MannKind at Jefferies Global Healthcare: Strategic Growth and Innovation

On Thursday, 05 June 2025, MannKind Corp. (NASDAQ:MNKD) presented at the Jefferies Global Healthcare Conference 2025, offering a detailed look at its strategic initiatives and financial health. The company highlighted key achievements and challenges, emphasizing its commitment to growth through innovative treatments and financial stability. While MannKind reported robust revenue growth, it also acknowledged slower sales in certain areas due to adjustments.

Key Takeaways

• MannKind has paid down over $250 million in debt, with only $35 million remaining.
• The company reported an 18% revenue growth year-over-year, with a 32% increase in royalties.
• Key products include Tyvaso DPI and Afrezza, with strategic expansions planned.
• Upcoming milestones include the INHALE 3 label change and pediatric approval for Afrezza.
• MannKind is advancing clofazamine for NTM and tetanib for IPF, targeting significant market opportunities.

Financial Results

• Q1 revenue grew by 18% year-over-year, driven by strong performance in key areas.
• Royalties increased by 32%, reflecting successful partnerships.
• Afrezza sales reached $15 million in Q1, impacted by $2 million in gross to net adjustments.
• MannKind holds nearly $200 million in cash equivalents.
• For every 10,000 patients covered, MannKind expects $300-350 million in revenue from DPI.

Operational Updates

• Tyvaso DPI continues to perform strongly, with a TETON-two study readout expected later this year.
• Afrezza is preparing for a Q4 label change and a pediatric data filing in late June/early July.
• The clofazamine program for NTM is on track, with interim analysis expected next year.
• Tetatinib for IPF is advancing, with CRO selection underway for a Phase 2 study.
• Manufacturing efficiency improvements are contributing to fluctuating collaboration and service revenues.

Future Outlook

• Afrezza’s growth platform includes adult label changes, anticipated pediatric approval, and new applications.
• MannKind is targeting a 12-year exclusivity for clofazamine in NTM, leveraging orphan drug status.
• The company is initiating a Phase 2 study for tetatinib ex-US due to FDA requirements.
• Tyvaso DPI is expected to maintain strong performance, with potential milestone payments on the horizon.

Q&A Highlights

• The clofazamine bridging study with the FDA will focus on safety and tolerability, involving around 40 patients.
• MannKind is optimistic about the underpenetrated ILD market, anticipating growth opportunities.

In conclusion, MannKind Corp. remains focused on leveraging its innovative delivery platforms and strategic partnerships to drive growth. For further details, readers are encouraged to refer to the full conference transcript.

Full transcript - Jefferies Global Healthcare Conference 2025:

Unidentified speaker: Thank you for the instruction. You can call me whatever name you want. I’ll be happy. So, because, Jeffrey’s our first time here in my nine years, I I kinda give a little bit of background on mankind as we dig into the slides and for those online listening in. When we think about MannKind, it’s really got five pillars of of strength that we look at.

Number one, Taveso DPI is a foundation of the company in terms of valuation and downside protection, with the upside optionality. Obviously, with the new data readouts they have coming up, we’re we’re excited about the continued partnership there. Afrezza is an asset that that founded the company a long time. It’s really well known for the inhaled insulin space. It’s still here.

And we’ve slow walked the growth of Afrezza while we waited for new data readouts over the last couple of years, and that that all that work has finally come to to fruition, and we’re finally at the end of that stage where it’s now about how do you scale Afrezza growth as we go forward into q four and beyond, and we’ll be getting ready for that FDA filing for pediatrics I’ll talk about in a short minute. In the, balance sheet side, as we’ve had excess capital, we started paying down the debts and reduced the risk of the company. When you look back in history, debt was one of the problems we we faced in a dramatic way and, we paid over $250,000,000 in debt down. We have 35,000,000 remaining on the balance sheet and convert. And then we have a nice upside optionality here around clofazamine dry powder inhalation that I’ll talk about today and give you some update on the trial progress and the 10 of DPI and where that’s going.

When you think about the company, when I got here in 2016, we were pretty much zero revenue and, we were getting a product back from a failed launch. We’ve done a very good job at fixing the balance sheet, getting new data sets read out, and kind of getting the growth going. And obviously this was through a lot of our partnership with United Therapeutics as well as purchasing V Go. On Q1 highlights, the diabetes revenue, we saw 20% NRx growth. A lot of questions I get around why wasn’t it year over year better, and that that really had something to do with gross to nets from last year when we were, we had, like, nine years of accumulated, gross to nets on the books for returns that we kinda had to make some adjustments for.

