MannKind Q1 2025 Earnings Report

MannKind EPS Results

• Actual EPS: $0.04
• Consensus EPS: $0.03
• Beat/Miss: Beat by +$0.01
• One Year Ago EPS: $0.05

MannKind Revenue Results

• Actual Revenue: $78.35 million
• Expected Revenue: $75.86 million
• Beat/Miss: Beat by +$2.50 million
• YoY Revenue Growth: +18.10%

MannKind Announcement Details

• Quarter: Q1 2025
• Date: 5/8/2025
• Time: Before Market Opens
• Conference Call Date: Thursday, May 8, 2025
• Conference Call Time: 9:00AM ET

MannKind (NASDAQ:MNKD), a biopharmaceutical company, focuses on the development and commercialization of inhaled therapeutic products for endocrine and orphan lung diseases in the United States. It offers Afrezza, an inhaled insulin used to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults. The company's product pipeline also includes Tyvaso DPI (Treprostinil), an inhalation powder for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease; MNKD-101, a nebulized formulation of clofazimine, for the treatment of severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial lung disease; MNKD-201, a dry-powder formulation of nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF). In addition, it has collaboration and license agreement with United Therapeutics Corporation for development, regulatory, and commercial activities of Tyvaso DPI; co-promotion agreement with Vertice Pharma to promote Thyquidity; and collaboration agreement with Thirona to evaluate the therapeutic for the treatment of pulmonary fibrosis. Further, the company has supply and distribution agreement with Biomm S.A. for the commercialization of Afrezza in Brazil; and license and distribution agreement with Cipla Ltd. for the marketing and distribution of Afrezza in India. MannKind Corporation was incorporated in 1991 and is headquartered in Danbury, Connecticut.

MannKind Q1 2025 Earnings Call Transcript

Key Takeaways

• The company’s endocrine business posted a 20% increase in new prescriptions and a 14% rise in total prescriptions in Q1, with an adult dosing label change filed and a pediatric expansion planned for mid-2025.
• The Tyvaso DPI partnership generated $30 million in royalty revenue and $29 million in manufacturing revenue in Q1, contributing non-dilutive funding for the pipeline and totaling about $1.1 billion in sales over the past year.
• MannKind-101 (inhaled clofazamine) has activated 85% of trial sites, with 55 patients randomized and no dose reductions reported, aiming for an interim analysis at 100 patients by year-end.
• MannKind-201 (inhaled nintedanib) completed a Phase 1 study with no serious adverse events and is preparing for a global Phase 2/3 trial to address IPF’s unmet needs.
• In Q1, total revenues rose 18% year-over-year and non-GAAP net income climbed 43% to $22 million, supported by a cash and investments balance of $198 million heading into 2025.

Presentation

[Operator]

Good morning, and welcome to the MannKind Corporation First Quarter twenty twenty five Financial Results Earnings Call. As a reminder, this call is being recorded on 05/08/2025 and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call and available for approximately ninety 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 03/31/2025 on file with the SEC, the earnings release, and the slides prepared for this presentation.

[Operator]

Joining us today for MannKind are Chief Executive Officer, Michael Castagna and the Chief Financial Officer, Chris Prentiss. I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

[Michael Castagna, CEO at MannKind]

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 mankind is today and are excited by our five key pillars of growth above.

[Michael Castagna, CEO at MannKind]

Now I'm gonna highlight our q one twenty twenty five 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 twenty twenty five.

[Michael Castagna, CEO at MannKind]

Our Tyvaso collaboration remains strong. I'm sure many of you have listened to the UT call. We are excited about our great partnership together, which resulted in Q1 royalty revenue of $30,000,000 and manufacturing revenue of $29,000,000 In terms of colfazamine and etendib, 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 22,000,000 or 43% growth over last year. Now let me bridge to our diabetes business.

[Michael Castagna, CEO at MannKind]

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 three 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 set the stage for Afrezza to realize its true potential. After leaving ATT and interacting with hundreds of US 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 three days we were there. Additionally, I have met many US customers on my travels around The US, and I no longer hear the objections I used to. And now what I hear is, why don't we increase patient requests?

