All right. Good morning. I think we'll start. Welcome to the third day of the Raymond James Institutional Investors Conference. We certainly appreciate the packed house on the third day with the sun shining out there, so we appreciate that. Thank you. I'm Jayson Bedford. I cover the medical technology sector here at Raymond James, and it's really our pleasure to have with us Tandem Diabetes for the 1st time at this conference, I think. We have the company's CFO, Leigh Vossler, and we have the company's CEO, John Sheridan, who will walk through the story.
Thanks, Jayson. It's nice to be here. I am on. Okay. Yeah, very nice to be here this morning. I think what I'd like to do is just kind of give you an overview of Tandem, where we're going, what the markets look like, our pipeline, and just give you a good sense of what you can expect from us over the next couple of years. I'll start off by saying that from the very beginning, Tandem was really focused on what we call user-centric design. We really want the device to be simple, intuitive, and easy to use. Very much like what you experience with consumer devices that you use today. The benefit of that is that it's, first of all, that, you know, people will..
It'll be easier for them to actually walk their way through the device. It's also, You can be more compliant because people are not going to make mistakes. They're going to use it properly. We have a team of engineers that work with our behavioral scientists and our human factors experts to really understand how the human interacts with the machine. We think that's a very important design principle, and it's something that we've really had in place from the very beginning. Another really important part of Tandem is that we are a mission-driven company. We are really focused on improving the lives of people living with diabetes.
There's 2,500 people across the United States and Europe who really believe that we want to relentlessly innovate and provide extraordinary customer service, really just to improve the lives of people living with diabetes. We have a great culture within the organization. I mean, if you come to San Diego, I would say half the time, most people are wearing shorts and flip-flops. We really believe in substance versus style. It's relaxed, it's entrepreneurial, but we have a great team. We have a core team that's really been there from the very beginning. We have added a number of people in the last couple of years that have focused on larger company, management experience for R&D, for the product management, for our managed care functions.
Things that are really important areas that we're focused on now as we're growing as fast as we have been. We also have a very strong board, which, you know, they have really added value to the organization as well in terms of managed care and technology. I just wanna say briefly that our financials are GAAP and non-GAAP. We've had some changes with the way we're recognizing revenue this year due to a choice program that's out there. If you have any questions, we'll be happy to answer those. The non-GAAP revenue numbers really are representative of the company's performance at this point in time. I'll say that, and 2022 was a challenging year for us.
We had experienced issues centered around COVID, the competition, and the macroeconomic factors that I think everybody experienced in 2022. Even so, during 2022, our worldwide installed base grew 29% to 420,000 people worldwide. We expanded the pump market, the worldwide pump market. We see about 50% of our new starts come from MDI or pens and needles to pump therapy, and the other come from competitive conversions, which is primarily Medtronic. We expanded the pump market, but we also have record growth in our renewals. In 2022, we saw more people renew faster. These are people who are already on a Tandem pump, and their warranty is expired, and so they're selecting a Tandem pump again.
In fact, in the fourth quarter, we saw our greatest renewal performance ever with about 75% year-over-year growth in that area. I think that's particularly meaningful when you consider the fact that this past year there has been a new competitor on the market. I think if there was an opportunity for somebody to transition over to the competitor's device, this would be a perfect time as you're switching from one renewal cycle to another. We saw strength, which I really think suggests that the Tandem install base is very sticky. We have over 550,000 years, excuse me, of patient data.
We've collected this data over time. This is a really invaluable treasure trove that allows us to support product development, clinical trial and clinical expert, excuse me, science and research. Also, just looking at outcomes data to work with payers to provide the outcomes data to them. We have, we introduced a new product last year, which was the... It was a Mobile Bolus feature that allows the user to bolus from their phone. This is the first device that the FDA has approved that allows somebody to bolus insulin from their phone from both an Android app and an iOS app, which is a huge feature for us.
It actually cleared the way in terms of working with the FDA, for them to get comfortable with our ability to use electronics and a cell phone to control insulin, which was quite a great accomplishment by our team. We also had two really important acquisitions. We acquired Capillary Biomedical last year. It's a developer of an Extended Wear Infusion Set, which we're working on now. We also acquired AMF Medical, the developer of the Sigi Patch Pump, which is all part of our portfolio approach, which I'll explain here in just a minute. I thought it'd be worthwhile just kind of going through what the market is, how it works, and how we take advantage of it. The first thing I just want to point out, it's a large and growing market.
