MannKind - Earnings Call - Q3 2025

Executive Summary

• Q3 2025 delivered a record revenue quarter at $82.1M (+17% y/y), with non-GAAP EPS of $0.07; revenue modestly beat S&P Global consensus ($80.25M*) and normalized EPS materially beat ($0.0188*) on stronger Tyvaso DPI royalties and manufacturing revenue. Values retrieved from S&P Global.*
• Segment mix remained robust: Royalties $33.3M (+23% y/y), Collaborations & Services $26.5M (+14%), Afrezza $18.5M (+23%), while V-Go declined (-19% y/y). Tyvaso DPI contributed ~$59.8M in combined royalties and manufacturing revenue in Q3.
• Strategic catalysts: closed SC Pharmaceuticals (FUROSCIX) on Oct 7; sNDA for FUROSCIX ReadyFlow auto-injector submitted (acceptance decision expected by YE25); Afrezza pediatric sBLA accepted (PDUFA May 29, 2026). Cash, equivalents and investments were $286.3M at 9/30/25; management drew additional term loans for the acquisition.
• Key “why”: revenue strength was driven by Tyvaso DPI demand and higher UT product sales; non-GAAP EPS outperformance reflects add-backs (e.g., royalty sale accounting, FX, stock comp, impairment) while GAAP EPS was pressured by a $6.4M investment impairment and higher SG&A tied to growth and acquisition activity.

What Went Well and What Went Wrong

What Went Well

• Tyvaso DPI momentum: “record revenue quarter” with $33M royalties and $26M manufacturing in Q3; UT developed an 80 mcg cartridge to improve patient convenience.
• Afrezza growth: Q3 Afrezza revenue +23% y/y to $18.5M; NRx +31% and TRx +27% y/y as focus shifts to type 1 ahead of pediatrics.
• Pipeline/regulatory progress: Afrezza pediatric sBLA accepted (PDUFA 5/29/26); FUROSCIX ReadyFlow sNDA submitted; ICON-1 NTM Phase 3 hit interim enrollment target ahead of schedule; IPF Phase 2 (INFLO/MNKD-201) initiated (first patient expected Q1 2026).

What Went Wrong

• GAAP profitability optics: GAAP net income fell to $8.0M vs $11.6M a year ago, largely on a $6.4M impairment and higher SG&A (+22% y/y); non-GAAP net income still rose to $22.4M (+45% y/y).
• V-Go contraction: net revenue fell to $3.8M (-19% y/y) tied to lower demand as product is no longer actively promoted.
• Elevated operating spend: SG&A up $5.2M (+22% y/y) to support Afrezza pediatric preparation and acquisition-related costs; R&D up 9% y/y given ICON-1 enrollment and MNKD-201 scale-up.

Transcript

Operator (participant)

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 the 5th 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 for 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.

Michael Castagna (CEO)

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 SC Pharmaceuticals. 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 related 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 SC Pharmaceuticals 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 bumetanide, also known as MannKind 701, for fluid overload and 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 MannKind 101 and 201, which I'll discuss at the end of our call. Now let me bridge to our near term growth catalysts. Built 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 306 auto injector was submitted to the FDA in Q3 as planned with an expected PDUFA date of Q3 2026. The Afrezza sBLA was accepted for review and if approved will be the first new insulin for pediatric patients in 100 plus 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. In 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 as it is 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 SC Pharmaceuticals' 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. SC Pharma invested heavily in building a high performing sales organization, expanding from about 40 representatives to more than 80 by early 2025. Establishing a salesforce 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 that is 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 SC Pharmaceuticals 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. 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. SC Pharmaceuticals achieves 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 this 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 readmissions 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 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 within major health systems through meds 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 in the community. A key milestone this quarter was the SNDA submission for the FUROSCIX Ready Flow 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 bumetanide DPI MannKind 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 get IV-like onset and sustained efficacy. In the short term a DPI formulation of bumetanide 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.

Chris Prentiss (CFO)

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 V-Go contributed $3.8 million, down 19% over the prior year period.

The performance of V-Go 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 INFLOW 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 MannKind 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 reps.

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 SC Pharmaceuticals 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 V-Go 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. Mike.

Michael Castagna (CEO)

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 100-plus years of diabetes therapy. We're extremely excited about this opportunity that lies in front of us now. Let me bridge to INHALE-1, 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 INHALE-1 study, which positions Afrezza as the very first choice bolus insulin for youth age 10 to 18 who were newly diagnosed with type 1 diabetes either upon discharge from the hospital or arriving at the doctor's office within seven days.

