Perfect. Welcome, everyone. I'm Tiago Fauth. I'm a biotech analyst here at Wells Fargo. We're joined today by MannKind, and we have Michael here for a fireside chat. So I always like to start big picture, right? So MannKind was on Afrezza story for the longest time, then it pivoted to Tyvaso DPI. Now, a little bit more focused on your internal pipeline. Can you just give us right now what's the setup, what's the rundown, and we'll get into some more debate there.
Yeah, I think when you look at the company, we've been around 33 years. That's the good news. Bad news, we've been around 33 years, so how do you reinvent yourself to continue to move forward? And when you look at what we've done over the last really six, seven years, it's pivoting the diabetes platform to getting some data readouts this year. It was getting Tyvaso off the ground, making sure we get scale manufacturing. And then the third leg here is the pipeline, and that's really one that's come into the prospective investors right now. We pivoted in 2019 to orphan lung, and people don't realize we've been working on some of these assets for five, six years now, and they're just now getting into humans and going in through phase I, phase II/III, as we'll talk about.
But that's the exciting part of the journey, is we're now going, you know, to two molecules in orphan lung in humans this year. Diabetes has a couple of readouts, and Tyvaso continues to be strong with some upside going in the next year with IPF. So, we don't control that part of the equation, but we make sure we make enough of it and, supply it, and that's important to patients.
Got it. So perhaps let's just get that part of the discussion out of the way. So, in terms of the deals, basically, you have royalty claims. You also get some manufacturing revenues out of United Therapeutics. How would you expect that to track over the next couple of years? Again, a huge pivot here is gonna be the IPF readout, so if that hits, great, but let's assume the base case. What are some of the economics, and how are you perceiving that inflow of capital?
Yeah, I think when you take a step back and say, you know, United Therapeutics has been a great partner. They've done a phenomenal job with Tyvaso, the DPI. They've been a market leader for a long time. And you know, the PH did a lot of conversion in the first 24 months of launch, and then you get the ILD, and that's been continuing to be penetrated. So we look at that and say, as they continue to penetrate the ILD segment, doctors get more and more experience. It's awareness, it's treatment, and that part continues to go well. From what we can tell, that should propel growth for the coming years. And then, you know, UT invested in two TETON 1 and 2 for IPF. You know, we heard that TETON 2 finished up enrollment.
Next year, around this time, plus or minus a quarter, you know, we should hear what that result looks like, and then hopefully TETON 1 would replicate that. Then they also have PPF, which someone reminded me, you know, that that's another-
Yeah
... indication, another 50,000 patients or so. So we look at Tyvaso, we feel like it's been a great opportunity to make sure we turn around MannKind and how we shepherd that capital, right, to make the better return for our shareholders is important. And that we don't wanna, you know, take that for granted. And so that's somewhere you saw. We took, when we started the process last year, we sold 10% of the royalty, mainly because it wasn't transparent to our shareholders about what we were getting and how that was valued, and we thought our stock was severely undervalued. And so being able to kind of put a mark on that royalty of $1.5 billion, which happened back in January, was an important milestone.
Plus, it's got an IPF contingent with, if you look at the revenue curve.
Yeah.
So that's been important, and that should kind of maintain a certain value underneath the company, and then you got the other pillars here that continue to look good.
Yeah. No, I think that makes a lot of sense. And my last question on Tyvaso, and that's mostly because you guys know the technology really well. A lot of questions on competition and how that may play out with either, like, a similar product like the Yutrepia or maybe longer term with hypo-osmolar formulations and all of that. So given the optimization you guys done on the PK/PD, how do you feel like some of these other modalities of DPI formulation might stack up from a product profile perspective? But that's all about the tail value of the franchise, right?
Yeah.
So how well insulated that is from a technology perspective?