When you consider the U.S. and the OUS opportunity, it's over 9 million people with Type 1 and insulin-intensive Type 2. In the U.S. market, there's approximately 1.8 million people who have Type 1, who basically need insulin every day. There's about 2+ million, maybe 2.3 million people that have Type 2. OUS, the market's twice the size in the 25 countries we're in. There's roughly 4 million people that have Type 1. Not as many with Type 2, still the Type 1 opportunity is really large outside the United States for us. I would say that when you look at the important part of that, it's the penetration rate. How many of those people use pumps actually?
The penetration is, I think a big opportunity for Tandem to continue to develop products that are exciting, that reduce the burden and provide technology to drive and improve the penetration rates. In the U.S. right now, about 35% of those people use pumps that have Type 1. There's about 650,000 people that use Type 1. We believe that that number can grow to about 65% over the next four or five years. If you look at CGM, for instance, CGM today is about 70% penetrated in the Type 1 space, and we absolutely draft off the CGM company success. We also are working on innovations to reduce the burden of diabetes and increase the therapeutic benefit.
By doing that, we expect to see, as I said, the U.S. penetration go from about 35%- 65%. In Type 2 in the U.S., there's about 100,000 people who use pump therapy. That's again, that's 5% penetrated. We still think that there's an opportunity there to grow that from 5% to possibly 10%-15% over the next couple of years. We are working on an indication for Type 2 for our products right now. We expect that to be available in the 2024 timeframe. Today, we can't market to that group, but we do have about 20,000 people who are using our technology today that do have Type 2, and they're seeing fantastic results. It's another opportunity for us.
When you look OUS, as again, it's twice the size of the market, significantly less penetrated even than it is in the United States. Right now it's roughly 10%-15% penetrated. I mean, when you look at that opportunity, I think that it's really, it's technology, as I said, that drives the therapeutic benefits of the product, improves the therapeutic benefits. It also reduces the burden of wearing the technology. That is what we're focused on. The same factors that are going to help us improve the penetration rates in the US exist outside the United States. I would say that in general, when you look at diabetes technology, it's a really interesting market. There's a great deal of competition, and there's a great deal of innovation.
I think the innovation's coming from ourselves, it's coming from our competitors, and it's coming from our partners. It really is this innovation that's driving this increased penetration rate. We think these are achievable numbers, and I think it really does sort of state the excitement that we have about the opportunity to grow the business in the near future. I would say that the interesting thing about diabetes as well is that it's very segmented. It's not a one-size-fits-all solution. There's not a one-size-fits-all solution out there. I mean, not one pump is not going to meet the needs of this very different need and different segmented market. There are people out there that want to have different ways to control the pump. They want to have different ways to wear the pump, different insulins.
It really does require a portfolio approach. That's what Tandem's approach has been from the very beginning, is to look at a portfolio of devices, multiple devices that address the needs and the differing needs of people who are living with Type 1 and Type 2. Over the last 10 years, we have driven significant growth through innovation. We have innovated faster than our competitors, and we have introduced a new product roughly about every year to 18 months for the past 10 years. We have the most exciting pipeline in diabetes right now.
I think I'll walk you through where we're going, but certainly, we have the most exciting pipeline, and we intend to introduce and deliver new technology to the marketplace this year and beyond that's going to drive similar growth that we've seen in the past. Certainly this year, with the competition and some of these macroeconomic factors, we have seen moderated growth. It's slower than we're used to, but I think that, you know, we never expected the growth rate to be linear over time. I mean, we have plans to get to 1 million people using our technology by 2027. As I said, it wasn't going to be linear growth. There were going to be periods of moderation when we experience competition like we have in 2022.
As we bring new products to market like we will this year and beyond, we expect that to drive growth and get us back to the same growth curves that we've had before. The t:slim X2 is our flagship product. It is a product that is a touchscreen, it's rechargeable, it's software updatable. What that means is, it means since it has a touchscreen, we can change the entire function of the system by just changing the software on the device. We have done that many times. We make the software available free of charge to people who are in warranty. That's a huge incentive for people to continue to use the Tandem pump 'cause they know that once they buy one, they're gonna have access to technology that we develop over time.
As an example, we introduced Control-IQ in January of 2020. We made that available free of charge. Within two or three quarters, we had about 80,000 people who had previously been using the previous version of the software update. It's been a very successful program. I mean, it's a very unique opportunity as well. We do not have to change the hardware to change the function of the system. This year, as in 2023, we are going to add sensor integration with the Dexcom G7 and the Abbot t Libre. When we do that, those will be software updates that we can provide to our user base to allow them to have access to this new technology.
