MannKind Corporation (MNKD) Earnings Call Transcript & Summary

Great. Well, good 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, can you maybe start just a little bit about ground of MannKind, the evolution of the company to where you are today?

Sure. Thanks for having us today, Sam. As you know, MannKind, technology and origination goes back to 1991. So it's been about 33 years of the journey with, [indiscernible] Alfred E. Mann, who then really did a lot of device innovation. And then when he made an investment, he kind of started to put together some of those companies to make what today is 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 are younger, who didn't know the history of company, and it's kind of funding them because they're picking up the story from here forward, but a lot of people don't understand the -- the company is a very unique company. It was really built on a mission of making sure we got inhaled insulin to hopefully bring sugar 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 8 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 2019 to orphan lung. And so that really began the journey of the transformation that led us to where we are today. We still have inhaled insulin in the market. In 2018, we did a partnership with a company called United Therapeutics that brought treprostinil to patients in terms of the dry powder inhalation and then now we have a pipeline that's really emerging this year going into next year with other orphan lung products.

Great. Yes, fantastic, and 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?

Yes. I think the big pivot this year was the pipeline. So if you think about those decisions back in '19 to go to orphan lung, that meant we had to start then to start to think about what are the next generation of molecules? What are the formulation of the animal models and those things which is always very hard in these situations. And so when you look at [indiscernible] 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 clofazimine going into Phase III. So it was really an advancement of the pipeline in the humans to share that, I think is our big transformation, followed by the work we've done over the last 8 years on Afrezza in terms of really fixing the inhaled nintedanib program and some of the flows 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 yes, maybe we start with the orphan lung portfolio initially Tyvaso DPI, So you've had a lot of success of the program. I guess just ground us in kind of the product where you're approved currently in the relationship with United?

Yes. So Tyvaso DPI was approved a little over 2 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 20 years ago. And the product kind of replaced the nebulizer that was really the backbone of the treatment for this disease in earlier stage population than 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 the platform they can really leave, they can take it with them. It just fundamentally changed their life. And we could see in our trial at UT wind up doing that was the 3 weeks switching from nebulizer to inhaled and DPI Tyvaso really made a difference for those patients. And so it's exciting to see our technology being widely adopted now among -- UT's done a phenomenal job. I think it's probably over 5,000 patients now taking the product. So it's fun to see in small disease, how quickly it's changed in 2 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?

Yes. I think that's a great question. So one of the things people don't quite appreciate and I didn't appreciate when I got here. Even I'm a pharmacist, I just spent thousands of drugs you think about but, albuterol, these are just powders going into device getting into the lungs. 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. And so that's really what we've been really good at is how do we formulate products around that. And 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 and the platform is pretty consistent around that dispersion of equal deep lung penetration. And so it's possible. Treprostinil is a great example where you can see we could triple the dose of the product and not have any more sites that can get that much higher level of the body. One of our thesis was, well, if we can really increase those, we could increase better outcomes because patients tolerate more drug than they couldn't tolerate before. And that really is turning out to be true, like it is really a great product, very easy to take. And so it's a 2-second inhalation -- a 4-year-old can do it. We tested device from 4 to 80-year-old and once you -- once that FDKP touches the lung, it disassociates, and then it leaves the drug into the lung and then the FDKP just gets excreted. So think about like the car carrying your passengers, somewhere in the city, dropping them off and it just goes back up. And that's what it does. And so it's been a great carrier. We know it really well, and it's -- we view it as 2 FDA-approved products, and we got a some more coming.

Right. Yes. And maybe kind of talk about the future of Tyvaso DPI kind of whatever indications expanding into the timing of that?

Yes. I think that's exciting. I mean, United Therapeutics has invested in 2 trials; TETON 1 and 2 and so what that means ultimately for MannKind shareholders is, Tyvaso on their pulmonary hypertension and ILD is then phenomenal and has still a lots of room to grow in those segments. But the TETON 1 and 2 is really a whole no indication for a disease called idiophathic pulmonary fibrosis. And that population, unfortunate to death sentence. If you get diagnosed today, 80% of people will be dead within 5 years. And those patients have 2 options that work a little bit more when we're working on an inhaled version. But they really don't have any options. And so this could really show those results when the trials' read out. It's going to 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 forward for the current indications, future indications and kind of how you expect that would be United?

