MannKind Corporation ($MNKD)

Good afternoon, and welcome to the MannKind Corporation conference call to discuss the U.S. FDA approval of Afrezza in pediatrics. As a reminder, this call is being recorded on May 29, 2026, and will be available for replay on the MannKind Corporation website shortly after this call for approximately 90 days. This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from these expectations. For further information on the company's risk factors, please see the Form 10-Q for the period ended March 31, 2026, this morning's press release and the slides prepared for this presentation. Joining us today from MannKind are Chief Executive Officer, Michael Castagna; and Senior Vice President, Therapeutic Area Head for Diabetes, Dr. Kevin Kaiserman. I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

Thanks, operator, and good afternoon, everyone. Thank you for joining us on today, which is a truly historic moment for MannKind, for the diabetes community and most importantly, for children and adolescents living with diabetes. Our founder, Al Mann, always dreamed this innovation will be available for kids, and we are honored to be able to fulfill that dream today. Our agenda today is with Kevin and I will lead the discussion and our President, Nick Marasco, will be available during Q&A. Our goal is to walk you through why this milestone is so critical to driving an inflection in Afrezza's future growth over the coming years. In fact, we've already received our first 2 patients in the last hour. As of this morning, Afrezza is now approved for pediatric patients living with diabetes ages 6 and older. This is more than a label expansion and is bringing a fundamentally different experience to children and families who manage diabetes every day. This is the first alternative to mealtime injections in 100-plus years of pediatric treatments. First, I want to thank the FDA for their collaboration and support to help get us across this finish line. I also want to thank the investigators, our patients and the parents who are part of the study. We are really excited about the label we received. Ages 6 and older covers approximately 95% of all children diagnosed with type 1 diabetes. This is a broad and meaningful indication. What makes Afrezza so unique is its differentiated clinical profile that simplifies mealtime management, reduces the need of the [ car count ] and manage the timing of your insulin administration. And most importantly, we're going to make Afrezza available for $35 for anyone less than 23 years old regardless of insurance coverage as we want to remove any barriers to patient access. This is a new chapter for Afrezza and for MannKind. Before we get into the pediatric data, I want to ground everyone on what makes Afrezza a fundamentally unique insulin. On the left side, you see the natural insulin profile of a healthy pancreas, peak concentration at 45 minutes. Now on the right side, you see how closely Afrezza mirrors that profile, with peak effect also at 45 minutes and insulin action that clears around 2 hours, right around the food -- right around when food is generally clearing. Compare that to injectable rapid-acting insulin, which doesn't start to kick in to about 45 minutes here on the gray line and doesn't reach its peak effect until about 90 minutes. That delta between the magenta and the gray is the mismatch that patients often struggle with years. It's a big reason why insulin pumps and pods were developed to try to modulate that gray line and close the gap. But whether you deliver the insulin in a pump, a pod or a pen, it's the same insulin. The delivery device changes do not alter a pharmacokinetic profile materially. The only things that could get closer to Afrezza's profile will be an implantable pump or a cure for diabetes, which we all hope for 1 day. Short of that, Afrezza was designed to help patients close the delayed effect we see in every dose of injectable mealtime insulin. This is more important today than ever as the majority of pediatric patients are using CGM to help manage their diabetes. Why does this matter? At the 1-hour mark, 90% of injectable insulins' glucose lowering effect is still remaining. Only about 10% of the work has been done. With Afrezza, nearly half the insulin effect has already occurred. That's a twofold difference [ I go ] 60 minutes. By 90 minutes, the gap widens at 3x, and by 2 hours, nearly 90% of Afrezza's effect is complete, minimizing the risk of insulin stacking and is approximately your food is being finished being absorbed, while injectable insulin still has roughly half of its effect left to go over the next several hours. This mismatch, insulin is still working long after the meal has cleared, has been the single biggest challenge of mealtime control, both adults and pediatrics. Afrezza brings insulin action closer to real-time eating, and this slide shows you exactly why. So how does this translate to clinical practice? On the left side, you see the head-to-head meal challenge results from our pivotal trial in INHALE-3 in adults. Afrezza reduced postprandial glucose discursion by more than 35% versus multiple daily injections over the first 2 hours. And keep in mind, the injectables was dosed 15 minutes before the meal, while Afrezza was given at the start of a meal. On the right side, you see the meal challenge data from our INHALE-1 pediatric trial. The peak glucose excursion with Afrezza in pediatric patients is very consistent with what we saw in adults. This consistency in the absorption profile between adults and children was the foundation for establishing Afrezza in the pediatric population. Why is this important? Because better postprandial control should translate to more patients getting to goal. At INHALE-3, we looked at a subset of patients who switched from MDI or AID systems, pumps and pods such as [ Tandem and Omnipod ] to Afrezza. At baseline, 21% of these patients were meeting the A1c target of less than 7, consistent with the national averages. By 30 weeks, that number doubled to 42%, twice as many people getting the goal by switching off to standards of care is a meaningful number. And this makes sense as patients approach an A1c of 7, the impact of postprandial glucose control becomes increasingly important. That's exactly where Afrezza's profile makes the biggest difference. Over the past decade, we've made a deliberate investment in data generation. And this slide shows you the breadth of that commitment. Rather than scaling up commercially with the label we had, we focused on getting the label right. That meant building the clinical evidence base for pediatrics, establishing a clear understanding of our clinical safety and efficacy and addressing questions that matter most to physicians and regulators. This data generation has given us the ability to correct 1 of the earliest setbacks. The original label conversion ratio underdosed patients on their very first dose and caused many to drop off before they ever experienced the full benefit of the product. The updated label that we got in January of this year now reflects a simplified 2:1 dosing ratio that sets patients up for success from the start. This new dose conversion has been used in our recent clinical trials, including the pediatric. All of this data has now gotten Afrezza recognized in the ADA Standards of Care. Last year, the 2026 Standards of Care were updated to recommend that clinicians evaluate inhaled insulin as an option of every patient visit. This has helped set the stage for launch. These updated guidelines are a fundamental shift. For years, Afrezza wasn't on a level playing field, and now it is. The ADA Standards of Care are what HCPs, payers and health systems use to guide therapeutic and formulary decisions, and inhaled insulin is now recognized right alongside the other standards of care multiple daily injections in AID. In fact, recent market research showed 3 out of 4 patients were not offered choice consistent with the FDA guidelines. This new approval brings Afrezza into routine standard of care conversations, which is exactly where it needs to be. The pediatric approval sets us up to relaunch Afrezza in a truly meaningful way. Now I'd like to introduce Dr. Kevin Kaiserman. Kevin is a Board-certified pediatric endocrinologist with more than 30 years of clinical and academic experience. He joined MannKind in 2020, right in the middle of COVID. Kevin's insights into the lives of children and families living with diabetes were critical to our development of this innovation. You couldn't ask for a more qualified person who have led the clinical program to help us prepare for this launch and gain FDA approval. With that, I'll turn it over to Kevin to talk about the unmet needs in pediatrics and why we're here today.

