Hello. On behalf of the senior management team at Tandem Diabetes Care, we'd like to welcome you to our 2021 R&D Day. I'm Susan Morrison, Executive Vice President and Chief Administrative Officer, and today we look forward to providing you with greater insight into our strategy and plans for driving near and longer-term growth through innovation. It's my pleasure to introduce the Tandem speakers during today's presentation, including John Sheridan, President and CEO, Elizabeth Gasser, Executive Vice President and Chief Strategy Officer, Leigh Vosseller, Executive Vice President and CFO, Dr. Steph Habif, Vice President of Behavioral Sciences, Jordan Pinsker, our Vice President and Medical Director, and Garrett Marin, Head of Product Management. Today's presentation will be about 2 hours, structured in 2 parts with a brief intermission about halfway through.
There will be an opportunity for Q&A, both prior to intermission and at the end of the presentation. Sell-side analysts who would like to ask a question may submit them through the Q&A function of the webcast, and we'll do our best to address as many as possible. Before we begin, please note that today's presentation will include forward-looking statements. These statements reflect management's expectations about future events, product development timelines, and financial performance and operating plans, and speak only as of today's date.
Please see slide number two of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or other factors.
In addition, today's discussion will include references to adjusted EBITDA, which is a non-GAAP financial measure. Adjusted EBITDA is a key measure used by us to evaluate operating performance, generate future operating plans, and make strategic decisions for the allocation of capital. Finally, an archive of today's webcast and the accompanying slides will be posted on the Investor Center portion of our website. Now, without further ado, John, would you like to kick us off?
Thanks very much, Susan. Hello, everyone, and welcome to Tandem's inaugural R&D Day. Tandem is creating new and exciting possibilities for people living with diabetes, their loved ones, and the healthcare providers who support them. We are innovating to create positively different experiences for all our stakeholders. Next summer will mark the tenth anniversary since first launching t:slim. Tandem has rapidly evolved since that time, and now we remain committed to offering best-in-class products, solutions, and services while partnering to deliver better outcomes through human-centered design and connected care experiences. Our systems manage insulin therapy.
They reduce the cognitive burden of diabetes. They create life-changing outcomes and positively different experiences. Importantly, our focus on innovation has positioned Tandem as the technology leader in our marketplace. As a diabetes care company, we recognize that there is not a one-size-fits-all solution to managing this complex condition.
We draw inspiration from the resilience and skills of the diabetes community as it motivates us to offer solutions that allow our stakeholders more time to enjoy life by spending less time managing diabetes. Our team has a deep understanding of the disease, which has enabled us to create better outcomes and improve the customer experience. At Tandem Diabetes Care, positively different is the sum total of our brand and operating mindset for the entire company, a lens for the activities of our organization, and it defines the qualities of our interactions and relationships with those whom we serve.
We are continuing to expand our history of firsts. We helped to pioneer the FDA's new system of interoperability, and we are the only company fully immersed in the operational management of these requirements with both our partner and the FDA for over three years now.
We are working to add to this list by being the first company to move from serial product improvements to a broader portfolio strategy in which we can currently offer different devices that meet the different needs of our market segments. We're also working to add to this list by investing in our connected ecosystem, developing a strategy that supports the diabetes community with mobile devices, cloud-based solutions, and third-party technologies to provide convenient access to data and insights wrapped in a consumer-like look and feel. Our new product launches has driven our historical growth. As we exit 2021, we emerge in the strongest place in the company's history. We intend to continue driving growth through innovation with our Mobile Bolus App, t:sport, and Tandem Source in the short term.
We feel very well positioned to execute on pipeline initiatives that will drive continued growth over the next five years. Of course, we'll be discussing more of this today. I'd like now to take a minute to introduce Rick Carpenter. Rick.
Hey, John.
How are you? Good to see you.
Thank you.
Rick has joined Tandem very recently as our Chief Technical Officer. He brings a great deal of experience leading complex R&D organizations like Qualcomm, Capsule, and Inseego. Rick also shares our company values and is very aligned with our company culture. He will play a key role in driving our pipeline initiatives that are ongoing now and into the future. Welcome, Rick, to Tandem.
Thank you, John. Thank you very much. It's great to be a part of Tandem, and I really look forward to working with you and the team to build life-changing and innovative technologies and products for people with diabetes.
Thanks, Rick.
Thank you.
Yeah. We are innovating at scale, and we remain committed to maintaining this leadership. We have over 200,000 people using Control-IQ today. More than 40 million patient days of Control-IQ use data. Over 90,000 customers have updated their pumps to Control-IQ. We're in 20 countries and counting, and we've published multiple peer-reviewed manuscripts and abstracts, including 2 in the New England Journal of Medicine. We are creating an overwhelmingly positive experience for our stakeholders. When we met in 2018 at our Investor Day, we outlined a revolutionary approach to providing our customers immediate access to our latest technology advancements, and we have delivered on this commitment. We've now done this multiple times, each update with meaningfully new features. We've done it at scale in real time, where thousands of customers have benefited what they have described as life-changing technology.
We have earned the trust and confidence of the diabetes community. In looking at our product development efforts, they fall into three pillars of innovation, which we'll use to frame today's discussion. These pillars are our key areas of investment and include delivery devices, delivery software, including algorithms, and data and insights. Our first pillar of innovation is delivery devices, starting with hardware. Our market research over the past 10 years has consistently shown that one size does not fit all in describing how people prefer to wear their insulin pump or how they want to control it. We routinely conduct market research and recently completed an assessment involving more than 1,000 people living with diabetes to better understand their needs and preferences from a hardware perspective.
Today, we'll share with you some of this information, but something that stood out to me is how consistent the results have been over time, dating back to before 2017. This is why as we look to the future of our hardware strategy, we are moving away from offering a single platform and will be emphasizing choice, which initially will be t:slim X2 and t:sport. As we look to the future, we envision adding additional hardware systems to our product family, different sizes, shapes, and features, each designed to meet the needs of new market segments and the new requirements. Our second pillar is software.
The customer experience we offer through our device software is unparalleled in our industry. It is a competitive advantage for Tandem, and we are driven to maintain this position. More specifically, this focus is on software used to control the pump.
Our automated insulin dosing technology and the software used to support remote pump update ability. Our innovations are focused on providing seamless integration with multiple delivery and controlling devices. Software that is highly reliable in both function and integrity of its wireless communication. The software teams have uncompromised focus on user-centric design, working closely with our human factors group to assure a positive patient experience characterized by simplicity and ease of use. These teams are also driving innovation in our algorithms, emphasizing automation, personalization, and simplification, all intended to continue to improve the therapeutic outcomes and again, provide a positive patient experience characterized by simplicity and ease of use. We believe ease of use drives MDI adoption to pump therapy and enables us to bring the benefits of our life-changing technology to this important group.
As we turn to our third pillar, data and insights have become a key area of focus for us. Asking people to do complicated math to manage their diabetes does not provide a user experience that we strive for. Healthcare providers have limited time to access and manage their patients' diabetes, so information has to be available efficiently. Our goal is to take the vast amount of data that we have collected and use technology such as AI to provide information and insights to people living with diabetes and their healthcare providers. Make these insights easy to understand in a flexible format with mobile and cloud apps available in real-time, all with the intention of continuously working to improve outcomes.
We also have an opportunity to share this data and collaborate with the payer community who value population health and health economics information that demonstrate the benefits that our technology is bringing to the healthcare system. As we look back in time, it wasn't too long ago that Tandem was a pump company, but we've grown, we've partnered and evolved the organization. Today, we have the market-leading technology that's changing the way people manage their diabetes, and our success is on an international scale.
As we continue to press forward and advance Tandem into a portfolio-driven company with ecosystems of digital products and insights supporting our stakeholders internationally, we will also be pushing into new markets, actively implementing short and longer term product and access strategies for bringing the features and benefits of our products to the intensive insulin type two community.
We are only in the early stages of AID adoption, and we believe there's a long runway of opportunity to support the needs of both the type 1 and intensive insulin type 2 communities. As we expand our portfolio, ecosystems, markets and geographic footprints, we are continuing to invest in size, scale, and the capabilities of our organization. We strongly believe in this approach, but we certainly recognize this does not come without its challenges and complexity. We feel the direction is necessary to provide a broad spectrum of products and services that meet the ongoing needs of diabetes community. We also believe that as we execute this strategy, we build a meaningful competitive barrier to new entrants and existing players. In 2018, we successfully launched Basal-IQ in the U.S., our first automated insulin delivery system.
We began the expansion into our markets outside the United States. In the midst of those two launches, we set an ambitious goal of reaching 500,000 customers worldwide by the end of 2024. This was the beginning of a complete change in the trajectory of our business, well beyond even our own expectations. In fact, now we have more than 300,000 customers worldwide and anticipate reaching 500,000 customers at least one year early. This begs the question: What will it take for Tandem to improve the lives of 1,000,000 people living with diabetes? Innovation is the key to answering this question and the focus of our presentation today. Thank you for joining us as we share more about our innovation and our new product development initiatives that will drive growth into the future.
Elizabeth, can I ask you to join us up next to discuss more about our strategy and the markets that we serve?
Thanks, John. It's exciting to consider the growth in our user base to date and where we believe our technology innovations can help take us over the next five years. From day one, Tandem's mission has been to improve the lives of people with diabetes. In terms of our strategy, we're intensely focused on meeting the needs of people using daily rapid-acting insulin, more commonly referred to as people on intensive insulin therapy. For people with Type 1, insulin therapy is not optional, it is a requirement. For people with Type 2, of the more than 200 million people diagnosed, less than 5% overall are treated intensively with insulin. Worldwide, across people with Type 1 and Type 2 diabetes, we estimate that this represents an opportunity to serve more than 30 million people.
Today, the majority of these people are on a multiple daily injection or MDI regimen and do not use pumps. However, over the next decade, we expect the more widespread use of CGM and the substantial advances being made in automated insulin delivery will drive significant growth in pump adoption. For Tandem, our medium- to long-term focus is on the U.S. and the more than 20 additional geographies in which we have launched our pumps over the past three years. Together, these account for almost a third of people on intensive insulin therapy worldwide. Within the U.S., this comprises 1.6 million people with Type 1 and a further 2.3 million with Type 2. In our international target markets, we see a larger base of 4 million Type 1 and a further 1.5 million Type 2.
