MannKind Corporation

Good afternoon and welcome to the Mankind Corporation fourth quarter end-year and 2024 financial results earnings call. As a reminder, this call is being recorded on February 26, 2025 and will be available for playback on the Mankind 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 risk and uncertainty, which can cause actual risk to differ materially from these stated expectations. For further information on the company's risk factors, please see the 10-K report filed with the Securities and Exchange Commission this afternoon, the earnings release, and the slides prepared for this presentation. Joining us today for MINDKIND, our Chief Executive Officer, Michael Castagna, and Chief Financial Officer Chris Prentice. I'd now like to turn the conference over to Mr. Skartania. Please go ahead, sir.

Thank you, operator, and good afternoon, everyone. Thank you for joining our call today. It's never been a better time to be on the journey with mankind. As I look at our future, we have five key pillars. We have two FDA-approved products on our Technosphere platform. a strong balance sheet with double-digit growth enabling us to have flexibility in the future, and also the ability to fund our two novel pipeline opportunities with clofazamine inhalation suspension and the tetanus DPI, as I'll talk about later in our call. Let me highlight Q4 and some of the year-end highlights from 2024. First, our endocrine business unit had record revenues with Q4 revenue of $23 million and full year at $82 million. We started this year by appointing Dominic Marasco as president of our EBU, which I'll talk about our growth strategy in a couple slides. We also closed out quickly at the end of the year with an approval in India, which we expect to launch in the second half of this year. Additionally, we announced our AnthraStar collaboration in December, which enabled us to promote Vaximi through our US sales force, allowing us to build up a pediatric footprint earlier than we would anticipate without this opportunity. We expect our pediatric indication to be filed here in the first half with an approval in early 2026. Today's DPI calibration remains strong, and we continue to be excited about the future of this important opportunity that we'll have on patients, especially those suffering from IPF. Chris will walk through the financials in a few moments. Our colfasmian inhalation suspension programs progressing nicely With our phase three study, now with 70% of sites activated, enrollment is on track to hit our interim goal by the end of this year, to hit 100 patients for enrollment, which will allow us to have an interim readout in 2026. On the intended DPI, we had an SDA meeting at the end of the quarter. Now that we've completed phase one, we are looking to advance this to the next stage of development. Our financial results in Q4, we had $77 million in revenue and $286 million for the full year. Our year-end cash position ended at $203 million, and we were able to reduce our debt principal by $236 million in 2024. Now let me bridge over to our diabetes business. Our diabetes program progression is built on several pillars. The first was bringing in Dominic Marasco, who's not with us today because he's at our national sales meeting and will join us at our call in May. As we look at the four pillars to Afrez's growth, it starts with our team and getting the right people on the bus and adding the clinical medical liaisons. The second is the international opportunity with India, which will allow us to bring more efficiency to manufacturing and help more patients around the world. And we'll also be looking for distributors in some international markets as we go forward. The next pillar here is pediatrics. This is something we've been waiting on and working on for seven years and is really important to us to transform the growth of Afrez, as we'll talk about in a moment. We expect to be able to file this in the first half of 2025 with an approval in second quarter of 2026. There are over 300,000 kids in the U.S. suffering from type 1 diabetes, and if you're like my kids, trying to give your kid a vaccine or any type of injection is very difficult, and we look forward to hopefully bringing an option to these patients in the future. And the fourth pillar we're starting to explore is that gestational diabetes, we're able to get an investigator-initiated trial off the ground, hopefully in the first half through the JAIB Center, as there are over 300,000 women who have gestational diabetes each year. As we look at the record revenue for AFREZA, we had a 17% year-over-year increase. We continue to grow AFREZA despite GLP growth, pump innovation, and as well as our focus on profitability. We are preparing to accelerate the growth of AFREZA over the next 24 months through the initiatives I just described. As we look out at the pediatric opportunity, This would lead us to projected sales at a run rate of over $200 million a year, which is almost three times where we are today. And I'll remind you, every 10% market share in pediatrics is approximately $150 million in revenue, in addition to whatever adult spillover or adult revenue we'd have ongoing. As you look at our market research we just finished conducting in the second half of last year, we saw that about 28% of patients could switch from MDIs, and 14% of patients could switch from AIDs, which would include Omnipod and Tandem. We generally would discount this type of projection by about 50%, but as you read the quotes here from the pediatric endocrinologist and the type 1 caregivers, there is a big opportunity here in kids to really help a lot of patients, whether that's reducing the complexities of counting carbs and insulin sensitivity ratios, or