Well, morning, everybody. Thanks for joining us today. I'm Sam Jones from the Morgan Stanley team, and I'm excited to have joining us today, Mike Castagna, CEO of MannKind. Before we get started, I will read a quick disclaimer. So for important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. So Mike, thanks very much for joining us again, this year at our conference. Before we dive in, could you maybe start just a little bit of background on MannKind, the evolution of the company to where you are today? Sure. Thanks for having us today, Sam. President of MannKind, the technology and origination goes back to nineteen ninety-one, so it's been about thirty-three years of a journey with a billionaire fellow named Al Mann, who then really did a lot of device innovation, and then when he made an investment, he kinda started to put together some of his companies to make what is today known as MannKind, and the company was founded to make inhaled insulin, was really the known factor for those who don't know. We met a lot of investors yesterday who were younger, who didn't know the history of the company, and it's kinda fun meeting them 'cause they're picking up the story from here forward, but you know, a lot of people don't understand the company's a very unique company. It was really built on a mission of making sure we got inhaled insulin to hopefully bring sugars under control a lot faster than we could with traditional insulins. You go through that journey, and it turns out we have a great inhaled technology platform that was never fully utilized over the years, and that's something we've really pivoted. We had a bunch of assets in development when I got here in eight years ago, but they didn't really fit a theme. And so it was like migraine and epinephrine and another one for chemotherapy, nausea, and vomiting. And so we wind up pivoting the company back in twenty nineteen to orphan lung. And so that really began the journey of the transformation to that led us to where we are today. And we still have inhaled insulin on the market. In 2018, we did a partnership with a company called United Therapeutics that brought treprostinil to patients in terms of a dry powder inhalation. Then now we have a pipeline that's really emerging this year, going into next year, of other orphan lung products. Great. Yeah, no, fantastic, and we'll, we'll definitely dive into a lot of the details around that. I guess you've made a lot of progress year to date. Are there kind of things that you would highlight particularly? Yeah, I think the big pivot this year was the pipeline. So if you think about those decisions back in 2019 to go to orphan lung, that meant we had to start then to think about what are the next generation molecules, what are the formulation, the animal models, and the dosing, which is always very hard in these situations. And so when you look this year, the fruition of all that work is really coming out, meaning we got our inhaled nintedanib, which I'm sure we'll talk about, going into first in humans. And then you have inhaled clofazimine going into phase III. So it was really an advancement of the pipeline in the humans this year that I think is our big transformation. Followed by the work we've done over the last eight years on Afrezza, in terms of really fixing the inhaled insulin program and some of the flaws that happened in development. Those readouts are happening this year as well. So it's a real exciting year. Tyvaso has done well, and you got the pipeline and in-line performance happening. Great. So yeah, maybe we start with the orphan lung portfolio and initially Tyvaso DPI. So you've had a lot of success with the program. I guess just, you know, ground us in the kind of the product, where you're approved currently, and the relationship with United. Yeah. So Tyvaso DPI was approved a little over two years ago. I can't believe that. It feels like yesterday. And it's a drug used in a disease called pulmonary hypertension, which United Therapeutics really established over twenty years ago. And the product kind of replaced the nebulizer. That was really the backbone of treatment for this disease at an earlier stage population than the late stage. And that drug has really helped those patients. When you think about it, they were trapped in their house. They were locked in a nebulizer all day and couldn't go very far. Now, with our technology and device and platform, they can really leave. They can take it with them. It just fundamentally changed their life. We could see in our trial that UT wound up doing that within three weeks, switching from nebulizer to inhaled DPI treprostinil, really made a difference for those patients. It's exciting to see our technology being widely adopted now in orphan lung. UT's done a phenomenal job. I think it's probably over five thousand patients now taking the product, so it's fun seeing a small disease, how quickly it's changed in two years. Absolutely. And maybe just touching on the technology, specifically Technosphere, kind of talk about how that's differentiated and how that translates into kind of benefits for patients. Yeah. I think that that's a great question. So one of the things you know, people don't quite appreciate, and I didn't appreciate when I got here, you know, even though I'm a pharmacist, I dispensed thousands of drugs, you think about, you know, albuterol