Good afternoon and welcome to MannKind Corporation 2023 Fourth Quarter and Full Year Financial Results Earnings Call. As a reminder, this call is being recorded on February 27, 2024, and will be available for playback on the MannKind Corporation website shortly after the conclusion of the call until March 12, 2024. This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainty, which could cause actual results to differ materially for those 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 earning release, and the slides prepared for this presentation. Joining us today from MannKind are Chief Executive Officer, Michael Castagna; and Chief Financial Officer, Steven Binder. I will now turn the conference over to Mr. Castagna. Please go ahead, sir.

Thank you, Valerie. We have never seen a better time for MannKind than we do today. As we look at our future, it's extremely exciting and I'm never more motivated to ensure we deliver on all key operational opportunities in front of us. As we think about today, Steve and I will go over the operational pipeline highlights of the financial review, and I'm also here today with Lauren Sabella, our Chief Operating Officer for Q&A. We will drive shareholder value by making a difference in the lives of the patients we serve. We will make over 25 million doses and devices in 2024 and helped roughly 25,000 patients take a MannKind-produced product in 2023, the most in our history. In Q4, we had record revenue for Tyvaso on both royalty and collaboration manufacturing, along with record production on Tyvaso cartridges. We advanced our pipeline in both the orphan business as well as the endocrine business, and our endocrine business hit its second consecutive profitable quarter. We finished a year in the strongest position we have been in, in terms of financial ability, as well as by selling the Tyvaso -- 1% of our Tyvaso royalty for $150 million upfront and $50 million in revenue milestones. Many of you asked, could we have sold more? Why didn't we sell more? And the reality is, we didn't need to sell more. We wanted to make sure we were comfortable with carrying the level of debt and cash on the balance sheet to control our future. We're very excited about Tyvaso DPI and what it's going to bring to patients and anticipate hopefully positive milestones for Tyvaso in the future and, therefore, want to preserve 90% of that value for our shareholders. At the same time, we want to deep risk on…

Thank you, Mike, and good afternoon. I'm pleased to review select fourth quarter and full year 2023 financial results. Please supplement this call by reading the consolidated financial statements and MD&A contained in our 10-K. 2023 was a year of substantial revenue growth for the Company in terms of both percentage and dollar growth. Total revenues doubled versus 2022 and reached nearly $200 million. Let's break this down by starting with the fourth quarter total revenues at the bottom of the table. Our total revenues grew a robust 62% versus fourth quarter 2022, and 99% for the 2023 full-year period, primarily due to the growth in our Tyvaso DPI-related revenues. Going back to the top of the table, you will see that Tyvaso DPI royalty revenue for the fourth quarter was $21 million, which is 132% increase versus 2022, the result of continued growth in use of Tyvaso DPI for patients suffering from PAH and PH-ILD. Please note that $2.1 million of the fourth quarter royalty revenue was sold to a third party and I will review the accounting for the royalty sale in a few slides. Collaborations and services fourth quarter revenue was $17 million, which was an 81% increase over 2022, was primarily representative of strong Tyvaso DPI production volumes in the fourth quarter. For the full year 2023, Tyvaso DPI royalty revenue was $72 million, an increase of 361% versus 2022, which was primarily due to the increase in patient demand for the product and the start of commercial sales by United Therapeutics late in the second quarter of 2022. Royalty revenue has now become our largest single source of revenue, which allows us to fund and progress our clinical development and product pipeline. Collaborations and services revenue for the 2023 full-year period was $53 million, an…

