MannKind (MNKD) Q3 2024 Earnings Name Transcript

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Our pediatric research shall be studying out very shortly right here on the finish of This fall, and we had a powerful monetary place with $268 million in money, and we’ve got $15 million in non-GAAP working earnings for the quarter. We’re leaving right here in Q3 in a really sturdy monetary place as we get able to fund our innovation right here with clofazimine-101 and 201 shifting ahead. Now let me bridge over to clofazimine-101. As we take a look at the medical growth program, there is a important unmet want in NTM lung illness resulting from present choices having very extreme limitations on each efficacy, security and tolerability.

We imagine oral clofazimine has been a part of the rule of thumb since 2020 and by growing an inhalation suspension, we’ve got an awesome alternative to place extra drug into the lung actually on the web site of an infection whereas minimizing the systemic publicity, which is admittedly vital as we take into consideration the clofazimine-related uncomfortable side effects of pores and skin discoloration, QT prolongation and drug accumulation within the organs. We additionally imagine our handy dosing cycle of 28 days on and 56 days off will present us a aggressive benefit. Sadly, as we glance out within the area, MannKind is among the final remaining corporations exterior of Insmed investing in NTM at this level because of the failures of a number of opponents this previous 12 months. I need to remind you of the ICoN-1 Part 3 research design, we’re now capable of have about 25% of web sites activated.

And when you concentrate on this trial, we’re aiming for about 180 sufferers as a major endpoint at six months, and we’ll begin with 28 days of therapy, we’ll be off for 56 days of therapy after which 28 days on and 56 days off. After that second therapy cycle shall be our major endpoint, and we’re going with a single dose suspension of 80 milligrams inhaled and a 2:1 randomization. We’ll have an interim evaluation after the primary 100 sufferers and that’ll look to make it possible for the trial is on observe to realize its endpoint or if we’ve got to make any changes based mostly on the statistical plan that is been pre-identified. I need to remind you it is a co-primary endpoint of sputum conversion and affected person reported outcomes for the U.S.

and the remainder of the world is simply sputum conversion. We are going to conduct one trial with each endpoints for the assorted international locations within the U.S., in addition to remainder of world. We’re at present in Asia proper now activating websites, in addition to having a kickoff assembly for investigators. I need to thank the workforce for all of the laborious work over there.

We do have FDA Quick Observe QIDP in orphan, which offers us with 12 years of exclusivity as we get off the bottom. Now bridging to nintedanib DPI. That is an thrilling alternative for the corporate. Once we assume again, I need to remind you that Technosphere know-how is usually made up of FTKP, plus our Dreamboat gadget.

And the rationale I convey this up is it is a platform know-how the place we actually know the place the product flows. And you’ll return to a few of our earlier research on radio labeled Technosphere insulin insulation powder, the place 90% of the powder is FTKP and about 10% is insulin, and we actually see extensive distribution throughout the lungs within the higher and decrease lobes. The rationale that is vital is lots of people ask, how do we all know this drug goes to fly the place it must? And a part of that is based mostly on all of the historical past we’ve got round understanding how FTKP is made, the place it flies within the lung and the way we bind the excipients by this. And we now have over 5,000 sufferers taking Tyvaso.

When you concentrate on that these sufferers have orphan lung illness of pulmonary hypertension, ILD, and I am certain there are some with comorbidities of IPF and COPD. So now that we’ve got two merchandise authorised on the platform, we’re very excited to proceed to maneuver ahead our subsequent one right here, which is admittedly MannKind 201. As we all know, IPF is a rising therapeutic space with over $4.2 billion in gross sales in 2022, and this continues to develop annually with nearly all of these made up of OFE, which is a good product. It is one among two medicine solely authorised, but it surely does have extreme GI uncomfortable side effects, which restrict sufferers’ means to remain on the product.

In order we strive to consider how will we develop improved merchandise, actually, this was the chance to decrease the systemic publicity whereas maximizing lung publicity. And we’re actually blissful to see in our Part 1 research right here, which is the place we tried three doses, we’ll name them cohort A, B — A1, A2, A3, adopted by a a number of ascending dose over seven days the place we examined A1 and A2 dosing. We actually did not must go to A3, however we need to make certain it was protected and tolerable for that information to occur sooner or later. Total, this trial was a hit.

We noticed no dose-limiting toxicities or dose implications on FEV1. And we additionally noticed in our continual tox research, no important alerts or opposed occasion findings that may forestall us from shifting ahead in a continual administration of this product. So we’re actually blissful to wrap these two issues up. We are going to meet with the FDA on our proposal for additional growth to maneuver this right into a Part 2/3, hopefully right here in 2025.

