MannKind - Earnings Call - Q4 2024

Executive Summary

• Q4 2024 revenue of $76.8M (+31% y/y) with GAAP net income of $7.4M and non-GAAP net income of $23.0M; strength driven by Tyvaso DPI royalties (+28% y/y) and 55% growth in collaborations/services (manufacturing for UT).
• FY24 revenue reached $285.5M (+43% y/y); cash and investments were $203M at year end, and total debt principal was reduced by $236M to $36M remaining in 2.5% converts.
• Strategic progress: Afrezza pediatric INHALE-1 achieved six‑month non-inferiority on mITT; sNDA meeting planned 1H25; Afrezza approved in India, with initial shipments targeted for 4Q25; MNKD‑101 (clofazimine) Phase 3 enrollment on track for interim target by YE25; MNKD‑201 (nintedanib DPI) successfully completed Phase 1 with FDA meeting planned in 1H25.
• No formal numerical guidance given; management highlighted an annualized revenue run-rate of ~$300M exiting 2024 and emphasized manufacturing readiness for potential Tyvaso DPI IPF expansion and disciplined investment ahead of a potential Afrezza pediatrics launch in 2026.

What Went Well and What Went Wrong

What Went Well

• Broad-based top-line expansion in Q4: total revenue +31% y/y to $76.8M, with Afrezza +18% y/y, royalties +28% y/y, and manufacturing/services +55% y/y.
• Balance sheet transformation: $236M of debt principal eliminated in 2024; year-end cash/investments of $203M; only $36M of converts outstanding (2.5% due 2026).
• Pipeline and market access milestones: pediatric INHALE-1 six‑month data supported mITT non‑inferiority; Afrezza approved in India with shipments expected 4Q25; nintedanib DPI Phase 1 completed; MNKD-101 global Phase 3 progressing.

Selected quotes

• “We…delivered robust revenues as we exited the year with an annual run rate of $300 million.” — CEO, Michael Castagna.
• “TYVASO DPI-related revenues were over $200 million in 2024…We are very excited about the opportunity this provides us to fund our pipeline with nondilutive financing.” — CEO.
• “We reported net income of $28 million…With this minimal debt balance and our robust cash position of $203 million, we have a strong balance sheet to execute on our objectives.” — CFO, Christopher Prentiss.

What Went Wrong

• V-Go continues to be de‑emphasized: flat in Q4 (+1% y/y) and down 4% for FY24; sales force no longer actively promoting V‑Go, suggesting limited growth contribution ahead.
• Higher operating costs in select areas: Q4 R&D +21% y/y and SG&A +17% y/y as development programs and personnel increased; full-year R&D +47% y/y.
• Non-operating volatility: Q4 included a $13.4M loss on settlement of debt which reduced GAAP earnings; other interest and financing expense items remained meaningful.

Transcript

Operator (participant)

Good afternoon and welcome to the MannKind Corporation Fourth Quarter and Year-End 2024 Financial Results Earnings Call. As a reminder, this call is being recorded on February 26th, 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 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 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.

Michael Castagna (CEO)

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 clofazimine inhalation suspension and the nintedanib 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 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 Amphastar collaboration in December, which enables us to promote Baqsimi through our U.S. 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. The Tyvaso 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 clofazimine inhalation suspension programs are progressing nicely with our Phase 3 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 Tyvaso DPI, we had an FDA meeting at the end of the quarter. Now that we've completed Phase 1, 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 Afrezza'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 Afrezza, 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 the 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 gestational diabetes. We're able to get an investigator-initiated trial off the ground, hopefully in the first half through the Jaeb Center, as there are over 300,000 women who have gestational diabetes each year. As we look at the record revenue for Afrezza, we had a 17% year-over-year increase. We continue to grow Afrezza despite GLP growth, pump innovation, and as well as our focus on profitability.

We are preparing to accelerate the growth of Afrezza over the next 24 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 million a year, which is almost three times where we are today. I'll remind you, every 10% market share in pediatrics is approximately $150 million in revenue, in addition to whatever adults spill over 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%.

