Q3 2025 MannKind Corp Earnings Call

Speaker #1: Kind Corporation . Third quarter 2025 financial results . Earnings call . As a reminder , this call is being recorded on November 5th , 2025 and will be available for playback on the Mannkind Corporation website .

Speaker #1: 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 .

Speaker #1: For further information on the company's risk factors , please see the form 10-q for the quarterly period ended September 30th , 2025 . The earnings release and the slides prepared for this presentation .

Speaker #1: Joining us today for mankind are Chief Executive Officer , Michael Castagna and Chief Financial Officer Chris Prentice . I'd now like to turn the conference over to Mr. Castagna .

Speaker #1: Please go ahead , sir .

Speaker #2: Good morning , and thank you for joining our Q3 2025 earnings call . Let me start with the Q3 highlights . We delivered a record revenue a quarter of $82 million .

Speaker #2: We also strengthened our portfolio with the acquisition of SC pharmaceuticals on the pipeline side , Afrezza supplemental Bla was accepted for review with a date of Q2 2026 .

Speaker #2: We also saw strong performance from Tyvaso DPI , which contributed $59 million in royalties and manufacturing related revenue , reinforcing the durability of our revenue streams .

Speaker #2: Chris will review the details of our third quarter results shortly . We're excited to have completed the acquisition of Vesti Pharmaceuticals and are pleased to welcome their talented team to mankind .

Speaker #2: Together , we're focused on unlocking the full potential of Furoscix , as well as the advancement of inhaled bumetanide aka Mannkind 701 for fluid overload and CKD and heart failure as our target indications .

Speaker #2: We are encouraged by the momentum across our clinical development programs that we've been working on in the past five plus years . In terms of mankind 101 and 201 , which I'll discuss at the end of our call .

Speaker #2: Now , let me bridge to our near-term growth catalysts . Build 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 .

Speaker #2: I'll point to a few of these milestones . The NDA for Furoscix Autoinjector was submitted to the FDA in Q3 as planned , with an expected date of Q3 26 .

Speaker #2: 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 .

Speaker #2: We've also completed enrollment into our mid-term target for Icon one and two . Phase three ahead of schedule , allowing us to confirm the sizing of the trial mid next year .

Speaker #2: 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 DPI , earning $33 million in royalties and $26 million in manufacturing related revenue .

Speaker #2: As Utsi 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 .

Speaker #2: Following UTS positive , Teton two 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 .

Speaker #2: Additionally , UBT 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 .

Speaker #2: In Q3 , Afrezza grew 31% and new prescriptions and 27% in total prescriptions year over year . As we shifted our focus to type one diabetes in preparation for pediatrics , our units per script have declined by about 15% year over year as the average person with type one diabetes requires less insulin than the average type two .

Speaker #2: The impact you can start to see as see reflected in the difference between our net revenue growth being lower than our TRX growth .

Speaker #2: 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 .

Speaker #2: 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 .

Speaker #2: 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 Pharma's experience team with the Mannkind team .

Speaker #2: 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 .

Speaker #2: Fluid overload remains a significant burden and Furoscix addresses a critical gap in care by helping break the cycle of hospital admissions and remissions .

Speaker #2: SC Pharm 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.

Speaker #2: 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 .

Speaker #2: 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 .

Speaker #2: 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 voice is accelerating product adoption .

Speaker #2: 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 .

Speaker #2: 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 FDA pharmaceutical Acquisition to put the growth we are seeing in perspective .

Speaker #2: 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 .

Speaker #2: There are 2.1 million addressable heart failure episodes in the US , mostly driven by congestion from worsening heart failure . And for patients 65 and older .

Speaker #2: 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 .

Speaker #2: This is where Furoscix makes a difference . It's key feature is to allow patients to treat edema at home and reduce hospital admission time and or readmissions .

Speaker #2: Now , I'd like to talk about the furoscix opportunity for intervention . Qrxpharma achieved success in Furoscix by focusing on community physicians who treat CKD and heart failure , often before a patient shows up for the E.R.

