All right, perfect. Thanks, everyone, for joining us. I'm Tiago Fauth, biotech analyst here at Wells Fargo. We're hosting a fireside chat with MannKind today. So I have Michael and Chris. Let's kinda walk through a lot of moving parts here. And the story just got a little bit more nuanced from this Monday, right? We'll get there, but perhaps, yeah, you can start with the business. Like, it's funny, like, we still get some investors that we talk about MannKind, it's like, oh, the Afrezza company or just, oh, the Tyvaso DPI royalty play. It's like, a lot has changed, so let's give you a couple of minutes to kinda run down to what the business actually is today.
Yeah, I think when you look back in time, it was a diabetes company, right?
Yeah.
You know, really, the drug device was a lot of challenges, I think, for the company. But I think when you fast forward, one of the things we've tried to do over the last six, seven years is differentiate us on the clinical development side, applying the technology to rare disease, and specifically orphan lung. The UT partnership has continued to blossom nicely, and the last thing you've seen is, you know, how do we diversify even faster? How do we get more catalysts? When we look at Wall Street, a lot of momentum investing, a lot of catalyst investing, and so, you know, we look out, we wanted to make sure we had enough positive things happening, and that gives investors things to look forward to and lots of shots on goal.
So when we look at, you got an in-line brand, you got royalty, and you got a pipeline, so you really got a lot of different things to look at.
Yeah. No, fair enough. And I guess we can probably start with my last question, which was gonna be the scPharmaceuticals acquisition. So you talk about diversification. To be fair, like, some investors just didn't understand, like, all the strategic fit. This feels a little less orphan lung, which is where the core areas of expertise had been in the past. So again, how can you make the business case with the acquisition? How much operational leverage could there be synergies? How are you thinking about that as a part of MannKind?
Yeah. I think number one, when you take a step back, what do these companies have in common, right? Drug device combinations, building on an injectable platform experience in terms of these guys had CRLs, they've learned through those own body injectors and subQ. The second part is, you know, does it have a large enough scale? We've been looking for something for a couple of years, and, you know, it just didn't work out, the ones we were looking at. And obviously, you'd like to have something that just fits nicely with orphan lung, but there's not a lot out there, and not a lot that you wanna pay for, that you're gonna take on clinical risk. We don't need to take on any massive risk at this point. The company is profitable, we're growing, we're diversified.
And so we were really looking for something that had revenue in, you know, in a $100+ million range, that had a big opportunity to scale. And, you know, there's not a lot of those types of opportunities out there. And so we looked at the SC came along, we felt that the team has done a really nice job. They're right in the beginning stages of their launch. And when you take a step back and you look at, you know, take insulin pumps, it's a $5 billion market, and all we're doing is taking a hundred-year-old product, trying to manipulate the profile to get it in the body. You take Remodulin, we get treprostinil in the body, you take Neulasta, we're preventing hospitalizations. These are multi-billion-dollar opportunities, and this thing has that opportunity right in front of you.
Heart failure is a huge market. Lasix has been around for 60 years. This, so this is something I would love, right? Being able to take a device and challenge with the formulation and put them together. It just fits really nicely, and we think it wasn't obvious on the surface around the synergies or the both ones in terms of when you think about cardiometabolic, heart failure, chronic kidney disease, large overlap in diabetes, large overlap in where we're targeting. And, you know, a lot of these patients are also on insulin. So when we think about long-term business, we're kind of all in this cardiometabolic space, and so it kinda fits nicely that way.
And just from a revenue perspective, it's not immaterial relative to your current top line, right? So the mix is gonna look fairly diversified over even the near term.
Yeah.
Is that fair?
Yeah. I think when you look out, we're trying to get to, like, a 50/50 ratio, roughly royalties, manufacturing versus in-line commercialization products.
Got it. No, perfect. That makes sense. Perhaps pivoting to, I guess, I won't call it the legacy business, but prior to SC, again, you were developing your own internal pipeline in rare lung, a nebulized product, the DPI product. To your point, you have expertise with Afrezza, with Tyvaso DPI, deep book of inhaled formulations or drug-device combos. Again, some companies have been less successful in developing good formulations, good devices that deliver reliable PK. What's kind of the secret sauce, and how are you applying that to 101 , 201 ? How should we think about it from a technology perspective, for both inhaled DPI?