This study will evaluate the safety and efficacy of inhaled insulin plus basal in up to 100 patients across 10 leading sites, including the Barbara Davis Center in Denver as well as the Joslin Diabetes Center in Boston. These 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 now that trial is expanding to full enrollment. In the INHALE-1 trial we plan to introduce a two unit cartridge for titration and utilize MannKind's BluHale tracking dose in this trial.

Some of you haven't heard from BluHale 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 timing 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 is 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 in a nintedanib DPI is our INFLOW phase II study, also known as MannKind 201. We have initiated the INFLOW phase 2 with the first patient enrollment expected in Q1 2026.

This randomized placebo controlled trial will include 210 patients with IPF and will evaluate two dose regimens totaling 8 milligrams of inhaled nintedanib a day over 12 weeks followed by a six 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 and A, I want to highlight the upcoming Scientific Medical 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. MannKind 102, a DPI formulation of clofazimine, bumetanide DPI, also known as MannKind 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.

Operator (participant)

Thank you. At this time, if you would like to ask a question, please click on the Raise hand button which can be found in the black bar at the bottom of your screen. When it is your turn, you will receive a message on your screen from the host allowing you to talk and then you will hear your name called. Please accept, unmute your audio, and ask your question. We will wait a moment to allow the queue to form. Our first question comes from Olivia Brayer with Cantor. If you would like to unmute yourself and ask your question.

Olivia Brayer (Director, Senior Biotech Analyst)

Hi, good morning guys. Thank you for the question. 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? I've got a follow-up question on IPF.

Michael Castagna (CEO)

Can you hear me okay, Olivia?

Olivia Brayer (Director, Senior Biotech Analyst)

Yep, coming through. Great.

Michael Castagna (CEO)

Okay, sorry.

I think on the competitors, you know, when we were going to 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 lifecycle management of the auto injector. That has been the key focus for us. I think in terms of the nasal one that got approved, you know, we could see how skinny that package was and how quickly that could get to market. Which played into our decision to advance A and inhaled bumetanide on our FTKP platform. The reason is, you know, we know our platform has IV-like responses and good bioavailability and we felt that's exactly what you're looking for in this fast onset of diuresis.

Especially as you read the Bumex branded label, you can see the quick onset with IV and the diuresis starts pretty much within 15 minutes or so. We hope that that really allowed us to create another differentiated product as a part of this acquisition, which we would not have done had we not bought SC Pharmaceuticals. I think from a competitive viewpoint we will 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 an intrapostanol, the market size grows with more share of voice, more noise, and more reminders of this opportunity. The market is severely underpenetrated and SC Pharmaceuticals had to fund all this on their own. Having more noise out there and more options, I think ultimately is going to help 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. You know, I think let's see what happens when they do. You know, the pricing of the product is not going to change the biggest barrier in Medicare, which is somebody's out-of-pocket cost. Whether it's $500 or $1,000 or $300, the out-of-pocket cost and the deductible is the same on Medicare, which is the majority of these patients in treatments. The real issue is not the WAC price of the product, but it's the net price to the patient. Unless somebody's doing smoothing, the payers aren't going to just cover any of these products willy nilly because they're going to be up against generics in the marketplace. You're going to need reimbursement and support.

You're going to need to figure out the smoothing and the prior refill. 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. 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. I think that we'll continue to watch it, we'll be competitive if we got to make changes. 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.

I think you can see in six months plus of their salesforce expansion, you started to see that kick in, in Q2, but really kick in in Q3 and ultimately Q4. I think from the time we make these investment decisions, you can expect to start to see impact, you know, six, six months, within six months. Hopefully you'll see the CAM expansion. That'll take at least six to nine months in terms of really starting to make impact in the health system. They don't change overnight. In terms of rep share voice, I think we could see an impact on prescribing sooner and I think that'll be our focus is to kind of minimize disruption with customer relationships, but expand the shared voice on cardiologists and nephrologists as we go into 2026.

Olivia Brayer (Director, Senior Biotech Analyst)

That's helpful.

Thanks, Mike. For the TYVASO bridging study in IPF, what can you guys tell us at this point? It sounds like it maybe is confirmed that a bridging study will be run, but any sense of timing and whether you still expect it to look similar to the BREEZE study?

Michael Castagna (CEO)

I do not want to speak for UT. I think they have said it could be a BREEZE-like study. I think let that communication go to the FDA. Now that they have the TETON-2 results, I expect them to move this as quickly as possible to the FDA for clarification and discussion.