Speaker #2: , which is on the left side of the slide . By intervening early , physicians potential to reduce hospitalizations and break the cycle of hospital readmissions .

Speaker #2: 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 .

Speaker #2: This approach aligns with CMS 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 .

Speaker #2: These changes underscore the importance of early intervention and strengthen Furoscix role as a key enabler for providers to meet quality and cost targets .

Speaker #2: 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 .

Speaker #2: 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 with a major health systems through the bed programs .

Speaker #2: This position furoscix for far greater utilization of 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 , prescribing level .

Speaker #2: A key milestone this quarter was the NDA 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 .

Speaker #2: Strengthen our portfolio and improving margins . Additionally , we're advancing bumetanide DPI mankind 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 .

Speaker #2: But a subpopulation may prefer to inhale versus inject . Our Technosphere technology should provide comparable bioavailability based on our historical development programs and 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 , non-invasive and highly portable solution enabling patients and providers to manage fluid overload without hospitalization .

Speaker #2: I'll now turn the call over to Chris to review our third quarter results . Thank you . Mike , and .

Speaker #3: 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 .

Speaker #3: These royalties increased 23% to 33 million , reflecting the continued strong performance of Tyvaso DPI under our collaboration with United Therapeutics collaboration and Services .

Speaker #3: 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 .

Speaker #3: 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 .

Speaker #3: 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 one trial of inhaled Clofazamine and preparations for the inflow phase two IPF study , which is expected to begin enrolling in Q1 2026 .

Speaker #3: These increases were partially offset by the completion of the inhaled three and Mannkind 201 phase one studies in 2020 for selling general and administrative expenses increased 5.2 million , or 22% , in the third quarter versus the prior year period .

Speaker #3: 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 .

Speaker #3: SG&A for this quarter also included 3.7 million of acquisition related expenses . Q4 , G&A expenses will include costs related to our October key account manager team , build out to support the Afrezza pediatric call point .

Speaker #3: 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.

Speaker #3: 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 30th , to fund the transaction , and have borrowed an aggregate of 325 million on our five year term loan facility with Blackstone .

Speaker #3: For the year to date period of 2025 , total revenues reached 237 million , representing 14% growth compared to the same period last year .

Speaker #3: 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 .

Speaker #3: 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 .

Speaker #3: 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 .

Speaker #3: 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 2020 .

Speaker #3: For 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 pediatric indication .

Speaker #3: Mike .

Speaker #2: Thank you . Chris . As we broaden our impact across cardiometabolic care , we're also advancing innovation and diabetes , starting with the potential to offer the first non-injectable insulin for pediatric patients in 100 plus years of diabetes therapy .

Speaker #2: 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 .

Speaker #2: We're focused on generating additional clinical evidence to support Afrezza's role in children with type one diabetes . This is why we're initiating the inhale .

Speaker #2: First study , which positions Afrezza as the very first choice . Bolus insulin for youth aged 10 to 18 who were newly diagnosed with type one diabetes .

Speaker #2: 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 and up to 100 patients across ten leading sites , including the Barbara Davis Center in Denver , as well as the Joslin Diabetes Center in Boston , who will be our first two sites to dose patients to ensure dosing protocol and training materials are meeting expectations .

Speaker #2: This is what we did in our gestational trial . In the first ten test , patients confirmed our expectations on that trial is expanding to full enrollment .

Speaker #2: In the inhale first trial , we plan to introduce a two unit cartridge for titration and utilize Mannkind's Blue Hill tracking dose . In this trial , some of you haven't heard from Blue Hill 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 .

Speaker #2: Integrate with CGM and remind you when you took your last dose , and how much Afrezza's on board , and start to show you your time in range by day , night and time of week .

Speaker #2: 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 .

Speaker #2: I'll first discuss our icon , one global phase three study in NTM , where the market is expected to exceed $1 billion by the end of the decade .

