MannKind Corporation (MNKD) Earnings Call Transcript & Summary

Good morning, and welcome to the MannKind Corporation First Quarter 2025 Financial Results Earnings Call. As a reminder, this call is being recorded on May 8, 2025, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call and available for approximately 90 days. This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainty, which can cause actual risks to differ materially from these stated expectations. For further information on the company's risk factors, please see the Form 10-Q for the quarterly period ended March 31, 2025, on file with the SEC, the earnings release and the slides prepared for this presentation. Joining us today from MannKind are Chief Executive Officer, Michael Castagna; and Chief Financial Officer, Chris Prentiss. I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

Thank you, everyone, for joining us this morning. Today, joining me is Chris Prentiss, our Chief Financial Officer. We'll be going through operational pipeline highlights, our financial review and some of my remarks at the end. As we've engaged with the investment community over the last several months, our discussions highlight that investors, especially in these uncertain times, are seeking commercial stage companies that have a profile of growing revenue, promising pipeline and a strong financial position, combined with very little debt that we have going forward. I'm proud to share that this depicts where MannKind is today and are excited by our 5 key pillars of growth above. Now I'm going to highlight our Q1 2025 key points. Our endocrine business grew 20% on NRxs and 14% on TRxs. We have filed for a label change for our adult, which is a 2x round-down conversion. We expect that to be hopefully approved in Q4 of this year. We plan to file the pediatric expansion in mid-2025. Our Tyvaso collaboration remains strong. I'm sure many of you have listened to the UT call, and we are excited about our great partnership together, which resulted in Q1 royalty revenue of $30 million and manufacturing revenue of $29 million. In terms of clofazimine and nintedanib, I will highlight those later in this call. And our financial results were very strong for the quarter, and we had non-GAAP income of $22 million or 43% growth over last year. Now let me bridge to our diabetes business. Since we last spoke, we had a very successful ATT showing with multiple KOL interactions that have earned a very positive reception for Afrezza, unlike anything before due to the positive INHALE-3 data and the excitement that is building in the pediatric opportunity. All of this gives us reason to believe the steps we have taken and continue to take sets the stage for Afrezza to realize its true potential. After leaving ATTD and interacting with hundreds of U.S. and international customers from around the world, the global expansion and demand opportunity is real as evidenced by our booth at ATTD, which was nonstop with traffic over the 3 days we were there. Additionally, I have met many U.S. customers on my travels around the U.S., and I no longer hear the objections I used to. And now what I hear is, why don't we increase patient request? Why is it not top of mind with our sales force? How do you dose and write a prescription versus previously, we heard about safety, payer roadblocks and dosing in fixed doses. We're very excited, and we believe pediatrics is a real opportunity to cause an inflection in Afrezza. And additionally, we recently had a payer app board that also described how they would probably allow pediatrics to go through relative to the history where they would block Afrezza to injectable insulin. Now as I look at the performance driven by our strong NRx growth, we've really seen this improvement. But what's more important is the 26% year-over-year growth in our top 50 prescribers -- top 50% of our prescribers. We're very pleased with the early indicators here and continue to go deeper on our call list to increase the number of prescribers that we can target. Our TRx activity is consistent with our gross revenues. And while net sales appear to be relatively in line with the prior year, this is due to onetime adjustments of our gross to net in Q1 and ordering patterns at the end of 2024. Data since the last -- end of the last quarter continues to give us confidence that our messages are resonating and our team is on the right path to continue making impact. Now I'll bridge over to the orphan lung opportunity. First, on Tyvaso DPI, this revenue coming in from United Therapeutics will provide the nondilutive pipeline funding that we need to move clofazimine MNKD-101 forward as well as nintedanib, our MNKD-201. What's really encouraging is we had about $1.1 billion of Tyvaso DPI-related revenue from United Therapeutics in the previous 4 quarters, and we received obviously 10% royalty on those sales. We recorded $29 million in manufacturing revenue in Q1, and we await the readouts of the TETON 1 and 2 trials that United Therapeutics is conducting. As I look to the NTM market, we get very excited that this market will likely exceed $1 billion by the end of the decade. Our focus is on the U.S. and Japan, which have the highest addressable populations, and this disease continues to grow 7% year-over-year. We see a large market opportunity with one branded treatment in the U.S. and Japan, and we believe MannKind will be the next potential launch with clofazimine as we look out. Current NTM therapies have their limitations in efficacy, safety and tolerability. As we look at the drug combinations, they have low efficacy and high systemic toxicity. These AEs are very severe and cause long-term consequences for patients. And the frequent dosing, these are almost like TB-like regimens and/or nebulizers that contribute to patient fatigue and low adherence to therapy. Now let me bridge over to the inhaled development rationale for inhaled clofazimine. The first thing we were trying to do is make sure we maximize the anti-mycobacterium activity at the site of infection by bypassing the GI tract and minimizing systemic exposure to hopefully improve the tolerability profile. Oral clofazimine is recommended by the clinical guidelines, and we've done some prework to really have comfort in the animal studies as we move forward in the progress of human development. Additionally, because clofazimine has a long half-life, we've been able to create a very convenient dosing cycle with the drug holiday, meaning they take the product for 28 days and load the lung and then 56 days off. And we hope this will alleviate the patient treatment burden as well as noncompliance. Now let me update you on our MNKD-101 study. First, 85% of our sites have been activated across 4 countries. Two, we've had 55 patients randomized with minimal dropouts and patients are now starting to move past the 6-month time point rolling over to extension. And as of today, there's been no down dosing to a lower dose. So we believe people are tolerating the product, and this is an indication of the direction the product hopefully will go. We remain confident in achieving 100 patients in the interim analysis enrolled by the end of the year. And even once we hit that number, we will continue to enroll so that when we get that readout in 2026, if it says we needed more patients, hopefully, we'll hit that mark by the time we get to that data point. Now I'll bridge over to IPF. For those of you who don't know IPF, it's a progressive and fatal disease, 80% of people will die within the first 5 years of diagnosis. There are only 2 drugs approved and the majority of the patients cannot tolerate either one of those products, hence, why we continue to move this forward and believe there's a real opportunity to help patients. We believe nintedanib will be the background of therapy as new combinations continue to come out and get approved over the coming years. We previously talked about our Phase I study, which was complete and met its safety and tolerability objectives in healthy volunteers. We had no serious AEs, and AEs typically seen with nintedanib such as diarrhea have not shown up, and we expect to continue to develop this in the next phase of development in a global trial, and I look forward to sharing those details at a future meeting. I'll now turn it over to Chris.