[Michael Castagna, CEO at MannKind]

Why is it not top of mind with our Salesforce? 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.

[Michael Castagna, CEO at MannKind]

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. Very pleased with the early in 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 q one and ordering patterns at the end of twenty twenty four.

[Michael Castagna, CEO at MannKind]

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 to move, sorry, clofazamine MannKind one zero one forward as well as natinib, our MannKind two zero one. What's really encouraging is we had about $1,100,000,000 of Tyvaso DPI related revenue from United Therapeutics in the previous four quarters, and we receive, obviously, 10% royalty on those sales. We recorded $29,000,000 in manufacturing revenue in q one, and we await the re the readouts of the TITOM one and two trials that United Therapeutics is conducting.

[Michael Castagna, CEO at MannKind]

As I look to the NTM market, we get very excited that this market will likely exceed $1,000,000,000 by the end of the decade. Our focus is on The US and Japan, which have the highest addressable populations, and this disease continues to grow seven percent year over year. We see a large market opportunity with one branded treatment in The US and Japan. We believe MannKind will be the next potential launch with clofazamine as we look out. Current NTM therapies have their limitations in efficacy, safety, and tolerability.

[Michael Castagna, CEO at MannKind]

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 in frequent dosing, these are almost like TB like regimens and or nebulizers that that contribute to patient fatigue and low adherence to therapy. Now let me bridge over to the inhaled development rationale for for inhaled clofazamine. 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.

[Michael Castagna, CEO at MannKind]

Oral clofazamine 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 clofazamine 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 twenty eight days and load the lung and then fifty six days off. We hope this will alleviate the patient treatment burden as well as noncompliance. Now let me update you on our MANKIND one zero one study. First, eighty five percent of our sites have been activated across four countries.

[Michael Castagna, CEO at MannKind]

Two, we've had 55 patients randomized with minimal dropouts, and patients are now starting to move past the six 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 their 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.

[Michael Castagna, CEO at MannKind]

Point. Now I'll bridge over to IPF. For those of you who don't know IPF, it's a progressive and fatal disease. Eighty percent of people will die within the first five years of diagnosis. There are only two 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.

[Michael Castagna, CEO at MannKind]

We believe natinib 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 one study, which was complete and met its safety and tolerability objectives in healthy volunteers. We had no serious AEs and AEs typically seen with natinib 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.

[Chris Prentiss, CFO at MannKind]

I will now discuss our first quarter twenty twenty five 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 five years as we compare the trailing four quarters on an annual basis.

[Chris Prentiss, CFO at MannKind]

It demonstrates impressive growth across our three 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 Tarveso 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.

[Chris Prentiss, CFO at MannKind]

Tyvaso DPI royalties contributed $30,000,000 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 $29,000,000 in the current quarter, an 18% increase from the prior year quarter. Afrezza net revenues for the first quarter were $15,000,000 a 3% increase over the prior year. It's important to note that the first quarter of twenty twenty four benefited from a onetime favorable adjustment to gross to nets.

[Chris Prentiss, CFO at MannKind]

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 $4,000,000 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 twenty twenty four. For the first quarter of twenty twenty five, we reported net income of $13,000,000 or $04 in earnings per share, a 24% increase compared to 11,000,000 or $04 per share for the first quarter of twenty twenty four.

[Chris Prentiss, CFO at MannKind]

On a non GAAP basis, we reported $22,000,000 of net income or $07 of earnings per share for the first quarter compared to $15,000,000 of non GAAP net income or $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 198,000,000 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.

[Michael Castagna, CEO at MannKind]

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. In Hail one, 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 MannKind one zero one, the key metric we're tracking is interim enrollment target, which we expect to meet by year end.

[Michael Castagna, CEO at MannKind]

And on 02/2001, it's continued to finalize details behind our global trial and work with their CROs to get a proposal to kick this off in the second half of twenty twenty five. 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 to 350,000,000 in revenue between manufacturing and royalties. We know there's a big opportunity here in TETOM one and two, and we'll actually 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.