just making it easier for parents to administer something for their children. So we're very, very excited about pediatrics. You'll continue to see us prepare and scale up our investments around this, but don't expect much change in the first half as we're really preparing for the second half once we know that this file will be on track with the FDA. Now I'm going to bridge to our pipeline. As we look at Tyveso first, DPI-related revenues were over $200 million in 2024, and this made the first billion-dollar product for United Therapeutics, which we're very proud to be their partner. We're super excited to see that Technosphere platform has achieved the billion-dollar status. We're actually very excited about the opportunity this provides us to fund our pipeline with non-dilutive financing. As we look out, we know there's a major milestone in front of us here with Teton II in the second half. And if that reads out, we would expect that to be reflective of a positive opportunity here for Tavesa DPI potentially going to IPF in the future. Chris will talk about the revenues of Tavesa shortly. Last year at this time, we had two other competitors ahead of us moving forward in NTM. And unfortunately for patients, they didn't make it to the end of 2024. We now see a clear opportunity to be the next leader in NTM. This product that we're working on has had nearly a decade of development opportunity put into it as of today. When we think about the NTM therapies have severe limitations, whether it's efficacy, safety, or tolerability, we fundamentally believe activity at the site of the lung will be critical to transforming these patients' lives. We believe the good adoption rate will happen with clofazamine when we think about the guideline support and the experience that patients and doctors have with clofazamine around the world. However, making this more convenient, better lung delivery, and the support of the guidelines, we believe will create a great opportunity for patients and mankind in the future. One of the key questions we get is around dosing and proof of concept of how we know how we know that clofazamine actually works. So I wanted to bring back some data that we used to use given the renewed focus from investors in our current stage of development. The preclinical data around clofazamine demonstrates superiority over oral clofazamine. This was in our preclinical data when we purchased the product that we saw the significant reductions versus control and versus oral clofazamine. We were seeing 99% reductions in colony-forming units. We think this efficacy is reflective of what we think is encouraging for patients. And the next thing followed by dosing. So when we looked at dosing, we had several choices to make as clofazamine had a long half-life and we were worried about drug accumulation. And so the way we thought about the drug was, you know, between the payer system in the U.S. and duration of effect and the burdensome that could come with a nebulizer, we looked at really making this 28 days on and 56 days off. And this was supported by the PK analysis we did originally in animals, followed by our phase one study extrapolating these curves out. So our analysis, insights, and recommendations have now been reviewed and approved by Japan, FDA, as well as several other countries. This is important, and it's going to be critical to our current development program and opportunity to launch successfully in this market. This all led to the design of our pivotal trial, ICON1, which is our global phase three trial. We are on track and expect to meet our interim enrollment target of 100 patients by the end of this year. Let me translate that. Once we get to 100 patients, it'll take another six to eight months in order to get the interim analysis, which will then determine do we have this trial sized appropriately or do we have to go up in size? We do not expect to cut off enrollment while we wait for this result and this insight so that if we are at 100 patients and we're seeing, let's just call it 20 patients a month enroll, If it would take six months, this would give us 220 to 240 patients. So that insight will give us the opportunity that if the trial does need to be scaled up, we'll hopefully have already met that opportunity by not closing down enrollment. As of today, we're projecting 25 to 30% of our required patients for this interim analysis to be enrolled by the end of Q1. Now I want to talk about IPF. IPF is a progressive and fatal disease that has significant unmet need for patients. Only one in five patients are currently on an FDA-approved drug, despite being diagnosed and despite knowing they have options. The current drugs have high discontinuation rates, and they're very, very difficult to take. Despite these drawbacks, the two products on the market today have worth over $4 billion in combined sales. As we look at Natadnib relative to Ofev, we believe we can provide comparable pulmonary exposure and efficacy, and we also believe, as we think about the other products coming in development, That Nutetanib will be used as part of the backbone of treatment. So whether there's oral Nutetanib or inhaled Nutetanib, we do not see this foundation being replaced. We see most of the new competition being added on to treatment as opposed to replacing one for one. We successfully completed a phase one study here in 2024, and this was the foundation of our FDA briefing book here that we're meeting with FDA in early Q2. If all goes well, we continue to progress this in the second half to hopefully a phase two trial. We're super excited by and with this committee for patience, but we're still early on in our discussions and look forward to bringing you more updates as the year progresses.