Speaker #2: We achieved our interim enrollment target ahead of schedule in the study . Our focus will be on the US and Japan , which have the largest populations and the greatest growth potential .

Speaker #2: 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 .

Speaker #2: I'd like to remind you that this trial is a co-primary endpoint in the US of sputum culture . And patient reported outcomes , but for the US market , it's just sputum culture conversion .

Speaker #2: Our next trial in a DPI is our Inflow Phase Two study, also known as Mankind 201. We have initiated the Inflow Phase Two with the first patient enrollment expected in Q1 2026.

Speaker #2: This randomized , placebo controlled trial will include 210 patients with IPF and will evaluate two dose regimens totaling eight milligrams of inhaled a day over 12 weeks , followed by a six month open label extension .

Speaker #2: 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 .

Speaker #2: More importantly , based on the positive Teton two 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 .

Speaker #2: In the future, before we move to Q&A, I want to highlight the upcoming scientific medical investor conferences where we'll have a presence.

Speaker #2: 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 .

Speaker #2: Mankind 102 , a DPI formulation of Clofazamine imatinib DPI , also known as mankind 701 , and our new collaboration with United Therapeutics .

Speaker #2: 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 mankind .

Speaker #2: With that , I'll turn the call over to the operator to answer your questions .

Speaker #1: 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 .

Speaker #1: 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 .

Speaker #1: Please accept the unmute your audio and ask your question . We will wait a moment to allow the queue to form . Our first question comes from Olivia Breyer with Cantor .

Speaker #1: If you would like to unmute yourself and ask your question . Hi .

Speaker #4: Good morning guys . Thank you for the question . Can you share any thoughts on on the recent approvals from Furoscix competitors ? And if you could contextualize the pricing differences and how that actually funnels down in terms of actual out of cost or out of pocket costs to patients .

Speaker #4: 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?

Speaker #4: And then I've got a follow up question on IPF .

Speaker #5: Can you hear me ? Okay . Olivia .

Speaker #4: Yep . Coming through . Great .

Speaker #5: Okay . Sorry . So I think on the competitors , you know , when we when we were going through the due diligence , we knew these two competitors were in the wings .

Speaker #5: 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.

Speaker #5: And then I think in terms of the the nasal one that got approved , you know , we could see how skinny that package was .

Speaker #5: And how quickly that could get to market , which played into our decision to advance a an inhaled bumetanide on our fdkp platform .

Speaker #5: And 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 .

Speaker #5: You can see the the quick onset with IV and the diuresis starts pretty much within 15 minutes or so . So that 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 SC Pharma .

Speaker #5: So I think from a competitive viewpoint , we'll be able to compete nicely with the new 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 .

Speaker #5: The market is severely under and SC Pharma had to fund all this on their own . So having more noise out there and more options , I think ultimately 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 .

Speaker #5: To my knowledge . And , you know , I think let's see what happens when they do . But , you know , it's the pricing of the product is not going to change .

Speaker #5: The biggest barrier in Medicare , which is somebody out-of-pocket costs . So whether it's $500 or $1000 or $300 , the out-of-pocket cost and the deductible is the same on Medicare , which is the majority of these patients in treatment .

Speaker #5: So the real issue is not the price of the product , but it's the net price of the patient . Unless somebody is doing something , you know , 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 .

Speaker #5: So you're going to need reimbursement support . You're going to need to figure out the smoothing and all . So I think I like the SC model .

Speaker #5: I like that we know where our patients are. We know when they get a refill. We know when the prior auth expires.

Speaker #5: So so I think the system that they have in place is good . You'll hear some complaints that people want access locally . And that's that's a lot of IDN contracting .

Speaker #5: So I think that what we'll continue to watch it will be competitive . If we gotta make changes . But I think in the end we feel pretty good about our price point and our and our net pricing .

Speaker #5: On the growth inflection . I mean , one of the things you'll start to see next year is increasing the share of voice .

