Thank you for the instruction. You can call me whatever name you want. I'll be happy. Because Jeffrey's our first time here in my nine years, I kind of give a little bit of background on MannKind as we dig into the slides. For those online, listening in, when we think about MannKind, it's really got five pillars of strength that we look at. Number one, Tyvaso DPI is a foundation of the company in terms of valuation and downside protection, with the upside optionality, obviously, with the new data readouts they have coming up. We're excited about the continued partnership there. Afrezza is an asset that founded the company a long time. It's really well known for the inhaled insulin space. It's still here.
We've slow-walked the growth of Afrezza while we waited for new data readouts over the last couple of years. That, all that work has finally come to fruition. We're finally at the end of that stage where it's now about how do you scale Afrezza growth as we go forward into Q4 and beyond. We'll be getting ready for that FDA filing for pediatrics. I'll talk about that in a short minute. On the balance sheet side, as we've had excess capital, we started paying down the debts and reduced the risk of the company. When you look back in history, debt was one of the problems we faced in a dramatic way. We've paid over $250 million in debt down. We have $35 million remaining on the balance sheet and convert.
We have a nice upside optionality here around Clofazimine Dry Powder Inhalation that I'll talk about today and give you some update on the trial progress and the tentative DPI and where that's going. When you think about the company, when I got here in 2016, we were pretty much zero revenue. We were getting a product back from a failed launch. We've done a very good job at fixing the balance sheet, getting new data sets read out, and kind of getting the growth going. Obviously, this was through a lot of our partnership with United Therapeutics as well as purchasing Vigo. On Q1 highlights, the diabetes revenue, we saw 20% NRX growth. A lot of questions I get around why wasn't it year over year, better.
That really had something to do with gross to nets from last year when we had like nine years of accumulated gross to nets on the books for returns that we kind of had to make some adjustments for. On Afrezza, we expect a label change here in Q4. That, I'll share with you around why that's important. Pediatric data, we just finished up our meeting with the FDA. Things went really well. We'll be filing that here likely in late June, early July. That should set us up for hopefully an approval next year for pediatrics right before ADA. On the pipeline, Tyvaso's doing great. Clofazimine's hitting our enrollment targets slightly ahead of schedule, but we're sticking to our year-end guidance. On the tentative, we're advancing that in the second half. We're just finalizing the CRO selection.
We feel pretty good and excited about moving that forward later this year. Financially, we had cash equivalents of almost $200 million. A lot of people ask me, what is unique about our platform as there's a lot of noise in the dry powder space these days? It's really about the Technosphere delivery particles as the excipient that we have. It's the device platform we have, the scalability of manufacturing. All that really does is really make sure that the drug gets deep delivered into the lung in a consistent way. Even when you have infections, we still get the particles into the lung. Wherever you see airflow, you'll generally see our particles flow with FDKP and the novel product attached to it. As we get to diabetes, obviously, this is an area we've been very familiar with. It's become competitive with insulin pumps.
Afrezza's got a broad indication in type 1 and type 2 diabetes. We mainly focus on the type 1 space as we go forward. About half our business does become type 2. One of the things with Afrezza is you don't have to guess when you're going to eat or how much carbs you're having. You really just have a fixed dose, and you modify that based on how much you think you're going to eat. You don't have to guess the timing of that. As we've continued to progress this program, we look out over the next couple of years, we've kind of got a multi-year platform of growth opportunity here. Number one is the adults and the label change we expect in Q4. We're getting ready for that as we speak.
The second part, a leg up here, will be pediatric approval, which we're anticipating hopefully Q2 next year. Then gestational came out of some of the work we were doing because we, some of the doctors who, who treat gestational diabetes saw our postprandial control in our first dose. They said, "That's such tight control. That's exactly what we want for pregnant women. Why aren't we using this drug there?" We worked this past year to get some pregnancy data published. We had five case patient series just get published, in PD in the Pregnancy Journal. We're now doing a single dose study with the investigators to show that the PKPD looks similar in pregnant women. There is a trial ongoing that Afrezza will be an option for. We'll provide free drug for it in pregnancy and using CGM.
