MannKind Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
February 26, 2025

There are 9 speakers on the call.

Operator

Good afternoon, and welcome to the MannKind Corporation Fourth Quarter and Year End twenty twenty four Financial Results Earnings Call. As a reminder, this call is being recorded on 02/26/2025, 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 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.

Operator

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

Speaker 1

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 MannKind. 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 chlofasmine inhalation suspension and natinib DPI as I'll talk about later in our call.

Speaker 1

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 $23,000,000 and full year at $82,000,000 We started this year by appointing Dominic Marasco as President of our EBU, which I'll talk about our growth strategy in a couple of 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 Anthosar collaboration in December, which enables us to promote Baximy through our U. S.

Speaker 1

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 twenty twenty six. The Phase II DPI collaboration 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 chlofazin inhalation suspension program is progressing nicely with our Phase three study now with seventy percent of sites activated.

Speaker 1

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 tenant DPI, we had an FDA 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 $77,000,000 in revenue and $286,000,000 for the full year. Our year end cash position ended at $2.00 $3,000,000 and we were able to reduce our debt principal by $236,000,000 in 2024.

Speaker 1

Now let me bridge over to our diabetes business. Our diabetes program progression is built on several pillars. The first was bringing in Dominic Marasca, who is 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 Afrezza's growth, it starts with our team and getting the right people on the bus and adding to 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.

Speaker 1

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 Afrezza's we'll talk about in a moment. We expect to be able to file this in the first half of twenty twenty five with an approval in second quarter of twenty twenty six. There are over 300,000 kids in The U.

Speaker 1

S. Suffering from Type one 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 the gestational diabetes. We were able to get an investigator initiated trial off the ground hopefully in the first half through the JABE center as there are over three hundred thousand women who have gestational diabetes each year.

Speaker 1

As we look at the record revenue for Afrezza, we had a 17% year over year increase. We continue to grow Afrezza despite GLT growth, pump innovation, and as well as our focus on profitability. We are preparing to accelerate the growth of Afrezza over the next twenty four months through the initiatives I just described. As we look out at the pediatric opportunity, this will lead us to projected sales at a run rate of over $200,000,000 a year, which is almost three times where we are today. And I'll remind you every 10% market share in pediatrics is approximately $150,000,000 in revenue in addition to whatever adult spillover adult revenue we'd have ongoing.

Speaker 1

As you look at our market research, we just finished conducting in the second half of last year, we saw that about twenty eight percent of patients could switch from MDIs and fourteen percent of patients could switch from AIDs, which would include Omnipod and Tandem. We generally would discount this type of projection by about fifty percent, but as I read the quotes here from the pediatric endocrinologists and the Type one 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. She'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.

Speaker 1

As we look at Tyvaso first, DPI related revenues were over $200,000,000 in 2024 and this made the first one billion dollars 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 $1,000,000,000 status and 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 two in the second half, And if that reads out, we would expect that to be reflective of a positive opportunity here for TAVESO DPI potentially going into IPF in the future. Chris will talk about the revenues of TAVESO shortly. Last year at this time, we had two other competitors ahead of us moving forward in NTM.

Speaker 1

And unfortunately for patients, they didn't make it to the end of twenty twenty four. 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.

Speaker 1

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 that clofazamine actually works. So I wanted to bring back some data that we used to use given the renewed focus from investors and 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 are seeing 99% reductions in colony forming units.

Speaker 1

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 clofazmin had a long half life and we're worried about drug accumulation. And so the way we thought about the drug was between the payer system in The U. S.

Speaker 1

And duration of effect and the burdensome that could come with a nebulizer, we looked at really making this twenty eight days on and fifty six days off. And this was supported by the PK analysis we did originally in animals and 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, ICON-one, which is our global Phase three trial.

Speaker 1

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 the 100 patients, it will 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 in this insight, so that if we are at 100 patients and we're seeing, let's just call it 20 patients a month enroll, it will take six months, this would give us two twenty to two forty patients. So that insight will give us the opportunity that the trial does need to be scaled up.

Speaker 1

We'll hopefully have already met that opportunity by not closing down enrollment. As of today, we're projecting 25% to thirty percent of our required patients for a symptom 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.