I'm sure you'll immediately note the relative difference in Type 1 and Type 2 populations between geographies, which is a product of different assumptions about the incidence of Type 2 and physician propensity to intensify insulin therapy. Even accounting for some conservatism in our view of Type 2 internationally, this drives a combined addressable market of almost 6 million people with Type 1 and almost 4 million with Type 2 diabetes. Importantly, these markets in which we are choosing to participate are at the leading edge for the adoption of advanced therapies, including automated insulin delivery systems or AID systems, which is rapidly becoming the standard of care and in which we have a clear technology leadership position.
We're going to talk a lot today about the populations we serve and how the journey and therapy choices of a person with Type 1 are meaningfully different from those of a person with Type 2. While we believe that pump therapy brings benefits to both groups, adoption levels differ and the product and technology roadmaps required to optimally serve them potentially diverge over time. As I said previously, intensive insulin therapy is non-optional for people with Type 1, and it is here we see the highest demand for pumps. Looking at people with Type 1 in the U.S., we estimate that 36% today are on a pump. I'm also pleased to note that approximately 35% of this group use a Tandem pump.
Internationally, adoption varies across the markets in which we participate, ranging from mid-single-digit adoption to almost 30% in more established markets like the Scandinavian countries. In the aggregate, we see 10%-15% of people in our target markets on pump therapy, of which almost 20% have already chosen a Tandem pump. Looking ahead, people with Type 1 diabetes and their physicians recognize the significant benefits that AID systems deliver. We expect pump adoption to continue to grow, reaching 65% in the U.S. and 20% across our international markets by 2027. In practical terms, this means an opportunity to serve the needs of almost 1 million Type 1 pumpers coming to market in the next five years, and we are focused intently on doing so.
That is not to say we are not also looking to the needs of the type 2 segment. It's just very different. For a person with type 2, insulin is usually a therapy of last resort, and there's a long period of intensification toward MDI. Within this group, pump adoption is low today at around 5%. In the U.S., we have line of sight to approximately 100,000 people with type 2 on pumps. We estimate there are likely a further 75,000 across our international target markets. Though we don't actively market to the type 2 population today, our installed base data shows almost 20,000 of the 100,000 estimated U.S. users are already on a Tandem pump.
Looking forward, we see growth in type 2 pump adoption as we and others seek regulatory indications to bring the benefits of advanced AID systems to this segment. However, given the clinical inertia we see in type 2, we don't currently expect pump adoption to exceed 15% by 2027. Though, given the scale of the type 2 population, this results in an expected net increase of at least 325,000 people with type 2 diabetes on pumps. Now that we've shared the opportunity we see ahead, I'd like to invite Dr. Steph Habif to share her perspective on the customers we are designing products for. Or, as she likes to remind us, the humans we serve.
Thanks, Liz. I'm a behavioral scientist, and in my role, I lead our teams that spend time with the humans we serve, listening and learning, testing, and validating. We work to understand what our customers need when, how they decide, and what types of tech works for them. Our primary market has been and is type 1 diabetes. Some elements of the type 1 diabetes experience is the same as type 2. For instance, irrespective of diabetes type, the majority of our customers first learn about pump therapy from their healthcare providers.
But as we heard Liz say, for people with type 1 diabetes, insulin is non-optional, whereas for people with type 2, insulin is often a last resort. These differences matter. For people with type 1 diabetes, they receive a diagnosis when their pancreas stops working properly, which can happen overnight and at a very early age.
A type one diabetes diagnosis is an acute life change because suddenly the body cannot process carbohydrate foods. Suddenly, the right dose of insulin is for survival, and the wrong dose can be dangerous and terrifying. The psychological distress for patients and their families is severe, and new lifestyle demands, such as mealtime carb counting, creates extreme mental burden. As one of our physicians says, "The more we can take the patient out of this extreme burden and avoid their need to constantly do diabetes math, which is like chaos theory at every meal, the healthier and happier they can be.
" This is what our automated insulin pump is for somebody with type one diabetes, a machine to assume the burden and provide a fast track to a life with safe, stable blood glucose control. Insulin-intensive type two diabetes is different.
It is a slow, progressive disease that takes years or even decades to manifest. The health profile of somebody living with type two diabetes often includes several comorbidities, which can mean a person may not tend to her blood sugars as needed due to competing health demands. People with type two experience many ups and downs in the healthcare system because even though insulin therapy should be prescribed much sooner in this disease progression, it isn't. Several other oral and injectable medicines are exhausted before insulin is prescribed.
Type two patients face enormous clinical inertia so that by the time they get the pump they need, they are older and might question their abilities to manage insulin successfully. At Tandem, we have almost 20,000 people with type two diabetes using a pump, which is an indication that success with automated insulin delivery does and can happen.
People in this segment require certain support and education. Meeting their needs is not just about putting products into the right access channels. It's about wrapping the best products in services for long-term success. We've been spending meaningful time with the type two community. For instance, we recently completed research with more than 750 people living with type two diabetes on intensive insulin therapy, 650 of whom were administering insulin through multiple daily injections. It was promising to see that approximately one-third of those people voiced interest in near-term pump adoption, especially since we know only about 5% of intensive insulin-using people with type two have a pump today. Significantly, a majority of these near-term pump adopters wear a CGM, suggesting openness to greater use of device technology.
The technology must provide discreetness in insulin administration, and most of these folks have access to online peer groups, diabetes educators, or endocrinologists. Many of them often feel like they are failing in their diabetes regimen and have significant worry about hypoglycemia and weight gain. These are just some of the factors that make them wonderful candidates for Tandem's automated insulin delivery portfolio. Our insights on the psychology, patterns, and preferences of the humans who comprise this segment are helping to inform our design strategy to bring the benefits of our solutions to more people living with type two diabetes.
No matter the diabetes type, diabetes is a chronic condition fraught with exhausting demands. People with diabetes spend only three hours a year on average with a healthcare professional. That means for the remaining 8,757 hours, they manage their diabetes themselves.
This is why, for instance, diabetes education is critical because so much of daily diabetes care happens at home. Research has shown the value of connecting with peer support communities, but not everyone has access to one. We have to consider a holistic approach. Through the years, our work has consistently shown that this is a highly segmented market. There is no one-size-fits-all solution for people living with diabetes. Timing of diagnosis, when insulin therapy is initiated, genetics and ethnicity, social determinants of health, experiences with health insurance, all of these dictate what can work best when. These factors evolve across a lifespan.
Thank you, Steph. As we look to our broader strategy, Steph's points on segmentation are particularly relevant. Developing solutions that meet the needs of diverse segments has driven our success with type ones and is foundational to our forward-looking portfolio model. As Steph has shared, our research increasingly underscores the opportunity to serve key user groups among intensive insulin using type twos, and we are in the early stages of using the insights we are gathering to execute a broader type two strategy that will contribute to our longer term growth. The people with type two, who we are initially working to serve, share many of the feature and form factor wants and needs of the adult type one customers we serve today.
As a result, our future portfolio is intended to have offerings that have appeal across both markets, and we look forward to giving you further insight into these today. Before we dive into our product and technology outlook, though, I'd like to take just a couple of moments to illustrate how our view of the market drives our overall strategy. While we have near-term corporate objectives that speak to the pursuit of operational efficiencies, our strategic imperatives are threefold. To deliver a portfolio that maximizes our reach and drives preference among people with diabetes on intensive insulin therapy. To expand the geographic footprint of our solutions, and to optimize the customer experience from referral to renewal, removing friction at every stage. Since today is an R&D day, we're going to spend our time focusing on our portfolio.
While we will share roadmaps with you today across each of these areas, the real value is how they interact to enable our market-leading insulin therapy management platform. Devices or pumps are at the heart of our offering as the point of insulin delivery. Here we are committed to delivering a range of highly competitive form factors to meet the needs and preferences of a diversity of people with diabetes. We differentiate our pumps with the software that runs on them and which controls them, whether it's on the pump or in the future, on the phone. Pump users see this in our UI and through the day-to-day performance of our algorithms. First Basal-IQ and now Control-IQ.
This software generates a rich stream of therapy and outcomes data, which we can visualize for the user on their phone or device, but which has most utility when we send it to the cloud. Here it can be shared with caregivers and physicians, and it forms the basis for richer and more efficient therapy discussions, which drive confidence in and preference for our platform. As with any data platform, access to high-quality input and a diversity of input is critical to making it useful. Today, we are partnering with the world's leading CGM makers to deliver the blood glucose readings that inform the Control-IQ algorithm, but which also support analytics that allow users and their physicians to optimize therapy. Over time, we have a goal to expand the range of data and device inputs to further enhance the experience.
Lastly, we remain hyper-focused on ensuring this is all wrapped in a high-quality user experience that means customers want to stay with Tandem products and services. Historically, this has been about customer care and training, primarily with high touch human interactions. Moving forward, we recognize the user benefit of integrating digital and omni-channel interactions to meet customers where they are. It's not a focus for R&D Day, but expect to hear more from us here in the coming year. With that said, I'm sure everyone is excited to see what's going on under the hood. I know we are excited to share. It is with great pleasure that I'd like to welcome Garrett Marron to the stage to share our pump roadmap with you.
Thank you very much, Liz, and thank you all for participating in today's R&D Day. I'm thrilled to have the opportunity to speak with you about our future portfolio of pumps. Today, I'm going to be sharing more with you about our pump roadmap, which has been designed to be positively different and will continue to expand the insulin pump market as well as enable Tandem to capture more market share. Our approach has always been to meet users where they are with our design.
We plan to continue that approach with multiple wear and control options from our portfolio of products. As you all know, Tandem's story begins with the t:slim pump. Nearly 15 years ago, Tandem set off to answer the question of why only 25% of the market chose insulin pumps when it had consistently proven to improve clinical outcomes.
