Olivia Brayer; Analyst; Cantor Fitzgerald & Co.
Good Afternoon and welcome to the Mannkind Corporation third quarter, 2024 financial results earnings call. As a reminder, this call is being recorded on November 7, 2024. And we'll be available for 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 risk and uncertainties which can cause actual risk to differ materially from those stated expectations. For further information on the company's risk factors. Please see the 10-Q report filed with the Security and Exchange Commission this morning, the earnings release and the slides prepared for this presentation. Joining us today for Mannkind, our Chief Executive Executive Officer Michael Castagna and Chief Financial Officer Chris Prentiss. I'd now like to turn the conference over to Mr Castagna.
Please go ahead, sir.
Thank you operator and to our entire Mannkind team for all the accomplishments we've had this quarter. I've never been more excited and energized about our opportunities to grow mannkind over the coming years today. I'll open up with operational and pipeline highlights followed by Chris giving a financial overview with closing remarks going to Q&A. As we look at our third quarter highlights (inaudible) collaboration continues to be record setting revenue and expansion opportunities. We look at our manufacturing revenue and continued opportunities with Taves. So in IP, we're super excited by the continued strong collaboration with United Therapeutics. And now as we start to migrate from just the Tyvaso DP I&A Fresa, the pipeline is emerging as one of our focuses this year and we're excited by the readouts in the in the 10 of phase one here, we just completed the phase one that we announced this this week as well as our coas inhalation studies is well under its way in phase three site activations where we have ongoing opportunities here in, in the US, as well as Asia as we're starting that trial. The EB net revenue for the quarter was $20 million or 10% versus last year.
And we saw a FRED overall for the year slightly impacted by headwinds throughout the first three quarters as we focus on profitable growth by realigning our sales force back in Q1.
As we look in Q4, we're looking to accelerate our growth on a present in 2025. And the early indicator here are some of the changes we made that I'll talk about here where we have 8% growth in a year over year.
Our pred study will be reading out very shortly here at the end of Q1 Q4.
And we have a strong financial position with $268 million in cash and we have $15 million in non-GAAP operating income for the quarter.
We're leaving here in Q3 in a very strong financial position as we get ready to fund our innovation here (inaudible) one on one and two on one moving forward.
Now, let me bridge over to Cozamin one on one.
As we look at the clinical development program, there's a significant unmet need in NTM lung disease due to current options, having very severe limitations on both efficacy, safety and tolerability.
We believe oral clofazimine has been part of the guideline since 2020 by developing an inhalation suspension, we have a great opportunity to put more drug into the lung really at the site of infection while minimizing the systemic exposure, which is really important as we think about the GFAS related side effects of skin discoloration, QT prolongation and drug accumulation in the organs.
We also believe our convenient dosing cycle of 28 days and 156 days off will provide us a competitive advantage.
Unfortunately, as we look out in the space, mankind is one of the last remaining companies outside of ined investing in NTM at this point. Due to the failures of several competitors this past year. I will remind you of the icon one phase three study design where now we have about 25% of sites activated. When you think about this trial, we're aiming for about 180 patients as a primary endpoint at six months and we'll start with 28 days of treatment will be all for 56 days of treatment and then 28 days on and 56 days off. After that second treatment cycle will be our primary end point and we're going with a single dose suspension of 80 mg inhaled and a 2 to 1 randomization. Well, an interim analysis after the 1st 100 patients and that'll look to make sure that the trial is on track to achieve its endpoint or if we have to make any adjustments based on the statistical plan that's been pre identified.
I'll remind you it's a co primary endpoint of sputum conversion and patient report outcomes for the US and the rest of the world is just sputum conversion. We will conduct one trial with both endpoints for the various countries in the US as well as rest of the world.
We are currently in in Asia right now, activating sites as well as having a kickoff meeting for investigators. I want to thank the team for all the hard work over there.