Speaker 1

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 over $4,000,000,000 in combined sales. As we look at natinib 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 natinib will be used as part of the backbone of treatment. So whether there's oral natinib or inhaled natinib, 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.

Speaker 1

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 natinib and what this can mean for patients, 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.

Speaker 2

Thanks, Mike, and good afternoon, everyone. I will now discuss our fourth quarter and full year '20 '20 '4 financial results. For a summary of our financials, please refer to our press release issued before this call and our Form 10 ks on file with the SEC. Fourth quarter revenues were $77,000,000 a 31% increase over last year's fourth quarter. For the full year 2024, we recorded revenues of $286,000,000 a 43% increase over the prior year.

Speaker 2

Tadazo DPI royalties contributed $27,000,000 in the fourth quarter. This was an increase of 28% over the same quarter last year. Royalties for the year were $102,000,000 or a 42% increase due to UT's increase in net revenue from sales of Tyvaso 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 $27,000,000 a 55% increase from the prior year quarter and $101,000,000 for the full year 2024, a 90% increase compared to the prior year.

Speaker 2

Afrezza net revenue for the fourth quarter was $18,000,000 an 18% increase due to higher demand and improved gross to net adjustments. For the full year 2024, AFFREZA revenue was $64,000,000 a 17% increase over 2023. This increase was due to higher demand, pricing and improved gross to net adjustments. V Go net revenue was approximately $5,000,000 for the fourth quarter, an increase of 1% over the same quarter in the prior year. And the full year 2024 revenues were $18,000,000 a decrease of 4% over the prior year.

Speaker 2

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 twenty twenty four, the sales force is no longer actively promoting V Go. 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 Cyveso DPI, which exceeded $200,000,000 for the year. Our annual revenue trends from 2020 through 2024 also show a consistent increase with double digit revenue growth year over year.

Speaker 2

We had a strong finish to the year, delivering significant growth across the three revenue streams, resulting in an annualized run rate of $300,000,000 Our 2024 revenues grew by 43%, driven by Tyvaso DPI related revenues, which provides non dilutive funding for our pipeline. For 2024, we reported net income of $28,000,000 or $0.1 per share compared to a net loss of $12,000,000 or $0.04 per share for 2023. On a non GAAP basis, we reported $68,000,000 of net income or $0.25 in earnings per share for 2024 compared to $6,000,000 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 $236,000,000 across three instruments, resulting in a remaining debt balance of just $36,000,000 related to our senior convertible notes. We used a combination of cash and stock to avoid potential dilution of 12,000,000 shares of common stock, while also saving $9,000,000 in interest expense through maturity.

Speaker 2

With this minimal debt balance and our robust cash position of $2.00 $3,000,000 we 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.

Speaker 1

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 Afrezza, we'll prepare to launch the product in the second half of twenty twenty five. INHIL-one, our pediatric opportunity I talked about really sets us up for 2026 opportunity assuming we can file this in the first half of twenty twenty five. In HALE three, we've had 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.

Speaker 1

As we 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. 02/2001, 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, Pareto dpi is a huge opportunity to help those patients suffer from IPF with the readouts of Teton one next year and Teton two 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 in March 1112, 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.

Speaker 1

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.

Operator

Thank you so much. And as a reminder to our tele audience, to ask a question, simply press 11 on your telephone and wait for your name to be announced. And it's from the line of Olivia Breyer with Cantor Fitzgerald. Please proceed.

Speaker 3

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 Afrezza business later this year? And then have a couple of follow ups on Tyvaso.

Speaker 2

Yes. 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 Tyvaso 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.

Speaker 3

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?

Speaker 1

Sure. Olivier, 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.

Speaker 1

So we kind of knew this was increasing as we came into the New Year. So I think it's nice to see that 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 will be the next steps here.

Speaker 1

So remember, they need TETON2, it's the earliest study we'll have this year, but TETON1 will be necessary, I believe, for The U. S. 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 TALM one readouts that come out sometime next year. So we're collaborating with them, but I think we're getting close enough that those discussions will accelerate pretty quickly going forward.

Operator

Okay, great. Thank you.

Speaker 2

All right. Thank you.

Operator

Thank you. One moment for our next question. And it's from the line of Faiza Khorsid with Leerink Partners. Please proceed.

