Hi, everyone. I'm Steve Lichtman, Medical Devices Analyst at Oppenheimer. Welcome to the 2024 Oppenheimer Mid-Tech and Services Healthcare Conference. Very happy to have with us. Up next, MannKind Corporation. With us today is Michael Castagna, MannKind's CEO. Mike will have a presentation. We should have some time for Q&A at the end. So if you have a question, just key it in, and I will get it over to Mike. But with that, happy to turn the microphone over to Mike Castagna.
Good morning, Steve, and thank you so much for having us today. I really appreciate the opportunity to be here. So today we'll be sharing some forward-looking statements. This is our forward-looking cautionary statement. So for those who don't know, MannKind are new to this story. Our mission is to give control people control their health and the freedom to live life. And when you think about our technology or where we're going with Tyvaso DPI, we really do free up people either from using a nebulizer full-time or, you know, full-time worrying about their sugars, or in the case of or going with NTM, right? These people relegated to their house having to be very sick and can't get out. So really exciting time here at MannKind.
We are focused on two therapeutic areas, endocrine, which is our historical diabetes franchise, as well as we're pivoted in 2018 and 2019 to orphan lung, where we've been investing in the pipeline over the last six years. We're not limited by our technology, Steve. I think it's one of those things that, you know, our founder, Al Mann, built an incredible lung delivery platform, but we know not every target, not every drug is always going to work within the platform. So we always keep an open mind, either other platforms or in the case of, clofazimine. We bought that. It was fast to stay on the nebulized version and do lifecycle management to a dry powder over time. So that, that's where we're going.
And when you look at the technology, you know, we're very fortunate as MannKind not to have one drug approved by the FDA, but two. There's very few dry powder platforms that survived over the last 30 years, and we feel very good about the differentiation and the delivery of the product across that lung, really giving deep lung penetration, as many people may not realize, and I didn't realize this as a pharmacist. You know, one dry powder is, in most cases, aren't that very different. They lose 60% to 70% of the drug on the way down to the lung, and it's mostly stuck in the upper airway. But if I was to show you a picture of what other powders look like. In our case, the FDKP is really the secret sauce here.
That allows the molecule to bind, deliver deep lung penetration, and consistent across the lung, and that's really what you see here in these visuals of TI. And the reason we believe this can be extrapolated is 99% of the case in a powder is FDKP in the case of Tyvaso DPI, and the case of Afrezza, it's 90% as well as the Technosphere. So those are all really important aspects of the powders as they get delivered. As a company, we've really had a tremendous transformation over the last eight quarters, and you can see our endocrine business has continued to grow.
Our manufacturing, you've seen here in the gray bars, has continued to grow, and our royalties have continued to grow with continued conversion from Tyvaso nebulizer to Tyvaso DPI, in addition to the new patients and, you know, approached almost $200 million last year. We were literally $1 million short from $200 million. But you can see Q4, we exited at $58 million, putting us on a roughly run rate of $240 million this year, if we look at 2024. When you think about the company, we've had a lot of great things happening. Afrezza, obviously, has been approved, and, you know, we've kind of minimized investments behind Afrezza in order to fund the pipeline over the last six years.
But we've kind of had to generate some new data on Afrezza, and that's really what our focus has been. I'll talk a little bit about that today because all that fruition of work is coming to deliver this year. So we're super excited about that. India had a clinical review with their equivalent of FDA last week, so we're awaiting the output there, which will happen hopefully shortly. And then you got pediatric, which we announced that trial completed enrollment in February and call it September, six months later, we'll have full primary results in Q4 by the time they clean up the database and analyze that.
And then we purchased V-Go almost two years ago, and that's been a nice little jump up in our ability to serve another population with another target audience that we didn't typically get adoption from Afrezza in diabetes. And so now when you look at our target audience with our sales force footprint, we have about 4,000 prescribers across both products that we find to be important. And we bridge over to the pipeline, Tyvaso DPI, I'll talk about in a second, as well as 101 and 201. So let me just start on Afrezza, Steve. I mean, this is where you and I met years ago, and this has been a building story. Obviously, I sit here eight years later, and I look at the marketplace and say, Omnipods continue to grow, Medtronic's grown, Tandem's grown.
