MannKind Corporation (MNKD) Earnings Call Transcript & Summary

Good afternoon, and welcome to the MannKind Corporation Second Quarter 2026 Financial Results Earnings Call. As a reminder, this call is being recorded on August 5, 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 June 30, 2026, the earnings release and the slides prepared for this presentation. Joining us today from MannKind are Chief Executive Officer, Michael Castagna; and Chief Financial Officer, Chris Prentiss. I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

Thank you, operator, and good afternoon, everyone. Thank you for joining us for our second quarter 2026 call. I'll start with some opening remarks, walk you through some business updates. Chris will talk about our financial results, and I'll close by giving a few closing statements here, followed by Q&A. Let me start by saying how we transformed our company and our potential growth trajectory with the strategy we outlined back in Q1. We laid out three major catalysts this year: Afrezza pediatrics approval, opening an indication opportunity we have not had access to; Furoscix ReadyFlow, which we have a CVR around because of the meaningful contribution this will have to the important growth of this franchise; and finally, the Phase Ib readout in nintedanib DPI in patients with IPF and underlying lung disease. These three things contribute to a solid foundation as we close out 2026 and move into 2027. Beyond the catalysts, Afrezza is off to a very strong start. Our top 20 key institutions have already written a prescription. Breakthrough T1D acknowledged the importance of this opportunity by funding a grant to go after insulin newly diagnosed patients. Furoscix showed strong revenue growth with 43% growth just over Q1, and our Phase II INFLO study has kicked off and underway with multiple shots on goal in front of us between Tyvaso DPI, ralinepag DPI, and nintedanib DPI, all focused on IPF disease. As we look at Q2 revenues, we grew 21% from Q1 '26 to Q2 '26. What's most important about this picture is when you double-click down, marketed products grew 27% quarter-over-quarter, where royalties declined 1% from Q1 to Q2. When you take out our collaboration service revenue, you can really see an underlying picture what's driving our growth quarter-to-quarter. Now let me talk about our first tier revenue mix evolution as we look to the success of our diversification strategy that we laid out. When you take out the collaboration service revenue, we grew 111% on marketed products year-over-year. This is obviously driven by the shift to Furoscix, and you can see that the royalties remain a durable revenue stream for years to come, but the predominant revenue growth of MannKind is being driven by marketed products, and this crossed the threshold in Q2 from Q1, where our two marketed products now demonstrate faster growth and a higher percentage of our revenue over the royalties by themselves. The royalties provide a great strong base business as we go forward into our launch trajectories. Let me talk about the launch of Afrezza in pediatrics, which many of you have been asking us about. Now that we're approved, this is the first alternative mealtime injection in over 100 years. This product is solving an unmet need and a challenge that parents and patients face when it comes to timing of administration and seeing the impact that insulin has on their sugars and their CGM, seeing the ultra-rapid effect of Afrezza, the earlier peak and the tail coming off allows patients to dose differently and treat their sugars in a way that they just cannot achieve with insulin pumps or injectable insulin. This is now backed by more than a decade of safety data on the market, clear commercial opportunity and access at $35 opens up the door for many patients to start this therapy. One of the main questions we get is why do we believe Afrezza will be different in pediatrics than the adult segment? First, the top left, a concentrated targetable addressable market. When you think about the adult prescriber base, there are 60,000 adult prescribers that make up 80% of rapid-acting scripts, which include a lot of type 2 patients. We pivoted about over a year ago to type 1. The pediatric prescribers are about 1,000 prescribers, make up 80% and they're predominantly institutional based. Second, there's a connected patient-centric community. We see this online. We see it on Instagram. We see it in education and nurse educators. The adults, we've only targeted prescribers. There is limited surround sound to patients. But the pediatric segment and the success we've had, we've seen noise come from caregivers, from CDEs, school nurses, influencers and advocacy organizations across the board, driving a lot of demand and questions into the pediatric community. Third, in the bottom left, a stronger clinical foundation and KOL support. When we launched with the adults, we had two studies published and not a lot of top KOL support. As you look at pediatrics, we have some of the top world-renowned thought leaders talking about our data, talking about the unmet need and the solutions that Afrezza can bring to pediatrics. This was followed by 10 years of safety on the market, new