Olivia Brayer (Director, Senior Biotech Analyst)

Okay, understood. Thank you.

Operator (participant)

Thank you. Our next question comes from Faisal Khurshid with Leerink. If you would like to go ahead and ask your question.

Faisal Khurshid (Director, Equity Research)

Hey guys, thanks for taking the question. Just wanted to add two questions. One, just on thinking about the SC Pharmaceuticals acquisition and FUROSCIX, could you comment a little bit on the integration process with respect to the field force, how that's been going and if you have any updated thoughts on kind of what the field force composition will look like across your kind of multiple commercial brands. Now that's the first one. I have a follow up as well.

Michael Castagna (CEO)

Sure. I'd say first, you know, as we got to integration, it's only been closed about three weeks and it feels like, you know, we have already met most of the employees once or twice. A person 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.

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 integrated them into our leadership team and our processes. 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 as it goes. You'll see SC Pharma continue to be independent through the end of the year in terms of their name and job posting, things like that. You'll start to see that integration fully in 2026, starting in January, all the way through any packaging changes, et cetera. 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. We'll try to phase those things in as we think about like the auto injector launching, things like that. I think that answers the integration question.

Faisal Khurshid (Director, Equity Research)

Got it. Then just on the balance sheet, how should we think about sort of your guys' kind of like relative priority between like investing in the launch of, you know, Afrezza Peds, FUROSCIX, delevering the balance sheet and kind of maintaining operational profitability. How do you kind of balance like these three different goals?

Michael Castagna (CEO)

Yeah, I think if we see we're already preparing for the Afrezza Peds launch, so you're seeing some increase in expenses this year with MSLs, key account managers, some commercial pre launch investments. I think you'll see that tick up.

I think on FUROSCIX we're also going to place a few bets here to grow the brand faster as we go into 26. We feel like these are the right decisions that we think investors want from faster growth and we think we can deliver that in 26 with what we have coming. I'll let Chris comment just on the deleveraging and some of the debt there that we're thinking about.

Chris Prentiss (CFO)

Yeah, the key item to deleverage is really on our convert. We have a $36 million stub that's due March 1st of 2026. We will 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 you are 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.

Faisal Khurshid (Director, Equity Research)

Got it. Thank you for the questions.

Operator (participant)

Thank you. Our next question comes from Andreas Argyrides with Oppenheimer. If you would like to go ahead and ask your question.

Andreas Argyrides (Managing Director)

Good morning and thanks for taking our questions.

Congrats on the progress in the court.

The closing of the SC Pharma 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? Thanks.

Michael Castagna (CEO)

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

Chris Prentiss (CFO)

I think Andreas was asking about the pediatric opportunity.

Michael Castagna (CEO)

Oh, sorry. On the pediatric side, we are just finishing up some research right now to get us ready for next year and I think that will. One of the things we know what the peak upside could be. We said roughly 10% market share is about $150 million in net revenue. And we've gotten research that would indicate, you know, up to 25% could be possible. I think the question is how fast is that trajectory going to happen? And we haven't yet given guidance on that. I think that's really what I'll be focused on to get ready for 2026 is, you know, we look at some of the competitive pump launches that happen this year and, you know, they're seeing nice, significant uptake in those markets. I think there is an opportunity to grow meaningfully faster post peds.

I think we gotta make sure our market research triangulates what we're thinking before we go public. Okay.

Andreas Argyrides (Managing Director)

The question on NTM and then a follow up on that one as well.

Michael Castagna (CEO)

Yeah, I think on the NTM a lot of, you know, Japan was going nicely, I think in the U.S. starting to pick up a little bit. The team has met at several conferences here, just raising awareness amongst KOLs to continue enrollment. I think that's there. We just got recently at FDA to agree to loosen the EKG monitoring requirements on entry in terms of the screening criteria so that we're implementing as we speak. In terms of power, I think we're 90% powered.

That is why we have the interim, to really make sure that that would be on track as we look at the patients. Remember, we're seeing people roll over to open label extension. These will all be important aspects as we go out.

Andreas Argyrides (Managing Director)

What are the, and just to follow up there, 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?

Michael Castagna (CEO)

Yeah, I mean, one is the sample size. If we're close and you'd want to increase the sample size, that could be it. The other one is the safety database, making sure we're continuing going that direction. You will have the futility, meaning it just is not delivering what we expect.

