Good morning, and welcome to the MannKind Corporation Fourth Quarter and Full Year 2025 Financial Results Earnings Call. As a reminder, this call is being recorded on February 26, 2026, and will be available for replay on the MannKind Corporation website shortly after this call and for approximately 90 days. This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from these expectations. For further information on the company's risk factors, please see the Form 10-K for the annual period ended December 31, 2025, 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.

Thanks, operator, and good morning, everyone. Thank you for joining us for our Q4 and year-end 2025 earnings call. Here is today's agenda, and I'll start with some opening remarks. I want to start by taking a step back and putting our relationship with United Therapeutics into context. Tyvaso DPI has transformed both United Therapeutics and MannKind's future to fund our respective innovation and growth. Tyvaso was a $450 million brand when we entered the collaboration in 2018, and Tyvaso DPI quickly grew within 36 months of launch to a $1 billion franchise by delivering a highly impactful therapy that has helped thousands of patients. This success has funded our diversification, setting us up for 3 important milestones. First, the opportunity to acquire and scale Furoscix and invest in inhaled Bumetanide dry powder inhalation. Second, it funded our growth of Afrezza over the past 6 years as well as the investment in our pediatric indication. While simultaneously third, investing in our pipeline programs, such as MNKD-201, which has blockbuster potential. When we signed the UT agreement in Q3 of 2018, MannKind was generating approximately $3.8 million in quarterly revenue and had a market cap of roughly $300 million. Today, we are a very different company. Excluding Tyvaso DPI, we have a $200 million-plus annual run rate and a market cap of approximately $1 billion. Our long-range plan is not dependent on future growth from UT-related revenues. And yesterday's announcement from United Therapeutics does not change our strategic direction or long-term plan, as the next 36 months should deliver over $350 million in royalties that have no cost against them. And our long-term supply agreement has 6 years left with minimum orders that should deliver over $400 million in revenue. Just as UT did not convert the entire market to Tyvaso…

Thanks, Mike, and good morning, everyone. For a summary of our financials, please review our press release issued before this call and our Form 10-K, which is now on file with the SEC. Now let me walk through our Q4 2025 revenues by category based on total revenues of $112 million, up 46% from the prior year quarter. As our acquisition of scPharmaceuticals closed on October 7, Furoscix is now included in our cardiometabolic revenues and contributed $23 million of product sales. We recorded sales of $23 million for Afrezza, an increase of 25% over the prior year quarter, which includes $600,000 of products sold to Cipla to support their initial launch of Afrezza in India. We are excited that the Cipla team is now able to bring a differentiated treatment option to people with diabetes in India and look forward to supporting their execution on the launch. Lastly, V-Go was $4 million for the quarter, a slight decline from the prior year period and in line with expectations, as we are not actively promoting the product. Collaboration and services revenue increased 5% over the prior year quarter to $28 million. Within collaboration and services revenue, $26 million of revenue was UT-related. This was primarily for the production of Tyvaso DPI and the recognition of deferred revenue, as well as recognition of a portion of the upfront milestone we received related to the second investigational molecule as part of our collaboration with UT. Recently, we amended our supply agreement with UT to add minimum annual quantities and volume-based pricing. This provides us better predictability as we prepare our Danbury facility to scale our development programs over the next few years. To give this context, our 2025 Tyvaso DPI manufacturing revenues were approximately $100 million. Based on our revised supply agreement,…

Thank you, Chris. Now let me bridge to the major catalysts driving this year. As we've discussed earlier, there are several exciting commercial catalysts between now and July for Afrezza and Furoscix. We continue working on early programs like inhaled Bumetanide and other undisclosed programs. But today, I want to focus on our clinical stage program, MNKD-201, which has blockbuster potential. On the clinical side, we anticipate enrolling the first patient in our Nintedanib DPI global Phase II study next quarter. And the U.S. Phase Ib study in IPF is enrolling nicely with top-line data expected in the second half of 2026. IPF is a progressive and fatal disease with problematic therapies available today. Only a minority of patients with IPF are on approved therapy. And why is that? Because patients can't tolerate these drugs. So they stop taking them, or they never even start. This is a disease where we believe patients are desperate for better options, and we believe Nintedanib DPI can fill this unmet medical need by delivering Nintedanib deep into the lungs. As we look at the competitive landscape, lung target delivery is emerging as a winning strategy in IPF. Systemic oral delivery has not translated into meaningful antifibrotic impact because it's difficult to achieve high lung exposure without compromising tolerability. Inhaled delivery changes this equation, and our Technosphere-based DPIs have demonstrated safety and tolerability in numerous patients with underlying lung disease. Nintedanib DPI pairs a proven molecule with direct lung targeting and gives us high confidence in its potential to reduce the GI-related adverse events seen with oral Nintedanib while maintaining or even enhancing efficacy. It also opens the door to combination use alongside current and future IPF therapies, which is increasingly how we see the market evolving. We believe Nintedanib will be the backbone…

[Operator Instructions] Our first question comes from Olivia Brayer with Cantor.