ADA guidelines, the INHALE-1 trial as well as the INHALE-1st trial being done in the top 50, 60 centers across the U.S. between all of our pediatric development. And then finally is removing friction. We know access is a hurdle for any new launch, and we've basically taken the opportunity to take away all objections around access, FTD-1 and providing point-of-care opportunities to make sure patients can have a frictionless, seamless experience when they go to start Afrezza. The first 8 weeks support these four pillars, are driving a different uptake curve than adults. When I look at the names of the institutions on this slide, these are some of the top centers in the country that treat the biggest volume of patients. In fact, one in three of the top 100 pediatric rapid-acting writers have already prescribed Afrezza. We have 20 priority accounts and all 20 have written at least one prescription since launch. We're really excited by these early metrics, and we'll continue to keep you posted as we go forward. And before I close on the pediatric launch, I want to talk about the media coverage, has really helped convert early momentum. Over 200 markets in all 50 states got episodes on CBS and ABC as well as numerous articles highlighting the new innovation in pediatrics. This has signaled more demand from HCPs and patients and awareness than we expected, and this media credibility is fueling real-world engagement, social conversations and pull-through opportunities that we didn't have otherwise. As I think about the road map to success, Afrezza's future includes additional product development, digital advancement and external innovation. Today, we had updated FDA-approved dose conversion in 2026. We have new guidelines support, and now we have the pediatric approval, providing a foundation for global expansion as an opportunity. As we look to 2027, we expect to be able to introduce a 2-unit cartridge, and INHALE IQ, which will be a Bluetooth connected device integrated with CGM. And then as we approach 2028, we expect to be able to have high concentration formulations of Afrezza, which ultimately will enable higher doses and lower powder loads at the current doses, minimizing any cough opportunity and increasing cost effectiveness as we get to higher doses in type 2. Now let me bridge to the FDA approval of the Furoscix autoinjector ReadyFlow. As we know, fluid overload across the patient journey is often something that happens at moments in time. The majority of patients can be stable on an oral diuretic at home. Oftentimes, though, these patients will start to have fluid overload in edema, in the gut, it stops the absorption of not only the diuretic, but also the other meds to treat heart failure, causing a compound effect and worsening of this condition for patients. We also hope that Furoscix in the majority of our use today is in this early intervention stage in the community setting, where we can hopefully prevent patients from going to the ER and progressing. The opportunity we see tomorrow, especially with this ReadyFlow, is the post-hospital discharge, i.e., can we get patients out of the hospital sooner that are stable or reduce readmissions to prevent the 30-day penalty that many hospitals get for not completely drying up patients before discharge. We see an opportunity here to increase intervention in the early stage as well as start to continue to get post-discharge protocols across the top health systems in the U.S. Since Q1, MannKind advanced several key Furoscix growth opportunities. First, we highlight a limited hospital presence. We increased our IDN engagement in hospital systems to drive stronger hospital pull-through. And as we see, our medical liaisons are engaging at the highest level on institution protocol development and discharge as well as our key account managers working with institutions in quality, purchasing and pharmacy, to drive continued contracts and growth opportunities across these IDNs. We saw 36% growth in Q2 over Q1. Second, the team is really focused on trying to launch nephrology while continuing to deliver cardiology sales. We're able to separate those sales force opportunities this year, and we caused some disruption here in Q1, but you can start to see the impact of that effort here in Q2 with 67% growth in nephrology in Q2 over Q1 and a record number of prescribers. The next is under-funded marketing spend. So we've made many changes to our marketing investments, and you'll start to see those in the second half of this year as we prepare for the Furoscix ReadyFlow launch. We believe those investments will continue to accelerate growth as we close out '26 and position ourselves for 2027. So what does ReadyFlow approval now mean? First, it's the only IV-equivalent diuretic delivered via an autoinjector. This will be available in the next 3 weeks to key institutions and community prescribers. This will allow us to deliver treatment from a matter of hours to seconds. It's demonstrated equivalent urine output, sodium excretion and potassium excretion to IV furosemide in healthy volunteers. The safety profile is consistent with oral and IV furosemide and the symptom relief may begin in an hour or less. This is a really exciting