We do have FDA fast track QIDP and orphan which provides us with 12 years of exclusivity as we get off the ground.
Now, Burlington and head of DPI this is an exciting opportunity for the company.
When we think back, I would remind you that technosphere technology is mostly made up of FDKP plus our Dreamboat device. And the reason I bring this up is it's a platform technology where we really know where the product flows. You can go back to some of our earlier studies on radio labeled techni for insulin inhalation powder where 90% of the powder is FDKP and about 10% is insulin. And we really see wide distribution across the lungs in the upper and lower lobes. The reason that's important is a lot of people ask, how do we know this drug is going to fly where it needs to? And part of this is based on all the history we have around understanding how FDKP is made where it flies in the lung and how we bind the excipients through this. And we now have over 5,000 patients taking TAO when you think about that, those patients have orphan lung disease of pulmonary hypertension ILD. And I'm sure there's some with comorbidities of IPS and COPD. So now that we have two products approved on the platform, we're very excited to continue to move forward. Our next one here, which is really mankind two on one.
As we know IPF is a growing therapeutic area with over $4.2 billion in sales in 2022. And this continues to grow each year with the majority of those made up of OFB which is a great product. It's one of two drugs only approved, but it does have severe GI side effects which limit patients' ability to stay on the product.
So as we try to think about how do we develop improved products? Really, this was the opportunity to lower the systemic exposure while maximizing lung exposure. And we're really happy to see in our phase one study here, which is where we tried three doses. We'll call them cohort a being A1, A2, A3 followed by multiple sending dose over seven days where we tested A1 and A2 dosing. We really didn't need to go to A3, but we want to make sure it was safe and tolerable for that data to have in the future.
Overall, this trial was a success. We saw no dose limiting toxicities or dose those implications on FEV one. And we also saw in our chronic tox study, no, no significant signals or adverse event findings that would prevent us from moving forward in a chronic administration of this product. So we're really happy to wrap these two things up. We will meet with the FDA on our proposal for further development to move this into a phase 23. Hopefully here in 2025 there is a very exciting time for mankind is this will be two assets we have going into full scale clinical trials which will pave the way for future exponential growth for mannkind.
I now want to bridge over to our diabetes business where we had the first large trial read out this year that we've been investing in over the last couple of years. This trial was designed to really look at usual care, which is inclusive of automated insulin delivery pumps, mainly tandem and omnipod in this trial as well as patients on MD I comparing that to a single shot of Degla or Tresiba plus Afrezza. And then at the end of 17 weeks, these patients were given a second meal challenge and we could see in the 1st and 2nd meal challenge, significant improvement in post pre control in the first two hours. And then at 17 weeks, everybody went into a single arm trial at this point and either you rolled over from the Fresa Dely or you switched to Usual Care. And what you see here on the next slide is we just released the 30 week data and I'm really proud to see that the longer you want to fre it here on the top left, you can see your A one C continue to improve over time. We also continue to see more people getting the goal of almost 42% got the goal, which is unbelievable here and it's a very tough disease in type one where the large majority of patients do not sit at goal today.
The second part of the study was to read out of those who switched from 17 weeks usual care. And what did that happen to them at 30 weeks? And you can see as clinicians got more experience with a Fresa, we saw an improvement in A one C in those 13 weeks of taking the product. Plus we were able to see twice as many people get to go here on the right side in 13 weeks, which is important as we think about the trial on what we can do. And I'll remind you, this is people who are already on the optimized treatments they were taking, they live with diabetes a long time. And by switching into a re we were to drive more people to go, which is ultimately a huge benefit to society.
Now, let's shift over to our revenues. Year-to-date when we look at the EVU profitability has been our focus this year. And when you think about the growth and the transformation we've had the fre grew 16% year over year while WEGO was slightly down as we shifted to managing WEGO for profitability this year away from volume. And we, we've been really happy with those outcomes. And then in year-to-date overall for the business, you can see this year versus last year is about a $12 million improvement and bottom line contribution between managing our expenses, improving our efficiency on COGS and continue to drive more to the bottom line.
