Good morning, I'm Sam Jones from the Morgan Stanley team. I'm excited to have joining us today, Mike Castagna, CEO of MannKind. Before we get started, I'll read a disclaimer. This is research disclosure. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. Mike, thanks very much for being here today. To start off, it would be great if you could provide an introduction to MannKind, maybe a quick overview of the great progress that you've made over the last few years and where you stand as a company today.
Yeah. No, thank you. Thanks for having us today. MannKind's been around 32 years this year. It's been a long time coming. It was originally, an inhaled insulin company platform that really was repurposed back in 2017 when we decided to fund Tyvaso, or at that time, it was called treprostinil or TreT, for, for phase I study. And then we moved quickly into orphan lung in 2019 and purchased our first company back then. And we've really pivoted the whole company to, to focus on orphan lung with kind of a diabetes optionality and, and Tyvaso DPI got approved last year, and that's really brought in a new revenue stream into the company to help fund our innovation. So it's been a, you know, a storied company, had a long, long, history.
Unfortunately, a lot of people still think of us as an inhaled insulin company, and, I think day by day, as we see our revenue grow, you know, that becomes a smaller part of the company. Still an important part of the company, what I'm sure we'll talk about today.
Great. And your recent Q2 earnings were a great example, I think, of the progress that you've made, achieving revenue contribution from three separate products. Obviously, strong growth from Tyvaso DPI and reaching positive operating income. We'll come on to the products in a bit, but I think just first on profitability, you know, it's been a big focus. As we mentioned, you've reached positive operating income. Kind of how are you thinking about the plan going forward in terms of investing in the business versus a focus on profitability?
Yeah, I think our number one focus is to ensure we don't need to raise capital, so we have a pretty robust pipeline coming. We've kind of committed to the street that our diabetes business will be cash flow break even, roughly by the end of Q4. As we look forward, our number one focus is making sure that we can fund our nitazoxanide program and our clofazimine program. Those are two important products.
If you're really gonna wanna try to 10x the company in terms of revenue and market cap, you've got to invest in innovation, and I think that's really where we are now, is we feel the cash flow positivity, the investments we've made in diabetes will start to come off the P&L next year in terms of the research studies, and then the clofazimine will kick in, and then nitazoxanide kicks in. So, we have a nice segue of opportunity to kind of continue to manage the expense base, fund our growth, and maintain our cash balance as best we can. But we have no intentions of raising money and, you know, I won't sacrifice the long-term growth of the company for profitability, but it's not gonna... You know, it'll be important to be profitable.
Our shareholders have hung in there a long time, and they want to see us continue to grow that profit, but that- that's not gonna come with the sacrifice of growing the company. But we, we definitely make sure we're self-sufficient and independent versus relying on the capital markets, which have been pretty tough the last couple of years.
Great. That makes a lot of sense. I guess shifting into the technology and the portfolio, can you maybe start by giving an overview of the Technosphere technology, kind of how it's used, how it differentiates, how that translates into benefits for patients?
Sure. So as you can see here, we have an inhaler, all proprietary, platform to MannKind. It has cartridges that are proprietary to us, the filling, the finish, all the manufacturing is all proprietary. You know, we spent a couple of billion dollars to get to this point, and now we're adding Bluetooth technology to our inhaler. I've been playing with this app, our team built called BluHale VIS, and we're using it in our new in a diabetes route called INHALE- 3. It's the first time we're seeing real live data on patients, how's the CGM working, how's your correction sugars, what you're dosing, and then you can print out a report, send it to your doctor, your loved one. And just for me, for example, you know, when you think about the platform, taking digital information and insights.
So I started looking at my own sugars, and I realized, like, every Wednesday and Friday, things are a little off. Well, why is that? I pick up my kids, we have pizza on Friday nights, it's probably fast food when I'm picking them up from sports. So you're starting to get insights. It's like, okay, I can probably increase my insulin a little bit better on those days and, and then make sure I'm having better coverage. And that's ultimately, it's about how do you use technology to improve your sugars? We're not wedded by our platform. As evidenced last year, we bought V-Go, which is a diabetes patch pump device, and that delivers basal bolus, and it's doing great.