I think. You know, most of the patients when I hear from UT are doing great on our product, right? We feel really good about the technology and the longevity of the patient. If somebody couldn't tolerate it, it's probably because they got cough. I think the question is, if you got cough and you have a lung disease, does throwing more powder in your lung gonna give you less cough? Probably not. I think when it comes to differentiation of our platform, you know, our advantage is it's a very low dose, very low powder load, and you get really good deep lung penetration. From that perspective, I think our technology is truly differentiated amongst any dry powder inhalers out there, and it's our inhaler platform that also helps deliver that technology.
I think that's it. It's not just making the particles and the powder fly. It's how does it come through your device to get deep into the lungs? It's really our powder and our device combo that makes us unique, not just one or the other. That to me is consistently a great patient experience. We see high retention rates in PH. We see high happiness in Afrezza. People like our device. It fits in your pocket. It's two-second inhalation. You don't have to clean it. You can't get much easier, is what I'd say, and that's the reality, so how do you make that better?
I think that's, that to me, is we have a nice competitive advantage when you look at the patient satisfaction, the patient scores, and the patient happiness, whether it's the diabetes business or the, hopefully, the DPI business, people are very happy with our technology and our products, so.
Got it. Perfect. So let's pivot to your internal pipeline. So a couple of different things there. So let's start with MAC, I guess. Was a market that no one was really paying too much attention to, and now folks believe with frontline, it can easily be a billion-dollar-plus opportunity. And again, some mixed track record in terms of development and how other competitors kind of failed to deliver on culture conversion, so on and so forth. So can you give us, like, the brief overview in your program? And I'll have a couple more detailed follow-ups shortly.
... Sure. So we were looking for additional dry product opportunities to put on the platform back in 2019, and that's when we stumbled on clofazimine. It was a small company, and we wanted to make a dry powder, and that turned into an acquisition, and that's how we got clofazimine. That was a nebulized form, and we felt that was the fastest way to market while we continued to experiment. The biggest question back then was, what is the target dose? Because our platform does have some limitations on how many milligrams of powder you can put on the delivery system, and so that's when you fast-forward today, we have a couple powder formulations, and we're making a decision very shortly on which one to pick.
But the nebulizer was the fastest to market and the fastest to trials, and we've kind of narrowed down that dose over time. And so now we feel like we got the right dose. And part of, if you don't know NTM, you know, clofazimine has been used off-label, whether it's through an expanded access program, Novartis or off-label through generics in Japan. There's a lot of data showing, whether it's animal models or human, that it works in NTM. So from a proof of concept risk, we feel very good that this product is going to help patients. And then the question was, how do you dose it properly? How deep can you get in the lungs, and how long do you... Duration of treatment?
That, that's the second half of this equation in the trial we designed, is we went after a 28-day dosing regimen, and so you load the lung up for 28 days, the macrophages bring it deep into the lung, and then as they turn over, it releases the drug little by little and hopefully gets to the bacterial infection. But these are really hard, this bacteria is really hard to treat. It's almost like tuberculosis, right? And so how do you get that deep lung penetration? How do you get the drug there? And then that drug loads up, and then over the next 56 days or so, it comes back out. It's got about a 45-day half-life.
So when you think about that uniqueness, it's once-a-month dosing in terms of every day for a month, and then you stop for two months, and then you dose again. So hopefully, at the end of that six months, we're going to see, you know, our benchmark is hopefully what we saw in Arikayce, refractory population. Now, we've added, M. abscessus co-infection, so up to 20% of the people in the trial could be co-infected, and we know they don't do as well overall, but they have no treatment options. And so we thought, whether it's from an enrollment criteria or we know clofazimine works in M. abscessus in MAC, how do we help both populations and make sure we get this to patients as quick as possible?