Speaker #5: And I think you could see in six, six months, plus of their sales force expansion, you started to see that kick in in Q2.

Speaker #5: But really kick in in Q3 . And Q4 . So 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 , there .

Speaker #5: So so hopefully you'll see the cam expansion that will take at least 6 to 9 months in terms of really starting to make impact in a health system .

Speaker #5: They don't change overnight . But in terms of share of 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 .

Speaker #5: But expand the share of voice on cardiologists and nephrologists as we go into 26.

Speaker #4: That's helpful . Thanks , Mike . And then for the Tyvaso bridging study and IPF , what can you guys tell us at this point ?

Speaker #4: It sounds like it . Maybe is confirmed that a bridging study will be run . But but any sense of timing and whether you still expect it to look similar to the study .

Speaker #5: I don't want to speak for you . T so I think , you know , they've said it could be a breeze like study .

Speaker #5: So I think what that communication go to the FDA now that they have the Teton two results , I expect them to to move this as quickly as possible , you know , to the FDA for for clarification and discussion .

Speaker #4: Okay . Understood . Thank you .

Speaker #1: Thank you . Our next question comes from Faisal Khurshid with Leerink . If you would like to go ahead and ask your question .

Speaker #6: Hey guys . Thanks for the question . Just wanted to add two questions . One , just on thinking about the farm and Furoscix , could you comment a little bit on the integration process with respect to the field force ?

Speaker #6: 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 ?

Speaker #6: Now that's the first one that I have a follow up as well .

Speaker #5: 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 .

Speaker #5: 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 26 .

Speaker #5: So I think the integration is going very smooth . The culturally , the companies are very similar . So there's not a lot of friction .

Speaker #5: We already have put some of their people in key positions on our side and integrated them into our leadership team and our processes .

Speaker #5: So I think overall integration , we don't see much disruption , sales continues to look strong in Q4 here . So so we're very happy to date with with the teams and the integration as it goes .

Speaker #5: You'll see SC Pharma continue to be independent through the end of the year in terms of their name and job postings , things like that .

Speaker #5: You'll start to see that integration fully in 26 starting in January , all the way through any , any packaging changes , etc. .

Speaker #5: 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 .

Speaker #5: So we'll try to phase those things in as as we think about , like the auto injector launching , things like that . So I think that the integration question .

Speaker #6: Got it . And then just on the balance sheet , how should we think about sort of your guys's kind of like relative priority between like investing in the launch of , you know , a present impedes veroe6 delivering the balance sheet and kind of maintaining operational profitability , like , how do you kind of balance like these three different goals ?

Speaker #5: Yeah , I think if we see we're already preparing for the Afrezza launch , you're seeing some increase in expenses this year with Msl's key account managers , some commercial pre-launch investments .

Speaker #5: So so I think you'll you'll see that tick up . I think going forward we're also going to place a few bets here to grow the brand faster as we go into 26 .

Speaker #5: So so we feel like these are the right decisions that we think investors want faster growth , and we think we can deliver that in 26 with what we have coming .

Speaker #5: I'll let Chris comment just on the deleveraging and some of the debt there that we're thinking about .

Speaker #3: Yeah , the key item to to deleverage is really on our convert . We have a 36 million stub that's due March 1st of 2026 .

Speaker #3: So we'll certainly be addressing that in the near term. And, you know, in terms of what Mike said, I think the priority right now is investing in growth.

Speaker #3: 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 .

Speaker #6: Got it . Thank you for the questions .

Speaker #7: Thank you .

Speaker #1: Our next question comes from Andreas Arteritis with Opko . If you would like to go ahead and ask your question .

Speaker #8: Good morning and thanks for taking our questions . Congrats on the progress in the quarter and the closing of the pharma deal . Just following up from some previous questions .

Speaker #8: 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 power assumptions for that study ?

Speaker #8: Thanks .

Speaker #5: 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 was analyst reports out there and it put it into $500 million plus range .

Speaker #5: And I think that, you know, 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.