[Michael Castagna, CEO at MannKind]

We now believe that every 10% share in kids represent about a hundred and $50,000,000 in net revenue to mankind. As we look out, the inhaled three data continues to be educated out there in the marketplace and present it, and the international opportunity continues to grow. And then as we close out here on 01/2001 and 02/2001, '1 zero '1 is a significant unmet net here unmet need here in NTM. In every one thousand patients, we believe, be a hundred million dollars in net revenue. And on 02/2001, 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.

[Michael Castagna, CEO at MannKind]

We are looking forward to continue to build upon these catalysts to make mankind 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 and A.

[Operator]

Thank you. At this time, if you would like to ask a question, please click on the raise hand button, which can be found on the black bar at the bottom of your screen. When it is your turn, you will receive a message on your screen from the host allowing you to talk, and then you will hear your name called. Please accept, unmute your audio, and ask your question. We will wait a moment to allow the queue to form.

[Operator]

Our first question comes from Faisal Khorsid from Leerink. Faisal, please unmute your line and ask your question.

[Heidi Jacobson, Equity Research Associate at Leerink Partners]

Hi, this is Heidi on for Faisal. Thanks for taking our question. Regarding MANKIND-two zero one, can you provide some initial thoughts on what a Phase twothree trial design for MANKIND-two zero one could look like? And any feedback you received from the FDA? And did they align on a seamless study design? Thanks.

[Michael Castagna, CEO at MannKind]

Hi. Thank you for the question. We aren't aren't giving too much guidance yet on the the feedback from the FDA. What I can say on the, in the phase two, three design was more for a global trial. So I think that'll be more of a question as we get to, ex US authorities.

[Michael Castagna, CEO at MannKind]

I 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 profenadone or naive patients or patients that are previously treated but not tolerating existing products? So that that's probably the extent we can share at this point.

[Heidi Jacobson, Equity Research Associate at Leerink Partners]

Got it. Thanks so much.

[Operator]

Thank you. Our next question comes from Olivia Brea from Cantor. Olivia, please unmute your line and ask your question.

[Olivia Brayer, Analyst at Cantor Fitzgerald]

Hi, good morning, guys. Thank you for the question. Mike, wanted to follow-up on your IPF study, especially as it relates to endpoints. Maybe it's 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?

[Olivia Brayer, Analyst at Cantor Fitzgerald]

And then also if if there's anything you can tell us with respect to dose levels, and then I've got a a follow-up question on Tyvaso.

[Michael Castagna, CEO at MannKind]

Sure. So so I think the the we'll be looking at a couple different doses. We're still finalizing the protocols you can imagine. But, conceptually, we're looking at a couple doses, and I think the question is, you combine those doses for 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.

[Michael Castagna, CEO at MannKind]

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, you know, should it be a hundred, 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 on the phase three with that with that efficacy could look like as we scale the next generation the next part of the trial.

[Olivia Brayer, Analyst at Cantor Fitzgerald]

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 for DPI. Do you know at this point if that would be an inferiority study between the two, DPI and and the nebulized formulation?

[Olivia Brayer, Analyst at Cantor Fitzgerald]

And anything you can tell us at this point in terms of timing around when that could kick off and and how long that could realistically take?

[Michael Castagna, CEO at MannKind]

I think it's too premature to to to comment yet. I 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 two zero one that I think will feed into the Tyvaso discussion as well. So I think give us another quarter or two. I know waiting for the TITAN two results is one of the first focuses that obviously, get that readout. But then the second focus, they have some preliminary ideas, and and I think we'll have a solid plan.

[Michael Castagna, CEO at MannKind]

I I I think we believe it'll be a breeze like study, as opposed to a large scale trial. So I think that's 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.

[Olivia Brayer, Analyst at Cantor Fitzgerald]

Okay. Understood. Helpful. Thank you, guys. Congrats on the quarter.

[Michael Castagna, CEO at MannKind]

Thank you.