We're excited about this multi-year opportunity that we look for growth. We look back here in the middle of 2016. That's when I arrived. There were only two major studies presented, which were Affinity 1 and Affinity 2. And a lot of our data was not published. You can see now all the new data in the blue that's been presented and published in various places and the various clinical studies that we've generated, really trying to help understand what we didn't quite understand in the development of Afrezza, which was how do you properly dose this drug? You're not counting carbs. You're not doing insulin sensitivity. Do you really need an insulin pump? And so a lot of our work has been around either switching off insulin pumps, adding it to insulin pumps, or showing that better dosing gets you better control without increased hypos.
All this work has cumulated now to two label changes that we expect over the next 12 months. This was one of the pivotal, I'll say, high-risk trials we took a bet on, which was INHALE- 3. This trial enrolled in record time in about 20 centers in the U.S. These are top-tier centers, like Joslin for diabetes and some other great ones you guys would know about. We went head-to-head against usual care. For years, I've been trying to do a pump switch trial. Many thought leaders in diabetes said, "I am not going to stand on stage and say you should be switching off an insulin pump when that's all we've been pushing for 20 years. That's what your founder built." I said, "Yes, but I'm not sure the data on these pumps is that great. It's single-arm trials, not well-controlled.
We really wanted to show that you could really get off the technology and simplify your life. We took a big bet here. At the end, everybody would get Afrezza. About half the patients were coming off pumps, half the patients were coming off MDI. There are a couple of key learnings here. Number one, when we look at the percent of people that got less than seven. When you think about it, we allowed about 25% of the people in the trial to come in at goal, but 75% were not. You can see whether you're on multiple daily injections, we got twice as many people to goal. If you're on AID systems, which is perceived to be the best standard of care, we got twice as many people that were on AID to goal.
Whether you're coming off injectable insulin or pumps or pods, we don't really care. We've shown that we can get more people to control without increasing hypoglycemia or safety. We did this study especially because kids, about 60%-70% of the time, are going to go on insulin pumps. If we really want to have a pediatric launch opportunity, we had to show that, hey, there's an opportunity here. Patients should have a choice. Parents are paying $3,000-$4,000 for a pump contract. Why not try Afrezza first and then think about technology second? Many times these kids don't want to be attached to things. They're running around. They're very active. In the INHALE- 3 data has not been wide, sorry, INHALE- 1 has not been widely shared.
We'll be sharing a little bit at ADA, but there'll be a fall conference where we'll share more of the data. The top-line data has been released, so there shouldn't be any dramatic surprises. It was a non-inferiority trial. It did slightly miss the primary, mainly because one patient was an outlier. We've disclosed that with the FDA. We don't think that's a hold-up to the approval, because they weren't taking their drug, and that was well-documented throughout the trial. Otherwise, you take that away, the variability and the non-inferiority are met in that scenario. This is the data that we are not using yet publicly in our promotional activities, but this was just presented back in March. What this shows you is injectable insulin is the red line.
Whether you're delivering that through a pod or rapid-acting injectable insulin, you can see your sugars are not coming down for the first 90 - 120 minutes. The blue line is Afrezza adults, and the green line is pediatrics. You are seeing a very similar postprandial control in kids or adults. In fact, kids are, you know, slightly better. This is really showing you that converting the patients at a higher dose right up front gives you tighter control. They are not going low, and therefore they should be discharged on a better dose than we give them historically. Historically, the number one problem with Afrezza for me is they underdose the patient. They do not titrate up fast enough, and they are just not getting great control.