CGM penetration has been incredible, but these have all taken decades in the making. And, you know, whether it's Omnipod starting to launch in kids and go into adults, CGM starting in kids and goes into adults, or Al Mann's pumps, starting kids who went into adults. We always believed pediatric was the pathway to transforming the standard of care. And we think that's critical, and even GLPs have been around 20 years before we hear about the craze we had this past year or two. So, you know, we've stood the test of time. We've improved our managed care coverage. It's now $35 for Medicare by statute, and we've lowered our commercial copay to $35 as well. We buy that down. And we've shown in small studies, improvement in time in range, right?
That's really one of the key things here as we look at these trials. We invested in 2 trials over the last several years. INHALE-1 started. We started probably five, six years ago when we were doing the part one study, and then part two was the trial you see today. It took us 2.5 years to get the first 30 patients to show that PK was the same, and then it took us another 2.5 years to get the next 300 patients. So I think the team has done a really nice job on INHALE-1, and we specifically wanted U.S. thought leaders. There's about 50 pediatric sites in the U.S. that make a difference, and we had 40 of them in this trial.
So it's really important as we thought about the standard of care, the clinical experience and the publication of that data, that it was U.S. experts and U.S. thought leaders that really get that going. On INHALE-3, we knew - was against multiple daily injections, and indirectly, the competition in kids is pumps and pods. And so we started INHALE-3 in adults because we couldn't—I wanted to have that data available at the time we get the kids' readout. I wanted to show what happens when you're on an insulin pump as well as MDI. And so we did an adult switch study, which is probably one of the largest switch studies done in reversing the trend of everyone going towards AID. We're the lone wolf, I'll say, in this scenario, where everyone has been focused on AID and proven AID.
We're going against that strategy and really showing you that our new conversion dose upfront, as consistent with the PE study, can deliver consistent glucose control over 17 weeks. And that's really important. And I'll just share with you today what we just shared over the weekend, is that very first dose, what happens. And so our goal here is really to show equivalency. We've already known we're as good as MDI, but the question is, are you as good as an AID pump? And that's really the setup that we've been going for. And we know not everyone's gonna tolerate a dry powder. We've seen 10% to 20% dropout rates in our various trials, but for the other 80%, you know, this is a real treatment option for those patients.
And there's a figure one in our package insert that we're looking to update that really shows a better conversion up front. And this was the data just released on Friday from ATTD in Europe last week. And this really showed you that the very first dose, postprandial glucose excursion, was reduced by 20%. Now, mind you, we let 25% of the patients in this trial were already at goal. So as we start to get the sub-analysis, you may not see the same delta that we've seen over time as you see in this chart. You may not recall, but last year, we did a study called ABC, and in that trial, we showed head-to-head a greater delta, and that was against AID or adding Afrezza to AID, but those patients' A1Cs were much higher.
In this particular scenario, we had 25% of the patients were much higher control, and we still saw a nice delta, whether it's on MDI or AID. And obviously, the augmented pumps have a head start with the way they mini dose insulin, so you won't see that as great of an effect, but you still saw a faster achievement of time in range in control here in the first 120 minutes. I think what's nice here is you can see where people came from, from AID systems were a majority of them, as well as MDI, and those AID systems were Tandem and Omnipod 5 for the most part. So we're seeing those patients that wanna be detached, or not have to be tethered to a pump all day, be the ones joining.
People ask me, "You know, why, why do we still believe Afrezza has a chance?" And I think that's a really good question. We're gonna take prudent capital investments around these decisions, but the very first step is INHALE-3, the readout that will be shown in June. And here, that's really the type 1 population, and we have taken a calculated approach here with INHALE-3 results, hopefully coming out positive. We got a 90-minute clinical update at ADA on the symposium starting Saturday, 8 A.M. That's not happening for inhaled insulin since Exubera in 2006. So we're super excited about the prominence it's gonna get. We got seven top thought leaders presenting the data. It's 10 minutes each presenter, and that's really a great opportunity. It's not a paid sponsorship. This is clinical data dissemination via the top thought leaders.
And then you bridge on later this year, we'll get INHALE-1. We'll showcase that data next year and hopefully file that with the FDA for pediatric expansion. And then what happened recently, which was amazing, is ATTD. I couldn't stop conversations. I was there for two days, and I had nonstop conversations morning, day, night with the top thought leaders. And two of the groups was around exercise-induced hypoglycemia and hyperglycemia, excuse me. And there's a study that's gonna be coming out where I think they're gonna use Afrezza as one of the arms in that trial. And then the other area was gestational diabetes.