That could also be an outcome as well as just, you know, you're on track to meet the 180. That said, in Japan we only need 180. In the U.S., you know, we're evaluating the total safety database required still with FDA.

Andreas Argyrides (Managing Director)

Okay, great. Thanks for taking my questions and congrats again.

Operator (participant)

Thank you.

Michael Castagna (CEO)

Thank you.

Operator (participant)

Our next question comes from Yun Zhong with Wedbush. If you'd like to go ahead and ask your question.

Yun Zhong (Biotech Equity Research Analyst)

Hi, good morning.

Thank you very much for taking the questions. On the SC Pharma acquisition, did I hear correctly that you said there was going to be an ongoing salesforce expansion? Is that mainly on the SC Pharma side on the commercialization of FUROSCIX? Once you report sales starting from fourth quarter, can you remind us how you expect the addition to impact the SG&A line in the income statement, please.

Michael Castagna (CEO)

I'll let Chris take the second one. I'll start on the first one. I think we'll be a little quiet on the Salesforce expansion and share of voice. What we expect, one of the things we looked at is last year when SC split some territories. How quickly did you start to see that growth rebound? How disruptive was that to the Salesforce? You could see in the first quarter some of that disruption was true. I think the bigger part was the medicine, your copay resets from Q4 to Q1. As we look at this year, you know, we'll expect a similar phenomenon is that, you know, patient resets happen and then the copays pretty much go to zero as people hit their deductible.

We want to get that salesforce share voice up as we go into the new year and really prepare for that Medicare transition period. That'll be important. I think we can definitely see share of voice does increase sales per customer per territory. We feel like that track record is there from when they went from 40 to 80. We won't comment yet on the expansion because we're still finalizing some of that. We do have some plans. We met with the team. You'll see the number one thing is the key account manager expansion. We think that's the nearest term, low hanging fruit. There will be some additional ways that we can incorporate increased sharepoints.

Chris Prentiss (CFO)

Yeah.

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. You know, I would expect most of those costs to be that they have experienced previously on the commercial side is what we'll be reporting in Q4 as well. Plus the investment in in cams that Mike just talked about. On the G&A side, you're seeing quite a bit of synergies are realized right away as we think about, you know, public company costs as we think about systems and tools that we all use in common.

Yun Zhong (Biotech Equity Research Analyst)

Okay, then on Afrezza, you talked about this. Sales not growing as fast as TRx. Do you expect the same pattern in fourth quarter?

At some point would you expect sales to catch up with the TRx?

Michael Castagna (CEO)

I would. Q4 should be pretty strong. Pattern may exist because of the NRx trends impacting TRx. In general in Q4 we see a lot of refill. A lot of those baseline patients in our business will refill before the end of the year. Co pays reset. I think it'll be pretty, pretty decent in Q4, but I would expect the trend to bottom out sometime over the next six months and then start to be stable more in line as we get through Q1 next year. You know, I think that as we look at the growth, the growth in outflows, growth in scripts, plus any price changes, once that volume per script starts to even out, we'll be there. It dropped.

I don't see it dropping much more, but I'm sure it'll drop another quarter to a little bit. I just. It's not another 20% but it's probably single digits.

Yun Zhong (Biotech Equity Research Analyst)

Great, thank you very much.

Operator (participant)

Thank you. Our next question comes from Brandon Folkes with HCW, if you'd like to go ahead and ask your question.

Brandon Folkes (Managing Director)

Hi, thanks for taking my question.

Congratulations on the results.

Maybe just from 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 know, put a lot of good.

Context around the peds side of Afrezza.

But just any help in terms of that label expansion?

Michael Castagna (CEO)

Okay, Brandon, you can hear me okay?

Brandon Folkes (Managing Director)

Yep.

Michael Castagna (CEO)

Okay, the label expansion was kind of three month delay from November to January. We expect a draft label in December based on their latest communication and that's fine. I mean we were going to launch the label change anyway in January. 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 number one adverse event is lack of effect. That's because doctors do not titrate up fast enough or they do not convert at the appropriate dose. Our top prescribers, this is generally not an issue and that's what drives most of our business.

As we expand the Salesforce, excuse me, those new prescribers who do not have a lot of experience, that is where we see the mistakes happen, that is where we see the patient dropouts happen faster. As we continue to expand, we want to get this fixed, we want to get this right so that patients start off on the right dose the first time. That is 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. We do feel our top prescribers know the information, but it is really the new prescribers, it will be important. That salesforce expansion for Afrezza is just getting out there, you know, over the next month or so. Call December, January, when the label change happens. The timing still mirrors up nicely.