Thanks, Mike, and good morning, everyone. I will now discuss our first quarter 2025 financial results. For a summary of our financials, please review our press release issued before this call and our Form 10-Q, which is now on file with the SEC. Before we get into the details of the quarterly results, I want to highlight our revenue growth over the last 5 years as we compare the trailing 4 quarters on an annual basis. It demonstrates impressive growth across our 3 revenue categories over this time frame, a testament to the extraordinary work of our team. Looking forward, we expect our royalty revenue to continue to grow based on the impressive performance of Tyvaso DPI. We expect our collaboration and services revenue to remain relatively flat on an annual basis in the near term due to production scale-up and efficiencies and will fluctuate over time based on UT's production orders. The commercial metrics that are unfolding give us confidence and excitement for the future of Afrezza, and we anticipate change in its growth trajectory, especially if we are able to gain approval for a pediatric indication. Our overall revenues in the first quarter grew 18%, led by revenues related to Tyvaso DPI. Tyvaso DPI royalties contributed $30 million in the first quarter, an increase of 32% over the same quarter last year. Collaboration and services revenue consists primarily of manufacturing revenue based on production volumes sold through to UT and the recognition of deferred revenue. We recorded revenue of $29 million in the current quarter, an 18% increase from the prior year quarter. Afrezza net revenues for the first quarter were $15 million, a 3% increase over the prior year. It's important to note that the first quarter of 2024 benefited from a onetime favorable adjustment to gross to nets. Additionally, the current quarter was negatively impacted based on the timing of shipments at the end of the year. As we look at the performance of Afrezza, we are encouraged by the growth in new and recurring prescriptions over the prior year and expect this trend to continue. V-Go net revenue was approximately $4 million for the first quarter, a 6% decrease driven by lower product demand. As discussed on previous calls, the sales force is no longer actively promoting V-Go as of the fourth quarter of 2024. For the first quarter of 2025, we reported net income of $13 million or $0.04 in earnings per share, a 24% increase compared to $11 million or $0.04 per share for the first quarter of 2024. On a non-GAAP basis, we reported $22 million of net income or $0.07 of earnings per share for the first quarter compared to $15 million of non-GAAP net income or $0.06 per share for the same period in 2024, a 43% increase. We started the year strong. Our operational results, combined with our quarter end cash and investments of $198 million will allow us to continue investing in our differentiated pipeline and execute on our objectives, including driving commercial growth. Mike and I will be at the RBC and Jefferies conferences over the next month, and we look forward to engaging with all of you there. With that, I will turn the call back over to Mike.