Thank you, Steve. And I appreciate the explanation of all the accounting. I never wanted to know. Now they know why I appreciate you. Next slide. So MannKind has been around 33 years, and I want to give a special thank you to our Founder, who passed away eight years ago on February 25th. The reason that's important the day I decided to join MannKind, and I'll forever be grateful for Al Mann. He was a special human being, who cared about society, our patients, and making a difference. We have the foundation left us within 2016, and we built this into a major self-sustaining growth Company against all odds. When you look at the history from '16 forward, we announced our United Therapeutics collaboration. We acquired Qrum, which is now our Phase 3 asset with clofazimine or MNKD-101. We purchased V-Go, which made our endocrine division more sustainable and brought us a couple thousand new prescribers, and Tyvaso DPI has been ahead of all the expectations since its approval. As I look forward, we are just getting started, expected 2024 milestones alone between Afrezza and the steady read-outs MNKD-101 -- MNKD-201. Not to mention that Tyvaso-DPI, which has two major trials going on in TETON 1 and TETON 2, which I heard this last week, were 70% enrolled. Once they finish up enrollment, they'll have 12 months there. We should expect to see data from United Therapeutics. Additionally, our team just this day completed the high-speed fill finish line in terms of qualification. I will now begin on the PPQ, hopefully producing much higher volumes of Tyvaso have that line as we exit Q1 going into Q2. As I look at our future, we have several key value drivers. As you can see, our insiders picked up some stock…

Thank you. [Operator Instructions] One moment for our first question. Our first question comes from the line of Andreas Argyrides of Wedbush. Your line is open.

Great. Thanks for taking our question. Congrats on all the progress. Just maybe two for us here, quickly. Despite an evolving competitive landscape in PH-ILD, the Sagard royalty puts a $15 billion valuation on Tyvaso DPI. A key component to DPI's advantage is the ease and convenience of the low-resistance device compared with other high-resistance devices. So the question here is, could you elaborate on the differences with the DPI device compared with the competitors? And how that plays into DPI safety and efficacy profile? And also, how do you see the DPI device playing a key role in the delivery of nintedanib IPF? Thanks.

Andreas, let me take that second question. Can you repeat that one?

Yeah, yeah, sure. So back to the advantages of the DPI device, how do you see it playing a key role in the delivery of nintedanib and IPF, mostly from, you know, delivery to safety perspective?

Yeah. No, I think that's what gets us excited, right. I'll start with that question first is, you know, when you think about our platform, it's the same device being used in the same audience that, you know, we're currently moving forward in orphan lung disease that United Therapeutics is also using, right? So the familiarity, the training, all that, and the comfort of, you know, bringing inhalation into this patient population with our current technology gives us that much more confidence because most of the powder is our novel excipient FDKP. So if they can tolerate that in the PH market, we know some of those patients overlap with ILD as well as IPF. Then being able to show that our powder at 99%, FDKP should be able to tolerate it in the nintedanib as we go forward. And so far, the animals, you know, the dissolution and all that looks positive. We're doing a chronic tox, and we'll have that done by the end of this year, at the same time, we get Phase 1. So I think this year, the nintedanib should feel like it's even more diverse than it already is, given it's a known asset and a known technology, that'll be a positive contribution for there. On the other side of the equation, you were asking me, you know, how do we differentiate our platform? I think our powders are built to fly with our devices. They're going hand in hand. We're not taking a novel powder and throwing into an off-the-shelf device. I think that it's about that deep lung penetration, it's about the velocity of those powders are coming out, and how consistent and deep lung penetration you're getting across lung, the bed. And so I think that's number one. Number two, we…

All right. I appreciate that. I'll jump back into queue. Congrats also on all the progress.

Thank you. One moment, please. Our next question comes from the line of Olivia Brayer of Cantor Fitzgerald. Your line is open.

Hey, good afternoon, guys. Thank you for the question. Can you talk about how NTM fits into your strategic priorities just as you grow into a more mature Company? And there is some competition in the space, although maybe less so these days, as you pointed out. So how should we be thinking about where MNKD-101 could fit into the treatment paradigm? And the last question is, just can you remind us on what the timelines are for expected enrollment and data read-outs there? Thank you.

