Knows about your story, and I think perhaps a good place to start is to give a brief introduction about the company and highlight year to date. Sure. So for those who don't know, MannKind, we've been around 33 years, public for 20 years, and it was originally founded on an inhaled insulin platform, I'll say, that Al Mann, our founder, helped create. And they spent a good chunk of time and money getting that product to market. But when I joined in 2016 and we had gotten back to product, we realized that the real value was the platform. And that was really a pivot we made in 2017 and 2018, where we funded a diversification strategy, I'll say. We either could have doubled down on insulin and kept going. But basically, we turned that business around little by little while we funded the pipeline and started growing the pipeline. At that time, we brought a product called Treprostinil in early development. We put that in the phase one. And then that turned into a deal in 2018 called S-59 Therapeutics for Tyvaso DPI, what we know today. And that was six years ago. So it seems like a long time ago, but that was the beginning of the rebranding of the company and, I'll say, retransformation. And then we decided to pivot and shut down anything that was not orphan lung related and moved our entire pipeline towards orphan lung. And that's where we are today. So I think this year, when you see the success, it's a combination of Tyvaso continuing to do well during launch. It's a combination of the data readouts that we've been investing in for years on Afrezza. And more importantly, the pipeline this year. That's really one of the conversations we pivoted with investors was we weren't getting much value up until this year with the pipeline, even though we've been investing for the last five years. Those data readouts and those milestones were really happening in 2024. And so I think, as you saw this year, the pipeline became more de-risked in terms of moving into phase two, three, in the case of clofazimine, or wrapping up phase one in the case of 201. So I know there has to be more questions about those, so I'll hold there. But as you think about the company today, there's a baseline value of the company for the royalty that we get from United Therapeutics. Then there's optionality, as you think about whether it's diabetes or the orphan lung pipeline. So we feel very good about where we are from evaluation and upside opportunities as we continue to move forward. Excellent. And perhaps, Chris, we're talking about the pipeline and the products that you or the product you have available. Can you perhaps talk about the capital commitment you have on the pipeline versus what you've got on market? Our marketed products being Afrezza and V-Go within our endocrine business unit are now profitable and have been over the last four quarters. Then, as Mike talked about, Tyvaso DPI, the combination of royalties as well as the revenues that we earn from manufacturing the product for UT really have allowed the company to be profitable and allowed us to fund our pipeline. For us, we've really been able to move the pipeline at speed without having to have any new or different financing needs. We're in a unique position. People have taken a little bit of time to kind of figure out where we are, but it's really an exciting place right now. Great. And just to touch upon the rest of the year, there are a few key catalysts left. That's unusual, and we've only got a month left. But perhaps can you outline this for everyone here and talk about the opportunity these could have? Sure. The first one, we just announced the MNKD-201 data. We're filing for an end-of-phase 1 meeting with the FDA. We're just waiting on some additional analysis on the plasma data coming in, and that'll go out. The next one will be an Afrezza label change we'll be filing as well based on the INHALE-3 data, trying to get a conversion table done for that product. The third one that we'll wrap up in this year is really the INHALE-1 readout for pediatrics. That's one that we invested a long time in, and we think it's a market expansion opportunity for Afrezza, which really would become the basis of, I'll say, an inflection point for Afrezza. That'll be important in terms of where that goes. The key question there is going to be the FDA has indicated they want 12 months of safety data. Once we see the six-month data, the next six-month readout will be called Q2 next year. If they want the full 12-month data set, we'll have it in Q2 next year. We'll file a meeting request with them based on the six months to see whether or not we can go a little bit sooner. If we can, then that'll be a 2026 event for launch one way or another if they accept the filing. We'll be anxiously waiting that data, and then that'll really set up, I think, the diabetes business as we think about 2026 and beyond. Understood. And if I look at INHALE-3, how are you going to go about maximizing that opportunity first? Yeah. For those of you who don't know what INHALE-3 was, as we looked at the Peds data in terms of the study design, we were going against multiple daily injections. And we thought in the Peds segment, when you look at the landscape, it's really automated insulin delivery pumps, the Omnipod. And so we want to generate some data in a clinical trial setting of head-to-head