Mannkind Corp Q3 FY2025 Earnings Call

Good morning, and welcome to the MannKind Corporation Third Quarter 2025 Financial Results Earnings Call. As a reminder, this call is being recorded on November 5, 2025, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call and available for approximately 90 days. This call will contain forward-looking statements. Such forward-looking statements are subject to 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 quarterly period ended September 30, 2025, 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.

Good morning, and thank you for joining our Q3 2025 earnings call. Let me start with the Q3 highlights. We delivered a record revenue quarter of $82 million. We also strengthened our portfolio with the acquisition of scPharmaceuticals. On the pipeline side, Afrezza supplemental BLA was accepted for review with a PDUFA date of Q2 2026. We also saw strong performance from Tyvaso DPI, which contributed $59 million in royalty and manufacturing-led revenue, reinforcing the durability of our revenue streams. Chris will review the details of our third-quarter results shortly. We're excited to have completed the acquisition of scPharmaceuticals and are pleased to welcome their talented team to MannKind. Together, we're focused on unlocking the full potential of FUROSCIX as well as the advancement of inhaled bumetanid, aka MNKD-701 for fluid overload in CKD and heart failure as our target indications. We are encouraged by the momentum across our clinical development programs that we've been working on the past five-plus years in terms of MNKD-101 and 201, which I'll discuss at the end of our call. Now let me bridge to our near-term growth catalysts. Building on the hard work and dedication of the entire MannKind team, we have a unique near-term opportunity to accelerate growth and deliver meaningful value through catalysts across our commercial products and pipeline programs. I'll point to a few of these milestones. The sNDA for FUROSCIX auto-injector was submitted to the FDA in Q3 as planned, with an expected PDUFA date of Q3 '26. The Afrezza sBLA was accepted for review, and if approved, will be the first new insulin for pediatric patients in over 100 years of diabetes therapy. We've also completed enrollment into our midterm target for ICoN-1-NTM Phase III ahead of schedule, allowing us to confirm the sizing of the trial mid next year. Now I want to bridge over to our commercial highlights, starting with Tyvaso DPI and our collaboration with United Therapeutics. In Q3, we recorded our highest revenue quarter for Tyvaso DPI, earning $33 million in royalties and $26 million in manufacturing-related revenue. As UT noted on its call, we have developed and produced an 80-microgram cartridge, which allows patients to take 15 nebulizer equivalent breaths in a single dose, improving convenience for patients. Following UT's positive TETON 2 data, we anticipate that the company will pursue a DPI bridging study in IPF, which would have the potential to expand the Tyvaso DPI label to include IPF and/or PPF contingent upon FDA approval. Additionally, UT recently exercised their option to expand our collaboration, and we've begun formulating a second investigational molecule as a dry powder platform using MannKind's proprietary Technosphere technology. In Q3, Afrezza grew 31% in new prescriptions and 27% in total prescriptions year-over-year. As we shifted our focus to type 1 diabetes in preparation for pediatrics, our units per script have declined by about 15% year-over-year, as the average person with type 1 diabetes requires less insulin than the average type 2. The impact you can start to see it reflected in the difference between our net revenue growth being lower than our TRx growth. On the revenue side, Afrezza grew 23% in Q3 2025 compared to Q3 2024. We're focused on driving prescribing among top prescribers and continue to see strong engagement from healthcare providers, especially with the potential to expand into pediatrics if approved. Ahead of that opportunity, we've enhanced our messaging and expanded our field force, which includes medical science liaisons, local field salespeople, as well as key account managers who will be focused on the top 50 pediatric centers. I'll now turn to FUROSCIX, a product we're very excited about. FUROSCIX is a high-potential brand that expands our footprint into cardiorenal medicine, and we now have the opportunity to merge scPharma's experienced team with the MannKind team. This addition enhances our commercial scale, accelerates growth, and aligns with our strategy to expand into adjacent therapeutic areas while delivering innovative patient-focused solutions. Fluid overload remains a significant burden, and FUROSCIX addresses a critical gap in care by helping break the cycle of hospital admissions and readmissions. scPharma invested heavily in building a high-performing sales organization, expanding from about 40 representatives to more than 80 by early 2025. Establishing a sales force is a substantial undertaking that requires a significant financial and operational commitment. That investment laid the foundation for the strong adoption we've seen in 2025. The expanded sales team, combined with more focused territories and stronger engagement with healthcare providers, is driving broader coverage and deeper prescriber interactions. These strong results are reflected in Q3 performance with over 27,000 doses dispensed, up 153% from the same quarter last year, reflecting continued prescribing adoption and growing confidence in FUROSCIX. With the demand continuing to rise, let's turn to the financial impact. For the year-to-date period, FUROSCIX revenue reached $47.1 million, a 95% increase over the same period in 2024, indicating the investment in driving share of voice is accelerating product adoption. For the third quarter of 2025, unaudited FUROSCIX revenue was $19.3 million. FUROSCIX revenues will be included in MannKind's financial results commencing with the close of the acquisition, i.e., Q4. Now I want to focus on a large unmet medical need in heart failure and CKD, which is what we saw as we evaluated the scPharmaceutical acquisition. To put the growth we're seeing in perspective, let's look at the size of opportunity in heart failure and CKD, areas with significant unmet need. Heart failure is a large unmet need, and market research shows 80% of heart failure costs are tied directly to hospitalization. There are 2.1 million addressable heart failure episodes in the U.S., mostly driven by congestion from worsening heart failure. And for patients 65 and older, heart failure is one of the top reasons for hospital admission. This represents a large addressable market and a significant portion of the Medicare Part A and Part B spend. This is where FUROSCIX makes a difference. Its key feature is to allow patients to treat edema at home and reduce hospital admission time and/or readmissions. Now I'd like to talk about the FUROSCIX opportunity for intervention. scPharma achieved success in FUROSCIX by focusing on community physicians who treat CKD and heart failure often before a patient shows up to the ER, which is on the left side of the slide. By intervening early, physicians have the potential to reduce hospitalizations and break the cycle of hospital readmissions. As we look post-integration, we're now expanding our focus to the post-discharge period, where readmission risk is the highest, creating a significant opportunity for FUROSCIX to improve outcomes and reduce costs. This approach aligns with CMS's proposed ambulatory specialty model for heart failure care, which begins in January 2027 and introduces mandatory two-sided risk for cardiologists in select regions with performance tied to quality, cost, and care coordination. These changes underscore the importance of early intervention and strengthen FUROSCIX's role as a key enabler for providers to meet quality and cost targets under CMS's new risk-based payment model. Beyond revenue growth, we remain focused on innovation to enhance patient experience and drive long-term value. Building on FUROSCIX's momentum, we will expand our hospital strategy by adding key account managers critical to helping ensure discharge protocols will include FUROSCIX and enable local access with the major health systems through medication-to-bed programs. This positions FUROSCIX for far greater utilization in hospitals and post-discharge settings. We're also planning to increase our share of voice in cardiology and nephrology to raise awareness amongst clinicians and patients, supporting sustained adoption at the community prescribing level. A key milestone this quarter was the sNDA submission for the FUROSCIX ReadyFlow auto-injector. If approved, this device will simplify admissions, expand treatment options, and reduce cost of goods significantly freeing up capital to reinvest in growth, strengthen our portfolio, and improve margins. Additionally, we're advancing bumetanid DPI MNKD-701 into preclinical development, another example of our commitment to innovation and long-term growth, as we believe FUROSCIX will be the standard of care, but a subpopulation may prefer to inhale versus inject. Our Technosphere technology should provide comparable bioavailability based on our historical development programs in insulin, treprostinil, and migraine, where we see IV-like onset and sustained efficacy in the short term. A DPI formulation of bumetanid could offer a rapid noninvasive and highly portable solution, enabling patients and providers to manage fluid overload without hospitalization. I'll now turn the call over to Chris to review our third quarter results.