On Afrezza, we expect a label change here in q four. That I’ll share with you around why that’s important. And pediatric data, we just finished up our meeting with the FDA. Things went really well, and we’ll be filing that here likely in late June, early July, and that should set us up for hopefully an approval next year for pediatrics right before ADA. On the pipeline, Tyvaso is doing great.

Clofazamine’s hitting our enrollment targets slightly ahead of schedule, but we’re sticking to our year end guidance. And on the tetanib, we’re advancing that in the second half. We’re just finalizing the CRO selection, and we feel pretty good and excited about moving that forward later this year. And, financially, we had cash equivalents of almost $200,000,000. A lot of people ask me what is unique about our platform is there’s a lot of noise in dry powder space these days.

It’s really about the technosphere delivery particles. It’s the excipient that we have. It’s the device platform we have, the scalability of manufacturing. All that really does is really make sure that the drug gets deep delivered into the lung in a consistent way. Even when you have infections, we still get the particles into the lung.

And so wherever you see airflow, you’ll generally see our particles flow with FDKP and novel product attached to it. As we get to diabetes, obviously this is an area we’ve been very familiar with. It’s become competitive with insulin pumps. Afrezza’s got a broad indication in type one and type two diabetes. We mainly focus on the type one space as we go forward about half our business does become type two.

One of the things with AFREZZA is you don’t have to guess when you’re going to eat or how much carbs you’re having, you really just have a fixed dose and you, modify that based on how much you think you’re going to eat and you don’t have to guess the timing of that. So as we’ve continued to progress this program, we look out over the next couple of years, we’ve kind of got a multi year platform of growth opportunity here. Number one is the adults and the label change we expect in Q4. We’re getting ready for that as we speak. The second part, a leg up here, will be pediatric approval, which we’re anticipating hopefully Q2 next year.

And then gestational came out of some of the work we were doing because some of the doctors who treat gestational diabetes saw our postprandial control on our first dose and they said that’s such tight control, that’s exactly what we want for pregnant women. Why aren’t we using this drug there? So we worked this past year to get some pregnancy data published. We had five case patient series just get published in the pregnancy journal, and we’re now doing a single dose study with the investigators to show that the PKPD looks similar in pregnant women. And then there’s a trial ongoing that Afrezza will be an option for it.

We’ll we’ll provide free drug for it in pregnancy and using CGM. So we’re excited about this multi year opportunity that we look for growth. If you look back here in the middle of twenty sixteen, that’s when I arrived. There was only two major studies presented which was AFFINITY one and AFFINITY two, and a lot of our data was not published. You can see now all the new data in the blue that’s been presented and published in various places and the various clinical studies that we’ve generated, really trying to help understand what we didn’t quite understand in the development of Afrezza, which was how do you properly dose this drug?

You’re not counting carbs, you’re not doing insulin sensitivity, do you really need an insulin pump? And so a lot of our work has been around either switching off insulin pumps, adding it to insulin pumps, or showing that better dosing gets you better control without increased hypo. So all this work has cumulated now to two label changes that we expect over the next twelve months. This was one of the pivotal, I’ll say high risk trials we took a bet on, which was INHALE three. This trial enrolled in record time in about, 20 centers in The US, and these are top tier centers, like like Joslin for Diabetes and some other great ones you guys would know about, and we went head to head against usual care.

For years, I’ve been trying to do a pump switch trial, and many thought leaders in diabetes said, I am not going to stand on stage and say you should be switching off an insulin pump when that’s all we’ve been pushing for twenty years, that’s what your founder built. And I said, yes, but I’m not sure the data on these pumps is that great. It’s single arm trials, not well controlled, and we really wanted to show that you could really get off the technology and simplify your life. So we took a big bet here, and then at the end, everybody would get Afrezza, so about half the patients were coming off pumps, half the patients were coming off MDI, and there’s a couple key learnings here. Number one, when we look at the percent of people that got less than seven, so when you think about without about twenty five percent of the people in the trial to come in at goal, but seventy five percent were not.

And you can see whether you’re on multiple daily injections, we got twice as many people to goal. If you’re on AID systems, which is perceived to be the best standard of care, we got twice as many people that were on AID to go. So whether you’re coming off injectable insulin or pumps or pods, we don’t really care. We’ve shown that we can get more people to control without increasing hypoglycemia or safety. We did this study especially because kids, about sixty percent, seventy percent of the time, are going go on insulin pumps.

And so if we really want to have a pediatric launch opportunity, we had to show that hey, there’s an opportunity here. Patients should have a choice. Parents are paying $3,000 4 thousand dollars for a pump contract. Why not try Afrezza first and then think about technology second? And many times these kids don’t want to be attached to things.