That's another example of how do we continue to bring innovation, how do we help more patients, how do we make sure our sales force is efficient? And, you know, that was a really exciting acquisition for us. Very small one, but meaningful. I think it did almost $22 million over the last 12 months in revenue. And the same thing, like we bought QrumPharma years ago, which has a nebulized product called clofazimine. We had to build a whole new capability around nebulizers and manufacturing, suspensions, things like that. So we continue to expand the company, not just from an inhalation platform, but just purely technology and capabilities. But we do have a pretty large infrastructure dedicated to making inhaled therapeutics. And the good news is, for our shareholders, they've already paid for that infrastructure.
Mm-hmm.
Our ability to move another asset quickly through the pipeline, you know, in terms of manufacturing, CMC risks, build out equipment, that's a sunk cost in this company. So, that does make some efficiencies where other companies have to build all that. And we went through all that time. It took a lot of time to get this factory built, and now we can actually just put more products in, which also makes the company more efficient.
Great. Yeah, no, fantastic progress. So maybe, yeah, moving to the programs and maybe first focusing on orphan lung, Tyvaso DPI in particular, and there's been a lot of focus on that and obviously the launch over the last year. For those unfamiliar, could you maybe just provide a quick intro to the product, kind of where it's currently approved, and the relationship with United as well?
Sure. For those that don't know the product, it's we used to call it TreT. United Therapeutics licensed it in 2018, and that was a large upfront payment plus milestones over the last couple of years, which really helped MannKind. United Therapeutics has been an incredible partner. They're a leader in pulmonary hypertension and orphan lung, trying to grow lungs in the future, and organs. The launch of DPI has done phenomenally well. You know, we had a forecast, we worked with our partner, we make sure we try to deliver that forecast, and the more we looked and the more the demand came in, the more new patients came in, the more conversions happened. So it's been a great success story.
You know, we had to work our butts off to keep ahead of manufacturing this year, but we've done that. We've done a really good job. The team has worked night and day, literally, to keep ahead. And, we're helping a lot of patients. I mean, there's a lot of great, great stories on Tyvaso and how it has helped them get off their nebulizer, how it's helped them live their life, go visit their family. A lot of these patients can't leave their houses, right? They're very sick, they're afraid to go too far, and, this has really given them a new, new lease on life. And then you combine that with, United got new indication ILD last year.
That's been a lot of growth for them as a franchise and ultimately for us in DPI, and that continues to do well, and that's a new population with no therapeutic options. So it's, it's really cool to see our innovation now in thousands of diabetes patients, thousands of PH and ILD patients, and it's gonna keep going. I mean, you know, the hard part is saving the company like we did. The better part is now launching products, saving lives, making people's lives better, and success breeds more success, and I think United Therapeutics has done an amazing job. And the next big study they have is IPF, right?
We're in the middle of a very large expansion in Danbury, Connecticut, where we're building a $60 million, you know, scale-up facility to handle the future demand of the product that should be coming online. It'll finish later. Early next year, I'll say, in the spray drying capacity next year. And so that's gonna, you know, continue to supply Tyvaso into the upside scenarios that we can see in the short term. And then United Therapeutics is building a duplicate facility, which I think is important. You know, if you're gonna have a multi-billion dollar asset, you don't want one single point of failure, which would be our one factory option.
While there's multiple parts of the factory for them, you know, at the end of the day, God forbid, lightning strikes, you want to be able to save as many patients as you can, and I think having that duplication is gonna be important. So they've announced a $500 million investment, and really to get ready for IPF. I think we can handle the future demand in the current facility we have, but if IPF hits, that could be 100,000 patients, which is extremely huge and beneficial to people, so, and MannKind.
Right. Yeah, no, congrats on all of that and, you know, the successful launch as well. I guess maybe just yeah, thinking forward in terms of IPF, kind of can you kind of outline the timelines that we should be thinking about there?
Yeah, I don't want to give guidance on United Therapeutics' timelines. I mean, that's their role. I think they've said they'll they expect to finish up enrollment late next year. So someone should double-check that, but that's what I've heard, and we're gearing up to make sure we can supply, and that... Because these patients have no options. 80% die in five years. So I think if there's good data, people are gonna be clamoring to get a hold of it because they really have no options. And the current treatments out there, as we'll talk about in a second, is just they don't have very high tolerability, they have 50% dropout rates, and so there's a lot of side effects. And so I think these people need something else, right?