Thank you, Mike, and good morning, everyone. In the third quarter, total revenues grew 17% over the prior year to $82 million, driven primarily by royalties earned on Tyvaso DPI. These royalties increased 23% to $33 million, reflecting the continued strong performance of Tyvaso DPI under our collaboration with United Therapeutics. Collaboration and services revenue was $27 million, up 14% from the prior year, and consists primarily of manufacturing revenue based on production volumes sold through to UT, as well as the recognition of deferred revenue. During the quarter, we announced a new collaboration with United Therapeutics and received a $5 million upfront payment. We will begin to recognize revenue related to this agreement in the fourth quarter as the development activities progress over the next several quarters. Afrezza net revenue rose 23% to $18.5 million, while VGo contributed $3.8 million, down 19% over the prior year period. The performance of VGo is consistent with our expectations as we no longer actively promote the product. On the expense side, quarterly research and development expenses increased $1.1 million or 9% over the prior year period, driven by the enrollment ahead of plan in the ICoN-1 trial of inhaled clofazimine and preparations for the INFLO Phase II IPF study, which is expected to begin enrolling in Q1 2026. These increases were partially offset by the completion of the INHALE-3 and MNKD-201 Phase I studies in 2024. Selling, general, and administrative expenses increased $5.2 million or 22% in the third quarter versus the prior year period. As we continue to invest in Afrezza to support the potential pediatric launch, we have higher headcount and personnel-related costs, including the deployment of the medical science liaison team, as well as additional sales representatives. SG&A for this quarter also included $3.7 million of acquisition-related expenses. Q4 SG&A expenses will include costs related to our October key account manager team build-out to support the Afrezza pediatric call point. Additionally, transaction costs associated with the close of the acquisition of scPharmaceuticals will be reflected in the fourth quarter. As a reminder, our fourth quarter results for our commercial product sales will include sales of FUROSCIX as of the deal close, as well as expenses incurred in their respective categories. Related to the transaction, I'd like to note that we utilized $133 million of our $286 million of cash and investments as of September 30 to fund the transaction and have borrowed an aggregate of $325 million on our five-year term loan facility with Blackstone. For the year-to-date period of 2025, total revenues reached $237 million, representing 14% growth compared to the same period last year. Our commercial product sales, consisting of Afrezza and VGo, account for 27% of our total revenues for the year-to-date period. With the addition of FUROSCIX in Q4, our commercial product sales will be a more meaningful component of our growth. On a pro forma basis, if FUROSCIX was included for the year-to-date period, commercial product sales would have been 39% of our total revenues. Considering the continued growth we anticipate in royalties we earn on Tyvaso DPI as well as meaningful and stable revenues from our collaboration and services, we have never been more excited about our revenue growth potential. I'd like to finish with GAAP net income for Q3, which was $8 million compared to $11.6 million in the prior year. After adjusting for non-cash and one-time items, our non-GAAP net income was $22.4 million, up from $15.4 million last year, and non-GAAP EPS of $0.07, up from $0.06 in Q3 of 2024. This reflects strong operational performance of our business lines even as we are making significant investments in future growth drivers. I'll now hand it over to Mike to discuss clinical updates, starting with our Afrezza pediatric indication.