They’re running around. They’re very active. So the INHALE three data has not been wide sorry INHALE one has not been widely shared, so we’ll be sharing a little bit of ADA, but there’ll be a fall conference where we’ll share more of the data. But the top line data’s been released, so there shouldn’t be any dramatic surprises. It was a non inferiority trial.

It did slightly miss the primary mainly because a one patient was an outlier. We’ve disclosed that with the FDA. We don’t think that’s a holdup to the approval because they weren’t taking their drug and that was well documented throughout the trial. But otherwise, you take that away, the variability and the non inferiority are met in that scenario. So this is the data that we, are not using yet publicly in our promotional activities but this was just presented back in March and what this shows you is injectable insulin is the red line and whether you’re delivering that through a pod or rapid acting injectable insulin, you can see, your sugars are not coming down for the first ninety to one hundred and twenty minutes.

And the blue line is Afrezza adults and the green line is pediatrics. So you’re seeing a very similar postprandial control in kids or adults and in fact kids is slightly better, but this is really showing you that converting the patients at a higher dose right up front gives you tighter control and they’re not going low and therefore they should be discharged on a better dose than we give them historically. Historically the number one problem with Afrezza for me is they underdosed a patient, they don’t titrate up fast enough, and they’re just not getting great control, and that’s when you look at the trial, you see that in doctors just not following our titration. So we know if you titrate properly, use the drug, you can get better results than you’re doing today. So this is important.

This is also the kind of data we generated in the blue and green line where the gestational doctors said hey, we really don’t want pregnant women going above 120, one hundred 40. This really tight time in range, tight time in control, you can get there with Afrezza, cannot get there with injectable insulin. So this is what precipitated the interest in gestational. So we’re excited about this, this is our label change we have submitted and it’s really about a better conversion up front and it’s hard, this was the first dose we did in the office and in order to use this data we need that label change coming up in the fall. So people ask me what does pediatrics really mean?

We believe this is the pivotal part of the brand for a relaunch strategy in that the doctors are more progressive in kids, the parents are active, and the kids are on social media. So as you can start to see awareness and trial pick up, there’s only 40 centers in The U. S. That treat the majority of the patients, and it’s a very small community, there’s a lot of camps, there’s a lot of kid interaction, and so we did some research here and we haven’t done this post our inhale three data coming out, but in terms of where they were pre pump switch data coming out, about twenty eight percent said they would come from MDI and fourteen percent from pumps. You can discount this back 50% as we know doctors always overstate what they will do, and we see about $150,000,000 for every 10% share.

We’ll do about $75,000,000 this year in Afrezza sales, so it kind of sees that Afrezza in near term we think can get to a 203 hundred million dollars run rate and continue to grow from there. So we pile that on top of what we’re doing, and the other upsides in the pipeline, we feel very good about investment thesis here. For those of who don’t know, Tyvaso DPI is manufactured by mankind. We licensed this to United Therapeutics in 2018. It’s been off to a phenomenal start.

We’re very happy with the success they’ve had. Obviously nice royalty growth, nice year over year growth. There’s a TETON-two study readout in the second half that we’re waiting on, and that to me is not quite built into our stock, and so if that comes out, we’ve built manufacturing capacity expansion to accommodate that future growth of Tyvaso, in this population. The next big program is NTM. For those of you don’t know, nontuberculum mycobacterium.

It’s a really tough disease. It impacts about one hundred thousand in The US and one hundred thousand in Japan. It’s really, I’ll say, only in those two countries. There’s a little bit of Australia, South Korea, but in terms of the market, it’s really those two markets. Unfortunately, lot of assets have failed.

There’s really nothing in development besides us and ARIKAYCE and it’s a complex disease and there’s a lot of patients who don’t have a lot of options. We look at ARIKAYCE, we continue to watch that one. We’re very happy to see them continue to succeed in Japan and The US. They launched during COVID, during a really tough time, and we look at this market as a billion dollar market with two players, more than enough business for both to help these patients. And, I can tell you Japan is about $100,000,000 run rate this year with them, and I can tell you from our trial side, we are seeing a really nice enrollment in Japan, very clean patients and really good investigators.

So that is off to a great start and probably by the next month or two we’ll hit our minimum patient requirement for Japan in order to file once we get the final study done. So people ask why 101, why clofazamine? Well clofazamine we know works in NTM. It’s an older drug but the oral formulation has three problems. It has prolonged prolongation, it has skin discoloration, and it has organ accumulation, three things you really don’t want.