This can be a very thrilling time for MannKind as this shall be two property we’ve got going into full-scale medical trials, which is able to pave the best way for future exponential development for MannKind. I now need to bridge over to our diabetes enterprise, the place we had the primary massive trial readout this 12 months that we have been investing in during the last couple of years. This trial was designed to actually take a look at normal care, which is inclusive of automated insulin supply pumps, primarily Tandem and Omnipod on this trial, in addition to sufferers on MDI, evaluating that to a single shot of Degludec or Tresiba plus Afrezza. After which, on the finish of 17 weeks, these sufferers got a second meal problem and we might see within the first and second meal problem, important enchancment in postprandial management within the first two hours.

After which, at 17 weeks, all people went right into a single-arm trial at this level and both you rolled over from the Afrezza degludec otherwise you switched to normal care. And what you see right here on the subsequent slide is we simply launched the 30-week information, and I am actually proud to see that the longer you need Afrezza right here on the highest left, you possibly can see your A1c proceed to enhance over time. We additionally proceed to see extra individuals attending to purpose of just about 42% bought to purpose, which is unbelievable right here and it is a very powerful illness in kind 1, the place the big majority of sufferers don’t sit at purpose at the moment. The second a part of this research was the readout of those that switched from 17 weeks normal care and what did that occur to them at 30 weeks.

And you’ll see as clinicians bought extra expertise with Afrezza, we noticed an enchancment in A1c in these 13 weeks of taking the product, plus we’re capable of see twice as many individuals get to purpose right here on the best facet in 13 weeks, which is vital as we take into consideration the trial and what Afrezza can do. And I will remind you, that is people who find themselves already on, they optimize remedies they have been taking. They have been with diabetes a very long time. And by switching them to Afrezza, we have been capable of drive extra individuals to purpose, which is in the end an enormous profit to society.

Now let’s shift over to our revenues year-to-date. Once we take a look at the EBU profitability has been our focus this 12 months. And when you concentrate on the expansion and the transformation we have had, Afrezza grew 16% 12 months over 12 months, whereas V-Go was barely down as we shifted to managing V-Go for profitability this 12 months away from quantity, and we have been actually pleased with these outcomes. After which, year-to-date, general for the enterprise, you possibly can see this 12 months versus final 12 months, it is a couple of $12 million enchancment in bottom-line contribution between managing our bills, enhancing our effectivity on COGS and persevering with to drive extra to the underside line.

Once we take a look at Q3, we’re capable of develop Afrezza regardless of a number of headwinds all through this 12 months. Once we take into consideration what occurred earlier this 12 months, we had payers put in double step edits. We had gross sales pressure restructuring compounded by a shift in stock in Q3 as we exited our Walgreens consignment and one among our specialty pharmacies was instructed to shift sufferers again out to retail by Optum for all of their sufferers, not simply Afrezza. And plenty of us triggered plenty of hiccups right here as we went by every quarter by this 12 months, and that is all behind us as we shut out This fall.

And this was additionally adopted by a mixture of quicker development in 4 and eight items versus 12, which is a direct reflection of our focus to develop extra within the kind 1 area versus kind 2. So once you take a look at all that noise, I will say, going into This fall, we’re excited by what we see as a result of to date within the month of October, new prescriptions are up 8% 12 months over 12 months. That is our earliest main indicator of our success as we take a look at this quarter and subsequent quarter on how we will do. In This fall, we additionally made a change by eradicating V-Go from the gross sales pressure to double down the concentrate on Afrezza’s development, and we elevated our goal incentives round hub referrals and new prescription development as we exit this 12 months.

Given the outcomes of the INHALE-3 and the upcoming INHALE-1 pediatric outcomes, we count on to proceed to shift Afrezza from a profitability mindset to a development mindset in 2025 and past. As we glance right here, I need to remind you of the pediatric alternative. There are over 300,000 children residing with kind 1 diabetes. This was a 52-week major research in INHALE-1, ages 4 to 17, little or no have been kind 2, majority have been kind 1.

And the first endpoint is at 6 months. And the info shall be coming in right here earlier than the tip of the 12 months, so we’ll have the ability to replace shareholders. And we’d count on a pre-NDA submitting assembly within the first half. The true concern right here is, will we need to attempt to argue that there ought to be a six-month submitting versus a 12-month submitting because the 12-month information will come out roughly late Q2 subsequent 12 months, and the submitting would occur after.