against AID and MDI. So we actually created INHALE-3 last January of 2023, and this year got those results. And so it was a record-setting time for the team to get that study done. And so what we were able to show is whether you're coming from what we think is the best technology out there in AID systems or multiple daily injections, that Afrezza was as good as the standard of care. And the reason that's important is we think people deserve options. And so give the patient the choice. Do you want an Omnipod? Do you want a Tandem? Do you want injections? Or do you want inhaled insulin? We're not in the choice set. And so part of the study is here to say, we at least are as good as what's out there. Let's be in the choice set for clinicians and patients. Because if you have a one out of four chance versus none, you'll take that. And then when you look at the actual data that just came in, we get twice as many people to goal than what's out there today. And if you know anyone who lives with type 1 diabetes, all they do is strive to get to goal. And so the fact that we can talk about that now is whether you're coming from MDI or pumps, we're getting more people to goal than you could otherwise. Now, on the flip side, some people did worse. And so it's obvious that our technology is not for every patient. If you were a patient who just gets the insulin delivered and it got you to an 8 A1C and you were comfortable with that, and all of a sudden you got to do something, maybe this is not the right drug for you. But to me, I don't think people want to live with an 8 A1C. They want to live with a hopefully below 7. And that's really what INHALE-3 shows you is if you want to get there, you can get there with our product. And you don't need all the attachments and skin scarring and everything else that comes with the hassle, I'll call it, of a pump or a pod for that matter. So we're excited about INHALE-3. And that data, we're just now cascading out there to customers. So this past two weeks, we've been doing evening events with different physicians around the country, starting to talk about the 72-week data. Because the 30-week data, we just released a press release for headline news that the full data set will be presented in March at ATTD. So do you think you can change people's original thoughts about the drug? Because initially, it appears that people weren't being properly dosed, right? Is there a perception that your product is just inferior and that you're just going to need more promotion that you're going to invest in to just change people's hearts and minds? Yeah. Yeah, Yeah, no, I think you're bringing up good points, which we look out there and say, why don't you use Afrezza? It comes down to a couple of things: misperception of dosing or dose accuracy, lung safety or lung function testing, and managed care reimbursement or prior authorization. So those aren't easy hurdles to overcome. And when you think about what we're doing, we're running the business for profitability. We're not running it for substantial growth. And part of that is we wanted to get the data sets out there. We wanted to see the reaction of the data sets. And if you remember in INHALE-3, we did it in 19 sites around the country, the majority of whom have never prescribed Afrezza. This was their first experience with the product. So now when you look at the subdata, you can see they didn't all basal titrate appropriately. Maybe they didn't move the mealtime doses up as much as we wanted them to, but in general, even despite those swallows, you got decent results, and so that's part of the thing. We're going to actually look to hire about eight MSLs going into next year just to cover the top academic centers and some of the guidelines committees and make sure people are aware of our new data, and really start to put to bed some of the objections out there around dosing and safety so that people know that this drug has been on the market for 10 years, and so we would find a safety signal if we were concerned about it by now, and then more importantly, we have $35 Medicare coverage now, and we've seen substantial growth in Medicare over the last two years. And so if that friction is pretty much removed on Medicare, how do we bring that to commercial and make that a little bit easier? So I think we got all the right pieces together going into 2025. How do we actually make some better impact as we execute for this year and set ourselves up? And then as we start to see the growth coming, then we can feed it faster and invest more. But I think we'll be cautious a little bit in where we're investing like MSLs in certain areas on the fringes to try to drive some of this incremental impact that we think are headwinds against us. In your comments just then on the PED side of things, have you talked to physicians about potentially your product and Peds? What's their reception been like? What's the need in the Peds? So I think when you take a step back, and I worked in growth hormone for a while, and if anyone has a kid, trying to inject your kid once a day is a nightmare. They're running away. They're screaming. They're afraid. We did everything we could to hide needles and all that stuff, but in the end, Baqsimi, if you look at nasal glucagon, has done very well in pediatrics versus Xeris, and the injection doesn't have any