This led us to understand more about the burden of living with diabetes and three primary emotions that people described when considering pump therapy. Fear, frustration, and embarrassment. The pump hardware, which we categorize as how people wear their pump and how they'd like to control it, was a primary driver for these emotions. Even at that time, we recognized that there is no one-size-fits-all solution. Our first step into the insulin pump market was to make the t:slim look and feel much more like consumer electronic devices over the historically bulky medical device looking alternatives. People with diabetes, our customers, live with these devices 24/7. They deserve the opportunity to choose the best platform that best fits their lifestyle.
Starting with the slim profile of our current flagship product line, t:slim X2, we are building a portfolio of solutions for users to customize their insulin pump therapy to their lifestyle. We chose to design and develop a durable insulin pump first, as this was the largest segment of the insulin pump market and there had been little innovation since the 1990s. The t:slim and second generation t:slim X2 have provided a discreet profile with easy-to-use on-device touch screen for nearly a decade.
When considering the rapid adoption of simplified user experience offered by touchscreen technology combined with the power of automated dosing, t:slim X2 has proven to reduce some of those initial emotional barriers to pump therapy and has opened the door to a wide population of users. This product line has served customers across ages and demographics and will continue to do so.
Flexibility has been a key component of t:slim's success, and infusion set choice has been a critical part of this success. It's an additional area which we provide users choice. With more than 5 different product families coming with a variety of tubing lengths, materials, adhesives, methods of insertion, and colors, Tandem offers a truly custom set of wear options for our users.
As we look to the future, we plan to drive further innovation and infusion set advancement through internal initiatives and working with our development partners. Our current development areas of focus over the next five years include making insertion easier and more user-friendly, reducing infusion set failures, specifically around occlusions, extending the wear time of the infusion set beyond the two-three days we see today, adding even more wear options, further reducing the body burden, and reducing material waste.
The t:slim X2 has been so successful that we have decided to update the product line with a next generation. We are committed to advancing our flagship platform as it continues to have high demand and positive feedback. We launched t:slim in 2012, t:slim X2 in late 2016, and have kicked off development on t:slim X3. t:slim X3 is being designed to feature enhanced technology, including greater processing power and capacity to support our advanced algorithms, increased battery life, improved durability, and will be capable of wireless software updates. t:slim X3 will also include a refreshed UI that will both modernize the experience and provide greater usability for our planned feature updates. We're also extending our pump portfolio with a new miniature durable pump product line, code-named t:sport.
t:sport gives us the opportunity to serve a new market segment with a small, discreet pump that utilizes the latest in battery charging and wireless technologies. As we have discussed in the past, our design goals have been to miniaturize the pump form factor utilizing an interface built entirely into a mobile application that will control the pump from a user's personal smartphone. The smaller form factor will continue to provide wear flexibility offered by our current family of infusion sets and adds a new shorter infusion set option.
As a reminder, t:sport will be submitted to the FDA as an ACE pump, which allows for it to be compatible with updated algorithms and iCGMs without additional regulatory review. This is particularly relevant with the timing of t:sport, as we'll be evaluating timelines to determine if it will launch with Dexcom G6 or G7 integration.
As we prepare for its upcoming regulatory submission and availability, I'd like to share a closer look at the commercial product. I'm very happy to introduce you to the world's smallest durable pump, Tandem Mobi. A pump designed to increase confidence, enhance mobility, improve discretion, and instill a spirit of freedom. A pump that is modern, intuitive, and raises the bar for any that follow. A pump that is miniature in size but massive in stature. We chose the name Mobi to represent the pump's mobility in the way it's worn and as a nod to its mobile control. As I mentioned, Tandem Mobi will be launched with the option for a shorter length infusion set. The new set will be four inches long and is the shortest infusion set commercially available.
From an algorithm perspective, Mobi will launch with Control-IQ, and it's also designed to support more advanced algorithms. I've reviewed a few of the features of Tandem Mobi already, but as a reminder, I've listed here even more of the features and capabilities of the Tandem Mobi pump, including that Mobi is capable of inductive charging, shown here, utilizing the same chargers used with smartphones today, and provides the automated insulin delivery algorithm embedded on the pump.
It includes an onboard bolus button, giving users the ability to deliver a bolus even when away from their smartphone. The pump will be waterproof with an IPX8 rating. The combination of the two product lines enables the broadest market reach for any one pump manufacturer. When we did research with almost a thousand people, over half said they'd choose Tandem, either t:slim or Mobi, over any other future competitive offering.
With these two pumps in our product portfolio, our users have the most choice available in the entire user experience, from the size of the pump to the way it is charged, worn on the body, and controlled. However, there's an additional market segment not served with these two options. There are still users that desire a fully on-body, tubeless experience from their insulin pump. Interestingly, the on-body segment is made up of a number of smaller segments, including adolescents who want the most discretion, people with highly active lifestyles, and people with type 2 diabetes.
To reach this market, we plan to further expand our portfolio of hardware offerings with a fully tubeless option. Not only does tubeless offer up another wear option for our insulin pumps, but also a more pharmacy-friendly transaction model for users to have increased access to our technology.
Our vision is to extend the Tandem Mobi product line with an option that doesn't have tubes. We're calling this Mobi Tubeless. This kit offers Tandem Mobi users the option to customize the way they wear their pump with each cartridge change, providing yet another option for Mobi to reach additional markets. Leveraging the Mobi pump design, Mobi Tubeless provides customers the ultimate in choice of wearability. The pump does not change, but the cartridge does to provide users a disposable docking set in place of tubing to provide a tubeless on-body experience. It's a design that we're very excited about, as it also meets some of our internal environmental objectives to reduce waste.
With this offering, a user would purchase a Mobi pump and swap between use of a tubed infusion set and the on-body patch, providing users options based on their personal preferences and lifestyle needs with every cartridge change. Since 2012, we've continued to take on new technologies, and for the first time in the history of the insulin pump market, Tandem will offer a portfolio of pumps for users to have the ultimate flexibility in the way they wear and control their device. Over the coming years, Tandem will add a new pump product line with Tandem Mobi, update our t:slim line with the latest and greatest technologies in the t:slim X3, and offer a fully tubeless option with Mobi Tubeless. We won't be stopping there.
We are actively working on a patch pump, a 100% tubeless pump offering designed on the same easy-to-use concepts that have made Tandem a leader in the durable pump market, thus continuing our trend to an even smaller form factor designed with concentrated insulins in mind. We are in early days, but we'll continue to provide updates as we look to the future of all our pump portfolio products. With this, I'll hand the mic back to Liz. Thank you again for your time today.
As you can see, we're committed to the idea of optimizing our device form factors to meet the diverse needs of the large and highly segmented worldwide population of people on intensive insulin therapy. Choice is a word you will hear us use repeatedly today. It's an idea that we think makes us positively different.
Super. Thanks, Liz. If you'd like to come on over and join us here at the panel. The H1 of today's presentation focused on our vision, the market segment, as well as our delivery devices. In the H2 of our day, we'll really focus on device software, our data and insights, as well as the financial outlook. A few questions it looks like have come in that are probably more appropriate for the H2 of the Q&A. We're gonna go ahead and hold those, and we're gonna dive into the questions really relating to the topics that we discussed right now. John, maybe I'll kick off this first one with you here. How should we think about your new goal for achieving 1 million customers worldwide? What is the timing for that?
Also, would you say it's a stretch goal and more of an aspirational one or one that you may actually even have potential upside to, as we've seen you exceed your installed base goals in the past?
Yeah. Well, thank you, Susan, and thanks everyone for attending our R&D Day with Tandem today. We're very excited about this. I would say that we're in the process, in the entire presentation, we're going to be outlining our five-year goals from 2022 to 2027. We anticipate that we'll have 1 million customers in the Tandem ecosystem by 2027. As far as whether or not we're confident in this, we are absolutely confident in this. There's a lot of ways for us to get there, and honestly, it doesn't require a lot of heroics. I think the things that are important are that we have innovation driving this pipeline that we're communicating to you today.
We have a portfolio of products, and I think we expect that this is going to drive MDI adoption. Specifically in the U.S., as Liz pointed out, we expect to see MDI adoption go from 35% to 65%. OUS, it's going to go from 10%-15% to over 20%. I think that the in addition to that, we also expect to see a continued geographic expansion. I think that the other interesting part about this is we're barely scratching the surface when it comes to the Type Two opportunity. Yes, we have a lot of confidence in achieving these numbers by 2027.
Thanks, John. Garrett, next one is for you. For Mobi Tubeless, can you confirm it's the same pump as Mobi and describe a little bit more about how the connection to the body works? Also, how long after Mobi launches would you anticipate bringing this tubeless version? Or I should say, yes, the tubeless docking station to market.
Yeah, absolutely, Susan. I can confirm it's absolutely the same Mobi housing or the same pump durable component of the pump with a dock, as you mentioned, that is inserted into the body to replace the normal infusion set tubing. A new cartridge is attached to the Mobi, and that is attached to the docking site.
Super. Thank you. Next one probably is a combination between Steph and Liz here. The person commented that they were surprised to see nearly 20,000 people with type 2 using a Tandem pump today. Are most of these people using Control-IQ? Have we seen an acceleration in type 2 adoption since Control-IQ launched?
Sure. Yeah, I can take the first part of that. Thanks for that question. So yeah, we do have almost 20,000 people with Type 2 diabetes today on a Tandem system, and the majority of those people are, in fact, using Control-IQ technology. We mentioned that to date, we haven't been able to market Control-IQ technology, so it's really a reflection of the appeal of the Tandem system and the decisions that are being made by healthcare providers and their patients. The number of people with Type 2 diabetes coming to Tandem has been growing steadily along with our installed base. I know Liz can speak to that a little bit more. The lion's share of that has been people transitioning to Tandem from multiple daily injections. I don't know if you'd like to add.
Not a whole lot, Steph. Just to note that consistently, Type Two has been between 5%-10% of our install base. Clearly, as our user base has grown rapidly over the past few years, the absolute number of Type Two within our ecosystem has definitely gone up along with that.