[Operator]

Thank you. Our next question comes from Gregory Renza at RBC. Gregory, please unmute your line and ask your question.

[Anish Nikhanj, Senior Associate - Biotechnology Equity Research at RBC Capital Markets]

Good morning, Mike and team. It's Anish on for Greg. Congrats on the progress this quarter, and thanks for taking our questions. Just a couple from us. First, on the label update for adults that you spoke about.

[Anish Nikhanj, Senior Associate - Biotechnology Equity Research at RBC Capital Markets]

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 TAVESO DPI and even longer term that on 01/2001 and 02/2001, just as we think about APIs, parts related to Technosphere, dry powder, etcetera? Thanks so much.

[Michael Castagna, CEO at MannKind]

Sure. A lot of questions wrapped up there. I'll try to hit them all. I think on the dosing, we are 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 two hours. So we're hoping that that label change will be approved here in q four.

[Michael Castagna, CEO at MannKind]

There's another part of label change where we're asking for that that we'll we'll see if that happens as well that will 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 in the execution on the adult side, but the real focus of the team right now is preparing for peds and getting the the core functional parts of the launch in place now that that we're being with the board very shortly. On the supply chain, given that we're predominantly US manufactured, we don't anticipate much impact from tariffs. Maybe I'll I'll let Chris comment on a couple of those.

[Chris Prentiss, CFO at MannKind]

Yeah. I think it's just important to remember that, you know, Afrezza as well as Tyvaso DPI as well as our two pipeline programs in 01/2001 and two zero one are all manufactured out of our Connecticut facility. So there's certainly certain materials that are purchased from other places throughout the world. The tariff situation is still evolving, think, 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.

[Michael Castagna, CEO at MannKind]

And and the other thing I was Thank you. Is we had several, quarters of V Go supplies here in The US. We were able to slow down shipments there just to kinda see where this goes to minimize any impact. But we do believe V Go will be exempt, from tariffs if if it does go forward as is. So we feel pretty good while minimal impact overall, but, again, time will tell.

[Michael Castagna, CEO at MannKind]

It's a day to day situation for all of us.

[Anish Nikhanj, Senior Associate - Biotechnology Equity Research at RBC Capital Markets]

Great. Thanks. Appreciate it.

[Operator]

Thank you. Our next question comes from Andreas. Andreas, please could you unmute your line and ask your question?

[Andreas Argyrides, Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.]

All right. Good morning and thanks for taking our questions. 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 give us a sense of where you see two zero one and even some color on DPI and fitting in treatment landscape? And then I have a quick one follow-up after that. Thanks.

[Michael Castagna, CEO at MannKind]

Yeah. I'm surprised. I don't think you're asking about one zero one, but I'll I'll hold back. On the two zero one, I I think as we look out, the the landscape obviously is challenging, meaning client had a an abysmal failure there in q four. It's unfortunate for patients.

[Michael Castagna, CEO at MannKind]

We know this is a very tough disease to treat. But as we look out for nitetinib, remember, eighty percent 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, you know, OFAB like regimen to market. We believe inhaled natendip could be a background of therapy for the the other new drugs coming. So we think about Tyvaso DPI or the new BI launch or the Bristol Myers one.

[Michael Castagna, CEO at MannKind]

You know, 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 get the tolerability, which I think has been the rate limiting issue to date is the two 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 as our trials move to phase two, three. And that's also creating one of the one of the well, I don't wanna comment too much on the study design because we're we're trying to think through, you know, what what do you do as these new agents come online over the next one or two years, and how would you add those into the trial or add on a natinib and hail on top of them.

[Michael Castagna, CEO at MannKind]

So, you know, 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 Natenda, 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.

[Andreas Argyrides, Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.]

Yeah. And and then, obviously, you know, when it comes to inhaled therapies, delivery is is paramount and, you know, we contend that device, plays a key role in that. How are you guys thinking just broadly? Maybe it's too soon or, you know, 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? Yeah. Thanks.