Speaker #5: Chris , I don't know if you have anything else to add before I .

Speaker #3: I think Andreas was asking about the pediatric opportunity .

Speaker #5: Oh , sorry . On the pediatric side , we are just finishing up some some research right now to get us ready for next year .

Speaker #5: And I think that one of the things we know with the peak upside could be we said roughly 10% market share is about $150 million in net revenue.

Speaker #5: And we've gotten research that would indicate up to 25% could be possible . I think the question is , how fast is that trajectory going to happen ?

Speaker #5: And we haven't yet given guidance on that . So I think that's really what I'll be focused on as we get ready for 26 is , you know , we look at some of the competitive pump launches that happened this year .

Speaker #5: And , you know , they're seeing nice significant uptake in those markets . And so I think there is an opportunity to grow meaningfully faster post PEDs .

Speaker #5: But but I think we got to make sure our market research triangulates what we're thinking before we go public . Okay . On that .

Speaker #8: The question on MTM and then a follow up on that one as well . Yeah .

Speaker #5: Yeah , I think on MTM , a lot of , you know , Japan was going nicely , I think in the US starting to pick up a little bit .

Speaker #5: The team has met at several conferences here , just raising awareness amongst colleagues to continue enrollment . So I think that's there . And then we just got recently FDA to agree to loosen the EKG monitoring requirements on entry in terms of screening criteria so that we're implementing , as we speak .

Speaker #5: And then in terms of power , I think we're 90% powered . And that's why we have the interim is to really make sure that that we'll be on track as we as we look at the patients , remember , we're seeing people roll over , you know , into Open-label extension .

Speaker #5: So these will all be important aspects as we go out .

Speaker #8: What are the and there's the 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 ?

Speaker #5: Yeah , I mean , one is the sample size . So , you know , if we're close and you'd want to increase the sample size , that could be it .

Speaker #5: The other one is the safety database . Making sure we're continue going in that direction . Then you'll have the futility meaning it just is not delivering what we expect .

Speaker #5: And that could also be an outcome as well as just , you know , you're on track to meet the 180 . And that said , in Japan we only need 180 .

Speaker #5: In the US , you know , we're evaluating the total safety database required . Still , with FDA .

Speaker #8: Okay . Great . Thanks for taking my questions and congrats again .

Speaker #1: Thank you .

Speaker #5: Thank you .

Speaker #1: Our next question comes from Yan Zhang with Wedbush . If you'd like to go ahead and ask your question .

Speaker #9: Hi . Good morning . Thank you very much for taking the questions . And as sea farmer Acquisition , did I hear correctly that you said there was going to be a or ongoing sales force expansion ?

Speaker #9: Is that mainly on the farmers side on the merger , commercialization of forensics and then once you report sales starting from fourth quarter , how can you remind us , how do you expect them ?

Speaker #9: The addition to impact the SG&A line in the income statement , please .

Speaker #5: I'll let Chris take the second one . I'll start on the first one . So I think we'll be a little quiet on the sales force expansion and share of voice .

Speaker #5: But we expect one of the things we looked at is last year when SC split some territories , how quickly did we start to see that growth rebound ?

Speaker #5: How disruptive was that to the sales force? And you can see in the first quarter some of that disruption was true. But I think the bigger part was the medical copay resets from Q4 to Q1.

Speaker #5: So as we look at this year , you know , we'll expect a similar phenomenon is that patient resets happen and then the copay is pretty much go to zero as people hit their deductible .

Speaker #5: So we want to get that sales force share of voice up as we go into the new year . And really prepare for that , that Medicare transition period .

Speaker #5: But that'll be important . I think we can definitely see , share of voice . Does increase sales per customer , per territory .

Speaker #5: So we feel like that track record's there from when they went from 40 to 80. And we won't comment yet on the expansion that we're still finalizing.

Speaker #5: Some of that . But we do have some plans . We met with the team and you'll see the number one thing is the key account manager expansion .