As people saw this first dose data that I just shared with you, prior to being public, they really felt this tight control you're looking for in gestational diabetes, that Afrezza is a real treatment option that needs to get more prominence. And so there's also a gestational diabetes trials kicking off later this year that we're hoping to be part of for making Afrezza available. So we think as you look at the future, these are large TAM markets, that build upon each other and really show you the safety and the efficacy of the product across these various populations. I'm gonna bridge over to Orphan Lung. First is really our Tyvaso product. I won't go too much into detail here, but we're just happy to see a really strong start to this product.
It's approaching $1 billion annually by United, which will translate to about a 10% royalty to MannKind, plus manufacturing. The reason this is important is it really lays the foundation for our pipeline. When you think about, you know, can you deliver a dry powder? Is it tolerable? Can people titrate? These are all the questions you get as you think about, you know, not a lot of dry powders in orphan lung disease. We felt very strongly that our, our technology, we know, delivers the right product at the right dose, at the right frequency. And we saw that in our original studies we did with Afrezza, where people who had COPD or asthma, you know, we did some poorly designed trials, but they still got proper drug absorption. Those are bronchoreactive airway diseases.
In the case of Tyvaso and IPF, these are remodeling lung diseases, right? These aren't bronchoreactive airway. And so we were happy to see Tyvaso DPI have linear PK/PD as we went up to the highest doses, and we believe we'll see the same effect as we look at IPF. So there are three areas we're going after. It's NTM, nontuberculous mycobacterium. These are devastating disease. It's prevalent in the U.S. and Japan, Asia-Pacific. It's IPF, which, you know, you have an 80% chance of dying within the first five years of diagnosis, as well as cystic fibrosis with our poloxamine 301. So I'm just gonna double-click on two of these. One, NTM, we are so excited about this area. We, you know, we bought this product in 2020, if I recall, December.
You know, we have been working on this and doing the tox data, the dosing data, the nebulization, you know, equivalents that we had to, we moved to a jet nebulizer. What you see is this disease just continues to grow with a huge unmet need. When you look at, you know, by 2030, you're talking almost 500,000 people in the world, split really U.S. versus Japan, where the predominant market is. So as we can see, in our case, launched in Japan, it's doing very well. It's doing very well in the U.S., and we're super excited because the better that is, it's paving the way for increased diagnosis, increased treatment, and increased penetration in this market, in a really unserved way. So when we looked at clofazimine, it's an antibiotic.
We know it works, we know the dose, and we know it kills the bug, and I think this is really the first dataset that was generated by the product. But when we do due diligence, which really shows you the bacterial recovery with 101 versus saline control or oral clofazimine, was significantly reduced. And we really felt, it's well known that clofazimine works in NTM. So we didn't have a real question of whether this drug works. Our question was: Could we deliver it in the right dose? Is it tolerable, and is it safe? And our tox studies, our chronic tox, panned out this past year. We got the dosing, we did the phase I study, and now we're full-blown into phase III. As you see here in our ICON1 trial, we're kicking off here next quarter.
The IND should be filed within the next 30 days, and our primary endpoint there is sputum conversion for Japan. It'll be sputum plus PRO for the U.S. So we use the same trial, same patient population, two different statistical plans. And what's really unique here is the dosing. This product has about a 75-day half-life, and so you load the lung up for 28 days, and then you stop for two months, and then you dose again for 28 days, and you stop for two months. You got two treatment courses in six months. That's very different in our case, which is every day, and then if, you know, congratulations, if you actually get a sputum conversion, you get another year of treatment every day for another 365 days. So this is an exhausting disease. People are tired.
They gotta clean their nebulizer. So we're really trying to minimize that dosing burden here, and we're starting with the nebulizer. We have a dry powder development with ourselves as well as other technology, and we're really just waiting for the FDA to approve our dosing for this trial. We had a high and low dose originally. We went to just a high dose because we felt ensuring adequate MIC coverage was important, and it seemed to be tolerable and safe. So we went to go to the max tolerated dose, and that's where we are. We're waiting for that, all that feedback in the next 30 to 45 days. We think this has the ability to be the second approved NTM product. Unfortunately, a competitor had a setback recently, and it really looks like we're clear.