Thank you, Chris. Quickly, I'll talk about some anticipated catalysts over the first and second half of this year. As we look ahead, there are a series of catalysts in our pillars here to highlight a few. INHALE-1, we just had our last patient enrolled last week and last visit, and now we can lock the database and get top line results here shortly and submit the sBLA in the next few months. For MNKD-101, the key metric we're tracking is interim enrollment target, which we expect to meet by year-end. And on 201, it's continue to finalize details behind our global trial and work with the CROs to get a proposal to kick this off in the second half of 2025. As we look to continue to build shareholder value in 2025 and beyond, obviously, there's a pillar of Tyvaso DPI and that for every 10,000 patients covered on insurance, we'll see $300 million to $350 million of revenue between manufacturing and royalties. We know there's a big opportunity here in TETON 1 and 2, and we anxiously await those results from United Therapeutics as well as the bridging work that has to be done in order to get that into IPF patients. With the endocrine business, we previously talked about what the opportunity of pediatrics means. It's a long-term strategy we've been pursuing as we ran the endocrine business for profitability versus significant growth. We now believe that every 10% share in kids will represent about $150 million in net revenue to MannKind. As we look out, the INHALE-3 data continues to be educated out there in the marketplace and presented and the international opportunity continues to grow. And as we close out here on 101 and 201, 101 is a significant unmet need here in NTM and every 1,000 patients, we believe, will be $100 million in net revenue. And on 201, the market is so large, we just need to make sure we have a product that works to help these patients who really have very little options to extend or enhance their life. We are looking forward to continue to build upon these catalysts to make MannKind a great opportunity. We have several upcoming scientific conferences, starting with ISPOR in Montreal here in May, where we'll present one of our first pharmacoeconomic analysis of Afrezza, followed by ACE, which is a clinical endocrine conference by an ADA here in Chicago in June. We look forward to these opportunities to discuss and present our new data. And with that said, operator, we'll now turn our call over for Q&A.

[Operator Instructions] Our first question comes from Faisal Khurshid from Leerink.

This is Heidi on for Faisal. Regarding MNKD-201, can you provide some initial thoughts on what a Phase II/III trial design for MNKD-201 could look like? And any feedback you received from the FDA? And did they align on a seamless study design?

Thank you for the question. We aren't giving too much guidance yet on the feedback from the FDA. What I can say on the -- the Phase II/III design is more for a global trial. So I think that will be more of a question as we get to ex U.S. authorities. I think on the trial design, we are thinking a several dose arm trial compared to placebo. And I think there's a few last-minute discussion points we're having around is it on top of pirfenidone or naive patients or patients that are previously treated but not tolerating existing products. So that's probably the extent we can share at this point.

Our next question comes from Olivia Brayer from Cantor.

Mike, I wanted to follow up on your IPF study, especially as it relates to endpoints. Maybe it's a little premature to ask, but are you guys looking to measure FVC in that study? And maybe just any comments around whether you're hoping to actually show improvement from baseline versus the delta from the placebo arm? And then also if there's anything you can tell us with respect to dose levels? And then I've got a follow-up question on Tyvaso.

Sure. So I think the -- we'll be looking at a couple of different doses. We're still finalizing the protocol, as you can imagine. But conceptually, we're looking at a couple of doses. And I think the question is, do you combine those doses for an analysis versus placebo? Or do we look for a dose response by the highest dose versus mid or low? That's generally where we're going at this point. We are looking for a delta from placebo. We're not scaling it for a statistical endpoint or powering it to have a distinct difference in terms of should it be 100 delta versus 50. But we are looking to get enough patients enrolled so that we can see a delta to have comfort as we go into Phase III what that efficacy could look like as we scale the next generation -- the next part of the trial.