When we look at Q3, we're able to grow a fresa despite multiple headwinds throughout this year. When we think about what happened earlier this year, we had payers put in double step edits. We had sales force restructuring compounded by a shift in inventory in Q3, Q3 as we exited our Walgreens consignment and one of our specialty pharmacies was told to shift patients back out to retail by Optum for all of their patients, not just the fresa and a lot of those calls, a lot of hiccups here as we went through each quarter through this year. And this is all behind us as we close out Q4.
And this will also fall by a mix of faster growth in four and eight units versus 12, which is a direct reflection of our focus to grow more in the type one space versus type two.
So when you look at all that noise, I'll say going into Q4, we're excited by what we see because so far in the month of October, new prescriptions are up 8% year over year. This is this is our earliest leading indicator of our success as we look at this quarter and next quarter on how we're going to do. In Q4, we also made a change by removing Vigo from the sales force to double down the focus on Afrezza's growth and we increased our target incentives around hub referrals and new prescription growth as we exit this year.
Given the outcomes of the inhale three and the upcoming inhale one pediatric results, we expect to continue to shift the fresa from a, from a profitability mindset to a growth mindset in 2025 and beyond.
As we look here, I want to remind you of the pediatric opportunity. There were 300,000 kids living with type one diabetes. This was a 52 week primary study in inhale one, ages 4 to 17, very little were type two, majority were type one and the primary end point is at six months and the data that will be coming in here before the end of the year. So we'll be able to update shareholders and we would expect the pre nd a filing meeting in the first half. The real issue here is, do we want to try to argue that there should be a six month filing versus a 12 month filing as the 12 month data will come out roughly late Q2 next year into filing. What happened after? If it's a six month filing, we'll be able to file that earlier in the year. But the FDA has indicated that they expect to see the 12 month data before we file. So as we look out, we got inhale three coming with, with the label change, hopefully on figure one as well as inhale one read out. And we're also, you're going to be seeing an iit we're funding and gestational diabetes very shortly. So we can take a look at a fresa multitude of growth opportunities in the coming years.
Let me stop there and turn it over to Chris to give us an update on our financials.
Christopher Prentiss
Thanks Mike and Good Afternoon everyone. I am pleased to discuss our third quarter, 2024 financial results. For a summary of our financials please refer to our press release issued prior to this call and our 10-Q which is on file with the FCC.
As Mike mentioned, our business demonstrated robust double digit revenue growth compared to last year led by revenues related to Tyvaso DPI third quarter revenues were $70 million which represent a 37% increase compared to last year's quarter for the year-to-date. We recorded revenues of $209 million a 49% increase over the prior year period.
Looking at the details. TAODP I royalties contributed $27 million in third quarter revenue, an increase of 34% over the same quarter last year and $75 million or a 48% increase for the nine month period. On United Therapeutics Q3 earnings call they noted the revenue growth was due to additional patients and an increase in price.
They also commented that referrals and start patterns remain very robust, reinforcing their confidence in the durability of the growth profile.
Collaboration and services revenue was $23 million a 78% increase from the third quarter of 2023.
For the nine month period, we recorded $74 million a 108% increase compared to the same period in 2023.
The increase over the prior year period was primarily attributable to increased manufacturing activities for Tyvaso DPI Collaboration and services revenue consists primarily of manufacturing revenue based on production activity sold through the UT and the recognition of deferred revenue. In the first half of 2024 and in prior years, we also earned approximately $3 million of revenue related to certain scale up activities in the first half of 2024. Resulting in the expected slight decline in the back half of the year.
Afrezza net revenue for the third quarter was $15 million a 12% increase due to higher demand and improved growth to net.
During the nine month period, Afrezza revenue was $46 million a 16% increase over the same period last year.