As I read the quotes here from the pediatric endocrinologists 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 Tyvaso DPI first, DPI-related revenues were over $200 million in 2024. 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 the Technosphere platform has achieved the billion-dollar 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 2 in the second half. And if that reads out, we would expect that to be reflective of a positive opportunity here for Tyvaso DPI, potentially going to IPF in the future. Chris will talk about the revenues of Tyvaso 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, and 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 clofazimine when we think about the guideline support and the experience that patients and doctors have with clofazimine 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 MannKind in the future. One of the key questions we get is around dosing and proof of concept of how we know that clofazimine 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 clofazimine demonstrates superiority over oral clofazimine. This was in our preclinical data when we purchased the product that we saw the significant reductions versus control and versus oral clofazimine. 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 is followed by dosing. So when we looked at dosing, we had several choices to make as clofazimine had a long half-life, and we were worried about drug accumulation.

The way we thought about the drug was 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. This was supported by the PK analysis we did originally in animals and followed by our Phase 1 study extrapolating these curves out. 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-1, which is our global Phase 3 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 the 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, it will take six months. This would give us 220-240 patients. So that insight will give us the opportunity that 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%-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 are very, very difficult to take. Despite these drawbacks, the two products on the market today have over $4 billion in combined sales. As we look at nintedanib 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 nintedanib will be used as part of the backbone of treatment. So whether there's oral nintedanib or inhaled nintedanib, 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 1 study here in 2024, and this was the foundation of our FDA briefing book here that we're meeting with the FDA in early Q2. If all goes well, we continue to progress this in the second half to hopefully a Phase 2 trial. We're super excited by nintedanib 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.

Chris Prentiss (CFO)

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. Tyvaso 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 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 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. Afrezza 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, Afrezza revenue was $64 million, 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 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 V-Go. While we continue to make the product available to patients, we believe V-Go 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 Tyvaso 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 Tyvaso 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, 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.

Michael Castagna (CEO)

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 2025. INHALE-1, our pediatric opportunity I talked about, really sets us up for a 2026 opportunity, assuming we can file this in the first half of 2025. INHALE-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 we look to MNKD-101, we expect to have 90% of our sites activated by the first half and meet our ongoing site 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, Tyvaso DPI is a huge opportunity to help those patients suffering from IPF with the readouts of TETON 1 next year and TETON 2 this year. As we look at our travel schedule, it's quite robust over the coming month. We'll be at Leerink and Barclays there on March 11th and 12th, then heading over to ATTD 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 with all of you and hopefully having a great 2025. Thank you for your time. We'll now be ready for questions, Operator.

Operator (participant)

Thank you so much. And as a reminder to our tele audience to ask a question, simply press Star 11 on your telephone and wait for your name to be announced. To withdraw yourself from the queue, press Star 11 again. One moment for our first question. And he's from the line of Olivia Brayer with Cantor Fitzgerald. Please proceed.

Olivia Brayer (Analyst)

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 DPI.

Michael Castagna (CEO)

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 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.

Olivia Brayer (Analyst)

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?

Michael Castagna (CEO)

Sure. Olivia to Mike here. Thank you for the questions. I think 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 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, will be the next steps here.

Remember, they need TETON 2 as the earliest study we'll have this year, but TETON 1 will be necessary, I believe, for the U.S. filing. 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 TETON 1 readouts that come out sometime next year. We'll work collaboratively with them, but I think we're getting close enough that those discussions will accelerate pretty quickly going forward.

Olivia Brayer (Analyst)

Okay. Great. Thank you.

Michael Castagna (CEO)

All right. Thank you.

Operator (participant)

Thank you. One moment for our next question, and he's from the line of Faisal Khurshid with Leerink Partners. Please proceed.

Faisal Khurshid (Analyst)

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

Michael Castagna (CEO)

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 clofazimine trial and the nintedanib trial. So I think that's what 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 if we really do believe Afrezza can get to the 200 million plus, that's probably the biggest revenue upside as we look at the next 18-24 months. And we really want to make sure we set that up for success.

Faisal Khurshid (Analyst)

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 and also kind of against capability?

Michael Castagna (CEO)

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 clofazimine. 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 clofazimine 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, Tyvaso DPI 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 in there, I guess, if that's your fundamental question.

Faisal Khurshid (Analyst)

Yep. Sounds good. All right. Cool. Thanks for taking the questions.

Operator (participant)

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

Hi guys. It's Anish 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 peds, how are you thinking about the plotting of a launch trajectory and uptake? 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.

Michael Castagna (CEO)

I think on the peds, 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 in peds. 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 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 that 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 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 some of the investments going into the second half to get us ready for that. So hopefully that answers the three Afrezza hurdles I see for peds. On the Cipla 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 there's a 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 improve the overall efficiency of our COGS for the company. And so 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 Afrezza peds in 2026 or India in 2026, or maybe going back to some distributors in 2026, we should start to see an inflection in Afrezza sales starting in 2026.

