patch pump is focused on Type 2, and it's one where we've gleaned insights from discussions with people with diabetes as well as healthcare providers. We are proud that it's being developed under the Breakthrough Device designation of the FDA. What that has allowed us to do is to have interactive discussions with the FDA, even through all the COVID EUA years while we are developing the product. A few key things to keep in mind when we talk about a patch pump for Type 2, right? The user needs are quite different.
Type 2 people with diabetes are looking for maybe less of an initial training burden, the ability to tailor alarms. Notably, people with Type 2 generally need more insulin a day than people with Type 1, so we are designing our product with greater insulin holding capacity than the currently available patch pump. Obviously, advantages over tube pumps. An algorithm that we are going to test and gather data through clinical trials for, that's really focused on Type 2. Fundamentally, as I'm sure you appreciate, Type 2 is different from Type 1. We are very excited about this program. We are committed to resourcing it to the level necessary to give it its best chance of success.
It can fundamentally transform our business because we have people with Type 2 that are currently using our products, but Type 2 is a progressive disease, so if it does progress to a point where somebody wants to adopt a pump, we wanna have a solution available for them. It will also utilize some of the same channels that we have. It's a fully disposable product, so it can go through the retail channel, which we have. Certainly in the US , we have almost 95% of the covered lives in the US through existing contracts, so it'll leverage some of the strengths we have. Since we became our own public company on April 1, we have been hard at work.
On the left-hand side, you see we had a bell ringing ceremony on November first, where we were honored to be accompanied by a number of advocacy organizations that really support people living with diabetes. We were fortunate to have a experienced team and an experienced board right at the outset on day one. We demonstrated certainly strong execution. I'm sure we would all like to forget, last year was a challenging year from an operational perspective. We demonstrated strong execution. We were able to maintain continuity of supply to all our customers from all our plants around the world. We've been making a lot of progress on doing the work necessary to be able to exit our TSAs, our transition services agreement.
Most of these agreements we plan to exit by April of 2024, so two years from spin. We are standing up our own systems, we are standing up our own processes, we are bringing in talent. We've continued to advance the patch pump product I talked about. In December, we announced a deal with Intuity Medical. I think this is an example of the kinds of deals that we are looking for. Intuity Medical has a novel blood glucose monitoring solution, an automatic blood glucose monitoring solution. Traditional BGMs use multiple steps to take one reading. This is a simple device with minimal steps all integrated into one device, where the person with diabetes just puts their finger on the device and can get pricked and get a reading, including on their phone.
What we are trying to do here is understand that there is a market need, that there is a product available in the market, and then we are using a channel that we have already in place to increase awareness of the product. We've done similar deals in smaller markets, one in France, one in China, all with the intention of what is the unmet need? Is there a product available, and how do we leverage our channel? We delivered on our second half expectations in 2022. Our revenue was approximately $566 million, down almost 5% on a reported basis and slightly over 1% on a constant currency basis. That was better than the guidance we had provided in August, which in itself was better than our initial guidance that we had laid out in May.
Our adjusted gross and adjusted EBITDA margins were around 67% and 36%, both of which were also better than previously provided guidance. Our TSA expense came in right in line with what we'd projected at 35%. We are proud of these results. They were the first 6 months of our company. If we look at it from a full year perspective, we delivered about slightly over $1.1 billion in revenue. Our reported revenue growth was a decline of 3%. Our constant currency revenue growth was flattish, negative 50 basis points. There were some puts and takes if you look at our full year results. We had some rebate reversals that occurred in 2021 that were not reported in 2022.
We had already decided to exit some customer relationships in late 2021. There was an unfavorable impact of that on 2022 versus 2021. We also benefited from some contract manufacturing that we did for BD in the second half of 2022 that we hadn't done in 2021. As we now roll into our fiscal year 2023, there are three key priorities that we have. Number one, we wanna keep strengthening our base business, right? It's a strong, stable platform. It's a profitable business for us, and it'll provide us a solid foundation to grow our business off of. We don't know fully what 2023 will bring, but I think we've demonstrated that we can navigate through operating challenges, and we'll certainly strive to do so through all of 2023 and manage costs diligently as we've done.
