Alright. Good morning, everyone. Welcome to day two of our Cantor Healthcare Conference. My name is Olivia Breyer. I'm one of the senior biotech analysts here at Cantor, and we're really excited to have MannKind with us. We've got CEO, Mike Castagna and and CFO, Chris Prentiss. Guys, thanks so much for making the trip. Happy to have you. Thank you for having us. So busy times at, at MannKind. You're you're off the heels of Teton two. You're off the heels of of announcing a big deal. Maybe just set the stage. I mean, what what are kind of the top priorities at this point as we get into the back half of the year and and really into 2020 Yeah. I I think as we kick off the back half of this year, number one is the acquisition integration and making sure that's that's that's on point. You know, when you do these types of acquisitions, integration is key and they can make or break things. The second thing is we actually have a label change coming up for Afrezza. That is important. We want to see that. And I think the third thing is now all the Teton data coming in. And so how do you make sure you're scaling up manufacturing? You're preparing for emergency supplies as UT gets ready for that? Any support that need on bridging study. And then our continued work on that, we announced another deal with them on formulation of a new opportunity. So that's another thing we got going on in q four. So busy back half here. Kind of Labor Day just started a sprint, and now we'll be running a marathon for the next eighteen months. Busy is good in in this market. Well, let me ask you. I mean, what what do you make of the TETON two data? Obviously, only top line so far, but but what's your take, and and what's your level of of enthusiasm just given that you guys do get a royalty economics on the DPI of of Tyvaso? Yeah. I I think for us and you and you made a bold call, so congrats to you first of all for getting out ahead of this. Congrats to you guys. So we we didn't bake Teton in anything we were doing as a company. Right? So for us, was all upside. If it didn't work, we wanted to still make sure we could fund our development programs and and our growth. If it did work, our job is to deploy capital and figure out how to do that better. Okay. Sorry. They said it might go in and out. So the second one is just deploying capital. So now with Teton results in, I would say we're dramatically derisked in terms of can we fund bigger growth opportunities, bigger ideas? Do we kind of you know, how do we deploy that capital to make sure we're making the best impact? So Teton is all upside from from that perspective. When you look back, June '23, we kicked off a royalties deal, and, we announced that in January. That deal was valued about 1,500,000,000.0 for 10% world 10 our 10%. And there was a $50,000,000 milestone payment to get to 1,900,000,000.0, which is basically if you get IPF, you can get these higher numbers. We weren't willing to sell majority of the royalty or even more of it because we thought there was more upside with the IPF, high discount rate on the on the on these types of royalty transactions. And so when you when you think about that, we were able to preserve 90% of the upside for our shareholders and that looks really good today. And and so that just puts, you know, the company had a call it a $200,000,000 royalty sale if all went well. That's a $2,000,000,000 valuation. Still today, a year and a half later, we're trading below that value. So I think when you look at the company now even with Teton, it's even more derisked and you still got a lot of upside on everything else. Yeah. So so maybe talk about the how you guys are thinking about the IPF market opportunity. I I know, you know, we'll we'll hear more comments from you soon, I'm sure, but you do have a 9% royalty that that you do record. So as you think about the windfall to you all, I mean, what what does that look like? Right? What does the overall opportunity look like in IPF? And then when you think about the, you know, what that translates to from a 9% economics, you know, how big are we talking? Yeah. So I think the first thing that this is wonderful for patients, The results are spectacular. Patients have no options. The options today, they'd rather die than take them. So it's really a tough market for these people. So for us, we're excited about that, number one. Number two, people may or may not know, we have two zero one in IPF, and that's an opportunity that just got derisked. So last year, earlier this year when Avalyn presented their PKPD PD data, we were excited because two companies got to a similar dose independently because that's a lot of the magic you do here. And so that we felt very good. May, if people like that, they're gonna love what they see when we present our data. And then on the the second big question we get is, do you think it's a systemic or a lung disease? And they showed delivering treprostinil via nebulizer to the lung worked, and it worked really well. So we got even more conviction, I think, on two zero one going into patients next year that our IPF program probably looks as good as it possibly could. And so as we look at the Teton data coming out at ERS, we'll be we'll be personally seeing how did the monotherapy do, how