or Advair, these are just powders going in a device, getting into the lungs. Mm-hmm. I didn't have appreciation for the technology that we have built here and the scale, which is really around a novel excipient called FDKP. So that's really what we've been really good at, is how do we formulate products around that? What FDKP is, it's a molecule that fundamentally bind with the API, and when you inhale it, we kind of pretty much know where it goes and where it gets dispersed in the lung. The platform is pretty consistent around that dispersion of equal deep lung penetration. Treprostinil is just a great example where you can see... You know, we could triple the dose of the product and not have any more side effects and get that much higher level in the body. And one of our thesis was, well, if we can really increase the dose, could we increase better outcomes? Could patients tolerate more drug than they could tolerate before? And that really turned out to be true. Like, it was really a great product, very easy to take. And so it's a two-second inhalation. Or, a four-year-old could do it. We've tested the device from four to eighty years old. And once that FDKP touches the lung, it dissociates and then it leaves the drug into the lung, and then the FDKP just gets excreted. So think about like a car carrying your passengers somewhere in the city, dropping them off, and it just goes back out. And that's what it does, and so it's been a great carrier. We know it really well, and it's, you know, we've used it on two FDA-approved products, and we got several more coming, so. Right. Yeah, and maybe kind of talk about the future of Tyvaso DPI, kind of what other indications it's expanding into, the timing of that. Yeah, I think it's exciting. I mean, United Therapeutics has invested in two trials, TETON one and two. And so what that means ultimately for MannKind shareholders is, you know, Tyvaso, on their pulmonary hypertension and ILD have done phenomenal, and has still lots of room to grow in those segments. But the TETON one and two is really a whole new indication for a disease called idiopathic pulmonary fibrosis. And that population, unfortunately, it's a death sentence. You know, if you get diagnosed today, 80% of people will be dead within five years. And those patients have two options that work a little bit. One of them, we're working on an inhaled version. But they really don't have any options, and so if this could really show those results when the trials read out, it's gonna be a phenomenal opportunity for patients. And it's usually an add-on in the trial, so you're not necessarily just replacing what's out there. You're adding on to the treatments that are working, hopefully. Fantastic. And maybe just a little bit on manufacturing. I know there's been a lot of investment on the manufacturing side. How should we think about kind of capacity going forwards, for the current indications, future indications, and kind of how you split that with United? Yeah, I mean, we United made an investment in Danbury, Connecticut, where we make all the things. And here in the company, we make our devices, we make our powders, and we fill everything there. And so that is a pretty scalable business, and the scale there is meant to be built to stay ahead of any readout. So as TETON one and two readout positive, it looks like they're gonna go for a new indication there. We'd be able to be well ahead of supplying that market. I think they also have another study called TETON PPF for another indication, so that's another 50,000 patients. So if you think about these diseases, you know, 50,000, 100,000. Well, today we're treating, you know, the entire pulmonary hypertension market's 50,000. So if UT really does get these other indications, it could really expand the portfolio that much more. And, that's a lot of the hard work we've been doing the last two years, is keeping the current manufacturing going while we establish a scaled-up facility that could really supply the market. So we don't see any issues supplying in the near term or the long term, today. That's fantastic. So maybe pivoting to the pipeline, orphan lung pipeline. You've had great momentum this year with MNKD-101 and MNKD-201, you know, getting INDs approved, initiating a phase III and phase I trial, respectively, and you've got fast track designation with 101. Maybe kind of just high level, starting with kind of how do you think about the pipeline generally, kind of balancing breadth versus, you know, focus, de-risk targets, speed of development, et cetera? The team that knows me knows every day I'm pushing for speed. So you know, how quickly can we go to help patients? Because you know, development takes a long time. I think our assets are relatively de-risked. So when we think about real novel innovation, NCEs, you know, you're taking 10-15 years to get to market. You know, in Tyvaso's case, we went from you know, phase I to pretty much ready for approval in 36 months, including manufacturing. So it was a really quick development program to go there. So when you think about clofazimine, this is a drug that was approved in the 1980s for leprosy. We picked it up in 2020. It was already worked on for 5 years before then, and we've been working on it the last 4 years to get to patients. So these are a long time coming, and we know that clofazimine works in nontuberculous