We had a lot of clinical sites call us up and say, "Hey, can we participate in your trial? We know we've rejected you, but we have patients in the waiting." We're excited because we think once this trial gets off the ground, the clinical profile you see here is very favorable market research, and hopefully, this could go a little bit faster than we were anticipating six months ago. The next product is around IPF, and so there's a brand out there, as most people are aware of, called Ofev. Ofev is really, you know, the lifesaver of these patients, and it's done very well. We're a $4 billion market in 2022 and continues to grow. And for us, we know Ofev has severe diarrhea, and patients, unfortunately, you know, they don't wanna live with this side effect.
It's very, very severe. It's not a moderate case of diarrhea. And that really prevents people from getting the clinical effect of this product. And so we were able to cut down the dose dramatically, pretty much triangulate that dose delivered to the lung, because Ofev has about 5% bioavailability, which all that other 95% is what causes the GI. So we're hoping to really isolate that 5% that you need, put it directly in the lung, and hopefully help titrate the dose even higher, and that's really the key point that we're looking at in our study here, which is dose escalation over a couple, you know, single doses each day, and then over seven days to show you that you can tolerate the drug once a day and twice a day in higher doses.
We're really looking to make sure that there is no GI side effects and that the higher dose is tolerable. And so far, you know, the animal studies look positive, and let's hope that that translates to human, and we'll be off to the races pretty much at the end of this year, if this study reads out the way we expect. So we got some feedback from investors around 2024, and what's exciting, and for us, it's the busiest, busiest year in our eight years. We have the key product of Afrezza with all the datasets we've been building up over the last seven years, finally reading out, right? Whether that's peds, INHALE- 3, India review, these are all things we've been working towards that are finally coming out for Afrezza, and the data will drive our investment decisions.
If we feel that there's real upside here, this is a meaningful product that's FDA approved. MannKind 101, we've been working on for four years. We're really, really can't wait to get this into patients and really bring that forward. And then 201 is, can be so dramatically impacting this population who has no treatment options. The disease is liver with failure. We feel like we have a great product that has a real leg up here, that's gonna be tolerated, go forward. And then you got Tyvaso DPI, where we continue to scale manufacturing, install the new equipment, and, you know, UT is expecting to complete enrollment here of TETON- 1 and 2, which is for IPF, for treprostinil, for those that don't know.
If that happens, you know, treprostinil has a tremendous ability to scale in IPF, where I would see combination treatments evolving on top of Ofev, on top of nintedanib. This could be a huge upside to our shareholders as well. So a lot of great things happening over the next 18 months at MannKind, and that's never been a better time to be an investor, a shareholder, a patient, or an employee. So we're super excited. We look at the value drivers here, 101, just to give people some color, every 1,000 patients is $100 million in revenue, roughly net to the company annually. And obviously, there's about 100,000 today in the U.S. and about 100,000 in Japan. So tremendous upside from where we sit today.
201, I don't even put a dollar value on, because this disease has 100,000 patients, of which only 10,000-15,000 are in treatment. The large majority would rather not be treated because of the side effects of the product. So, the upside here is in the billions of dollars, and, it's just, if the drug works, it's gonna be, it's really, really exciting. In terms of DPI, you know, we try to give we can't predict what UT will do or how big the market can get, but we just say for every 10,000 patients, it's about $250 million to $300 million in revenue to MannKind between manufacturing as well as royalties. And, there's a tremendous upside with Tyvaso, as UT has talked about this, 25,000 patients.
In 2025, we're just prepared to be ready to supply that many patients if that's where it goes. Then INHALE-1 with pediatrics. So Afrezza did about $60 million last year, and, you know, the diabetes business is finally profitable, so it's no longer a drain on the company. It's throwing off cash, and it's allowed us to reinvest in the pipeline or pay down our debts, and that's what we're doing these days. But pediatrics is a new opportunity to relaunch the brand, and that's every 10% share in kids is about $150 million net to the company, and we got the clinical data coming. And then, you think about V-Go, I didn't talk a lot about. V-Go is about $20 million a year, net. Really, we're focused on improving profitability there.
There's a lot of noise coming into the pump market for type twos, and that's something we're evaluating, is does that rise all tides as V-Go have upside as we go forward? And I think we'll continue to watch that quarter to quarter. So we're firing on all cylinders. It's never been a busier time in the company, and, I just wanna thank you again for having us today and, all, investors who dialed in listening here. Happy to take, some questions in our last few minutes.
Yeah, thanks, Mike. And we did get a number of questions. Apologies if I don't get to all of them. So I guess maybe first on INHALE-3, you know, are those results and the results that we'll see in June, hopefully, enough to drive a change in prescription patterns and drive, you know, an inflection in share for Afrezza? And what—so what should investors be thinking about, you know, in terms of those results in June?