Can you guys hear me now?

Yes.

Okay. Perfect. Sorry about that. Mike, you made some intro comments around minimum supply agreement with United. Can you just maybe help contextualize some of those numbers to help give us a sense of what the real downside risk here is? How are you thinking about that $350 million number over the next 36 months? And Chris, I know you mentioned a minimum floor of $50 million through 2031. So is that the annual minimum supply agreement that UT is contractually obligated to...

Sorry about that. But maybe just to kick it off about the minimum supply agreement. So this is a schedule that was just attached to our 10-K that was issued this morning. It is redacted, so you can't see the quantities or dollar amounts, but it is a volume-based agreement. And so we were just trying to put that in dollar terms. So if you think about 2025, it was approximately $100 million. That will be in line for the next 2 years. And then after that, when we get to minimum quantities, you're looking at about half that amount, so approximately $50 million for the out years.

And those are minimum, Olivia. And I think on the royalty, I think you heard yesterday, UT talk about the robustness and double-digit growth of Tyvaso DPI. So if you were to just take a conservative approach and look at that number for this year, and bridge to next year, which we don't expect any major competition. I think you get 2 years there, and you at least get to the third year and get a decent number as well. So we wanted to get some context around what this means and how much cash flow it still is going to bring in, not just in the near term, but the longer term, and that it's our job to deploy that capital in an appropriate way.

Okay. Very helpful. And then on MNKD-201, how big of a strategic priority is that program at this point? And when will we actually see those Phase Ib data? I know it's later this year, but maybe beyond the timelines, like what will we actually see from that data set that could help drive confidence in the profile of a DPI and IPF patients?

Yes. I think a couple of things. Number one, from a priority 201 is critical in terms of we are spending a lot of energy and money and people on this one. And so it is a big priority focus from that perspective. The team is actively kicking off and enrolling a Phase I trial here in the U.S. and activating a Phase II trial globally as we speak. And so that's a tremendous amount of resources being put against it to go as quickly as humanly possible. In terms of enrollment in the Phase I, it's a 2-part study, and it's 12 patients in each part. And we already have, I think, 4 enrolled in the first part and 10 in screening. So we hope to wrap up Part 1, hopefully in the next month. And then there'll be a second part, which is the next dosing after you complete the first part, and that will hopefully be in Q2. So how fast that goes is why I put it in the second half to give the team time to analyze the data. What we're really going to get out of that study is hopefully tolerability, followed by looking at the FEV1, any changes there. It's a 7-day study. We don't expect much. But the tolerability, the cough, and all that is what we are most focused on here for IPF patients. The same dose in office will be given in the Phase II study. So we'll collect that same data in the Phase II. But this is really to satisfy the FDA request from our meeting last year, so that we can hopefully, maybe even think about moving the Phase II to the U.S. Right now, the Phase II is completely ex U.S. But once this is done,…

Our next question comes from Roanna Ruiz with Leerink Partners.

So another question about the UT supply contracts for DPI. I just wanted to check, could they be updated again in future years depending on DPI's ramp? And then as a positive counterbalance to that, I also wanted to ask what tailwinds could be driving future revenue growth, both from Afrezza and Furoscix this year and into later years, especially how you're thinking about the new guideline updates and the Autoinjector launch for Furoscix.

Yes. I think on the supply agreement, for us, it was important -- we never had minimums because we -- if you recall, maybe if I don't recall -- Roanna you weren't there in the beginning of the launch, but the launch took off a lot faster, which put a lot of capacity constraints on us in the beginning. And so we had to build that up pretty quickly, and we weren't in a position on either side to predict the outer years. And I think as this became mature and we saw the uptake and we saw the additional work that was happening, we needed to put some minimums in there so that we could operate Danbury for the long run, not just the short run, as we were in pretty much manufacturing hell for a couple of years when I look back. And so that agreement is there. I wouldn't say anything can be modified if you have mutual parties agree to that. But we do think there's a minimum production, and any brand you look at in the long term is always going to have some supply coming, and we believe that we'll be the sole supplier there for Tyvaso for a while. On Afrezza and Furoscix, I think what you've seen really over the last 2, 3 years for Afrezza, we were reducing expenses and running it for profitability. So it wasn't being run for growth. And I think that's an important context for everybody is people say, why didn't Afrezza grow faster. And the reality is until we had peds safety and efficacy, it wasn't going to be something we can invest in because we always believed peds was the inflection point for the brand. We tried various things over the years in the adult…

Our next question comes from Gregory Renza with Truist Securities.