If it is a six-month submitting, we’ll have the ability to file that earlier within the 12 months. However the FDA has indicated that they count on to need to see the 12-month information earlier than we file. In order we glance out, we bought INHALE-3 coming with the label change, hopefully on Determine 1, in addition to INHALE-1 readout. And we’re additionally you are gonna be seeing an IIT we’re funding in gestational diabetes very shortly.

So we proceed to take a look at Afrezza’s multitude of development alternatives within the coming years. And let me cease there and switch it over to Chris to present us an replace on our financials.

Christopher B. Prentiss — Chief Monetary Officer

Thanks, Mike, and good afternoon, everybody. I’m happy to debate our third quarter 2024 monetary outcomes. For a abstract of our financials, please consult with our press launch issued previous to this name and our 10-Q, which is on file with the SEC. As Mike talked about, our enterprise demonstrated strong double-digit income development in comparison with final 12 months, led by revenues associated to Tyvaso DPI.

Third quarter revenues have been $70 million, which signify a 37% improve in comparison with final 12 months’s quarter. For the year-to-date, we recorded revenues of $209 million, a 49% improve over the prior-year interval. Trying on the particulars, Tyvaso DPI royalties contributed $27 million in third quarter income, a rise of 34% over the identical quarter final 12 months and $75 million or a 48% improve for the nine-month interval. On United Therapeutics Q3earnings name they famous the income development was resulting from extra sufferers and a rise in value.

In addition they commented that referrals and begin patterns stay very strong, reinforcing their confidence within the sturdiness of the expansion profile. Collaboration and companies income was $23 million, a 78% improve from the third quarter of 2023. For the nine-month interval, we recorded $74 million, a 108% improve in comparison with the identical interval in 2023. The rise over the prior-year interval was primarily attributable to elevated manufacturing actions for Tyvaso DPI.

Collaboration and companies income consists primarily of producing income based mostly on manufacturing actions offered by to UT and the popularity of deferred income. Within the first half of 2024 and in prior years, we additionally earned roughly $3 million of income associated to sure scale-up actions within the first half of 2024, ensuing within the anticipated slight decline within the again half of the 12 months. Afrezza web income for the third quarter was $15 million, a 12% improve resulting from greater demand and improved gross to nets. In the course of the nine-month interval, Afrezza income was $46 million, a 16% improve over the identical interval final 12 months.

This improve was resulting from greater demand, a value improve and improved gross to nets. V-Go web income was roughly $5 million for the third quarter, a rise of 5% and the nine-month interval was roughly $14 million, a lower of 6%. This is because of decrease product demand, partially offset by improved gross to web changes and elevated value. Our annual income tendencies from 2020 by the most recent 12-month interval additionally present a constant improve with double-digit income development 12 months over 12 months.

These revenues and our administration of the industrial enterprise have led the outcomes on the underside line. Within the third quarter, we recorded GAAP web earnings of $12 million, which when adjusted for non-GAAP objects, leads to non-GAAP web earnings of $15 million. This compares to GAAP web earnings of $2 million within the prior-year quarter and non-GAAP web earnings of $4 million. For the nine-month interval of 2024, we reported web earnings of $20 million and non-GAAP web earnings of $45 million, whereas for a similar interval in 2023, we reported a web lack of $13 million and a non-GAAP web lack of $1 million.

As we highlighted earlier on the decision, final 12 months, we transitioned to working the endocrine enterprise unit for profitability, which has contributed roughly $11 million year-to-date in working earnings. This, mixed with our web royalty earnings and the margin earned from collaboration and companies has allowed us to fund our two promising growth packages so far and likewise achieved web earnings of $20 million for the year-to-date interval and $45 million non-GAAP. The operational execution of our enterprise, mixed with our money and investments of $268 million as of the tip of September, leaves us with a powerful steadiness sheet and the flexibility to put money into the enterprise for development. With that, I will flip the decision again over to Mike.

Michael E. Castagna — Chief Government Officer and Director

Thanks, Chris. As we glance again on 2024, we have executed the entire milestones we have laid out to date with the final one arising on INHALE-1, which we absolutely count on to share with the Avenue right here by the tip of the 12 months. We’re trying ahead to closing out the 12 months. As we take a look at the primary half, we’ve got a number of key regulatory updates coming round 201 with an finish of Part 1 assembly, Tyvaso DPI and the spray dry enlargement, hopefully coming on-line, 101 continued web site activations world wide and affected person enrollment and screenings persevering with.