Sure. I think there's a couple of things of how it fits in the Company. You know, the first will be a decision on licensing outside the US. So we'll run the trial in the key countries where NTM exists, but we may choose to partner out, Japan, for example, where we saw Indomed went independent. We haven't made those decisions. We don't have to make those decisions. We are looking for partners and talking to partners, but, you know, it's up to us. And we're a little bit in control of that process there. In terms of how it fits into MannKind, I think there's core capabilities that we have today around reimbursement support, patient training, and how do you treat a specialty product from distribution, things like that we have that will be applicable to the NTM space. And then when you think about where it fits into the treatment regimen, there's two points there. Number one, we're going after the refractory patients first. And in that population, the only drug approved is Arikayce. And we think there we have a significant clinical advantage, as well as a convenience advantage that, you know, we should be able to displace or grow that market opportunity very quickly as we enter it. The other part is we are actively working on a dry powder version of clofazimine, and we expect that that will be used for a naive population so that it can be used earlier in lines of treatment. So we do intend to cover early and late stage. And that's one of the benefits of being where we are as a Company, is when that opportunity presents itself and we choose to want to fund maybe a second trial at that point. We can decide and part of that will be how fast is the Phase 3 enrolling on the refractory population. If we look at into the lead example, right, they got about 180 patients in 15 months. And so that's about what we need. So if you really think about where we are today, 15 months from now, we could be fully enrolled, but we only need half of that population to do our interim analysis. So we hope to have that interim analysis sometime in the second half of next year. And then we would just be waiting for the full patient population to get there in order to hopefully file on six-month data. So that's our goal. It's a primary endpoint of six months. And when you think about the grand scheme of life, we're not that far away from hopefully kicking this trial off here in the second quarter. And more importantly, you know, we're sitting here, next year at this time, we should be quickly enrolling halfway if everything goes as planned.

Thank you. One moment, please. Our next question comes from the line of Steve Lichtman of Oppenheimer and Company. Your line is open.

Thank you. Evening, guys, and congrats on the progress. Just level setting into ATTD, what is the data exactly that we're going to see there? I know we'll see the 17-week this is on INHALE-3. Excuse me, what -- I know we'll see the 17-week at ADA, but what's the anticipation at ATTD?

Yeah, so we have a presentation there by Irl Hirsch, which will be the first dose on the meal tolerance data. And Steve, what I think that will allow us is the opportunity to obviously have Afrezza on the podium there in front of everybody. But I'm sure Irl will be presenting some of the data and rationale why Afrezza deserves a more fair chance in treatment. And he'll show that first dose data and that'll be the primary focus there. As you know, it's a technology conference with lots of innovation and that's really a Type 1 community that comes from there. I think the other part of this is starting to talk about, do you go to Europe, for example? Is there another opportunity, once we see the full data set, to expand to other markets in a meaningful way? So we're there for that reason as much as anything in terms of showing the data and meeting global thought leaders.

Got it. Okay. And then just on the endocrom business, in general, I know you've been balancing growth and profitability. And you noted in your prepared remarks, you know, optimizing the sales force footprint. So I guess, are you reducing the footprint, being more strategic there? Talk a little bit about what you've been doing. And then what are the range of commercial investments you would consider assuming positive outcomes in INHALE-3 and INHALE-1? Would you add more to the salesforce? Would be something else? Thanks.

Yeah. I think on the sales force footprint, yes, you have rewind back 18 months. When we bought V-Go in May of '22, we dedicated roughly 2025 FTEs to that brand alone. And one, it was on a two-year decline, not being promoted, we want to stabilize it. And two, we didn't want to disrupt the Afrezza field team. So we held overlapping expenses for quite a while in both of those businesses. And really our focus going into July and January this year was a two-step process around integrating V-Go into our commercial footprint on Afrezza. And then the second step was integrating the sales force into one voice, one team. And that took place in January of this year. There were some headcounts that were freed up as a result of that process. And we reinvested some of those headcount into the field reimbursement support, the training and the key account managers. We think the key account manager is critical as we go into pediatrics and academic centers. That's not where Afrezza has been widely adopted. So, you know, the first step is getting the key account managers to make sure we stabilize those big accounts. And then second step will be hopefully filtering in some reps underneath them where they can maintain accounts or grow accounts day-to-day while those key account managers take on the next group of accounts and get us ready for PEDS. So we have a multi-step process here. It's not going to happen overnight. But the first step was getting the one field footprint, one voice with one team, and one new marketing campaign, which we're actually rolling out this week. So I think the team will see that. We've invested a lot in training. We have a couple of field trainers now.…

Understood. Thanks, Mike.