As we look forward, as you say, our ability to market Control-IQ, which we think is the right product, to lean into for the type two category, we believe will make a difference. At that point, we're looking for that to be the catalyst, if you will, for increasing the proportion of type two that we expect to come to Tandem.
Great. Thanks. John, the next one's for you. Do you anticipate adding first pump with mobile control to your list of firsts? And have you heard anything from the FDA on your mobile bolus filing?
We certainly hope so. As we've indicated, we've submitted all of our responses to the FDA back in the August timeframe, and the FDA is actively reviewing these responses. I'll say that the interaction between the company and the FDA has been minimal up until this point. It's really there's some unpredictability, as everybody knows, with the resource issues the FDA is facing as they support COVID. We're hoping to get this done as quickly as possible. We're targeting to have it any day now in terms of its availability. We'll be working and communicating more as we hear more back from the FDA, but we expect it to be an early 2022 launch.
Great. Garrett, there's been a couple questions that have come in just looking to understand the product timing and how people should think about the cadence of launch. Maybe do you wanna walk through those, and then I may have a few follow-ups.
Sure. Absolutely. What I talked about in my presentation holds true for all of the timing of the different features and pumps that we're offering. What we're looking at next is, notwithstanding Mobile Bolus, of course, the Mobi pump to come out next, followed by the t:slim X3 and then followed by Mobi Tubeless option and then building into the patch in the five-year horizon. I'll remind everybody, all of these features and products come out within the five-year horizon. We're talking about the 2022-2027, as John had mentioned.
Great. Thanks.
Yeah. I'd just add, Susan, that, yes, as Garrett said, there's a sequence of availability over the next five years, and it's roughly in the same sequence as Garrett communicated to you. When it comes to Mobi's availability, we've also indicated that we're really waiting for the Mobile Bolus feature to be approved before we can actually comment on that. As I said, we're hoping to get that approval here shortly, and as soon as we do, we'll be able to talk to you more specifically about when we expect Mobi to be on the market.
In a follow-up, there's a question about the patch pump specifically and what are really the challenges or risks or next steps in even bringing that to market from a development perspective.
Well, we've been working on it now for a while, and I think that as we've discussed, it's gonna be smaller. It's going to have these concentrated insulin. It's going to use full mobile control. I would say that in terms of specifics about the device, we're really not going to talk about anything else just due to competitive or the competitive circumstances.
Thanks. Then there's a question about the human. Steph, I think you'd be a great one for this one.
Yes.
What different patient groups do you think are served with a patch pump versus Mobi Tubeless?
Great question. Thanks for that question. I'll take a shot, and then I'll actually have Garrett join me. We know that we have a very highly segmented market. We know that there are a multitude of factors that play a role in how people want to choose which insulin delivery device to use.
When it comes to the portfolio of pumps that we have in our pipeline, a lot of the folks who are gonna choose which one will depend on things that are steeped in decisions and desires around wearability, how they wanna be able to wear it, and what kind of lifestyle they lead, if they have a very active lifestyle or if they're a little person and they love to bump into things all the time, whether or not they desire to manage their diabetes through their personal smartphone, as well as a couple of other factors like real estate availability on their body and whether or not scar tissue or other things related to their skin is playing a role.
We know that some people struggle with adhesives, and so we really feel excited that all these various choices will bring the most of the market to Tandem.
Yeah. I would say you said it perfectly, there, Steph. I think when it comes to the t:slim, it is already a small device, and people that are comfortable and with the form factor of having everything controlled from their pump, I think that they'll probably continue down that trend and pick t:slim. When they want wearability options and flexibility, whether that's Mobi tubeless or just anywhere else on their body or discretion, as well as that tech-savvy nature of wanting to potentially control from your smartphone instead of on the pump. I think those are the big key factors that we look at in our market research.
Thanks. Liz, for type two, it sounds like the opportunity is a combination of having the right product and putting the right marketing efforts behind it. What is the right way for us to think about when you would start to see an inflection in type two adoption? And then is there opportunity to drive growth by more heavily marketing to type twos now?
Great question, Susan. Thank you for that. I think as we've looked at the space, the thing that's the real problem for type 2 is hyperglycemia, which is excursions beyond 180 milligrams per deciliter at the high end of the range. today Basal-IQ is something we could market to the type 2 population, but we don't necessarily think it's the right product. It suspends glucose at the low end, but it doesn't offer that protection at the high end, which is why physicians today who are prescribing off-label are gravitating to Control-IQ. For us, we very much think Control-IQ is the right product. Not being able to lean into that at this point in time is not acting as a headwind to our current growth.
taking those two things together, we really do believe in waiting till we get the indication. At that point, we'll be closer to our tubeless options for that group of patients too, where we know that discretion is a major priority.
The inflection point comes with Control-IQ indication, and it comes with tubeless options for this population. At that point, we'll lean into marketing to type 2 on MDI and frankly, type 2s who may have made disposable pump choices in the interim as well.
Thanks. I think this next one's probably part Steph and part Garrett. When you think about the remaining patients that have not yet migrated from daily injections, is there a way to rank order the biggest impediments for adoption, cost, form factor, access, functionality, UI, or user experience? How is that different between domestic and outside the United States?
Ooh. There's a lot going on there. Do you wanna go first?
Sure. I'll start with some of those options that you had talked about just a minute ago, which is access to the technology, but also understanding of the technology. A big part that we talked a lot about today is the form factor of the device itself, right? The discretion, the wear options, getting understanding that you can put it on different parts of your body, and it's not going to you know create that body burden. I think that would be a big part of this. I think when we talk about you know the differences in U.S. Versus OUS, I don't know, Steph, I mean, when you do your market research, do you have any you know differences there?
Well, I'll go ahead and jump in here and start talking about, especially here in the United States, financial cost.
Yeah.
We all know for those of us who live here in the United States, we know that cost plays a role in how we navigate and make decisions in the healthcare system. It is a dynamic and complicated element that plays a role in the decisions that people make when it comes to what kind of health insurance people have or what the out-of-pocket costs are. We're very regularly looking at cost and pricing here in the United States. One way we think about it, especially with Control-IQ technology, is how effective our system is at reducing the number of adverse events and hospitalizations.
We all know that ending up in the emergency room or in the hospital is extraordinarily expensive, and we're continuing to see and publish evidence around how well Control-IQ does at keeping people safe and out of the hospital. We can get really creative with the way that we think about cost and pricing, and so we do that, right? We're always looking for ways to enable more people to access and onboard to Control-IQ. Yeah.
Thanks.
Susan, I'll just add a little bit to that.
Mm-hmm.
I think that our basic philosophy is that ease of use drives adoption. If you look in the market over the last couple of years, there's been a great deal of technology that's come to market whether it's our competitors or whether it's our partners. It's amazing this technology shift. If you actually look at the MDI statistics, we've seen in the last three years a significant acceleration in MDI conversions to the pumps and to technology. I think that as we continue to innovate, we continue to provide technology that reduces the threshold that people have to overcome to get to the point where they're comfortable with the device on their body.
That's happening because the outcomes are so substantial, they're so substantially improved, and the devices are just very easy to use now.
Mm-hmm.
That's really where we're gonna continue to go as we drive this pipeline of products that Garrett just outlined for us.
Thanks. Is there any more detail that you can share on patch? I think the other question is really just confirming there's 2 tubeless offerings that we're working on between now and 2027. First part, can you confirm that please, Garrett?
Yes, absolutely. We definitely will have two tubeless options, one with Mobi that will have flexible options for the current infusion sets, a shorter infusion set, and ultimately the Mobi tubeless kit that we talked about. A separate offering that would be the patch offering that we're looking at a fully tubeless miniaturized version, as John mentioned, even smaller than Mobi, as well as something that we're looking at being disposable as well.
Liz, how should we think about this from a make versus buy perspective? Is it intended to be a fully functioning basal bolus pump?
Yes. I can clarify that we are.
Yes.
We are definitely focusing the patch effort around a full-featured basal bolus patch device, continuing to evaluate portions of disposability versus durability actually in that design. We're investing organically today. That's where our energy is. Of course, we do talk to many companies around the industry, and we're always open to options to evaluate where we take our roadmap. Our balance sheet in that regard gives us an awful lot of flexibility in terms of considering both investment and acquisitive pathways. I don't have anything specific to disclose on that front today.
Thanks. Steph, can you tell us any more about the type 2 survey that you did? Seeing 30% of intensive insulin-using type 2s voice interest in near-term pump adoption is a big jump from where we are today.
Yes, absolutely. Thanks for that question. As I mentioned, we have been spending meaningful time with the type 2 community here in the United States. We were very pleasantly surprised to see about 30% of people with type 2 diabetes who are currently using intensive insulin therapy express interest and intention for pump therapy or as we like to refer to it as near-term pumpers. There are several factors that put somebody into this sort of category or the way we're thinking about this group of people. One is that they're very likely on a CGM already. They are aware of diabetes technology and have kind of indicated an openness to use it, try it, wear.
Technology to help manage their diabetes. They're also people who have access to either an endocrinologist or a diabetes educator or some sort of health professional that specializes in diabetes. With that, these are folks who know what insulin pump therapy is. They've heard of a pump. They've heard of using insulin pumps for managing their insulin delivery and feel excited about that. We're continuing to learn more, but really a lot of those factors play a role, really reiterating the widespread adoption and continued adoption of CGM technology as well as the role of healthcare providers in aiding somebody with Type 2 to choose insulin pump therapy.
Thanks. Garrett, the next question is about Mobi and our intentions to launch from an app perspective. Are we gonna launch with both iOS and Android?
Yeah, that's a great question. The short answer is yes. We absolutely believe in having iOS and Android, and it's why we've launched our current app with that, with both capabilities. The timing and the sequencing of events there will be based on regulatory reviews, and we'll go from there.
Maybe just to wrap up this section, we'll end one with Liz. If t:slim and Mobi allow Tandem to capture 50% of people, what does the addition of Mobi tubeless and patch get you to?