mycobacterium. And so it's a you know. So the question was: Can you get the right dose? Why would you reduce the dose? Are you covering the infection that you're trying to target? And then, how do you design the trial to hopefully enroll the trial quickly and show the effect size that you're trying to demonstrate? So that to me is an exciting program. And then nintedanib, the other program, was another example of a molecule we know works, has some toxicities and tolerability issues, and could we identify a way to put it directly into the lung and treat fibrosis? Another program that I'd say is relatively de-risked, meaning we know the molecule, we know IPF is hard to treat, and we know the drug concentration we're trying to get to. So we feel very good that we got two programs with defined targets, defined molecules, and a dose range that we're trying to achieve. You know, when you think about R&D, that's not a crapshoot. That's more than a 10% probability of success, so- Right. We're excited, and we're going as quickly as we can to get those trials off the ground and get going. Great. And so maybe spending some time on 101, kind of why NTM? What does that market look like today? Yeah, I mean, I'm sure most people never heard of nontuberculous mycobacteria. It's a very rare disease. It's very concentrated in parts of the country or parts of the world. So when you think about doing a trial, usually U.S. and Europe is your first two markets. Here, it's U.S. and Japan, and so that's exciting. It'll be a global trial in nature, about 100 sites, and market is a... This infection in patients that kind of resembles tuberculosis a little bit. So it's a three-drug regimen, mostly generics, a lot of toxicity and failure and tolerability issues, and only one drug has ever been approved for NTM to date in a refractory population, and that's what we're mirroring. Kind of some of our development program is, let's go into the sickest people first, show that we can demonstrate dosing and tolerability, and then we'll move up the value chain. And we've developed a dry powder version as well. So we'll start out with a nebulizer. That was the fastest path to market for patients, and then we'll move into the dry powder version as a lifecycle management play. Great. And you're in a phase III currently. Maybe just kind of touch upon the program design. And you kind of touched upon it, but the kind of geographies that you're thinking about as well? Yeah. So and it'll be about 100 sites, and you think about really Japan is about 35 sites, roughly, U.S., about 50 sites. And the trial design, there's a few unique things that we've done. Number one, we're really loading the lung up in the first 28 days with clofazimine, and then we stop dosing 'cause it has about a 45-55 day half-life. And so you load the lung up, and then over the next two months, you're not on drug. You're just letting it come back out of the lung and out of the lung tissue, and then you dose again. So it's really two dose courses over a course of six months, which from a patient burden and what they're doing, this is gonna be a big relief to them. Then, if a patient has a positive sputum or negative sputum, I mean, we convert them. We would then follow them for another year and treat them for another year. So it's really about 18-month treatment for those that succeed. Then those that don't succeed in six months, I think we're thinking about giving them a third dose just to see how much longer is the duration that you could go. And so that's exciting. Then the other part of this trial that's unique is we're allowing co-infected patients. So there's part of NTM called MAC, and there's part of NTM called M. abscessus. And so we're allowing about 25% of the patients to have a co-infection, which has never been done, and that's because we feel like we know clofazimine works in that population. So how do we demonstrate a broader efficacy and a broader label that would help more people? Yeah. And how's enrollment going? Kind of anything you can infer from kind of enrollment to date? Yeah. Not yet. So the trial kicked off. We had our investigator meeting in June. We activated roughly 15 sites, I think, over the summer. I think it's hard to launch a trial over the summer when all the doctors are on vacation and patients are on vacation. Mm-hmm. So, I think we've got a few patients screened now, and they should be hopefully starting to roll in September here. And, you know, our goal is to get the US up and running this year, and Japan starting at towards the end of the year. So we'll give updates as we get to Q3 and Q4 earnings, because that'll be the time where we can start to see site activation, and that'll be the biggest predictor of enrollment. So that's what we're focused on right now. Great. Yeah. No, we'll definitely stay tuned on progress there. Maybe shifting over to MNKD-201, maybe just level setting, kind of give a quick overview of the program and current status there. Yeah. So 201 is Nintedanib, and that we originally went after. There were two drugs for IPF. We actually formulated both of them for dry powders, and then we didn't feel there was a need, to your point, like, how do you constrain in a resource-constrained environment, how do you develop? What are your best priorities and biggest shots on goal? So we picked nintedanib to go forward and killed