did the combination treatments do, how did the sub analysis do, And, that's what we'll be we'll be focused on, as we look at the data ourselves with with UT. Obviously, UT owns the asset. We're just a bystander here, we'll be a happy one. But when you think about this market today, Natinda does about $4,000,000,000, and that's with a huge dropout rate, a huge patient population can't tolerate it. Treprostinil is is a great product, and I think we're gonna see, you know, things that we should be looking for as investors and as companies, like how how how was the dropout rate? How does it compare to the tetanib? And that's gonna give you some perspective. I believe Treprostinil will become the backbone of treatment now. I think this this effect size is really good. Yeah. And and we'll come back to your own internal IPF candidate in in a minute. But as you think about, you know, full details coming out of ERS and and potential success of TETON one next year, that's obviously a a big question as we get into The US readout. Any thoughts? I mean, are you expecting any surprises at ERS? Are you expecting any surprises from TETON-one at this point? Is 95.6 milliliter FEC treatment benefit? I mean, can anybody argue with that? Yeah. I mean, populations are similar that they designed in the trials in terms of demographics. See we're looking at this for our own program in terms of Europe versus US. And so I don't expect a big difference. Could you see a small shift possibly just nature of running these studies? But I think in general what TTOM-one is going to give you is a now two datasets with 1,200 people. Really, a sub analysis will be that much more powerful as you combine them. So for me, I I don't I I just think it'll be duplicate of what we have. So we always felt like even if this one didn't work out, you got a second chance. There could be some statistical anomalies that happen in these types of studies. But the fact that it was so good, right, just gives you that much more conviction And for the second then so I think everybody in the audience knows, but the TETON-two obviously studying Tyvaso as a nebulized formulation, you will get royalties on the DPI formulation. So what's next? Right? I know you talked talked about a potential bridging study. I mean, what what is your conviction in Tyvaso DPI in IPF? It's a question we get a lot. Right? Is there a risk that, you know, the lung function won't be able to in an IPF patient won't be able to handle a DPI? What do you make of that or what are your thoughts there? So so I'd say having spent a lot of time with these IPF patients, and I have a family member who has this disease. They in the beginning, they're healthy as can be, and and and they're taking the meds and they feel healthy. And then towards the end, they start to really, collapse, I'll say. And and that those patients can still inhale two kilopascals for two seconds, which is what you need for inhaler. So it's not a huge burden. Could people get a small cough? Sure. But they cough, that's all they do like every five minutes, right? And so whether they do that, you know, one extra time in an hour every five hours, it's not the end of the world. But I think even today, I'm sure if you looked at the IP the ILD and PH data, I'm sure a third of those patients have IPF already. So you can already see in the real world there's probably people taking treprostinil DPI that are doing fine. And if it's that big of a burden, I mean, think these patients do anything to take the drugs that they they're they're you could take an asthma inhaler. There's just different things you could do if it's really bothering you. Just like they take Imodium to to prevent the diarrhea on the tetanib. They they want to live. And so I think as long as it's generally pretty tolerable, the the cough is not we've studied this in three thousand patients. We've studied in COPD and asthma. People still get their drug levels. They still get the efficacy. They just have a slight cough, but very few people discontinue because of the cough. And and so I think that that'll be it should be minimal, but again, time will tell. Do you think there's a world in which before Tyvaso becomes approved in IPF that we could actually start to see some off label use or an accelerated use, right, in some of those patients that maybe have background pH and an IPF diagnosis? That's what keeps me up tomorrow Because I worry that there's such a large demand out there that when you're dying, you do anything you can do. When you've got cancer, first thing you do is search all day long, who's the best doctor, what are the treatments. I think when you only have two options that aren't that good and you find this one is great, I I think you're gonna see people find this one way or another. And and the data, once it's published and presented, I think it's gonna be hard for insurance companies to say that there's not an effect size here for a drug that's on the market. Or, you know, I'm not speaking for UT to be clear, but couldn't UT create an expanded access program or something like that? So I I think there's a duty to make sure patients have access to this as soon as possible, and given how good the results are, then hopefully that that will happen. So Yeah. And then