share in Peds, really, and so that's just an example. In the Peds market, when people have a choice, they'd rather take the nasal than the injection in a glucagon rescue setting, but we also think parents will want something that really gives them the flexibility and freedom for their children, so they're not chasing them down to change a pump set or a pod or that. So we feel that we have to be we said for every 10% market share in kids is roughly $150 million to MannKind. And the reason we took that threshold is we feel like that's got to be the threshold that we assume if we were to get the approval that we would invest to actually launch it in a bigger way to really set us on track for at least that minimum threshold. Because if you think about this year, we'll do roughly $60 million plus that, plus the incremental growth. You're getting to a $200-$300 million range here that we'd have to be convinced that Afrezza has that to launch in kids. Excellent. Okay. If we switch gears to 101, inhaled clofazimine, I think. Clofaxine? Clofazimine, refractory for refractory NTM caused by MAC, perhaps. For everyone here, can you give us an overview of MAC, the current treatments there are, and what gives you excitement going into this area? Yeah. I mean, NTM is a disease most people have never heard of. It's called nontuberculous mycobacteria. There's lots of different mycobacterium diseases, but this one is predominantly in females in humid conditions like Florida, Hawaii, Japan, and it seems to linger, meaning even if you take what the standard of care is today, which is really three generic drugs that are almost a TB-like regimen, they have severe side effects, complex dosing schedules, and they're not very tolerable, so people often drop out of treatment and don't complete, or if they do respond, they often relapse within 12 months, 18 months, so it's kind of a chronic treatment, I'll call on and off sporadically, and there's only one real drug approved for NTM today, and that's even in a refractory setting, and that's Arikayce. They've really done a nice job building up the market, helping them raise disease state awareness, and establish this market. They've also gone into Japan, US, and Europe. You're starting to see, obviously, Europe's grown a little bit, but Japan's doing very well, and US is doing very well. When I look at the footprint there in a disease, the flip side is there was two other competitors at the same time as we were running. Both of them failed this year. Now it's really just us and Arikayce as we look out there, either in front of us or behind us. We kind of have this wide open moat because our product is clearly differentiated from Arikayce in that respect. Clofazimine as a molecule is already on the guidelines. It was available as a generic to treat leprosy in the 1980s. It's actually still available in Japan, Australia, and some of these other markets. In the U.S., it's restricted access. People know the drug. They like the drug. It just has some Achilles heels around skin discoloration, which you can imagine in Asia is not very popular. QT prolongation, not good with the other drugs. Organ drug accumulation. Our thesis here was by decreasing the dose put in directly into the lungs, we would get deep lung penetration and hopefully clear this infection. The way we're dosing it is also differentiated. It's 28 days on and then 56 days off. You have two dosing cycles in six months. That becomes a competitive differentiation in addition to hopefully a burden on the patient. Because setting up a nebulizer every day, paying the copays every month is a lot. So that's kind of the profile of the product and our belief and the reason we invested in the product and where we are today in a phase 2, 3. Can you perhaps talk about some of the early PKPD data? What gives you excitement here? How do you think that translates when you get into humans? Yeah, that's a big million-dollar question I get. So I think a lot of people, because of the failures in Aerovate or AN2 Therapeutics and a couple others this year, are worried a little bit about dosing and how you calculate your dosing. And so I could say we've done a multitude of models and modeling between animal and human PK, where we're looking at the lung plasma ratios. We're looking at the durability over the seven days of dosing and the 28 days of dosing we've done in animals. And so there you can really see it has this long half-life, and that half-life carries it up, and then it comes down over the next two months. And so that we feel very good about the triangulation of that dosing. And then even in our dose selection, we decided we were going to go to a lower dose, but because of either resistance concerns of Arikayce to us, vice versa, or just not calculating it correctly, we went with the higher dose just to give us a little bit more comfort. We saw it was safe and tolerable. And so that was the comfort. We kind of put a little bit more of a cushion in the trial to make sure we weren't missing that. Hopefully, that's not the end. When we unveil that card, we hope that we don't say we underdosed. That will hopefully be one of the outcomes here. It seems like you've got an aggressive plan to move from phase one to phase three very, very quickly. Have you spoke to FDA about the design here and how are you thinking about