pirfenidone. And the reason we did that is we felt that the drug target concentration was important. When you get to pirfenidone, it was three times a day, number one, and then a lot of powder, potentially, number two. And so we felt that this would be a differentiated product and really eliminate what we believe is one of the key side effects of the oral product in terms of diarrhea. And so we hope by lowering the dose and really putting it directly into the lung, we would eliminate the number one side effect. And that we just went into phase I, and we'll be looking for safety and tolerability. We'll be looking at PK and really making sure that people aren't experiencing that, because if, if that was to happen, then, you know, why would you bring an inhaled version of an oral pill that's the same? So we really think that's our differentiation. And then the second part we're testing is, you know, you have a target dose, and then can you dose even higher? And that's one of our thesis in this program is: Can we give a higher concentration than the drug that's approved directly into the lung to get, hopefully, better efficacy? But I don't think you have to win on efficacy. I think you have to win on safety and tolerability. So phase I will at least give us some indication. It won't be all the answers, but it'll give us a confidence between that and the chronic tox data coming in next month. Those two things, I think, will give us the confidence to go into the phase II, III, and then the FDA will be part of the process. Great. And obviously, IPF is a large market with the current commercial products, and there's a lot of assets in development as well. I guess, how do you see 201 fitting in a landscape and, you know, obviously, Tyvaso DPI, obviously, in development as well? Yeah, I think that's a great question. When you take a step back and look at disease states, especially those that are newer, I'll say, in treatments, there's only been two drugs approved in a decade for IPF. And so I go back to my HIV days and rheumatology days when you started with the first drug, and you got one or two drugs in patients, and then you added the third drug, and then you added the fourth drug. And I think that's where we are with IPF, is these patients have a high probability of dying. I think you'd see more people probably die than people with HIV these days with IPF. And so, given the high mortality rate, I expect a lot of people will be taking combination treatments with what's coming. I hope we... There’s a few products ahead of us in development, but the way they’ve been studied is mostly add-on to backbone. And so when I think about Nintedanib, that’s part of the backbone, and hopefully, you know, we can start to be part of that combinations of the future in terms of, you know, maybe you’re using a new novel drug from Bristol Myers or Boehringer Ingelheim, and maybe we become the part of the backbone that they would use in the future. So that’s how we see the evolution as really being a core part of all the future treatments coming out. Great. And I guess, you know, thinking about data, not necessarily, you know, what you're gonna see from the phase I, but kind of as you think about success for 201, you know, how do you think about that in terms of kind of efficacy, safety? Do you think you need to see better efficacy than the current product or, you know, you're just looking for similar efficacy and better tolerability? Yeah. I think for us, the win is similar efficacy, better tolerability, because literally one out of two people can't tolerate the side effects. And so even if the product was to go generic, you know, you got a population who just cannot even get past the first couple months here. And so they would rather literally die than take their drug, and that's a really sad outcome. So I think if we can help that population at a minimum, that's gonna be huge. And then if we can help those that are on it do a little bit better, that's a big win. Great. And you touched on the phase I, maybe just, you know, you have the phase I kind of coming out later this year. Kind of what are the next steps post that path forward? Yeah, I mean, I think the two steps here is first making sure the chronic tox shows up fine and clean. So, you know, we don't expect anything. We've studied FDKP extensively over the years, so Nintedanib was a well-known molecule. But I wanna have that data in hand to feel comfortable before we go into a larger scale trial. Phase I gonna show us tolerability and safety, and we'll get some PK, and we'll see if anybody has any diarrhea in that particular healthy volunteer study. And then maybe you can correlate dose and diarrhea. We'll find out. I mean, you know, there'll be some insights there we get in Q4. We'll wrap all that up. We're ready for manufacturing, so that... We'll wrap that up and go to the FDA for an end of phase I meeting, and then that's where the fun will begin. You know, so the FDA want, you know, two trials, or they want one trial. Can we do a phase II, three bridging trial? We feel strongly that one trial with extrapolation of indications should be acceptable for a 505(b)(2), and that, you know, it could be a gated approach of, you know, phase II to a phase III, and how does that look as one trial? Because the big work is activating all these sites, right? If I think about trial development and