Got it. And you already spoke a little bit about that, but perhaps taking a step back, like, one of the challenges we've seen with NTM MAC is translatability of either a novel mechanism of action that works in a petri dish, but then you go into humans, and it doesn't translate for whatever reason, right? So you mentioned some existing experience with clofazimine that should lead it to work, but can you give a little bit more detail in terms of how confident you are on that translatability? What can you do pre-clinically or early-stage clinically to actually de-risk that you can achieve the right lung exposure, that you believe the mechanism of action, it's not going to generate any resistance, so on and so forth? Like, how should we think about some of those more fundamental questions on the program?
Yeah. Those are really good questions, and as we look out, you know, part of it, we knew what the MIC was, we knew what the target-
Yeah.
lung concentration was, and so how do you... You know, part of what we've done for 33 years is formulate close to 50 molecules by now and trying to triangulate a compartmentalization model between animal to human, and we've done that quite a few times, and I know a lot of companies have struggled with that and maybe not have had success. But that is some of our secret sauce, right? Of about, you know, how do we translate that animal dose to human? And, you know, I think on clofazimine, we were actually targeting two doses for a while. And as we fine-tuned it and looked at it, we said, "Why not just go. The higher dose is tolerable, and so rather than risk a low minimal dose, let's go to the higher dose that should cover MIC, should cover M.
abscessus, and not risk any resistance, not risk someone missed dosing a little bit." And so, yeah, it'll be a little bit more API and a little bit longer nebulization time. But fundamentally, that was a de-risking moment to say: Let's not underdose these patients and look back. Let's go to the higher dose and go right to phase III. In some ways, we're taking a little bit of risk because we're not doing a phase II. We're going right to phase III. But otherwise, these trials take a long time, and so if you feel good about your dosing, you feel good about the drug, you feel good about the activity, I think those are risks worth taking. And, you know, it'll be... And we're the only ones there now. So if you look at Arikayce and then nothing, and then us, and then nothing.
Yeah, kind of yeah.
We're kind of at the end of the road here, like, building the NTM market with Insmed and really helping patients, and I think we have a wide opportunity to get the trial enrolled quickly. There's a lot of interest in Japan. It's going to be a global trial, about 100 sites, and we're excited to get to patients.
And you have a big interim analysis as well.
Yeah.
Like, after 100 patients, or approximately?
We baked in. The target's 180 patients for a moment, 234 with 180 valuable patients. And so when we get to about 90 patients for six months of treatment-
Treatment population.
-we'll, we'll-
Got it.
We'll do a size reestimation.
Got it.
You know, depending on how enrollment's going, when you, when you fast-forward to that time period, you know, when you got 100 sites, you might be getting 20, 30 patients a month by then. Even if we have to get the trial a little bit bigger, the reality is we're probably going to let recruitment keep going until we get to that final size reestimation, because it just takes a while to get these things off the ground. Once they're going, and, and you saw that in IMPALA- 2, they had a, you know, a slow start, and then boom, they had 100 patients in six months.
Okay.
We're excited about watching what they did to enroll, and hopefully, we can get some enrollment moving as well.
Got it. And again, you did have relatively, especially in the refractory setting, relatively low rates of sputum conversion. Is that kind of the only way you can differentiate? I guess one of the pushbacks you might get is, like, hey, Arikayce has been on the market for several years. They're going to have a front-line label potentially by the time you're approved. So bigger picture questions of how they're thinking about that market and how you think that you're going to fit in that niche and kind of compete versus Arikayce.
Yeah. I think just purely on. There's a couple different aspects here, right? Let's see what the conversion looks like. We benchmarked it to Arikayce, about 20% delta, and so we feel like we've set a relatively acceptable bar, because then you get to the advantage of dosing. So if you're doing it for 28 days, then off for 2 months, that's a huge advantage for patients. They don't have to clean their device every day. They don't have to, you know, the liposomal formulations are more sticky and messy than our formulation. And so we think that dosing advantage, copay advantage to a patient will be helpful. And then the side effects, right? We've seen ototoxicity go up in the population of NTM, and I have to imagine that's because aminoglycosides, right?