Thank you, Mike. So what are some of the challenges that children and adolescents face in diabetes management? One of the major issues is missed insulin doses. Up to 1 in 5 doses are missed, regardless of whether you're using multiple daily injections or pumps. The result: less than 20% of adolescents with type 1 diabetes are achieving the glycemic goal of having an A1c less than 7%. And when you look at why, functionally, you have changing insulin sensitivity and irregular eating patterns. Socially, there's discomfort with injections or pump site activity in public and fear of having hypoglycemia in front of your peers. And emotionally, you're dealing with injection anxiety, fear of needles and disease exhaustion from managing ever-changing food timing and activity levels. These are the realities of managing diabetes as an adolescent, and they're exactly the types of barriers that Afrezza is designed to address. INHALE-1 was our Phase III open-label randomized controlled trial in youth aged 4 to 17 with type 1 or type 2 diabetes conducted across 38 U.S. sites. 230 subjects were randomized 1:1, 117 to the Afrezza plus basal group, 113 to the rapid-acting injectable plus basal group. Both groups use [ DexCom G6 ] continuous glucose monitoring. There was a 26-week randomized treatment period, followed by a 26-week extension period where all subjects use inhaled insulin plus basal. As previously disclosed, the primary endpoint was nominally missed, driven by the impact of a single subject with a very high A1c level, who is documented as being not inherent to therapy. Once this single subject was removed, the sensitivity analysis demonstrated that non-inferiority margin was met. One of the notable benefits we saw in the trial was the lack of weight gain with Afrezza. Body mass index percentile, which accounts for age, gender and weight, showed no change in the Afrezza group over 26 weeks. In the rapid-acting insulin analog group, BMI showed a 3.6% increase, and the difference between groups was statistically significant. Another important finding was treatment satisfaction. Both teens and parents reported significantly improved treatment satisfaction with Afrezza compared to subcutaneous insulin. When you pool the results, the difference between treatment groups was statistically significant. Very importantly, pulmonary function was monitored over the full 56-week study period. There was no difference in change in percent predicted [ FEV1 ] between the Afrezza and RAA groups. Also, after week 26, all subjects use inhaled insulin. So the dash line here represents the group that started on subcutaneous insulin for the first 6 months and then switched to Afrezza. You can see that when they switched over, there was no change in their percent predicted [ FEV1 ] over the following 6 months. With that, I'll turn the call back over to Mike to talk about the launch strategy.