[Michael Castagna, CEO at MannKind]

So so I think on 02/2001, you know, obviously, our device platform has been very successful in the in the PH 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 02/2001, and, you know, that device has been used quite widely now amongst pulmonologist, treaters in in that space. So we think that's an advantage of having the clinical experience with the device and the training that it'll just blend into those centers. On the case of clofazamine, we'll start with a nebulizer, a jet nebulizer that is pretty widely utilized in this patient population already because they have other products they're nebulizing.

[Michael Castagna, CEO at MannKind]

But we have a dry powder version that we are looking to hopefully fit into the DreamBuild platform. And so as we look out, you know, that that's one of our core focuses. I'm not sure we need other device platforms. They're usually off the shelf, and not many of them have been scaled successfully. But we'll keep you know, we're always open to ideas for innovation and patient support. So

[Andreas Argyrides, Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.]

I appreciate, and congrats on the quarter. I'll jump back in the queue.

[Michael Castagna, CEO at MannKind]

Thank you.

[Operator]

Thank you so much. Our next question comes from Yun Zhong from Wedbush. Yun, unmute your line and ask your question.

[Yun Zhong, SVP - Equity Research at Wedbush Securities]

Hi. Good morning. Thank you very much for taking the question. And so my question is on Afrezza. It's very encouraging to see a higher increase in NRX versus TRX.

[Yun Zhong, SVP - Equity Research at Wedbush Securities]

Would you attribute that to maybe higher promotional activity or new data or the combination of the both?

[Michael Castagna, CEO at MannKind]

I I think it it's a combination of what you just said, the new data combined with the execution at the Salesforce. So we started a a strong education campaign around, you know, October time frame on the Inhale three dataset, and I would say we had several speaker events and national events that led to a strong q four. And in in q one, we didn't make any major changes to our our Salesforce. We did increase our Salesforce 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.

[Michael Castagna, CEO at MannKind]

And, those will continue to propel us as we come into q two and q three. So we're hearing good feedback. We're hearing less resistance. We're hearing good managed care coverage this year. So I I'd say overall for Afrezza, I mean, I 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 through customers. So

[Yun Zhong, SVP - Equity Research at Wedbush Securities]

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

[Michael Castagna, CEO at MannKind]

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

[Yun Zhong, SVP - Equity Research at Wedbush Securities]

Right. So go into pediatric potential launch, and what would be your strategy just come like, the same as you took for the outpatient?

[Michael Castagna, CEO at MannKind]

I think the strategy for PACE is actually very different. Eighty percent of the patients are treated in a 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 gonna be the same as the adult side.

[Michael Castagna, CEO at MannKind]

We we expect that to be a very different launch and a launch trajectory from from where we are in adults.

[Yun Zhong, SVP - Equity Research at Wedbush Securities]

Great. Thank you very much. Thank you.

[Operator]

Thank you. Our next question comes from Anthony Petrone from Mizuho. Anthony, please unmute your line and ask your question.

[Anthony Petrone, Managing Director Equity Research at Mizuho Financial Group]

Hi. Thanks and 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 appraiser, maybe Mike, can you give us an idea when you think about how that patient population behaves and your thoughts on adherence? You know, obviously, with peds, you have a caregiver, tends to be a slightly more diligent sort of patient population relative to adult.

[Anthony Petrone, Managing Director Equity Research at Mizuho Financial Group]

So maybe just your your your thoughts here on what adherence looks like in pediatric diabetes and really what the uptake could be. I I would imagine maybe there's a potential for more rapid uptake in peds, versus adults and all of the follow-up.

[Michael Castagna, CEO at MannKind]

Yeah. Thank you. I think, nice to hear you and thank you for your initiation there. The the ped side, to your point, has different dynamics than the adult side. Number one, I think pedendos are much more progressive doctors, and they're more used to trying new technologies.

[Michael Castagna, CEO at MannKind]

An an example, is that you just have group of patients who have parents that are very active in their kids' life. Anyone that has kids knows you're gonna fight for your children more than anything in the world. And when it comes to newly diagnosed children, you're you're dealt with a life sentence, unfortunately. And you're gonna you know, I think that's where we have a strong opportunity with the Afrezza's. Who who really wants to learn how to count carbs, inject insulin, you know, multiple times a day, worry about hypo, nocturnal, dead in bed.