let's shift gears to your own in house candidate or MNKD two zero one. Maybe just give us the backstory there. Why did you all decide to develop an inhaled Nintentative version or an inhaled version of Nintentative? And then as you see the landscape evolving and you mentioned that Tyvaso may become you know, backbone standard of care, where realistically does does this fit in, and is this more complementary, right, than than competitive with Tyvaso? We've always had the belief that natinib directly to the lung will will work, and so that's been foundation for six years. I've been working on this with the team. I always believed that this would be a combination opportunity for patients. I don't think one drug in IPF is enough. We just don't have additional drugs. So I think as the data comes out, you know, again, monotherapy versus combination treatment, how are those effect sizes different? Because I think when you look at the only data we have today on profanidone and natendib, it just isn't that great because there's so much dropout, there's so much overlapping toxicity, that's probably not the best regimen. But can you get to a Natetinib Tyvaso and how does that look? And I think those are some of the data sets we want to see as the data reads out. My background is in HIV, so I did a lot of combinations in my life. And you look at combination asthma drugs, combination COPD drugs. I do think these combinations will be opportunistic in the future. And you all have talked about kicking off the phase two in the not so distant future. What have you decided at this point around trial design, dose levels, different arms? What background standard of care do you plan to study against or as a monotherapy? So right now we pivoted ex US 100% for the trial. We'll submit it to the FDA. If they want We'll open it up here. But I think by the time we kick it off in Europe and and and other countries, we'll we'll have enrollment. Enrollment should go pretty quickly on this one. We're looking at 228 patients, I believe. So it'll be seventy five we we're looking at, a six milligram daily dose and an eight milligram daily dose. And so those will be, in a bid and a tid. We're looking at different dosing regimens. And, we're looking about seventy five patients in each arm, two to one randomization against placebo, and we'll test the first dose in the office. So I think that that's one of the things that we'll be looking for early in the New Year is, hey. If everyone's tolerating in the first dose, generally, that's where you get the cough. Generally, it gets better after that. And and so I think that'll derisk the program the longer that trial goes on, And we expect to have some top line readout in '27 on that trial. And Mike, why go ex US and then the sites that you do plan to activate? Is there any potential synergy there with what United's doing or do you have you know, active engagement or relationships already with some of those ex US sites? I mean, the good news is there's a lot of CROs who have a lot of good history with IPF because of all the failures, unfortunately. But so it was a tough call because, obviously, the people around the UT trial did a great job. We we we looked at them. We looked at a couple others. So I think we have a great CRO partner that'll be key for these markets. The reason to go ex US is the FDA wants you to have placebo controlled trials for thirty weeks on top of background therapy. It's just not feasible ethically IRB to get these things through the IRBs. You're switching off the standard of care, and so to add the background therapy, you would never finish that trial adding on the profenadone, there's just not enough people. And so we felt that pivoting ex US we actually could go a lot faster and you can get to a placebo trial which the FDA wants. So we took some of the feedback they gave us, incorporated that into what we're doing. So when we do come back, do have the placebo while the first dose in the office, we'll have some early reads on efficacy, and we'll have on top of profanidone. And we're writing the protocol because the BI drug should be approved soon. And so that'll be another drug that we could be on top of, and so we'll look at that as well as an opportunity. So I think when you look at the future landscape, you'll probably see treprostinil and the BI drug, the new one coming out be maybe some more background and then maybe Natinda becomes the add on in the future versus where it is today. Yeah. That's a good problem to have and I guess you'll figure that out when the phase three comes around. What about so for the phase two, I mean, what kind of FEC treatment delta realistically would you be looking for? Or have you disclosed what it what you plan to power for? Yeah. We're we're not we're not trying to power the study to show we wanna see descriptive statistics here. Right? Do we see a trend? We'll do some synthetic modeling on on on the on the comparator. The the twelve weeks will be the primary endpoint of the trial, and we think when you look at the the BI when you look at the TENNET data, within twelve weeks, you start to see the separation, and then it just continues. Right? And so the the patients at twelve weeks on the placebo can roll over to active, so we'll get that