Thanks, Kevin. Let me start with how we're thinking about the entry point. Type 1 diabetes in pediatric is the focus of this launch. There are about 360,000 children and adults aged between 6 to 22 living with type 1 diabetes, and approximately 30,000 are newly diagnosed each year. The reason we highlight age 22 is that many of these patients stay with their pediatric endocrinologists through college, so the addressable population is larger than many people think. This is also a strategic entry point that compounds over time as they progress into adulthood. We believe these children transition from pediatric endocrinologists to adult-treating endocrinologists. Those physicians will see the positive outcomes these patients have had on Afrezza firsthand and begin to use it more widely as their go-to mealtime insulin, just as they've used this playbook for insulin pumps, pods and CGMs. And beyond type 1, with once weekly [ basal ] insulin getting approved this year for type 2, we now have a road map to enter the much larger type 2 market with higher dose cartridges, which we'll discuss shortly. Pediatric type 1 is the entry point. It's where the unmet need is the highest. It's where being the first insulin on child users creates a long runway for the brand. And it gives us a focused, high-impact launch with the ability to expand over time. Critical to launch success is the foundation of how we're approaching this launch differently than the adult market. There are real reasons the adult opportunity never reached its full potential. Physicians weren't trained on the product or its pharmacology during their training. Awareness of our data is low despite a robust clinical data publication and presentation strategy. We pressure tested our strategy against these real-world barriers and built specific solutions into our launch model. And let me walk you through each one. The first is awareness. The reality is that Afrezza hasn't historically been top of mind due to our limited commercial footprint. Pediatrics is a concentrated market made up of roughly 60 key institutions consisting of approximately 1,000 prescribers that treat the majority of pediatric patients. 38 out of the top 60 centers participated in our clinical trial, so they already have hands-on experience with the product, unlike our adult clinical program, which is primarily international. Our talented field infrastructure of key account managers, MSLs and patient navigators are hitting the ground running today. Additionally, we have a concerted effort on direct-to-patient effort running alongside our prescriber engagement. When a parent asks for Afrezza by name, that's a powerful catalyst for continued adoption. Second is long-term safety. Lung safety has been 1 of the top objections since approval. We now have 2 independent studies published this year confirming long-term lung safety. A third MannKind study will be coming out shortly, and 1-year pediatric data that Kevin just shared with INHALE-1 showing no impact on [ FEV1 ], as well as over 10 years of post-approval safety and surveillance. No one can credibly argue the safety of inhaled insulin at this point. Third is FEV1 testing. Spirometry can feel like an operational hurdle, especially in pediatric practice that may not routinely perform lung function testing. We've created starter kits with FEV1 devices that can be used at the point of care, removing a perceived barrier. Fourth is dosing complexity. We've got our label changed. We built a one-stop shop hub for an online dosing calculator, a prescriber portal, EMR integration as well as preprinted forms, all designed to simplify dose selection and prescribing from the very first prescription, clear tools that will give physicians confidence from day 1. And then finally, [ prior off ] and affordability. The pediatric population is primarily commercial and Medicaid. We have -- we are in active discussions with payers to minimize friction for pediatric patients. We have a white glove service that will ensure every patient can get Afrezza for $35 or less regardless of insurance coverage and Afrezza delivered to the doorstep within 24 to 48 hours. As a pharmacist by trade, I can tell you that cost at the pharmacy counter is 1 of the biggest barriers for families trying a new therapy. We're removing this potential barrier upfront and hope to improve the prescriber experience and fulfillment process. Every known barrier has a specific funded and operational solution behind it. This is a system built to convert awareness into prescriptions, prescriptions into starts and starts into long-term patients. We touched on the market research on previous calls, but I want to come back to a few of these numbers because they really inform how we're executing and how excited we are about this opportunity. 2 out of 3 pediatric endocrinologists tell us they're likely to prescribe Afrezza. About half cite eliminating mealtime injections as a primary driver. 1 out of 4 indicate they would consider Afrezza in a newly diagnosed patient, consistent with our inhaled first population and a strong signal of why we launched the study. Our patient share potential range is 23% to 37%, indicating an opportunity of $300 million to $500 million in revenue coming from pediatrics, which will compound over time to adults. That indicates a compelling opportunity ahead. I also want to mention that we'll have a significant presence at the American Diabetes Scientific sessions later this month. We have 9 poster presentations, and we're going to have an immersive virtual reality experience where people can actually follow the powder through the lungs into the bloodstream. There will also be educational dinner programs and many executive encounters and one-on-ones. We're excited about leveraging our new creative campaign, Insulin in the Moment, which captures exactly what Afrezza delivers, insulin that works in the moment, right when kids eat and live. It's a centerpiece of our prescriber and consumer messaging, and this is the most significant presence MannKind has ever had at ADA, and the timing is right after our approval could not be better. Now I want to close by talking about our road map for growth. Starting with INHALE-1. This is our pediatric study evaluating newly diagnosed patients. The strategic question we're trying to answer is can Afrezza to be the first mealtime insulin a child ever uses? When you think about it, a newly diagnosed kid will have to live with diabetes for the next 70 years. The first 10 patients enrolled in INHALE-1 gives us optimism that Afrezza can be the first insulin when you're newly diagnosed. As we look to future innovation in Afrezza, the pediatric launch is a catalyst, but it's not the end of the Afrezza story. Starting with the 2-unit cartridge, which we expect to file with the FDA by year-end, will give us the flexibility for smaller dose adjustments and is exactly the kind of dose granularity that some health care providers and patients have been asking for. Next is our [ INHALE Q ] digital ecosystem that detects and tracks Afrezza dosing alongside CGM. We also expect to build dosing calculators into the platform. These digital tools are what physicians and patients increasingly expect. We're also advancing Afrezza high concentration formulation that could enable up to 20 units in a single-dose cartridge opening up to type 2 market further. And finally, the pediatric approval and the release of our long-term safety PMR open up the opportunity for global expansion. Together, these represent a multiyear road map of Afrezza innovation that will support growth well beyond its initial pediatric approval both domestically and internationally. We had 3 major catalysts for '26, and we celebrate our treatment of the first one, pediatric approval today. On Monday, we'll be back focused on achieving these next 2 catalysts, which are equally transformative to driving shareholder value. Before I close, I want to mention that we'll be at the Jefferies Healthcare Conference next week in New York, and we look forward to engaging with many of you there. With that said, operator, I'll now turn it over for Q&A.