Whether it's single use or combination use, it's gonna be important.
Great. Maybe kind of switching to the pipeline, still within orphan lung. You've talked about there being a focus on R&D over the next few years. You obviously hired a new head of R&D, and you've mentioned kind of aiming for one launch per year, starting roughly in 2025. I guess maybe can you start off, talk about the general strategy with the pipeline and kind of how you see the pipeline developing going forwards?
Yeah. In 2019, we pivoted to orphan lung, and then COVID hit, which unfortunately is gonna create a lot of lung disorders in the future. The other thing I learned, I was meeting with one of the IPF experts the other day, is a lot of these immunotherapies in oncology are causing interstitial lung disease and IPF longer term. So people are surviving cancer, but now they're getting another downstream effect. And it's probably related to the whole immune system and what's causing some of these things in the lung. But we pivoted to orphan lung, and so when you look at our pipeline now today, you know, first up is clofazimine, which is nontuberculous mycobacterial. That had a slight delay in... We had a fire, unfortunately, at our partner in Germany, but we've now moved all the equipment.
We've inspected everything, we've installed it. We had a clean room available, fortunately, so that saved us a lot of time. So now it's, we're running test batches, and hopefully, that leads to a lot of stability next month. And if all goes well, we will plan to launch this in Q2 for a clinical trial. And the good news with the delay, you know, Insmed announced positive data last week on their quality of life questionnaire, which was critical for us in FDA feedback about, you know, can this tool be validated? Is it gonna work? And that just de-risked our program, that news, that it did show a correlation with speed of and quality of life. And then the other parts, we continue to look at the programs enhancing with the new head of R&D.
So Burkhard is looking at everything from top to bottom. Where does he see gaps? How do we continue to de-risk the programs? And we're super excited about the overall pipeline. But clofazimine is gonna be, I think, a really meaningful opportunity for patients. The FDA has been very supportive. In fact, we're gonna be activating sites next year and getting ready, and hopefully, start warehousing patients for the trial in Q2, so that when the trial does turn on, the contracts are done. We're not arguing with finance people to get contracts, and I get that, which could take six months. The next thing in the pipeline is nintedanib, which is an oral OFEV out there today with Boehringer Ingelheim, a multi-billion dollar product. But the big challenge is, half the people can't tolerate it.
They're really at the max dose from the GI toxicities, and, you know, I've watched my family members suffer. It's really a tough disease. We believe the inhaled version will be able to dose higher into the lungs and hopefully minimize any GI, and these are two big benefits that are unmet needs. And even though there's, you know, United Therapeutics will be probably next up in IPF readouts, Boehringer Ingelheim just had some positive data this year. Even their new asset has about 40% GI side effects. So we see that population still continue being on that need, you know, even if pricing in that environment changes. I think we have a unique product that really helps patients in a simple-to-use dry powder version.
And the good news is, when you think about the platform, thousands of patients and doctors using it on PH-ILD. Now, by the time we come up with IPF, it's gonna be the same platform. So gonna have some familiarity with it, how it uses, how it works, how it trains. So that's exciting. So that's nintedanib. And then the third asset in our pipeline that's up is Pulmozyme, and we made an inhaled version of that. We just got some good stability data that now we can feel confident around moving it forward. And that was a hard molecule to make, but we feel pretty good about where that's gonna go as well.
Great. And I guess maybe just back on inhaled nintedanib, kind of what gives you confidence around, you know, potentially removing some of those side effects and the GI-
Yeah.
side effects in particular?
No, that's a great question. I mean, we... And what people don't realize is we made some of these decisions three, four years ago. That's just how long it takes to do dosing studies, tox studies, formulation work, stability work. And so, you know, people, people don't realize what's coming so fast. Even the thought leaders we just met with last week, they said, "Oh, when are you gonna go into humans?" And I said, "Early next year." And they said, "What? Like, you're that close?" I said, "Yeah." I mean, MannKind is... If you take a step back, whether it's Tyvaso DPI, hopefully, in the TETON studies, that read out positive for UT one day, we'll be there with the nintedanib, and then we have an early-stage asset called TGF-beta ALK-5, which is, we call 501 at MannKind.