Thank you, Chris. As we broaden our impact across cardiometabolic care, we're also advancing innovation in diabetes, starting with Afrezza's potential to offer the first non-injectable insulin for pediatric patients in over 100 years of diabetes therapy. We're extremely excited about this opportunity that lies in front of us. Now let me bridge to inhale. First, our naive treatment for pediatrics. We're focused on generating additional clinical evidence to support Afrezza's role in children with type 1 diabetes. This is why we're initiating the inhaled first study, which positions Afrezza as the very first choice bolus insulin for youth aged 10 to 18 who are newly diagnosed with type 1 diabetes, either upon discharge in the hospital or arriving at the doctor's office within 7 days. This study will evaluate the safety and efficacy of inhaled insulin plus basal and up to 100 patients across 10 leading sites, including the Barbara Davis Center in Denver, as well as the Joslin Diabetes Center in Boston, which will be our first two sites to dose patients to ensure our dosing protocol and training materials are meeting expectations. This is what we did in our gestational trial, and the first 10 test patients confirmed our expectations, and that trial is expanding to full enrollment. In the inhaled first trial, we plan to introduce a 2-unit cartridge for titration and utilize MannKind's BlueHale tracking dose in this trial. Some of you haven't heard from BlueHale in a while, and I want to show you the updated version of the product as well as some screenshots that you can start to see how this is going to absorb the dose, integrate with CGM and remind you when you took your last dose and how much Afrezza is on board and start to show you your time and range by day, night and time of week. We're looking forward to testing this device here and having this ready for the pediatric launch. We're also advancing programs in orphan lung indications that leverage our inhalation technology to address serious unmet medical needs. I'll first discuss our ICoN-1 global Phase III study in NTM, where the market is expected to exceed $1 billion by the end of the decade. We achieved our interim enrollment target ahead of schedule in the study. Our focus will be on the U.S. and Japan, which have the largest populations and the greatest growth potential. It's also the two markets that we've seen the highest enrollment rates in our trial. This is a global health concern and a real issue in these two countries. I'd like to remind you that this trial has a co-primary endpoint in the U.S. of sputum culture and patient-reported outcomes, but for the ex-U.S. market, it's just sputum culture conversion. Our next trial, Nintedanib DPI, is our INFLO Phase II study, also known as MNKD-201. We have initiated the INFLO Phase II with the first patient enrollment expected in Q1 '26. This randomized placebo-controlled trial will include 210 patients with IPF and will evaluate two dose regimens totaling 8 milligrams of nintedanib a day over 12 weeks, followed by a 6-month open-label extension. The primary objective is safety and tolerability with FVC as the key efficacy endpoint. Doses are designed to achieve exposure levels consistent with or above prior studies, supporting our confidence in this program. More importantly, based on the positive TETON-2 results, we've modified our trial design to include a QID arm instead of a TID arm, which preserves the option for future combination approaches and simplification for patients who will likely be on multiple products to manage their IPF in the future. Before we move to Q&A, I want to highlight the upcoming scientific medical, and investor conferences where we'll have a presence. These events are important opportunities to showcase our progress and strengthen our relationship with key stakeholders. As we look at our pipeline, I'll close with the updated pipeline slide that reflects the addition of FUROSCIX into our portfolio, as well as three additional programs we discussed today: MNKD-102, a DPI formulation of clofazimine; Bumetinib DPI, also known as MNKD-701; and our new collaboration with United Therapeutics. Consistent with our DPI license agreement, this program, if successful, will generate $40 million in total milestones and earn a 10% royalty on net sales of the product, providing yet another exciting growth opportunity for MannKind. With that, I'll turn the call over to the operator to answer your questions.