That's, that's when you look at the trial, you see that in doctors just not following our titration. We know if you titrate properly, use the drug, you can get better results than you're doing today. This is important. This is also the kind of data we generated in the blue and green line where the gestational doctor said, "Hey, we really do not want pregnant women going above 120, 140. This really tight time and range, tight time and control. You can get there with Afrezza. You cannot get there with injectable insulin." This is what precipitated the interest in gestational. We're excited about this. This is our label change we have submitted. It's really about a better conversion up front. It's hard. This was the first dose we did in the office.
In order to use this data, we need that label change coming up in the fall. People ask me, what does pediatrics really mean? We believe this is the pivotal part of the brand for a relaunch strategy in that, you know, the doctors are more progressive in kids, the parents are active, and the kids are on social media. As you can start to see, awareness and trial pick up. There are only 40 centers in the U.S. that treat the majority of the patients. It is a very small community. There are a lot of camps. There is a lot of kid interaction. We did some research here, and we have not done this post our INHALE- 3 data coming out.
In terms of where, where they were pre-pump switch data coming out, about 28% said they would come from MDI and 14% from pumps. You can discount this back 50%. As we know, doctors always overstate what they will do. We see about $150 million for every 10% share. We'll do about $75 million this year in Afrezza sales. It kind of sees that Afrezza in the near term, we think get to a $200-$300 million run rate and continue to grow from there. We pile that on top of what we're doing and the other upsides in the pipeline. We feel very good about investment thesis here. For those of you who don't know, Tyvaso DPI is manufactured by MannKind. We licensed this to United Therapeutics in 2018. It's been off to a phenomenal start.
We're very happy with the success they've had. Obviously, nice royalty growth, nice year-over-year growth. There's a Teton 2 study readout in the second half that we're waiting on. That, to me, is not quite built into our stock. If that comes out, we've built manufacturing capacity expansion to accommodate that future growth of Tyvaso in this population. The next big program is NTM. For those of you who don't know, Nontuberculous Mycobacteria, it's a really tough disease. It impacts about 100,000 in the U.S. and 100,000 in Japan. It's really, I'll say, only in those two countries. There's a little bit in Australia, South Korea. In terms of the market, it's really those two markets. Unfortunately, a lot of assets have failed. There's really nothing in development besides us and Arikayce. You know, it's a complex disease.
There's a lot of patients who don't have a lot of options. We look at Arikayce. We continue to watch that one. We're very happy to see them continue to succeed in Japan and the U.S. They launched during COVID, during a really tough time. You know, we look at this market as a billion-dollar market with two players, more than enough business for both to help these patients. I can tell you Japan is about a $100 million run rate this year with them. I can tell you from our trial side, we are seeing a really nice enrollment in Japan, very clean patients, and really good investigators. That is off to a great start.
Probably by the next month or two, we'll have hit our minimum patient requirement for Japan in order to file once we get the final study done. People ask, why 101? Why Clofazimine? Clofazimine we know works in NTM. It's an older drug, but the oral formulation has three problems. It has QT prolongation. It has skin discoloration, and it has organ accumulation, three things you really don't want. By moving it to an inhaled dose and cutting it down, we can really get to a dose that we think eliminates those three risk factors. The other thing it has is a 28-day half-life. Sorry, about an 80-day half-life. We can dose it for 28 days and then come off treatment for a few months.
When we did our in vitro studies, you can see a reduction in the nebulized form really does, versus oral clofazimine, reduce the bacteria in vitro. Then we ran some animal studies in terms of dosing. We confirmed this in our human that they correlated. You see about an 80-day half-life. You give the drug for 28 days, and then we back off for two months, and then you go back again. It really has deep lung penetration and consistent duration of activity, even though you're not nebulizing it every single day. This led us to a trial design of 28 days on, two months off, 28 days on. Generally, it'll be two cycles for patients to see if they're responding. They'll probably take a third cycle while they wait for the negative sputums to come back.
