Good morning, and welcome to the MannKind Corporation call to discuss the six-month results from its phase 3 INHALE-1 study of Afrezza in children and adolescents. As a reminder, this call is being recorded on December 16th, 2024, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call, and will be available for approximately 90 days. 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 from these stated expectations. Chief Executive Officer Michael Castagna and Senior Vice President, Therapeutic Area Head of Endocrine Diseases, Dr. Kevin Kaiserman, are joining us today for MannKind. I'd like to turn the conference call over to Mr. Castagna. Please go ahead, sir.
Thank you, and good morning, everyone. Today I'll be talking about our 26-week results, as well as several other business updates to kind of summarize and close of the year on our diabetes business. Before I get started, I want to say thank you to all the site investigators, patients, and parents, as well as our staff, as we've been working on this opportunity since I arrived at MannKind. We knew it was going to be a long road when we embarked on this journey, but we believe the long-term growth of Afrezza is and was directly related to the outcome of this data. As we see, any innovation in the insulin market has always started with pediatrics and worked its way into adults, whether this be the original invention of insulin to AID systems, CGM, Baqsimi, or Omnipod, are a few examples.
We are very excited to release these results today, as we believe the efficacy, safety, tolerability, and totality of the data will support an FDA submission that should lead to an expanded label for pediatrics. The main question in front of us with the FDA is, will they allow us to file with six or twelve months of safety data, given the majority of the people, or roughly 65%, have reached twelve months? I may note there is no control arm in the second half of the study, as everyone has switched over to Afrezza, so we are only collecting safety data at this point, which has been consistent with all of our other data that has been generated in thousands of patients. This is a very difficult-to-treat population, given they are mostly teenagers going through puberty or small kids who depend on their parents.
When we set out to do this trial, we thought it was important to partner with a reputable organization like Jaeb and focus on U.S. sites, given the small community that serves these patients. As one can see, we enrolled patients who weren't as tightly controlled by allowing A1C levels for people above seven who were not in control to a cap of 11, with an average of 8.2 at baseline, when many companies would cut off patients around 9.5 to ensure they had some control and understanding of the disease. Overall, you can see we met our goal of this trial. The full intent-to-treat population found that the group difference between the mean A1C change over 26 weeks exceeded our pre-specified noninferiority margin. This was largely driven by the variability of a single patient who did not adhere to the study protocol.
Our modified ITT analysis showed we did achieve noninferiority when the single patient was removed. Additionally, the main concern coming to this trial was the safety and impact on lung function, because these are growing kids over one year. We had to measure this based on predicted value and not just an absolute value as we have in the past. Again, you can see in this particular aspect, there were no significant differences between the arms and predicted or absolute change. Overall, because safety has been such a talking point for Afrezza/inhaled insulin, we would expect peds to have a halo effect on the adult market as we prepare to grow the brand over the coming years. That will close my remarks on the pediatric 26-week data. I will now focus on our diabetes updates for a closeout of the year.
About two weeks ago, you all saw that India received the CDSCO approval. India has a large population with 80 million people living with diabetes. Any new drug approval is a two-step process, and we've completed the first step, which is the receipt of an FDA approval. This should result in a payment of $1 million, which we expect to be recognized in Q4. The next step is to register our Danbury manufacturing site so that we can import drug, which usually takes approximately nine months, and this is why we said we expect to be shipping product at the end of 2025. A second business update I want to give you is that we've signed a promotional agreement with Amphastar to drop Baqsimi into our sales force and collaborate with them in 2025.
Our salesforce will join theirs in promoting Baqsimi as part of a strategic partnership, aiming at increasing their sales footprint and enhancing awareness among our target audience. We do not have to add more targets. We do not have to redirect our current focused efforts on Afrezza. We will receive some revenue in 2025 as a result of this relationship. Next, we have partnered with someone to work on an ITT, which is an investigator-initiated trial for a single dose in gestational diabetes, and this trial was approved and recently cleared IRB and will be kicking off in 2025. Another update is our INHALE-3 data, which was our 26-week data against head-to-head best standards of care using AID systems and MDI, which was just published in Diabetes Care a little over a week ago.