Yeah, I mean, you know, when I walked into ATTD on Friday, the first slide up, I walk in and, Dr. Edelman's presenting a slide on the Afrezza PK/PD. And then he said, "You know, ways to improve mealtime control, Afrezza is a key tool." It was really nice to see that. But then he talked about, you know, how do you treat type one, and he really focused on 4 insulin pumps. And so that's really the conversation we wanna change, right? We want to not just be considered an add-on or a nice to have, we want people to really consider Afrezza as an alternative to an Omnipod or a Tandem or Medtronic, not as just a nice token toy to help with high sugars every now and then.
That doesn't mean it won't be used in that, and on top of the pumps, but from a regulatory perspective, from a promotional perspective, we really wanna show that you can take Tresiba plus Afrezza, or maybe hopefully, Novo gets once-weekly basal plus Afrezza, that we can really show that people can maintain control or improve control with minimal attachments to their body, minimal disruption to their life, minimal disruption in counting carbs. I mean, I just watched several people just coming back two nights ago. You know, on an airplane, someone crashes in the back of the plane with a hypoglycemic event. I'm thinking, you know, if we got a land emergency, how much does that cost? How big of a disruption this is? We reduced the side effect of hypoglycemia by 30% to 50% from pivotal trials.
We think this is such a challenge. This is why in type 1, we spend all this time on pumps, and what we're trying to do is minimize hypoglycemia but maximize efficacy. And we think our product profile allows patients to have the luxury of both. And with CGM, it gets even better these days. You may not see the dramatic effect in hypo in the future because of CGM, but hopefully, we can show the dramatic effect of hyperglycemia, which continues to be a challenge for patients while moving A1C down. And, and so that, that's what this INHALE3 trial is gonna allow us to see, is, are you as good or better than MDI? And are you as good or better than, than pumps, whether it's hyperglycemia, time in range, or hypo?
We got lots of secondary endpoints we'll be managing, but the primary outcome is that we're no worse than, right? That we're non-inferior. And doctors have told us, "If you're as good as a pump, then why am I going through all this hassle?" And I always say, "I don't know." Right? Like, like, really, fundamentally, if you don't need-- like, other than somebody just being lazy and wanting to pump there, you still got to bolus the pump, you still got to program the pump, you still got to pay attention to the pump, you still got to transfer in your sites. People are really complaining about skin scarring. I've had several patients in Europe reach out to me to get Afrezza because they're just out of skin sites, and they have no other choice right now. They cannot get consistent absorption.
That's what people do not appreciate. After 30, 40 years of using all these pumps and CGM now, you are getting tremendous skin scarring, and that's not something a pediatric endocrinologist thinks about. These are real issues that are starting to come up now, that we think inhaled insulin has a real value proposition in the future in type 1.
How do you think that this data can make its way out, you know, into the community? And that's something, you know, some people have had questions on in terms of how it can sort of shift practice. Will the, the fact that it's, you know, I guess, highlighted, as you just mentioned, that a big symposium at ADA, how, how do you leverage that, you know, coming out and really getting the word out?
So I think first, the good news is we're gonna have two major data sets that will be cut 42 ways till Sunday to really show the marketplace all the ways, all the questions you're gonna have clinically and how we can answer those questions, right? Hyperglycemia, hypoglycemia, we'll do more meta-analysis of all of our data, dose-response data. So when you think about the scientific conferences over the next two, three years of publications, I think you're gonna see a lot of clinical data coming out on Afrezza in robust studies.... So that's number one, is how do you disseminate the scientific information through publications, conferences, CME, et cetera? That's number one. The second part is our sales force.
We restructured the sales force this year to put a different model in place, make sure we have good reimbursement support, we take reimbursement off the table, that we have good training, so we take training off the table, and the sales reps can go in and sell with new clinical data. That's probably the second pillar. And then the third pillar is medical, right? How is our medical team going out there and disseminating this information and working with the thought leaders? And this is, Steve, one of the first times in my history, when you go back to the company, while we did many, many trials, very few were, you know, focused on the U.S., U.S. thought leaders and U.S. sites. A lot of these trials enrolled patients outside the U.S., and therefore, you just didn't have that clinical experience in academic centers.