This increase was due to higher demand a price increase and improved growth to net Vigo net revenue was approximately $5 million for the third quarter, an increase of 5% and the nine month period was approximately $14 million a inecrease of 6%.
This is due to lower product demand, partially offset by improved growth and net adjustments and increased price.
Our annual revenue trends from 2020 through the latest 12 month period also show a consistent increase with double digit revenue growth year over year.
These revenues and our management of the commercial business have led the results on the bottom line.
In the third quarter, we recorded GAAP net income of $12 million which when adjusted for non-GAAP items results in non-GAAP net income of $15 million.
This compares the GAAP net income of $2 million in the prior year quarter and non-GAAP net income of $4 million for the nine month period of 2024 we reported net income of $20 million and non-GAAP net income of $45 million. Whereas for the same period in 2023 we reported a net loss of $13 million and a non-GAAP net loss of $1 million.
As we highlighted earlier on the call last year, we transitioned to running the endocrine business unit for profitability, which has contributed approximately $11 million year-to-date in operating income.
This combined with our net royalty income and the margin earned from collaboration and services has allowed us to fund our two promising development programs to date and also achieved net income of $20 million for the year-to-date period and $45 million non-GAAP.
The operational execution of our business combined with our cash and investments of $268 million. As of the end of September leaves us with a strong balance sheet and the ability to invest in the business for growth.
With that. I'll turn the call back over to Mike.
Michael Castagna
Thank you Chris as we look back on 2024. We've executed all the milestones we've laid out so far with the very last one coming up on inhale one, which we fully expect to share with the street here by the end of the year, we're looking forward to closing out the year. As we look at the first half, we have several key regulatory updates coming around 201 with another phase one meeting TYBA with DPI and the spray dry expansion. Hopefully coming online. One on one continues site activations around the world and patient enrollment and screening is continuing.
We'll also be having discussions with the agency on our inhale one read out and our inhale three data label change. As we go forward, the next adventure of the company is extremely exciting as we look at our key value drivers going forward, we have one on one with every 1,000 patients being $100 million in revenue. As we look out in the NTM space. Our case is approaching $400 million in annual sales. As we look to 2025 we feel very good that this market helping NTM patients. We have very robust opportunity in the coming years.
201. As we move that one forward, we think this has a real opportunity to help impact the patient's lives, impact with IPF who suffer every day from severe diarrhea and GI side effects.
As you think about the DPI it's hard for us to control that revenue stream. We try to give you clarity that we continue to see very strong demand growth in manufacturing opportunities. Now, for every 10,000 patients here is roughly 300 to $350 million in revenue to mankind.
With the upcoming readouts next year of T to one and two, we're going to be extremely excited about this IPF opportunity as well as T to PPF. Looking forward to continue to leverage the manufacturing scale that we built up as well as the opportunity to help a whole. Another area of patients suffering from IPF within the endocrine space. I want to remind you the pediatrics. Every 10% share is roughly $150 million in net revenue. We feel very comfortable. If we can get this indication, we'll be able to achieve a substantial opportunity in Children to make their lives hopefully better than what they go through today.
The inhale three study will be reading out. We're just starting to educate our sales force and customers around this data and we also will have international expansion updates as we progress throughout 2025 we're looking forward to bringing all this forward and landing us a continued growth opportunity in the years to come.
We have several opportunities to share scientific and investor updates here in in the Q4 as well as Q1 next year. Starting off with the UBS Global Health Care Conference. Next week, we'll be there on Tuesday, followed by an opportunity we're invited with Oppenheimer here in December 12th in New York for the Rare Disease Summit.
And we'll also be attending the ATTD conference where we already had several abstracts and presentations accepted around our inhale free data and possible inhale one as we find out more notifications being acceptance. So we have several opportunities to continue to update you as well as our key stakeholders in the scientific community around our key data sets in 2025. These are just a few as we start out the year and looking forward to hopefully many more opportunities in 2025 to communicate with you and our other key stakeholders. Thank you very much. We look forward to closing out the year strong. I appreciate your continued support. We'll now open up for Q&A.
