MannKind Corporation (MNKD) Earnings Call Transcript & Summary
November 12, 2024
Earnings Call Speaker Segments
Trung Huynh
analystOkay. Great. Good morning, everyone. My name is Trung Huynh. I'm the UBS large-cap pharma and SMID-cap biotech analyst at UBS. It's my pleasure to welcome Michael Castagna, Chief Executive Officer of MannKind, and also Chris Prentiss, Chief Financial Officer. Gentlemen, thanks very much for coming.
Michael Castagna
executiveThank you for having us.
Trung Huynh
analystExcellent. I do have one point of admin. If anyone has any questions in the room, please go to [ Rivka ]. She's going to -- she's got a microphone and she can pass that microphone to you and we can have your question asked. With that said, you've had a great year so far. Stock is up 80% year-to-date from this morning. Not many stocks you can say that in biopharma. However, I realize not everyone here in the room knows about your story. And I think perhaps a good place to start is to give a brief introduction about the company and highlights year-to-date.
Michael Castagna
executiveSure. So for those you 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, 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 the 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. And at that time, we brought a product called treprostinil in early development. We put that into Phase I, and then that turned into a deal in 2018 called United Therapeutics for Tyvaso DPI, what we know today. That was 6 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 then more importantly, the pipeline this year. And that's really one of the conversations we've pivoted with investors was we weren't getting much value up until this year because with the pipeline even though we've been investing for the last 5 years, those data readouts and those milestones were really happening in '24. And so I think as you saw this year, the pipeline became more derisked in terms of moving into Phase II/III in the case of clofazimine or wrapping up Phase I in the case of 201. So I know you'll ask me more questions about those. I'll hold there. But as you think about the company today, as a baseline value of the company for the royalty that we get from United Therapeutics, and 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 a valuation and upside opportunities as we continue to move forward.
Trung Huynh
analystExcellent. 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?
Christopher Prentiss
executiveWell, our marketed products being Afrezza and V-Go within our endocrine business unit are now profitable and have been over the last 4 quarters. And then as Mike talked about, Tyvaso DPI, the combination of royalties as well as the revenues that we earn for manufacturing the product for UT really have allowed the company to be profitable and allowed us to fund our pipeline. So for us, we've really been able to move the pipeline at speed without having to have any new or different financing needs. So 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.
Trung Huynh
analystGreat. And just to touch upon the rest of the year. There are a few [ fair ] catalysts left that's unusual, and we only got 1 month left. But perhaps can you outline this for everyone here and talk about the opportunity these could have?
Michael Castagna
executiveSure. So the first one, we just announced the 201 data, so we'll be filing an end of Phase I meeting with the FDA. We're just waiting on some additional analysis on the plasma data coming in, and that will go out. And then 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. And then the third one that will wrap at the end of this year is really the INHALE-1 readout for pediatrics. And 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. And so that will be important in terms of where that goes. And the key question there is going to be the FDA has indicated they want 12 months of safety data, so once we see the 6-month data, the next 6-month readout will be, call it, Q2 next year. So if they want the full 12-month dataset, we'll have it in Q2 next year. We'll file a meeting request with them based on the 6 months to see whether or not we can go a little bit sooner. And if we can, then that will be -- it will be a 2026 event for launch one way or another, if they accept the filing. So we'll be anxiously awaiting that data, and then that will really set up, I think, the diabetes business as we think about '26 and beyond.
Trung Huynh
analystUnderstood. And if I look at INHALE-3, how are you going to go about maximizing that opportunity first?
Michael Castagna
executiveYes. 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 all the way to insulin delivery pumps, OmniPod. And so we want to get -- 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 '23, 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 a 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. So part of the study is here to say, we at least are as good as what's out there. Let's see, let's be in the choice set for clinicians and patients because that's -- if you have a 1 out of 4 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 don't want to lose with type 1 diabetes, all they do is strive to get the goal. And so the fact that we can talk about that now is whether you're just coming from MDI or pumps, we're getting more people to go 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, I'll call it, a patient who just -- the insulin delivered, it got you to an 8 A1c and you were comfortable with that and all of a sudden you got to do something, maybe it's not the right drug for you, right? But to me, I don't think people want to live with an 8 A1c. They want to live with a roughly 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, 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 to our customers. So this past 2 weeks, we've been doing evening events with different physicians around the country, starting to talk about the 17-week data because the 30-week data, we just released a press release or a headline news that the full dataset we presented in March at ATTD.