Okay. Understood. And then obviously, Tyvaso IPF data coming up in a few months for the nebulizer. I know they've talked about a potential bridging study for DPI. Do you know at this point if that would be an inferiority study between the 2 DPI and the nebulized formulation? And anything you can tell us at this point in terms of timing around when that could kick off and how long that could realistically take?

I think it's too premature to comment yet. I think UT and us will be meeting very shortly to discuss these things, and we'll have some insights from the IPF meeting we had for 201 that I think will feed into the Tyvaso discussion as well. So I think give us another quarter or 2. I know waiting for the TETON 2 results, on one of the first focus is to obviously get that readout. But then the second focus, they have some preliminary ideas, and I think we'll have a solid plan. I think we believe it will be a BREEZE-like study as opposed to a large-scale trial. So I think that's the direction I've heard from UT. But again, I would defer to them to comment for their initial thoughts, but that's generally the comments I've heard.

Our next question comes from Gregory Renza at RBC.

It's Anish on for Greg. Congrats on the progress this quarter. Thanks for taking our questions. Just a couple from us. First, on the label update for adults that you spoke about. Maybe if you could just give some color on the rationale behind the update and how you're thinking about the delta in uptake in adults? And second, just given the macro backdrop, how are you thinking about the potential impact to supply chain for Afrezza, the manufacturing of Tyvaso DPI and even longer term that on 101 and 201, just as we think about APIs, parts related to Technosphere, dry powder, et cetera?

Sure. Lot of questions wrapped up there. I'll try to hit them all. I think on the dosing, we are looking to -- we know from all the data we've given, we've published and presented that a better conversion dose leads to better time and range, better control in the first 2 hours. So we're hoping that, that label change will be approved here in Q4. There's another part of label change we're asking for that we'll see if that happens as well that should help us commercially. I think on the adult uptake, we are looking to scale faster where we are even with the current footprint, but maybe expanding that footprint as we go into the second half. So we do believe there's upside growth in the execution on the adult side. But the real focus of the team right now is preparing for peds and getting the core functional parts of the launch in place now that we're being with the Board very shortly. On the supply chain, given that we're predominantly U.S. manufactured, we don't anticipate much impact from tariffs. Maybe I'll let Chris comment on a couple of those.

Yes. I think it's just important to remember that Afrezza as well as Tyvaso DPI as well as our 2 pipeline programs in 101 and 201 are all manufactured out of our Connecticut facility. So there are certainly certain materials that are purchased from other places throughout the world. The tariff situation is still evolving, I think, it's fair to say. But what we are aware of right now, we feel good that our key products are either exempt at this point in time or we are in a good position to manage through it.

And the other thing is we had several quarters of V-Go supplies here in the U.S. We were able to slow down shipments there just to kind of see where this goes to minimize any impact. But we do believe V-Go will be exempt from tariffs if it does go forward as is. So we feel pretty good about minimal impact overall. But again, time will tell. It's a day-to-day situation for all of us.

Our next question comes from Andreas.

Lots of focus on IPF, understandably so. Could you just give us a sense of -- I mean, with the rapidly evolving clinical development treatment landscape, can you give us a sense of where you see 201 and even some color on DPI fitting in the treatment landscape? And then I have a quick follow-up after that.

Yes, surprising, none of you're asking about 101, but I'll hold back. On the 201, I think as we look out, the landscape, obviously, is challenging, meaning Pliant had an abysmal failure there in Q4. It's unfortunate for patients. We know this is a very tough disease to treat. But as we look out for nintedanib, remember, 80% of patients generally aren't on treatment or can't tolerate existing treatments. So our real focus is on how do we expand the opportunity to help more patients and hopefully bring a tolerable OFEV like regimen to market. We believe inhaled nintedanib could be a background of therapy for the other new drugs coming. So we think about Tyvaso DPI or the new BI launch or the Bristol-Myers one. If these products make it to market, we'll be very excited because we do believe they'll be used in combination and that combo treatments will hopefully provide better efficacy for patients, assuming they can get the tolerability, which I think has been the rate-limiting issue to date is the 2 drugs out there are not very tolerable. And when you combine them, you're getting overlapping toxicity. So to have something that we think could provide some efficacy at potentially the equivalent dose or higher doses, then how do we then think about that in combination with the new treatments coming. And I think that's really evolving quickly over the next year or 2 as our trials move to Phase II/III. And that's also creating one of the -- I don't want to comment too much on the study design because we're trying to think through what do you do as these new agents come online over the next 1 and 2 years? And how would you add those into your trial or add a nintedanib inhaled on top of them. So there's a lot of differences of opinion on can you run a placebo trial? Can you run a naive trial? Can it be on top of background? And in the case of nintedanib, it doesn't make sense always to have it on top of background therapy because one of the drugs we're trying to replace would be oral OFEV. So hopefully, that helps give you some color.