Yeah. I think when you take a step back, again, you got 34 years of the company existing around inhalation formulation, technology, and scale. And in that time frame, the team has probably formulated close to 50 products. Some have gotten to Phase 1, some Phase 2, some approved. And so a lot of that magic is around, can this be scaled? Can you get the right dose in? And does it work? And then even once you get there, will the payers pay for it, and is there a population on that need? And so many times, things got killed because they were great drugs, they'd have a fast onset of action, but we didn't think the payers would actually reimburse the proper reimbursement. And I can name multiple things that we didn't do in that space.
But when you take a step back, we try to say: How do we best apply our technology to make the biggest impact on human life? And we felt IPF is an unmet need, NTM is an unmet need. We have our dry powder development as much as a nebulizer. And then what's the core capability around these drug device combos and predicting that dose, calculating that dose? A lot of companies just have not survived dry powder products or nebulizers, and they probably miscalculate. A lot of their animal models are see-through. And so I think it's a little bit more art than science sometimes, and people have unfortunately made mistakes that were devastating. So far, our team has been right more than they've been wrong on their shots on goal.
There you go. And again, for 101, before we go into the actual clinical trial design and a more nuanced discussion. So again, NTM MAC, there was a lot of skepticism back in the day for AZD, even for ARIKAYCE, right? And that turned out to be a sizable market. I think the story has moved on from that on their side, but still, like, a reasonable market, even on the relapsed refractory setting. What is the unmet need, I guess, that remains, right? 'Cause there's gonna be some questions around competition versus ARIKAYCE, why this specific product that you chose, so on and so forth. So what was the unmet need that you guys were searching to close?
Yeah, I think when we were looking at the time, we were looking for what else can we put on the platform that would be scalable, be it an orphan disease and lung. And that's when NTM popped up on our screening, and so we were able to find something, and at the time, we were looking for a license in the dry powder. That discussion turned into a full acquisition, which is how we got Clofazimine back in 2000. And then just had a lot of work to do on CMC and scale and FDA. So all that work got done. We're now in Phase 3. When you look at the unmet need in NTM, you know, there's only one drug approved in the case of ARIKAYCE. It's only in refractory.
Everything in front of us has failed, and everything behind us has failed, so there's nothing else really in development. And I think Insmed's done a really nice job. They launched right in the middle of COVID, which is not easy. They brought it globally, which is not easy, and it's gonna do $400 million-$500 million this year, right? And so thinking about an orphan disease, making a difference, challenging product, and it does have some safety and tolerability issues. And so when we look at Clofazimine, it's a drug that's well known. We know it works in NTM in all the preclinical models and real-world evidence. But then how do you best position it? How do you best dose it? How do you minimize the toxicities that were known of Clofazimine, which is skin discoloration, organ accumulation, and QT prolongation?
Really narrowing that dose down, hopefully getting to the most effective lung-delivered dose. And to your earlier question, one of the things we did was we tested low, medium, high, and all of them looked safe and tolerable. And when we saw AN2 had a problem in ARV, we actually decided to go up a dose higher just to make sure to have a little bit of safety margin, because as much as like we like the team and all the work they've done, you just don't know till you put in patients what happens. And so we actually went to the middle dose and said, "If people can't tolerate that, they can down dose." And so far, 90 patients, nobody's down-dosed yet. And so feel pretty good about the tolerability profile so far, but we'll continue to watch it.
Yeah, but just from a conceptual perspective, this looks a lot more like ARIKAYCE than some of the other alternatives. I saw some of them were novel anti-infective mechanisms, some of them were kind of repurposed. The whole liposomal amikacin, like, you're basically just doing, again, nebulized Clofazimine, which is a drug that you know should work in this indication and just limited by some of the aspects you mentioned, correct?
I think some of the differences is, Clofazimine is very lipophilic, so when it gets into the lung tissue, it gets absorbed pretty deep, and then the macrophages eat it up, and they crystallize, and they break it down. Clofazimine has about a seventy-day half-life, so you load up the lung for twenty-eight days, and then you stop taking it, and then you're off for two months, and then you retake it again. So you got this unique dosing regimen that removes the burden off the patient, solves some of the copay issues, and really, they don't have to clean the nebulizer every day, and we have a dry powder coming. So we hopefully will make that easier, and the dry powder may have a different dosing regimen. We might dose it every day, a smaller dose.