Yes. I mean I made an investment in Danbury, Connecticut, where we make all the things and the company would 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 TETON 1 and 2 readout positive, it looks like they're going to go for a new indication there. Where we'd be able to be well ahead of supply in 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, 50,000, 100,000, well, today, we're treating the entire pulmonary hypertension market of 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 in the last 2 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, 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 focus, derisked targets, speed of development, et cetera.

The team that knows me, knows every day I'm pushing for speed. So how quickly can we go to help patients because development takes a long time. I think our assets are relatively derisked. So when you think about real novel innovation NCEs, you're taking 10 to 15 years to get to market. In Tyvaso's case, we went from Phase I to pretty much ready for approval in 36 months, including manufacturing. So it's a really quick development program to go there. So you think about clofazimine, this is a drug that was approved in the 80s for leprosy. We picked it up in 2020. It was already worked on for 5 years before then. We've been working on the last 4 years to get to patients. So these are a long time coming and we know that clofazimine works in [indiscernible] so it's -- 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 [indiscernible] 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. So another program that I'd say is relatively derisked, 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've got 2 programs with defined targets, defined molecules and dose range that we're trying to achieve. And when you think about R&D, that's not a crapshoot, that's more than a 10% probability of success. So 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?

Yes. I mean I'm sure most people never heard of nontuberculous mycobacterial, 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 2 markets. Here, it's U.S. and Japan. And so that's exciting. It will be a global trial in nature, about 100 sites. And market is this infection in patients that kind of resembles tuberculosis a little bit. So it's a 3-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 the nebulizer. That was the fastest path to market for patients and then we'll move into the dry powder version as a life cycle 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?

Yes. So it will be about 100 plates and you think about really Japan is about 35 sites roughly. U.S. about 50 sites in the trial design, there are 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 stopped dosing because it has about a 45, 55 day half-life. And so you load the lung up and then over the next 2 months, you're not on drug, you're just letting it come back out of the lung and out the lung tissue. And then you dose again. So it's really 2 dose courses over the course of 6 months. But from a patient burden and what they're doing, this is going to be a big relief to them. And then if a patient has a positive sputum or negative sputum, 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 and then those that don't succeeded in 6 months, I think we're thinking about giving them a third dose just to see how much longer is the duration as you could go. So that's exciting. And 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 is part of NTM called M. abscessus. And so we're allowing about 25% of the patients that 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.

Yes. And how is enrollment going? Kind of anything you can infer from kind of enrollment to date?

Yes, not yet. So the trial kicked off. We had our investor meeting in June. We activated roughly 15 sites, I think that was in 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 too then. I think we've got a few patients screened now, and they should be hopefully starting to roll in September here. And our goal is to get the U.S. up and running this year in Japan starting towards the end of the year. So we'll give updates as we get to Q3 and Q4 earnings because that will be the time where we can start to see site activation, and that will be the biggest predictor of enrollment. So that's what we're focused on right now.

Great. Yes. No, we're definitely stay tuned on progress there. Maybe shifting over to MNKD-201. Maybe just level setting kind of a give a quick overview of the program and current status there.

Yes. So 201 is the -- we originally went after -- there's 2 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 resource constrained environment, how do you develop, which are best priorities and biggest shots on goal. So we picked the tenant to go forward and kill pirfenidone. And the reason we did that is we felt that the drug target concentration was important. When you get to pirfenidone 3 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 #1 side effect and that we just went into Phase I. 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 that was to happen, then why would you bring an inhaled version of an oral pill, it's the same. So we really think that's our differentiation. And then the second part we're testing is 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 in 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 at least give us some indication. It won't be all the answers, but it will give us confidence between that and the chronic tox data coming in next month. Those 2 things, I think, will give us the confidence to go into a 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 obviously, Tyvaso DPI, obviously, in development as well?

Yes. 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 2 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 1 or 2 drugs in patients and then you've added the third drug and then you added the fourth drug. And I think that's where all of the IPF is. These patients have a high probability 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. And so I hope 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 the tenant, that's part of the backbone. And hopefully, we can start to be part of that combination of the future in terms of maybe using a new novel drug from Bristol-Myers or [indiscernible] and maybe we've 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 thinking about data, not necessarily what you're going to see from the phase I but kind of as you think about success for 201, I mean 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're just looking for similar efficacy and better tolerability?