Speaker #5: We think that's the nearest term low hanging fruit . And then there'll be some additional ways that we can incorporate furoscix in the increased share of voice .

Speaker #3: 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 .

Speaker #3: And so , you know , I would expect most of those costs to be that they have experienced previously . On the commercial side is what will be reporting in Q4 as well .

Speaker #3: 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 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 .

Speaker #9: Okay . Then on Afrezza , you talked about this sales not growing as fast as TRX . Do you expect the same pattern in fourth quarter ?

Speaker #9: And at some point , would you expect sales to catch up with the TRX ?

Speaker #5: I would Q4 should be pretty strong . Pattern may exist because of the trends impacting TRX , but in general Q4 , we see a lot of refills .

Speaker #5: So a lot of those baseline patients in our business will refill before the end of the year . Co-pays reset . So I think it'll be pretty , pretty decent in Q4 .

Speaker #5: But I would expect the trend to bottom out sometime over the next six , six months . And then start to be stable .

Speaker #5: More in line as we get through Q1 next year . But , you know , I think that as we look at the growth , the growth in outflows , growth in scripts , plus any price changes , you know , once that volume scripts starts to even out , we'll be there .

Speaker #5: But it dropped a lot . I don't see it dropping much more , but I'm sure it'll drop another quarter to a little bit .

Speaker #5: So it's not another 20% , but it's probably a single digits .

Speaker #9: Great. Thank you very much.

Speaker #1: Thank you . Our next question comes from Brandon Folkes with H . CW . If you'd like to go ahead and ask a question .

Speaker #10: Hi . Thanks for taking my question . And congratulations on the results . Maybe just from me on Afrezza . Can you just help us think about the potential tailwind you expect from .

Speaker #10: The freezer ? Fraser conversion dose label update . And how you expect to leverage that label expansion to drive the Fraser growth . You know , put a lot of good context around the PEDs side of Fraser .

Speaker #10: But just any help in terms of that label expansion .

Speaker #5: I mean , okay , Brandon , you can hear me . Okay .

Speaker #11: Yeah .

Speaker #5: Okay . So the label expansion was kind of three month delay from November to January . We expect the label in December based on the latest communication .

Speaker #5: And that's fine . I mean , we were going to launch the label change anyway in January . So so that timing is not that far off .

Speaker #5: The key thing about the label expansion is it really allows us to talk about the postprandial control . And our number one adverse event is lack of effect .

Speaker #5: And that's because doctors do not titrate up fast enough or they don't convert at the appropriate dose . So our top prescribers , this is generally not an issue .

Speaker #5: And that's what drives most of our business . But as we expand the sales force excuse me , those new prescribers who don't have a lot of experience , that's where we see the mistakes happen .

Speaker #5: 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 off on the right dose the first time .

Speaker #5: 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 .

Speaker #5: With the sales force . So we do feel our prescribers know the information , but it's really a new prescribers that will be important .

Speaker #5: And that Salesforce expansion for Afrezza is just getting out there . You know , over the next month or so . So call it December , January when the label change happens , the timing still mirrors up nicely .

Speaker #5: So if people start off better , they'll stay on the drug longer . They'll they'll be happier . The doctors will write more .

Speaker #5: Right . So it's kind of a self-fulfilling prophecy here . In the end .

Speaker #10: Great . Thank you . And then one more from me , if I may . Can you just elaborate a little bit on the development path ?

Speaker #10: You're thinking about for DPI ?

Speaker #5: 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 talk studies won't be chronic because it's an acute drug .

Speaker #5: So call it 28 days of talks . Roughly . And then you'll have a PK study , which will not be need to be , you know , multiple time periods , probably looking at single , maybe multiple days , but not not a ten day or anything like that .

Speaker #5: So the PK studies should be pretty straightforward . And then the other thing about Bumetanide that we like is , you know , you can give it , I'll call it , you know , it works .

Speaker #5: It's got a very short half life . So 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 a way .