Now I'd like to turn it over to Chris. Thank you. Thanks, Mike, and good afternoon, everyone. I will now discuss our fourth quarter and full year 2024 financial results. For a summary of our financials, please refer to our press release issued before this call and our Form 10-K on file with the SEC. Fourth quarter revenues were $77 million, a 31% increase over last year's fourth quarter. For the full year 2024, we recorded revenues of $286 million, a 43% increase over the prior year. TIDESO DPI royalties contributed $27 million in the fourth quarter. This was an increase of 28% over the same quarter last year. Royalties for the year were $102 million or a 42% increase due to UT's increase in net revenue from sales of Tyveso DPI. 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 $27 million, a 55% increase from the prior year quarter, and 101 million for the full year 2024, a 90% increase compared to the prior year. AFRESA net revenue for the fourth quarter was 18 million, an 18% increase due to higher demand and improved gross to net adjustments. For the full year 2024, AFRESA revenue was 64 million, a 17% increase over 2023. This increase was due to higher demand, pricing, and improved gross to net adjustments. VGO net revenue was approximately $5 million for the fourth quarter, an increase of 1% over the same quarter in the prior year. And the full year 2024 revenues were $18 million, a decrease of 4% over the prior year. This is due to lower product demand, partially offset by improved gross to net adjustments, and increased price. As a reminder, As of the fourth quarter of 2024, the sales force is no longer actively promoting Vigo. While we continue to make the product available to patients, we believe Vigo has reached its peak annual sales given the lack of promotion behind it. As we previously mentioned on this call, our business demonstrated robust double-digit revenue growth compared to last year, led by revenues related to Dybaso DPI, which exceeded $200 million for the year. Our annual revenue trends from 2020 through 2024 also show a consistent increase with double-digit revenue growth year over year. We had a strong finish to the year, delivering significant growth across the three revenue streams, resulting in an annualized run rate of $300 million. Our 2024 revenues grew by 43%, driven by Tyveso DPI-related revenues, which provides non-dilutive funding for our pipeline. For 2024, we reported net income of $28 million or $0.10 per share compared to a net loss of $12 million or $0.04 per share for 2023. On a non-GAAP basis, we reported $68 million of net income or $0.25 in earnings per share for 2024 compared to $6 million of non-GAAP net income or $0.02 per share for the prior year. In 2024, we transformed our balance sheet. paying down debt of $236 million across three instruments, resulting in a remaining debt balance of just $36 million related to our senior convertible notes. We used a combination of cash and stock to avoid potential dilution of 12 million shares of common stock while also saving $9 million in interest expense through maturity. With this minimal debt balance and our robust cash position of $203 million,

have a strong balance sheet to execute on our objectives including driving commercial growth and funding our pipeline with that i will now turn the call back over to mike thank you chris and thank you for all the great work you did in 2024 looking forward to 2025. as we look at our anticipated catalysts across our pillars here first is with the frezza we'll prepare to launch the product in the second half of 25. inhale one our pediatric opportunity I talked about really sets us up for a 2026 opportunity, assuming we can file this in the first half of 25. In HAL 3, we've submitted a label change, and we await the feedback from the FDA on this opportunity to update our label in the second half of this year. As you look to 101, we expect to have 90% of our sites activated by the first half and meet our ongoing study enrollment goals by the end of this year. 201, we have a meeting already set up on the books with the FDA. And that will set up the stage for the next phase of development of this asset. As I talked about, IVASA DPI is a huge opportunity to help those patients suffer from IPF with the readouts of TETON1 next year and TETON2 this year. As we look at our travel schedule, it's quite robust over the coming month. We'll be at Lee Rink and Barclays there on March 11th and 12th, then heading over to ATT in Amsterdam, where we have a great opportunity to have five presentations and several meetings with KOLs. as we start to get ready to scale up our diabetes business. In addition to these conferences, we look forward to engaging with you over the next few months, either through our non-deal roadshows, conferences, or one-on-one opportunities. There's a lot of interest in our turnaround story, and our stakeholders we talk with are excited by the next pillars of growth that we've laid out for our future. I look forward to talking to all of you and hopefully having a great 2025. Thank you for your time. We'll now be ready for questions, operator.