Speaker 1

Hey guys, thanks for taking

Speaker 4

the question. Just wanted to ask, how are you thinking about sort of like the balance of like defending operational profitability profitability versus investment in the potential like pediatric launch for Afrezza?

Speaker 1

Yes. 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.

Speaker 1

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 a next best source of capital on top of the clofazmin trial and then the TETENIV trial. So I think that's where you should be thinking about is how 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.

Speaker 1

And I think you kind of saw, if we really do believe Afrezza can get to the $200,000,000 plus, that's probably the biggest revenue upside as we look at the next eighteen to twenty four months, we really want to make sure we set that up for success.

Speaker 4

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

Speaker 4

And also kind of like against like cash stability?

Speaker 1

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 clofazamine. 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, clofazamine powder.

Speaker 1

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, Tyvaso 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 the patients over the coming years. So you'll continue to hear that we're not running it, I guess, if that's your fundamental questions.

Speaker 4

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

Operator

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

Speaker 5

Hi, guys. It's Anish on for Greg. Congrats on the progress this quarter and through 2024 and thanks for taking our questions. Just a couple from us on Afrezza. First, as you think about a potential launch in Pedes, how are you thinking about the plotting of the launch trajectory and uptake?

Speaker 5

What hurdles do you anticipate along the way? And second, maybe just on the agreement with Cipla in India, how should we be thinking about the relative contribution to Afrezza's top line over the next couple of years? Thanks so much.

Speaker 1

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 Afrezza and 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.

Speaker 1

I think the second one is historically we've been stronger in private practice offices, which has been great to have a small sales force 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 sales force 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.

Speaker 1

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 ten years.

Speaker 1

There's obviously a 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 got to really manage that and message that properly and clearly around the balance of 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 to the second half to get us ready for that. So hopefully that answers the three Afrezza hurdles I see for Peds.

Speaker 1

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.

Speaker 1

Just know that it could have decent volume implications, which would ultimately make the factory more efficient and improve the overall efficiency of our COGS for the company. And so that's I think as we get clear 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 Afrezza Peas in '26 or India in '26 or maybe going back to some distributors in '26, we should start to see an inflection in Afrezza sales starting in '26.

Speaker 5

Great. Thanks so much.

Operator

Thank you. Our next question comes from the line of Andres Arguidades with Oppenheimer. Please proceed.

Speaker 6

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 is there potential for a catch up in Q1? And then quickly, thinking about the updates that we're going to get on 02/2001 later this year, You're planning to meet with the FDA in the first half.

Speaker 6

What are some of the safety efficacy endpoints that you guys are considering? What could a Phase one sorry, a trial look like off the Phase one? Yes. Thanks.

Speaker 1

Okay. On the contracting dynamics, I don't think I have much more to add other than what Tyvaso 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 Tyvaso DPI throughout the year.

Speaker 1

And I think 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 IPS and the bridging study.

Speaker 1

We're not building in that outside revenue scenario to fund our growth. We want to be able to self fund our growth in 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 IPF hits later this year. On the 02/2001, we meet with FDA, I believe in the April, albeit that meeting. We have two meetings with FDA the same week, so it will be a busy week between Afrezza and two zero one.

Speaker 1

And I think both of those meetings will lay out really what is a solid foundation of milestones over the next twelve to eighteen months, whether that's the peds filing timeline to 02/2001 progressing to Phase two, with hopefully as we kick that off that could set us up for midterm twenty six readout on clofazamine followed by hopefully within a short amount of time an update on the Phase two of two zero one. So if all goes well, I think you'll see some nice clinical updates that will decrease the relative risk of these assets in 2026 or early twenty twenty seven. 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 natinib or naive patients or three different doses or dose regimens so that we can really show different types of combinations and what they would look like in terms of frequency as well as dose target.

Speaker 1

That study we've been designed to be about thirty weeks. I can't remember if that's the endpoint 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 twenty six to thirty week study, four arms looking at different doses compared to a control arm. And our goal is to get comparability. If it's better, that's great.

Speaker 1

If it's slightly more tolerable, that's even better. But those will be the key aspects that we're looking for.