[Michael Castagna, CEO at MannKind]

These are not fun things as a parent. You know, hearing the stories of parents sleeping next to their child because they're afraid they're gonna go into a 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, you know, less hypos in our pivotal trials. It, the one set and offset of action allows you to predict a little bit more of your control.

[Michael Castagna, CEO at MannKind]

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 and educating them and or the kids that are teenagers in 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, I don't know, at least ten, fifteen of them in the last two months here. They are very open to Afrezza.

[Michael Castagna, CEO at MannKind]

Once they saw the lung safety data, that was the number one question coming into peds, that lung safety data looks looks very strong over the the twenty six and fifty two 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 that's also the the the an important point for launch. And then the last one is your 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.

[Michael Castagna, CEO at MannKind]

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 and so I think your average diagnosis is around 12 years old, and and those kids are are going through major hormonal changes between 12 and 15.

[Michael Castagna, CEO at MannKind]

So we we think that, you know, so far, people will probably more likely adhere to Afrezza, where the younger kids may have some challenges in the schools and the nurses administration. We'll continue to work on programs to to to support that where the teenagers, you know, can take it on take the product themselves and carry it, much easier for them to control their sugar. So, that's that's generally what we see and feel, on the Afrezza peds and some of the high level thoughts on the launch.

[Anthony Petrone, Managing Director Equity Research at Mizuho Financial Group]

Very helpful. And pipeline is more of a totality question. Really, when you look at the TETOM programs with with United and then you take one zero one clofazamine two zero one in IPF, both you and your partner go for same indication. And just looking at a blue sky scenario, it's a heck of a lot of technosphere devices if if it all comes to fruition. So just a recap on a Danbury capacity.

[Anthony Petrone, Managing Director Equity Research at Mizuho Financial Group]

If the blue sky scenario plays out over the next five years, would you would you need a growth CapEx in injection? Thanks.

[Michael Castagna, CEO at MannKind]

You know, I think we can all thank Al Mann for dreaming big. He he built a huge scale facility for diabetes, and as you know, that that disease is thirty million people just in The US, let alone, you know, three to five hundred 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 two zero one 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.

[Michael Castagna, CEO at MannKind]

So we have plenty of equipment to fill cartridges for 02/2001 if that continues to grow as well as Afrezza. So we're not too worried about the capacity there. And then on one zero one, you you may or may not have noticed over the last couple quarters, but we actually have been building out the manufacturing capacity there in Danbury. The equipment's 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.

[Michael Castagna, CEO at MannKind]

So 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 I don't see any major coming in the next five years unless we were to buy something that needed something that'll be different. Where we are today, I think we we don't need to build another plant in the next five years, and we have plenty of capacity to support the growth of the company. Thank you.

[Operator]

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

[Michael Castagna, CEO at MannKind]

Well, thank you everyone for all your interest in MannKind, the questions here. We're really proud of the work we've done. Two zero one, you know, we had a great great discussion. We got great direction we need to go. On one zero one, the pipeline with with clofazamine, which we were nervous to how fast or slow that trial would go.

[Michael Castagna, CEO at MannKind]

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 Fresa is on track to be filed here midyear. So so everything is going in the right direction. The tariffs obviously are are impacting the overall economy, but for mankind, we believe we can navigate through those headwinds. And we got a great company for investors and a great company for employer employees and patients.

[Michael Castagna, CEO at MannKind]

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.

Participants

Executives

• Michael Castagna, CEO
• Chris Prentiss, CFO

Analysts

• Heidi Jacobson, Equity Research Associate at Leerink Partners
• Olivia Brayer, Analyst at Cantor Fitzgerald
• Anish Nikhanj, Senior Associate - Biotechnology Equity Research at RBC Capital Markets
• Andreas Argyrides, Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.
• Yun Zhong, SVP - Equity Research at Wedbush Securities
• Anthony Petrone, Managing Director Equity Research at Mizuho Financial Group