Operator
Thank you. (Operator Instructions) One moment for the first question.
And our first question will be coming from Andreas (inaudible). Your line is open.
Thanks that thanks guys and congrats on all the progress. This quarter, the two questions from us regarding one on one can you just give us a sense and thinking about our case and in the number that you provided, what percentage penetration that is in the market and then where, where does one on one fit in that? And how, how much bigger and that is going to be? And then for two on one, can you just give us a little bit more details on the, the phase one and how that helps inform the phase 23 design, what you may have seen from an efficacy standpoint and then maybe a little bit more detail on the time line if you could, I appreciate that. Thank you.
Michael Castagna
Sure.
Thank you, Andreas. I think it came in a little little blurry but I think I heard your first question was on one on one around our case penetration and where does one on one fit in? And as we look at the the landscape, I think the first thing is hopefully displacing our case in the factory population as the administration and hopefully tolerability of one on one. If it works efficacy wise, should sustain the ability to do that to do that very well.
The second area is we are down to a final formulation selection very shortly on one on one and mid to long term. We also expect to bring a dry powder formulation out that would help penetrate earlier lines of treatment. And so our, our ultimate goal is to be used first line and second line or factory between a dry powder and nebulizer. Just the nebulizer was the faster way to market and, and so they're, they're right on top of each other in the grand scheme of things. But that's, that's generally where we expect to be able to compete in early and late lines of treatment in NTM.
We'll give further updates in terms of that strategy and bridging study or new study, naive study, etc etc Sometime in 25.
The two on one details on how that informs us. I think the first thing was making sure the chronic talk data was okay, because that to me was the first step in this, this area. And then the phase one study was really looking to see what if any GI side effects could have occurred or is there anything related to oe type side effects that would give us concern or at least confirming our thesis that they should be minimal, which is what we expected and, and they were, and then the second part of that is while they were healthy volunteers, it was the first time we're really putting the 10 in a healthy volunteer lung. And we're pretty confident FDKP as I stated earlier in the call. But, but demonstrating that there was no adverse reaction to at 10, we could clearly see in the phase one, whether it's the control arm or the call placebo or the active, there was, there was no indicators or any concerns for that. So that, that's really shapes us up for, for the phase two.
We, we know the FDA and their preliminary comments, wanted a dose range finding study. So that's what we'll go to them with next year. So we're trying to get to either a phase 23 bridge or even just go into our, our single dose that we want to target and, and see whether we could down dose if somebody had tolerability issues. But until we meet with the FDA, I think it's all you know, we, we can't really predict where their heads are going to be and, and, and we have a good rationale, but whether they agree or disagree is the question. So that's where we are. We expect to get there hopefully in Q1 and we'll provide updates, you know, right after we meet with them.
Appreciate the color and congrats on all the progress and I'll hop back into two things.
Michael Castagna
Thank you.
Operator
Thank you one moment for the next question.
And our next question will be coming from Olivia Brayer of Cantor Fitzgerald & Co. Your line is open.
Olivia Brayer
Hey, Good Afternoon. Thank you for the question. What more can you tell us about? And then KD two on one profile just in terms of any differentiation you've seen so far, you know, you guys are, are obviously not the only ones developing an inhaled version of the drug and did you guys look at, at PK as it relates to the oral formulation, if so any comparisons there?