[Operator Instructions] Our first question comes from Ben Burnett.

Congrats on the progress. I wanted to just ask, how quickly do you expect the pediatric sales to influence kind of the overall sales of Afrezza?

Thank you, Ben, and thanks for coming late on a Friday here. I think June will kind of start to get the early foundation laid out here. But I would say we want to see probably a quarter behind us, see how many prescribers come into the fold, how many repeat patients we get. So I think you'll start to see it build in Q3 and ultimately Q4 to set us up for a really nice '27.

Okay. That's great. And then I appreciate all the comments around some of the price dynamics. Where do you see the average kind of price going from here? Would this change materially long term?

The pediatric population from a percent of insulin units and the payer is very little. And most of the payers we've talked to wanted to see the approval, number one. They want to see the demand, number two. But they've indicated their desire to remove any friction for children. They don't want to be on the news for that. They've been very collaborative. We do have contracts that have been outstanding. So they could move it up to preferred, they could move it up to single steps. But we're just trying to remove the friction from the process. And so far, most of our discussions with the top PBMs have been very positive, and we'll be hitting the ground Monday, trying to push them even harder. But we expect, like in October 1, the January 1 formularies to kind of get easier and easier. And the reason we put it at $35 is our commercial patients generally pay that or less, and Medicaid patients will pay less. And so we don't expect, even as you get formulary changes that the cost of the patient will change much. We're trying to make that as seamless as possible.