That's a known side effect, and we're not an aminoglycoside. So I hopefully will see. We know clofazimine works. The oral dosage has warts around QT prolongation, skin discoloration, organ accumulation, and we've been able to lower the dose and not see some of those side effects, I'll say, in our development program so far, and that's what we're watching for, right? Can we give you the benefits of clofazimine without the toxicities of the legacy? And I think that's the point of the inhaled version, is it really reduces the dose a lot for the systemic, but puts it in the lung where it needs to be, and hopefully, it'll minimize systemic circulation.
Got it. That makes sense. And again, so you're running the phase III trial with the inhaled suspension and developing a DPI kind of in a parallel track, and-
Yeah.
It could look like just a bridging study, perhaps, in the future.
It could be. I mean, we think about the DPI more for the naive early treatment population.
Okay.
Our vision here is clofazimine can work in a bunch of different indications, and so the first one we're going after is NTM. It's gonna be a hard population to treat, but if you're successful there, right, that sets the benchmark. What are the other adjacent indications you gonna be thinking about? What would be ideal for, like, lung, immersed in the lung? Inhaled dry powder may be great for that. And so are there other indications we can go after, not just for naive patients in NTM, but other indications for the dry powder? That's some of the work the team's doing. Once we pick the dry powder formulation, then we'll start to evaluate what's the best way to do the bridging and then what's the best next indication we should be thinking about.
Because one can argue, you don't want to put all your eggs in the NTM basket. And so do we wanna spread that risk a little bit, or do you wanna double down and get early and late? Part of me, the guidelines will drive a lot of treatment decisions, and so, you know, even if you don't have the data, there's a lot of naive patient data, I'll say, early treatment of clofazimine that shows it works. And so I think just showing that we have new options for patients will be important.
Got it. Let's pivot to some of the other programs you have. So nintedanib DPI. So again, if it feels like there's a common theme here, right? And you saw with inhaled nintedanib, some programs tried to do a couple of things related to that, inhaled TKIs. This felt like it could have been a good solution just in terms of reducing toxicity and getting to a therapeutic level. What are some of the challenges that folks had that you think you were able to crack to get an efficacious DPI formulation of this?
So I think the biggest challenge is 99% of IPF assets have failed.
Right.
And that there's really no predictive model, and that was one of the reasons we went forward and said, "Look, we're--" When we were thinking about our next round of investments, we had, we actually formulated pirfenidone and nintedanib, and we brought them both to a point of decision. We said, "You know, pirfenidone has a lot of powder, a lot of milligrams, three times a day. Nintedanib could be twice a day." And we felt, Okay, let's get the one that fits better on our technology, that we can deliver better to the lung. And that, you know, part of the issue in IPF is people still debate, is it systemic or is it a lung disease? And without that clarity, people are afraid to take different bets.
So we've taken a bet that we want to treat the lung and the lung disease and get the best concentration of the lung. And when you think about the Achilles heel of nintedanib, it's really the diarrhea, right? As a patient explained to me last year, it felt like Niagara Falls coming out of the ass. And so that's not a good feeling, and that causes 50% of the people to drop out. And we felt if we could lower the dose, get a more tolerable form, we could help at least 50% of the population, and then those that are on the drug doing well, well, maybe they'd like this, maybe they wouldn't. But we look at the future being combination treatments, and we think if we can really help this population...
What people don't realize is we've already done the bleomycin studies. That's the best signal you can get, right?
Sure.
As far as that model is, we already showed our lung dose that we're targeting is already comparable to the oral dose of nintedanib. And we didn't publish the data because we're not trying to impress anybody, but our proof of concept internally to give us the conviction to keep going is already there. And then, so that's some of what people miss, is they think we didn't, we haven't done as much as we've done, but we've done a lot. And now we're just about to finish up the last dosing cohort, and we'll have that data here in Q4. So when you look at Q4, we're gonna have the chronic tox data is done, we'll have the dosing phase I and multiple ascending doses, and we'll make that assessment go to the FDA for, and then the phase I meeting.