Yes. I think for us, the win is similar efficacy, better tolerability, because literally 1 out of 2 people can't tolerate the side effects. And so even if the product was to go generic, you got a population you just cannot even get past the first couple of months here. And so they would rather literally die then take their drug, and that's a really sad outcome. So I think if we can help that population at a minimum, that's going to 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 have the Phase 1 coming out later this year, kind of what are the next steps post that path forward?

Yes. I mean I think the 2 steps here is, first, making sure the chronic tox shows up fine and clean. So we don't expect anything. We studied FDKP extensively over the years. So nintedanib [indiscernible] molecule, but I want to have that data in hand to feel comfortable before we go into a larger scale trial. Phase I is going to 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 there will be some insights there we get in Q4. We'll wrap all that up, we're ready for manufacturing. So we'll wrap that up and go to the FDA for an end of Phase I meeting and then that's where the fund will begin. So [indiscernible], 2 trials, they want 1 trial, can we do a Phase II/III bridging trial. We feel strongly that 1 trial with extrapolation of indications should be acceptable for a 505(b)(2) and that it could be a gated approach of Phase II to Phase III and how does that look as 1 trial? Because the big work is activating all these sites, right? If I think about trial development, time-consuming tasks, it's activating sites. So if we can do all that for Phase II, get data real quickly and then convert into Phase III, I think that will be the fastest way to help people. So that's our goal. We'll get to 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 101, 201. I guess how should we think about the pipeline going forward in terms of kind of looking to grow that potentially? Or kind of how are you thinking?

Yes, I think that's a great question. So if you -- a lot of people ask me this question this week, we picked up R&D sale in Boston in Q3 here. And so we're excited that we were able to pick up 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 2 or 3 former products was limited. Plus Danbury has been around a long time so the facilities would be updated as we keep going. And so 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 and the difference in that technology and our technology that 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 20, 30 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 [indiscernible] clofazimine to get that into 1 dose a day or something that will be important. So that new site is there, we expect to see more molecules going into development. People don't realize, we formulated probably close to 50 products over the years. 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 just kill to be either because of money or resources that we are going to bring back and move faster or what other new ideas have that could help complement the orphan lung strategy that we've been building on. So -- and there are 2 assets in the pipeline, we haven't talked about a lot lately, and [indiscernible] to go there now, so I can wait.

Yes.

So one is Pulmozyme, which was for cystic fibrosis that was approved in the '90s. And so that one, we formulated. It's been kind of dwelling a little bit, and that was because we just had to get to everything else to get back to that one. And so now we're going to be going to the FDA to see if there's a path forward for that one because what happened in CF was 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 end point when maybe they're not having exacerbations as much and so you're comparing it to what placebo or are comparing it to active drug and what's your endpoint. So that's going to be something 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 5 inhibitor through a partner, should be established years ago. So there's 2 other molecules that we're working on. We don't hear much about them and they're kind of at that stage, where maybe we'll advance them more next year and maybe they'll be replaced with something else, we'll see. But we've got a lot of shots on goal, plenty to keep us busy and exciting times.

No, absolutely. And maybe we shift away from the pipeline and kind of over to the endocrine business and Afrezza. 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 lung sitting together and how that kind of gives you a good mix in the business?

Yes. That's a great question. It's actually come up again a couple of times with investors. When you think about launching products, half the battle is getting the infrastructure down and supporting that infrastructure that's all fully laid on 1 product. It also becomes a burden and during that launch phase. And so the good news for us is we're doing almost $80 million in revenue this year between the endocrine business, 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 have built up for the endocrine business now over the last 6, 7 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. So when we think about the endocrine, the big thing here has been the journey we've been on of 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, 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 in the '25 and '26.

Yes, fantastic. And maybe spending some time on those trials, maybe starting with in 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 to see?

I mean it's been a nice surprise, I would say, for KOLs and diabetes because this trial was done in roughly in the top 20 sites in the U.S. So it's really the first time in over 10 years, they've ever touched the drug and we have dosed the drug and we had a clinical trial in the product. So when you look at ADA, we had 7 world-class presenters back-to-back releasing the INHALE-3 data. And this trial is also groundbreaking. In fact, for 2 reasons. One, we let people in who had an A1C go less than 7. So about 25% of the patients were already successful. And 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 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 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 one of the key highlights how this trial was showing that we 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 1. So they've been diagnosed [indiscernible] 10 to 12 years old, and they still are perfect, right, after 30 years of living with it. 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 going forwards?