Our next question comes from Roanna Ruiz from Leerink Partners.

So a couple for me. One question I was thinking about is you talked about removing barriers like making sure patients can access Afrezza for $35 or less. Are there any other barriers that you're planning to proactively mitigate? And can you just give us an update of how smooth or what's the ultimate goal here in terms of streamlining the process for prescribers?

Sure, Roanna. I'm going to put this one to Nick. And Nick, maybe talk about our launch strategy and the institutions and how you're focused on the centers of excellence?

Yes. So thank you for the question. The pediatric market is quite different from the adult market, which we've talked about prior. As Michael had mentioned a few moments ago, a majority of the pediatric business tends to be concentrated in roughly 60 key academic institutions and across a much smaller population of prescribers, roughly 1,000 pediatric endocrinologists. And so we've been able to adapt our field forces to account for a more streamlined focus on that target market. We've deployed key account managers. We have medical science liaisons as well as patient navigators that will support 1 of the key friction points, which was the ease of prescribing as well as ensuring that the prescription makes its way to the hub and ultimately to the patient with proper training. And so some of the friction points I would say beyond just the access and payer is a more enhanced and proper prescriber education and awareness, parent and child education and awareness, certified diabetes educators, school nurses. And so a surround sound of education, which ensures most parties that are involved in the diagnosis and treatment selection are trained and educated and aware of inhaled insulin as an option. And then ultimately, ensuring that the patient journey is smooth. So when the physician decides that she or he wants to write a prescription, understanding how it's dosed, writing the prescription properly, ensuring that all the necessary clinical and medical information is attached to the prescriptions submitted to the hub and ultimately ensuring a more rapid prior authorization process and ultimate ensuring a coverage of the prescription to the patient.

And then the other thing Nick's going to be doing is we've got centers of excellence, 5 every week or 2, we're going to be launching. And that's going to work out any kinks that we identify in the first 30 days. So that's another key part of the launches, figuring out where we may have missed something or how we self-correct as we continue to evolve each week.

Okay. That's super helpful. And I also noticed you mentioned that the addressable pediatric population could be larger than people think. Could you frame a little bit more, what's supporting that perspective? And it also sounded like some of that might come from targeting teenage or college age individuals. Could you talk a bit more about that?

Yes. If you think about -- especially as kids get to adolescence -- and Kevin can comment if he wants. The barriers in there of people wearing insulin pumps and the activity in sports and some of the college habits of kids, they don't all want to be treated the same. And so a lot of times, if you think about it from 18 to 23, let's just call that 5 years. And if there's 30,000 new kids a year, that's about 150,000 kids that live in that 18 to 23 range that are still covered by [ PDs ] for the most part. So that's where we talk about this. The market is not just -- yes, it's 16 and below, but we have not been calling on [ Pedendos ] for the last 10 years. And so only this year are they getting to know MannKind. And therefore, that population was typically treated by [ pendo ] not adult endos, and that's opening up an opportunity. And that's been 1 of our focuses, if you saw, we launched a scholarship fund to try to build awareness of MannKind out there in the college community.

Our next question comes from Olivia Brayer from Cantor Fitzgerald.

Congrats on today's approval, really looking forward to this launch. Can you talk about some of the launch prep that you've been doing just in terms of identifying patients to put on therapy now that you are approved? And Mike, you mentioned that you already have 2 patients ready for treatment. What other indicators of early success are you may be seeing from your field teams that may be shaping how you're thinking about the initial launch curve in these patients?

Sure. I'm going to kick it off to Nick and I can close with any further comments.

Yes. I would just say, we've done the -- key account managers have been deployed into the institutions over the past 7 to 9 months. We've been working with the institutions to understand through our medical affairs, proper patient identification of middle school, high school, early college years. And so I would say we've had a nice head start in working with some of these key institutions. Not to mention, as Michael mentioned, at least 2/3 of these institutions have been involved in our INHALE-1 or other clinical trials. So I think there's been quite a bit of prep work in patient identification and laying the groundwork appropriately.