That's a great question because as you heard Garrett note, our tubed offerings today do test incredibly well against all future competitive offerings when we present them to users. I think as we've noted a number of times, though, in prior investor discussions, the first choice that a user makes when adopting pump therapy really is form factor driven. It's tubed versus tubeless. We model the market that way, we think about the market that way, and we do believe that the tubeless category does offer incremental addressable volume across the diversity of disposable and durable form factors.
While it's always impossible to predict exactly where the market will be several years from now, we do believe having additional tubed wearable options and ultimately tubeless products allows us to contest that demand very actively and competitively, and we'll go from there.
Super. I'm actually going to sneak one more in because I think this is helpful context for folks. The question is, can you expand more on why the type 2 opportunity outside the United States is so much smaller relative to the type 1 opportunity domestically? Or outside the United States compared to them being more similar sized markets in the United States.
Great way to wrap up here on a very technical question. So look, outside the U.S., data on the incidence of poor glucose tolerance is a bit more challenging than in the U.S. We do have to work as an industry in the land of assumption a little bit here. Our modeling suggests 9 million people with insulin on insulin-intensive therapy with type 2 worldwide. Within that, we do estimate the U.S. to be about 25% of that number, in large part because there's a relatively high incidence of type 2 in the U.S. and also broad access to specialist care.
Outside of the U.S., for the specific markets in which we are participating today, the incidence of diabetes is relatively lower compared to both the U.S. and actually compared to markets such as Southeast Asia, where we don't participate. It seems reasonable to model a slightly smaller proportion of the market being accounted for by that population. As such, it's modeled a little closer to where we see Type 1 being today in terms of the relative share in those markets. We think that's a perfectly fair and reasonable basis for our projections. It may end up being conservative, but it's where we're fixing our assumptions and estimates for now.
Okay, great. Thanks. I think now we will go ahead and move into a very brief intermission, and we'll go ahead and kick things off. Liz, you can start things off in about five minutes here at 2:35 P.M. Eastern, 11:35 A.M. Pacific. We'll see you in just a few minutes. Thanks again.
Tandem is as much a software company as we are a device company. We were the first and remain the only pump company to have delivered new features and capabilities to our base of pump users via software updates. How do we think about software? It starts with the embedded layer. Like an operating system, this manages the device. Importantly, it is the layer with which we manage connectivity between the pump and CGM sensors and between the pump and our mobile application. Reliable connectivity across this system is critical.
Fortunately, we are building on multiple years of experience, having so far integrated three generations of sensors from Dexcom and having delivered an integrated mobile app experience across both iOS and Android platforms since early 2020. On top of this, we have our algorithms. These are at the heart of our AID system.
Having started with our predictive low glucose suspend algorithm, Basal-IQ, in 2019, we followed with our hybrid closed loop algorithm, Control-IQ, in January 2020. Today, more than 200,000 people are benefiting from Control-IQ. We're excited to share more about how we plan to keep innovating here. Lastly, there is the user interface layer. This is how a user engages with the system. Our first innovation here was the rich touchscreen UI that you see on the t:slim X2. This was and still is unique. Moving forward, we are operating in a mixed environment across the pump and user smartphones. Critically, this layer is the jumping off point to the cloud and the pathway to delivery of richer data products over time. We will touch on all of these software elements today.
However, we're most excited to share the work Tandem teams are doing to further evolve Control-IQ to deliver greater therapy, personalization, and ease of use, along with the clinical investments we are making to expand its indication. With that, I'd like to hand off to Dr. Jordan Pinsker to share more.
Thank you, Liz. Let's talk about the power of automated insulin delivery. These are two photographs of pump screens from individuals using our t:slim X2 insulin pump with Control-IQ technology who quickly learned to trust the system. Both were so excited with Control-IQ technology, they sent me pictures of their pump after they started. What is Control-IQ technology to them? To answer that question, we have to understand that there are many algorithms out there, many different feature sets you're hearing about from us and others. But what matters is the person, the individual, improving their health and their quality of life. We very much want to do both. With all of these different algorithms out there, you cannot compare feature to feature across algorithms. Instead, we need to focus on the lived-in experience from the customer.
On the left, the experience of this individual mirrors the sleeping beauties, as we call them, where over and over again, we see improvements in glycemic control overnight, with individuals getting a good night's sleep. For her, it was how the system let her sleep through the night that was most important. On the right, we affectionately call him our favorite cookie guy. For many years, he had to have a snack before bed and really struggled to figure out the right insulin dose. He would have high blood sugars, then low blood sugars. It was a real challenge for him. With Control-IQ technology, he decided to have that cookie every night and just let the system handle it, let the automation bring his blood sugar back into range.
This freedom to eat that small snack when he wanted to, rather than when he had to, and let Control-IQ technology handle it, made all the difference. When we think about growing the market and capturing share, you may ask, "Who are the new users of our products going to be?" First, we are focusing on optimizing the current AID experience. We are working on adding features related to new form factors, ease of use, and improving outcomes for existing users of Control-IQ technology. Most Control-IQ technology users are already doing very well, as I will show you in a moment. When we think about all those individuals who could benefit from our technology, we know that only about 20% of individuals with type 1 diabetes have an A1C at the target recommendation from the American Diabetes Association.
Therefore, we are also focusing on insulin pump users who are not meeting their glucose control goals today. Finally, there are so many individuals with diabetes who are not even using an insulin pump. All of them can benefit substantially. I want to share results from a publication looking at about 9,500 users of Control-IQ technology across age groups for one year of real-world use. The take-home point here is improvement in outcomes. 2.4 hours more time in range with real-world use was immediate and sustained to one year out. We see the same themes we saw in our pivotal clinical trials, but now with these very large numbers from real-world use.
Immediately after starting Control-IQ Technology, at two weeks of use time point, individuals are meeting international consensus time in range guidelines without any sort of run-in or lead-in period, and the results were sustained to one year out. These immediate and sustained results speaks to the incredible power of Control-IQ Technology and how users continue to use the system to achieve these amazing outcomes. What comes next in pursuit of the fully closed loop? Thinking back to 2012, we released our first t:slim insulin pump. In 2015, we paired a glucose sensor to our pump to release a sensor-augmented pump. In 2018, we released Basal-IQ Technology, a predictive low glucose suspend technology. In 2020, we released Control-IQ, our flagship product.
When we think about the next generation of closed loop, there are two areas we are focusing on. The first is personalization. This includes alternative targets, settings optimizations, new meal bolus features, and enhanced exercise options. We're also looking at greater ease of use. With this, we are working on adaptation, smarter alerts, new signal integration, and new form factors. When we think about expanding indications for Control-IQ Technology, right now, Control-IQ is indicated for individuals six years of age and older with type 1 diabetes. We want everyone to benefit from use of our product.
Currently, we have a clinical trial ongoing, the PEDAP trial, with over 100 preschool-aged children, two to five years old, using Control-IQ technology and hope to gain an indication for this age group after the trial completes. We are also looking at expanding Control-IQ technology for use by individuals with type 2 diabetes. Our feasibility study for individuals with type 2 diabetes has already recruited the first participant, and we are underway. To be able to add these new features, gain new indications for different populations, we are looking at the possibility of using new insulins with our pumps. First, we are looking at faster insulins. By using what are known as ultra-rapid insulins, we can improve the lived experience around meals and meal boluses.
Concentrated insulins allow us to serve the portion of the market that is using larger amounts of insulin each day, making it even easier for them to use our product. This applies to individuals with both type 1 and type 2 diabetes. Generics to include biosimilar insulins, reduce cost of insulin being used in our pumps, which is very important to everyone. Now back to Liz.
Thank you, Jordan. As an industry, we talk about mobile apps and smartphones a lot. While we've shared our roadmap before, we thought it worth revisiting here to underscore its intersection with our pumps. Today, our mobile app provides users with convenient and discreet data display and alerts on their iOS and Android phones and functions as a pipeline for getting pump data to the cloud. Moving forward, our focus is on its evolution as a control interface. Our two devices each need a different type of app. Our first control feature will be Mobile Bolus for t:slim X2. This is currently under FDA review, and we are targeting its launch early next year via a simple app update for iOS and Android. Mobile Bolus does exactly what its name suggests.
It allows a user to manage bolusing from their personal smartphone and is one of the most frequently requested features from our users. Why? Because as Jordan has illustrated, with Control-IQ keeping you in range in the background, there are few reasons to get the pump out of your pocket during the day for anything other than mealtime insulin delivery. For many users, this is inconvenient and not very discreet. This is also the hardest feature to get right from a usability and safety perspective. It's a critical precursor for the full control app that will launch with Mobi.
This later version of our mobile app will have bolus capabilities but will also include additional control features such as managing pump settings and delivering wireless software updates that become necessary once you no longer have a UI on the pump and it moves to a personal smartphone.
As I mentioned at the start of this section, we were the first and remain the only company to have delivered new features and capabilities to our base of pump users via software updates. While it seems obvious that a mobile app should be updatable, this is a design principle for our whole system. It allows us to deliver feature innovations like additional CGM integrations, AID algorithm enhancements, and new user interfaces rapidly and at scale. This is hard to do, and we're getting awesome at it. Our Tandem Device Updater has been used to enable new capabilities on our pumps more than 130,000 times. Of the more than 200,000 people who adopted Control-IQ in the past two years, almost half downloaded it to their pump from the convenience of their own home.
Our mobile app for secondary display of data, which is available in the U.S. today, has been downloaded more than 160,000 times to iOS and Android devices. As we think about the idea of delivering immediate access to innovation, it's worth pausing to consider the implications for our CGM roadmap. We recognized early that as new generations of CGM came to market, customers wouldn't want to purchase new hardware to access them, whether it be a new pump or a new controller. As a result, managing for a seamless, multi-generational, multi-sensor experience has become a priority for our software teams. This focus is what allowed us to transition users from Dexcom G5 to G6 when it first launched, and it is how we will provide access to Dexcom G7 to both existing and new customers.