You might load up the lung, take one week on, one week off. We have some flexibility. We'll get the animal models shortly, and then we'll start to look at the dosing regimen for that.
Yeah, no, interesting. And let's talk about the Phase 3 design again. So you went from a Phase 1 directly to a Phase 3 with an interim readout in the middle, right? I guess just from a timeline perspective, I don't think you thought it made sense to run a proof of concept, small Phase 2, and then see it from there. Like, what gave you confidence, I guess, to move, and can you talk about Phase 3 design?
Yeah, I think we don't have any questions that Clofazimine works, right? And I think if you did, you'd wanna do a Phase 2 to kind of get to a tighter size. I think in the end, we were up against competition, number one. We were up against watching two companies take forever to enroll the trials.
Mm-hmm.
We were very fearful that, you know, what if Phase 2 took three years? You wind up killing the drug, probably. So we kind of felt, let's get to the endpoint. If it fails, it fails. If it works, it works. But there's no question it can work, and so all the energy put into a Phase 2, to really not. We didn't think the dosing was gonna show a difference whether you used high, medium, or low dose. So then, what are you wasting two years of a Phase 2 study for? We took a little bit of risk. We actually had originally two doses in the Phase 3 trial, and then we looked at ARIKAYCE.
They only had one dose, and we kinda asked ourselves, "Do we really need two doses?" FDA agreed we can go down to one dose, and it was definitely a negotiation with the regulatory authorities in Japan and other places, but they all, once they saw the data and how we got to our dose calculations and lung concentrations, everybody agreed that it was a sufficient level. And so, you know, there's no, there's no reason to do a Phase 2, to be honest with you.
Got it, and you do have an interim readout, right? So what are you powering that for, and what are the actual outcomes of that? Are you actually gonna see the data? Is it mostly gonna be a sample size re-estimate? Like, what should- how should the street think about that?
Yeah. It's mostly a sample size re-estimate. So as you... One of the things, again, back to the companies that were out there, were taking forever to enroll 50, 60, 70 patients. So we wanted to get this to be as small as possible, but also statistically possible, right? And then, so that got you to about 180 as the smallest you could go, so 120 on active, 60 on placebo. And then at six months, the 60 placebo can roll over to the active. So we'll get 180 patients for minimum of six months, and then, you know, 120 for 12 months, hopefully. So that'll give you a long enough duration of effect. It'll show you any re- relapse breakthrough.
We'll also see some people that enrolled in the trial who may have had a negative sputum, and we'll confirm that it was negative, and then do they maintain negativity and how do people kind of progress, so we're gonna get a lot of information out of here, but in terms of the size reestimation, the number one thing is we'll let the trial keep enrolling until we get to that data point. It's powered a little bit more on the sputum than it is the PRO, because we feel like the PRO is not sensitive enough. You know, you could just find yourself with a large variability, and.
Yeah.
Honestly, we need 500 patients. You'll never finish the trial, so but the PRO so far looked positive with ARIKAYCE. We're using the same one. We're probably using a little bit differently, but I think that that should predict the sputum, and then, you know, we're powering it for a 20% delta from placebo. So as long as we meet that threshold, then we'll be good, and you know, you could see it go from 180 to 210, 230. It's all predefined in the statistical plan, and there's also a futility as well. So we'll know if the drug works or not.
Fair enough. But and there was a lot of discussion with things about ARIKAYCE back in the day about sputum being enough. There was, again, a colleague, there was a lot of discussion around that. So you have both sputum and the PRO as co-primaries. That seems to be a little stricter, I guess, than the precedent that was set before you. Is that concerning at all? Like, how true is that? Do you think it's reasonable? Do you think if you actually just see a very strong signal in sputum and a trend on the PRO, that might be filable? How should we think about the scenarios?
I think, yes. I think as long as the sputum, the efficacy on sputum has to be there.
Yeah.
Table stakes, right? And so then you get into the PRO and which directions is the PRO, what are you measuring and what do you see? And I think some of that will be in the details and how it reads out. We're picking the most bothersome symptom, and then does the patient improve, and they're able to measure against their own self, so I think the way it's being calculated de-risks it a little bit, but to your point, ARIKAYCE got approved with no PRO, so we think that's the baseline opportunity, because as long as you have better dosing, better tolerability, good safety profile, it's gonna be hard for the FDA to say this shouldn't be an option for patients, because without this, there is nothing else, and so we feel good about that.