Thank you so much, and as a reminder to our teleaudience to ask a question, simply press star 1-1 on your telephone and wait for your name to be announced. To withdraw yourself from the queue, press star 1-1 again. One moment for our first question. And it's from the line of Olivia Breyer with Cantor Fitzgerald. Please proceed.

Hi, good afternoon, guys. Thank you for the question and congrats on all the progress. Appreciate the updates on all the pipeline programs there. Chris, can you talk a little bit about how we should be thinking about margins over the next few quarters, but also just the coming years, just given some of the investments you all plan to make in the Afrezit business later this year, and then have a couple of follow-ups on Tyveso.

Yeah, as I think about margin, I'm thinking about really the revenue less the cost of goods. And so really the utilization of our manufacturing plant with the buildup of Tyveso DPI in addition to Afrezza has allowed our margins to improve. Those are probably getting to a fairly steady state that you can think about for going forward.

Okay, got it. And then on DPI, can you guys give any more granularity or put some numbers around the gross to net discounting and rebates that happened this quarter and whether that's the new norm going forward? And then also, we are getting closer to those Teton readouts and IPF. So what's your base case right now in terms of when a DPI bridging study could actually happen and just what the next steps and timelines might be for DPI and IPF?

Sure. Olivia, it's Mike here. Thank you for the questions. I think like you probably may have heard this morning on United's call, they believe the new norm is roughly what we saw here in Q4 and should be consistent through the year. So that's our operating assumptions here on this side. So, you know, we kind of knew this was increasing as we came into the new year. So I think it's nice to see that it's now built into their Q4 going forward. On the bridging study, I believe UT said publicly that they are looking to do the bridging study. We have a meeting coming up here in Q2 that I expect us to discuss what that could look like and how that would shape up. And that, to me, would be the next steps here. So remember, they need TITAN 2. It's the earliest study we'll have this year, but TITAN 1 will be necessary, I believe, for the US filing. So if we get decent results here in Q3 from United, then I think that gives you enough time to align with the FDA and the bridging study and hopefully get that done as soon as possible, close to CTOM-1 readouts that come out sometime next year. So we'll work collaboratively with them, but I think we're getting close enough that those discussions will accelerate pretty quickly going forward.

Okay, great. Thank you.

All right. Thank you.

Thank you. One moment for our next question. And it's from the line of Faisal Khursid with Learing Partners. Please proceed.

Hey guys, thanks for taking the question. I just want to ask, you know, how are you thinking about sort of like the balance of like defending operational profitability versus investment in the potential like pediatric launch for Afrezza?

Yeah, I mean, I think the good news is we have to deploy capital. We have capital to deploy, I'll say. And I think we got to best deploy that capital that drives the best return for shareholders. And so we believe we've taken out the number one debt was our focus here. So I think the next big focus for us is launching pediatrics appropriately. I don't think you'll see an incredibly crazy spend against it, but I do believe that's the next best source of capital on top of the clofazamine trial and then the tetanus trial. So I think that's where you should be thinking about is how are we best deploying the profitability that we do have. And I think investors want growth on the top line and milestones and opportunities for readouts of clinical data sets over the next two, three years. So that's really what we're aiming for. And I think you kind of saw, you know, if we really do believe if we can get to the 200 million plus, that's probably the biggest revenue upside as we look at the next 18 to 24 months. And we really want to make sure we set that up for success.

Got it. Okay. And then how are you thinking about, like, potential pipeline expansion opportunities? Is that a priority? And where does that sit kind of relative to these other goals? And also kind of like, again, like cash availability.

So we have several additional product opportunities, I'll say, that aren't public yet that we are working on. And so I do believe maybe towards the end of the year, you'll hear a little bit more maybe early next year, but we are working on different ideas in addition to lifecycle management of Afrezza as well as clopazamine. So those are the other things that you don't see that are coming that we'll give updates on as the year progresses. So just how do we get a lower dose, a higher dose cartridge of Afrezza clopazamine powder? So those are additional work capacity things that the team is working on, on top of the scale-up of the facility. So I would just say there's a large group of people working pretty hard on clinical supply manufacturing, scale-up manufacturing, Tybaso expansion, and Afrezza lifecycle management. So there's just a lot going on. And in addition to that, we got additional molecules we're looking to formulate and develop and bring to patients over the coming years. So you'll continue to hear that. We're not done on that. I guess that's your fundamental question.