This will be a great opportunity to lay out the foundation for 2025 with new data against the best standards of care out there today, showing Afrezza was as good and actually showed it could help more patients achieve their goals. This data is important because we expect it to be able to lead to a label change on Figure 1, which is our dose conversion, as well as some other changes in our label that will help our commercial efforts in future years. We expect to submit this label change in Q1, and we will find out from the FDA whether that is a four-month or ten-month review upon submission. And finally, as we close out the year, the ADA just released their annual update on standards of care, and in several places, you can see inhaled insulin was put on parity with injectable subcutaneous insulin.
This has been in the works for many, many years, and the team has worked really hard to ensure that the guidelines are up to date on all of our new information and that Afrezza stands against the best options out there for patients. I'm going to stop there and ask Kevin if he has any parting words as we close out today's call and open it up for Q&A.
Thank you, Michael. I would like to start by thanking all of my coworkers at MannKind, my clinical research colleagues at 40 sites across the United States, and all the participants and their families who allowed us to reach this important milestone. As a pediatric endocrinologist with more than 25 years of direct patient care and clinical research experience focused on improving the lives of people living with diabetes, I initially joined MannKind in 2020 for the opportunity to conduct this pediatric study to extend the choice of providing inhaled insulin to children and adolescents. It is exciting to share the efficacy and safety results today on the randomized treatment period of the INHALE-1 study in support of our discussions with the FDA to bring this important therapeutic option to the pediatric population.
Thank you, Kevin. And operator, we can open it up for Q&A.
If you'd like to ask a question at this time, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Olivia Brayer with Cantor.
Hi, good morning. Thank you for the questions. Is there anything more you can tell us about that one patient who was excluded from the modified analysis and what their A1C levels were at baseline and at 26 weeks? And then on safety, how many patients have actually hit that 12-month safety mark, and how many will actually have 12 months' worth of safety data by the first half of 2025? And then I've got one follow-up.
Okay. I'll let Kevin answer the details around that one patient. And the second one was the number of patients that at the time of database lock were 65%. So you can imagine by the time we get to the FDA, you'll see a large majority of people almost at that 12 months, but we won't always have that data because the database lock will happen only at 12 months. But Kevin, why don't you take some details around that patient?
So that patient was highly noncompliant, documented throughout the study period, not taking their medication, and had an A1C at the end of the study that was extremely high at about 15%, and also not adherent to the other study procedures as well.
Okay. Understood. And then, Mike, can you frame the growth opportunity a bit more? I think you all have previously talked about being able to realize around $150 million in sales for every 10% of the market. Is that still how you're thinking about Afrezza's potential in peds? And then can you just talk through some of the metrics that get you to that $150 million number as it relates to pricing and other dynamics?
Yeah. I think we previously said every 10% market share in kids is approximately $150 million net in revenue. Obviously, that changes with time if you increase your discounts or things like that. At this point, I don't think that number has changed dramatically. I think we're waiting on the results before we start to kind of put the details here together on how you get there and do you get there in 18 months or 36 months. But those are some of the guidances we will try to bring to the market in 2025. But I think if you just think about, the pump market is probably 2,000-300,000 patients just on kids. And so it doesn't take a lot to think about 10% of patients and what that would mean to the brand.
I think that's really our goal is how do we start to march not just in kids, but adults. With all these new changes this year and all the new updates, it's a different opportunity than it was in the past.
Great. Thank you both.
Okay. Thank you.
Our next question comes from Faisal Khurshid with Leerink Partners.
Hey, good morning, guys. Congrats on the update. This is a question on how should we think about the potential commercial strategy in a pediatric indication, and also how should investors think about the level of incremental investment needed to unlock that opportunity?