Trung Huynh
analystSo 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's -- you're just going to need more promotion that you're going to invest in to just change people's heart and mind there?
Michael Castagna
executiveYes. No, I think you're bringing up good points, which when 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 want to get the datasets out there. We want to see the reaction of the datasets. 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 sub data, you can see they [indiscernible] basal, titrate it appropriately. Maybe they didn't move the mealtime doses up as much as we wanted them to. But in general, even despite those [ falls ], we got decent results. And so that's part of the thing. We're going to actually look to hire about 8 MSLs going into next year, just to cover the top academic centers and some of the guidelines committees to 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 for concern 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 2 years. And so if that's -- that friction is pretty much removed Medicare, how we bring that to commercial and make that a little bit easier. So I think we're -- we got all the right pieces together going into '25. How do we actually make some better impact as we exit Q4 of 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.
Trung Huynh
analystAnd in your comments just then, on the peds side of things, have you talked to physicians about potentially your product in peds, what's their reception being like there? What's that need in the peds?
Michael Castagna
executiveSo I think when you take a step back and I worked in growth hormone for a while, and if you or 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 [indiscernible] 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, right, 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 down to change a pump set or a pod on 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 million, $300 million range here that we'd have to be convinced that Afrezza has that to launch in kids.
Trung Huynh
analystExcellent. Okay. If we switch gears to 101, inhaled clofazimine, I think.
Michael Castagna
executiveClofazimine.
Trung Huynh
analystClofazimine, refractory, sort of 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?
Michael Castagna
executiveYes. I mean, NTM is a disease most people have never heard of. It's called nontuberculous mycobacterium. 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 the standard of care today, which is really 3 generic drugs that are almost a TB-like regimen, they have severe side effects, complex dosing schedules and they're not very tolerable. And so people often drop out of treatment and don't complete or if they do respond, they often relapse within 12 months to 18 months. And so it's kind of a chronic treatment, I'll call it 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. And they've really done a nice job building up the market, helping them raise disease state awareness and established this market. And they've also gone into Japan, U.S. and Europe. And you're starting to see, obviously, Europe has grown a little bit, but Japan is doing very well and U.S. is doing very well. So when I look at the footprint there in the disease, the flip side is there was 2 other competitors, again, at the same time as we were running. Both of them failed this year. So now it's really just us and ARIKAYCE as we look out there, either in front of us or behind us. And so we kind of have this wide open moat because our product is clearly differentiated from ARIKAYCE in that respect. And then clofazimine as a molecule is already on the guidelines. So it was available as a generic to treat leprosy in the '80s. It's actually still available in Japan, Australia and some of these other markets. In the U.S., it's a restricted access. And 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 and then organ drug accumulation. And so 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. And the way we're dosing is also differentiated. It's 28 days on and then 56 days off. So you have 2 dosing cycles in 6 months. And so that becomes a competitive differentiation in addition to, hopefully, a burden on the patient because setting up a nebulizer every day, paying the co-pays 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 II/III.
Trung Huynh
analystAnd can you perhaps talk about some of the early PK/PD data? What gives you excitement here? And how do you think that translates when you get into humans?
Michael Castagna
executiveYes, that's a big million-dollar question I get. So I think a lot of people because of the failures in ARIKAYCE and a couple of others this year are worried a little bit about dosing and how you calculate your dosing. And so I can say we've done a multitude of models and modeling between animal and human PK, where we're looking at plasma ratios. We're looking at the durability over the 7 days of dosing and the 20 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 2 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 on a lower dose. But because of either resistance concerns of ARIKAYCE to us vice versa, or just not calculating it correctly, we want 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 want to deal that card, right, we hope that we don't say we underdosed, and that will hopefully be one of the outcomes here.