opportunity to help patients prevent them from going into the hospital or hopefully getting them out of the hospital early or preventing those 1 in 4 patients from going back in. The Furoscix ReadyFlow launch campaign is built to drive immediate awareness and adoption, and we're looking at field activation immediately along with integrated surround sound at the major health systems and opportunities where patients are showing up in these health systems as well as online with the prescribers and patients. We're excited to be present at these upcoming conferences in the fall, and we expect the awareness of Furoscix ReadyFlow to immediately take off in the coming weeks. Now I'm going to bridge to nintedanib DPI. This is an exciting opportunity where we just had a quick update last week, and we kind of walked you through the totality of the program. And today, I'm just going to give you a few key highlights. Number one, our positive Phase Ib study demonstrates safety and tolerability in patients with IPF. We saw no serious adverse events, no GI burden, no discontinuations due to safety and no difference in spirometry parameters between placebo, which is an empty cartridge and nintedanib DPI. Our Phase II study is underway. Our first patient has been dosed, and we expect to continue to activate sites around the world and throughout 2026. One of the things I want to highlight before we talk about the PK/PD is that Cmax is known to drive efficacy in pulmonary fibrosis. This means AUC is less of a driver in terms of nintedanib efficacy and hitting a peak threshold concentration matters more than total lung exposure. Beyond the peak, lower exposure adds very little added benefit, and this is one of the challenge you have with oral delivered product is it's very hard to get high tissue levels in the lungs. We've known from our preclinical work that we can see significantly higher lung concentrations than plasma by targeting the lungs directly. So we believe that brief high peaks are sufficient with short burst of high concentration to inhibit fibrotic pathways is the data that's been generated out there today on nintedanib. Now as I move into our own program, let me talk about the data we have. Our Phase Ia validated efficient deep-lung delivery of nintedanib DPI. We had rapid dose proportional exposure and a favorable safety profile in our healthy volunteer data. When you look at our Phase Ia study, significantly 6- to 8-fold higher concentration on Cmax in our Phase I study compared to a study out there that's been published in nebulized treatment. When you look at the data on the right, our 7-day treatment shows you a dose proportional response when you zoom in on the key attribute here looking at Cmax and AUC. Now let me walk you through the data we just released last week. For those that didn't see it, this was the first inpatient study to assess safety, tolerability and PK in patients with underlying IPF. This was a two-cohort multiple-ascending dose study where cohort 1 got 2 milligrams 3 times a day and cohort 2 got 4 milligrams twice a day delivered at 2-milligram cartridge, i.e., a patient took four cartridges a day in cohort 2. When you look at the baseline characteristics, the age was 73, the females were 37% and the pulmonary function at baseline is consistent with what you'd expect in this population with an FEV1 of almost 2 liters. So in our Phase Ib study in patients with underlying IPF, we saw a clean safety profile with 0 safety signals, 0 bronchospasms and 0 discontinuations or down doses. This becomes a challenge when you think about discontinuations of oral therapy can be as high as 50%. This overall profile supports chronic use and derisks our program as it advances into Phase II. Now let me double-click down on the overall treatment adverse events, which was one of the questions we got post our call last week. And as you can see here, as previously stated, cough was about 39% in this trial. But there was no other single adverse event that really showed any concerns as we look at safety and tolerability in the placebo group or the active group. So now let me double-click down on the cough. There were no discontinuations and no serious adverse events. As I stated, 60% of patients had no cough post inhalation and about 30% of patients had a mild cough. This mild cough is considered transient, does not progress over time and basically is something that gets better with time as people use the product. So when we think about 90% of patients had very mild cough and none of these were severe. The cough typically happens with the first dose and does not worsen with time. And this is not a product that you're going to continue to increase the dose over time, so we do not expect the cough to change from this first 7 days of treatment. There were over 450 doses administered over 7 days in patients with IPF and not one patient had the dose reduced due to the powder load or the cough from the powder itself. We're really proud of these results, and we're not surprised given that Technosphere powders have been studied in thousands of patients, and we've seen very low single-digit discontinuations due to cough. Now I'm going to turn it over to Chris for our financial results.