You know, we got three shots on goal for IPF, which is a huge unmet need. It's littered with failures, but you ask, "Why? Why believe this product?" And I think we've already done the animal models to show you we impact the wheel in mice and lung. It's really the best model you have, even though they all aren't that good. We saw the impact with our inhaled version versus the oral. We went head-to-head. So that gave us the confidence to dose it into the lung, and then the one thing we think is we can dose higher. The reason is, if you look at the PK and the bioavailability of OFEV, 95% of it does not even get in the body. It just goes through the gut and causes all those side effects.
Only 5% is bioavailable, and of that, even less of it gets to the lung. So we are taking the dose, and our technology delivers deep lung penetration. And we're gonna spread that asset across the lung all through and get really deep lung penetration. So you're gonna want it on the inner, the parenchyma and the outer. And we think that, you know, being able to dose much higher and cover the lung versus an oral formulation has very hard penetration, they're night and day. And so we're trying to minimize the systemic side effects and maximize the lung exposure, and that's really what you want ideally for this disease.
Great. And how should we think about you kind of developing these programs? I know you've talked a little bit about partnering in the past. Kind of how should we think about how you make those decisions in terms of kind of taking things forward yourself, potentially partnering?
Yeah, I mean, I think if you take a step back and say, you know, if you wanted to 10x this company from a valuation, you need to launch a multi-billion dollar asset at some point, right? And we look and, you know, I'm really happy for Tyvaso, but that's also an opportunity. We look back and say, "We could have kept that ourselves, and our shareholders could have benefited." I'm really happy at that time we were making choices on trade-offs, and so I believe, you know, we gotta be able to self-fund clofazimine and the nintedanib. I think both of those programs have high shots on goal, high probability of success, high unmet needs, and a real good high probability of launch success. And I think if you take a... The nintedanib, I see this being used in combination treatment.
So whether Tyvaso gets approved, I see them being used together, right? So people are like: "Oh, how are you guys gonna compete?" I'm not worried about that. These patients die. And so if we can... Like, I want to work in HIV, we evolved the combination treatment, you know, we've really seen this in other diseases, diseases as well. So, you know, I'm not too interested in, in partnering. I think if you think about clofazimine, realistically, we're not gonna go to Japan. Japan is the second biggest market, or Asia Pacific, I'll call it. So we'll look for a partner there, and we kind of paused some of that work because we wanted to make sure we can manufacture it. If someone comes in and does due diligence, we couldn't do that with what we had set up in Germany. So that's a good thing.
So we'll continue to expand that opportunity. We plan to launch about 75 sites around the world, and about 20-30 of them will be in Japan. We believe that asset will be fileable with the trial we're designing for that market. The nintedanib, again, there's an ex-U.S. market, so if someone was interested in ex-U.S. rights, we would think about that. And then Pulmozyme is one that it's kind of like where we were with UT, which is, it's a great product. I think it's gonna make a huge difference for people living with cystic fibrosis, but we're at a point now where Roche is the market leader. You know, should they take on this development from here on out? Or should we keep doing it?
I think that's where we were with UT, and we felt that UT was the best partner for Tyvaso DPI in order to really help those patients as quickly as possible. Now, we've seen that conversion, we've seen the uptake, we've seen the strength, and I think the same thing is true of Pulmozyme. You know, is there a partnership with them one day? That'd be great. And if not, we're at the crossroads where I gotta spend money now doing the next cell line development, and we can do it. It'll take us about a year, but if we can save a year in development by going with a great partner, we'll be open to that as well.
So generally, that's where we stand, and the TGF-beta is so early, we're not a, y ou know, it's got a 1% probability of success, but if it works, it's huge.
Mm-hmm.
So that's where we are.
Great. That makes a lot of sense. So I guess shifting maybe to endocrine, at this point and, Afrezza, could you maybe just provide an intro to Afrezza, kind of positioning in the market, where you see it's differentiating itself?