time-consuming tasks, it's activating sites. So if we do all that for phase II, get that enrolled quickly, and then go right into phase III, I think that would be the fastest way to help people. So that's our goal. We'll get through the FDA, and they'll help us define that protocol in the end, but that's our recommendation. Great. And obviously, you've got a lot going on with one oh one, two oh one. I guess, how should we think about the pipeline going forward in terms of kind of, you know, looking to grow that potentially or kind of... Yeah, how are you thinking? Yeah, I think that's a great question. So, a lot of people have been asking me this question this week. We picked up a R&D site up in Boston in Q3 here, and so we're excited that we were able to pick up a dedicated team that comes with that site, a newly built facility with equipment. And one of the reasons that was important to us is we've been so busy on the pipeline and dealing with Tyvaso and scale-up, that our capacity to do, you know, two, three, four more products was limited. Mm-hmm. Plus Danbury has been around a long time, so the facilities would be updated as we keep going. Where do people do work, and how do we keep balancing that as we continue to upgrade R&D? But we fully now have a nice R&D staff. We now have additional capabilities with that acquisition of that site because we were able to get the technology. The difference in that technology and our technology is it allows you to put a little bit higher drug load concentration, and so that is something that is a limitation of ours. So if you wanted to give, you know, twenty, thirty milligrams in a dose, that's a different platform, and that's one of the reasons we wanted to see, with clofazimine in particular, could you put a higher payload clofazimine to get that into one dose a day or something? You know, that'll be important. So that new site there, we expect to see more molecules going into development. You know, people don't realize we've formulated probably close to fifty products over the years. Wow! Several have been approved, several have been through phase I, and so some of that work, we're also going back and saying: "What have we done in the past that we may have just killed, either because money or resources- Mm-hmm ... that we could either bring back and move faster, or what other new ideas do we have that could help complement the orphan lung strategy that we've been building on, and there are two assets in the pipeline we haven't talked about a lot lately, and I'll let you ready to go there now, so I can wait. Yeah, yeah, yeah. So one is Pulmozyme, which was for cystic fibrosis. That was approved in the 1990s. And so that one, we formulated. It's been kind of dwelling a little bit, and that was because we just had to get through everything else to get back to that one. And so now we're gonna be going to the FDA to see if there's a path forward for that one, because what's happened in CF with, amazingly with Vertex, is these patients no longer have some of the mucus plugs. And so how do you design a trial? What's your endpoint when maybe they're not having exacerbations as much, and so you're comparing it to what? Placebo, or are you comparing it to active drug, and what's your endpoint? So that's gonna be something we'll, we'll see where the FDA is, and if we can see a quick development program there, we would explore that faster. And then we have a smaller NCE with ALK-5 inhibitor through a partner, Shipley, established years ago. So there's two other molecules that we're working on. You know, we don't hear much about them, and they're kind of at that stage where maybe we'll advance them more next year, or maybe they'll, they'll be replaced with something else. So we'll, we'll see. But anyway, we've got a lot of shots on goal, plenty to keep us busy. Yeah. Exciting times. No, absolutely. And maybe we shift away from the pipeline and kind of over to the endocrine business and Afrezza. You know, this is a different leg of the stool, I guess, compared to the orphan lung business. Maybe just start with an overview, and kind of, I guess, how you see endocrine and orphan lungs sitting together, and how that kind of gives you a good mix in the business. Yeah, that's a great question. That's actually come up again a couple of times with investors. When you think about launching products, you know, half the battle is getting the infrastructure down and supporting that infrastructure. If that's all fully loaded on one product, it often becomes a burden during that launch phase. And so the good news for us is, you know, we're doing almost $80 million in revenue this year between the endocrine business, between V-Go and Afrezza, and that gives us the ability to establish capabilities like patient trainings, reimbursement support, co-pay cards, marketing capabilities, global filings, indication expansion. So all those things that we've built up for the endocrine business now, over the last six, seven years, now can be extrapolated for the pipeline. So there'll be synergies as we go forward, getting ready for launch. We've already hired the head of marketing for the orphan lung business, but now we're really building out the endocrine team to get ready for a pediatric launch, and so when we think about the endocrine, the big thing here has been the journey we've been on of, you know, how