Michael Castagna
Sure. I, I think the, the, the I think first of all, you know, we're probably in a speed to move this into patients in a bigger way and I believe we have the ability to do that in the dry powder formulation in terms of CMC is pretty much ready as well as our trial design. So it's really just getting this to the FDA I think in, in terms of you know, one can ask, is there a difference in a nebulizer versus a dry powder? We probably have a little bit of a bias towards dry powder given our company history and background and the success of Taesa DPI and what we saw there over their nebulizer. So that, that's really our, also our key points of differentiation as we go forward. There's always enough room in the market for two players. So it's really about making a difference in the patient's lives and letting competition compete. But we think that this disease requires hopefully some innovation that we can bring to the marketplace. In terms of the the clinical differentiation, you know, as you may or may not realize these patients, you know, take immense amounts of odium just to try to stay on O and that'll be some of the stuff we look at is, you know, do we reduce the number of Imodium or reduce diarrhea? Our proposal for the FDA is a combination of naive and experienced patients. So hopefully, we'll be able to see AGI side effect from OEN versus us in that profile. Again, the FDA could change our trial design and we would focus only on experienced patients potentially.
But otherwise, we, we think the administration is not going to be the biggest burden in terms of a pill versus inhaled. But the side effect profile of EV is really what we're going after and hopefully we can get higher lung concentration that, that we did measure plasma PK in this trial not to compare it to but just to kind of triangulate to our animal models to, to see where we were and that data is still coming in as we speak. So we'll have that full analysis before we go to the FDA.
Olivia Brayer
Okay. Understood. Thanks Mike. And then just in terms of kind of data disclosure for measuring, you know, plasma and PK is the, is the, should we expect to see that sometime next year or is that something that you'll just go to the FDA with and not necessarily presented at a medical meeting or published?
Michael Castagna
I, I don't want to speculate yet because I don't know what the data says relative to our animals and, and you know, how would we triangulate that or put some information out there? I do think people have been asking around the Leom Mycin study and this and so we'll think about how we can you bring some more articulation of our confidence as we go forward and, and what that trial design looks like and the data behind the support around that. So, and, and that's probably, you know, the one area I think we're still having some internal discussion on which is, you know, do you do a smaller phase two just to get the efficacy data? So people could see that sooner and then, you know, that'll take a little bit longer of a phase two than a phase three. But it would give you more certainty. And so those are some of the discussions between the FDA and our internal clinical development team.
Olivia Brayer
Okay, great. Thank you. I appreciate the color.
Michael Castagna
Okay.
Operator
Thank you. One moment for the next question. And our next question will be coming from the line of (inaudible) of Leerink Partners. Your line is open.
Hey guys, thanks for taking the questions. I just wanted to ask if you could say a little bit more around the adverse event profile that you saw in the phase one for the inhaled in tentative like with the (inaudible) drop and cough events, could you tell us a little bit more like what's your hypothesis around, what caused that like is that excipient related? And you know, just anything around, like kind of time course of those events? And just any more insight you can give around that. Thank you.
Michael Castagna
Yeah, there was no, I think in the seven day part we look to see, you know, did it get worse over the seven days? Did you have it on day one? Have it on day seven? The bottom line is there was no real concerns around the drop or the significance of the drop or it didn't continue to get worse. In fact, no one discontinued because of it. So people that, they have got on day 1 may not have had on day seven. Some people didn't have it on day one, got it on day seven. So there was no consistency about when or how it appeared. There is one thing I'll highlight for you that I think is important is these patients had to do an FEV one, I think like every 15 minutes roughly. So there was like 4 to 5 FEV one in and in the hour to two hours post dosing. And so that, that itself would have a lot of irritation of the lung. And that's something that the FDA wanted. So we did it, but not sure it's going to tell us much. We'll, we'll look at the summary of all that data. But there's a lot of, I'll say administration of, of FEV one throughout the time period of measurement. And so we're looking at total fev one drops from the initial dose all the way through two hours. And that's after the repeated feb ones for per patient. So there's a lot of data drawn, a lot to still be summarized, but there was nothing at the highest level when we looked at the data that was of concern or, or consistency I'll say, and it seemed to happen in both the control as well as the active arm. So there wasn't anything specific around the tenant that we would say. Is also, I think it's much more around putting dry powder in the lung than anything and and the the frequency of FU one testing that was required.