Control-IQ is the most advanced AID system on the marketplace. It has the trust and confidence of the physician and the endos, both in the U.S. and outside the United States. We have very strong clinical data. I think that if you talk to endos today, they would say it's absolutely the best system. The reason that's the case is because we have basal modulation, which as the system sees your insulin needs increasing, it will basically gradually increase the basal rate. If the slope of your blood sugar goes up rapidly, it'll actually give you a bolus. That's the reason we get immediate and sustained benefit from this product.
The other devices that are on the market today, they just have basal modulation, and as a result, it takes quite a bit of time for them to learn your system and actually get you in control. It can be weeks, it can be months before that happens. If anything changes in your metabolism or your diet, you have to start over again. I think that there's a real difference between the way Control-IQ performs. Again, it's immediate and sustained. The first day you start to use it, you see the benefits. I think it also explains the fact that there are people who are using our product today love it. They love the results, and they are switching.
They're very sticky as a result of the positive experiences they're getting with this. As I mentioned, we are working with Abbott and with Dexcom. You know, we've been partners with Dexcom now for seven or eight years. We're in the process of integrating a fourth generation sensor. Dexcom has an outstanding device. They're right around the corner from us. We have a close working relationship with that team. As I mentioned in previous conferences, that we anticipate... Now that Dexcom has approval from the FDA, we anticipate bringing this product to market in the latter half of the second quarter. We're excited to do that. The big news on Monday, Abbott received clearance for the FreeStyle Libre 2 and 3 to be used in the AID system.
I think there was some concern that they wouldn't get that or uncertainty as to when they'd get it. This is great news for Abbott and clearly for us as we do anticipate integrating that system. It's difficult to say exactly when because they have to modify the device and then actually introduce that device to the marketplace. We'll be working with them to understand what the timing of that looks like. We have said previously that it would take us a quarter or two after they've received clearance, which now they have. We'll talk more about the timing of the availability for that integration on our first quarter call, which is in April. Mobi is a product that's currently under review by the FDA. We're very excited about this device. It is a...
It's That's actually our first significant change to the form factor of the pump. It's half the size of t:slim, and it is controlled entirely by a mobile app. The benefit of this really is there's a significant improvement in convenience and discretion when you have a mobile app controlling the device. You can basically be at lunch with friends. You need to deliver a bolus, and all you have to do is take up your phone and do it on the phone, and nobody understands that's really what's going on. Discretion is hugely important for people with diabetes, and we think this device is gonna go a long way to improving that. It's also small and discreet. It's probably gonna be used by people who are more tech-savvy, I'd say, people who are active.
We think that this is going to be an exciting new product in our portfolio of devices. As I said, it's going to address the needs of segments of the diabetes community that are out there. We think it's going to be significant, and that drives an inflection point in our revenue going forward. The other benefit that it has is that it has a much better gross margin. The cost of Mobi is about 10%-15% less than the t:slim device, and that's primarily because it doesn't have a touchscreen. It also has a better margin on the cartridge, about 20% less cost on the cartridge. Our efforts are to drive gross margin improvement as we introduce new products over time.
We basically stated a goal that in 2027, we expect to have gross margins of about 65%. Right now we're in the mid-fifties. This is gonna get us halfway there. This is a significant jump and benefit for us as we go to market and actually scale the device. As I said, we're working with the FDA right now. We have questions. We're dealing with questions. The. I'd say that there's nothing surprising about the interaction. I would say it's normal. There's work for us to do. We're doing it. It's a positive process at this point in time. It's difficult to predict the actual timing of FDA approvals these days.
We would expect that the best thing to do really is not to try to predict it, but just be ready for clearance. We anticipate we'll get clearance in the second half of the year, and we will have, we'll probably need about a quarter to bring the product to market after we get approval. We do anticipate this being a product on the market in the second half. The next thing that we're working on is t:slim X3. The t:slim X2 has been around for about 10 years, this is really intended to be a technology upgrade for the product. We anticipate that this is going to be an important product going forward for us. And, you know, there's supply chain challenges we want to avoid.
It's really a matter of making sure that all of the electronics, all of the components that go into the system will be available for 10 years. In addition to doing the technology upgrade, it'll be wirelessly, we can wirelessly update the software. It'll be wirelessly charged. There's a few other benefits that it'll have. We'll have a upgraded user interface, a variety of things that will come along with this. We think that this is not gonna necessarily drive revenue, but it's gonna put us in a position to continue to offer the product for the long run. The next exciting product that we've got is Mobi Tubeless.