The rest of the world only needs a sputum and only needs a hundred and eighty patients. And so we feel as long as we hit that 180 mark, we're good to file the rest of the world.
Got it. Okay. And then just thinking about actual commercial positioning here, and there's this, I, I don't know exactly why, but this concern that because of ARIKAYCE, there might not be room for additional players. Like, sometimes I infer that there's always gonna be some degree of resistance in some patients. The sputum conversion rates are not.
Yeah.
They're high, but they're not 100%, right? So what is the, the commercial opportunity here initially?
I mean, there, there's a hundred thousand patients in the U.S. and a hundred plus thousand in Japan. The enrollment in Japan has been off the charts, so you know, even though ARIKAYCE is launched there, we can see that there's a large unmet need, a lot of excitement. In the U.S., it's a little bit harder to enroll because people don't want to be in a placebo trial. People want to try ARIKAYCE first, and you gotta be clean out of ARIKAYCE for a little while to get our trial. But there's a scenario where you'll add this to ARIKAYCE because they're probably synergistic together. There's a world where you probably use it before ARIKAYCE, and there's a world you use it after ARIKAYCE, but there's more than enough patients to build a sustainable business around.
And to your point, you know, a lot of people stop ARIKAYCE after a month or two, right? And so that population is looking for something else. But then you got this huge early treatment population.
Yeah
That we think a dry powder is gonna do nicely. And so that's really one of our goals, is to get the dry powder to a point next year where we can move that into humans, and that'll be exciting because that really opens up to us, the major market.
Got it. Anything that we didn't cover for one oh one before I move on to?
I think you got it all. No.
Okay. So let's talk about 201 , I guess. Nintedanib. So again, kind of a similar playbook. You know, nintedanib has systemic tolerability issues, likely driven by systemic exposure. Theoretically, if you deliver a DPI, you could reduce that. But what is the data that suggests the efficacy is driven perhaps by the positioning in lung tissue? Like, I'm curious if you're not gonna perhaps miss some of the efficacy if you don't have the systemic exposure. That was one concern with Aerovate and some other players back in the day, so.
I mean, I think that is a little bit of a debate out there. I'm actually really excited about the Tyvaso data that came out yesterday because they showed you can deliver a prostacyclin directly into the lung and see a lung effect size.
Yeah.
Right. We didn't have any data on delivering a target to the lung and showing effect size till yesterday. So to me, that just de-risks 201 a little bit. That question will always be there till we get the data readout, but I think we feel good. I mean, I think when you take a look at the other competing program on a nebulizer, two companies independently calculated a dose very comparable, and so we feel very good about the dose calculation. I'm sure the other company feels good. The part we feel better about, back to your earlier question, is how do we have confidence? We know our FDKP, we know our delivery platform, we know where the drug goes, we know how much gets delivered.
That's pretty consistent from API to API because FDKP is the magic ingredient. And so when you think about... We haven't really started PK/PD data yet, but if you like the other company's data, you're gonna like our data better. We really have good, deep lung concentration, penetration. You know, we'll put a publication out next year. We just released our target dose on the Phase 2 at last earnings call. So I think you're seeing we're targeting a six to eight milligram dose. We're looking at a TID and BID because, to your point, is it the frequency of the target? Is the Cmax? Is the AUC? Like, so we wanna make sure we're covering those bases.
Basis.
So that's an example where I would love to skip Phase 2. Sure, but I'd be running a large Phase 3 with a lot of risk. And so in this case, Phase 2 makes more sense. Yeah.
Got it. And so let's talk about the Phase 2 design in terms of inclusion, exclusion criteria, length of treatment. Again, it feels like FDA has been fairly strict around IPF programs overall. So can you just discuss some of those regulatory interactions and why you landed in the current design for the Phase 2?
Yeah. I mean, we honestly went to the FDA with a Phase 2, three designs, and we were optimistic 'cause a lot of the time lost in trials is the activation of sites.
Yeah.
And so we really wanted to kind of build a bridging study, we can keep going and save some time and money. The FDA was adamant that it has to be on top of background therapy and placebo-controlled. And so we kinda looked at the experience out there. We think IRBs will have a hard time approving a placebo-controlled trial for 30 weeks in the US. And on top of background therapy, you would never finish enrollment in the US because you're only replacing the nintedanib, so the only background therapy is pirfenidone.