Speaker 6

Okay, fantastic. Thanks for the update and looking forward to all the progress in the remainder of the year. Appreciate it.

Operator

Thank you. Our next question comes from the line of Brandon Folkes with Rodman and Ranshaw. Please proceed.

Speaker 7

Hi. Thanks for taking my questions and congratulations on all the progress. Maybe just first up from me, if Teton is successful, how should we think about the potential for a manufacturing element there for mankind as well? What are you willing to kind of say at the stage? Is it on the table?

Speaker 7

Should we model just the royalty? How should we think about it in our models if we do see successful Teton data over the next few or eighteen odd months?

Speaker 1

Brandon, it came in light, 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 the successful Teton readout in terms of manufacturing revenue. Did I get that right?

Speaker 7

That is correct, yes.

Speaker 1

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 to the second half when they're going to get the data readout.

Speaker 1

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.

Speaker 7

Great. Thanks very much. And then maybe just a follow-up for me. On the year $200,000,000 plus on Afrezza, 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?

Speaker 7

Thank you.

Speaker 1

Yes. 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 if we do the proper awareness and the proper successful execution upfront, that should have hopefully a faster uptake than we've seen in our growth historically. And I'll just remind you, 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 thing you've seen us try to do really good with Afrezza and we're really trying to get in with these offices and the thought leaders as we speak. So that'll be important.

Speaker 1

In terms of the uptake, I think you saw a line in the deck that's every 10% share is roughly $150,000,000 So I think it's a reasonable when you look at the expectations from the physicians even if you discount that data 50%, our goals really hit that 10% range as quickly as possible is that twelve months, eighteen months, twenty four 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

Speaker 8

from

Speaker 1

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.

Speaker 7

Great. Thank you very much.

Operator

Thank you. One moment for our next question. It is from the line of Yoon Seong with Wedbush Securities. Please proceed.

Speaker 8

Hi, good afternoon. Thank you very much for taking your questions and congratulations on the progress. First question on Afrezza, you shared anecdotal feedback on PDX reviews and I was curious, have you heard anything from adult subjects in light of the Health III data? And second question on 101 interim analysis and assume will be a 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 any idea by how many patients you are going to increase? Thank you very much.

Speaker 1

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

Speaker 8

Interim analysis, 101, yes.

Speaker 1

Okay. Thank you. Sorry, I'll make sure I got it right. First of all, thank you for your support and your initiation of MannKind. We appreciate that.

Speaker 1

In terms of inhaled three, you're asking additional analysis we plan to present? So the patient and physician feedback. Thank you. So I think the in the patient side of this, about fifty percent of the patients in inhale three indicated they wanted to stay on Afrezza at the end of the study. So I think that's honestly, if we switched 100 people and got 50 to stay, I think that's a really good opportunity to expand pretty quickly.

Speaker 1

So I think that just shows you the level of satisfaction whether they were coming off an AID system or multiple daily injections. 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 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 mealtime the meal tolerance test we were doing.

Speaker 1

And you can really see as you look at the sub results, 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 that 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 fifty percent want to stay on and fifty percent 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 INHIL-one or INHIL-three.

Speaker 1

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 is these offices need help and we can clearly see they need reminders. And so that's what we'll some of the work we're trying to get ready for kids. On 01/2001, there is an interim analysis after 100 patients are reaching their six month endpoint and we want to have 100 evaluable patients.

Speaker 1

And so hopefully by that 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 9,100 patients. And so we think that will satisfy potentially any type of study size adjustment. It could go two thirty to 300 patients with those adjustments.

Speaker 1

And I think our goal is to make sure it's statistically valid results between the placebo and the active arm. And then so let's kind of wait and see, but I think we have anticipated that it could be 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 enroll. 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 in term enrollment targets to keep us on track.

Speaker 1

So we're evaluating all these options as we speak, but I think you'll see clofazamine 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.

Speaker 2

Great. Thank you.

Speaker 1

Thank you.

Operator

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

Speaker 1

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 this company forward to greatness. And I just want to say thank you for your continued support and 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 MannKind family.

Speaker 1

So thank you for all your support. Have a great

Operator

day. And with that, we thank you all for participating and you may now disconnect.

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Earnings Conference Call
MannKind Q4 2024
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