Yeah. I think the first thing is making sure that our clinical data is out there in the domain, and what I mean by that is the pediatric market. Honestly, if you did research today, the majority of them would not know inhaled insulin is available in adults. They would not know the history of our data or development program, and we've been working on this for over 25 years. So I think the first step in our journey is making sure we scale up education and awareness of what is out there today, and that will prepare, hopefully, to answer any questions around dosing, safety, hypoglycemia, etc. So the peds data will be a capstone of that information as we start to now analyze it and release it for other conferences and publications. The other parts of this is working in academic institutions.
When you think about our history as a company, a lot of the early adoption of Afrezza has come from private practice doctors who actually allow sales reps in and allow them to listen to the information and share the information and attend dinners. Traditionally, we've not been strong in academic centers, and that'll be an important factor as we go into 2025 and start to expand that capability and also drive around how do you partner with fellows, how do you partner with training programs, how do you get into where we are educating the future generation of doctors. That'll be something the medical team will be tasked with of just getting out there, helping us there, and then bridging that over to the salesforce as we get approval. That's the number one way to think about it.
I think the next thing I'd say is conferences. We've generally been more quiet around the various conferences around the world, and I think you can see that we'll be hopefully a little louder around those types of things. Those are just opportunities for share of voice. It's where investigators and thought leaders are, and that's something that all the innovation around ATTD, and this year it'll be in Amsterdam. We're looking to see what can we do there to help raise awareness around technology and new innovation here. These are the types of things that you'll start to see more of. We're going to make our incremental investment. We have lots of flexibility here. I don't think you should expect to see us to spend tens of millions of dollars more in our cash burn or anything like that around this.
The pediatric market is probably about 50 sites around the country and 500 doctors. So it's not a large effort beyond what we do. It does mean we'll have to tweak some things to focus on that audience, but it doesn't mean it's a major expense to get there.
Got it. That's helpful. And then could you describe a little bit more of this promotional agreement you guys just announced and sort of what that means overall to the strategy?
Yeah. I think number one, we stopped promoting V-Go here in Q4, and that created some share of voice within our salesforce to take on more responsibility. And we've been looking for a second product for years, and we've tried different things. And this is an opportunity we believe the number one side effect of insulin is hypoglycemia. And unfortunately, the percent of people who die as a result of this event has not changed in over a decade. And so we do think there's a large opportunity to provide and be a better service to our customers by bringing valuable information and share of voice. And that's really what we set out for to look at a hypoglycemia partner. And Baqsimi, as you guys know, we buy our insulin from Amphastar. We have a great long-term relationship that goes back over a decade with Amphastar.
And this was an opportunity to work closer together around the diabetes community and how we can help raise more awareness around Baqsimi because we have this opportunity to go into customers, and not every customer buys Afrezza every time we show up. And so we think this is an opportunity for our salesforce to get more into these offices, especially as you go to academic centers and pediatrics in the future. Baqsimi will be an important opportunity to get in the door and start to talk to these customers. So this is a great opportunity to help Amphastar raise more awareness and share of voice. And it's a great opportunity for MannKind sales representatives to help reduce the hopefully impact of hypoglycemia on patients. As we know, this is a major side effect of insulins. And I think it's an opportunity where it's undertreated in patients.
Doctors often forget to prescribe, I'll say, a hypoglycemic agent with their insulin. We think it's important to kind of use that extra capacity we have to help these patients and help the company.
That's helpful. Thanks. And congrats again.
Our next question comes from Gregory Renza with RBC Capital Markets.
Morning, Mike and team. It's Anish for Greg. Congrats on the progress, and thanks for taking our questions. Just a couple from us. First, as you come away from the data today, how are you thinking about labeling implications? And second, maybe if you could just highlight any parental feedback you may have collated over the course of INHALE-1 and how that informs upon Afrezza's value proposition. Congrats again, and thanks so much.