arm. And then the people who are inactive can continue on for another another six months. So I think we'll see patients going on for six to nine months, and we'll start to see that delta. We'll look at the combined arms. I don't think we're gonna see a true efficacy difference between the two, but because it's idiopathic, we don't know what it is. We don't really know Natem's activity. Mhmm. Some of the work we're doing is is TID better than BID? Do you see some sub trends? Do you see different combinations? Is it receptor engagement? And and kinda those are some of our questions, so that's why we decided to go TID and BID. We don't expect to see a huge dose response between the two, so combined and we'll look at some subsets. But we'll have one hundred and fifty patients between both arms. And so I think we'll be able to see the delta there at twelve weeks. Yeah, and you mentioned Avalyn, who's another company that is doing a similar approach. Are there any ways that you can expedite the clinical path forward for your inhaled and tentative program or essentially catch up, right, to not that there's a lot of competition out there, but you know, when you think about timelines and when you could come to market and and and the fact that the IPF landscape will very likely and and realistically look different by the time that you come to market than it does today. You know, just just talk us through some of the strategies that that maybe you can implement to accelerate while obviously still maintaining No. No. I I think that's a big reason we pivoted was we we we did we did not wanna wait and argue with the FDA for six to nine months. I did that for clofazamine for a year. Yeah. We we feel coming back to The US for a phase three design, by the time that happens in '27, you'll have, hopefully, Tyvaso DPI on the market, you'll have BI on market, you'll have propranolone. Now we could actually do it on top of background therapy trial in The US. FDA will be happy with that. We'll have the efficacy. That'll go smoothly. The other thing that's in our control is, you know, we're spending a little bit more money on 02/2001 to activate a few more sites to actually go a little bit faster. So that's in our control. We could have saved a couple million dollars, but instead we'd rather have data sooner. We'd rather take some of that risk. We're getting you know, we know this brings the timeline up a quarter or two, and so that's what anything we can do to drive timelines faster, will. But there's just a rate limiting of how long it takes you to activate sites, how many patients come in per site, and then, you know, it'll wrap up pretty quickly. So I think that's number one. CMC, we're in control of. We make it ourselves. We have our own plant. We're not depending on third parties and their timelines and so that's a positive for us. And otherwise I think it's on track to, we should be up and running by the end of the year. And hopefully first patient will be in this year, early next year. We're looking forward to the momentum from that program. So SC Pharma, congratulations on that deal and your financing with Blackstone. So a question that we've been getting asked a lot is why do that deal right before tea time? You know, we we were getting questions around does it change your conviction in your own internal pipeline? I mean, what what do you say in response to that? So so we've been looking for a bolt on acquisition for a couple years. We bid on some we didn't get and some just didn't make sense in the end once we got to the to the finish line. This one, you know, we wanted something more in the orphan lung space to be honest with you. We just couldn't find anything that was worth we don't need to take on clinical risk at this point. Right? So we see a lot of BD deals take on a lot of clinical risk, then you're out. A company of our size, we want a de risked asset that had commercial de risking with what could we add value? And I think that's when you see SC, it wasn't a natural observation, but as you dug in and said, do we have, we're looking for assets that could bring in 100 to 500,000,000 revenue, that we could bring some value to drive a little bit faster. I think that's what we saw in SC is the synergies weren't obvious around diabetes. But as we dug in, we can see the large overlap in people who have diabetes and heart failure, a large overlap in CKD. So how do we increase share of voice? How do we increase the funding for them to accelerate sales faster? Mhmm. Because what we see is a great company with great people, but they were just understaffed, under resourced, under you know, you're in the middle of a launch and you have 40 reps, that's not enough. And then you go to 80, it's probably still not enough to cover two indications. And so that's what we see as a real opportunity that's meaningful around a drug device combo. That's been our background as drug device combos. It's been my personal background in injectables as well. And so how do we, help them go faster and do what they're doing and just do it better? And and I think that that that's one thing you'll see at Bolt On. I think in terms of Afrezza, you know, it is a single product, and and so having two products in the cardiometabolic space makes that a