It's Anish on for Greg. First, just for Chris. How should we be thinking about the evolution of gross margins and operating margins over 2026 as you take the reins with Furoscix and have Afrezza potentially going into peds this year? And second, for Mike, maybe if you could just give us more color and remind us on how MannKind leverages FDKP to enhance the delivery, efficacy, and tolerability of dry powders and how doc and patient fees have evolved over the years in PAH and PH-ILD, and how this might translate to IPF?

Thanks, Anish. To talk about gross margin dynamics. So the on-body infusor has a slightly lower gross margin than Afrezza historically has. So you could say before the autoinjector is approved and launched, there'll be a slight decline in gross margin. That will then improve significantly as the autoinjector is launched later this year. So I think you'll see a little bit of a hit in '26 and then a significant improvement in '27 and beyond. And maybe the other thing to note is just as a ramification of the purchase accounting, we now have this intangible asset, which is the on-body infusor, and when approved, the autoinjector that those are intangible assets that are amortized. You see that's $4 million in Q4. That will obviously play out over the year. That is technically part of COGS. And so if you look at our COGS and our margin disclosures in the 10-K, you'll see a more significant impact to margin. Those are -- that's a noncash item, but that will be included in margin going forward.

And then your question on FDKP, if I heard it correctly, is just how is that critical? Why is that important? And FDKP is really what founded the formulation behind Afrezza and the scalability in the company and the moat that we have around our technology. It really is used to deliver drug deep into the lungs by either protecting the molecule, make sure it gets there, and making sure the molecule can fly there. As you may or may not know, many dry powders and nebulizers have wide variability in their delivery. And so it's not just the FDKP and the powder, it's also the device platform we have. And those 2 things go hand-in-hand to deliver deep lung penetration and consistent lung penetration. And we see that in Afrezza and the 3D imaging studies we did, that's important. And so we believe, as you look at the various molecules we've already worked on and got approved as well as what's in the pipeline, 80% to 99% of that powder is FDKP. So it's a critical ingredient in everything that we do and the formulations that we make. And you continue to see that help, whether it's in the Bumetanide work that we're doing, the IPF for 201 and Nintedanib as well as Afrezza and that Furoscix and treprostinil. So we think it's important. We think it helps shape the particle size, and there is a barrier to access this molecule. And we think there's more innovation as we look out that we can start to think about with FDKP and continuing to take that to the next level as well.

Our last question comes from Brandon Folkes with H.C. Wainwright.

Maybe just 2 from me. Firstly, on the Afrezza pediatric opportunity, can you just talk about the market research you did? What did this sort of return and where the opportunity lies initially, versus new patient starts versus switch patients? And then should we think about any bolus of switch patients upfront, looking to go needle-free or pump-free? And then maybe secondly, for me, just a quick one. Coming back to UT, which is taking a different approach. In your press release, you continue to include the second molecule, 1505, that collaboration. So is there anything molecule-specific on 1501 that give you confidence that they would move forward on a dry powder on that molecule?

Yes. I think on the Afrezza peds market research, this is new research that just came in over the last few weeks. And I think we were looking to update the research we did previously that gave us some conviction. So we feel that, that was important to share. This is recent data. And it was really done amongst a group of physicians in a quantitative way that wasn't in an interactive or, I'll say, trying to sell them was just displaying what the data says and the product profile. So we were encouraged to see those results because that's before medical education or rep detail, et cetera. And so I think it just shows you that there's a large opportunity. The one that did surprise us is the percent of naive patients that may potentially come in, into the product as it wasn't in our original framework. And I think as we were looking to do INHALE-1, it just reconvinced us that, that was the right study to do and scale. And that study is enrolling nicely, and we're just kicking off the first 10 patients, and then we'll evaluate that and then open up for the other 90. So that study is well on its way, and I think it will be an important study to just understand the dynamics in endo practice and children's hospitals around how do they create teaching protocols, how do they -- what do they have to change for onboarding patients, how do they train patients on basal versus meal-time control, when do they give doses, school nurses program. So there's a lot in that trial that actually we're learning from daily that I think will apply to the launch. And so that's really good there. And then -- but is there going…

That concludes the questions.

Thank you, operator. I see no other questions here in the queue. So I want to thank our employees for their dedication and hard work. I want to thank the patients and families who are participating and continue to participate in our trials and use our products every day. Everything we focus on is about helping people live life more human. We remain committed to our mission, and we look forward to moving our company forward in 2026. Thank you.