Yeah. Yeah, that sounds like a workout just to clarify. The placebo arm was like just a straight excipient without the intend it. It's the same kind of dry powder inhalation. Just no active drug.
Michael Castagna
Yeah, it's Yeah, just EKP is the, is the excipient?
Got it. Great. Thanks for taking the questions.
Michael Castagna
Okay. Thank you.
Operator
Thank you one moment for the next question.
Our next question will be coming from the line of Gregory Renza of RBC Capital Markets. Your line is open.
Gregory Renza
Hi, Mike and team. It's (inaudible) for Greg. Congrats on the progress this quarter and thanks for taking our questions just firstly on one on one. What's the broader value proposition from an economical standpoint for patients and physicians to use mankind? 11 over Erica or even Oracle Iine and NTM. Maybe if you have some early thoughts on where you'd like to land on out of pocket cost and then Justin keying in on Taso or Taso DPI and the Teton IPF and PPF studies might two on one also be clinically usable in PPF. I know, I know there's some research out there. Just wanted to get your thoughts. Thanks so much.
Michael Castagna
Yeah. No, thank you. I do think that's as we saw another company switched from IPF to PPF, I think we'll see some results on IPF next year with the T time one and two. So I think there is an opportunity there to your point. Some of that will be we, we would expect to get in my mind, extrapolation of indication. So if we look at what an intent is indicated for, I think it's really picking the right population with the right trial to get the right endpoint and, and I think it's part of our request with the FDA, just like we got ILD with TBA with DPI, we would hope to get extrapolation with them with that, with that focus. So that, that'd be our first focus on that. But to your point, maybe we could go through PPF instead of IP F if we really wanted to and I think that that's still an ongoing discussion, but I think a lot of this is the bigger population of IPF and the predictability of enrollment in that trial.
I'll, I'll bridge over to your one on one question on the brand value proposition. So I think when you, when you look at clofazimine, it's in all the guidelines, doctors really love it. Our team is over in Asia right now in Australia activating sites and kicking off the investigator meetings over there and clofazimine, it has much, much more wider use, I'll say in those markets. And so the receptivity of our nebulizer form is very high and, and the belief in clofasimine as a treatment for team is very high. And when you think about the the couple side effects of clofazimine, in particular oral formulation, you're getting skin discoloration, qt prolongation and potentially organ accumulation. So those are three things you don't want that with the reduced dose in the systemic circulation, but better concentration in the lungs, we would see a better value prop and then combine that. I, I think with our case, our case is a im glycoside. So it's got ototoxicity by nature. And I do believe those will be clinically differentiated, especially as you get to infectious disease, docs and hospitals who are used to dealing with these things. I think there'll be a clinical differentiation, potentially a safety. Again, we gotta get trial results before we get too excited. But, I think conceptually that that's where our heads are and then you get to the dose of administration, you know, every day cleaning a device for, you know, six months to 18 months of your life is, is a burden. And that's one of the reasons we chose the, the, the, the dosing we did with clofazimine, which is 28 days on at 56 days off. One is the, the use of a of a nebulizer and the PKPD of the product allows us to get that long.
And then the second is the copay burden on the patient. And so there is no real incentive to the doctors to use alcohol nebulizer or an oral form of a product, unlike diabetes where there's an incentive to use an insulin pump that doesn't happen in this disease. But being able to really get that, that nebulizer down to once a month, which should remain one co pay to the patient. And so while the overall whack cost per month supply will probably comparable to a three month supply, I would say that that duration of effect will last you to three months and the co pay will be a one month thing. And that's important especially for Medicare, which is generally capped per month as we go into 25. So that, that's kind of the value problem, the cost, economic side and the dosing and safety that we're thinking about?
Gregory Renza
Great. Thanks so much.
Operator
Thank you.
I'm sorry.