It is how we will enable customers to access an integrated Libre sensor when it launches. It is what will allow us to rapidly deliver additional sensor integrations to Tandem pumpers over time. Once you start thinking this way, you start to consider all of the points of integration that can bring benefit to our customer base. For example, with our current CGM partners, we're not just looking at how to pull data off a sensor and onto the pump for use by Control-IQ. We're working on complete experience across the pump, app, and data management layer, including cloud-to-cloud integrations that will see us return blood glucose and insulin data to their platforms. Down the road, we see potential to pull in additional information from other consumer devices and data sources.
Use cases here include easier logging of information like food intake or the use of biometric trackers to register exercise and sleep patterns and make therapy suggestions to users. For example, moving to exercise mode for a while. Access to insight in this context also matters. There is no reason to constrain users to viewing their therapy data through just the pump or app interface. As such, our longer-range development plan also envisages opening up enhanced data display options for users.
Taking a cue from the feature set we acquired with the Sugarmate app in 2020, which presents information to the Apple Watch, to CarPlay, and via Alexa. The last portfolio area that we would like to talk about today is our data products. The investments we are making here are central to delivering on our therapy management platform vision and key to our long-term strategy.
Data products mean different things to different people. At Tandem today, data products include our data management platforms, t:connect and Tandem Source, which enable users and their physicians to engage in a meaningful therapy dialogue. Looking forward, our data products will include additional tools and applications which may be delivered as enhanced features or standalone products. Importantly, we think about data products along a continuum that has three primary elements. Visualize, how do we present therapy and outcomes data in a way that is useful and supports therapy discussions between people and our products and their care teams.
Monitor and analyze, how do we provide continuous access to data and deliver analytics that enhance decision-making? Recommend and predict, how do we further process data to offer insights and suggestions to users and physicians at the right time? Can we automate these capabilities?
This is an area where we think a great deal about our other customers, healthcare providers. I'd like to invite Steph and Jordan back to talk about their needs in more depth and how we're evolving our products to meet them.
I'm a psychologist, you're an endocrinologist. Healthcare providers. We spend a lot of time with healthcare providers, and we've been talking about how intensive insulin, diabetes care requires really advanced math. Way too many numbers for the average human to keep track of hour after hour. Insulin is a miracle drug, and we know how to titrate it for optimal outcomes, but we don't know really quite yet how to fully automate and scale it for lots and lots of people. It's just a matter of getting better at that, right?
The importance of all this data around insulin delivery and glucose values is that it gives insights into behaviors at scale. When you make a clinical decision, you have to look at patterns. It is the numbers, but it's also when does an individual press the bolus button, for example, before or after a meal? What patterns do you see? And then which settings would you change? All this wraps up into data products and platforms for healthcare providers. To take it in all manually can be totally overwhelming.
Mm-hmm. Mm-hmm. Yes. Recently, we had a conversation with two of our friends, endocrinologists, Dr. Nick Argento and Dr. Joyce Lee. Nick is an adult endocrinologist, and Dr. Lee works with pediatrics. Let's hear what they had to say about the importance of data.
Hi, my name is Joyce Lee. I'm a pediatric endocrinologist at the University of Michigan. I take care of children and adolescents with type 1 diabetes, mostly. I actually do a lot of telemedicine, probably about 60%-70% of my visits are telemedicine. Data completely drives the visit. It makes it absolutely worthwhile, and the lack of data really reduces the utility of the visit.
Mm-hmm.
Data is very important to them.
Mm-hmm. Nick, how about you?
Right. I'm Nick Argento. I'm a clinical endocrinologist that's for adults, that specializes in type one diabetes and insulin-requiring type two diabetes. I'm in a private practice, and we interact with people mostly in person, but also remotely. The key for me in seeing people when they're so often on diabetes technology is getting the data efficiently in an organized way so that we can try and solve problems.
Mm-hmm.
as opposed to just kinda tinker with the technology.
Dr. Lee mentioned that she does a lot of telemedicine, and we know that during the pandemic, telemedicine as a practice really surged, as she mentioned. Dr. Argento talked about the type of information and data he wants to be able to work with his patients to solve problems.
The data we as physicians need, when presented in the right way as part of these data products, quickly and easily tells us what has been happening in a patient's life.
Mm-hmm.
We need to be able to recommend insulin doses. We asked our panel about this.
Mm-hmm.
I work with teenagers, and if I see a pattern, for example, high blood sugar after a meal, I have to understand if that's because they forgot to bolus their insulin or if I truly need to change their doses. So it's really critical to actually see the behavior, have a conversation about that with the patient and the family, and come up with a solution. Without the data, I could be completely prescribing the wrong medical management.
Nick, what about you?
I would echo that. What I want to know is what people actually do, not what they think they do or they say they do. It's not that people are dishonest, they just honestly don't know.
Mm-hmm.
Because it's sort of like running through a forest. You're dodging trees, but you can't step back and see the whole pattern. What the data does for me is gives, if it's efficiently organized, it summarizes, and in a glance, I can tell where we're doing well, what are the challenges, and allows me to focus on problem areas and explore what we can do to address those problem areas which involve my part of it, sort of recommending doses, but also the patient's behavior.
Dr. Argento was really great at explaining the sort of patterns he needs to understand with his patients, particularly related to their behaviors, so that he feels confident that he knows what's happening. We have a lot of data, but it's not about that. It's not about the amount of data, right? It's about automating the data and delivering it in a way that enables safe, fast, and easy decision making.
I don't think patients need more data. I don't think physicians do either. What they need is organization of data.
Yep.
Not because we're hit by this stream of data overload, and if it's disorganized, it's really very difficult to elicit patterns. You see what you look for. You know what to look for when you've seen it before.
Mm-hmm.
when it's organized, you recognize things more efficiently. That's the key about data organization.
Mm-hmm.
The other thing, the step that's also happening is data analysis to pattern recognition for AI to say, "It looks like you frequently have rebound hyperglycemia after a low." Okay.
Mm-hmm.
That's insightful. Okay, you're pointing me to something. Now we can have a productive conversation. "Oh, okay. Well, what do you do when you get low? Do you drink three glasses of orange juice, or do you take three glucose tablets and wait a couple of minutes?" The latter approach is what you want people to do. That's where AI can really help us organize uniform data so it's organized and know what's there. Everything I want is there, and a lot of superfluous stuff is not. I can interact with it.
Also AI these can go through zillions of bits of information quickly, point out when are people high, when are people low, identify so that I can then look at it, or the patient can look at it and try and modify it so that there's this feedback modification loop.
Mm-hmm.
you have in cruise control.
Yep.
I think that's what we want. That feedback loop to move toward a goal of better blood sugar control, better quality of life for patients, longer lifespan, all those things. I mean, that's what we need from data. The key to this is packaging up data in a way that scales.
Mm-hmm.
By bringing all the data together in a way that is easy to visualize for each patient in their own unique situation, it can help providers who just have too much of a workload.
Mm-hmm.
to bring all this data together quickly. Dr. Lee discussed this in detail.
One of the features that I really think is really interesting about the t:connect download that has helped me a lot as a clinician is seeing what the algorithm does, right?
Oh.
I can see the CGM pattern, I can see the human behavior, but then I can see where the wingman or the wing woman went in and did a little bit of extra to help my patient out, right? I think those are really important signals, right? What is the algorithm doing? How did it react? Or when or where did it have to do something, take an action? I think that really helps guide me as a clinician to say, "Hey, we still need to fine-tune," right? "We still need to do some adjustments." That information is actually really critical for finding the areas to do the adjustment in. I do again think it's very interesting, right?
'Cause now it's the patients and then in my case, the parent and the algorithm, right? There's actually a whole new relationship that is developing between those three individuals on how to manage the diabetes. Without that information, without that visualization, there is just there is a lot of missing information that we need to really help modify and improve the care.
Now let's talk about our data products. As you have heard in the video, we have been served very well by t:connect, our web-based application used to visualize insulin pump downloads. This includes pump settings, insulin delivery data, glucose values, and more. We are very excited to share our next generation web-based system, Tandem Source. This system offers all the features users know today, but adds customizability of the interface with movable tiles that let the user, whether that is the patient or the provider, customize the visualizations to help see those important patterns that are needed to adjust treatment doses. We have begun evaluating the system internationally with great results. Now, we have discussed our goal to get to greater than 60% market penetration. How are we going to do that?
We just finished discussing the burden and challenges of continually adjusting insulin pump settings and how important these settings are in the clinical setting. There are still some individuals with lower time in range and more frequent hypoglycemia, as you can see from the black dots on the slides. One of the ways we can help expand use of our product is by automating pump settings adjustments with the goal that everyone's outcomes would fall within the big blue dot on the top left of this slide with less hypoglycemia and more time in range.
This is a way not only to help the user, but also help the provider. Many individuals are seen in small practices or even primary care, and having settings automation, a data product we are now building, empowers those smaller practices to be able to help customers use our pump without the need to see the expert endocrinologist at the larger practices so frequently. We are confident this increased level of automation will improve outcomes like this. Now back to Liz.
Thank you both. It's so exciting to see the power of data in driving innovations in user experience that have the potential to make our portfolio accessible to a larger population of people, especially as we look at meeting the needs of type two. Although we are showing you only a small slice of our data products today, the potential for innovation here is significant. While anyone can build nice data presentation tools, the ability to drive meaningful insight from data requires significant scale. Today, we have more than 40 million patient days of data on Control-IQ logged in t:connect.
As you can see from the graph, it's been growing exponentially. More data means more ability to detect and drive patterns. Better pattern detection means better data products, and better data products mean more engagement and more data. Around we go.
A true virtuous circle effect, delivering greater value to customers and reinforcing their trust in our insulin therapy management platform. Once you have data at scale, you can use it as an engine for innovation across the portfolio. For our existing products and services, we are using the data in our platform to evaluate ease of use across our various user interfaces, automation of features like pump settings, and further AID algorithm refinements. For emerging products and capabilities, data is being used to evaluate and drive the development of payer-facing tools to evaluate member outcomes, decision support capabilities, including dosing and setting adjustments, and additional user-facing applications and services. We're just at the start of our journey here, but it's why we believe the investments we are making in our data management infrastructure today are a long-term growth enabler.
With that in mind, I'd like to invite Leigh Vosseller to share our view of the growth opportunity ahead with you all. Leigh.