Thanks, Mike, and good afternoon, everyone. Second quarter revenue was $109.4 million, up 43% year-over-year and first half revenue reached $199.5 million, up 29% over the first half revenue of 2025. At the product level, Afrezza generated $17 million in net sales. Once we are through the initial launch phase for the pediatric opportunity, we intend to provide separate visibility into adult and pediatric performance metrics. As you would expect, because the pediatric indication was approved on May 29, the quarter included only a limited period of pediatric launch activity. Furoscix generated $22.2 million in net sales, an increase of 43% from the first quarter. This was driven by a 49% increase in units sold, with the offset due to an increase in gross to net adjustments, which were 29% for the current quarter. As we acquired Furoscix in October 2025, we are not making prior year comparisons. Our United Therapeutics revenue streams also continued to provide a meaningful contribution. Royalty revenue increased 4% over the second quarter of 2025 to $32.4 million, while collaboration and services revenue increased 53% to $35 million. The increase in collaboration revenue was primarily attributable to a higher volume of products sold through to United Therapeutics and to a lesser extent, price. In addition, we recognized $4.9 million of revenue associated with ralinepag DPI development milestones during the quarter. As we've noted previously, this revenue stream may fluctuate between periods depending on production scheduling at our Danbury facility across Afrezza, our development programs and Tyvaso DPI. Based on our production plans, we expect Q2 to be the highest quarter of manufacturing-related revenues with the annual revenues in line with the prior year. Overall, the quarter reflects increasing revenue diversification from our promoted commercial products relative to our stable base of UT-related revenues. Turning to the bottom line. For the second quarter of 2026, we reported a GAAP net loss of $19 million compared with GAAP net income of $700,000 in the prior year quarter. Our non-GAAP net loss was $2.7 million compared with non-GAAP net income of $13.9 million in the second quarter of 2025. The year-over-year change primarily reflects the planned investments to support Furoscix, including the ReadyFlow formulation, the pediatric Afrezza launch, investment in our MannKind-201 development program and the incremental increase in our cost structure following the scPharma acquisition. As you review our non-GAAP adjusted net income, I'd like to call out two lines that are new this year. The first is the amortization of acquired intangible assets. This relates to our acquisition of the Furoscix on-body infusor, which is being amortized over its current expected useful life. Now that the autoinjector has been approved, we will begin to amortize this intangible asset in the third quarter and on a full quarter basis will be approximately $2.2 million. It is important to note that the amortization of these intangible assets are noncash, but we will see these expenses flow through our P&L for many years to come. The other new item relates to the accounting for our contingent value right associated primarily with the recent autoinjector approval. We will pay out the $45 million CVR in Q3 and the balance of expense, approximately $16 million, will be recorded in the quarter. In conjunction with the autoinjector approval, we announced a $50 million pipe financing, providing us pro forma cash position at quarter end of $161 million and giving us sufficient cash to pay the CVR and continuing to fully support our two launches and accelerate the development of our 201 program. On the expense side, R&D expense was $18 million compared with $13.7 million in the prior year quarter. The increase was primarily attributable to development of the Furoscix ReadyFlow formulation, higher personnel costs following the scPharma acquisition, and increased development costs driven by our MannKind-201 program. SG&A expense was $58.3 million compared with $31.6 million in the prior year quarter. The increase primarily reflected the promotion and support of Furoscix as well as the expansion of our field-based teams and activities to support the pediatric Afrezza and Furoscix ReadyFlow launches. As we discussed last quarter, 2026 is a deliberate investment year. With both approvals now achieved, our focus has shifted from launch preparation to disciplined execution. We will continue to monitor performance, prioritize investments behind the opportunities showing the strongest returns and appropriately managing our cost structure. Before I hand it back to Mike, I want to mention that we'll be participating in the Wells Fargo Annual Healthcare Conference in Boston as well as the Cantor Global Healthcare Conference and the H.C. Wainwright Global Investment Conference in New York. We look forward to engaging with many of you there. With that, I'll turn the call back over to Mike.