Speaker #5: Bumex label is written versus today in the nasal . You won't . You don't look like you have that because of the max daily dose , but on an inhaled version which will have should have greater bioavailability , we should have more flexible dosing .

Speaker #5: As we look at the labels and furoscix , I think does get you that 24 hour diuresis and looks strong . Whether it's in the autoinjector or the infuser .

Speaker #5: So we feel like we'll have two products out there in this space . So depending on how people want to treat , will be competitive on both angles here over over the near term .

Speaker #5: But we don't look at this as a very long development program . Probably long poles in the tent will be scaled up and stability more than the trials themselves .

Speaker #5: So the team is just 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 .

Speaker #5: But 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 of Furoscix .

Speaker #5: So .

Speaker #1: Okay . Thank you . Our final question for today comes from Anthony Petrone with Mizuho . If you would like to unmute your line and ask a question .

Speaker #12: Thanks . Just can you hear me ? Okay .

Speaker #5: Are you fine ?

Speaker #12: Okay . Great . Thanks . Mike . Few on SC Pharma just on the SCP 111 Snda submission . That's already taken place .

Speaker #12: Just just want to know if there's any early questions from from FDA . You know , the Bioabsorbability profile looks good . You know , maybe just probability of success on getting that through .

Speaker #12: And then I'll have a couple of quick follow ups on on the Furoscix to SCP 111 transition .

Speaker #5: Yeah , I think on the FDA , I can tell you they're are active despite the government shutdown , whether it's factory inspections or inquiries on the various programs we have in front of them .

Speaker #5: So we feel they're they're on top of the submissions . I'm glad we got the submission in September as he did it . We didn't do anything but but that is allowing IRS to come in already .

Speaker #5: 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 a Fresno or are we getting them on SC ?

Speaker #5: So it does look like they're checking the boxes going through the file . And so far there's no red flags . And that's true for the the pediatric filings as well .

Speaker #5: When we got there the letter you know they identified the same thing . We already knew , which is that one outlier in the trial .

Speaker #5: And so that that we feel is pretty straightforward as we go forward . I'm sure there'll be more inquiries as we review everything .

Speaker #5: But but in general , it seems like a reasonable request so far from everything we can see .

Speaker #12: And if we think ahead to a positive outcome here, the Ready Flow Injector dramatically reduces the admission time. You know, what do you think could happen to unique prescribers if you get this on the market?

Speaker #12: And when you think about , you know that auto injector relative to the current delivery device , what do you think it could actually do to margins ?

Speaker #12: You know , for this product ? Yeah . Again .

Speaker #5: I you know , it's been a few weeks , so I don't want to comment too much as I'm still working with the team to think about the right segmentation .

Speaker #5: But I think we look at this as market expansion . So when you 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 and support that .

Speaker #5: But the real opportunity is the expansion , right ? There's a lot of people , whether they're in nursing homes or in discharge protocols or elderly patients being taken care of by their kids , where people would much rather use an auto injector .

Speaker #5: And so that to me is the upside that we're looking for in inflection that that could spark faster growth . That's one reason we want to get the share of voice up right , is get , get , get the awareness up of the product and we still see I would say there's like 40,000 cardiologists .

Speaker #5: So so the team is targeting 5 to 7000 . So we think we can boost up the number of cardiologists aware of the product .

Speaker #5: And the conferences . And education . But 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 .

Speaker #5: And competitive . But 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 album at night , one day or the auto injector or future I think will be able to provide a lot of solutions to the various patient types .

Speaker #5: So I wouldn't look at one replacing the other as much as I would looking at how we can grow it faster .

Speaker #12: I see. Thanks again.

Speaker #1: 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 .

Speaker #5: I just want to say thank you to everyone in the company for for working on the integration and 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 .

Speaker #5: Thank you for all the investors and your belief in the management team and the direction we're going . And I'll look forward to seeing many of you at the Jefferies conference in London , as well as the scientific people at the conferences coming up .