The only thing I'll say is we have a series of travel events that -- I'm pretty sure my family want see me for the next 6 months. We're going to be on the road. We got a lot of speaker programs. We got a lot of KOL interactions with Kevin, [ Grand Rounds ], CME events, there's going to be a lot to kick off going forward. And I think the last part I would say is it's the first time -- we've been here a long time. But here -- and doctors say, Monday morning, I got my patients lined up, I'm going to be making phone calls, I'm going to be sending in people. We were expecting to launch Monday morning, not end of day Friday. And so we happy to see when we're already seeing referrals come in today. So we'll see how quickly it goes, but we want to be cautiously optimistic given the history here, but we've done everything we can to get the best people on the ground to be on the front lines of this company to make the biggest difference for patients.

And then a quick follow-up on the payer angle. What's your actual plan to communicate just progress on the reimbursement side, but both on Medicare and commercial? Is that sort of a quarterly cadence update that we should expect on earnings calls?

I think if we were to get like a big formulary win or a national formulary, we would announce that publicly at that time. We're not aiming for preferred status, just to be clear. We want to get preferred status. But I think at the end of the day, that preferred status has to happen if someone may be -- like remember, most people are already on insulin that we're targeting. And that's mostly what insurance companies want. They want people to know they tried and failed the preferred insulin. We get it. We understand it. And that's been some of our discussion with the payers is when you fail the first insulin, what happens? You go down the insulin pump route. And that is the journey that we put most families on forever. And many times you get to adults, they've been attached to the pump longer than their spouse. And so this is really part of the discussion with payers is don't look at it against injectable insulin. Look about the alternative that people are going down and what is that lifelong cost and journey. And so far, those discussions with payers have been resonating. To say we're not trying to displace all insulin that's out there, really try to help these kids get access as quickly as possible. And so far, it seems like that's the right tone.

Our next question comes from Gregory Renza from Truist Securities Inc.

It's Anish on for Greg. Congrats on the updates this afternoon.just firstly, maybe if you could help us assess the range of your peak market share projections of 23% to 37% for Afrezza. What gets you from 1 bookend to the other? I know we're at the launch phase here, but that would be helpful for us. And secondly, just revisiting the label. With the requirement of basal insulin in type 1 and like before Afrezza use being perhaps contraindicated in patients with asthma, how might that gate the eligible pediatric pool?

Yes. About -- you can say 1 out of 5 people on the high end would have COPD or asthma, and that seems to be consistent as we look across the population. So we kind of take that out of our own forecast projections, number one. I'd say number two, what drives some of the range of the forecast is we are actively focused on kids who are on multiple daily injections. And to our surprise, there's a lot of clinicians who said, "I want to use this as my first insulin now." There's nothing preventing them from doing that. Our label allows it, and dosing, as long as they need 4 units or more, they're good. So we were also surprised at how early that initial insulin uptake could happen in the naive setting. So we started INHALE-1 to get ahead of it, but it just turns out that's going to be a nice bonus to support it as much as anything. And I think what drives the range is we don't know there is a large insulin pump and pod segment. We're not actively saying they were on our good devices. Most clinicians have used them for decades, and they're comfortable with them. And we really want to focus on the adolescents who are on MDI, most of them who are like 8 and above A1c, to try to help get experience there with the providers so they can see the benefits of the product. Over time, in our market research, we saw a range of patients who could come from the pumps and pod market. And that's probably what gives you the greatest variability in the forecast is how much do you want to assume could switch from that or try this or go back and forth or even use it on top of those devices. And so that's why you have a range here. There's a certain assumption on MDI and then there's another assumption here that gets you to the higher end if people start really trying this instead. So I think the market will bear that out over the next 18 months. but I think we'll hopefully see that trajectory as we exit the year in which direction we're headed.

Our next question comes from Brandon Folkes from H.C. Wainwright.

Congrats on the approval. Maybe just 2 for me. You talked about compliance. Can you just give us your view on compliance and potential for missed doses with a [ Frasen ] pediatric? How do you look to address this or assist in the compliance early in the pediatric patients' journey? Especially as they sort of going to school in some of these places where they may not be an add-on -- well, parent supervision, I guess, early on in the launch to drive it as habit?