So, and again, given that the API is relatively well understood, you're kind of trying to optimize for tolerability, right? If I'm hearing you correctly. How much does the phase I healthy volunteer data actually gives you an insight into that, relative to the kinetics of the AEs for the oral formula? I'm curious, how much can we actually extrapolate from this phase I results?
No, that's a great question. So people ask me, what's success look like, right? The first is, can you tolerate the inhalation of the various doses, right? And not just the single dose, but the multiple ascending doses. And then the second one will be, you know, is there any... We're doing PK as well, so we'll find out if there's any systemic circulation, and then how does that compare to the oral? And then the third is, is there any diarrhea? And so, I don't know those answers yet, but I think that'll be important, if you really think the advantage. I had heard, if you look at the pirfenidone nebulized product that was out there, they still have photosensitivity even though they changed the dosing.
And so we really don't know, right, even in this study, did we start to see less diarrhea? But our real opportunity, to me, for nintedanib is they got their max dose in the oral formulation. They couldn't physically go any higher without causing more severe side effects. Delivering it directly to the lung should allow us to deliver a higher target dose to the lung than you could in the oral formulation. And so that's really our goal here, is not just to match the tenet, but can you deliver a better Ofev directly to the lung and minimize the side effect profile? And our delivery technology allows you to put a better concentration of drug into the lung than nebulizer, realistically. So that's where we're focused on. And let's get our data and see what happens.
But we're really focused on the safety and the tolerability and the efficacy.
Yeah. And the maintenance dose, is that a month of it? Like, how long is the dosing at for-
We did a single dose and then seven days.
Seven days.
Because, you know, people don't want to be locked up for 20 days in the clinical study unit, so.
Fair enough. Fair enough. So but again, like, just across some of those three programs, we have Tyvaso, you have drug for NTM MAC, you have something potentially for IPF. How are you thinking about the relative market opportunity here? What's most interesting around arc from lung? Is there something else you're working earlier stage? I mean, it's a lot of different priorities here.
Yeah.
How are you thinking about that?
I think from an investor perspective, you have to realize we made some of these decisions four and five years ago when we were a tenth of our size today, right? And so the decisions we're making now are for the 2030 s. And if we're thinking about the next pipeline assets to put in development, what's the next disease targets we want to go after? Are there additional adjacent orphan lung disease perspectives, are there additional adjacent indications with our current assets? And I think that's where you can look at the company and say, whether it's Tyvaso and the multitude of investments that UT has made, or Afrezza, and how we're looking at Afrezza or clofazimine or nintedanib. You know, each of these brands will have multiple indications opportunistically.
And then we got the pipeline and BD that we haven't even really talked about a lot, right? But that's before we get inorganic growth. And then we still have Pulmozyme in this ALK-5 in our pipeline that we're still moving forward, and just waiting for some FDA insights before we keep pushing on some of those. And then we got the next round of molecules. You know, we just picked up an R&D site here in Boston, and so we're really excited about that facility. Because one of our limitations was just how many formulations can our teams work on, given all the work we're doing. And so, you know, it's been a small company that's really expanded. But-
Right
... our facility in Danbury is 20 years old and needs some investment, and then we got the facility here already done. And so now we just pretty much doubled our R&D capacity to put more into the pipeline. And so that's. That was a great limiting effect until we go into the second half now.
Yeah. But again, you deliver on two products, Afrezza, Tyvaso, and PI. Like, you feel like you-
No.
That's replicable, it sounds like.
No, I'm not out of ideas yet. So, you know, we got a couple of good ones, and hopefully, we'll have some better ones, but-
Got it. Now, and again, like, originally, MannKind was all about endocrine, so we need to talk about Afrezza. It's been part of the core business for some time, with good growth, relatively small base. What's the pitch for this asset, and what's the long-term outlook?