And by moving it to an inhaled dose and cutting it down, we can really get to a dose that we think eliminates those three risk factors. The other thing it has is a twenty eight day half life and so it gives you a very long duration, sorry, about an eighty day half life so we can dose it for twenty eight days and then come off treatment for a few months. So when we did our in vitro studies, you can see a reduction in the nebulized form really does, versus oral clofazamine reduce the bacteria in vitro and then we ran some animal studies in terms of dosing and we confirmed this in our human that they correlated. And so you see about an 80 half life. So you give the drug for twenty eight days and then we back off for two months and then you go back again.

So it really has deep lung penetration and consistent duration of activity even though you’re not nebulizing it every single day. So this led us to a trial design of twenty eight days on, two months off, twenty eight days on. Generally it’ll be two cycles for patients to see if they’re responding. They’ll probably take a third cycle while they wait for the negative sputums to come back. And so this is an area that we think is a competitive advantage in terms of frequency and dosing.

Cleaning a nebulizer, we really differentiate versus the drug that’s out there today. It’s a co primary endpoint for The US of sputum and patient reported outcome. We’ve scaled the trial and the interim analysis that we’ll get to next year roughly in Q3 and that interim analysis will be skewed towards sputum culture as opposed to PRO. Both will be important but the PRO could have a lot of variability that we don’t think is worth the effort but we’d have to do that for the FDA. Most of our sites are now activated.

There’s a couple stragglers. We’ve two more waiting on The U. S. That are important sites, but the last couple of U. S.

Sites that became active were some of the largest NTM centers in the country, and they took a little longer, but they’re now coming on board in the next couple weeks here. So we’re excited about the continued enrollment. This drug will have about twelve years of exclusivity for orphan, protection as well as QIDP and fast track designation. The interim analysis is based on evaluable patients and so we’re allowing people to come into the trial who may have had a sputum, that was positive in the last three months, but we’ve to do another one. But it takes eight weeks to get that result so we may find out eight weeks into the trial they mysteriously, cleared the infection and therefore they’re not going to qualify for efficacy but they’ll qualify for safety.

So by that time those patients will have had their first month and we’ll watch what happens. This is the first time we’re sharing enrollment details. The yellow line was our internal target we laid out for and you can see last year as we were activating sites, not a lot of activity in the second half, but as you look in Q1 and Q2, we’ve really accelerated enrollment and, we’re ahead of schedule so we feel very good about our projected and we were conservative here in June. We know there’s already 10 patient screenings scheduled and, you know, we should hopefully hit that number or more for the month of June and go forward. So we’ll keep pushing this as more and more U.

S. Sites are coming back from ATS. We had a lot of good meetings there. Hopefully this will continue to accelerate and if we can pull this forward by a month or two it will just give us an interim analysis a little bit faster next year. That interim analysis, the question I get is is it going to be for futility and it will, so we’ll have a futility analysis so if patients aren’t responding at that point we will not move forward but we believe the trial scaled up for 90% power with 180 patients.

On 02/2001 it’s our IPF asset and so for those of who don’t know IPF there’s only two drugs approved. It’s a very tough disease. Twenty percent, twenty five percent of people are only on the drugs, meaning seventy five percent of people generally can’t tolerate it, and they’d rather die than take the treatment. We find this to be an awful outcome for patients when you’re given a death sentence. And we started developing DPI back in 2019 and we felt that this was a real opportunity to differentiate the product from a GI side effect and really target the lung delivered dose.

We now have gotten this through development. We completed our phase one data last year. We moved this into a phase two. We met with the FDA in April and, long story short, we’re now moving this forward ex US mainly, because the FDA really believes you need to add on to background therapy and have placebo, and we don’t think any IRB’s gonna approve a thirty week study for patients to have a placebo controlled trial when you’re at risk of dying. And so we do believe in the Ex US we can get that enrolled.

We’ve done some feasibility with some of the CROs and so we are looking at about 150 patients in the study of four arm trial with two different doses. It will look at twelve weeks of efficacy. We think that’s a reasonable time point to see some separation and we will allow, if they’re on profanidone, if they had treatment experience to natetinib but not currently taking it, or naive patients. And we know in these countries it takes about twelve weeks to get access to the standard of care, so we feel like it’s an ethical place to run a study where you can study patients in a naive way and or on placebo and, allow them to still have access to standard of care. So by then, hopefully Tyvaso DPI has positive readouts or BI’s drug is launching and the FDA wants you on general background therapy.

And so, you know, we can study it if there’s three or four options, but when natinib is 80%, ninety % of the market, it’s hard to study on top of that when that’s not a reasonable approach. And so that’s we expect to come we will submit the phase two for The US, and we’ll open up sites if the FDA allows us. If not, we’ll come back for phase three, and we by then, we’ll have the data the FDA is looking for. Financial updates. So as a company, q one, we had a good good 18% revenue growth year over year.