Yeah, I'm getting a lot of questions on diabetes lately because of all the GLPs. And so I, I think when you take a step back and look at the macro environment. Look, GLPs will be great. There's always these weight loss crazes that happen, and they eventually die down, and the world settles in a different spot. I think what we're seeing today is amazing for patients, that people really can lose 50 pounds. That's great. They're very hard to tolerate drugs, and I think at the end of the day, when you fast forward, we already know insulin was delayed seven to 10 years in Type 2, from the time somebody needed mealtime insulin to when they got it. I think all GLPs are gonna do is push it back an extra two, three years.
So, you know, if someone needed it in seven years, they're gonna need it in nine years. At the end of the day, the very first thing that goes is your mealtime response. GLPs are not gonna cure you for five years, right? Look, for long-term data, it's hard to find on these products. They have huge benefits, but at the end of the day, your body's missing a hormone. It wants back the hormone, give it back the hormone, right? And so I try to make it simple. So we have positioned Afrezza mainly for type 1 now. So if you look at what we're doing, the PEACH Trial is the pivotal moment for this company next year. It's something I've been working on for five years since I got here, and we're working with a great partner named Jaeb Center.
They're a diabetes innovator, down there and doing research. The trial, we'll, we'll know in the next earnings call in terms of did we fully enroll, and are we wrapping it up in the next six months, or do we need more patients? It could be futile or non-futile, I guess, but we think that's a low probability, that the trial's been enrolling nicely. Dropout rates have been manageable, probably half what we expected, so that tells you people are properly, properly dosing for once. And when you look at diabetes, innovation, and technology, Al Mann built the insulin pumps in kids. Dexcom built CGM in kids.
We believe inhaled insulin will be the next innovation for kids and parents who really do not want to run around all day and chase their kids and try to stick them with injections or attach pumps to them or pods. We think this is a real opportunity, even if, you know, we're a fair choice for kids. That's where all type 1s are diagnosed, pretty much, right? So how do we help that population and be an equal choice? That study is gonna be important to prove that out and get that indication. That would be our first launch. As we think of 2025, that'll be what we expect to launch that year. The other study we just kicked off for type 1 is INHALE- 3, and that's...
You know, we've kept looking, like, who's going against the grain and switching away from insulin pumps? Nobody. You got everybody pushing type 1 to insulin pumps, whether it's kids or adults, and all you've seen in my last six years here is we've gone from Medtronic being a great company, to Tandem being a great company, to Animas getting out of this, to Omnipod. And we just see patients going from one pump to another pump to another pump. And why are they doing that? They just want better control. They think the algorithm is better, but when you look at the data, take a step back over 20 years, A1Cs are the same today as they were 20 years ago, despite all the advancements in AID, despite all the advancements in CGM.
So what type 1s really need is a real-time insulin that works, and hopefully with this app that, that'll show you in the BluHale VIS, now we can start to show you. You can see your insulin, you can see your sugars, almost in the hour, what's happening, and fix your insulin, right? And fix your sugars. And that, that's really important. So INHALE-3 , we, you know, we told people we wanna switch people off insulin pumps, and they said we were crazy. And last year we did a small study called ABC, and we showed that you can safely get off an insulin pump, switch to Afrezza Tresiba, and not harm your outcome. Now, that was a short study, very small.
Now, we scaled that study up to 20 centers around the country, and when we kicked off the investigative meeting in June, no one believed their patients would switch off a pump, but they know that was the goal of the trial. You fast-forward 60 days later, this trial is almost halfway enrolled in 60 days, and the docs are shocked. Like, "Hey, my patients aren't as happy as I thought they were." So that tells you, like, we have a real opportunity to change the game with Afrezza, but it's been nine years. It's been a long ride. Most CEOs would have killed this program by now, but the patient stories are amazing. The dosing has been off, and we're hoping between the PEACH Trial and INHALE-3 , that these two dosing will really show you when you properly dose your mealtime insulin, you get better control.
No mealtime insulin has ever beat another mealtime insulin in 100 years, so maybe we'll be the first ones. We'll find out next year.
Great. Yeah, yeah. No, definitely lots to kind of look forward to as those two trials progress. And I guess you mentioned kind of BluHale earlier. Kind of, how does that fit into the Afrezza offering, maybe, you know, thinking about from a commercial perspective as well?