Yes. I would say a couple of things, and that's where Nick talked about the educated, the nurse educators and the schools, the camps. We're putting a lot of energy on that over the summer and back-to-school. I think in terms of compliance, even in our trial, we saw similar dropout rates to the adults. So it's not that kids had a worse dropout rate. It was consistent, if not slightly below what we expected. Kids are no different than anyone else. A lot of times I've been to a camp with Kevin here, and you talked to some of these kids, they have much bigger issues than worried about their insulin control, but you want to find the best tool that meets their life. And if it's fitting their lifestyle, they're going to be compliant. And yes, they're going to miss doses, they're kids. But many times, like when you go to the camp and you see it firsthand, they're dosing blindly, their insulin. They're not sure if they're going to be 1 chicken nugget or 5, 1 ball mac & cheese or none. And that's really the challenge, I think parents face is how do you properly dose your child, how do you keep up with them? What are they doing in school? And now you can clearly see what's happening. With Afrezza, it does start to see that CGM move in the first hour, 1.5 hours. So you'll know what your child is doing pretty quickly. But just like anyone, there's always going to be compliance issues. And I say if someone is a 9.5 or 10 and they're struggling, then maybe insulin pumps are the right product to get some insulins better than none. But I think anyone that really wants to bring their sugars down and improve mealtime control, that's why I think we have a big opportunity. And if you really think about children, their alternative is going to be wearing an insulin pump or pod or getting an injection. I think most kids would rather say, okay, I'll take my medicine and let me take it. So this is much easier. And I never forget a few months ago, we had ad board. And 1 of the doctors said thank you for bringing this forward. The hardest part of my job is telling a family that their child is going to require injections to live the rest of their life. [indiscernible] And this is going to say, give them hope that maybe they don't need to give injections to the rest of her life. They're going to be a basal but maybe we can eliminate the 3 to 5 injections a day mealtime or bolus as they got to take put their pump.

Great. And maybe 1 more. During these ad boards or discussions with KOLs, has there any discussion about use of Afrezza in patients with [ ecsema ] that may actually not be diagnosed with asthma just yet, sort of any hesitation there or any discussion or view on that?

Hesitation about undiagnosed asthma? Is that the context?

Yes.

We -- in the trial, we allowed some patients in the trial, I think, INHALE-3 that may have had a history. And we could see people that may thought they resolved childhood asthma had slightly more cough or challenges. But I think in the kids, Kevin, we have the same, right? And there wasn't a big difference in FEV1s or anything there. So we have some of that clinical data. We can go back and see -- I can't res like 10 or 20 patients that had asthma historically or somehow diagnosed during the trial. And there was no major issue. So we'll have that data as a medical response if doctors have that question.

Our next question comes from Yun Zhong from Wedbush Securities.

Thank you very much and congratulations on the approval. On the label, first question on the label, it -- sorry, did the FDA tell you why the label is for children 6 years and older instead of 4, that's the age in INHALE-1? And in INHALE-1, I believe the study is enrolling patients above the age of 10. So how are you going to get those patients below the age of 10 that are treatment naive? And the second question, I believe in the 8-K that you put out yesterday, the filing mentioned that there is still post-marketing requirement for you to confirm safety and maybe efficacy in pediatric patients. So are you able to provide any additional details related to what needs to be done here, please?

I'll start with that question first. So there was 4 PMRs when Afrezza got approved in 2014. We completed 3 of them, including -- I would say the last 1 wasn't a completion. It was an agreement with the FDA that we were released from our long-term safety study, which is great to have right before pediatrics. The last 1 is the pediatric study, which we did. And so now that we have the approval, we don't have to file that with the FDA and ask to be released from the PMR. So there's no additional work to be done. This study should satisfy that post-approval commitment that we did as a result of the study. They've indicated that it will be the case, but it's a formality now with the FDA that we have to go through. So we don't expect any challenges, but that will be the next step. Your next question is a good insight there, you call, is we expected 4 to 17. And I think as part of the FDA in the discussion, we realized there wasn't enough patients or really any patients below 6 in the trial. So it's kind of hard to argue for 4- and 5-year-olds when you just -- they just didn't enroll. There was a couple in the control arm, but they weren't in the active arm. And so we didn't really have much of a debate with FDA on that one. It was -- we'll be happy with 6. It's really about how many units of patient needs as opposed to age, but we really didn't have any 4 and 5 year olds in the trial to have any real debate with the FDA on that topic. And it's important, but it's not critical, what I'd say is there are patients there, doctors can make their own clinical judgment. We can always run a post-marketing study in that population if we need to. But I don't think it's going to be a significant barrier to success. And I think as we get to 2 new cartridge, that's probably going to be more important for that population than the 4 units we have today. And your last comment or question was around INHALE-1 being 10 to 17. At the time we started this trial with the FDA, we were pretty confident that the tenant above would be approved, we weren't sure where the FDA would line below 10 as there wasn't as many patients who wasn't sized for each age range. And so now that we have the approval down to 6, we are going to ask the investigators, should we go down the 6 years old or stay with 10. There's no clinical reason we can't go down the 6 at this point.

