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Leerink Global Healthcare Conference 2026

Mar 10, 2026

Roanna Ruiz
Senior Biotech Analyst, Leerink

Welcome everyone back to Leerink Global Healthcare Conference. My name is Roanna Ruiz. I'm one of the senior biotech analysts here at Leerink, and it is my pleasure to welcome MannKind here with me. I have Mike Castagna, CEO, and also Chris Prentiss, CFO. Thanks for joining me.

Mike Castagna
CEO, MannKind

Thank you for having us.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yeah. Great. I'll kick it off with a bigger picture question before we dive in. Maybe could you just recap a bit about MannKind's core strategic focus heading into this year and beyond? And how has the business evolved following the scPharmaceuticals acquisition?

Mike Castagna
CEO, MannKind

Yeah, I mean, I've been at the company 10 years on Monday, CEO over the last nine. I would say that that journey's been really about transforming the company from who we were as a single product, inhaled insulin to a multi-diversified company. It started in 2018 with where we were at Tyvaso, which got us to where we are today. As we entered into 2026, you know, we started out probably the last year or two prior to that, really looking for an opportunity to diversify ourself further. I think we found scPharmaceuticals as that opportunity. We closed that deal in Q4, and we're really happy with the acquisition. Even you can imagine in Q4, you're doing integration work, and you're moving things in the right direction.

As we entered in 2026, it's about how do we continue to grow the company faster than we were Wall Street's thinking, or we can execute. I think we have several shots on goal this year. I think as we think about it, you got two FDA approvals and a phase II trial kickoff. It's gonna be a busy year, let alone all the things our partner, United Therapeutics, will be working on.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yep. Yeah, a lot going on. So you're talking about revenue run rate and unit growth. I just want to check in on, you know, how are you thinking about your revenue going forward, both with Tyvaso DPI royalties and also the part of the business that excludes that? I think you mentioned previously it's now about $200 million annually. So how should investors think about your revenue streams diversifying going forward? You know, how are you thinking about growth levers from there in terms of FUROSCIX®, and you also have Afrezza and things like that?

Mike Castagna
CEO, MannKind

Yeah. It's a really exciting time right now. When you think about first I would do is, if you're looking at the company, I would say let's pull out the collaboration service line because what we learned last week is MannKind will be the exclusive manufacturer for Tyvaso for the foreseeable future. That's no longer being shifted out. When we had signed the minimum purchase agreement, that was assuming UT was the primary, and we were backup. Some of what you heard us talk about is that was minimums. Now that we know we're officially going to be the primary, the minimums will probably be a little bit higher, given that they're no longer manufacturing. We're gonna have to put more in for us and so that's great.

I would say collaboration and service line should be stable over the coming years, number one. Take that out because that has really the manufacturing, which doesn't have a huge margin, but it's a line that will probably be pretty steady. Then you really look at the variable revenue streams, and I would say that's the royalty, and that's the revenue we control. If you went back to Q3, UT was probably 60%-70% of our revenue in that quarter. If you look at Q4, it's moving into the fifties. By the end of Q4 this year, about 70% of the revenue will be in MannKind's control, that we control outside of the royalty.

I think that's what we've really been trying to do, is diversify the revenue, so when you come to a quarterly basis, we don't get a surprise like we got last week. It's really, you know, we want our investors to focus on the Afrezza Peds launch, the FUROSCIX® auto-injector, and the nintedanib program. All of those are far more valuable to our future than where we're sitting today, including where we're at on our market cap. As we look at Q4 exit, if everything goes as planned this year, you know, it's we're not at 70%, I'll call it roughly MannKind versus UT because UT is dropping. It's because everything is growing nicely, including the Tyvaso DPI royalty this year, which we do expect this year, next year, and continued just double-digit growth. We're pretty excited about that opportunity as well.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yep. Got it. Thinking ahead, you know, in terms of the products that you're following, that you have complete control over in the business, if you're able to share, like, how are you thinking about when collectively those may start to overtake the DPI royalty stream? Just curious.