Yeah. I think the first step will be, excuse me, the first step's going to be submitting our meeting request to the FDA. And we'll have several questions there. But the main one will be, are we able to file on six months of safety data? Because we know that they've been interested in the long-term safety of 12 months. But I think when you look at the data, there's really no safety signal here in any parameter we could look at: hypoglycemia, FEV1 change, absolute change, or predicted. And so we feel very good that that part of the product has stood on its feet. And it wasn't, I think you had to have data before you could ask the FDA for this type of request. We will see where they are, but that'll be the main question.
And if they say they want 12 months of data, we would expect that endpoint to be reached in roughly April of next year. So by the time we have the meeting request, we're not that far off. And so if we can file sooner on the six-month data, it'd be great to get this to patients faster. But at the end of the day, if it's not, it's not that big of a delay. But we would like to get this to patients as soon as possible. That's on the FDA. The second you were asking is the implications on the business?
Yeah. So just the second was just if you could highlight Afrezza's value proposition in peds based on any parental feedback or investigator feedback as well?
Yeah. I think two things. Anyone that has a kid and just tries to give their child a vaccine, it's an extremely difficult moment, whether you're donating blood. I had to do recently with my child. These are very hard to chase down a kid, and doing it three to five times a day, whether you're changing the site injections or pumps or putting on a pod or just trying to give them MDI, these are very, very difficult things to do every single day consistently, which is why you see the difficulty in treating this population. I previously worked in growth hormone where it was just one shot a day, and parents would often cringe at that thought for doing that for three to five years, let alone doing this for life.
So when you think about inhaled insulin, this is really the first time ever that they will have an alternative to what they've been doing for 100 years. And so we're super excited. And I think the parent feedback - we've gotten some letters and some pictures on the internet of parents who have had great results with Afrezza. But we can also see in the data that there are some people who don't have great results with Afrezza. And so I think when you look at the totality between INHALE-1 and INHALE-3 now, I do think there are several things we can see, which is, number one, the higher dose conversion hopefully will lead to less dropouts. And so that's really important when somebody first starts Afrezza. If they are underdosing from day one, they will generally drop out a little bit earlier.
And hopefully, we can now show that that higher dosing upfront, which is why we're trying to update our figure, will lead to a good safety tolerability profile. And when you look at the data, all of our single-dose upfront doses have shown really good postprandial control. It's when we get into the real world where patients either aren't being monitored or aren't following the doctor's instructions, or the doctors aren't titrating up. And that, to me, is the value prop that we have to work on, which is how do we have a decision support software process system training that helps those patients in those first 60, 90 days? Because we're seeing people's sugars trend above 180, 250 on both arms, not just our arm, but the competing arm. And that, to me, is unacceptable these days.
We know Afrezza works well, and we know it brings down sugars fast. But how do we do that in a more systematic way that uses the CGM and uses Afrezza's opportunity to make that happen? And so that's some of the work you're going to see us now embark on. It's just like insulin pumps have a whole software system and support system. We'll now start to invest in that for Afrezza for the coming years. And I think overall.
Great. Thanks so much.
Yeah. And the last comment I was going to make is Baqsimi has a large market share in kids versus injectable glucagon. And I think that's an important segment to think about is, one, given the choice, people don't want to inject. And I think it's just a question of how do we give patients the choice? How do we make that happen? And how do we raise awareness that this is an opportunity for parents and patients as we go forward? And part of that will be making sure we help out in the summer camps and volunteer there and raise awareness. And it'll also be important for the school nurses and things like that. There's a whole system that we have to change differently to help that value prop work.
Actually, when you think about asthma inhalers in kids, things like that are changing how these kids can operate and work and use their insulin. Okay. Thank you. Operator, any more questions?
Our next question comes from Brandon Folkes with Rodman & Renshaw.