do we fix some of the flaws in the development program of Afrezza, and that just took a long time, so this year is a pivotal moment for the endocrine business, where we'll be sitting here hopefully by the end of this, I guess, next quarter, we'll have pediatric data readout, we'll have 30-week data from INHALE-3, and the entire endocrine business should be set up for success as we go forward into 2025 and 2026. Yeah. Fantastic. And maybe spending some time on those trials, you know, maybe starting with INHALE-3. You read out data recently, and then you, as you mentioned, you have the 30-week data coming up. I guess maybe to kind of orient us on the data, what that showed, any feedback that you've had from the data today? Yeah. I mean, it's been a nice surprise, I would say, for KOLs and diabetes, because this trial was done in roughly the top 20 sites in the U.S. It's really the first time in over 10 years they've ever touched the drug, ever dosed the drug, ever had a clinical trial on the product. So when you look at ADA, we had seven world-class presenters back-to-back, releasing the INHALE-3 data, and this trial was also groundbreaking, in fact, for two reasons: one, we let people in who had A1C goal less than seven, so about 25% of the patients were already successful. So here we're testing, can you take a very successful patient and maintain that efficacy, getting them off the latest, greatest technology of AID systems and multiple daily injections, which are the gold standards of care. And then the second part of that trial was using CGM, using a new dose conversion table, and those were all critical things in the trial. So we now can see, you know, despite all the advancements in AID, you could actually get off all this technology, get away from being attached to devices, and just use basal once a day, plus Afrezza, and maintain your efficacy or improve your efficacy. So I think one of the key highlights out of this trial was showing that we can get more people to goal than the standard of care, because so many patients struggle managing their diabetes every day despite living with the disease for a long time. These are Type 1s, so they've been diagnosed probably since 10 to 12 years old, and they still aren't perfect, right? After 30 years of living with it, and, and that's really what we could see with Afrezza, is we can help give them a new tool to move more people to goal, and that's really important for control and outcomes. Great. And I guess, how do you see that translating into kind of impact with patients and payers and prescribers, and kind of adding to the growth of Afrezza? Yeah -going forwards? Yeah. When you think about the doctors, it's not just that it's inhaled, and it's a lot of perception. It's like, "Well, it's inhaled. I'm fine doing what I'm doing." Well, that's not why we spend our days trying to keep Afrezza going. It's really about improving care, and I think that's something payers struggle with, right? They're adding, you know, billions of dollars in costs over treatments, and yet we're not seeing outcomes change after 20, 30 years. And so that's really our message to payers is, "Hey, provide patient access. We can move the population more to goal on average than not." And it's not the right drug for everybody, but there is a subset of patients who can do very well, and we really want that to be there. The same thing with doctors, like, give your patients a choice, and I think that's, that's where we are today. Like, if a doctor sees a patient, they'll think about, you know, a NovoLog, a Humalog, a Fiasp. They'll think about the pumps, the pod, different pumps, but they're not actually saying, "Hey, your third option is Afrezza. Mm-hmm. And if we can just become part of one of those three options, that's, that's a night and day difference going into next year. And I think this data would help support people to say, "This is a real option for patients that we gotta start considering." And then that goes into the guidelines of, like, what do you do for ADA guidelines to make sure that Afrezza is a real option in the standards of care? And so that's all the work we've been doing now, and that data has to get published. That's probably the next big thing for us, is getting that to be a referenceable data source, so payers and guidelines can start to use that as a reference point. And then you'll have, right behind that, the INHALE-1 data- Yeah -which is kind of a mirror of the INHALE-3, so. Yeah. And I guess, how do you think about that? You've got the data coming up in Q4, I think. Kind of what are you expecting for the data there? It's against multiple daily injections, and people's A1C, which is generally a little bit higher, 'cause we didn't let people less than seven in the trial. So I think in that population, you're gonna see you know, kids are really hard to study, so I think that's first. We don't know if they took their doses. Did they eat chocolate candy bars in the closet? You know, kids have funny things that they do. But I think in general, whatever happens in our arm should happen in the control arm, so we should be excited about that result. We spent a lot of time making sure the dosing was proper in kids, and that hopefully, this is the first head-to-head trial for a label change that we'll see that could result in an updated label for Afrezza. Against MDI, that