Yeah, I mean, I think, you know, you see. I'd say, like, I'll never forget, one day, it's probably 15 years ago, I'm with my boss's boss at a Starbucks, and he pulls out the app to pay for the Starbucks. I'm like: "Do they have an app?" And he's like: "Yeah. Where are you?" Like: "You're 20 years younger than me." And it just shows you, that was version 1.0, and now they've gone to carrying, like, tons of cash and making money on cash balances and order on demand. And I think we are at 1.0 in our BluHale business. It's taken us a long time to get the prototype through the system, get the architecture done, but once this thing's up and running, then you innovate from there, right?
How do you make a system feedback loop? How do you do predictive AI and dosing, things like that? When I was in New York this week, I met a young gentleman who's starting a company on, "Hey, what dose should I take today?" He's just gonna tell you: "Well, last Friday, you did this, and you were here, and you should take 20." So he's trying to get AI to really predict, you know, what dose you should be based on your location, based on your history, based on what you're doing that day, you know, your activity. So it's pretty cool where this is going, and, and it's like, how do we take those types of models and either open source our API so other people can connect to them, or we bring people like that to help us, right?
And bring the journey along. So, but that's where I think digital health is a really big, important part of the future, especially when you have a feedback loop like CGM. And so that's where BluHale will really help. And it was also nice just playing with it over last week is seeing good reports. What's my average dose? And how do I send that to my doctor to say, "Hey, here's how well I'm doing, and here's my dose-response curve." So that's pretty cool. And then V-Go, which I don't know if we're gonna talk about, but I'll-
Yep.
Leave that to you.
Yeah. No, I think that's, that's a good, a good segue into V-Go as well. Yeah, maybe talk about kind of how that fits into the-
Yeah
-the whole offering.
I'm sorry. I know there was a question on, I've gotten from shareholders on, on Cipla and what's happening over there, and I think, the trial results are in. They're intending to file that for approval, and I wanted to just clarify that because since we're here talking about the, the, trials for Afrezza, so that trial has been done, and that, that's on track to.
That's the inhaled, too?
Yep.
Afrezza.
So we'll hear more about that sometime in the future. On V-Go, obviously, it was a new product for us. We've watched it for a long time. They actually used to have a BluHale—I mean, a Bluetooth-connected device on the back of the device, and it got lost in the transition. But as we play with our platform, it's like, "Hey, is this stuff that we have to bring back and relook at?" Because I do think connected devices are very important. But V-Go itself has been a great device. We've positioned that for type 2. So I talked about Afrezza for type 1. We think that's gonna be differentiating, and the GLPs aren't really gonna majorly impact that, despite a small study coming out this week saying GLPs may impact type 1.
I think that's gonna be minimal impact in the end of the day. The type 2 market, you know, most patients are still gonna need basal bolus. V-Go has, you know, 90+% of its use in type 2. The majority of that is probably Medicare, maybe 60%, 70%, and that's where we really position our V-Go device. At the end of the day, if you're gonna go from, you know, GLP to basal to bolus, ultimately, you're gonna find you're not taking your doses, you're missing them, and V-Go is really gonna help you. And so that's how we position that product. So when our sales force is out there, you know, if they're not gonna write inhaled insulin, then you got plenty of patients that have type 2.
Let's try to help those patients, and that's really our focus, is making sure our sales force is efficient and effective and bringing as many offerings to customers as we can. And that product stabilized and grew in Q2. We're wrapping up Q3 soon, so we'll see how it finishes strong. But now we've integrated that to all 80 reps that we have in the field, and so you got everyone selling V-Go and Afrezza on one team, one voice, one, one vision.
Great. Yeah. No, I think it's just over a year since you made that acquisition, so congrats on the turnaround with the program. I guess maybe kind of thinking just, you know, forward plan for the company. You know, we've talked obviously a lot about the pipeline programs and the programs that you have with Afrezza. Kind of how would you characterize the evolution of the company going forward? Kind of what are the, you know, obviously, the strategy and how you think the company will develop over the next five years?