This is also a year where we have to do a lot of separation and stand-up work. We are 9 months into now a 24-month TSA period. We've 15 months to go here. We have to execute on an ERP implementation globally. We have to close our China entity, which was a deferred entity at close. As we go through that process of transferring that entity from BD to us, we have to manage a temporary suspension of manufacturing operations at our Suzhou facility. Finally, there's a whole host of separation projects that we have to do, setting up distribution network, all the back office functions. W e have products that we need to re-register in virtually every country around the world. That's gonna be a multi-year effort. There's a lot of separation and stand-up work that we have to do.
While we are doing 1 and 2, w e don't wanna lose focus of the fact that Our number 1 goal at the end of this is to actually change the long-term growth profile of the company. We'll continue to advance our patch pump development. We'll continue to seek M&A and partnership opportunities. That concludes the presentation part. I'm gonna turn it over to Caroline to sort of moderate the Q&A. We are obviously happy to take any questions that you have, Caroline , and if you have time, the audience has.
Sure. Thank you. I guess maybe just going a little bit off what you already mentioned in the presentation, can you provide a little bit more detail on the key objectives for the company in the short, medium, and long term?
Yeah. Let me start with the long term, right? I mean, look, we've been a flattish business for a number of years. I think if you look at our investor presentation that we did even pre-spin, we, on a revenue basis, we sort of said, "Look, our expectations are this is gonna be flattish through 2024." What we want to do is change that growth profile, right? We haven't lost sight of that is our number 1 long-term objective. If I flip quickly to the short term, right, I laid out some of the things that we have to do in 2023. I mean, it is going to take some time for us to stand up a business that had been part of a larger business for close to 100 years.
That is certainly a focus for us. In the interim, it's a little bit of a mix of both, right? There is going to be some sort of tail stand-up work to be done. We want to sort of lay the seeds for what is going to cause that long-term growth profile to go, right? We are actually going to be increasing our investment in R&D, we have already, so that we can continue the patch pump development, and we are going to be seeking M&A and partnership opportunities. We are mindful of our balance sheet capacity, right? We want to keep an eye on our net leverage as well, right? We don't want to overextend ourselves, both sort of financially as well as operationally. We want to transition from where we sit today to get that revenue growing again.
Can you maybe provide a little bit more detail turning to the market from both a product and a geographical perspective?
Yeah, sure. Let me start with the product. M aybe think about it in terms of the fact that insulin administration, right, generally delivered via injection. The modality of those injections has changed. It is changing. It used to be primarily syringe, now more and more pen needles, right? Our product mix has been changing. More pen needles, less syringes. There has always also been the adoption of pumps, most notably in Type 1, right? Where penetration rates now in the U.S. for Type 1 are estimated to be somewhere in the 35%-40% range, much lower in Type 2.
We are mindful of the fact that our core injection business in developed markets there are gonna be some challenges on volume as people adopt pumps, but at the same time, we want to develop that pump for Type 2. These are users that are using our product today, we wanna provide them a solution for if they do migrate to wanting to use a pump, that we have one for them. Geographically, the growth I talked about before that's occurring in diabetes globally, the bulk of that growth is in emerging markets. In emerging markets, as you well know, there are costs and affordability concerns, right? That is going to remain a bread and butter injection devices markets.
I mean, they're your people that are honestly simply trying to get diagnosed, and once they get diagnosed, to get access to insulin. If you get access to insulin, obviously want some ways to administer insulin, right? Pump adoption is going to be limited there for at least a period of time. We want to utilize the strengths we have. I said we have more than 300 commercially focused employees in emerging markets. We have a plant in China, we have a strong commercial team in China and in other parts of Asia Pacific. We want to use that sort of growth in the number of people with diabetes that's gonna be a bread and butter injection market.