Our first question comes from Olivia Brayer with Cantor.

Can you share any thoughts on the recent approvals from FUROSCIX competitors? And if you could help contextualize the pricing differences and how that actually funnels down in terms of actual out-of-pocket cost to patients? And then just in terms of FUROSCIX growth, when do you think we'll actually start to see a bigger inflection in growth from all of the different initiatives that you're doing to help drive greater adoption? And then I've got a follow-up question on IPF.

So I think on the competitors, when we were going through due diligence, we knew these two competitors were in the wings. And I think we felt the product differentiation stood on its merits, along with the life cycle management of the auto-injector. So that's been the key focus for us. And then I think in terms of the nasal one that got approved, we could see how skinny that package was and how quickly that could get to market, which played into our decision to advance an inhaled bumetanide on our FTKP platform. The reason is we know our platform has IV-like responses and good bioavailability. We felt that's exactly what you're looking for in this fast onset of diuresis, especially as you read the VuMex branded label, you can see the quick onset with IV, and the diuresis starts pretty much within 15 minutes. So that really allowed us to create another differentiated product as a part of this acquisition, which we wouldn't have done had we not bought scPharma. So I think from a competitive viewpoint, we'll be able to compete nicely with the new people coming on the market. I think just like we see in the case of Liquidia launching in treprostinil, the market size grows with more share of voice, more noise, and more reminders of this opportunity. The market is severely underpenetrated, and scPharma had to fund all this on their own. So having more noise out there and more options, I think, ultimately is going to elevate the market and the believability of this opportunity. In terms of pricing, I mean, these companies have stated a price, but they have not yet actually publicly loaded their prices to my knowledge. And I think let's see what happens when they do. But the pricing of the product is not going to change the biggest barrier in Medicare, which is a patient's out-of-pocket cost. So whether it's $500 or $1,000, the out-of-pocket cost and the deductible is the same on Medicare, which is the majority of these patients in treatment. So the real issue is not the WACC price of the product, but it's the net price to the patient. Unless somebody is doing smoothing, the payers aren't going to just cover any of these products really, nearly because they're going to be up against generics in the marketplace. So you're going to need reimbursement support. You're going to need to figure out the smoothing and the prior refill. So I think I like the SC model. I like that we know where our patients are. We know when they get a refill. We know when the prior auth expires. So I think the system that they have in place is good. You'll hear some complaints that people want to access locally, and that's a lot of the IDN contracting. So I think that we'll continue to watch it. We'll be competitive if we got to make changes. But I think in the end, we feel pretty good about our price point and our net pricing. On the growth inflection, I mean one of the things you'll start to see next year is increasing the share of voice. And I think you could see in the six months plus of their sales force expansion, you started to see that kick in, in Q2, but really kick in, in Q3, and ultimately Q4. So I think from the time we make these investment decisions, you can expect to start to see impact within six months there. So hopefully, you'll see the total addressable market expansion that will take at least six to nine months in terms of really starting to make impact in the health system. They don't change overnight. But in terms of rep share of voice, I think we could see an impact on prescribing sooner. And I think that will be our focus is to minimize disruption with customer relationships but expand the share of voice on cardiologists and nephrologists as we go into '26.