Michael Castagna
No good. Thank you. The next question. Alright.
Operator
Alright. Thank you one moment for the next question. And our next question will be coming from Brandon Folkes of Rodman and Renshaw. Your line is open.
Brandon Folkes
Hi, thanks for taking my questions and congratulations on the progress during the quarter. I actually want to switch gears and talk a little bit about a fraser.
Can you just talk about the growth in Ara and sort of especially the growth in terms of the breadth and depth of subscribers?
And what is the unaided awareness out there in the market just in the investment that mankind has put into a further data over the last year? Is there some level of anticipation of that data among your current prescribing community?
And then how do we see the commercial footprint evolving over time just given that backdrop especially as we, you know, sort of move into the pediatric label and then sort of really make a move on the inhale.
All both sets of inhaled data. Thank you.
Michael Castagna
Thank you, Brandon. Nice to hear from you. There's a few questions wrapped up in there. And so I I would say the unaided awareness of a fresa, you know, amongst doctors is, is what we'd expect given the investment in our narrow target, meaning we we target probably about 4,000 to 5,000 docs any given quarter. And you know, the number that actually write it on a consistent basis is obviously much less a and so that, that gets you to our focus, which is not broadening prescribers right now. It's actually going deeper with the current prescribers who have used the product because we got to a point this year where we, we, we really reduced our sales force from roughly 80 people down to 50. And so with that 40% cut, you know, we had to go narrow and deep and that strategy seems to be working. We're seeing growth within our targets that we're, we're really on top of and we've seen that we've lost a little bit of scripts in the, in the non targets, I'll say, or in some of those docs that we had to, to leave with, with the reduction in the sales force. But the hope was we would make up that drop on those that we are targeting. So it does appear to be kind of making that transition as we got from Q2 to Q3 to early Q4. The other part that we are seeing in the, in the inr space and you can kind of see in the influence scripts. I think the overall tr has dropped roughly 3 to 5% in Q3 in the overall rapid acting mealtime market. And Fre. Fre obviously dropped from Q2 to Q3 a little bit. And some of that is we're seeing the endos switch from treating diabetes to actually treating weight loss and they're just literally wholesale, shifting their focus and their patient volumes. And so we'll see how that continues to play out. I don't expect it to impact the fres in a dramatic way because we have more than enough prescribers that we still need to help and, and work on. But, but that was some of our top prescribers. We, we start to see if and you know, that's why it is important to broaden our commercial, our commercial focus beyond the, the ones that we do have. And overall, you know, as we go forward, we want to kind of see the reaction to the in health free data. So that came out the 30 week data just came out a few weeks ago here and that data will be published in a reputable journal probably in the next 4 to 8 weeks. And so that's been accepted. And then we have a bunch of presentations at ATTD and we're just starting to educate the marketplace. So we'll be looking to bring MSLs out in 2025 to really start to get into the academic centers and fellowship training and really focus a little bit more on, you know, getting out from underneath the, the the burden I'll say of the safety perceptions of inhaled insulin and how we start to put that on the table and move forward on the efficacy opportunities to help more patients. So it's a lot in your question, but I do think we got a good grasp of what's going on and we feel pretty good about the direction we're going in our, in our ability or desire to shift investment to grow it faster, at least put some resources behind key areas to make a difference.
Brandon Folkes
Great. Thank you very much and congratulations again.
Operator
Thank you.
Thank you. And this does conclude the Q&A session for today. I would like to turn the call back over to management for closing remarks. Please go ahead.
Michael Castagna
Thank you, Lisa for moderating today and thank you to all the Mankind team and our shareholders. We've had a great year so far. We're going to close the year strong, looking really forward to 2025 and we'll continue to give you guys updates as things come in, but there's obviously a lot going on all in a great way and look forward to continue to open up that communication line and feel free to reach out with any questions. Thank you.
Operator
Thank you all for joining the conference call today. You may now disconnect.