Mike Castagna
CEO, MannKind

I think, I mean, if you look at Q4, we did just on the royalty stream was, what, $33 million, and we did $23 million on FUROSCIX®, we did $22 million on Afrezza and about $4 million on V-Go. We overtook the royalty stream in Q4 with the SC acquisition, so we're already there. We're moving from the 50s into the 60s, hopefully get to the 70s. We gotta accelerate the growth of our portfolio. Nothing like where we're heading now is we have just such an amazing opportunity to just drive better success in the things we control. That's our laser focus on, you know, increasing trial enrollments faster, executing on the Peds launch faster, getting the conversion done on the auto-injector and getting that moving quickly.

We just have a lot of shots on goal this year to really drive significant change.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Another question I've gotten from investors that I think is pretty interesting, just optionality going forward, sticking with the Tyvaso DPI for a second, just in terms of optionality into IPF and how you're thinking about it, how UT is thinking about it, you know, is that still baked into your internal estimates, or could you frame, like, how are you thinking about that optionality as well?

Mike Castagna
CEO, MannKind

I think there's a lack of clarity for us and them in the marketplace. I don't think much about it at this point. It was never built into our long-range forecast, and we feel like, look, they need the TETON-1 data to really go back to the FDA and get that clarity. We think there's a real opportunity here. The product that I think is gonna be of interest is the 201 program, the phase one, because we're gonna dose 24 patients. I'll call it 16 will be on active drug. But what's gonna be important is can those patients in IPF tolerate our powders, right? Do they have the cough? Are they getting through it? Is there any FEV1, FVC changes?

We wanna have that data, and I think there'll be a very productive dialogue, not just for our own program with the FDA, but obviously UT as well. I think all things are still moving in the right direction. I don't think, you know, we're not like as you see, we wanna focus on things we can control right at this point.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yep. Yep. I hear you. I'll move to things you can control in the future. Focusing on FUROSCIX® for a bit and the upcoming auto-injector for that product as well. How are you thinking about you brought it on board, you had your first full quarter of revenues for FUROSCIX®, and thinking ahead, what are your expectations going into 2026 and, you know, how could things possibly inflect with the auto-injector coming online?

Mike Castagna
CEO, MannKind

Yeah. I'd say, you know, SC did an amazing job building up a marketplace that really didn't exist, and that takes capital and time and patience and people, and they didn't have all those. Hence, we were able to bring them on board, and I think that's what you're seeing us do. When I think about the hospital segment in particular, right? There's a large opportunity there of unmet need. I've talked to a lot of hospital systems just in the last week, and I think, you know, a simple auto-injector that can be given to the patient on discharge or even in the ER, things like that, there's just such a large market. There's 600,000-700,000 hospitalizations a year due to fluid overload, and we have people just sitting in hospitals taking up beds to pee.

That is not the best use of healthcare resources in society. The TAM here is billions of dollars. The cost in the hospital system is billions of dollars. You know, where SC was focused on the community physicians, which got them off the ground, preventing hospitalizations, preventing ER visits, preventing readmissions, that's the bread and butter of the company. Where we're going is really scaling up this other segment that we think is a large opportunity. For us, like, we gotta deal with the community physicians, and we actually increased our share of voice there. We actually took out. When I look out, I say, "What are the things we're doing differently?" We have hospitals. We added more reps to call a nephrologist. We got the auto-injector coming, right?

All those things are very meaningful opportunities. You're not gonna see that hit in Q1, just to be clear. Q1 Medicare copay is reset. Generally in Q1 you're gonna see a decline, and as those patients come out of that copay, you know, March, April, May start looking a lot better. We can already see March is growing significantly over February and January. It's exciting. We'll close the quarter strong as we can. I think when you look at the rest of the year, we've communicated $110-$120 we think is reasonable, and that's assuming we don't even get the auto-injector. If we get the auto-injector, hopefully that just brings even more value.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yeah

Mike Castagna
CEO, MannKind

To us.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Sounds good. I think for investors that are digging into FUROSCIX® 'cause it's newer into your portfolio, could you frame what FUROSCIX® did towards the end in the hands of scPharmaceuticals? Then how does that connect the dots to your recent $23 million number and beyond?