Thank you. One moment, please. Our next question comes from the line of Gregory Renza of RBC Capital Markets. Your line is open.

Hi, Mike, and team, it's Nishant for Greg. Congrats on the quarter and thanks for taking my questions. I just wanted to parlay some questions on INHALE-3 there. How should we be thinking about clinical bars for HbA1c over the 17-week period in June? And then just considering real-world translatability of the trial design, maybe if you can just remind us on the foreseen pushes and pulls for getting patients to switch between injectable insulin or pumps to Afrezza. Thanks again.

I think the first question I was kind of the non-inferiority margin, maybe an inhale rate between the two arms, and I think that's a 0.4%, which was consistent with our pivotal trials on Type 1. And so that was -- you know, those trials were done with a different conversion. And so we're hoping one of the things we saw in those trials was we got to the right dose. It just took twelve weeks. We're hoping by starting at a better dose up front, we have twelve more weeks of benefit. And we saw the other last year, if you may or may not recall, we did a small study called ABC, which was a pilot trial on 25 patients to show, could you switch off an insulin pump. How do you adjust the basal? What happens over the twelve weeks of that study? And that study gave us a lot of insights on things we had to correct for this larger trial before we spent the money. For example, one site titrated basal very well. The other site we learned that you could be a little more aggressive in their basal titration. And so those are the types of things we tried to get more guardrails around in this trial to ensure proper titration, proper conversion. And obviously, doctors know how to use the insulin pumps. And so that was the other thing we saw. In the original trial, was they knew how to manipulate a pump very well, because these doctors use pumps all day long, where Afrezza was new to them. They didn't know how to use it to its advantage in terms of dosing and -- follow-up dosing if necessary. So we kind of feel pretty good about the trial design, the controls within…

Great. Thank you so much.

Thank you. One moment, please. Our next question comes from the line of Oren Livnat of H.C. Wainwright. Your line is open.

Thanks. I got a couple 101 questions. Can you just help us better understand how you arrived at the pivotal study sample size and powering, you know, what's that based on? And with regards to the PRO endpoint, I guess, since that's a new subjective endpoint in the space, you know, what is the bar there? What does that need to look like to be an effective competitor? And I've got a follow-up. Thanks.

Oren, these are two great questions and I think it's the biggest challenge to developing products for NTM. And it's why I think you're going to see continued lack of investment because you have to be -- either have enough capital to go through with it. In the case of Indomed, which spent many years building out this space and working with the FDA as well as the patient communities. And we know that the physician KOL population really wants clofazimine. We know the patient population really wants clofazimine. And even the FDA will say, there's been nothing but collaborate along this whole journey for five years and going back with Qrum. So I think the market forces are aligned to help support us with the winds in our backs to push us forward. And then you get into risks of running these trials. And I think the reality is there are risks in this population. But given the efficacy on clofazimine, we estimated about a 20%, 30% effect size delta between us and placebo. And that's going to be the interim analysis to see, are we on track for that? If not, we might have to increase the sample a little bit. That's number one. The second part is the pro. We went back and forth with the FDA for years, not just months, on the PRO endpoint, the PRO division and the feedback from the PRO division, for two reasons. One, we weren't comfortable running a placebo-controlled trial, given that you can pretty much know what the active arm is. And we think that makes the PRO a difficult tool and therefore we tried to make it a secondary endpoint. The FDA was insistent it should be a primary or co-primary endpoint. And so we rounded around a long story short, we landed where we did, which is a co-primary endpoint, with the understanding that this is a little bit of a risky endpoint, but that they agree we've done the best we can to create the baseline measurement and the improvement in those key measurements that we've aligned to with the FDA. And that the efficacy is going to have to matter in terms of sputum conversion as much as the PRO tool by itself. And so just like I know, I listen to the Indomed call. I mean, what they're going through with the FDA, we've had a lot of those questions. We've worked with them. We've gotten a lot of their feedback already incorporated into our trial design. So you know, now it's about the data, and then what happens with data and how you analyze that data once it comes in, all be really important. But again, we'll work very closely with the FDA. I think they understand where we are. They understand the pros and cons and rather than keep debating it, we thought it was more important to get the data and help get this drug cross the finish line.