I think inhaled insulins fortunately got a bad rep, and it's severely misunderstood. You know, this product was nothing like Exubera, but it's got the hangover of that product from 20 years ago now. You know, we took the long road on Afrezza, meaning you know, we had. My belief was: You're not going to change the adult endocrine community rapidly. These guys are on average 63 years old, 67 years old. There's not enough new ones. They've treated someone for 30, 40 years, so they're not in a rush to transform anything. That, you know, for me, the pivot was really pediatrics.
So when you take a step back in diabetes, you know, Al Mann built the insulin pumps in the 80s and 90 s, Dexcom built the next CGM for kids, and Omnipod started, and podders back in the mid-2000s here. So all those innovations have transformed to significant shareholder value for those companies, whether it's MiniMed, Medtronic, Omnipod, or Dexcom. But it all started with children. And when you think about the overall insulin market, a lot of questions I get around GLPs and that stuff. The insulin market, 50% is type 1 patient population and 50% is type 2. And what you've seen us do over the last 24 months is really starting to double down on the type 1 population, whether that's through the INHALE-3 trial, the pump switch trial we did initially with ABC, or the pediatrics.
So it's really been about creating a long-term, sustainable growth platform for Afrezza in a population that's going to demand it more than the adults. And that those kids will quickly turn into adults, and just like the other key innovations in diabetes have gotten adopted in adults, it's got to start with the kids going up and then going into that direction. So it took us, probably by the time we get the data, six, seven years since I got here, just to do the PK study and then get the other study and then get the funding. So it's a long road, unfortunately, and people say Afrezza has been around a long time. But I will say we haven't been investing to grow it faster.
We've been investing for profitability in the last 18 months, and the data coming out here in Q4 will be the pivotal moment for the company.
Yeah, and again, you had some recent data presentation at ADA, and you have the INHALE-1 upcoming readout. So can you just recap how important that is and how much that can actually drive additional growth? So to your point, Peds for INHALE-1 is kind of a key growth driver, but what does that mean in terms of peak revenue opportunity relative to what you see today, just from a-- just trying to get a sense of scale here?
Yeah. So when you take a step back and say our biggest prescribers of Afrezza are mostly private practice doctors who understand our data, aren't fearful of safety, and know how to get the drug approved. And those doctors, we can have 20%, 30%, 40% market share. So we had to have enough conviction to make the investment that we can get 10% or 20% market share in pediatrics, because every 10% share will roughly be about $150 million in revenue to MannKind, and that's just starting, right? And so then that those kids will turn into adults, and that'll start to compound this growth over the next 10 and 20 years.
And so that's really how we've taken a step back, saying, you know, "Do you have conviction?" And we're actually conducting some independent research right now to give us that conviction. So we'll need the data to support it. But assuming the data is good and you got the additional work we're doing, plus the INHALE-3 study that we just read out, you got a new data package to go to the FDA and start to fix some of the flaws in the product. And one of them is the conversion table on the label. So the label from approval, unfortunately, underdoses patients by 50%. And so that's been a big problem around, you know, the initial launch and some of the feedback. If doctors don't have experience, they underdose the patient, the patient drops off.
And so that's been the INHALE-3 trial and the INHALE-1 trial actually used the new dose conversion. And so that's why we're excited about those results, because this will be the first time you're seeing real large phase III data, phase IV data in a better dose conversion. What does that look like? In the near term, what does that look like over 17 and 50 weeks? And so all that data is coming out. Literally, I got 30-week data just hit us, and I got the phase III data coming in, and 26-week endpoint, and we'll have 52 weeks data next year. And so we got a lot of data coming on Afrezza, and I think that's exciting because that's what we've been waiting for.
And how are you thinking about the profitability of that business unit? Because, again, these are fairly disparate end markets, right? And you can kind of think about capital allocation in different ways here. So, so far, is Afrezza kind of a break-even product? Is that going to be a contributor to profitability going forward? How are you kind of thinking about the capital allocation between some of these businesses?