Really we make sure that the position we have, the strength that we have can capitalize on the growth opportunity over there. From a product mix just to sort of high level more pen needles, less syringes. Geographically, I would think about the emerging markets as being really over a long period of time, being a core injection market where we are very well positioned to provide the needs of that market.
As we look at kind of the drug launches over the last several years, can you talk a little bit about what the impact of that has been on your business specifically?
Yeah. Maybe one of the best ways to sort of think about that is to just look and see what's happened in the U.S., right? Most of the impact of novel therapies has really been felt in the U.S. where there is good reimbursement for these drugs to get adopted. Once you go outside the U.S., by the way, even in developed markets and certainly in emerging markets, I mean the effect is a lot more muted. In the U.S., if you look at our U.S. business over the last several years, our U.S. business has been fairly stable. That's in spite of these new drugs, that's in spite of pump adoption that we talked about before. I think there are a couple factors.
One is certainly what we've seen so far is that when new drugs come into play, they don't necessarily make insulin unnecessary. There is an impact of a delay in the onset of insulin, but they haven't sort of eliminated the need for insulin, not so far. Secondly, cost and affordability do limit even in the U.S. Thirdly, if you just look at from a pump standpoint, you know the adoption numbers, right? You measure pump adoption in the tens of thousands of people in the U.S., but the top of the funnel is in millions, right? The vast majority of people still use injections. For all those reasons, our U.S. business certainly over the last several years has remained stable in spite of new drugs, in spite of the pump adoption.
Now maybe turning a little bit more to the financials. You beat your Q4 and H2 of 2022 expectations. Yet we still saw a pretty big jump in the stock. Do you mind kind of talking a little bit more about why you think that happened and maybe what has changed in the last couple of months versus earnings?
Go ahead, Jake.
Yeah, sure. Thanks Caroline. Embecta is a September 30th, fiscal year end and as we mentioned, we spun out about 6 months into our fiscal year in or April 1st. On our first earnings call in May of last year, we provided initial financial guidance for the second half of 2022. In the August timeframe of last year on our 3rd quarter earnings call, we had the opportunity to increase that second half of the year financial guidance. Ultimately in December when we reported our actual results for 2022, we even exceeded those already increased expectations.
A s it relates to the second half of 2022 performance post spin, I think we remain very excited and very happy about that performance, particularly considering the operating environment and everything that we needed to do post spin. A s far as what's changed, I think the short answer is structurally from our perspective, nothing has changed as it relates to our thoughts as to what the financial profile of this company looks like in the near term or certainly through 2024. And if you, if you step back just prior to spin in March of last year, we sort of outlined for the investment community what we thought the financial profile of Embecta looked like.
That included essentially a flattish constant currency revenue CAGR and adjusted EBITDA margin of approximately 30% by 2024. We remain very committed and think that those are still the correct financial metrics through 2024 for Embecta. Quite frankly, we've probably absorbed anywhere from let's call it somewhere between 200-300 basis points of additional gross and EBITDA margin pressure since that March timeframe through now, just as it relates to inflation and increased supply chain costs and foreign currency headwinds. Yet we still think that that flattish constant currency revenue CAGR and adjusted EBITDA margin of 30% through 2024 are the right numbers for us.
Your fiscal fourth quarter results were very strong. Again, you came in above targets on all the key metrics. The fiscal 2023 guide seems to accelerate the decline in margins to sort of what we thought the fiscal 2024 targets were going to be. Maybe can you talk a little bit more about what's driving some of that margin decline specifically?
Yeah.