Okay. Just so I'm clear, you're going based on some clofazimine experience, efficacy-wise, and are you assuming an improvement on that with your powering assumptions, or you've been conservative on that?

Now, I think when you look -- if we were going after naive patients, we'd think we'd see a much higher efficacy rate, but because we're focused on refractory, we think it'll be a little less obvious in naive patients. And I think you saw that in the Indomed Arikayce data out there. There's only one study to really judge NTM endpoints on, and that's the Arikayce. And so I think when you go back in their development program, they had a 20%, 30% delta between the control and theirs -- I'm not sure they had a placebo. I have to go back and double check the data. And so that's some of the work that we were going back and forth on, is incorporating the placebo could have a placebo effect, and how much more do you have to be, and how do you power a trial with that potential risk? And that's a lot of backend forth with FDA. So we've done the best we can. We'll have an interim analysis. We think that's the most important aspect that we will get to in this trial. But assuming that's on track, then we feel very good about wrapping up this trial to bring this to patients very quickly.

All right. And then just with regards to the Tyvaso DPI situation, you know, we're seeing a lot of headlines with regards to potential competition and lawsuits and I'm sure you couldn't or wouldn't comment directly on anyone else's litigation. But if you are willing, I'm curious if you're able to comment on whether your orders coming into this year and your efforts at inventory or manufacturing capacity expansion reflect, I guess, any possible assumptions or risks around competition. Are you potentially waiting to do anything? Or is it pedal to the metal, so to speak, on that front?

Yeah. On the Tyvaso DPI, I mean, we are making as much as we can around the clock. Nothing slowed down there. We know we want to build up inventory as well. So between the demand and the current amount we can manufacturer, there's no slowing down where we are with Tyvaso DPI. In terms of competitor coming, I mean, we've been hearing about this for years, and whether it was the higher dose it was the indication everyone's been doubting us about. Is this going to get approved? When we did get approved, then you're going to have ILD. We got ILD. We've been very honest with the market ever since this drug was under review, and everything we've said has come true, right? We said we would expect ILD. We got ILD. We said we manufacture, we've manufactured. We said it would have a nice conversion. It's had a better conversion than anyone expected. So from my perspective Tyvaso DPI is delivered on all parameters above and beyond expectations, despite an under-forecast launch, which put a lot of pressure on MannKind. And we did not miss one beat to make sure every patient had an everyday supply. You know, we did a lot. Our team worked incredibly hard last year to make that happen. We had record production in Q4. And we'll have hopefully equal record production in Q1 and even more production in Q2. So if you look at their story, they were after ILD, they are differentiated for some reason. And I'll be honest if a patient can't tolerate a dry powder for ILD, I don't see how they're going tolerate theirs, which has three or four times more powder, if I recall. So, you know, it's really about the patient tolerability, it's about the titration,…

Okay. And I look forward to talking to Steve some more about this accounting.

I'll stay out of that conversation.

Thank you. One moment, please.

Thank you, Oren.

Our next question comes from the line of Thomas Smith of Leerink Partners. Your line is open.

Hey, guys. Good afternoon. Thanks for taking the questions. And let me add my congrats on all the progress. Just a couple on our end, I guess, first, on MNKD-201, the inhaled nintedanib program. Just walk us through your expectations for the Phase 1 data in Q3? And how quickly you think you could turn this around and advance it into a Phase 2 trial on IPF patients? And then just remind us how you're planning for clinical supply and scale on 201.