Good.
And that's gonna be a very small subset of patients. And so that caused us to go redraw what we thought was a possibility, and so we are addressing some of the FDA concerns. We'll go ex-U.S.. It'll be a 12-week endpoint 'cause we think we can get there from an IRB perspective. If you look at the BI data, at 12 weeks, you start to see separation, and then it just continues to build. So that we felt that that was the earliest point you could ethically treat to not stop them short. And then if they wanna roll over for another six months, they can continue on the treatment. So while some patients go six to nine months, some people will stop at 12 weeks, I'm sure. And so, so that's number one.
Number 2 is you could be on top. If the BI drug gets approved in the time frame we're launching this, you could be on top of the new one. You could be on top of pirfenidone. You could be naive. We think a lot of the patients in where we're doing the study, they will be naive while they're waiting for the new innovation to come, or pirfenidone or the nintedanib oral. It takes about 12 weeks to get access, and so we'll be able to run the trial in the 12-week window, get it enrolled quickly, come back to the U.S. And now we're excited 'cause we weren't sure which way Tyvaso was going to go.
Yeah, yeah, yeah.
Now, when you go to background therapy in two years, you got Tyvaso, you got BI's drug, maybe BMS and Pirfenidone. So now you might have four options. And so to do a Phase 3 globally, it comes out much easier. So.
Got it
I think the background therapy will be important then.
Yeah. So it's, it's not just about enrollment dynamics and competing versus... 'Cause again, we had a few failures in IPF more recently.
Yeah.
So you're not actually competing for the patients, it's not the issue. The issue is just optimizing inclusion e xclusion criteria.
There's obviously IPF stuff happening, but we feel like there's a nice window here to kinda get this moving quickly.
Got it. Okay, and what would be, at least from your perspective, a win when you actually get those Phase 2 data? Again, it's not a long enough treatment window. They may see it.
Yeah.
What sort of signal is reasonable to expect, given the shorter duration?
I think you'll look. You know, we'll use borrowing and modeling to kinda show the effect size and how that trends out over time. But there'll be 75 patients in the six mg arm and 75 patients in the eight mg arm. So we'll have 150 patients to do a combined analysis and compare that to placebo. So if you're not seeing an effect size signal in 150 patients, we probably have a problem. And also, we'll be looking at tolerability. So we'll be giving the first dose right in the office to make sure the tolerability is there. So that's the only thing people will be worried about. And so as long as we can show the IPF is, you know, and the DPIs are tolerable, that'll happen pretty early in the trial.
I think that becomes de-risked as you see more and more patients go in. Otherwise, we feel like we've de-risked the program. We're moving as quickly as we can. Clinical supplies are getting made as we speak, and so we'll be off and running hopefully at the end of this year, early next year.
Got it. And, and, you know, we did mention nintedanib a couple of times. Let's, let's dive deeper there. Again, we were skeptical about the readout, turned out to be wrong, so now, I guess you have a different problem to optimize for in terms of manufacturing capacity. You're gonna have more royalties. There's gonna be a bridging study, so what does the positive nintedanib-2, and presumably, nintedanib-1, should recapitulate that, and what does that mean for MannKind overall?
Yeah, I mean, I think it's great for employee, shareholders, patients. You know, we're optimistic we'll get a DPI IPF product for them. From a manufacturing perspective, you know, MannKind's been, and UT's been thinking about this for years. They've invested close to $100 million in Danbury to scale up the facility. They're building a duplicate plant down in North Carolina, so it'll be the only other plant in the world that does what we do. So that, from that perspective, you know, there'll be enough manufacturing capacity to supply the market. We're doing things to make sure we can supply. If demand picks up sooner than later, we'd be ready. So I think from that perspective, it's good.
From a royalty perspective, it's great, but when you go back in time, you know, we sold 1% of our 10% royalty back in January of 2024. Part of the reason was we believed the IPF was gonna be upside to our current stock price, and we wanted to preserve that return for our shareholders, and then the interest rate was very high. So when you look back, you're like, "Okay, this was a good move," right? Because that was a $1.5 billion valuation of the company back then, plus the milestone if we hit revenue that would be correlated with the IPF.