Thanks, Liz. I'm going to close off our event today with an update on our long-term goals. Over the last four years, we have demonstrated incredible financial success through our focus on innovation. We took the lead in automated insulin delivery with our Control-IQ technology and proved that better control does not have to mean additional burden for people living with diabetes. As a result, we grew our worldwide sales from nearly $200 million in 2018 to nearly $700 million in 2021, which reflects a CAGR of 56%. That growth was driven almost equally by people choosing pump therapy for the first time and people converting from other systems.
The rapid and efficient scale over that time frame resulted in gross margin improvement of over 500 basis points to approximately 54% and a positive operating margin in 2021 for the first time on a full year basis. Adjusted EBITDA, which excludes the impact of non-cash stock-based compensation, has now reached 15% of sales. Our goal is to continue to outpace high-growth medtech companies. As we look ahead to 2022, we anticipate that we can continue our strong growth trajectory with sales growth of at least 20%. Today, though, we would like to remain focused on our long range plan. Stay tuned for our 2021 year-end earnings call, where we will discuss our 2022 assumptions in more detail.
Looking back to the Q3 of 2018, we laid out a five-year vision to triple our U.S. install base to approximately 175,000 customers and to grow our install base outside the U.S. to more than 50,000 customers. By the end of the Q1 of 2021, we already met both of those goals in just over two years. We believe that we can triple our worldwide install base again to 1 million customers in 2027 with a persistent focus on innovation, executing on our strategy to develop a family of products to meet the varying needs of people living with diabetes. By providing choice within our own portfolio, we can expand our reach into segments within both the type 1 and type 2 communities that have not traditionally viewed pump therapy as a solution.
The primary driver for reaching this goal is an increase in the overall market penetration of the U.S. type 1 population to 65%. Our outlook also includes assumptions for acceleration of type 2 penetration, growing international penetration that mirrors our success in the U.S., and expansion into new markets beyond those where we operate today. One strategic imperative to reaching this goal beyond launching new products is to capitalize on data solutions through managed care and health economic initiatives. We have amassed a large body of strong clinical evidence in the real-world setting that supports the value of our offerings for each of our customers. When we say customer, we are referring not only to the people who use our pump and their caregivers, but also healthcare providers and healthcare systems that provide reimbursement.
We continue to be encouraged by the receptivity to conversations between us and our partners within the U.S. payer community regarding Control-IQ clinical data. Through our digital platforms, we are able to demonstrate improvement through comparison of pre and post clinical outcomes customized for each payer's own subscriber base. In partnership with the payer organizations, we can then aid in prioritizing clinical efforts to optimize quality of care, as well as translate that information to true economic value across the healthcare system. The array of future products that we will be offering also broadens opportunities for channel access, specifically in the U.S. market. Certain of our products may still be best suited for the traditional DME channel, where we enjoy the benefits of pricing stability and direct visibility to our customers.
Some of our new products are being designed to unlock potential in the pharmacy channel and offer the privilege of choice for our customers. Our growth margin expansion to date has been primarily driven by sheer scale of the business, leveraging our fixed infrastructure and driving cost savings in the manufacturing process. Scale from volume growth is one of the key drivers that will continue to provide favorable benefit on a more linear basis across future periods through expansion and enhancement of capacity. The reimbursement initiatives I just discussed provide another key opportunity.
The timing of the reimbursement benefits are more difficult to predict on a year-to-year basis, but we anticipate meaningful contribution to our long-term gross margin goal. The third key driver of gross margin expansion is the introduction of new products with a lower cost profile. One past example was the introduction of the upgradable t:slim X2 platform.
At scale, it drove a 25% reduction in the manufacturing cost of the pump. t:sport provides the next step change opportunity, where at scale we estimate that it will cost nearly 20% less to manufacture than the t:slim X2, with cost advantages on the t:sport cartridge as well. Implementation and validation of the manufacturing equipment is currently underway in prep for the t:sport launch. These three factors will drive achievement of long-term gross margins to at least 65%, even as we consider changes to our geographic and product mix over time. I will now pause here while we take a moment to view a video of t:sport automation in our state-of-the-art manufacturing facility.
I hope you enjoyed the video clip, and I look forward to the future when we can once again provide in-person tours of the facility. On to operating margins.
We will continue to make thoughtful investments to prioritize innovation and sustain this trend, while also driving towards increased profitability over time with a goal of reaching 25% operating margins in the long term. Research and development will be our primary area of investment. In particular, spending will increase more substantially in the near term as we commence activities in earnest to drive the pipeline initiatives we have outlined today, as well as increase our clinical trial activities in line with FDA standards for algorithm enhancements and product indications. We have assumed R&D spending will settle in at a CAGR of just over 20% by 2027. Our innovation investments are also targeted to building out the ecosystem to deliver products and services that will enhance support for our customers and long-term retention efforts.
We expect that these initiatives will also provide leverage opportunities in spending associated with our customer service, sales, and marketing efforts. As we continue to evaluate the type two opportunity, we do not anticipate that this will require a significant expansion of our sales force, since our research shows that our target customers are primarily served by the same endos that we call on today. We anticipate investments in SG&A will grow in the range of a 10%-15% CAGR, and similar to R&D, near-term investments will be greater as we focus on development of these future leverage opportunities. We have the strongest balance sheet in our history, with nearly $600 million in cash, and are generating an impressive cash flow. In 2021, through the Q3 alone, we generated over $100 million in cash.
This provides us the strategic flexibility to persistently pursue our planned investments in innovation, whether it be purely organic or in combination with third-party collaborations, licensing, partnerships, or even acquisitions. Most importantly, we remain committed to growth. Thank you for your time and attention today. This concludes our prepared remarks. We will now open it up for Q&A.
Great. Thanks, Leigh. As Leigh comes over to join us, we're gonna go ahead and kick off the second portion of our Q&A today with a question for Jordan. Jordan, can you walk us through how we should think about the various clinical studies underway and when we may start to see readouts or data presented?
Absolutely. Our clinical strategy is based on three foundations. First, we want everyone with type 1 diabetes to be able to benefit from our technology. You see that in our ongoing trial of two- to five-year-olds. Second, we want to expand to different populations. We've talked a lot today about our ongoing efforts with type 2 diabetes. Finally, we are going to evaluate new insulins, rapid-acting insulins, concentrated insulins, as well as generics or biosimilars. All of these will allow us to improve outcomes. We're going to have a lot of data to share throughout next year.
Thanks. There's a few questions that have come in regarding Mobi Tubeless and patch and just the opportunity with pharmacy channel. Leigh, maybe you can talk about how Mobi Tubeless provides an opportunity to access pharmacy channel. Is there an opportunity to service patients through that channel with Mobi, or is that catalyst really something that we should look more so with a tubeless or a patch?
Sure. Thanks, Susan. I'll start by saying, taking it up just a level, reimbursement is very complex, obviously. When you think about the two different channels between DME and pharmacy, sometimes you have to think about product fit. That's one of the considerations for where the product might be best suited. For example, pharmacy has been very conducive to the disposable or consumable-like products. When we think about our product portfolio in the long term, we fully expect to be within both channels for some products and pharmacy for the other products. When you think about pharmacy in particular, there's already a tubeless category there that people are very accustomed to and familiar with. As we think about the long-term portfolio of our products, we'll continue to evaluate which ones fit more cleanly into that channel.
Stay tuned when we get closer to commercial launches, we'll have more color on the reimbursement and the innovations we can make on the business model side.
Thanks. John, next question is for you. Would you consider launching Libre integration outside the United States in advance of receiving or it receiving iCGM integration here or designation domestically?
No, we wouldn't. I think it's important that we work with Abbott and the FDA to address the issues that the FDA currently has with the product in the United States relative to iCGM before going anywhere else.
Thanks. Next one I think is probably split here between Liz and Jordan. You mentioned that having your own data management application puts you at a competitive advantage. I appreciate where having the data gives you added value from an analysis of data perspective, but can you speak to how having your own system matters from the pump user or the HCP side with third-party offerings that are available today?
Yeah. Thanks, Susan. I'll kick that off and then maybe pass it to Jordan for the physician perspective here. As you say, there's clearly immense strategic value to the large base of therapy data that we're building within our platforms. But the primary reason for going there in the first place is really around the idea of having an end-to-end philosophy on the solution we're providing. Although we do today actually provide uploads to device agnostic platforms, it is the reason why we continue to invest in our data management layer. It's really twofold there.
At this point in time, we have a very deep perspective on the functioning of our pump and our algorithms, and that insight allows us to really tailor the data that we are able to provide to help physicians understand how the algorithm is working. As Dr.
Joyce said, that third entity in the conversation providing nudges and input along the way, we can provide the color on that by owning that platform piece of it. Secondly, when you have both sides of the equation, it also allows you to make investments in pipeline optimization for the data, with the goal being to ultimately make it as continuous and transparent as possible for both the user and the physician. Jordan, would you comment on the physician perspective there?
Yes, Liz. As you said, we know our customers best. We also know what prescribers expect from our products. When you set up an insulin pump today of any brand, you have to enter settings, you have to maintain those settings. That's a lot of work, and it requires, in many cases, seeing an endocrinologist, seeing an expert provider. Now, in some cases, there just aren't enough endocrinologists. We know, for example, many people with type 2 diabetes don't get to see an endocrinologist and have to rely on their primary care.
When we look at some of these items, like automated analysis and changes of insulin delivery settings, we see a tremendous opportunity to provide value for those individuals who might be seeing their primary care doctor, for those who are seeing small practices, and we think they're gonna get a lot of benefit in this market.
Thanks. Leigh, this next one is for you on pricing. How should everyone think about pricing for t:slim X2 versus t:slim X3 versus Mobi?
Sure. Great question. First of all, I'll start by saying with t:slim X2 and X3, they were designed to fit into the normal billing codes that we use today, as well as Mobi, at least the first version of Mobi. As we continue to evaluate the channels that we could bill through and evaluate other business model opportunities, we can talk more about what Mobi tubeless or even a patch pump might look like. As of today, you can at least assume for X2 and for the initial version of Mobi that they would be through the same billing codes that we currently use.