Yep, sounds good. All right, cool. Thanks for taking the questions.

Thank you. Our next question is from Gregory Renza with RBC Capital Markets. Please proceed.

Hi, guys. It's Anish on for Greg. Congrats on the progress this quarter and through 24, and thanks for taking our questions. Just a couple from us on Afreza. First, as you think about a potential launch in PEDS, How are you thinking about the plotting of the launch trajectory and uptake? What hurdles do you anticipate along the way? And second, maybe just on the agreement with CIPLA and India, how should we be thinking about the relative contribution to Afrez's top line over the next couple of years? Thanks so much.

I think on the P, that's the work we're doing here as we get ready for Q2 to give you guys an update, hopefully on the next earnings call here. But I think if I had to say, there are probably three critical success factors as we think about of Fresno Kids. Number one is ensuring the reimbursement hub is best in class so that that process is as smooth as possible for customers to access the product or get the product. And we're making changes right now here in Q1 that will be ready in Q2 so that we can launch those in the commercial aspects today. But that's really important for the pediatric market and make that simple. I think the second one is historically we've been stronger in private practice offices, which has been great to have a small Salesforce footprint. But as you think about where we're going, we need great access and ability to sell into institutions. And that's a different skill set than what our Salesforce has today. So we're looking to see how we can bolster that up with key account managers. There's about 40 key academic centers. They were all in our clinical trials. And so I'd say institutional selling ability and capabilities will be the next big pillar here. And then the third one is education and awareness. And I think that goes into consumer social media stuff, conference planning, whether that's consumer conferences or physician conferences, and then just pure medical education. So the product's been on the market 10 years. There's obviously always a safety overhang around the lungs. And I think as people look at the pediatric data, you can see the lung safety data looks really clean. And therefore, we've got to really manage that and message that properly and clearly around the balance of education the safety profile that people may have questions around. So I think if we nail those three things, we'll see a nice, fast uptake. If we're missing any one of those pillars, I think that'll hurt the uptake, and that's why we're making so many investments going into the second half to get us ready for that. So hopefully that answers the three AFRESA hurdles I see for PEDS. On the simplest side, I would say we expect the import manufacturing approval here in the Q3 timeframe. And then just depending on the packaging and the shipping and some of that aspects, we would expect to be able to ship our first order by the end of the year. That could slip in the event there's a delay in India or the shift in packaging or printing or lead times on something critical. But at this point, we are aiming to be ready by the end of the year to hopefully get our first shipment out. But I wouldn't try to put a lot in there for the future years. Just know that it could have decent volume implications, which would ultimately make the factory more efficient and, you know, improve the overall efficiency of our cogs for the company. And so that's, I think, as we get clearer long-term supply arrangements with CIPLA, we'll be able to give you a little bit more guidance on the longer-range forecast. But I think when you look out, whether it's Afreza Peas in 26 or India in 26 or maybe going back to some distributors in 26, we should start to see an inflection in Afreza sales starting in 26.

Great, thanks so much. Thank you.

Our next question comes from the line of Andres Argirides with Oppenheimer. Please proceed.

Good afternoon, and thanks for taking our questions and providing all these updates. Congrats also on a solid year. Just wanted to follow up on a question that was asked earlier. If you could just elaborate a little bit more on the contracting dynamics whether this was a kind of a one-time change during the quarter and their potential for a catch-up in Q1. And then quickly, thinking about the updates that we're going to get on 201 later this year, you're planning to meet with the FDA in the first half.