Thanks, Chris. Let me close with where this leaves us. I told you at the start of this year that three catalysts would define 2026 for MannKind, and we delivered on all three. Afrezza is approved in pediatrics and is launching well. Furoscix ReadyFlow is now approved and will be available by end of this month. And nintedanib DPI showed positive results in Phase I with IPF patients, which validate our continued Phase II advancement and investment. Our job for the rest of this year is execution, and we have the team, the products and the evidence to make it all happen. Before we take questions, a quick note on where our teams will be this week. First, starting out, ADCES, which is the CD conference. And this fall, we'll have a presence at major heart failure and nephrology meetings, HFSA and ASN. And the last one I'd like to flag with you is ISPAD in November, where our INHALE-1st pilot phase findings were selected for two oral presentations. At the pediatric diabetes communities annual meeting and having our newly diagnosed data presented there, [indiscernible] launch here is meaningful for how this therapy gets understood by the clinicians who will drive its use potentially around the world. With that, operator, we'll now turn the call over for questions.

[Operator Instructions] Our first question will come from Ben Burnett from Wells Fargo.

Congrats on the progress. I wanted to ask about Afrezza. You conveyed some good early momentum. I guess what proportion of scripts that you're seeing are coming through your cash program? And do you expect these patients will convert to more standard channels? And if so, kind of when would you expect that?

Thank you, Ben. When we look at all the scripts dispensed, we're still -- because we got the hub and then we have some IQVIA data we're reconciling. But we are seeing a good portion go through as fully paid, and we're seeing the other half at least go through as cash. It's too early to tell how quickly that will convert. But obviously, we're pursuing the prior authorizations and the appeals to make sure patients get it. And in parallel, we're also meeting with payers as we're trying to continue to increase cost and coverage for patients, especially as we go into '27. This program is going to go through the end of '26, and we would hope by then we work through most of the payers to move forward there. So far, I can tell you, our pediatric approval rates are consistent with the adult approval rates. And so that's one indicator what we're looking at. But otherwise, there is -- more than half grown through is cash, but that we expect many of those to convert to paid.

Our next question comes from Olivia Saunders from Cantor.

I know it's obviously very early in development still, but can you maybe help walk us through how you're thinking about the regulatory path forward for your IPF program? Obviously, the ongoing Phase II will be a big part of that. But what feedback have you gotten maybe more recently from the FDA around what you'll need to get this to patients and whether there are things that you can do to help accelerate that path forward? And then as a follow-up, is PPF something that you guys are looking into at this point as you think about your long-term portfolio, just given how big of a market it is and how much R&D interest there seems to be around it right now?