Hi. Thanks for taking the question, and congrats on the results. Maybe just following on from an earlier question, just if you do get the INHALE-3 data in label, how do we think about the rollout of a new promotion efforts and focus with perhaps the pediatric approval coming not too long after that INHALE-3 label expansion, especially if it's sort of the longer 10-month review? How should we think about where there's perhaps greater potential to bend that Afrezza curve early on between INHALE-3 and INHALE-1 and maybe where we would see the focus?
Yeah. It's going to be a busy 12 to 18 months for everyone, meaning that by the time we get INHALE-3 out there and all the materials and the label and advertising done, we'll be on the cusp of launching PEEDS probably right behind it. And so I do think it's going to be a good, I'll call it two to three years of new data publications and analysts' analysis and marketing opportunities going forward. And I think the biggest thing with INHALE-3 is really just getting Figure 1 updated. And so it's not necessarily trying to get all the data in the label because that's actually not our goal. The data we generate is very consistent with the other studies we've done in terms of type 1.
And I think it's just a matter of getting this figure updated and showing the FDA the safety related to a higher dose conversion on day one. Because part of the challenge I see out there is when doctors don't see sales reps and you didn't have a large medical presence, they would just read the package insert or go into some up-to-date app, and they would convert at a much lower dose than they should. And they don't know that they should titrate up faster versus injectable insulin once they titrate up over time. And those patients often see a high hypoglycemia happen very quickly. And I think it's really how do we help change that outcome?
We really want those docs who may not see sales reps to at least get the right information and know that they have to titrate up quickly or convert at a more equivalent dose to injectable insulin. And that's our main focus here with Figure 1 and the FDA. I think the FDA has been supportive. It's been a complex discussion because we are taking. It was an FDA-approved label 10 years ago. And we've been working ever since I got here to show a stepwise fashion that this is safe and effective for patients. And I think we're finally at a point where all the data is in, and hopefully, the FDA will support this change.
Thanks. And one more if I may. Can you just help us think about perhaps the prescribing hierarchy in practice here for the pediatrics? And what I mean by that is, what do you think is going to drive the initial conversion? Is it going to be just route of administration? Obviously, we've seen good safety. Or could some physicians look at sort of incremental A1C control? Just how do we think about sort of what are going to be the fast movers? And then maybe sort of what portions are going to maybe take a little bit longer?
Yeah. I mean, I think that some of the work we've been talking about, which is, do you try to go after early stage, I'll say, newly diagnosed patients? Do you try to get patients when they're switching from MDI to an insulin pump? Because usually, they'll start on MDI for a period of time before they move to technology. And I think that that's the question. Where's the lowest barrier to help intervene to get that trial and adoption ultimately? And I think there's several segments. It could be parents who are struggling with injections. It could be patients who are struggling with high sugars that we can show that we can help manage that there. And there are patients that are not the right people for Afrezza.
I think that we can clearly see as we start to dig into the data, people that aren't going to take their insulin. Maybe an AID system is a little bit better because getting some insulin in the body is better than nothing, and so I do think that when we look at INHALE-3 and INHALE-1 in totality, you're starting to get to a more predefined Afrezza patient that's ideal. I also see the data in that there's a lot of site variability, and so how do we start to help sites operationalize Afrezza better? Because if they only write it once a year, they're never going to be great at what they're doing, so we really got to think about just like they have a pump process in their practice or an Omnipod practice in how they treat or a CGM.
When I go into these offices, when they use CGM, they have it set up so every day, five, 10 people are getting trained, well, how do you do that for Afrezza? Just like they do that for insulin pumps, they have pump training classes, pump selection classes, so these are all the things that we're not in the selection. We're not in the mindset, and now with all this data generated between INHALE-1 and INHALE-3, I think being able to say we're a fair treatment option that should be offered to patients, that should help us get picked a lot more than when you're not presented to patients, and that's a lot of the work we'll be doing to help increase that shot on goal, I'll call it, as we go out there.
So we definitely have work to do, but I think we have a lot of the data to now support, fine-tune our messaging, and then also think about what's our direct-to-consumer strategy. And there could be some differences as we think about that opportunity in the future.