Mike Castagna
CEO, MannKind

Yeah. I mean, I think the team focused on execution in Q3 and Q4. We announced the deal in Q3. It could add a lot of distraction. In Q4, they hit record numbers. I think what that showed you is when you take away the copay friction, meaning someone gets hit with a $1,000-$2,000 copay, they'd rather go sit in the hospital than get hit with another fee. I think when you take away that friction, you can see the average units per script goes up. You can see the average patient fill rate goes up. You can see the doctor's belief in prescribing goes up.

This is one of the things we're talking, like how do we get to CMS and explain to them, you know, they're putting penalties on physicians starting in 2027 on ASM, the ambulatory specialty model here. And that is gonna make a doctor make 9% less or 9% more depending on readmission rates and success. Well, if the patients can't get the tool to get out of the hospital or not come back in, that's not fair to the hospital system or the doctor. There's gotta be some collaboration with the government on this topic. And you know, we were able to do this for inhaled insulin. We were able to get inhaled insulin capped at $35 for Medicare.

We can see quickly that our market share got up to national average of injectable insulin when it came to Medicare percent of our business. These copay out-of-pockets are real issues for the seniors, and fluid overload's a real issue for hospitalizations. Every time those patients are in there, if they can get out one day earlier, the risk of complications, the risk of infection, the risk of bed sores, the risk of recovery, all that gets so much better, right, in terms of getting people out of the hospital. That's our real goal is, you know, if we can get that from five days to four days or four days to three days, that's gonna be huge opportunities for patients and society.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yep. Makes sense. You just mentioned that for FUROSCIX®, you increased the field rep footprint, et cetera, behind the product. How should investors think about, you know, with that added investment, what's the productivity ramp look like, and when could it start flowing through to future revenues for FUROSCIX®?

Mike Castagna
CEO, MannKind

I think it generally takes a rep four to six months to get the lunches, get the appointments, even though the patients are showing up. We started in January at the end of the sales meeting, you know, kind of fast forward, that gets you to May-June timeframe. I think we'll see a good inflection here in Q2, and then that'll really set up for Q3-Q4 with the auto-injector. The other part is, you know, they're in place now. As we get the auto-injector and we train them, you know, they're gonna be ready to go even faster, right? That'll be important aspects. We think that share of voice is really important, right? I think there's such an unmet need, but there's still such a lack of awareness.

I've been with several cardiologists or cardiac surgeons and just questioning like, "Okay, is this an opportunity? Is there an unmet need here?" Across the board unanimously, actually, a lot of people don't even know it's approved as FUROSCIX® on-body. That's where we're starting at, the hospital systems, the integrated networks. They don't even know this product's on the market. The community docs know because that's where SC has been. But we got a lot of work to do on the other side, and the good news is nothing but positive receptivity on the customers. The question isn't how big it is gonna be, it's how fast can we make it.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yep

Mike Castagna
CEO, MannKind

There.

Roanna Ruiz
Senior Biotech Analyst, Leerink

That's great. Thinking about the auto-injector, let's say everything goes well, it gets approved on its PDUFA date. You've talked about previously a preference to drive, you know, pretty strong conversion from the on-body infuser to the auto-injector. Just could you frame how quickly do you plan to do that? What are some of the steps you need to go through, and how should investors think about this change?

Mike Castagna
CEO, MannKind

We haven't made a decision yet what that looks like. We think there might be a segment for the on-body infuser and a segment for the auto-injector. You know, some market research we're doing to kinda understand the size and reasons behind it. Some doctors believe, "Hey, an infusion's good. Okay, great, here it is." Some doctors, and I think more the nurses who have to deal with the training say, "Oh, an auto-injector is easy. GLP-1s, everybody's using them today." I think the auto-injector by itself is gonna create a new segment. Is that more the hospitals? Is that nursing homes? There's a whole bunch of use cases, I think, that make that easier.