Thank you, Olivia, and great questions. Obviously, we're very excited about just the nintedanib IPF opportunity. But to your point, we will continue to look at IPF, PPF, ILD and all the indications related to nintedanib. We did meet the FDA last year as we finished up our Phase I to go to Phase II. And we originally proposed a Phase II/III study because most of the time in starting these trials is site activations, and we're trying to minimize that. And at that point, that's why we decided to do the Phase Ib to minimize any distraction related to FDA feedback. They really want to know what the powders look like in patients with IPF. We've now demonstrated that. We have submitted the Phase II protocol to the FDA to open up potential U.S. sites. and we'll have feedback on that in the fall. I think you've seen the FDA kind of indicate probably one trial is probably all will be required in addition to the Phase II, and that's our underlying assumption. But again, the FDA will have to confirm some of those. And I think depending on the significant effect size that we may or may not see, that's probably going to drive some of those other indication extrapolation discussions versus do you need additional studies? The pulmonary division is very different than the other divisions. And so I think it's still TBD. But we're going to learn -- like you see on Tyvaso DPI as UT talks to the FDA, we'll learn things there. And there was indication extrapolation in DPI for ILD. And I think UT still needs to work through that on Tyvaso DPI. So a lot of precedent setting around this set of patients and unmet need. And I think a lot of it with the FDA will determine the effect size and how much they understand this. But too early to tell, is it two trials, one trial, each indication extrapolation. But our working assumption is at least one trial for IPF and likely additional data generated in other target populations, but that's our working assumption. Will we do that in parallel to IPF? I think that's still TBD of how many bets we want to place simultaneously, but we want to make sure we establish the dosing here in Phase II.

Our next question will come from Roanna Ruiz from Leerink.

You have Ryan on for Roanna. Congrats on the quarter. Maybe going back to Afrezza, can you guys just help us understand the pace of script trends that you're seeing in the pediatric setting over the last month or 2? As your reps spend more time in the field, are you seeing an acceleration in script or steady growth? And then just as we look out in a couple of quarters and years, how do you expect this mix of adult and pediatric scripts to trend?

Thank you, Ryan. What I'd say in the first week or 2, there was obviously a bolus of patients waiting for approval, and we saw really fast submissions and getting those sites on board and our team getting out there to get them to use our reimbursement hub. I've been out there in the field. The excitement is palpable with the customers, the patients, the social media. And you saw kind of even though we had July 4 holidays and people on vacation, we've seen a nice consistent, steady referral pattern into our reimbursement hub. The last 2 weeks, you're starting to see that build up with potential refills as well as momentum. So I expect continued momentum as the quarter and the months progress ahead. And we're also adding another, call it, 1,000 targets roughly in the pediatric community to our 70 reps who are selling Afrezza for adults. So they will now be kicking in here in August, and we'll actually be training them next week. So I expect continued momentum building, but it is a nice, steady group every week, and it has been growing in the last few weeks as well. I think we had our highest week 1.5 weeks ago of the last 8 weeks. So it is growing, and we are hitting new peaks every week, and that's exciting. And we think we're just getting started here. How that builds will be part of what we're looking for in terms of -- obviously, you want to know how to build your models, but us, too, right? We're making lots of investments here, and we want to see how the refill patterns look, how the adult coming in and where are these patients coming from? We just got research this morning. The good news is we're seeing a significant number of patients are coming from MDI. They're using Afrezza full time, probably 60%, 70% and about 1/3 are using it intermittently. And that means they may take a pump break. They may use it on top of their pump. But we are seeing a large percentage of people say they will use it full time and a lot of good patient demand for it. So that's the overall picture, I'd say, for peds. Happy to dig in, in terms of -- but some of our biggest prescribers are asking every patient on every visit, "Do you want to try inhaled insulin?" And we've seen something right over 20, 30 patients already. On the adult side, I want to remind people, we pulled back resources this year on the adults. So obviously, we see a little softness in Afrezza year-over-year. And that's related to really the top 10 prescribers had a disproportionate amount of decrease relative to the next 1,000. And so when you take away that top 10, you look at the underlying adult business, it does look like it hit a nadir here in Q2, Q3, and that momentum in July did start to build back up with new patients growing almost 30% over the month of June. So I do think we'll start to see the compound in the second half of Afrezza adult and peds. And if you ask me personally, I think the peds response, the uptake, the number of patients coming in, the number of prescribers, the feedback, everything points that peds will continue to build momentum and adults, we want to hold steady, and we believe the adult segment will grow with peds. And just to give you some color, we had -- sorry, we had roughly -- lost my page, sorry. We had roughly about 450 docs come in since launch that are new prescribers. And I'd say -- and this is just one part of the data, not all the data but on the conservative side. And of those, about 200 were peds and about 250 were adults. So you're seeing more adults coming in with the peds approval and the confidence. And we had about 1,800 writers of Afrezza since the June 1 launch. So we're seeing overall writing increase. We're seeing repeat writing increase. We're seeing new writers increase. So that broad base of prescribing, I'll say, is what we're watching and seeing how much we can get depth and breadth of that audience.