know what are some of the safety other exam points that you guys are are considering and what could what could a phase one uh sorry a trial look like um off the phase one yep thanks on the contracting dynamics i don't think i had much more to add other than what tyveso and united therapeutics described today which is it looks like it started to build up in q3 i think q4 they got to the even Percentage you can see that had some I think volume and what I hear from them is volume referrals and contracts Are looking strong patients should have decent access to Tyveso DPI throughout the year When I think that that's great. I think that's what we want and I wouldn't expect From their comments at least publicly I wouldn't expect any additional shifts in major way in terms of gross margins or net revenue given the trends and the discounts that are built in to the current dynamics, so It's a long way of saying I expect steady state is what we're budgeting and building in the rest of the year. I think someone asked earlier about the IPF and the bridging study. We're not building in that upside revenue scenario to fund our growth. We want to be able to self-fund our growth on our current trends, and we feel very good about those plans and abilities to continue to do that. So that's all upside in terms of capital allocation if the IPF hits later this year. On the 201, we meet with the FDA I believe, in the early part of April. I'll be at that meeting. We have two meetings with the FDA the same week, so it'll be a busy week between AFREZA and 201. And I think both of those meetings will lay out really what is a solid foundation of milestones over the next 12 to 18 months, whether that's the PEDS filing timeline to 201, progressing to Phase 2, with hopefully, as we kick that off, that could set us up for midterm 26, readout on copazamine, followed by hopefully within a short amount of time, an update on the phase two of 201. So if all goes well, I think you'll see some nice clinical updates that'll decrease the relative risk of these assets in 26, early 27. So that's our goal. We've designed a phase two trial that's four arms. We're proposing to the FDA a control arm on the tetanib or naive patients or three different doses or dose regimens so we can really show different types of combinations and what they would look like in terms of frequency as well as dose target. And that study we've designed to be about 30 weeks. I can't remember if that's the end point off the top of my head, but again, that's all under discussion with the FDA. So that's kind of how we think about the phase two is a roughly 26 to 30 week study, forearms looking at different doses compared to a control arm. And our goal is to get comparability. If it's Better, that's great. If it's slightly more tolerable, that's even better. But those will be the key attributes that we're looking for.

Okay, fantastic. Thanks for the update. I'm looking forward to all the progress for the remainder of the year. Appreciate it.

Thank you. Our next question comes from the line of Brandon Foulkes with Rotman and Renshaw. Please proceed.

Hi, thanks for taking my questions and congratulations on all the progress. Maybe just first up for me, You know, if Teton is successful, you know, how should we think about the potential for a manufacturing element there for mankind as well? You know, what are you willing to kind of say at this stage? Is it on the table? Should we model just the royalty? You know, how should we think about it in our models if we do see successful Teton data over the next few 18-odd months?

Brandon, you came in late, so I'm going to repeat your question to make sure we heard it. I think your question was, how do we expect things to shift with a successful Teton readout in terms of manufacturing revenue? Did I get that right?

That is correct, yes.

Okay. So we are working pretty hard. In fact, we just got some good news from the FDA on the expansion of the facility. So I think from a pure capacity manufacturing ability, we will be well ready to launch any types of supply that come in from orders from United Therapeutics with an upside scenario in IPF. So we feel very good about our ability to handle that and deliver that really as we get into the second half when they're going to get the data readout. So now that would, if the volumes increase dramatically, then that would also change our expectations on collaboration services revenue as well. So I think we'll be ready and we'll have the capacity available in the event that all comes through.

Great, thanks very much. And then maybe just a follow-up for me. On the 200 million plus on Afreza, can you just talk about the timeline there? Is this just sort of, should we just think about that being in line with the label updates that should come online post-inhale three and inhale one? Thank you.

Yeah, I think we'll be looking to benchmark our launch uptake curves in PEDS to kind of maybe look at some of the recent launches in diabetes or diabetes devices in particular. And seeing, you know, if we do the proper awareness and the proper successful execution up front, that that should have hopefully a faster uptake than we've seen in our growth historically. And I'll just remind you, you know, we've not ever had the luxury of having excess capital to deploy or ability to recruit the best people or work with thought leaders in a meaningful way. And I think that's one of the things you've seen us try to do really good with the president. We're really trying to get in with these offices and the thought leaders as we speak. So that'll be important. In terms of the uptake, I think you saw a line in the deck that every 10% share is roughly $150 million. So I think it's a reasonable, when you look at the expectations from the physicians, even if you discount that data 50%, our goal is really to hit that 10% range as quickly as possible. That 12 months, 18 months, 24 months, I think we'll get, as we get closer and as we continue to fine-tune our strategy and research, I think that will be clear, but I think if you look at that 10% threshold plus the adult sales plus spillover from kids to adults, you can really start to see how Afrezza compounds over the next three years from a marginally good growth to a major transition. And that's what we're aiming for, and that's why we're gearing up for all that right now.