We feel pretty good that either both of these products will coexist, and we'll continue to see them into the future, or there's a real strong reason why one needs to fully push the other. This is an acute treatment, right? If the decision was to go ahead and convert, well, within 10 days, we can pretty much convert most of the patients over, right? There's an incentive for us to drive the conversion from a cost, but I think we gotta make sure that we're serving the needs of the patients and the providers and the health systems. I think the upside of the auto-injector is huge. You know, whether that means the on-body infuser stays a stable, steady business, or do we drive it faster, we'll see.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yep.

Mike Castagna
CEO, MannKind

Those decisions will be made closer to launch.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Got it. You alluded to this a little bit in terms of benefits on cost. Thinking about the COGS impact of a possible, you know, gradual shift between the on-body to the auto-injector, like, what does that sort of advantage look like over time?

Mike Castagna
CEO, MannKind

Yeah. If you just took our $110 million number this year for simplicity's sake, and you said you got about 30% COGS, right? That takes you to $33 million. We probably reduced that by 70%. You'll go from $33 to $9, and that drops right to the bottom line. It's pretty significant cost reduction that allows us to take that capital and reinvest into our business, right?

Roanna Ruiz
Senior Biotech Analyst, Leerink

Mm-hmm.

Mike Castagna
CEO, MannKind

Again, there's a huge incentive, and it could happen quickly, or there's a need, and we can grow faster over time. That's important as well. We'll make that. There is a huge COGS difference. Yeah, this year we're making big investments to get this off the ground and do it right, and Afrezza as well. As we look into 2027, you know, we're still gonna be roughly cash flow break even for the year when you take away the debt payments for Blackstone. When you look for the year, we'll be okay, and then that investments will start to pay off next year.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yep. Makes sense. Thinking about the competitive marketplace a second, I know there's some new form factors coming through for diuresis, and there's a company called Esperion that recently acquired an inhaled diuretic. I was curious if you have any thoughts about how the treatment paradigm might evolve over time, you know, thinking about FUROSCIX®, et cetera, and competitors.

Mike Castagna
CEO, MannKind

I think any market, there's room for two or three players. I think then let the markets compete each other but I think it's not around competition in my mind. There is such a lack of awareness on the treatment paradigm opportunity that, you know, there'll be some people who may want that product, there'll be some people who want our injector, there'll be some people who want our inhaled. At the end of the day, I don't. I think raising more awareness around this as a disease condition, right, and how do we treat at home or how do we get people out of the hospital is a great thing. You know, their form factor is interesting.

I think the challenge is that they only have healthy volunteer data, and they've never really had inpatient heart failure patients. We really don't know what the real diuresis is in a really critical setting, and I think that's gonna be an important data set they need to generate, because you can't just say, "Oh, what's in healthy volunteers, it's the same." These people have edema, they have fluid overload. We've done those studies. We've shown the diuresis is the same and that bioavailability is the same. That is not necessarily true there. When you gotta look at the bioavailability and the pharmacokinetics, you know, do you need four of these nasal things, eight of these nasal things, 12? I'm not sure.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yeah.

Mike Castagna
CEO, MannKind

You know, there's a play there that the market will figure out. We've already started working on our own inhaled version. People do like bumetanide, and if they do like it, great, then they're gonna like our inhaled version even better. We've already prepared that if that's an opportunity in the market, we will be able to serve that market need. I think when you look across the board, we're gonna be taking our delivery platform that delivers an IV-like experience in our own dry powders, just like bumetanide naturally does in IV. We're gonna have that, we're gonna have the auto-injector, and we're gonna have an on-body infuser. We're gonna satisfy the needs of the whole segment, and I think that's what's important.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yep. I hear you. I'll switch topics to Afrezza for a bit. Thinking about how it's performed so far, I think you've framed it a little bit of a shift from profitability mode to growth mode in the near term. Could you just frame what does that shift look like in practice, and what are the main drivers behind that kind of momentum?

Mike Castagna
CEO, MannKind

I think when you look, we came out of COVID on Afrezza, and we cut a lot of cost against it, because we actually thought we were gonna lose quite a bit of sales. What we saw in COVID was actually sales went up, which we were surprised by because reps weren't out there, doctors weren't seeing patients. Some of that was probably the lack of sampling, and all of a sudden people had to fill scripts. Then we came out of that, and we just never saw the productivity come back from the sales force. We kind of said, "You know what?