Great. Thanks for taking my questions and congrats on the results.
Thank you.
Our next question comes from Oren Livnat with H.C. Wainwright.
Hey, guys. Thanks for taking my questions. I actually have several if you'll accommodate me. But just to start, can you just give us a little more context on, in this study in particular, on average, how long were these patients already on multiple daily injections? How stable were they going into the study? And how long did they have to train on Afrezza before going into the observation period? I guess you sort of touched on that issue in the real world just now. And I'm essentially trying to gauge if Afrezza was almost disadvantaged even in this study versus MDIs. And also, you mentioned earlier that some patients didn't do well on this when talking about parental feedback. So I'm actually just curious. You gave us an average non-inferiority result.
But can you talk a little bit more about whether some patients did much better on inhalable potentially on A1C, even if the average came out the same? And then I follow up.
Yeah. So I'd say a couple of things. One, literally, the data just came in last week. And so we've had less than a week of looking at the data, doing any analysis. And the big one was just looking at the outliers and just understanding what outliers and what they mean. So I'd say in terms of double-clicking down, insights really on the quality of life questionnaire, insights on A1C, insights on a lot of these things have not been done yet. Our goal was to get top-line level to investors like yourselves as soon as possible. And that's what we did. And so we haven't had a lot of time. We will continue to conduct many of those analyses as we start to go into FDA discussions. So I'd say just at a high level, there's not a lot there yet to share with you.
Kevin, I think a couple of those questions would be directed to you around duration of disease and run-in period, which I know we didn't have a long one, and maybe you can just comment on some of those versus what you've seen in other trials.
Yeah, so there was a period here, a very short period of run-in, just a couple of weeks, and so there wasn't a long period of run-in. Most of the patients coming in were already using CGM, but not all, so there were some people that were new to CGM and wore initially a blinded CGM and then real-time when they were randomized, so again, to your point, there was not a large run-in period during this study. It was approximately two weeks.
But Kevin, were they even on Afrezza? Were they just going from baseline MDI?
Yeah. They're going from baseline MDI. Yeah. Going from baseline. And again, they could have Type 1 or Type 2 diabetes, although the vast majority of them had Type 1 diabetes. So.
And then I think the average duration of disease, Kevin, you might want to comment on that. I think the average age in the trial.
So they had to have type 1 diabetes and be on insulin for at least six months or at least three months for type 2 diabetes prior to coming into the study. So again, not terribly long, although I'd say for a longer period than the environment. And I don't know if I have the average age right here, but I'll try to find it for you guys.
Then, Oren.
I'd like to say is you asked about Afrezza being disadvantaged a little bit. I think there's something there in that you're right. These 40 sites have never used inhaled insulin in their life. This is their very first time where they've used inhaled insulin their entire career. I think the same is true with INHALE-3. When we look at those 19 sites, the majority of those sites have never written more than one script of Afrezza. So we are going into 60, I'll call it, new centers, mostly academic-based, who actually have very little to no experience with inhaled insulin.
And so that's a lot of the learnings I think you see in the trial and the sub-data as we look at analysis of why some sites did well, why some sites did a little less well, is really about how do you dose, how do you up-titrate, how do you adjust the basal. And even though we gave very clear directions in the trial, we can clearly see that those were not followed. And so there's a learning curve here, right, with something new and innovative. And we'll continue to work on how do we minimize that risk. But despite those disadvantages, I'd say the results stand on themselves of whether it's INHALE-3 or INHALE-1 here. Okay. And as we think about the patients in general, you mentioned that these were maybe less well-controlled than your typical study.
I'm just curious how pediatric patients tend to do in general over six months, just based on real-world epidemiological experience. Would we expect this population to generally be stable like we saw in MDI in the real world, or do they tend to actually get worse? And maybe what we saw here with flat A1C in the control arm is probably better than what you'd expect in the real world. And then I have one last follow-up. Sorry.