Trung Huynh
analystAnd it seems like you've got an aggressive plan to move from Phase I to Phase III very, very quickly. Have you spoken to FDA about the design here? And how are you thinking about recruitment...
Michael Castagna
executiveYes. 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 that's why we spend a lot of time there. But the FDA is comfortable with the dosing, they agreed with our math and somewhat it's a sponsor risk, where as 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.
Trung Huynh
analystAnd on the cost side of things, how should we think about costs building as this trial comes on board? Have you mentioned how much something like a Phase III study could have lost?
Christopher Prentiss
executiveWe have not provided guidance. So that has not been explicitly stated. But the Phase III began this summer. And so we have started site initiations and the very beginnings of enrollment have begun. And then we'll talk about 201 in a second, which is our -- we just wrapped up the Phase I program, and then we'll go into a Phase II/III later this year. So 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. So some trade-offs there, and it will just be a modest bump, I think, is what the net will be as we go forward.
Trung Huynh
analystOkay. 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.
Michael Castagna
executiveYes. I mean, Afrezza, I don't know. IPF, it's a death sentence. 80% of patients die within 5 years. And so it's a very serious condition. Only 2 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. 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 nintedanib, and we want 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 I study, we were looking for any GI-related side effects, anything that would signal OFEV problem because then if you saw anything there, you probably wouldn't move forward without some benefit, right? 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 dysfunction, anything that concerns us. So now we feel pretty good about moving that product into Phase II/III. And the only thing we know the FDA would prefer a dose-ranging study to really think about looking at 2 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 II study would not be powered for efficacy. It'll really be safety and tolerability with some descriptive statistics, I'll call them efficacy. So do we run that type of study? Or is it a 505(b) program where you can argue we're just going to go with our higher dose that we want to, 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? Could you just do a Phase II? 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 in patient life. And so if we can get there faster and hopefully extend people's lives, that will be great. But we want make sure the drug works at the same time.
Trung Huynh
analystSo in the Phase I that you just recently disclosed, there was is it 2 or 3 doses that you tried?
Michael Castagna
executiveSo we studied a single-ascending dose in 3 different doses. And the way you think about that is the first dose was our target and the target to match OFEV. The second dose we studied was hopefully a little bit higher than OFEV, and the third dose was even higher than that. And we never intended to go to the third dose. We wanted to see where the max tolerability was. And the good news is all 3 doses were tolerable in the Phase I. And then we went to a multiple-ascending dose where we took the 2 lower doses, which were our target doses and that we intend to go to Phase II 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 II.
Trung Huynh
analystYes. Okay, interesting. And your meeting with FDA first quarter of next year, how should we think about the time lines if it was for a phase -- if they said, "Look, you need to do a Phase II and then subsequently a Phase III?" And then if you went into straight II/III.
Michael Castagna
executiveYes. I mean I hope when I'm sitting here next year with you that we'll be in Phase II/III somehow, right? Whatever the right format is will be in alignment with the 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 and negotiate with the budgets. And so there's probably 6 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 II into Phase III and minimize, I'll call that friction point between the 2 trials, that would be ideal for us. And that's some of what we have proposed to the FDA is like let us get the right dataset, determine it's safe and then just continue right into Phase III so we don't lose that activation time and site initiations because it's going to be the same sites for Phase II as Phase III.
Trung Huynh
analystYes. 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 most negotiation with the FDA?