We're gonna make it profitable." We actually, you know, went to bare bones infrastructure to kind of keep it running and kind of keep it going $7 million-$10 million a year, well, 'cause we wanted to wait for the children's data. Once we knew in December when we had the kids' data, we kind of said, "Okay, it looks pretty positive that we should be scaling this up." The reason we did that, we always believed two things. One, it was underdosed, and two, children were the way to the future. When you look to the history, Alfred Mann with MiniMed, which just went public again, how ironic. You know, that was formed in the 1980s, but the pumps really got adopted in the kids' 1980s, 1990s, and 2000s.

What you saw is from the 2000s on, it all became adults. That's where the growth was, and now we have a $5 billion pump market. CGM started in 2008 all the way through 2018 was mostly kids. Dexcom, you know, $5,000-$10,000 a year kids treatment, and now it's a multi-billion dollar category with everybody. Omnipod did the same thing. Started with kids, called podders, and invested in that and started growing, and it's been compound ever since the last eight years I've been watching them. That there's three examples where, you know, children and doctors and parents are way more progressive than the adult endos. These kids are gonna watch social media. They're gonna go to camps. They're gonna see their friends. They're gonna be on the internet, right?

We gotta make sure that that experience at launch is so frictionless and so seamless that people are excited to try it and they have good experiences, right? If it's launching like a clunky wheel on a car, it's, you know, Yugo or something, it's not gonna be fun.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yep.

Mike Castagna
CEO, MannKind

We'll launch when we're ready. We'll hopefully get the approval here in May. The FDA's sending us IRs. Everything looks positive so far. But you never know, it's the FDA. We'll keep answering them, we'll be prepared to launch as quickly as we can after the FDA approval. But we're pretty excited about that opportunity. So what you saw in the investment, we started hiring people in Q4. You saw that expense already, and we have optionality now as we go through the year. How big do we think consumer push should be? Do we think that's gonna be necessary? How fast can we go? So these are now the double click downs that we're doing.

Roanna Ruiz
Senior Biotech Analyst, Leerink

With the approval potentially coming, just kinda digging in here, and you mentioned the pediatric data, how are you gonna leverage some of the main takeaways from the data as you go into the pediatric launch for Afrezza? You know, what sort of penetration rate are you sort of expecting initially?

Mike Castagna
CEO, MannKind

Yeah. I think a couple things changed in the last 90 days. Number one, in December, the ADA changed their standards of care and put Afrezza directly into the chart where it says, "You must do this stepwise approach," and now we're equal to a pump and we're equal to multiple daily injections on the guidelines. That's a big change. We gotta get that into the payer's mind so they can see that and start to fix some of the prior auths. Number two, we got a label change in January for doubling our dose right up front, and that was a big 8-year battle with the FDA in terms of how can you double the dose and not cause more hypo?

Because that's what we're trained, that's what everybody believes, but that's how underdosed Afrezza was and that was our education and these trials we had to do to show the FDA that we could actually double the dose and not cause more hypoglycemia. That was important for two reasons. We used that method for our trial for kids, and so we didn't wanna have a conflict in our label for kids starting dose and what we had in our label. That starting dose label was important in preparation for the kids. Those are the two things that are now done, right? Now you got the third with the actual approval coming. There's a lot different commercially, clinically, and education-wise that are out there.

I think finally, in terms of data, the ped endos are saying, "Look, I don't need better efficacy. Your value proposition of no injections, take it when I eat." Think about school nurses, think about kids snacking, think about the grazing, think about the sports knocking off pumps. All these use cases in kids are incredible. So far we're getting feedback, and we've done market research three times over the last five years. Right now we're doing it right before launch to confirm. They're telling us 20%-30% market share. We've said previously, historically, 10% market share is about $150 million. If you got to 20%, that's $300 million just on that segment. You got $75 million in kids and, I mean, in adults.