Jordan, back to you. A question really relating, how does a feasibility study inform a pivotal study?
There are many market segments in the type two market that you're talking about specifically. There are those who use a lot of insulin and those who use very little insulin. There are those who are on additional medications, such as SGLT2 inhibitors. There are those who are not as familiar with technology and those who have really embraced diabetes technology, and they have different training needs. We're using this feasibility study to really do our homework in making sure that we're setting up a great pivotal trial for next year.
Thanks. Maybe we'll just stay with you for a moment. How should we think about AID advancements over the next couple of years? Are there any features in particular that you'd highlight as driving greater adoption than others?
You know, there are. I think we've mentioned we're looking at customized glucose targets, right? We're looking at using new insulins, and we're looking at features around meal boluses and exercise to improve outcomes. Finally, clinical decision support, I think, is also a key role here that will help improve outcomes as well.
Thanks. Back to Lee. When the t:slim X2 launched, you mentioned that it cost less than the original t:slim. Should we think about X3 as offering additional margin opportunity also?
Thanks, Susan. When we think about gross margin, generally, we have three key categories of ways that we expect to save and to have gross margin expansion in the long term. The first one is just sheer scale on an efficient basis, which we've been demonstrating for the last few years. Reimbursement is another opportunity which we've discussed at length, I think. The third one would be new product introductions. Every product that we design and develop, we're looking to also reduce the cost of that. Like you said, X2 is a significant reduction from the original t:slim. It was about a 25% improvement in manufacturing costs. Mobi, we're looking to have nearly 20% cost reduction.
As any new product rolls out, we expect to see cost efficiencies to the prior version that will help with our meeting our gross margin goals.
Thanks. Another one for you, Jordan. What level of time in range do you think needs to be achieved to create another step change in adoption?
That's a great question. We know that every 5% improvement in time in range is associated with a clinically meaningful improvement in outcomes. For this next generation of automated insulin delivery, I think what we're really looking at are reduced burden, ease of use, confidence in the system that people can sleep through the night without hypoglycemia. Now, we're already achieving great outcomes with Control-IQ technology, but I believe our products are really positioned to improve on all these aspects and really bring us to the next level.
Thanks. This one, it kind of crosses over. John, the question is on Mobi. Is it a waterproof device?
Yes, it is waterproof. It's IPX8 certified. As we said, it's got a number of new technology features. It's inductive charging, it's waterproof, it's small, it's mobile control. It has a mobile, sorry, it has a bolus button on it that enables you to use the system if the battery on your cell phone were to run out of charge. There's a lot of really cool and interesting features on it. It'll also have the latest generation of our AID algorithms on it as well.
Thanks. Leigh, next question is for you, and it's really talking about upgrade programs. Will current t:slim users be able to switch to t:sport or Mobi prior to the expiration of their t:slim warranty?
Sure. We've always had upgrade programs in place to help give our existing customers access to the new technology, especially before we had upgradable software on the pump. As we look forward, we do anticipate that we'll have some sort of pathway for patients. When we get closer to our commercial launch, we'll get more details on that.
Great, thanks. We'll let this one sneak in. I know the focus of today is on longer term, but you mentioned 20% growth as a starting off for 2022. Is that correct?
That is correct. To be more precise, at least 20% growth next year. I'll say that some of the major assumptions, the things that have made us so successful in the last two or three years are still in place for next year. We expect further penetration in the MDI population. High level of competitor conversions and renewals are really starting to step up and become a more meaningful opportunity. I'll leave it at that today and save the details for the year-end earnings call.
Thanks. Next question, Liz. Do you plan to discuss innovation with Apple? What are the big items that you're working on there?
That's a great question. Not least because today, 70% of our user base is iOS consistent with the type one community more generally. Look, I think, as you think about high quality interfaces to the data that we are pulling off these devices and presenting to drive insights for users, it's logical to look at additional display options. We're building some great experience with those, looking at the Sugarmate asset we acquired in 2020, which today presents to Apple Watch but also to CarPlay. We are absolutely not ruling out any and all innovations on the display front and potentially other input-based innovations over time. That's probably where I would leave it today.
Thanks. This is a broader question for you, John. When Tandem considers its portfolio across diabetes devices, we've seen a number of pump innovations today. Do you expect Tandem to remain solely focused on diabetes, or are there other areas that you're interested in?
That's a great question. I would say that there is so much opportunity right now just in bringing the amazing technologies that we have to diabetes community, that's really where our focus will remain, for the near to longer term future. I think as time goes on, if we see other opportunities to consider different types of drugs for using our pumping system, we might consider it. You have to recognize that the approval process is very long for a dual drug and device product filing. It's unlikely we're gonna do anything like that in the short to longer term.
Thanks. Then there's a question on, it's just clarification for Mobi and asking if there's a disposable component. Maybe just take the opportunity to clarify that the Mobi pump is the same. You can use it if you'd like, with a tubed infusion set or Mobi Tubeless. It's really just a tubeless infusion set option. Pricing when you think about Mobi pump, consider that separate from the actual disposable piece. Leigh, maybe there's a question too about reimbursement and how reimbursement works between the two different as well as training. Do you wanna maybe speak to the first part and then either Liz or Steph, you can talk to training?
Sure. I'll start with the reimbursement perspective. At least from the durable pump perspective today, there's the upfront cost that comes when the pump is first delivered, and then there's the supply stream along the way that you get reimbursed for. While we look at Mobi Tubeless as a very innovative and creative product for a patient's perspective, for how they wear it and how they enjoy the benefit of their pump therapy, from the reimbursement perspective, it's really just an innovation or a variation of the consumable piece of it. Like I mentioned earlier, we're going to continue to explore if that creates new options within the pharmacy channel or with a different business model altogether. At this point, you can think about it to be not too dissimilar from the standard Mobi pump.
Thanks. Then to the question on concentrated insulin, is the intention for Mobi Tubeless to use standard U-100, or is that just something that's gonna be. Is concentrated gonna be available for the Mobi products as well? John, do you wanna take that one?
Sure. I mean, I think that concentrated insulins make a lot of sense going forward when you consider in particular us entering into the type 2 community, where there is a segment of the type 2 group that uses a great deal more insulin. I think concentrated insulins make a lot of sense for the Mobi product as well as for the patch product, and possibly even with t:slim.
There's also a question here just confirming that the patch pump is a single piece rather than two, and that's correct. The patch pump is a single piece. Next question I'd say is really about manufacturing capacity for Mobi at launch. Leigh, do you wanna talk about that?
Sure. When we think about Mobi and the launch of any new product, frankly, we look at the market research. That's our baseline assumption for what we can expect in terms of demand. We always look to upside scenarios because the last thing we wanna do is not be prepared for a surge in demand beyond our initial expectations. We're building out manufacturing capacity comfortably to meet any level of demand with the Mobi product.
Thanks. Jordan, here's a bit of a technical question: What are your thoughts on incorporating flexible set points for the algorithm in development? Are there any pluses and minuses of having multiple set point options?
Well, it's a great question. We're already exploring customized targets, customized glycemic targets as part of our future development. We'll be able to present some of that outcome data sometime next year.
Thanks. Leigh, with a strategy of multiple hardware platforms, how do we think about the margin implications? Does a broad portfolio impact your ability to drive leverage, or is there more overlap in manufacturing component sourcing than we can appreciate today?
Yes. You know, this was all factored into our long-term gross margin goal of being at 65% by 2027. As I mentioned earlier, when we design and develop new products, we look for cost efficiencies in mind and also reimbursement opportunities. We've comfortably factored in those elements as we've thought about that gross margin goal. To your point, Susan, some of the products have some similarities where we can leverage the same manufacturing capacity that we've already built today.
Thanks. This is back to you, Joyce Lee. Do you expect the gross and operating margin expansions to be linear or like by 2025, 2026, 2027, or do you think they're gonna be more back half weighted?
Right. The one key element, for gross margin expansion, the scale piece of it, you would expect it to be more linear. We've been demonstrating that for the past few years. Really where you see step changes come with product launches. Mobi in particular, when we launch it and we get to a level of scale, that's where we expect to see the step change, where we see that benefit from the cost reductions in the pump itself. You can think of it along those lines when you think about how you can see the gross margin step up over time.
Thanks. Maybe, Liz, if you wanna take this one. Your mix between MDI patients and existing pumpers has been very stable. How do you think this might change through the long term?
That's a great question. As you know, it has been pretty consistently split 50/50. I think, as we look at it today, for the next few years, we believe there's continued room for competitive conversions to represent a significant portion of our new customer adds. Over time, I think, where we expect the market to go is probably in the direction of a little more weighted to MDI. Behind that will come our own renewal cycle, as we keep the customers we've acquired within the Tandem ecosystem. I think competitive conversion MDI today, shifting to a little bit more MDI and renewals in the future is probably a fair way to characterize the medium to long range.
Thank you. Looks like we are at time. I'm gonna go ahead and ask, John, do you have any closing comments for us?
Sure. Well, I'd like to first say that Tandem is in the best place of our company's history, which is, and when you consider just a few years ago, the transformation has been amazing. It's really, we've had a great team, as you can see, of just a great team all contributing to make all of this happen. We are certainly excited about the pipeline of products that we've talked to you about today. I, we think it's revolutionary, in fact. The portfolio approach to having different products that address different segments is really a revolutionary approach. I think we see the portfolio approach, the innovation in the pipeline, really allowing us to provide solutions to different segments of the type 1 and the type 2 marketplaces.
We think that creating a positively different experience, improving outcomes, and reducing the burden of diabetes is going to continue to enable us to penetrate the market at a much higher rate and continue to accelerate market penetration, not only here in the States, but elsewhere outside the United States. Most importantly, it's going to allow us to continue to provide the benefits of our life-changing technology to the people we serve, the 1 million people that we plan to be in our ecosystem in the next five years. With that, I'll just say thank you for coming today. It's been great to be able to show you the pipeline and this new technology we're bringing to market, and stay safe, and we look forward to seeing everyone again face to face at some point, hopefully in the near future.