Mobi Tubeless is intended to use the exact same pump as used today in the tubed version, but it provides an opportunity for someone to go tubed or tubeless with the same pump. When we introduce the device this year, it'll have a tubed option, and you will need to use an infusion set. You can use a small one, you can use a patch and actually adhere it to your abdomen with a small infusion set, and it's near patch-like at that point. In when we introduce Mobi Tubeless, you'll be able to take out the cartridge and actually put a new one on it that integrates with a tubeless design and put a basically a sled on your abdomen or your arm that you can integrate the pump into it.
You get, again, you get a very much like a tubeless experience. We think this is the ultimate in choice. You'll now be able to have tubed or tubeless options with the same device. We think that, again, it's back to choice and preferences. There are times in people's lives where one or the other makes sense for them. This device here is the next one we'll bring to market after t:slim X3. The Sigi Patch Pump is it's AMF Medical. I mentioned that we acquired it just recently. We have been working on our own patch device for a while, and in our R&D day, which is in December of 2021, we indicated that we were going to develop a patch pump and bring it to market by 2027.
During this past year, we've done a great deal of market research. We've looked at our own device. We've looked at the competitive devices that are on the market. We also looked at 4 or 5 startups that are underway in, you know, various places around the world. We did market research pre-preference testing with all of those groups. What we found is we found that Sigi scored better than anybody, including our own internal product. Our internal product was really focused on miniaturization using concentrated insulins. This device here is rechargeable, and it also has a prefilled insulin cartridge, which allows you to change the cartridge very simply. The rechargeability is a significant environmental benefit. I think that really resonated with people. I mean, people particularly in Europe, there's a high sensitivity to environmental issues.
I'd say that the younger generation here in the States feel the same way, and I think there's increasingly more focus and interest in having environmentally friendly devices. We think this is a really important aspect of our design going forward. As I said, the prefilled insulin cartridge really gives you the ability to just change the insulin out quickly, and you get a great deal of flexibility along with that. The device will be controlled again entirely by a mobile app, and it will have Control-IQ, and it will integrate with our sensor technologies that we're working with our partners on. This is a device that again, we're kind of in the process of integration today. We think it's gonna be earlier than 2027.
I think as we have the opportunity to work more closely with a team in Switzerland, we'll be able to comment specifically on when we expect it to get to market. I will say that we're gonna do everything we can to bring this product to market as quickly as possible. I'll say that the team in Switzerland are incredibly capable. They have, they're strong engineers with a sense of an experience in automation and manufacturability. Again, this is going to be accretive to gross margin. It's gonna be a very reliable device. I think that form factor and ergonomics really will make it appealing. When we have these devices, now you can see we'll have t:slim. It will have with a touch screen.
We'll have Mobi, which is also a tubed and tubeless option. Then we'll have a completely tubeless option with Sigi. As I said, this is the portfolio of products that we'll have going forward. They'll be indicated for Type 1 and Type 2. All of these products will use Control-IQ. As we continue to advance the Control-IQ algorithm, we'll be able to integrate that onto these devices, as I said, using software updates. I think this is a really exciting portfolio, and we would anticipate having all these products on the market in the next couple of years. One of the things I mentioned is renewals. The reason renewals are so important to us is our growth really took off in the 2018 timeframe.
In 2017, I think we had about 17,000 new starts. In 2018, we had about 30,000. These are U.S. starts. In 2019, we had about 50,000. These now, four years later, the warranties are expiring on these pumps, and they are now opportunities for renewed pumps. As I said, we're seeing significant improvement in the number of people renewing and the speed at which they're renewing. Right now, as I said, we're going into 2023 with 50,000 people as candidates for the renewal opportunities this year. Our goal is to get 70% of those, and I think we're very close to doing that. It just doesn't happen right away.
It turns out that most, maybe about 50% of the people will renew within the first year, and then it takes a little bit of time. It takes probably about five years for people to get through the process. The pump is reliable, and it was still working. Oftentimes, people won't renew it until it has some sort of defects that requires that to happen. As I said, we have a number of programs in place. We've strengthened we to the technology that we've got. We make it available to people who are candidates and in warranty. That's a incentive for people to continue to update with our systems. We also have a team. We've really enhanced the team of people that stay in touch with all of our install base. They have relationships. They have email.
They basically keep, you know, in touch with this group so that we've got access. When they are close to being renewal, we can make sure that they are where it's time and we can work them through the process. I want to just spend a moment on the fact that we are working to create value. I think that we have, as I said, we have a plan to get to 1 million people using our product by 2027, a gross margin of 65% and an operating margin of 25%. As I said, we don't expect to see that all occur in a, in a linear growth. There's going to be periods of moderation that we experienced last year.