Sure. I think the right jump off point to kind of compare against is the 4th quarter of 2022 margins. That's really the most representative to date for Embecta. In the 4th quarter of 2022, we generated adjusted gross margin of about 64% and adjusted EBITDA margin of about 32%. Our guidance for 2023, for full year 2023 calls for adjusted gross margin of approximately 62% and EBITDA margin of 30%. That decline obviously is gonna be driven by the adjusted gross margins, and that's largely because of the need to continue to stand up and separate Embecta. There's a few drivers.
The main driver going from sort of that fourth quarter gross margin of 64% down to about 62% largely has to do with our need to continue to separate and stand up Embecta. As a result, we're gonna incur additional regulatory quality supply chain manufacturing costs throughout our business. Then in addition, we do continue to expect to see some incremental headwinds from inflation and increased labor costs.
Caroline , if I may add to that from a revenue standpoint on that guidance as we sort of commented in December, just a few weeks ago. Look, I think there are three big factors that sort of we thought about when we thought about the revenue guidance, right? One is contract manufacturing. We do manufacture, contract manufacture some products for BD. Depending upon what that is going to be in 2023 versus 2022 on the low end it could be a 1-point decline, contribute to a 1-point decline. That's one factor, right? What's contract manufacturing revenue gonna be? The second one is sort of the developed markets v olume versus price, what happens over there. The third one, frankly, is, notably what happens with COVID in China.
Emerging markets, as I mentioned before, is an important part of our business for us. Certainly in 2022, I think the COVID impact, not just for us, for many companies, was maybe larger than they would have anticipated certainly at the beginning of the calendar year. As you know now, we are in a state of flux over there, right? Hard to foretell what 2023 is gonna look like. Those are the three factors that we try to t hink through what, where they might fall as we thought about our revenue guidance for fiscal 2023.
Maybe just digging a little bit more detail on that for fiscal year 2023, how are you thinking about the U.S. and OUS relative growth mix as well as the growth stemming from emerging markets?
Wanna take that, Jake?
Yeah, sure. I would say I think the low end of the guidance range essentially assumes low single digit declines, if you will, in certain developed markets, whether it's the U.S. because of contract manufacturing revenue headwinds or lower expected contract manufacturing revenue in 2023 as compared to 2022. That alone drives about a point of a headwind year-over-year. As well as just low single digit declines in Europe. I n terms of Asia, the low end essentially assumes flattish , product volumes and really no ability, if you will, globally to kinda raise prices.
At the higher end of the guidance range essentially assumes less headwinds, if you will, in terms of the contract manufacturing revenue year-over-year, flattish volumes in developed markets, particularly in the, in the U.S., and low single digit growth, throughout Asia, as well as an ability to generate about 50 basis points of positive pricing year-over-year. You know, we realize that we're obviously in an inflationary environment, and we're doing our best right now to try and have those conversations with customers to try and pass along those cost increases in the form of price.
Oh, yeah, go ahead.
I have a question on the patch pump projects. What would be your estimated timeline for the whole development process, and how much capital do you plan to allocate to this project? The second one is, for your products, what would you say are the major differentiations versus the current pumps on the market? When you mentioned you probably will target some small companies for M&A, what would be the focus areas, like the size of the company as well as the technological focus?
I'm gonna repeat the question for those that are listening to the webcast. There was multiple parts to that question, right? It was about the patch pump timeline, cost, as well as differentiating features. That was sort of one set of questions. The second one was on M&A target areas and focus. On the pump, we haven't publicly spoken about a timeline and we wanna be mindful of the fact here that certainly there is a history here where prior teams have spoken about timelines and the pump never came to be, right? What our focus is on is really focus on the development, get it done to a point where we achieve some critical milestones, and then we'll be talking about publicly.
We don't wanna get into forecasting sort of long-term milestones here for the program. It is a multiyear program. We are investing behind it. The program is producing as planned. With respect to spend, we've already inched up our R&D spend. You know, it's approximately 7%. Through 2024, we said we are not including any revenue on the patch pump, but we've certainly included the development cost through 2024 on the patch pump, right? With respect to differentiating features, a few key ones. I did say that we were focused on Type 2. Number one is on a patch pump, we are designing the pump with increased insulin reservoir capacity.