recruitment and enrollment? Yeah. I would say the FDA has been nothing but collaborative on this asset. I mean, very, very cordial. We spent a lot of time on the blinding of the product because it's actually difficult to blind. It's an orange dye, so it's hard. And because one of the endpoints is a PRO, often that's hard to mask. And then that's why we spent a lot of time there. But the FDA is comfortable with the dosing. They agreed with our math and said it's a sponsor risk. Whereas you go to Asia and some other parts where they're only going to look at sputum conversion, not the PRO side, a lot more questions around dosing. And so we explained how we got there and the modeling and everything. And so far, they've all signed off on that today. On the cost side of things, how should we think about the costs building as this trial comes on board? Have you mentioned how much something like a phase 3 study could have cost? We have not provided guidance, so that has not been explicitly stated, but the phase three began this summer, and so we have started site initiations, and the very beginnings of enrollment have begun. Then we'll talk about 201 in a second, which is our we just wrapped up the phase one program, and then we'll go into a phase two, three later this year. You will see R&D spend tick up a little bit, but we've also had some Afrezza programs on the R&D side that are wrapping up at this point. Some trade-offs there, and it'll just be a modest bump, I think, is what the net will be as we go forward. Okay. Excellent. And 201, perhaps a very similar question about IPF, the disease, the unmet need that's there, and your excitement about the opportunity in IPF. Yeah. I mean, Afrezza and IPF, it's a death sentence. 80% of patients die within five years, and so it's a very serious condition. Only two drugs approved, and they're not very tolerable. And that was really what became our case for this one was, could you deliver the lung concentration that you're getting from the oral and bypass a lot of the GI side effects that become the rate-limiting effect for Ofev? And so we've done a lot of work on the modeling, and we were just waiting on the chronic tox data, which just came in, and that was clean. And so the reason that was so important is we know there's dose-limiting side effects of the nintedanib, and we wanted to make sure we weren't seeing any of those in our animal models via the inhaled version, and we weren't. And so when we did the phase one study, we were looking for any GI-related side effects, anything that would signal an Ofev problem. Because then if you saw anything there, you probably wouldn't move forward without some benefit, right? And so that's the benefit we expect. And then you get into the dosing. These are healthy volunteers. There's no patterns of lung function dysfunctional or anything that concerns us. So now we feel pretty good about moving that product into phase two, three. And the only thing we know the FDA would prefer a dose-ranging study to really think about looking at two doses. We've identified, I'll call it a target dose and a high dose. And the target dose will be basically matching the Ofev lung concentration. The higher dose would be hopefully, could you get a better benefit? But the phase 2 study would not be powered for efficacy. It'd really be safety and tolerability with some descriptive statistics, I'll call it efficacy. So do we run that type of study, or is it a 505(b)(2) program where you can argue, we're just going to go with our higher dose that we want to try to get better outcomes here and really just show head-to-head against Ofev what that looks like? And so some of this will be in our discussion with the FDA coming up here in hopefully Q1 next year. And the flip side, the investor community is really asking us, how do we know you're right on your dosing? Should you just do a phase 2, get that result, and be done? And then you got proof of concept and conviction. So there's no right or wrong answer on this one. It's just a matter of speed and patient life. And so if we can get there faster and hopefully extend people's lives, that'll be great. But we want to make sure the drug works at the same time. So in the phase one that you just recently disclosed, there was, is it two or three doses that you tried? We studied a single ascending dose in three different doses. The way you think about that is the first dose was our target, the target to match Ofev. The second dose we studied was hopefully to go a little bit higher than Ofev, and the third dose was even higher than that. We never intended to go to the third dose. We wanted to see where the maximum tolerability was. The good news is all three doses were tolerable in the phase 1. Then we went to a multiple ascending dose where we took the two lower doses, which were our target doses, and then we intend to go to phase 2 with, and both of those were tolerable. There was no dose-related FEV1 declines or anything that was of concern. So we feel like we have a wide open moat to go with either one or both phase two. Okay. Interesting. And you're meeting with FDA first quarter of next year. How should we think about timelines if it was for a phase if they said, look, you need to do a phase two and then subsequently a phase three, and then if you went into straight two, three? Yeah. I