As we bring new products to market, we expect that to return to the same cadence and aggressive growth that we've seen in the past. We're definitely investing in innovation. We want to have a long-term pipeline. We have a long-term view of where we're going. I think when you see the fact that we've got these three really interesting products coming to market over the next three or four years, that really is going to enable us to have this extended growth period, and continue to invest in R&D. We are being very careful about spending. That's something that we've always done, particularly in a time like now, where we are seeing moderated growth. We really wanna control spending so that, you know, we continue to have positive operating margins.
One of the ways that we're doing that is we have systems and processes internal to the organization that do require a lot of people to staff them. We're working on lean initiatives and new systems and processes so that as the company grows, we don't have to scale that aspect of the business the same way we have in the past. There's definitely opportunity to leverage these processes and continue to see positive growth in our operating margin. I'll wrap up by saying that it is a worldwide market, large and under-penetrated. That's very exciting. We currently have the best technology in the market. We have 420,000 customers worldwide using it. You saw the renewal opportunity. That continues, you know, into the future. We've had...
You know, we went from 50 to 70 to 80 to 90. There's, you know, there's great opportunity, I think, in renewals. I think we've got the most exciting pipeline, which really is going to drive the growth, the conversions from MDI to pump technology. You know, I think that, you know, Tandem has a exciting and very positive future going forward.
All right. Well, well, well done, John.
Thanks.
Thank you.
Yeah.
We've got a couple of minutes here, and then we'll obviously have the breakout downstairs. Just, with the news on Monday and Abbott, have you had discussions with Abbott since Monday? I'd just be curious, can you frame the opportunity as you see it?
Well, we haven't spoken to them since Monday. We did talk to them before Monday, when they were obviously aware that they're going to make the announcement. We still need to get together with them to understand what the timing is on the availability of the product. That's kind of number one for us. I would say that when you look at the U.S., there's roughly 300,000 people today who are using the FreeStyle Libre sensor, the FreeStyle Libre 2 sensor, and they're not connected to an AID system. We know that AID technology substantially improves the therapeutic outcome and is a real positive in just terms of the way you feel on a day-to-day basis.
This population of people really become this. It's a great growth opportunity for Tandem. It's even larger OUS. When you look at the total number of people using the Libre sensor today, it's 4.5 million people worldwide. I mean, I think that when you look at our growth going forward, this is going to be an important part of that.
You mentioned international. What's the timeline or integration dynamic with, in international?
We haven't given a timeline. Certainly will be after U.S. I think that the fact that FreeStyle Libre 2 and FreeStyle Libre 3 were both approved, gives us something to think about. We've got to really figure out, does it even make sense to go with FreeStyle Libre 2 international when we'll have to redo it? I think we're in the process right now of just trying to evaluate what the best step forward is here. I think that we'll have more information about it, probably on the first quarter call.
Okay. One of the other new products that I would characterize as a new product is just integration with G7.
That's true. Yeah.
Do you expect integration with G7 to trigger or catalyze the renewal cycle?
Certainly. I think that's the idea of making it available to people who are in warranty. It'll be made as a software update. I think that it's a great product. I mean, it's easier to apply. It's got a faster warm-up period. Ergonomically, it's a much more, you know, positive form factor. I think that we expect it to certainly drive growth for Dexcom. Anytime Dexcom grows, we basically have benefited from that. I think that in this particular case, we will see growth as well. We will see strength this year in sales as a result of the G7 integration.
Okay. I think we're bumping up against your time, but a simple question. You mentioned pump adoption, 35% in Type 1s. CGM, I think you said 60-
70
7
Yeah. Yeah.
Why the big gap there? Why is this market not more penetrated?
Yeah, I mean, I get asked that question all the time. I w ould just say that the sort of the form factor of a CGM is it's not that large. You can just put it on. I think it's much easier to wear. A pump's different. The pump is delivering insulin. You know, you've got to overcome, I think, some fears that you might have about the performance of the system, the safety of the system, and those sorts of things. It's a much more, I think, significant decision that people have to make. That being said, I think that we've really come a long way in the last couple of years by providing very safe systems that have excellent therapeutic outcomes. We are seeing people...
I mean, there's a burden people have to get or hurdle people have to get over to get onto pump therapy. It's definitely coming down as we provide these devices that have great therapeutic outcomes as well as they're easy to use. That's the direction we have to continue to go in.
All right. We've hit our limit here. Thank you all. The breakout is downstairs, and I think Amirante one. Thank you.