Great. Thanks so much.

Operator (participant)

Thank you. Our next question comes from the line of Andreas Argyrides with Oppenheimer. Please proceed.

Andreas Argyrides (Managing Director and Senior Biotech Analyst)

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 201 later this year, you're planning to meet with the FDA in the first half. What are some of the safety advocacy endpoints that you guys are considering and what could a Phase 1, sorry, a trial look like off the Phase 1? Yep. Thanks.

Michael Castagna (CEO)

On the contracting dynamics, I don't think I have much more to add other than what Tyvaso DPI 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. And 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 into 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 IPF hits later this year. On the 201, we meet with FDA, I believe, in the early part of April. I'll be at that meeting. We have two meetings with FDA the same week. So it'll be a busy week between Afrezza and 201.

I think both of those meetings will lay out really what is a solid foundation of milestones over the next 12-18 months, whether that's the peds filing timeline, the 201 progressing to Phase 2, with hopefully, as we kick that off, that could set us up for midterm 2026 readout on clofazimine, followed by hopefully within a short amount of time, an update on the Phase 2 of 201. If all goes well, I think you'll see some nice clinical updates that'll decrease the relative risk of these assets in 2026, early 2027. That's our goal. We've designed a Phase 2 trial that's four arms.

We're proposing to the FDA a control arm on nintedanib 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, and that study we've designed to be about 30 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 2 as a roughly 26-30-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. If it's slightly more tolerable, that's even better, but those will be the key attributes that we're looking for.

Andreas Argyrides (Managing Director and Senior Biotech Analyst)

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

Operator (participant)

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

Brandon Folkes (Biotech Equity Research Analyst)

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 MannKind as well? What are you willing to kind of say at this stage? Is it on the table? 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 18-odd months?

Michael Castagna (CEO)

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?

Brandon Folkes (Biotech Equity Research Analyst)

That is correct. Yes.

Michael Castagna (CEO)

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 and 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.

Brandon Folkes (Biotech Equity Research Analyst)

Great. Thanks very much. And then maybe just a follow-up for me. On the $200 million 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-3 and INHALE-1? Thank you.

Michael Castagna (CEO)

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 if we do the proper awareness and the proper successful execution upfront, that 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 of the things you've seen us try to do really good with Afrezza. 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 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. Is 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.

Brandon Folkes (Biotech Equity Research Analyst)

Great. Thank you very much.

Operator (participant)

Thank you. One moment for our next question. It's from the line of Yun Zhong with Wedbush Securities. Please proceed.

Yun Zhong (Senior Research Analyst)

Hi. Good afternoon. Thank you very much for taking the questions and congratulations on the progress. First question on Afrezza. You shared anecdotal feedback on pediatric use, and I was curious, have you heard anything from adult subjects in light of the INHALE-3 data? And the 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-primary 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.

Michael Castagna (CEO)

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

Yun Zhong (Senior Research Analyst)

Interim analysis, 101. Yes.

Michael Castagna (CEO)

Okay. Thank you. Sorry, I'm not sure I got it right. First of all, thank you for your support and your initiation of MannKind. We appreciate that. In terms of INHALE-3, you're asking additional analysis we plan to present? So the patient and physician feedback, thank you. So I think in the patient side of this, about 50% of the patients in INHALE-3 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. 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 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 mealtime, the meal tolerance test 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 looked 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 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-1 or INHALE-3. 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. And 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.

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. We want to have 100 evaluable patients. Hopefully by that time, we'll have 100 sites up and running. If we had 20% of the sites referring a patient a month, that would give you roughly 15-20 people enrolling. You can see while we're waiting for those interim results, we can easily enroll another 90-100 patients. We think that will satisfy potentially any type of study size adjustment. It could go 230-300 patients with those adjustments. Our goal is to make sure it's statistically valid results between the placebo and the active arm. 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 clofazimine. 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 clofazimine'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.

Yun Zhong (Senior Research Analyst)

Great. Thank you.

Michael Castagna (CEO)

Thank you.

Operator (participant)

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

Michael Castagna (CEO)

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 a 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. MannKind is firing on all cylinders, and it's a great time to be part of the MannKind family. So thank you for all your support. Have a great day.

Operator (participant)

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