This is an area that we think is a competitive advantage in terms of frequency and dosing, cleaning and nebulizer. We really differentiate versus the drug that's out there today. It's a co-primary endpoint for the U.S. of sputum and patient report outcome. We've scaled the trial and the interim analysis that we'll get to next year, roughly in Q3. That interim analysis will be skewed towards sputum culture as opposed to PRO. Both will be important, but the PRO could have a lot of variability that we don't think is worth the effort, but we'd have to do that for the FDA. Most of our sites are now activated. There's a couple of stragglers. We got two more waiting on the U.S. that are important sites.
The last couple of U.S. sites that became active are some of the largest NTM centers in the country. They took a little longer, but they're now coming on board in the next couple of weeks here. We're excited about the continued enrollment. This drug will have about 12 years of exclusivity for orphan protection as well as QIDP and fast-track designation. The interim analysis is based on evaluable patients. We're allowing people to come into the trial who may have had a sputum that was positive in the last three months, but we have to do another one. It takes eight weeks to get that result. We may find out eight weeks into the trial they mysteriously cleared the infection, and therefore they're not going to qualify for efficacy, but they'll qualify for safety.
By that time, those patients will have had their first, first month, and we'll watch what happens. This is the first time we're sharing enrollment details. The yellow line was our internal target we laid out for. You can see last year as we were activating sites, not a lot of activity in the first, in the second half. As you look in Q1 and Q2, we've really accelerated enrollment, and we're ahead of schedule. We feel very good about our projected. We were conservative here in June. We know there's already 10 patient screenings scheduled, and, you know, we should hopefully hit that number more for the month of June and go forward. We'll keep pushing this as more and more U.S. sites are coming back from ATS. We had a lot of good meetings there.
Hopefully, this will continue to accelerate. If we can pull this forward by a month or two, it'll just give us an interim analysis a little bit faster next year. That interim analysis, a question I get is, is it going to be for futility? It will. We'll have a futility analysis. If patients aren't responding at that point, we will not move forward. We believe the trial scaled up for 90% power with 180 patients. On 201, it's our IPF asset. For those who don't know IPF, there's only two drugs approved. It's a very tough disease. You know, 20-25% of people are only on the drugs, meaning 75% of people generally can't tolerate it, and they'd rather die than take the treatment.
We find this to be an awful outcome for patients when you're given a death sentence. We started developing a DPI back in 2019, and we felt that this was a real opportunity to differentiate the product from a GI side effect and really target the lung-delivered dose. We now have gotten this through development. We completed our phase one data last year. We moved this into a phase two. We met with the FDA in April. Long story short, we're now moving this forward in ex-U.S. mainly, because the FDA really believes you need to add on to background therapy and have placebo. We do not think any IRB is going to approve a 30-week study in IR, you know, for patients to have a placebo-controlled trial when you're at risk of dying.
We do believe in the ex- U.S. , we can get that enrolled. We've kind of done some feasibility with some of the CROs. We are looking at about 150 patients in the study, a four-arm trial with two different doses. It will look at 12 weeks of efficacy. We think that's a reasonable time point to see some separation. We will allow, if they're on Pirfenidone, if they had treatment experience to Nintedanib, but not currently taking it, or naive patients. We know in these countries, it takes about 12 weeks to get access to the standard of care. We feel like it's an ethical place to run a study where you can study patients in a naive way and/or on placebo and allow them to still have access to standard of care.
By then, hopefully, Tyvaso's DPI has positive readouts or BI's drug is launching, and the, you, the FDA wants you on general background therapy. You know, we can study it if there's three or four options. When Nintedanib is 80-90% of the market, it's hard to study on top of that when that's not a reasonable approach. We expect to come, we will submit the phase two for the U.S., and we'll open up sites if the FDA allows us. If not, we'll come back for phase three. We, by then, will have the data the FDA is looking for. Financial updates. As a company, Q1, we had a good 18% revenue growth year over year. You can see our royalties were up 32%. We think Tyvaso should continue to be strong as far as we can see.