more sustainable business. But there's nothing to me, you'll look at the future of an orphan lung business in 02/2001 and 01/2001, and Tyvaso royalties, and then you'll have the in line commercial business with the pipeline, but I mean, with the online assets. But the big thing for us was diversifying revenues. When you think about MannKind, almost 65% of our revenue was Tyvaso related. So this will hopefully push it to fiftyfifty, but now with Teton, maybe it pushes it faster, I don't know. But these are good problems to have. But I think when you look at MannKind, it's just a good growth story and with optionality. Yeah. And and as you think about the commercial rollout for for the SC Pharma product, where do you feel like you all can add value? I mean, I I recognize that that they had some capital constraints and and that that was probably the biggest burden that they were facing. But as an organization, are are there ways that you feel like you can expedite the launch? Or or are there catalysts coming, you know, whether it's next year or or Yeah. Or this year even that you feel like could actually start to accelerate the launch and maybe create a little bit more of a, know, uptick in revenue, so to speak. So I think that, you know, a lot of people we don't give guidance, is always one of our challenges, right? So I think you can see the CVR here has a 110 to $120,000,000 number for '26. We feel very confident in that range. They felt confident to take on that CVR. And so that that puts a mark in the in the sand that we'll be aiming for. And and I think that's important. And the question is, can can you go faster? Right? And I think sub q will give a better COGS reduction and better opportunity to scale faster. And so if that happens in July, if they get that filed this month, then we'll be really excited to have five months of launch next year. And you can see a nice back half upside to to where they they are. Freeing up COGS would actually give you more money to deploy whether you're removing rebates and restrictions or you're putting more energy in the sales and marketing. I think that that's TBD. It's too really and and for us to give you that guidance. But at a bare minimum, I think they need more key account managers calling the hospital systems. I think they need more reps calling on cardio. They need more reps to share voice on on NEF. And so that's where you start to get to the benefits of the combination, which is we have we'll have 70 reps by October selling Afrezza. We can easily give them more support. And another product, we have Baqsimi in the bag this year. So they're already doing two products. You know, that's not a big deal to help more share voice. And then SC, you know, when you think about what they have, they have call 80 reps roughly, you know, 40 on if you did the FTE allocation, 40 on cardio, 40 on neph, that's not a lot in cardio. You know, these people have hundred, two hundred reps easily. So I think those are the key opportunities and and and there's just no shortage of places that have struggles with fluid overload. And and to me, that's nursing homes, it's hospice, it's hospitals, it's ERs, everywhere you look, there's patients unfortunately struggling with edema, and, there there's there's a big opportunity here. And there have been some challenges, right, around the Part D redesign and and patients having to hit their max out of pocket spend. So are there are there things that you guys can do to smooth that over? No pun intended. Or or or ways that you feel like you can increase adoption commercially while still while still facing the realities of the Part D redesign? Yeah. I actually like where their price point is because it's got a great pharmacoeconomic analysis. And so when they first launched, IRA wasn't in place. Right? It wasn't until they came into this year that all of a sudden they could start to hit their stride. Unfortunately, you know, these single product companies, often struggle in the beginning and then you work out your kinks and then you can take off. And so by the time they got to where they were in Q4 last year on their sales force expansion, you started to see that impact in Q2. Q3 is not out there, but you know, you can assume we can we're excited about the trends that they have, the number of prescribers, the depth of prescribing, the breath the the indication of prescribing. And and to your point, in the beginning of the year, you're gonna have this huge co pay and everyone waits to fill a drug. We see that on Afrezza. But by the as the year goes on, and now whether it's Tyvaso, DPI, Furosex, Afrezza, patients start to refill their drugs better in the second half than the first half. And so they generally hit their max out of pocket. And so I do think that phenomenon is is a problem for all Medicare patients, but the Part D redesign I think is a benefit for patients and we see that even Afrezza got $35 Medicare by law and we could see our sales jumped up 30% Medicare just because of that compliance cost. So it is a barrier to patients and I do think that that's smoothed out. You'll start to see patients. You know, what we hope to see is one day they just keep four zero six in their cabinet. They're gonna need it. It's not a question. Right? They