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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 08, 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 filed 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 the 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 five 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. 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 from 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 set 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 non-stop with traffic over the three days we were there.

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 five years, as we compare the trailing four quarters on an annual basis. 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 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 one-time 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. [Operator Instructions] Our first question comes from Faisal Khurshid from Leerink. Faisal, please unmute your line and ask your question.

Hi, this is Heidi on Faisal. Thanks for taking our question. Regarding MannKind 201, can you provide some initial thoughts on what a Phase 2/3 trial design for MannKind 201 could look like and any feedback you received from the FDA and did they align on a seamless study design? Thanks.

Hi, thank you for the question. We aren’t given too much guidance yet on the feedback from the FDA. What I can say on the Phase 2/3 design was more for a global trial, so I think that’ll 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 naïve patients or patients that were previously treated but not tolerating existing products? So that’s probably the extent we can share at this point.

Got it. Thanks so much.

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

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 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 we’ll be looking at a couple different doses. We’re still finalizing the protocol as you can imagine, but conceptually we’re looking at a couple 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 3, 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 their 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 two 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 then 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 MNKD-201 I think will feed into the Tyvaso discussion as well. So I think give us another quarter or two. I know waiting for the TETON 2 results is one of the first focuses 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’ll 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.

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

Thank you.

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

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. 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 MNKD-101 and MNKD-201, just as we think about APIs, parts related to Technosphere, dry powder, et cetera? Thanks so much.

Sure. A 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 timing range, better control in the first two hours. So we’re hoping that that label change will be approved here in Q4. There’s another part of label change where we’re asking for that, that 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 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 meeting 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 two pipeline programs in MNKD-101 and MNKD-201 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, I think, is 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 another thing I’ll add 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 while minimal impact overall. But again, time will tell. It’s a day to day situation for all of us.

Great, thanks. Appreciate it.

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

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 you give us a sense of where you see MNKD-201 and even some color on DPI and fitting in the treatment landscape? Then I have a quick one follow-up after that. Thanks.

Yes. I’m surprised. None of you are asking about MNKD-101, but I’ll hold back. On the MNKD-201, I think as we look out, the landscape obviously is challenging, meaning client 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 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 two as our trials move to Phase 2/3. 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 one and two years and how would you add those into the trial or add a nintedanib inhale on top of them. So there’s a lot of differences of opinion on, can you run a placebo trial, can you run a naïve 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? Yes, thanks.

So I think on MNKD-201, obviously our device platform has been very successful in the PH and PH-ILD market. I would say in the diabetes market, the device platform is not a reason, it’s not successful. So we’re planning to use the same device platform for MNKD-201. And that device has been used quite widely now amongst pulmonologists, treaters 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 clofazimine, we’ll start with a nebulizer, jet nebulizer that is pretty widely utilized in this patient population already, because they have other products they’re 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, they’re 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. I’ll jump back in the queue.

Thank you.

Thank you so much. Our next question comes from Yun

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

I think it’s a combination, what you just said, the new data combined with the execution at 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 through 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 pediatrics is actually 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 a launch trajectory from where we are in adults.

Great. Thank you very much.

Thank you.

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

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 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 impedes [ph], 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 more rapid uptake in impedes versus adults and all of the follow-up?

Yes. Thank you, Anthony. Nice to hear you and thank you for your initiation there. The impede side to your point has different dynamics than the adult side. Number one, I think [indiscernible] 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 the Afrezza’s 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 parents sleeping next to their child because they’re afraid they’re going to 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 less hypos in our pivotal trials. The one set and offset of action allows you to predict a little bit more of your control. And use of cGMP 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 impedes. 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 10, 15 of them in the last two months here, they are very open to Afrezza. Once they saw the lung safety data, that was the number one question coming into impedes, that lung safety data looks very strong over the 26 or 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 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 impedes and some of the high level thoughts on the launch.

Very helpful. And pipeline is more of a totality question. Really, when you look at the TETON program with United and then you take 101 clofazimine, 201 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 it all comes to fruition. So just a recap on a Danbury capacity. If the blue sky scenario plays out over the next five years, would you need a growth CapEx in injection? Thanks.

I think we can all thank Al Mann for dreaming big. He built a huge scale facility for diabetes, and as you know, that 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, 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 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. 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 is – something that’ll be different. But where we are today, I think 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.

Thank you. 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.