Yes, there's other launches coming, but there's more than enough business for people that ILD is severely under penetrated. I think that market will continue to grow. Afrezza sales here on endocrine on the bottom, you can see we had $15 million in Q1, not a big growth over last year, but there was about a $2 million gross to net. If you really compared $12 million to $15 million, you see that growing. We're not investing to leapfrog Afrezza growth. I think that's important. As we get to Q4 and the label change, you'll start to see that change. Right now, we're continuing to maintain our $7-$10 million growth rates that we've had historically. Collaboration and service revenue is mostly manufacturing. That will fluctuate quarter to quarter.
We had a lot of production in Q1. We may not have as much in Q2. We may have more in Q3. Depending on when we make Afrezza, when we make Tyvaso, those two things will shift quarter to quarter. In general, great quarter. I'd say you're going to see the collaboration and service revenue not continue to grow in step with the royalty revenue, not because things are slowing down, but because we have efficiencies and scale in the factory. At this point, as royalties keep growing, the factory is more and more efficient. We've built a lot of redundancies and scale-up activity. We're finally seeing that payoff this year. On Catalyst, I think I walked through a lot of these as we get to the second half, where we just got approval for India.
We just got the last step in that process. We'll be manufacturing that here in the second half and launching that there. We're excited to help. There's about 80 million people in India who have an average A1C of 10. INHALE-1 is the pediatrics. We'll wait for that acceptance in, in the fall. INHALE-3 label changes also in the fall. In 101, study enrollment, we expect to meet our target by the year end. We see nothing slowing us down. We just came back from a Japan tour. Those investigators started strong. We were a little worried. Is that a bolus of patients or are we going to continue? We believe that will continue. In 201, we expect to initiate in the second half. We'll be making clinical supplies and placebo and getting all that ready.
DPI, we're waiting for UT's readout because then there'll be some bridging work that has to get done. As we look to building value for shareholders, we've really built this over many, my nine years here. We always had a vision that DPI would fund the pipeline and fund the growth. Tyvaso has continued to do strong. For roughly every 10,000 patients covered, we expect $300 million-$350 million revenue to MannKind. We do have a milestone payment to the upside if Teton one and two were to read out. If sales accelerated a little bit, you could see us getting a $50 million milestone from the royalty deal we did last year. If not, we have a second chance in 2027.
If that still does not work out, we get a royalty cap, and then that 1% will come back to us. We will continue to be watching DPI closely. Endocrine-wise, every 10% share in kids is about $150 million in net revenue. We think that is a reasonable low bar to hit. We think there is more than enough opportunity. The average kids' A1C is about 8.3-8.6. They are not doing well. It is a bad way to start life with living with diabetes. We really think we can help kids have a better option. The label change international are all upsides, growth for Afrezza. For 101, for every 1,000 patients in NTM, it is going to be about $100,000 a year. Think about that price point. That gets you to about $100 million in revenue.
There is more than enough patients for those companies. We are starting out in a refractory population. We fully expect to bring a dry powder clofazimine. I just approved that yesterday to move forward. We will be moving that in the second half, through animal studies and then in the humans in 2026 and 2027. We will keep you posted there. We do know a dry powder will help us penetrate earlier lines of treatment in NTM. That will be important. OFEV, we do not even talk about how big that could be. It is a huge unmet need. If we get through phase two, we will all be really happy. It is a population that really has no options. We are hopeful that we will be able to help them progress. Thank you for your time today. Thank you for attending.
I'll, any questions, I'm happy to take. For Clofazimine, what would be a bridging study for 201?
Okay. Excuse me. Sorry. Sorry. He's correct.
That'll be up to UT in terms of their negotiations with the FDA. We don't want to comment that they've said that they would do the bridging study work that has to get done, but they're going to wait for the Teton to read out, and then they'll go
. Simultaneous then.
Yeah. I think they've commented they expect it to be a breeze-like study, which was around 40 patients, safety and tolerability. Others? Thank you again. I look forward to hopefully seeing many of your shareholders and continue to progress the company as we go forward. Thank you.