mean, I hope when I'm sitting here next year with you that we'll be in phase two, three somehow, right? Whatever the right format is, it'll be in alignment with FDA, and the biggest, I mean, I don't know how much people pay attention, but it's so hard to get these site contracts in place and get the cost negotiated with the budgets, and so there's probably six to 12 months of wasted time in clinical trials these days just on contract negotiations and site initiations, and so if we can design a trial that allows us to go phase two into phase three and minimize, I'll call that friction point between the two trials, that would be ideal for us. That's some of what we have proposed to the FDA is like, let us get the right data set, determine it's safe, and then just continue right into phase three so we don't lose that activation time and site initiations. Because it's going to be the same sites for phase two as phase three. Yeah. Understood. And what do you think are the points that you need to agree with FDA on to get this thing approved? What's the key things you think that you're going to have the most negotiation with FDA in? You know, I think the endpoint's pretty consistent trial to trial, so we don't think that's a negotiation. I think the one area of negotiation could be, do you really need 52 weeks of data versus or 26? All new drugs have been going, including the ones on the market, for 52 weeks of data. This is really a 505(b)(2) with a different delivery. Could you argue we know the molecule? Six months of data would give you enough of an indicator. That'll be a question we ask them. Maybe it's nine months, but can we get there a little bit faster on the trial endpoint because of the known asset? That answer may be yes and may be no, right? So that's probably the one area of negotiation we'll shoot for. Then the second area is really how do you bridge this? Is it a phase two stop and then a phase three, or can you really do a phase two rolling into a phase three? And we did this on clofazimine. We were originally a phase two, three, and then we actually decided, let's just go with one dose in the phase three. And the FDA did agree with that. In this division, I think the pulmonary division is a little more conservative. And so far they've indicated they want 52 weeks and a phase two, phase three traditional design. But that wasn't without any negotiation, no trying, no data. So I think now that we have some more data, it'll be worth a discussion point because so many assets have failed IPF that, and NTM, there's just not a lot out there for patients right now. And so people are trying, but it's very hard. So we'll see. But I don't expect, I think they'll be very collaborative in the end. Okay. Excellent. Let's switch gears to Tyvaso. So. Obviously, it continues to be a very key strategic product here. One area where I think there's a bit of confusion on the street is on manufacturing and the cost base here. And if cost keeps going up, how does that relate to the proportion of cartridges sold? So how should we think about that manufacturing going forward come 2025? I think you saw a jump up this year in our collaboration service revenue. Part of that is there's a chunk on the balance sheet that Chris could talk to around deferred revenue. But the main part of this is Danbury costs so much money to run. And so once you get past your assumed cartridge production to make more cartridges, your manufacturing revenue doesn't keep going up proportion to the royalty revenue. And that was just kind of people thought they were linked like a one-to-one or 1.5, but they're really not. Once we get past a certain volume, that actually becomes much more cost-effective for UT as well as MannKind to produce those incremental cartridges. So we think as you go forward, closing out this year, we've said this will be $20 million-$24 million. You saw Q2 was, sorry, Q3 was $21-$23 million. So I think we're getting in that range where it was 26 the first two quarters. It's come down a little bit. Part of the reason it's come down is there was some scale of revenue in the first half that we don't have in the second half. And then the second part of this will be it just becomes more efficient to make more cartridges. So I think that revenue will get a little bit better next year as we go in, but then I don't expect it to continue to ramp up proportion to sales. Okay. Straightforward. So you're studying Tyvaso in IPF, the TETON studies. I think that's how you pronounce it, TETON. They're evaluating the nebulizer, not your DPI. So perhaps can you explain why they've gone with the nebulizer and your excitement for the IPF opportunity? Yeah. I think first, and I would agree with where they are. If you go back in our development program, we switched devices in the middle of the Afrezza trial, and that caused a CRL. And so the best thing you want to do when you're spending this much money on a trial is switch the device format because it could either may impact your results or it may cause you to get CRL, and that's not really worth it. So you can easily probably do a bridging study, which I believe is UT's position here. And that bridging study, they'll work to get alignment with FDA to get that done. I'm guessing it's something like we did with the BREEZE study, which was 40-some patients switch for safety