Yeah. I mean, I think we're just still looking at the data order. And I think in general, what I'd say is between divorced parents and socioeconomic status and technology, these patients, puberty, they're all over the place. Some of them are doing good at some point in their life, and there's some of them who struggle to keep control. And there's a lot of factors. And I think the higher A1C you go, the more variability you see. And I think that's a large part of what we can see is many other companies won't do trials in people with an A1C above 9.5, and they'll let people in good control also in the trial. So you start to get a tighter population. And I think we just expected that you would have been dosing our protocol fine. We know we would have won on these high sugars.
But if you don't actually take the drug and you don't titrate up basal, there's not much I can do. And so I think at the end of the day, we know the drug works. It's insulin. And we know when you follow our instructions, it works really well. We just have to kind of continue to get that out there and create the tools to make that easier for prescribing physicians.
Okay. And just lastly, I'm sorry. I appreciate it, the six-month extension phase. Can you just remind us what you would even hope or expect to see there, given your prior experience of running trials where you had control arms then switching over? And what portion of patients did switch over, both from the MDI group or carry over from Afrezza? I'm just curious how important is this data beyond just a formal label expansion on the population, but how important might this data be that you'll presumably publish later to drive commercial uptake? Thanks.
I mean, I think our focus is on the primary six-month endpoint. The FEV1s will be interesting to see at 12 months, but remember, half these patients going to 12 months will be switched over at 26 weeks. And so you're only going to, when I look at the data, you're going to have 200-some patients for six months, roughly, six months of treatment, whether that's the extension phase or the first phase, and you're going to have half of them roughly with 12 months of FEV1. And I think that's the main goal of this trial. I think there's always going to be trial fatigue of anyone that goes out past three to six months on a trial. It's pretty intense to follow up with the visits and phone calls and stick to anything, and that's important, and people move away and change schools and things like that.
But I mean, for me, the six months is the primary focus here with the FEV1. At 12 months, it'll be interesting to note. But again, we see nothing of concern or nothing that's there that should change in the next six months of the data.
Got it. Well, thanks so much. I look forward to talking later.
Thank you, Oren.
That concludes today's question and answer session. I'd like to turn the call back to Michael Castagna for closing remarks.
First, thank you, everyone, for all the questions. These are great questions. I think we're excited about where we're going. We definitely have work to do, but a big milestone in our last eight-year journey has been around getting ready for pediatrics and the state of readout, and we believe this has always been a pivotal moment for Afrezza in terms of, yes, we could spend more money to launch better in adults, but at the end of the day, the real transformation starts with kids.
And so I think as you look at the stepwise approach we've taken on the clinical side of this product with all the different data sets we've generated, we can comfortably and confidently tell you how to dose the product now, how to convert the product from injectable insulin, and that we're as good as what you perceive as any best standard of care out there. And this is really the totality of all the data we generated, really summing up the last two weeks of this year between the ADA guidelines, standards of care getting updated, our publication in Diabetes Care with the 26-week INHALE-3 data and now the INHALE-1 data. So it's been an extremely busy year. We have tons of data now analyzed and presented at future conferences.
And I think you can start to see our reputation out there amongst KOLs has been strong this past year with Irl Hirsch and others trying to help raise awareness around this opportunity. And then we start to now move into the payer segments, which is how do we now educate the payers to streamline prior authorizations, remove friction, how do we ensure ease of access and training upfront? And these are all the things that honestly are the controllables, but we needed the data to come out the way we did in order to start to fix the controllables, and that's the stuff you'll see us focus on in 2025 and beyond. So I want to say thank you again to everyone that helped us with this trial. It's a great opportunity for patients and MannKind in the future direction we're moving.
And as you'll see, we have plenty of great opportunities in 2025 between the rest of the company and the diabetes business, as well as what we're seeing in the inhaled pipeline and Tyvaso DPI. So the next two years aren't going to be very boring for the company. We're really excited about our future. Thank you again.
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