need it. And so when they they hit their out of pocket deductibles, can they wait and have some available so that they're not worried about the out of pocket as much? Yeah. And and to that point, mean, what what is and and now maybe I'm I'm thinking a little bit forward to the more convenient dosing. Right? And and the I guess what I'm trying to figure out is one, what is the shelf life of the more convenient formulation? And two, I mean, this realistically become like an EpiPen? Right? Where patients are carrying this around? Yeah. So I think they want to carry it around everyday but they'll carry it in their medicine cabinets. And so I I think today the product has a couple of year shelf life and that's the point. So carry it around, you're gonna need it within a year or two. Obviously, sixty percent of hospitalizations are because of heart failure, so I don't think that's that's an issue. When you get the sub q, they have two different sub q devices, and so I think depending on how they they flow in the marketplace or approvals, they will have some dating that the the company will will I think that message will be there, and the convenience factor will be there. And and then the other part of that brings is the with the cost reduction, you can actually bring this to other markets. Today, you really can't go to Europe with an all body injector, but you could get there with a sub q. So Okay. And then your other commercial franchise, Afrezza, you did mention that you do have a potential label expansion opportunity coming up. So where does that stand? How are you guys thinking about the pediatric opportunity more broadly? So it's two two steps. So we got an October label change which will give us new dosing in our label, and we'll see if that you know, how that looks and and and that'll be exciting. Because what that does is allows us to actually talk about the postprandial control of Afrezza. We've reduced postprandials over the standard of care by about thirty five percent. We get twice as many people to go, And if you ask most doctors and most practitioners, they don't even know our data. So that's our fault for not getting that out there, and we'll try to do a better job of that going into next year. And then pediatrics, if all goes well, should be accepted in the next month, and then we'll be on track for hopefully a May approval. And our target is to launch that at ADA next year. And I think even when we talk to the adult docs, they agree there'll be a different launch trajectory in kids than as adults. And you talk there's a 500 pediatric clinicians out there. There's 50 academic centers, hospitals, children's hospitals. We're gonna hire a dedicated 20 count person team just for kids and make sure there's no distraction, that they can focus on that. And 39 of those 50 were in our trials. So we have a lot of experience already. Those docs have already come back and said, hey, we're doing the gestational trial because of INHALE three data that came out. We're now doing an INHALE first trial, which is the very first insulin a kid will get ever. So they'll go to the hospital and they get discharged within five to seven days, they'll be on Afrezza. Are being done it'll be 10 centers built to two academic centers. There's Joslyn and Barbara Davis. And so having two of the biggest pump centers in the world actually do inhale first is actually exciting, because people say, oh, it's ten years old. Is anything really gonna change? Well, this is where it's going and if that works out, we'll all be very happy in the end. Yeah. Are you starting to see a shift in the way that physicians are thinking about inhaled insulin more broadly? Because that's obviously been a big pushback, right, is changing prescribing patterns in this market is not easy and not trivial. So what's been the receptivity to some of the latest data you've been putting out? Yeah, I think the new data coming out last year and this year, two things have happened. One, I don't get questions on lung safety anymore. And we'll have a large lung safety analysis coming out early next year. And so I think that'll put that to bed. When you look at the kids data especially, these are growing lungs in a couple 100 kids. We saw no safety signal at all. And and so that's exciting. And that's if you ask me, like, the number one reason doctors are not prescribed inhaled insulin, it's because of lung safety. Even if they don't tell you that, that's why. And so being able to put that to bed after ten years, I think, takes a major burden away. And the second one is patient access. And then and that has been a headache. The payers have been really restrictive. They were getting billions of dollars of rebates from our competition. As insulin prices have come down, that barrier is actually getting reduced. So we talk to payers, there is an opportunity maybe to contract away for peds to open up access faster. There's an opportunity on Medicare because of thirty five hour by law. So I do think the access question for Afrezza will get better. And if we can solve those two problems, do think you'll start to see some more momentum happen. Okay. Great. Michael, Chris, really appreciate it. Great discussion, and and congrats on all the progress. Thank you. Thanks for having us.