When you look at what we've done, we just invested in 60 trial sites across, you know what? 450 patients in these two studies, all U.S. thought leaders, all top-tier sites. And that's really when I'm sitting there at ADA and ATTD, and we got Earl Hirsch presenting, you got EDA, we got some tremendous thought leaders in diabetes seeing our data for the first time, presenting on our data for the first time, and really starting to say, "This is how I can use it here. This is how I use it here. This is what we've been waiting for." And you're, kind of, are we at that tipping point? The question is, we'll know at ATTD-ADA, right?
When we see the full data set, we could be at that tipping point where all of a sudden people are now wanting to put Afrezza in their trials, just like they were putting AID systems or just like they were putting CGM. And, these conversations I had at ATTD remind me of where we were at CGM eight years ago, right? Can I use it in gestational? Can I use it in hospital setting in COVID? Can I use it on top of the pump? Can I use it in type two? You know, CGM is getting adopted everywhere, and now there's more prescriptions for CGM than there is insulin in a given month. And, we feel like Afrezza could finally be at that precipice where it's gonna get, wide, wide support. And then the question is the guidelines.
Can you get the guidelines updated with the new published data? That's gonna be important. We spoke to ADA about ensuring the guidelines are properly highlighting Afrezza. Now that we've generated so much data in the last six t seven years, how do we make sure they're aware of it?
Another question on ICON1. How long should iCON1 take to get interim analysis?
So we'll kick off the trial in June, and it'll be predominantly U.S. sites, and then later in the year, Japan sites is what we expect. And that, depending on how the enrollment goes, let's just say the earliest you'd see this is Q1 of some time, that you'd hit this 50% mark, that's gonna give us the interim analysis, and then you got to treat for six months. And so I think the earliest we'd see an interim analysis would be late next year, and then depending on what that analysis tells you, do you need more patients, or you're properly enrolled.
The good news is by the time we get to that, you know, April, May timeframe, we should have most of the sites activated and enrolling, and you'd see start, you know, probably see about 20 patients a month coming into the trial. So by the time we get to that interim analysis and sputum results, you know, you're gonna see the trial fully enrolled. And then if we had to go up a little bit, we'll keep it going a little longer, but we should be pretty much at the purview we need to have by late next year.
Someone's curious on what effect the insulin price caps have on your Afrezza business.
Yeah, that's a great question. We always think patient access is really critically important. We've worked with CMS and Medicare for two years to ensure Afrezza was covered in the $35 Medicare, and we fully support the Biden administration to bring $35 to commercial. Because unfortunately, we saw firsthand, you know, the competition blocks patient access through the rebates and PBMs. They force us to be second line. They force patients to have less sugar control. We don't think that's fair to patients, we don't think that's fair to providers. And you can see we had tremendous growth last year, and that was predominantly because of this $35 Medicare. We were able to get coverage, we were able to get people consistent access, and they weren't interrupting their treatment because of random PAs popping up all the time. And so it has not impacted us.
There's a value proposition for Afrezza. It's why we invested in the head-to-head pump trials, because at the end of the day, you know, if you can avoid people crashing their cars, landing airplanes early, 200,000 hospitalizations a year for hypo- or hyperglycemia, every one of those hospitalizations is $25,000 to $40,000. We think we reduce the healthcare cost in the system. We reduce, hopefully, the ability to use insulin pumps. These are all costs that people incur. People are spending thousands of dollars a year on pump supplies that doctors don't think about. And these are really what we look at, Steve, as critical ways to think about not just the cost of insulin, but the cost of care in type 1 diabetes.
And now on type 2, we have GLPs, which are costing $15,000 to $20,000 a year, and that value prop against Afrezza, we've shown early type 2 data with proper dosing of 1.5-1.7 A1C reduction. So we feel that, you know, if you really want to value the product in type 2s with GLPs or type 1s with all the technology, we have a good value proposition story, and that opens up the international markets for us. We look at Omnipod's success and the pumps, they're generating billions of dollars outside the U.S. I never thought that was possible eight years ago, and now when I look out, I say: "Wow, you know, markets are paying for innovation, they are paying for better care.
How do we make sure Afrezza is part of that conversation in Europe and other parts of the world?" And so I think you'll see us take a different approach globally for the product than we have historically.
We are out of time. I apologize if we didn't get to all questions. But, Mike, I really appreciate you taking the time to be with us today. Thanks, everyone, for dialing in, and I hope you have a great rest of the day.
Thank you, Steve. Appreciate it.