Great. Thank you very much.

Thank you. One moment for our next question. And it's from the line of Yun Song with Wetbush Securities. Please proceed.

Hi. Good afternoon. Thank you very much for taking your questions, and congratulations on your progress. First question, Afrezza. You shared anecdotal feedback on pediatric use, and I was curious, have you heard anything from adult subjects in light of the health-free data? And the second question, on 101 interim analysis, and assume we'll be blinded to the company, but is that interim analysis going to look at both co-partner endpoints, and in case you have to increase the study size, do you have an idea by how many patients you are going to increase? Thank you very much.

That second question, just to clarify, is that in relation to 101, or which product were you referring to?

Interim analysis, 101, yes.

Okay, thank you. First of all, thank you for your support and your initiation of mankind. We appreciate that. In terms of inhale three, you're asking additional analysis we plan to present? So the patient and physician feedback, thank you. In the patient side of this, about 50% of the patients in inhale three indicated they wanted to stay on Afreza at the end of the study. So I think that's a, you know, honestly, if we switched 100 people and got 50 to stay, I think that's a really good opportunity to expand pretty quickly. So I think that just shows you the level of satisfaction, whether they were coming off an AID system or multiple daily injections. You know, I'd be really happy if we could help that many patients of the millions of people on insulin. So, I think that's kind of where the patient satisfaction was. On the physician side, I will say I've talked to several of the investigators, and a lot of them, this is the first time they've ever prescribed Afrezza in terms of just running the trial. It's the first time they've ever seen that first dose data in the office of the meal tolerance tests we were doing. And you can really see, as you look at the subresults, those doctors who really understood the dosing and basal titration had really good results and they were very happy and excited and look forward to adopting it. I'll also say, as you can see, some of the people got worse. There's a handful of offices who didn't dose properly, who didn't titrate up, who didn't follow our instructions and those patients did a little worse and that's probably why you see 50% want to stay on and 50% went back because I think a lot of that was doctor dependent and that's one of the things we're trying to correct as we go out there is how do we make it more consistent for prescribers, whether it's the reimbursement support, the dosing and titration, and the follow-up around the basal, because that's what we see in the trial results, whether that's inhale one or inhale three. And so that's a lot of the work that I'll say we'll be doing as a result of these trials. And it's a lot of excitement. I think I just saw Omnipod launched a decision support around Omnipod, and I think that's what you're seeing. These offices need help, and we can clearly see they need reminders. And so that's some of the work we're trying to get ready for kids. On 101, there's an interim analysis after 100 patients are reaching their six-month endpoint, and we want to have 100 valuable patients. And so hopefully by the time we'll have 100 sites up and running, and if we had 20% of the sites referring a patient a month, that would give you roughly 15 to 20 people enrolling. So you can see while we're waiting for those interim results, we can easily enroll another 90, 100 patients. And so we think that will satisfy potentially any type of study size adjustment. It could go 230 to 300 patients with those adjustments. And I think our goal is to make sure it's statistically valid results between the placebo and the active arm. And so let's kind of wait and see. But I think we have anticipated that it could go from 180 to 300. And that's why we'll keep enrollment going, so that we're not waiting by the time we get that interim analysis to continue enrolling. And there's also an FDA guidance here that we want to hit, which is around the 300 patients safety database. And so one of the other aspects we're looking at that the FDA actually just gave us the green light to consider is launching an expanded access program for clofazamine. So that, to me, would be another opportunity to hit some interim enrollment targets to keep us on track. So we're evaluating all these options as we speak, but I think you'll see clofazamine's got a lot of great options ahead to hit the marks that we have to hit to ensure we can file as quickly as possible for patients. Thank you. Thank you.

Thank you, and this concludes our Q&A session for today. I will turn it back to Mr. Castaña for final remarks.

Thank you, everyone, for dialing in today, listening to our call. I think, as you can see, we had a record year for 2024. We're really turning over every stone to look at how we can grow faster, hire the best talent, and continue to march as company forward to greatness. And I just want to say thank you for your continued support. I'm looking forward to a year of much progress, whether it's the clinical side, the commercial side, or our partnership with United Therapeutics. Mankind is firing on all cylinders, and it's a great time to be part of the Mankind family. So thank you for all your support. Have a great day.

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