Last question comes from Anthony Petrone with Mizuho.

And congratulations to the team here on the approval, big milestone for the company and patients. Maybe just in terms of the market opportunity, Mike, when you think of 360,000 target patients, you're mentioning the 2 unit dose, you have the 4-unit dose. I don't know if 8 and 12 is at play here, and then you have a 20-unit dose in the prepared materials here. So when we think about just dose distribution in pediatrics, how do you think it plays out from 2 unit cartridges all the way up to 20 unit cartridges? And I have a couple of quick follow-ups.

Okay. Anthony, thanks for calling in late on a Friday here in New York. And I'd say the average dose in pediatrics was 12 to 20 units of meals. So we weren't seeing as much on the -- in terms of the low doses being -- people wanted 2 unit cartridges because they want to give the fine-tuned doses between 4 and 8 and 8 and 12. But we didn't have that available in the trial, but we saw most people going into the higher doses, especially those adolescents who are going through hormonal changes and need much higher insulin needs. So that's generally we see -- the 2 high concentrations we're working on are really to get to like a 16 or 20 unit cartridge, and that's really to get people to 1 dose instead of 2. That ultimately reduce the COGS, reduced the utilization of the cartridges and it will help for like places like India and international, where we do see people needing much higher doses in type 2s or international markets.

No, that's helpful. And then the follow-up is just you have the $35 out of pocket, but when you look at just retail pricing or even also acquisition costs and price or you're kind of ranging at $450 to $1,500 a month, and that's the 4 to 12 unit range. You're adding 2 and going up to 20. So I don't know when we think about it, are we ranging kind of the net price to MannKind at like 250 up to 2,000 a month? Is that kind of the way to model it out? And then the last 1 real quick is just ADA next week. Do you expect like a bump in new prescribers coming out of ADA? Congratulations again.

Thank you. I think on pricing, we have time to figure that out, meaning we -- 2 unit maybe a flat price to 4, maybe slightly cheaper. But as you get to the higher doses, they're actually more efficient to make. So I don't know if we'll still continue linear pricing help that way. And so it might be -- from a modeling perspective, I would just assume whatever the average price per prescription is today and that continuing is how I would look at it. And you can manage a similar gross-to-net until we give different guidance of where we are. But I wouldn't expect that the prices will keep going up exponentially with higher doses. And then...

And then just ADA.

And then ADA. It's a big conference. I'd say more than half the attendees are international. And then the other half, I'd say half practice medicine half for just awareness thought leaders. And so it's really making sure our engagements with the half that matters that are coming to our dinner events, the one-on-one meetings and that they do go back and they are aware of the data. We're getting really good feedback on the new standards of care. We keep reminding people that this is a choice and needs to be a choice that's offered to patients. And we think as clinicians go back and do that more and more, the patients will choose this as an option, and we think that's an important aspect. But more importantly, the peds, I don't know, Kevin, it's not the biggest compensate, but there's quite a few there. So I think we want to make sure we're in the field right after ADA, we're training our team next week live, and they'll be out there right after ADA hit the ground.

Thank you.

Well, thank you, everyone, and thank you for dialing in so late on a Friday, especially for those on the East Coast. I know it's -- your waiting for happy hour. I am, too. I have a big reason to celebrate. I've spent 10 years of my life here MannKind making sure we get this available option to children. It's a really proud moment for me and the team and all the hard work despite many obstacles to the patients and the families who participated in our trial and other pediatric studies who believe in this program, our regulatory team, our medical team, commercial team, Nick, Kevin, our pediatric leadership group, this approval is the result of your years of dedication and hard work. We didn't get here overnight. We got here because people refused to accept the status quo and give up on the idea that kids 1 day deserve this option versus mealtime injections. With that, operator, I'm going to close the call. We look forward to launching this successfully and meeting you at the future conferences. Thank you.

This concludes today's call. We thank you for your participation. You may now disconnect at this time.