Sure. On the Phase 1 study, because it's a pretty quick study, we're actually going to IPF patients. It was the FDA, who pushed us to consider healthy volunteers. So we actually switched from, I'll say, IPF patients to healthies, which saved us a lot of time and money. So that's number one. So that turnaround time should be pretty quick in terms of wrapping up Phase 1 and filing an end-of-Phase 1 meeting with FDA, hopefully, by the end of the year. And then we're having good discussions internally. We just hired a new gentleman, Dr. Wasim, who will be pivotal in leading our development program beyond Phase 1 for 201. And we're having good discussions internally, for example, do we do a 1b study to get data sooner in parallel, while we continue to wait to kick off the trial for the next phase? Is it a two-study going into Phase 3? So that work is happening as we speak. And I don't want to prematurely guess where we land. But just like clofazimine, where we push to not do a Phase 2 trial, one could argue that's a little risky. At the same time, we know these drugs work. We know the approximate dose we're trying to go after, and we know that that dose has produced a signaling effect that we expect. So in the case of 201, we actually want to dose higher, and that's where we need the chronic toxic data in Q4 to help support that higher dosing, assuming a patient can tolerate that higher dose, we think that's going to be one of our clinical differentiators for 201. So that'll be the things we look for in the trials. Can we dose higher? Is it tolerable? And do you have any of the GI side effects that we see with the oral formulation?

Got it. That's helpful. And then just on the pipeline strategy and the priorities here, obviously, you have a lot on your plate across the INHALE studies for Afrezza and the clofazimine and the 201 program. But now that you have the financial flexibility. I'm just wondering if you could talk about how you're thinking about balancing external business development opportunities versus advancing sort of the internally derived candidates out of your platform.

Yeah, no, that's a great question. I think the team is bursting at the seams on everything we're doing today. And the good news is we have a great team, who's working extremely hard to make sure we get these INDs in to get the INHALE-1 and INHALE-3 study wrapped up. And so, you know, from a financial flexibility, people don't realize we probably spent, don't quote me exact numbers, but over $30 million between INHALE-1 and INHALE-3 between people and trial costs. So those trials are wrapping up this year going into next year. As you think about clofazimine, there'll be a little bit of overlap with the 101, but these other trials wrap up and so you kind of see that phased in. People also miss that. We have been funding tox trials and other data sets in R&D over the last couple of years on 101 and 201 as well as 501. So there's been other investments in our idea that aren't as transparent because we don't talk about them as much. But again, some of those are wrapping up and those extra funds will be used to fund the Phase 3 trial. So I think we have the financial flexibility to ensure, yeah, if we can't fund it out of cash flow generation that we are today that we have the cash on the balance sheet if we needed to. But our goal is to continue to run the Company lean like we have been and not get too far ahead of our skis until we continue to show consistent delivery as we go forward. Steve, I don't know if there's anything you want to add there.

No, Mike, I think the other original question was also around BD versus Internal. I think you're exactly right. We're going to focus in on the internal priorities that we have, and if opportunities come along, we'll certainly assess them, but the focus will be internally first.

Yeah. And on the BD side you know, we get lots of inbounds these days. We're just busy. And so if we see something compelling, we'll look at it. But we're not actively trying to pursue anything. We want to work with what we have and maximize the value what we have on our plates right now.

Got it. That makes sense. All right, guys. Thanks for taking the questions.

Thank you.

Thank you. One moment, please. Our next question comes from the line of Anthony Petrone of Mizuho Group. Your line is open.

Thanks for squeezing me in here, and congrats on strong results. Also, condolences on Alfred Mann passing to the team. Maybe, Steve, a couple on Tyvaso, just the royalty agreement, just high level. Why was 1% sort of the right number? Oren's point there's potential competition. So what was the calculus on settling on 1%? And can you -- is there an option to further monetize Tyvaso royalty under a scenario maybe where you want to fast-track 101 and 201? Or even add to the portfolio for future growth investments? Would you consider monetizing the royalty further as a source of funds? And then I'll have a couple of follow-ups on diabetes for Mike.