You're talking $300 million-$500 million in the not too distant future. Is that gonna be ramped up in the first year? Is that the three-year? I think that's the work we're kinda trying to triangulate still, but.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yep. Yep, got it. I think I'll switch to some pipeline questions too. You mentioned 201 I think briefly earlier, and wanted to ask a little bit about the INFLO-1 study. You know, what would constitute a clinically meaningful signal, and can you update us on FDA feedback so far regarding U.S. sites for the trial, et cetera?

Mike Castagna
CEO, MannKind

I think on the, if you go back, 'cause a lot of people don't know, we have not published a lot of our data, so people wonder what we have. I'd say first, you know, people should know we did a bleomycin study years ago showing, you know, was it comparable to oral, right? Those studies are hard to do, but it's probably the only thing that we have some hope on in that. We killed another compound years ago we worked on because we just couldn't see any activity in bleomycin. We're not afraid to kill things.

Then we did a healthy volunteer study, and we got that data, we shared that with the FDA this April, and they said, "We'd like you to do an IPF patient study." We said, well, we offered that up when we came out with the Naïve, and if you told us, we would've done that first. We had to go. We went, we were like, "Do we go back and argue? Do we just do it?" We just went ahead and did it. That's what's going on right now. That study's gonna do two things. It's gonna show us that the doses are tolerable, and it's gonna show us what the FVC impact could be or FEV1, and it's gonna show us what the cough rate is.

We know from the healthies the good news is there's no diarrhea, so if there's no diarrhea in healthies, there's not gonna be any diarrhea in this population. We know that that is good. Number two, we know our goal on lung concentration. We have some early insights from Avalyn 'cause they have presented their data, and so we know what their target dose is, we know what their lung concentrations are, and we know what their animal data shows. The good news is our data looks as good or better than what they have in their IC50s and stuff they showed. We feel pretty good that, you know, two different companies independently came up with a rough target dose that's correct. That's a de-risking event that I'd say.

What we don't know is, does that dose actually work, and that's the goal of the phase II program, which again, we'll have those results late next year in the phase II. Then I think and then also in the healthy volunteers, we could see there was some mild cough, but no one really dropped out major for cough or had bronchospasm in healthies. Now we'll be seeing, can we replicate that data in the IPF population.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Mm-hmm.

Mike Castagna
CEO, MannKind

So far we have four or five patients enrolled. They've dosed through day seven and they seem okay so far. Let's watch it. Let's get all 24 and we'll have that data here in the second half of this year.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Sounds good. Maybe to help frame the opportunity, could you talk a little bit about the differences between inhaled nintedanib's potential and oral nintedanib in IPF, and is there, what's the thesis behind improved tolerability, you know, higher local lung concentrations? Like, what should we be thinking about?

Mike Castagna
CEO, MannKind

Yeah, I didn't answer your question on the U.S., I just realized.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Oh, yes.

Mike Castagna
CEO, MannKind

And so-

Roanna Ruiz
Senior Biotech Analyst, Leerink

We can circle back.

Mike Castagna
CEO, MannKind

Sorry. We're still waiting for the feedback is the short answer. We'll get it, and then we'll decide if we wanna incorporate it or not, so.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Fair enough.

Mike Castagna
CEO, MannKind

One of the debates we're having is, you know, it's probably gonna cost you another $10 million-$20 million to bring U.S. sites on, and do we really wanna spend that kind of money for an extra quarter of time? I say, even if we can include them, will we actually, right? It may not make sense. We'll have all that depending on the feedback. On the advantages, I think you're right. You hit it spot on, which is, you know, is this a lung disease or a systemic disease? The short answer is most people don't know, or actually nobody knows.

We're taking the bet that it's a lung disease, and I think when you look back at the proof of concepts out there, you got Avalyn, who showed pirfenidone oral, went to pirfenidone inhaled, and showed comparable efficacy, better tolerability. You have Tyvaso, which is given oral, IV, inhaled. We showed that, hey, giving Tyvaso directly to the lung caused a nice dramatic effect here in IPF. I think that concept now of lung-delivered therapy has already been proven twice. We'll be the third time. Hopefully, third time's the charm. We'll be really happy. We feel pretty good about the lung concentration target that we're aiming for. We know we have a delivery platform that works. We know we can scale these powders.