And then for the Tyvaso bridging study in IPF, what can you guys tell us at this point? It sounds like it may be confirmed that a bridging study will be run, but any sense of timing and whether you still expect it to look similar to the BRE study?

I don't want to speak for you, T. So I think they've said it could be a BreezE-eng study. So I think with that communication, go to the FDA now, they have the TETON 2 results, and I expect them to move this as quickly as possible to the FDA for clarification and discussion.

I have two questions. First, regarding the scPharma acquisition and FUROSCIX, could you provide some insights on how the integration process has been going with respect to the field force? Do you have any updated thoughts on what the field force composition will look like across your various commercial brands now? That's the first question, and I have a follow-up as well.

Sure. I'd say, first, as we got to integration, it's only been closed about three weeks, and it feels like we've already met most of the employees once or twice. I personally was at five of the regional sales meetings. Nick, our President, was at the other three. We had multiple days of integration calls getting ready for 2026. So I think the integration is going very smooth. Culturally, the companies are very similar. So there's not a lot of friction. We already have put some of their people in key positions on our side and integrating them into our leadership team and our processes. So I think overall integration, we don't see much disruption. Sales continues to look strong in Q4 here. So we're very happy to date with the teams and the integration process as it goes. You'll see scPharma continue to be independent through the end of the year in terms of their name and job postings, things like that. You'll start to see that integration fully in '26 starting in January, all the way through any packaging changes, etc. So we're trying to make sure we're smart about it. We're not looking to waste money on changing the name on a box for no reason. So we'll try to phase those things in as we think about like the autoinjector launching, things like that. So I think that answers the integration question.

And then just on the balance sheet, how should we think about sort of your relative priority between investing in the launch of Afrezza and Peds, FUROSCIX, deleveraging the balance sheet, and kind of maintaining operational profitability? How do you kind of balance these three different goals?

Yes. We are already preparing for the Afrezza pediatric launch, and you will notice an increase in expenses this year related to medical science liaisons, key account managers, and some commercial prelaunch investments. I expect that to rise. Regarding FUROSCIX, we plan to take some actions to accelerate the brand's growth as we approach 2026. We believe these are the correct choices, and we understand that investors are looking for quicker growth, which we think we can achieve in 2026 with our upcoming initiatives. I'll now let Chris address the deleveraging and share some of our thoughts on that.

Yes. The key item to deleverage is really on our convert. We have a $36 million stub that's due March 1, 2026. So we'll certainly be addressing that in the near term. In terms of what Mike said, I think the priority right now is investing in growth. And so you're seeing us make that a priority, but still doing that in a sustainable way and making sure that we are in a good position to certainly continue to pay our obligations with our new debt facility.

Congrats on the progress in the quarter and the closing of the scPharma deal. Just following up from some previous questions, how are you thinking about the peak sales opportunity for FUROSCIX? And then on NTM, what do you attribute to the faster pace of enrollment? And can you remind us of the powering assumptions for that study?

I think on the peak sales for FUROSCIX, we looked at the deal, there was not guidance by the company, but there were analyst reports out there, and put it in the $500 million-plus range. I think that until we give guidance there, I wouldn't quote anything beyond what we've seen out there in the public domain prior to the acquisition. Chris, I don't know if you have anything else to add before.

I think Andreas was asking about the pediatric opportunity.

On the pediatric side, we are currently completing some research to prepare for next year. We estimate that reaching about 10% market share could generate around $150 million in net revenue, and our research suggests that achieving up to 25% might be possible. The key question is how quickly that growth will occur, and we haven't provided guidance on that yet. My focus will be on preparing for 2026, especially considering the competitive pump launches this year that are experiencing significant market uptake. Post-pediatrics, there is potential for Afrezza to grow at a much faster rate, but we need to ensure our market research aligns with our expectations before making any public announcements. Regarding NTM, Japan is progressing well, and there are some signs of improvement in the U.S. The team has attended several conferences this year to enhance awareness among key opinion leaders and facilitate enrollment. We've recently received FDA approval to ease the EKG monitoring requirements for entry screening, and we're currently implementing those changes. In terms of powering, we are approximately 90% powered, which is the purpose of the interim measures to ensure we remain on track with patient progress. We also need to remember that patients are transitioning to the open-label extension, which will be crucial as we move forward.