If people start off better, they'll stay on the drug longer, they'll be happier, the doctors will rate more. Right. It is kind of a self-fulfilling prophecy here in the end.

Brandon Folkes (Managing Director)

Great, thank you. One more from me, if I may.

Can you just elaborate a little bit?

On the development path you're thinking about for MannKind 701 DPI?

Michael Castagna (CEO)

Yeah. So when you, I think at a high level, what got us excited is you can, it looks like you can choose to. First, the tox studies won't be chronic because it's an acute drug. So call it 28 days of tox roughly. And then you'll have a PK study which will not be, need to be, you know, multiple time periods. So you're probably looking at single, maybe multiple days, but not, not a 10 day or anything like that. So the PK station, pretty straightforward. And then the other thing about bumetanide that we like is, you know, you can give it alcohol, you know, works, it's got a very short half life.

You could give it really quickly, get a quick diuresis going and then decide six, eight hours later if they want to give another dose. You'll have more flexibility as the way Bumex's label is written versus today in the nasal you don't look like you have that flexibility because of max daily dose. On an inhaled version, which should have greater bioavailability, we should have more flexible dosing as we look at the labels. FUROSCIX I think does get you that 24 hour diuresis and looks strong whether it's in the auto injector or the infuser. We feel like we'll have two products out there in the space. Depending on how people want to treat, we'll be competitive on both angles here over the near term.

I, we don't look at this as a very long development program. Probably long poles in attempt will be scale up and stability more than the trials themselves. The team's just starting to get the formulation work moving and you know as soon as we feel pretty good we'll be able to formulate it relatively quickly. Then we got to meet with FDA in parallel and try to get that alignment, which we think we know what that's going to look like given the history here at FUROSCIX.

Brandon Folkes (Managing Director)

Okay.

Operator (participant)

Thank you. Our final question for today comes from Anthony Petrone with Mizuho. If you would like to unmute your line and ask your question.

Anthony Petrone (Managing Director Equity Research)

Thanks. Just can you hear me okay?

Michael Castagna (CEO)

Fine.

Anthony Petrone (Managing Director Equity Research)

Okay, great. Thanks Mike. Few on SC Pharma, just on the SCP-111 SNDA submission that's already taken place. Just want to know if there's any early questions from FDA. You know the bioabsorbability profile looks good. You know, maybe just probability of success on getting that through and then I'll have a couple of quick follow ups on the FUROSCIX to SCP-111 transition.

Michael Castagna (CEO)

Yeah, 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. We feel they're, they're on top of the submissions. I'm glad we got the submission in in September.

SC did it, we didn't do anything but that is allowing IRS 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. It does look like they're checking the boxes going through the file and that so far there's no red flags and 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. 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.

Anthony Petrone (Managing Director Equity Research)

If we think ahead to a positive outcome here, the Ready Flow Auto-Injector dramatically reduces the admission time. You know, what do you think could happen to unique prescribers if you get this on market? When you think about, you know, that auto-injector relative to the current delivery device, you know, what do you think it could actually do to margins, you know, for this product?

Michael Castagna (CEO)

Yeah. Again, you know, it's been a few weeks, so I do not want to comment too much as I am still working with the team to think about the right segmentation. I think we look at this as market expansion. When you look at the audience today, some may like the infuser for various reasons and we will make sure we understand those targets and the reasons that support that. The real opportunity is the expansion. Right.

There's a lot of people, whether they're nursing homes or in discharge protocols or elderly patients being taken care of by their kids or people would much rather use an auto injector. That to me is the upside that we're looking for in inflection that could spark faster growth. That's one reason we want to get the shared voice up. Right. Is get the awareness up of the product and still see, I want to say there's like 40,000 cardiologists, so the team's targeting 5,000-7,000. We think we can boost up the number of cardiologists aware of the product and 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.

I think the patient demand and the unmet need in CMS, all the things are going in the right direction and our ability to compete, whether it's going to be an LB MET night one day or the FUROSCIX Auto-Injector All Body fuser, I think will be able to provide a lot of solutions to the various patient types. I would not look at one replacement as much as we are looking at how we could grow it faster.

Anthony Petrone (Managing Director Equity Research)

I see. Thanks again.

Operator (participant)

Thank you. 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.

Michael Castagna (CEO)

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. 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. Thank you again and we'll try to close the year strong and talk to you next year.