Our next question will come from Gregory Renza from Truist Securities.

This is Anish on for Greg. Congrats on the quarter. Just first on the Afrezza peak share source. With the previously quoted 23 to 37 peak share range, how much assumes conversion of pumps and pods versus capture of multiple daily injection patients? And second, on the 201 registrational path or nintedanib DPI, what is the shortest credible route to approval? Does the study need to show FVC benefit on top of background antifibrotic therapy or non-inferiority to oral nintedanib?

Okay. I'll just keep building on the Afrezza theme, and then I'll jump into 201. On the overall data, we would expect roughly half our patients to come from MDI, and maybe 20%, 30% to come off pumps or added to pumps and then the remaining 15%, 20% be insulin-naive patients. And so that's the segment that we're seeing some early data. We got almost, maybe 20% of the naive trial enrolled already. And the 2-unit cartridge is really going to be helpful for the naive setting. But I think in terms of MDI and pumps, that's the majority of our patients coming in today are patients coming from MDI or people wanting a pump break. And that's been some of the anecdotal feedback from doctors as they offer to everybody. They didn't realize that people have burnout and that they're tired and they love to be detached from something for a little while. And it doesn't mean they're always going to use Afrezza full time or a pump full time. They're going to go back and forth realistically depending on their needs. So that gives you a breakdown of Afrezza. And I would say the research we just got in this morning reiterated that kind of breakdown of what we're seeing in our initial launch assumptions and how it's being used in the first 6 weeks and how we expect to see that continue on. And also the research that came in reiterated the 20%, 30% share that we talked about previously that the doctors now, that, that's approval there, they're continuing to indicate that's a real possibility. So we continue to remain bullish and excited here for what we see in the early days, but it will take time to show these trends. And the last thing I'll say on Afrezza is just, some of the pharmacies are reporting and some of them are not reporting. And so that noise will sort out, and we'll continue to keep you updated, but we are working through that consistently as Wall Street may try to look at one data source but not have the full data. On 201, that's an interesting question in terms of the fastest pathway. Having done a lot of biosimilars, my initial goal was to convince the FDA that a biosimilar like-pathway could be appropriate here, meaning a non-inferiority trial with indication extrapolation. I think we need to get the Phase II data to show the effect size to alleviate any concerns that we would be putting this in a large population and not knowing are you switching off stable nintedanib to inhaled versus an add-on. And so I don't think the FDA has any clear guidance on what they prefer. But I think what they would like is an add-on design trial with placebo. And the good news with the Jascayd launch, there's clearly going to be more patients to add on, on top of background therapy, especially as we look at Tyvaso nebulizer. So I'm hopeful as we get to Phase III, the ability to look at naive patients as well as add-on and enroll that trial quickly, will happen, and that's our assumption. And the size of the trial and the primary endpoints will be TBD. But that's really what I look at the IPF market is saying, it was only nintedanib and it had to be an add-on, it would be a hard study to enroll. But given the success of Jascayd and pirfenidone and Tyvaso [indiscernible] nebulizer coming in, I'm excited about the Phase III design here.