What are the different outcomes for the interim readout, like the potential for increasing sample size, for example? Can you give us some color there?

Yes. I mean one is the sample size. So if we're close and you want to increase the sample size, that could be it. The other one is the safety database, making sure we continue to go in that direction. Then you'll have the futility, meaning it just is not delivering what we expect, and that could also be an outcome as well as just you're on track to meet the 180. That said, in Japan, we only need 180 in the U.S., and we're evaluating the total safety database required still with FDA.

scPharma acquisition, did I hear correctly that you said there was going to be ongoing sales force expansion? Is that mainly on the scPharma side on the commercialization of FUROSCIX? And then once you report sales starting from fourth quarter, how can you remind us how do you expect the addition to impact the SG&A line in the income statement, please?

I'll let Chris address the second question. I'll begin with the first. We will remain somewhat reserved regarding the sales force expansion and share of voice at this time, but we expect to see growth rebound similarly to last year when SC divided some territories. We noticed that there was some disruption to the sales force in the first quarter, primarily due to co-pay resets from Q4 to Q1. This year, we anticipate a similar situation where patient resets occur and co-pays drop significantly as individuals meet their deductibles. Our goal is to enhance the sales force's share of voice as we enter the new year and prepare for the Medicare transition period, which is crucial. Historical data shows that an increase in share of voice can lead to higher sales per customer within each territory. We observed this from the previous increase from 40 to 80, and while we are not ready to discuss expansion details as we are still finalizing plans, we have had preliminary meetings with the team. The primary focus now is on expanding the key account manager role, which we see as a readily achievable opportunity. Additionally, we will explore more ways to incorporate FUROSCIX into our increased share of voice strategy.

Yes. In terms of the expense line for Q4, if you think about the selling side, I would just emphasize that this is a bolt-on acquisition from a commercial perspective. And so I would expect most of those costs to be what they have experienced previously on the commercial side, is what we'll be reporting in Q4 as well, plus the investment in CAMs that Mike just talked about. On the G&A side, you're seeing quite a bit of synergies realized right away as we think about public company costs, as we think about systems and tools that we all use in common.

Okay. Then on Afrezza, you talked about this sales not growing as fast as TRx. Do you expect the same pattern in fourth quarter? And at some point, would you expect sales to catch up with the TRx?

Q4 should be quite strong. There may be a pattern due to the NRx trends affecting TRx. However, generally in Q4, we anticipate numerous refills. Many of our baseline patients will likely refill before the year's end as co-pays reset. I expect Q4 to be decent, but I anticipate the trend will bottom out within the next six months and begin to stabilize as we progress through Q1 next year. In terms of growth, once the volume per script levels out alongside the growth in outflows and any price changes, we should reach that point. While I don't foresee another significant drop, I do expect it to decrease a bit more over the next couple of quarters, though not by 20%; it's more likely to be in single digits.

Congratulations on the results. Maybe just for me on Afrezza, can you just help us think about the potential tailwind you expect from the Afrezza conversion dose label update and how you expect to leverage that label expansion to drive Afrezza growth? You put a lot of good context around the peds side of Afrezza. But just any help in terms of that label expansion?

So the label expansion was kind of a three-month delay from November to January. We expect the draft label in December based on the latest communication. And that's fine. I mean we were going to launch the label change anyway in January, so that timing is not that far off. The key thing about the label expansion is it really allows us to talk about the postprandial control. Our #1 adverse event is lack of effect, and that's because doctors do not titrate up fast enough or they don't convert at the appropriate dose. Our top prescribers, this is generally an issue, and that drives most of our business. But as we expand the sales force, those new prescribers who don't have a lot of experience, that's where we see the mistakes happen. That's where we see the patient dropouts happen faster. So as we continue to expand, we want to get this fixed. We want to get this right so that patients start up on the right dose the first time. And so that's really our goal. The data is published, so we can still disseminate it through our medical liaisons, through medical response letters, and through reactive responses with the sales force. So we do feel our top prescribers know the information, but it's really the new prescribers that will be important. And that sales force expansion for Afrezza is just getting out there over the next month or so, so call it, December or January, when the label change happens, the timing still mirrors up nicely. So if people start off better, they'll stay on the drug longer, they'll be happier, and the doctors will write more, right? So it's got a self-reinforcing prophecy here in the end.