Yes. And then obviously, when it comes to inhaled therapies, delivery is paramount, and we contend that device plays a key role in that. How are you guys thinking just broadly, maybe it's too soon or you do have a lot on your plate, but how are you thinking about opportunities to collaborate with other companies on the delivery side of things?

So I think on 201, obviously, our device platform has been very successful in the PAH and PH-ILD market. I would say in the diabetes market, the device platform is not the reason it's not successful. So we're planning to use the same device platform for 201, and that device has been used quite widely now amongst pulmonologist treaters in that space. So we think that's an advantage of having the clinical experience with the device and the training that it will just blend into those centers. On the case of clofazimine, we'll start with a nebulizer, a jet nebulizer that is pretty widely utilized in this patient population already because they have other products for nebulizing. But we have a dry powder version that we are looking to hopefully fit into the Dreamboat platform. And so as we look out, that's one of our core focuses. I'm not sure we need other device platforms that are usually off the shelf and not many of them have been scaled successfully. But we'll keep -- we're always open to ideas for innovation and patient support.

I appreciate and congrats on the quarter.

Our next question comes from Yun Zhong from Wedbush.

And so my question is on Afrezza. It's very encouraging to see a higher increase in NRx versus TRx. Would you attribute that to maybe higher promotional activity or new data or the combination of both?

I think it's a combination of what you just said, the new data combined with the execution of the sales force. So we started a strong education campaign around October time frame on the INHALE-3 data set. And I would say we had several speaker events and national events that led to a strong Q4. And in Q1, we didn't make any major changes to our sales force. We did increase our sales force a little bit in terms of having more feet on the ground. We did increase our share of voice at the ATTD Conference, which I think were good investments and hopefully, those will continue to propel us as we come into Q2 and Q3. So we're hearing good feedback. We're hearing less resistance. We're hearing good managed care coverage this year. So I'd say, overall, for Afrezza, I mean, I'm very optimistic that we'll continue to see nice progress, especially as the new team comes on board and starts to make the changes they're making and those flow out through the field for customers.

Would you say the strategy will be the same for pediatric patient?

Say that again, I'm sorry, I heard pediatric patient.

Right. So going into pediatric potential launch and what would be your strategy just like the same as you took for adult patient?

I think the strategy for peds is actually be very different. 80% of the patients are treated in a children's hospital or academic medical center, and that will take a very different launch strategy as we go forward. And I think you'll be hearing some of that rollout as we get to the next quarter. We have a pretty comprehensive plan we're working on. And I think that will be shared once it's approved by the Board. But at this point, it is not going to be the same as the adult side. We expect that to be a very different launch and the launch trajectory from where we are in adults.

Our next question comes from Anthony Petrone from Mizuho.

Congrats on a strong start to the year here. I'll start with one on pediatric Afrezza and then move over to the pipeline. On pediatric Afrezza, maybe, Mike, can you give us an idea when you think about how that patient population behaves and your thoughts on adherence? Obviously, with peds, you have a caregiver, tends to be a slightly more diligent sort of patient population relative to adult. So maybe just your thoughts here on what adherence looks like in pediatric diabetes and really what the uptake could be? I would imagine maybe there's a potential for a more rapid uptake in peds versus adults. And I'll have a follow-up.