Yes. When you think about the doctors, it's not just that it's inhaled and it's a lot of perception. It's like it's inhaled [indiscernible] find what I'm doing. Well, that's not why we spend our days trying to keep a [indiscernible] point. It's really about improving care. And I think that's something payers struggle with, right? They're adding 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, you 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 their understanding with doctors like give your patients a choice. And I think that's where we are today. Like the doctor sees a patient, they'll think about Novolog, Humalog and Fiasp. They think about the pumps and pod, different pumps, but they're not actually saying, hey, you're third option is Afrezza. And if we can just become part of one of those 3 options, that's a nice [indiscernible] 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 got to start considering. And then that goes into the guideline. I like, what do you do for ADA guidelines to make sure that Afrezza is a real option and 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 of payers and guidelines can start to use that as a reference point. And then you'll operate behind that, the INHALE-1 data, just kind of a mirror of the INHALE-3.

Yes. 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?

For there, it's against multiple daily injections. And people, they won't see it was generally a little bit higher because we didn't let people less than 7 in the trial. So I think in that population, you're going to see -- 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. Kids have plenty of 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 that dosing was proper in kids and that, hopefully, is the first head-to-head trial for a label change that we'll see that could result in an updated label for Afrezza. And against MDI, that should hopefully show that this population could benefit. When you think about kids, that population is where innovation has changed diabetes care. If you go back in time, Alfred Mann built the insulin pump with kids going into adults in the '90s. Dexcom really started in kids and went to adults over the last 10 years. And Omnipod is a great example, starting in kids in mid-2000s and bridge 2 adults with Omnipod 5 and has had a phenomenal success. So I think we're plying in the long run 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, and the data and then the indication that we'll feel good about the next decade for that product.

Right. Maybe just touching on kind of financials quickly. You're profitable year-to-date through June 30, 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. And maybe just how do you think about capital structure and how you think about capital deployment going forward as well?

Yes. I mean it's amazing where the company has come. You would help me see a list of biotechs on where they were trading in the values. And when I went through the list I think 375 companies on there and you say, how many of them are getting $250 million to $300 million in revenue, how many of them are profitable. How many of them have an FDA approved product. And all of a sudden MannKind in the last 8 years is going from the bottom 10% to the top 10% of publicly traded biotechs less than $5 million, I think, was that market cap. And so that's exciting for us to really see the future so bright. We got to hear this 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 we maintain our success. I'm not -- we're not necessarily running the company at earnings per share, but we want to make sure that we can self-fund our growth in our future and control that. And so from that perspective, we have plenty of cash. We've got this convertible note that's hanging out there. We want to make sure we can pay that off if we need to at the time it's due. And from a capital allocation and capital cash flow generation, I think we'll -- we should be generally cash flow positive. Maybe we'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. .

Yes. Fantastic. And we've touched upon a lot of stuff across the business, the pipeline, the data readout that you've got coming up. Maybe just to close it kind of what are the key things that we should be focused on in the next 12 months for MannKind?

There are so many great things happening in the 12 months. I think when you take a step back and the stocks had a great return year-to-date, you kind of ask ourselves, are we at the top or are we in the middle or are we 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 a basis, then 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 billion to $3 billion a year opportunity. That means MannKind could get another $100 million to $300 million in revenue. That's huge, right? And so that's the unknown that will come out next year, hopefully, around Q3, Q4 time frame. And so that's a huge upside that I know shareholders will be watching as we get to next year. It's not really built into our stock in a meaningful way. And then you got the pediatrics on Afrezza come up here in Q4. You got global expansion for Afrezza. So we're expecting, hopefully, the launch in India next year. We hopefully expect maybe [indiscernible] in Europe and Japan and other countries. So the [indiscernible] data is going to not allow us to bring that to more partners globally or launch it ourselves. And then you got the pipeline enrollment rates on clofazimine. That's going to be a critical thing people are watching because that's going to predict the launch and the reality is I don't think people realize clofazimine should launch within the next 5 years. right? So this is not any analyst forecast, it's not in any numbers that people think about. And then if nintedanib goes into Phase II/III, that can happen next year, and that can be coming out of patients [indiscernible] 2026 Phase II at least, so we know what the drug works. And if that works, it's also another home run. So I think we have multiple shots on going, multiple moon shots that could leapfrog the company, and we're kind of derisked at this point. So we feel like we're just getting started from the journey we've been on.

Great, yes. No. 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 for getting us to where we are. It's been great. Thank you.

Thank you.