Mm-hmm.
If you look now, if we had 1.9 billion, if Tyvaso is 1.9 billion, we would get roughly a $50 million milestone.
Milestone
Next year on the royalty. So I think that deal, you know, today, would be worth even more if we went out. Interest rates are a little lower, IPF is now de-risked, and the data looks really compelling, so we're really excited for everybody.
Got it. In terms of allocation, I guess, of that money, so you seem to have your hands full with some proprietary, that you have the acquisition. How are you thinking about capital allocation? I'm gonna touch on Afrezza as well, but just right now, it feels like there's a lot of moving parts. Yeah, capital allocation, internal, external, just did some BD. How much is gonna be integrating that business before thinking about the next flag?
Yeah, kind of have a lot of going on as we finish off 2025 and going into 2026. So if you think about key priorities in 2026, it's certainly the integration of SC and making sure that FUROSCIX is supported to the best place possible. So I think that's how you think about the early part of next year. You also have the pediatric launch that we hope will get approval for mid-next year. So making sure that, you know, the sales force and the Afrezza side is supported and ready to go there are kind of the key big priorities. Obviously, we've talked about the development programs as well.
And then specifically, I should have addressed that before, but thinking about nintedanib conducted with nebulizer, you did kind of a bridging study for Tyvaso in the past. Like, what is the strategy there, and how quickly can you guys get Tyvaso DPI on the market with IPF on the label as well?
Yeah, I don't want to speak for UT on that one. They have to negotiate with them.
Okay.
I know they have a plan, but I don't wanna-
Different strategy.
I don't wanna speculate. Yeah.
Fair enough. And again, for the Afrezza pediatric launch, again, it's not a product that gets as much attention, at least in our investor interactions, although, again, our bias is more towards the orphan rare disease side of the business. What are some pushes and pulls there? Like, why could this actually be an inflection point for Afrezza revenue going forward? And how much investment will there have to be before you start to see what's playing out in the marketplace?
I think the first de-risking event will be when the file gets accepted here, October-ish, and that'll be number one. Number two, we're gonna be hiring a dedicated key account management team just to launch peds. When you think about pediatric diabetes, there's about 500 prescribers in the country that treat majority of patients. There's about 50 centers, and we had 39 of them in our trial. So we had a very high concentration of top-tier centers enrolled in our trial, getting that experience with the patients, seeing the data firsthand. When you go back in time with diabetes, even though pediatrics, when you think about type one diabetes, they're 5% of all mealtime insulin prescriptions, the pediatric segment. But the type one market is 50% of all insulin prescriptions.
So when you think about the insulin at a macro level, half is type two, half is type one, but the peds is what influences the other 95%. Because if you're using insulin for type one, why would you not use it for type two? And everyone says, "Oh, GLPs is gonna replace t he insulin market is still flat. It's not going down. Diabetes is a pandemic in this country, and GLPs are not gonna cure it, unfortunately. We're just seeing, you know, good demand. We're seeing patients, yeah. Patients may use less insulin because they're on GLP, but the first thing that's gonna go is their mealtime response. And so we still feel like there's a good opportunity. That's some of the work we're thinking about, is to use Afrezza on top of a GLP. We're looking at gestational diabetes. We're looking at, obviously, the pediatric, and now we're gonna be looking at the very first insulin you get, newly diagnosed kids. And so when you think about the kids in the long-term, twenty-year trajectory of a brand, if you can become the first insulin de facto when you start, why would you go to injectable insulin?
Why would you go to an insulin pump? You're gonna save those options for later. That's how we look at the kids market. You know, Al Mann built the insulin pumps in the pediatric community. Dexcom got their start in the pediatric community. Omnipod got their start in the pediatric community and then went to adult. Name me something that started in adults and then went to kids and became successful. It doesn't happen that way. Afrezza kind of did it backwards, I'll say, unfortunately, and it took us seven years to get this data set in. Once the data came in back in December, and we could see the lung safety was strong, that was the signal we needed, right? We were just waiting to make sure growing lungs and kids weren't gonna have an issue.