So if you look at starting in the third quarter of last year, the diabetes business has been profitable since then. And so, I have to go back and look at every quarter, but I think pretty much every quarter we've made profit on the endocrine business unit. And that's what we've been running it for right now. So yes, it's growing, but it could be growing faster if we invest more money, and those are the trade-offs. So right now we are deploying capital to make sure Clofazimine gets off the ground. That tentative phase I is done, and we have enough cash on the balance sheet to continue to fund our growth plans. And so, you know, part of it was getting into this year, understanding where Tyvaso was, where the competition was, where manufacturing is.
So everything is looking really good so far. We're pretty much in September.
Yeah.
So, I couldn't ask for a better year.
Sorry for it, but just on the manufacturing, can you just kind of remind us what's currently your agreement with United Therapeutics? How much revenues can you expect from that in the future, if any? Blanking out on the details here.
Yeah. So we don't disclose the margin on the manufacturing, but I think if you look at last year, it was $10-$15 million a quarter. This year, it's been $26 million the first two quarters, and some of that is the scale of work we're doing. So as we get the new equipment manufactured, that some of that product will turn into commercial products, so we get the bill for that in the quarter. Some of that is deferred revenue from the last two years that's being recognized. As volume goes up, that recognition goes up. And then the other part is volume, right? This product is growing rapidly year over year.
And so I think when you look at the demand and the volume coming out of the factory, you know, we're running 24/7, making Tyvaso nonstop, pretty much for the last two years. And so that launch curve has done so well, and just getting ahead of that demand curve has been important to make sure UT has confidence to just keep going. You know, whether it's international or U.S. or additional indications, they want to make sure they have a runway on supply issue. May or may not know, they like to keep at least a year of inventory, which, you know, has not been our policy for MannKind. But building that up for Tyvaso is important to them and having that reliable supply, that's one of the things we don't want to miss.
And we're well ahead of that curve, fortunately. Last year got a little tight, but we got through it.
Sorry, just to pivot back on the whole capital allocation. Again, it sounds like the end of business, definitely not a drag on results, starting to contribute to profitability, and if it grows, it's going to be even a bigger driver going forward.
Yeah.
You have Tyvaso, which kind of flows as a royalty, so really good economics there. I think your only offset to that is going to be the manufacturing cost, but it sounds like you had a cost plus.
Yeah, we make our own manufacturing, so that's good.
Okay.
And, uh...
And those are fairly reasonably... You have fairly good visibility across some of those two drivers in the next few years. Is that fair enough to say?
Yeah. No, I mean, I think when you look at the next two, three years, Afrezza has positive upside. If we go here, TETON 1 and 2 reading out has positive upside, and then you got the pipeline upside. So, I think when you look at the company, you have multiple shots on goal to really hit multiple milestones, right? And so whether it's the pipeline, the platform, the in-line, international expansion, there's very few places we're not trying to grow the company right now, which is exciting, challenging, and fun all at the same time.
Okay. And how are you thinking about funding all of that? So again, what's your current cash position? And again, it sounds like you have a pretty steady inflow of capital, but is that enough to kind of keep everything going at the rate-
Yeah
-that you want everything to go?
To your point, it's capital allocation. So right now, we are focused on paying down debt, and so that's been our number one thing this year. So we've paid off some of the convertible notes with the Mann trustees, some of the MidCap debt. The only thing left outstanding is now the convertible debt, which is in the money. But we really want to reduce dilution that's back in that convert, and so how do we do that over time? That's due in eighteen months, and so we want to make sure we have enough cash to pay that down. And whether we do that in cash or cash in stock, we'll deal with that at the time.