All that feels like it's de-risked from manufacturing CMC, that part, and now we just need to get to the phase II. We're hoping at 12 weeks we'll start to see a delta, but let's get through phase one tolerability, and we should have the first patient in phase II here in Q2.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yep

Mike Castagna
CEO, MannKind

We're excited about that. The last thing I'll say is, we just did some research over the last week just saying, you know, how do you think about the Tyvaso DPI tolerability given the news? How do you think about nintedanib DPI? They weren't aware of it, which was great, so we can kinda get their feedback naively. They said, "Look, I'd be willing to take off a little bit of efficacy for better tolerability," which was a surprise 'cause we're actually aiming for equal or better efficacy. The reason they said is because 50% of these people drop out. They can't tolerate the diarrhea. They don't wanna take Imodium. They don't feel really well.

If you can solve that, and that means I have a few less FVC points, their quality of life is better while they live, that's way more beneficial to anyone. We feel very excited about this program. We think this could be a real blockbuster.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yeah. Nice. This sounds good. Maybe I'll throw a question to Chris as well.

Chris Prentiss
CFO, MannKind

Please do.

Roanna Ruiz
Senior Biotech Analyst, Leerink

You get a little bit of a break. Thinking ahead, you know, you've got a lot going on. You've got the new factory that's coming. You've got the auto-injector, pushing different parts of the business forward. How would you prioritize just commercial and R&D investment versus balance sheet strength, over time, thinking about the business?

Chris Prentiss
CFO, MannKind

Yeah. We are definitely considering this an investment year, that's for sure. As Mike commented earlier, you know, previously we were running the commercial business for profitability. We've pivoted this year. I will say from an operating cash standpoint, we will be, you know, neutral to positive this year. Even though it's an investment, we're still gonna be fine. As we think about really the capital structure right now, the update from us last week was that we paid off the stub of our convert. Really we have, you know, cash flow generating business, and we have a five-year term loan with Blackstone that's due in 2030.

We feel very good about really what the balance sheet looks like now and, you know, the ability to invest in both of these launches as well as moving the 201 program forward as quickly as we can. It's been good to be here and to be in a position of strength to do that.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Yeah. Sounds great. I'll zoom out for a bigger picture question for both of you. I mean, what do you think the market still underappreciates most about MannKind today?

Chris Prentiss
CFO, MannKind

Can I say two launches and a development program?

Mike Castagna
CEO, MannKind

Everything.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Sure.

Mike Castagna
CEO, MannKind

No, I mean, I think, look, we've been trading at the NPV of the royalty, which is a couple years ago we sold 1% of the royalty because it wasn't public what it was, and so we felt we were undervalued. Back then, we were $800 million as well, and we're like, "Come on, guys. Like, the royalty's worth a lot." We sold it, and people saw that. Then you had a lot of investors buy in either for a hedge to UT or really the royalty stream, and they thought they had the upside in these other things. I think when you saw the exits last week, it's because if you have a partner who said, "Hey, we're gonna be moving in a different direction," they exited, right? That's natural. There's no buyers to pick up that much stock quickly.

I think there's an overreaction in the sale price. You could see insiders bought last week, so that can tell you some upside as we feel the board and the executive team said, "We believe in our future. We're not dead. We're growing. We're excited." I just think what they're missing is really just value in the company outside of Tyvaso.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Mm-hmm.

Mike Castagna
CEO, MannKind

Right? I mean, it's that simple. We got real assets. We got real growth drivers. We got 15+ years of IP in front of us. There's no generic entrants coming for things we're doing. We got difficult to make products. I think we gotta show the launches can actually do very, very well, and I think the stock will rebound incredibly well.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Sounds great. Looking forward to seeing more updates.

Mike Castagna
CEO, MannKind

Thank you.

Roanna Ruiz
Senior Biotech Analyst, Leerink

Thanks again. I think we're out of time.

Mike Castagna
CEO, MannKind

Thank you for having us.

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