We got the fifty-two-week data in June; everything looks great, and so we're excited to get that there. If anyone has kids, they know, trying to get your kid a vaccine, trying to get your kid a needle for the dentist, like, you can't do one shot every now and then, let alone three shots a day, five shots a day, and worry about going low. So we think there's a good use case. I relaunched two growth hormones. That was just one shot a day, and that was hard enough, and that's why you see once-weekly growth hormone. So if you can get to it, it really solve some of this issue with the kids, the timing of the meal, the sports, the active kids; I think there's a large unmet need in pediatrics still.
You talk to the parents, the kids, the pumps are great. They do amazing work, but they're not peaceful either. So I think you'll find that there's an opportunity there that we can play.
Yeah, because I think that was gonna be the pushback, is basically, you are still going against a well-established.
Yeah.
So, what is the selling point that kind of resonates the most, or is it something specific about the data that you think is gonna highlight some of these high-volume prescribers to consider Afrezza for starts?
We anticipated that in the pediatric market, we're gonna hear, "I use insulin pumps." And so we started INHALE-3 study last year. We got that data, and we showed that within 12 weeks, switching off an insulin pump or MDI, you got more people to goal by coming off the standard of care, as opposed to staying on the standard of care. And so for me, it's frustrating to see that even when you show data, right, how do you get these people moving? But you've got now data showing more people get the goal switching off a pump, and these were Omnipod, Tandem. They weren't like old pumps. These were the latest AID systems. And so showing people that you can use a basal like Tresiba plus Afrezza is great.
And so that becomes part of an economic argument for the payers to make sure you're covering the product for kids. And then the other part of the pumps is, you know, we saw in our studies, if you had a higher A1C, pumps are great because they give you some insulin if you're not doing your job and keeping track of everything, at least they're helping some patients. But, you know, we've never seen data that showed an insulin pump was better than the old pump or an insulin pump was significantly better than MDI. We can't find that data set. And then, so now we actually have a data set showing you inhaled insulin is as good or better in populations. The guidelines that got updated last year just put Afrezza equal to injectable insulin everywhere.
I think they'll get updated again this year with some more support. You know, I think Afrezza from a clinical viewpoint is gaining traction. You're seeing KOLs get behind it. They're coming to us with ideas for studies. You know, we got a lot of positive things happening. But, you know, it's good. People don't expect much on Afrezza. Keep expectations low. We'll be prudent with it.
It's probably very early to talk about potential guidance or anything like that, but just in terms of the size of the opportunity relative to your current revenue base, is there a good way of trying to common size it at peak? Or how to think about the trajectory and how long it might take to get an inflection point?
I think as we get closer to launch, we'll give more guidance. I think the guidance we gave for now is every 10% share in kids is roughly $150 million net revenue. And so we take that, plus your adult, you're getting into the $200-$300 million range. And then the obvious next question is, well, can you get 10% a year, six months, two years? How long is that gonna take? And that'll be all part of our guidance as we go out to next year, you know, make sure we get the label we want, make sure we get the timing we want, and then we'll feel good about the trajectory.
But in terms of build-out of commercial infrastructure and also, I think that's already gonna be just a plug-in.
Yeah.
Yeah.
No, we're hiring KAMs in Q4. We have BAQSIMI. People forget we're promoting that this year for Amphastar, so that allows us to get into the pediatric market, allows us to get into certain offices. So we're building up the infrastructure to continue to support that product, let alone our needs. And BAQSIMI's had some nice growth this year, so I think you can attribute because a lot of people say, "Well, can MannKind really commercialize things, right?" I think that's an obvious question when you look at Afrezza. But, you know, we've chosen not to invest in Afrezza to fund the pipeline. So these are strategic trade-offs that we made, and I think those trade-offs are paying off today. And so they're.
Got it.
They're hard to live through the years 'cause you know you can grow faster, but you gotta spend a lot more money, and where's the balance you're gonna constantly?
Fair enough. Any last topics or aspects of the business that we haven't discussed? I think we've covered a lot of ground, but just anything else that you think is misunderstood by the street?
No, I think if I had to summarize MannKind, think about us as a diversified company, many shots on goal, royalty providing some downside protection with the optionality of a pipeline and launches next year. And I think most investors would like a stable company that's profitable, that's growing. We don't understand why we don't see more good, high-quality investors jumping in, but you know, we'll keep moving forward, and people will catch up to the story as we track it.
Thank you. Yeah, fair enough. Also, we can probably leave it at that. So again, I appreciate the time.
Thank you.
Yeah. All right.
Thanks for having us.