Michael Castagna
executiveI think the endpoint is pretty consistent trial to trial. So we don't think that's a negotiation. I think the one are of negotiation could be, do you really need 52 weeks of data versus, call it, 26. All new drugs have been going, including the ones on the market, for 52 weeks of data. This is really a 505(b) with a different delivery. Could you argue we know the molecule? 6 months of data would give you a nice indicator. And that will be a question we ask them, maybe it's 9 months, but can we get there a little bit faster on the trial endpoint because of the known asset? And that answer may be yes, may be no, right? And so that's probably the one area of negotiation we'll shoot for. And then the second area is really how do you bridge this? Is it a Phase II, stop, and then a Phase III? Or can you really do a Phase II rolling into a Phase III? And we did this on clofazimine. We were originally a Phase II/III, and then we actually decided, let's just go with the one dose in the Phase III. 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 II, Phase III traditional design. But that wasn't without any negotiation, no trying, no data. So I think now that we have some more data, it will 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.
Trung Huynh
analystOkay. Excellent. Let's switch gears to Tyvaso. Obviously, it continues to be a very key strategic product there. 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 '25?
Michael Castagna
executiveSo 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 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 1:1 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 and closing out this year, we've said this will be $20 million to $24 million. You saw Q2 was -- sorry, Q3 was $21 million, $23 million. So I think we're getting in that range where it was $26 million, the first 2 quarters, it's come down a little bit. Part of the reason it's come down is there was some scale-up 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 proportionate to sales.
Trung Huynh
analystOkay. Straightforward. So you guys 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?
Michael Castagna
executiveYes. I think first, you -- 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 last 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 a 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 the FDA to get that done. I'm guessing it's something like we did with the BREEZE study, which was 40-some patients switched for safety and tolerability. And the good news is we have over, what, 5,000 patients taking DPI today with PAH and ILD, and I'm sure some of them have COPD and comorbidities of IPF. So we feel pretty good about that profile of the product for that population. But 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. But I wouldn't expect a difficult road to go from A to B once they get that dataset.
Trung Huynh
analystAnd so you don't think that bridging study, there's going to be no complications there. Have you spoken to FDA about that?
Michael Castagna
executiveI don't want to speak on behalf of UT, but I think they're speaking later today, so I'll defer to them.
Trung Huynh
analystOkay. 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?
Christopher Prentiss
executiveI mean the team has 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 steady progress over the years, and all the hard work is kind of coming to fruition at this point.
Trung Huynh
analystOkay. 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?
Christopher Prentiss
executiveDo you want to take that?
Michael Castagna
executiveSure. I'll sure try. I think the catalyst for next year is going to be obviously the acceptance or not of the pediatric file once we get that dataset. I think the alignment with the FDA on the Phase II/III for 201, the continued site activations as well as trial enrollments for 101, that one is for 25% of site activation 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 somewhere 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. So I do think there's quite a few, I'll say, clinical milestones and enrollment milestones for trial that will be key. And then we'll keep operating a tight company like we have for the last 6, 7 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 will continue on into 2025. So hopefully, you could 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.
Trung Huynh
analystAnd Chris, as the CFO, what are your priorities for come 2025?
Christopher Prentiss
executiveI 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 is -- 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 them.
Trung Huynh
analystExcellent. 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 3 things you have hoped to achieve by then? And I'll put you on the hook for that and start next year.
Michael Castagna
executiveI think, first, for sitting here this time next year, it will be hopefully preparing for a 2026 launch in pediatrics. That will be a nice milestone for Afrezza and the legacy of the company, Al Mann. That make me proud if we can get there by this time next year. It won't be approved at 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 '26 to have that interim analysis. And that will 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? And that will be exciting for the company. And then the third one is, hopefully, we're enrolling 201 in patients. That will be an exciting opportunity to help that population as well. So those are my 3 priorities. I don't know, Chris, if you have anything else? All right. So that will be our corporate objectives for next year.
Trung Huynh
analystExcellent. Well, I'll leave with that and the start to next year.
Michael Castagna
executiveAll right.
Trung Huynh
analystThank you, gentlemen. Thank you for coming. Thanks a lot.
Michael Castagna
executiveThanks, everyone.
Trung Huynh
analystHave a good rest of the day. Thank you all.
Christopher Prentiss
executiveAppreciate it.
For developers and AI pipelines
Programmatic access to MannKind Corporation earnings transcripts and 32,000+ others is available through the
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