Anthony, it's Steve. So what we did is we looked at what the value was for the Tyvaso royalty in a very competitive environment. We had originally over 25 different purchasers come to the table. And we wanted to keep a vast majority of the royalty to MannKind. So we thought 1% was right to get to about $300 million on our balance sheet, which would fund not only our pipeline, but put us in a good position to fund the convertible debt when it matures in 2026. So, yes, we can further monetize the royalty if there was a need for it, but we don't expect there to be a need for it at this point in time.

Steve, I'll just add two things, Anthony, to your question. The thing that drives royalty valuation is interest rates and the calculation you're using for expected interest rates. And so over time, if interest rates come back down, the overall value of this royalty may go up even further, even if the sales came off a little bit of trend for some reason. But we think that when we started this process, the royalty rate was not transparent to the public. When you look back in June, July of 2023. And we want to bring value to our company around what is 10% of this royalty worth because we thought we valued, and that 10% felt the right way to demonstrate that clearly to investors. In the meantime, and we're midway through that process, UT disclosed the royalty so we didn't have to kind of work around that issue, number one. And then number two, the interest rates are high, and that does create a bigger discount factor into that future cash flow. So those are things going in our favor, hopefully, over the coming years. And the thing about a competitor coming, we know there's about x percent converted from nebulizer to DPI. However, if there was another competing product out there, that may help drive more adoption and earlier adoption of DPI, which indirectly may help us as you think about the future. So we're pretty bullish on DPI, and whether there's one or two players out there, it only helps more patients that can hopefully use the product more in earlier lines of treatment as well. So that's kind of how we looked at it. And we think MannKind indirectly benefits as more competition does come.

Appreciate that. And just on INHALE-3 and INHALE-1, just from a combined outlook there for Afrezza, when you think about using Afrezza with automated insulin pump and then the pediatric indication. Just to kind of level set again from the MannKind standpoint, how it's looking at those two opportunities from a market expansion standpoint for the product. And actually which of the two indications are you most excited about? Do you think you get faster traction, pediatrics, or would it be in the combination use? Thanks again and congratulations.

Yeah, no, thank you. I think the challenge with adding Afrezza on top of pumps besides the FDA, I'll just put that out there, is really the need that a patient sees. And are they always going to carry all this extra supplies with them, and do they use it on special occasions? Do they use it when they get home? It's not a full-time patient when you think about that value. And that's one of the things I think I've seen when people used to criticize our refill rates. We knew roughly 20%, 30% of our Type 1s use Afrezza intermittently, which kind of hurts your refill rates, right? And then we know Type 2s are not as compliant as we want to be. So that's why it's so important to make sure that we are a front-end center choice for patients who have mealtime control or want to improve their A1C as we look out there, can we improve A1C? Can we improve time and range? That's what we're hoping to see with these new trials versus when we got approval, it was just to show that the drug was as good as a standard of care. We think that's good enough for PEDS approval. But to cause an inflection, right, we want to show that hopefully we're improving something on the product. If you ask me, which is going to be more critical, I think INHALE-1 will be the study that causes Afrezza to become the next standard of care. And what I mean by that is, look, can we grow faster by putting more people out there, more marketing, more advertising? Absolutely. I think we can. Is it going to be an inflection point that looks like a rocket? I think it's going to take another…

Appreciate that.

Thank you. I'm showing no further questions at this time. I'd like to turn the call back over to Michael Castagna, CEO, for any closing remarks.

Thank you, Valerie. Thank you all for the analysts coming in. We look forward to seeing hopefully a couple of you at ATTD also will be on the non-deal road-show, hopefully in some key cities, meeting with our investors. And just want to say thank you to everyone. It's been a great year so far. We're super excited. Everything's off to a great start. And we're looking forward to making 2024 another record-setting year. So thank you again for everything. And Steve and Dave and everything else, thank you for all the work everyone's doing. Have a great day.

Thank you. Ladies and gentlemen, this does conclude today's conference. Thank you all participating. You may now disconnect. Have a great day.