should hopefully show that this population could benefit. When you think about kids, you know, that population is where innovation has changed diabetes care. Mm-hmm. You know, if you go back in time, Al Mann built the insulin pump with the kids going into adults in the 1990s. Dexcom really started in kids and went to adults over the last ten years. And Omnipod was a great example, you know, started in kids in mid-2000s and bridged to adults with Omnipod 5, and has had a phenomenal success. So I think if you're playing the long road on this one, kids is the critical transformation. And once you start establishing yourself there, those kids turn to adults, and that really transforms the next generation standard of care. So that's what we're hoping. We'll see with Afrezza, but again, I need the data and then the indication, and then we'll feel good about the next decade for that product. Right. Maybe just touching on kind of financials, quickly. You know, you, you're profitable, year to date through June thirtieth, and strong cash position. You've done a few things earlier in the year to kind of tidy up the capital structure, did the royalty monetization. Maybe just, you know, how do you think about capital structure, and how you think about capital deployment going forwards as well? Yeah, I mean, it's amazing where the company has come. You would help me see a list of biotechs and where they were trading and the values. And when I went through that list, there was, I think, 375 companies. You You say how many of them are getting $250-$300 million in revenue? How many of them are profitable? How many of them have an FDA-approved product? And we all of a sudden, MannKind, in the last eight years, is going from the bottom 10% to the top 10% of publicly traded biotechs, less than $5 billion, I think, was that market cap. And so that's exciting for us to really see the future is so bright. We got to here despite all odds against us, and now we're profitable, and I think our job is to make sure we're great stewards of capital. So how do we maintain our success? We're not necessarily running the company to earnings per share, but we wanna make sure that we can self-fund our growth and our future and control that. And so from that perspective, you know, we have plenty of cash. We got this convertible note that's hanging out there. We wanna make sure we can pay that off if we need to, at the time it's due. And from a capital allocation and cash flow generation, I think we'll. And we should be generally cash flow positive. You know, maybe it'll bounce a quarter here and there, but I don't think it's something that we worry about every single day. It's like, how do we make sure we're growing the pipeline, growing revenue, and, rewarding shareholders and patients as we go forward? Yeah. No, fantastic. And, you know, we've touched upon a lot of stuff, you know, across the business, the pipeline, the data readouts that you've got coming up. Maybe just, you know, to close it, kind of, what are the key things that we should be focused on in the next twelve months, for MannKind? There's so many great things happening in the next twelve months. I think when you take a step back, and the stock's had a great return year to date, you kinda ask yourself, "Are we at the top or are we in the middle or at the bottom?" And I think we're in the middle, meaning the royalty sale really established a valuation for the company, and if you just take that as a basis, now you got the upside in Tyvaso IPF coming. That could be worth a lot more money. And if you think about... Let's just say IPF did work. It's likely a $1-$3 billion a year opportunity. That means MannKind could get another $100-$300 million in revenue. That's huge, right? And so that's an unknown that will come out next year, hopefully around Q3, Q4 timeframe. That's a huge upside that I know shareholders will be watching as we get to next year. That's not really built into our stock in a meaningful way. You got the pediatrics and Afrezza coming up here in Q4. You got global expansion for Afrezza, so we're expecting, hopefully to launch in India next year. We hopefully expect maybe filings in Europe and Japan and other countries. So the phase III data is gonna not allow us to bring that to more partners globally or launch it ourselves. You got the pipeline, you know, enrollment rates on clofazimine. That's gonna be a critical thing people are watching 'cause that's gonna predict the launch. The reality is, I don't think people realize clofazimine should launch within the next five years, right? So this is not in any analyst forecast. It's not in any numbers that people think about. And then if nintedanib goes into phase II/III, that could happen next year, and that could be coming out of patients going into 2026, phase II at least, so we know when the drug works. And if that works, it's also another home run. So I think we have multiple shots on goal, multiple moonshots that could leapfrog the company, and we're kind of de-risked at this point. So we feel like we're just getting started from the journey we've been on. Great. Yeah, I know. Well, congrats on all of the progress, and exciting things ahead for MannKind. Thanks very much for joining us, Mike. Thank you, Sam, and thanks for all of our employees and shareholders, getting us to where we are. It's been great. Thank you. Thank you.