And then the rest of the company is profitable now, so we are putting cash on the balance sheet, and we are investing to grow. And, you know, if we got to spend a little more money here and there, I think we can do that within our own means. And, you know, the company is in a much better financial position, so if you really wanted to take out a new debt instrument, that is available to us. So I don't see us needing to raise capital in the public markets per se, in terms of shareholder dilution. I think it's how do we reduce dilution through the convertible debt, and how do we, you know, fund our growth in ways that we think either self-funded through profitability or, you know, leverage if you had to.
But at this point, we need some data and some bets to place, but I think that's all coming to fruition, and we feel pretty good about the ability to either share those, and there's companies who would share risk in the trials, right? Those are the things that I don't worry. Like, if we got a big trial, it's gonna cost money, but this could be a $3-$4 billion opportunity. There's plenty of people who take that risk with us. And so that's the thing about nintedanib. It could be so big that, you know, if you're going forward and you really think it's that big, then you have no problem sharing some of that risk. But what I'm not willing to do is just give it up.
And I think that's when I look back in Tyvaso, we did give up Tyvaso at the time, and I think it was a good decision. UT's been a great partner, but if I look at how much money they're bringing in every quarter, and that was MannKind shareholders, our shareholders would be ten times happier, in market cap. So I do think we're not in a position that someone said to me, "Why not sell something?" I said, "Okay, I get $500 million. What do I do?" Right? The reality is we are well-balanced, well-funded, and we're in control of our destiny at this point, and we feel very good about those shots on goal.
Got it. No, I think that's fair. And my last question, I guess, is just related to the messaging, and I was surprised when we started doing work on MannKind to prep for this and all of that, because a lot of the pipeline has evolved without drawing a lot of attention. So what is the messaging to investors? How do you get a different shareholder base to invest in the business? How are you thinking about that?
January this year, we decided to pivot. The last two years prior, that was all Tyvaso and making sure we could make that right. And this year we pivoted to the pipeline. And it's because, you know, when I talked to the IPF community last year, they had no idea we were coming for NTM. They had no idea we were coming for IPF. They were literally shocked, and they're like: Well, how many years away are you? I'm like: We're going to the patients next year. And so that's when we realized we made some investments at the ATS conference this year, the NTM conference, some of the other IPF things. And so, you know, you'll see our name out there more and more. We're meeting KOLs. People are pleasantly happy with our technology.
The good news is, you know, it's a platform technology, so when they know Tyvaso DPI, and they know how our patients love it, when you think about IPF and nintedanib, they'd be like: Oh, so it's the same. Right? So they're understanding now that FDKP, our novel excipient, and how we attach that and deliver that to the lungs is a platform, and that, you know, you can really get deep lung penetration, consistent lung penetration, in a two-second inhalation. And so people are really starting to buy into the nintedanib one. And now we've got to get that through the FDA, right? And so for me, how quickly can we get to a phase II-III design with the FDA? Can we confirm it's one trial? We think it's all there. Does it have to be 52 weeks, or can we argue a shorter duration?
Do we do a phase II roll over to phase III? So that, that's all the work we're doing right now in the second half, to hopefully convince the FDA this is a great opportunity to help patients faster. And, you know, patients... FDA, I think, wants patients to get something in IPF. It's been a long road for a lot of companies, but, they need to win, so.
Yeah, that's fair, and again, sounds like there are some novel mechanisms of action, but failure rates are high.
Yeah.
This is at least relatively well understood.
One thing we got. So I think that's exciting. You know, when investors look at the company now, you know, in Q4, you literally have pediatric readout, chronic tox, phase I, clofazimine enrollment range, inhaled TKI 30-week data. We have so many great news coming here in Q4, and hopefully they're all positive, but even if they're not, we still have enough positive shots on goal. So I feel pretty good about the balanced approach we're taking between pipeline, in line, and expansion growth.
Perfect. That's fair enough. Yeah, I guess we can probably wrap up there.
All right.
Sounds like we've heard enough.
Thank you. Thank you for having us today.
Of course.
It's been great. Thanks, everyone.