You can see our royalties were up 32%. We think Tyvaso should continue to be strong as as far as we can see. And, yes, there’s other launches coming, but there’s more than enough business for people that ILD is severely underpenetrated, and I think that market will continue to grow. And Afrezza’s and and Afrezza sales here in endocrine on the bottom, you can see we had 15,000,000 in q one. Not a big growth over last year, but there was about a $2,000,000 gross to net.

So if you really compared 12,000,000 to 15,000,000, you see that growing. But we’re not investing to leapfrog Afrezza growth, and I think that’s important. As we get to Q4 and the label change, you’ll start to see that change, but right now we’re continuing to maintain our 7,000,000 to $10,000,000 growth rates that we’ve had historically. And then collaboration and service revenue is mostly manufacturing. That will fluctuate quarter to quarter, so we had a lot of production in q one.

We may not have as much in q two. We may have more in q three. So depending on when we make Afrezza, when we make Tyvaso, those two things will shift, quarter to quarter. So in general, great quarter, but I I’d say, you’re gonna see the the collaboration service revenue not continue to grow in in in step with the royalty revenue, not because things are slowing down, but because we have efficiencies and scale in the factory. So at this point, as as royalties keep growing, the factory is more and more efficient, and we’ve we’ve put built a lot of redundancies and scale up, activity.

So we’re finally seeing that pay off this year. On, Catalyst, I think I walked through a lot of these as we get to the second half where we just got approval for India. We just got the last step in that process, so we’ll be manufacturing that here in the second half and launching that there. We’re excited to help. There’s about 80,000,000 people in India who have an average a one c of 10.

Inhale one is the pediatrics, so we’ll wait for that acceptance in the fall. Inhale three label change is also in the fall. And then 101, study enrollment, we expect to meet our target by the year end. We see nothing slowing us down. We just came back from a Japan tour.

Those investigators started strong. We were a little worried. Is that a bolus of patients that are gonna continue? We believe that will continue. And then two zero one, we expect to initiate in the second half.

We’ll be making clinical supplies on placebo and getting all that ready. And DPI while waiting for UT’s readout because then there’ll be some bridging work that has to get done. And as we look to building value for shareholders, we’ve built this over many my nine years here. We always had a vision that DPI would fund the pipeline and fund the growth and Tyvaso has continued to do strong so for roughly every 10,000 patients covered we expect $300 and $350,000,000 in revenue to mankind. We do have a milestone payment to the upside if if Tton one and two were to read out, and if sales accelerated a little bit, you could see us getting a $50,000,000 milestone from the royalty deal we did last year.

But if not, we have a second chance in ’27, and then if that still doesn’t work out, we get a royalty cap, and then that 1% will come back to us. So, we’ll continue to be, watching DPI closely. Endocrine wise, every 10% share in kids is about $150,000,000 in net revenue. We think that’s a reasonable low bar to hit, and we think there’s more than enough opportunity. The average kid’s A1C is about an 8.3 to 8.6.

They are not doing well and it’s a bad way to start life with living with diabetes and we really think we can help kids have a better option. And then the label change international are all upsides growth for Afrezza. And then for one hundred one, for every 1,000 patients in NTM, it’s gonna be about $100,000 a year, so think about that price point, that gets you about $100,000,000 in revenue, and there’s more than enough patients for those companies. We’re starting out in a refractory population. We fully expect to bring a dry powder clofazamine, I just approved that yesterday, to move forward and we will be moving that in the second half through animal studies and then in the humans in ’26 and ’27.

So we’ll keep you posted there, but we do know a dry powder will help us penetrate earlier lines of treatment in NTM and that’ll be important. And then OFEV, we don’t even talk about how big that could be. It’s a huge unmet need, if we get through phase two, we’ll all be really happy. It’s it’s a it’s a population that really has no options, and we’re hopeful that we’ll be able to help them, progress. So thank you for your time today.

Thank you for attending, and I’ll any questions, I’m happy to take. So so for clofazamine? What would be a bridging study for 02/2001? Havasu, excuse me. Sorry.

Sorry. He’s correct. So that’ll be up to UT in terms of their negotiations with FDA, so we don’t wanna comment that they’ve said that they would do the bridging study work that has to get done, but they’re gonna wait for the tetan two to read out, and then they’ll they’ll go from Simultaneous then? Yeah. I think they they’ve commented they expect it to be a Breeze like study, which was around 40 patients, safety and tolerability.

Others? Okay. Well, thank you again, and, look forward to hopefully seeing many of your shareholders and continuing to progress the company as we go forward. Thank you.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.