And then one more for me, if I may. Can you just elaborate a little bit on the development path you're thinking about Nintedanib DPI?

At a high level, what excites us is the potential flexibility in dosing. The toxicology studies won't be chronic since it's an acute drug, so expect around 28 days of toxicity studies. Following that, we'll conduct a pharmacokinetic study, which will likely require only a few days rather than an extended period. The pharmacokinetic studies are fairly straightforward. What we appreciate about bumetanide is its short half-life, allowing for quick administration to achieve rapid diuresis, with the option to administer another dose after six or eight hours. This gives us more flexibility in how VuMax's label is structured compared to the current nasal version, which has more restrictions due to a maximum daily dose. The inhaled version, which should offer better bioavailability, should allow for more flexible dosing as we examine the labels. FUROSCIX provides 24-hour diuresis and is strong whether delivered via the auto-injector or the infuser. We anticipate having two competitive products in this space catering to different treatment preferences in the near term. However, we don't expect a long development timeline; scaling up and stability will likely take longer than the trials themselves. Our team has begun work on the formulation, and we expect to progress quickly once we're satisfied with it. We'll engage with the FDA simultaneously to seek alignment, which we believe we understand based on prior experiences.

A few on scPharma, just on the SCP-111 sNDA submission that's already taken place. Just want to know if there's any early questions from FDA. The bioavailability profile looks good. Maybe just probability of success on getting that through. Then I'll have a couple of quick follow-ups on the FUROSCIX to SCP-111 transition.

Yes. I think on the FDA, I can tell you they're full-stream active despite the government shutdown, whether it's factory inspections or inquiries on the various programs we have in front of them. So we feel they're on top of the submissions. I'm glad we got the submission in September; we didn't do anything. But that is allowing inquiries to come in already, and the ones that have come in seem like they're pretty minor and they're not uncommon questions. We've either gotten them on Afrezza or we're getting them on SC. So it does look like they're checking the boxes going through the file, and so far, there's no red flags. That's true for the pediatric filing as well when we got the PDUFA letter; they identified the same thing we already knew, which is that one outlier in the trial. So that we feel is pretty straightforward as we go forward. I'm sure there'll be more inquiries as we review everything, but in general, it seems like reasonable requests so far from everything we can see.

If we think ahead to a positive outcome here, the ReadyFlow injector dramatically reduces the admission time. What do you think could happen to unique prescribers if you get this on market? And when you think about that auto-injector relative to the current delivery device, what do you think it could actually do to margins for this product again?

It's been a few weeks, so I don't want to comment too much; still working with the team to think about the right segmentation. But I think we look at this as market expansion. When you look at the audience today, some may like the infusion for various reasons, and we'll make sure we understand those targets and the reasons to support that. But the real opportunity is the expansion. There are many people, whether in nursing homes or in discharge protocols or elderly patients being taken care of by their kids, where people would much prefer to use an auto-injector. So that to me is the upside that we're looking for in an inflection that could spark faster growth. That's one reason we want to get the share of voice up, is to get the awareness up of the product. I still think there are like 40,000 cardiologists. Our team is targeting 5,000 to 7,000. We believe we can boost up the number of cardiologists aware of the product at the conferences and education. This is still, I think, the first inning of a baseball game; hopefully, not an 18-inning baseball game, but a baseball game that I think is going to be well played and competitive. The patient demand and the unmet need in CMS, all the things are going in the right direction, along with our ability to compete, whether it's anetinide day or the FUROSC auto-injector or OModDyFuser. I think we'll be able to provide solutions to the various patient types. I wouldn't look at one replacing the other as much as we're looking at how we can grow it faster.

That concludes the question-and-answer portion of today's call. I will now hand back the call to the MannKind team for closing remarks.

I just want to say thank you to everyone in the company for working on the integration, preparing for the call. It's obviously a little more complex with the integration. But overall, the company is operating in every facet you can imagine. Thank you for all the investors and your belief in the management team and the direction we're going, and I look forward to seeing many of you at the Jefferies Conference in London, as well as the scientific people at the conferences coming up. So thank you again, and we'll try to close the year strong and talk to you next year.