Yes. Nice to hear you, and thank you for your initiation there. The ped side, to your point, has different dynamics than the adult side. Number one, I think ped endos are much more progressive doctors, and they're more used to trying new technologies. An example is that you just have a group of patients who have parents that are very active in their kids life. Anyone that has kids knows you're going to fight for your children more than anything in the world. And when it comes to newly diagnosed children, you're dealt with a life sentence, unfortunately. And you're going to -- I think that's where we have a strong opportunity with Afrezza, who really wants to learn how to count carbs, inject insulin multiple times a day, worry about hypo, nocturnal dead in bed. These are not fun things as a parent. Hearing the stories of parent sleeping next to their child because they're afraid they're going to go into the seizure at night. These are all the things that go through pediatric diabetes. And so we do think having something like Afrezza, which we've seen over time has less hypos in our pivotal trials. The onset and offset of action allows you to predict a little bit more of your control. And use of CGM these days, I think, will give parents some comfort when they start to get used to the Afrezza profile. So I think net-net, what that means is a consumer approach will be important in peds. And whether that's the parents in educating them and the kids that are teenagers and camps, that's a whole different game than what we've had to deal with in Afrezza adults. The doctors themselves, I mean, I've met at least 10, 15 of them in the last 2 months here, they are very open to Afrezza. Once they saw the lung safety data, that was the #1 question coming into peds. And that lung safety data looks very strong over the 26 and 52 weeks. So I think that question is off the table in terms of any concerns of lung safety or any impact of Afrezza there. So that's also an important point for launch. And then the last one is your comment on compliance. And that's one of our surprises in the Afrezza trial was how well, especially the teenagers did. They're hormonal. They're taking high doses. They are rebellious in some cases. They're worried about weight gain of insulin. We saw very high success rates in that population. And so I think your average diagnosis is around 12 years old, and those kids are going through major hormonal changes between 12 and 15. So we think that so far, people will probably more likely adhere to Afrezza. Where the younger kids may have some challenges in the schools and the nurses and administration, we'll continue to work on programs to support that where the teenagers can take the product themselves and carry it much easier for them to control their sugar. So that's generally what we see and feel on the Afrezza peds and some of the high-level thoughts on the launch.

Very helpful. And pipeline, this is more of a totality question. Really when you look at the TETON programs with United and then you take 101 clofazimine, 201 in IPF, both you and your partner go for the same indication. And just looking at a blue sky scenario, that's a heck of a lot of Technosphere devices if it all comes to fruition. So just a recap on the Danbury capacity, if the blue sky scenario plays out over the next 5 years, would you need a growth CapEx injection?

I think we can all thank Al Mann for dreaming big. He built a huge scale facility for diabetes. And as you know, that disease is 30 million people just in the U.S., let alone 300 million to 500 million worldwide. So when you think about capacity of device manufacturing, we have a very high capacity to scale up there if needed, and I don't expect any major CapEx. On the filling equipment lines, we believe 201 can be fit into the current facility we already built and whether that's excess capacity on the Afrezza line or an old production line as we scale up to Tyvaso. And we have another line that's idle. So we have plenty of equipment to fill cartridges for 201 if that continues to grow as well as Afrezza. So we're not too worried about the capacity there. And then on 101, you may or may not have noticed over the last couple of quarters, but we actually have been building out the manufacturing capacity there in Danbury. The equipment has been coming in. We're actually doing a field application test this week. And that is already being built and in our CapEx run rate. So I think most of the pipeline and CapEx is already behind us. I'm sure there'll be small things here and there, Chris, but I don't see any major coming in the next 5 years unless we were to buy something that needed something, that will be different. But where we are today, I think we don't need to build another plant in the next 5 years. and we have plenty of capacity to support the growth of the company.

That concludes the question-and-answer portion of today's call. I will now hand the call back to the MannKind team for closing remarks.

Well, thank you, everyone, for all your interest in MannKind and the questions here. We're really proud of the work we've done. 201, we had a great discussion. We got great direction we need to go. On 101, the pipeline with clofazimine, which we were nervous that how fast or slow that trial would go. As you can see, the trial has done very well in terms of enrollment, and we remain on track there. And then the peds for Afrezza is on track to be filed here midyear. So everything is going in the right direction. The tariffs obviously are impacting the overall economy. But for MannKind, we believe we can navigate through those headwinds. And we've got a great company for investors and a great company for employees and patients. So thank you again for everything and look forward to talking to you soon at the upcoming conferences or on the next quarterly call. Talk soon.