Yeah, I think, you know, back in my career, back in the day, I took a job at a company called Pharmasset, and I said to the guy, "Your name, what is it?" And he said, "Well, originally it was Pharmasset. We were taking assets, developing them, and collecting a royalty." Well, that model didn't succeed. They ultimately pivoted and discovered SOVALDI, the cure for hep C. I think the same was true here. We went through our growing pains and saying: What are we? Are we a platform company? Are we a licensing company, or are we just gonna develop products and formulate and sell them off? And I think the way you really create value is to become a self-sustaining biotech pharmaceutical company. And you look at the margins, and you look at the, you know.
While we can get royalties, that's great, at the end of the day, if you're a CDMO, you're stuck in a very low-margin business, and you're on high-risk failure, and assets don't come along fast enough to sustain your company when you see these models. And so we really did pivot in 2019 to say, "We are gonna be, you know, fully focused on our pharma and leverage our technology, help those patients." We felt that was the biggest unmet need out there. And the Tyvaso data gave us some conviction, the clofazimine data gave us conviction. And so I think when you look out there, you know, part of people say, "Why do you still have Afrezza?" Well, part of it is you need a marketing team, you need a sales operations team, you need, you know, data integration teams, IT.
We have all that infrastructure now. So while, you know, one could say, "I can get rid of some of those expenses," at the end of the day, if we're gonna be launching two, three, four products, we need all that backbone infrastructure. We need that talent base. And it took us many years to hire the right people and go through the cycle of building the best talent, and now our people are looking to grow the company, and they wanna jump into the next launch in the company. So it's exciting. We have a great group of employees, great sales reps, great management team, and they really care about patients. And so when you look at the company, we're really focused on driving innovation, launching our own brands, and helping as many people as we can.
Great. And maybe just quickly on, on kind of capital structure. You kind of, I think you referenced earlier, you think you're kind of capital sufficient going forward. Kind of anything to kind of talk about just in terms of kind of how you're set up from a capital?
Yeah, I mean, I think if you took last quarter... You know, when I got here in 2016, I think we were doing, like, I don't know, $1.7 million a year or something, and so last quarter, we did $50 million in revenue. So that puts you on a $200 million run rate as you go forward. We don't see... I mean, something could happen I can't control, but at this point, Tyvaso is going gangbusters. Afrezza is having a great year 'cause of Medicare coverage. V-Go stabilized and growing. The pipeline is advancing. Everywhere I look is about growth, and that is gonna create a decade of sustainable growth or more, and we have IP going into the 2030s and 2040s, so huge runway ahead of us. Everything is doing great, thank God. Lots of clinical data readouts, lots of things going into clinical trials.
So there's a lot of upcoming milestones when you look out over the next 12, 18, 24 months that, you know, people are very excited. I mean, this week I've probably met 20, 30 investors, and most of our discussion is around our pipeline, which is great because that's kind of what we thought this year. Everyone's gonna get over Tyvaso. What happens to manufacturing? Once you get over all that, what's next? And the pipeline is what's next. And, and that's been very exciting to see some new investors. We just met one last night who took a pretty big position in our company, and, you know, you listen to them, and you want to hear what's going on, and you want to hear from your investors and how they perceive things. But that's just exciting.
You look at our, you know, our cap table and our people, you know, I think 70+% of our shareholders now are institutions, you know, money who's gonna be stable. They want to see a nice return. They've seen our five years. They wanna see the next five years. So it's exciting. So our stock's down a little bit this year. That bothers me, but hopefully, by the end of the year, we'll close strong. It's been a hard sector overall. But, MannKind's in a really good spot. I think we closed Q2 with roughly $145 million. If you look, Tyvaso alone did $19 million royalties. That drops to the bottom line. So that gets paid in the next quarter.
So as you look and it keeps growing, that cash burn will continue to decline as we go forward, as Tyvaso DPI keeps growing. And we're gonna minimize the rest of the expenses in the company, so we should start to see cash flow positivity in the not-too-distant future as we keep going.
Great. Yeah, no, fantastic progress. Lots of exciting things on the horizon, so we look forward to those progressing. Thanks very much for your time today, Mike.
Thank you for having us. Appreciate it.
Thank you.