and tolerability. The good news is we have over, what, 5,000 patients taking DPI today with pH and ILD, and I'm sure some of them have COPD and comorbidities of IPF. We feel pretty good about that profile of the product for that population. I think getting TETON 1 done and hopefully getting positive outcomes will be game-changing for patients and then ultimately game-changing for both UT and MannKind as we think about DPI for that population. I wouldn't expect a difficult road to go from A to B once they get that data set. So you don't think that bridging study is going to be no complications there? Have you spoken to FDA about that? I don't want to speak on behalf of UT, but I think they're speaking later today, so I'll defer to them. Okay. Brilliant. Chris, perhaps can we catch up on where you are in terms of expanding manufacturing capacity for the DPI? I mean, obviously you've expanded into a second production site at your existing manufacturing site. So is there any numbers you can kind of give us around this expansion? I mean, the team's just made amazing progress over the last couple of years in terms of scaling up the facility. And kind of the last piece of that is some spray dryers that I expect to come online later this year. And that's the last piece of really the build-out. And from there, we feel like we can meet any demand that UT has for the product. So we're really only a few months away from being able to achieve that. So great study progress over the years, and all the hard work is kind of coming to fruition at this point. Okay. Excellent. And can we talk about the catalyst for 2025 as we exit 2024? Where should investors be looking at for potential points of inflection for you guys? You want to take that? Sure. I'll just short-short it up. I think the catalyst for next year is going to be obviously the acceptance or not of the pediatric file once we get that data set. I think the alignment with FDA on the phase two slash three for 201, the continued site activations as well as trial enrollments for 101, that one's for 25% of site activations to date will be 50% roughly by the end of the year, so continue to see how that progresses. And the good news is Australia is ending their summer around January, February, so all of a sudden that trial I think will pick up for a lot of enrollment in that part of the world, and then in the second half, you got TETON 1 and then TETON 2 reading out. I do think there's quite a few, I'll say, clinical milestones and enrollment milestones for trials that'll be key. And then we'll keep operating a tight company like we have for the last six, seven years is making sure we're not running to a profitability goal, but we like that we're independently funding our own research and being able to make choices. And so if we see opportunities to grow the company faster, we will. And you'll see, I'll say, a more focused approach on Afrezza next year. In Q4, we actually pulled back on V-Go a little bit to dedicate more energy on Afrezza, and that'll continue on into 2025. So hopefully you can see if we put a little more pressure out there in the sales and marketing angle, we can actually grow sales a little bit faster than we have. Chris, as the CFO, what are your priorities for the coming 2025? I think the one thing that I would add is we do have a convert due in March of 2026, and so we will look to resolve that in some fashion between now and then. Lots of options on the table. The company has a great balance sheet, and obviously the stock price, as you noted earlier, has performed well, which gives us lots of flexibility and optionality. So we continue to think through that, and we'll resolve that one. Excellent. And we'd love to have you here again next year. One of the things that I'm asking all of the companies that I've got on stage is come this time next year, what are the three things you have hoped to have achieved by then? And I'll put you on the hook for that and start next year. I think first, for sitting here this time next year, it'll be hopefully preparing for a 2026 launch in pediatrics. That'll be a nice milestone for Afrezza and the legacy of the company now, man. That'd make me proud if we can get there by this time next year. It won't be approved by this time, but at least on track for approval, hopefully. The second big thing for me would be clofazimine. We have an interim analysis on the first 100 patients. And so by this time next year, we're probably just about to be approaching that or maybe there, who knows, depending on how quick enrollment goes in the first half. So at a minimum, I'll say we'll be on track between roughly Q1 of 2026 to have that interim analysis. That'll tell us is the trial appropriately sized, do we go up a little bit higher, and are we ready to file in the near future? That'll be exciting for the company. Then the third one is hopefully we're enrolling MNKD-201 in patients. That'll be an exciting opportunity to help that population as well. Those are my three priorities. I don't know, Chris, do you have anything else? All right. That'll be our corporate objectives for next year. Excellent. Well, I'll lead with that at the start of next year. All right. Thank you, gentlemen. Thank you for coming. Thanks a lot. Thanks for having us. Hope you have a good rest of the day. Thank you all. Appreciate it.