That's an important differentiator because typically people with Type 2 need more insulin a day than Type 1. Secondly is if you look at the penetration rates for pumps, right now they are 35%-40% for Type 1, but only in the single-digit range for Type 2. We believe the reason for that is that the currently available pumps are not suitable or really, t he design features of the currently available pump sort of limit the adoption. So we are designing the pump with sort of initial easier training requirements, fewer basal settings, maybe fewer bolus settings, the ability to tailor alarm. We also recognize the fact that we want this pump to be available through a retail channel, so it needs to be fully disposable.
We also recognize the fact that in many cases, people with Type 2 are seen by primary care physicians, so the technological complexity needs to be less than what it is, you know, if you were being treated by endocrinologists, right? Those are the differentiating features. With respect to M&A and target areas, look, people with diabetes have a number of comorbidities. What we are focused on is saying, "Listen, we wanna be able to leverage something that we have." What is it that we have? We have great high volume manufacturing and distribution capabilities. We have the unique ability to take a product through a retail channel. Then finally, we have great emerging markets infrastructure, and we recognize that markets have unique needs. We are not looking for a one-size-fits-all solution.
We are looking for needs where we can say, "Listen, here's an innovative company. It has a product that's approved. We can get into the hands of people who need it, leveraging one of the strengths that we have." That is truly sort of generally what we're looking at. It's not specific product focused or a, you know, here's what it needs to look like or feel like. It's really wanting to make sure that we leverage something that we have so we can create value.
Will your pump integrate with the couple of CGMs that are on the market, Dexcom and Abbott, to do smart insulin delivery, which has been very successful in the Type 1 arena?
Yes. The way we are thinking about a pump is we're gonna first sort of come out with an open-loop product, right? That won't have integration. We'll run through a clinical trial and have a closed-loop or a AID. At this point, Dexcom sensor is the only one that's approved for AID in the U.S. All expectations are that Abbott's will get approved as well. Our view is that we are pump and sensor agnostic, right? We wanna be open to all sensors. We don't want to be the limiting factor. The answer is yes, but there is gonna need to go through a clinical trial, especially in Type 2. There's a lot of Type 1 clinical data out there on AID. There's very limited in Type 2.
The extent and scope, duration, number of sites, number of patients, that's all to be worked out, but our intent is to have a closed-loop system for Type 2. There's a question back there.
Thanks. Just wondered if you could speak to the importance of AID going down in price, you could actually have a differentiated system for Type 2s that is less expensive, effectively might be seen as higher value from payers, and could itself have an impact on reducing complications, maybe not because of the molecule, but because people are taking the right amount of insulin at the right time, et cetera, things that you've talked about before. Thank you.
Yeah. T hose are, I would say, look, I mean, our initial focus is wanting to make sure we get that open-loop product done, then we go to closed-loop, and then these are things that, in my mind, you sort of build through clinical evidence along the way, right? One of the ways to obviously impact price is not just reduce cost per unit, which is easier to do if you scale up, right? The greater the volume, the easier it is to drive cost per unit down. But also think about, you know, are there opportunities to increase wear time, right? So that effectively decreases cost per day. And obviously, it's a huge benefit to people with diabetes as well if they have to change their product frequently.
These are things we think about, but to be honest with you, we are very focused on sort of, look, you gotta, you know, march, right? One step at a time. Let's get the hardware done. Let's get the open-loop done. Let's find the right Type 2 algorithm. We don't intend to develop the algorithm on our own. It's gonna be sort of licensed. Let's get the clinical trial, and then we can build on that clinical trial and get all the additional data we need to be able to make the right claims that can help decrease cost as well as potentially show a reduction in complication rates.
I think that's all the time we have for today, but thank you very much.
Thank you. Thank you all for your interest.
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