We’ll even be having discussions with the company on our INHALE-1 readout and our INHALE-3 information label change as we go ahead. The subsequent journey of the corporate is extraordinarily thrilling as we take a look at our key worth drivers going ahead. We’ve 101 with each 1,000 sufferers being $100 million in income. And as we glance out within the NTM area, ARIKAYCE is approaching $400 million in annual gross sales as we glance to 2025, we really feel superb that this market serving to NTM sufferers shall be a really strong alternative within the coming years.

201, as we transfer that one ahead, we predict this has an actual alternative to assist impression the sufferers’ lives impression with IPF that suffer each day from extreme diarrhea and GI uncomfortable side effects. As we take into consideration Tyvaso DPI, it is laborious for us to regulate that income stream, however we attempt to offer you readability that we proceed to see very sturdy demand development in manufacturing alternatives and that for each 10,000 sufferers right here is roughly $300 million to $350 million in income to MannKind. With the upcoming readouts subsequent 12 months of TETON 1 and a couple of, we’re gonna be extraordinarily enthusiastic about this IPF alternative, in addition to TTOM-TPF, trying ahead to persevering with to leverage the manufacturing scale that we constructed up, in addition to the chance to assist a complete one other space of sufferers affected by IPF. Inside the endocrine area, I need to remind you of the pediatrics, each 10% share is roughly $150 million in web income.

We really feel very snug if we will get this indication, we’ll have the ability to obtain a considerable alternative in youngsters to make their lives hopefully higher than what they undergo at the moment. The INHALE-3 research we’ll be studying out. We’re simply beginning to educate our gross sales pressure and prospects round this information. And we additionally could have worldwide enlargement updates as we progress all through 2025.

We’re trying ahead to bringing all this ahead and touchdown us in a continued development alternative within the years to come back. We’ll have a number of alternatives to share scientific and investor updates right here in This fall, in addition to Q1 subsequent 12 months. Beginning off with the united statesGlobal Healthcare Convention subsequent week, we’ll be there on Tuesday, adopted by a chance we invited with Oppenheimer right here on December twelfth in New York for the Uncommon Illness Summit. And we’ll even be attending the ATTD convention, the place we already had a number of abstracts and shows accepted round our INHALE-3 information and doable INHALE-1 as we discover out extra notifications being acceptance.

So we’ve got a number of alternatives to proceed to replace you, in addition to our key stakeholders within the scientific group round our key information units in 2025. These are only a few as we begin out the 12 months and looking out ahead to hopefully many extra alternatives in 2025 to speak with you and our different key stakeholders. Thanks very a lot. We stay up for closing out the 12 months sturdy and respect your continued assist.

We’ll now open up for Q&A.

Questions & Solutions:

Operator

Thanks. [Operator instructions] And our first query shall be coming from Andreas Argyrides of Oppenheimer. Your line is open.

Andreas Argyrides — Analyst

Thanks, operator. Thanks, guys, and congrats on all of the progress this quarter. Two questions from us. Relating to 101, are you able to simply give us a way in fascinated with ARIKAYCE and the quantity that you simply offered, what proportion penetration that’s of the market? After which, the place does 101 slot in that and the way a lot greater can it’s? After which, for 201, are you able to simply give us just a little bit extra element on the Part 1 and the way that helps inform the Part 2/3 design, what you might even see from an efficacy standpoint? After which, perhaps just a little bit extra element on the time traces, if we might.

I respect that.

Michael E. Castagna — Chief Government Officer and Director

Certain. Thanks, Andreas. I believe, it got here in just a little blurry, however I believe I heard your first query was on 101 round ARIKAYCE penetration and the place does 101 slot in. And as we take a look at the panorama, I believe the very first thing is hopefully displacing ARIKAYCE within the refractory inhabitants because the administration and hopefully tolerability of 101, if it really works efficacy-wise, ought to maintain the flexibility to do this very nicely.

The second space is we’re all the way down to a ultimate formulation choice very shortly on 101. And mid- to long run, we additionally count on to convey a dry powder formulation out that may assist penetrate earlier traces of therapy. And so, our final purpose is for use first line and second line or refractory between a dry powder and a nebulizer. Simply the nebulizer was the quicker method to market.

And so, they’re proper on high of one another within the grand scheme of issues, however that is typically the place we count on to have the ability to compete in early and late traces of therapy in NTM. We’ll give additional updates by way of that technique in a bridging research, or new research, naive research, and many others., someday in ’25. The 201 particulars on how that informs us. I believe, the very first thing was ensuring the continual tox information was OK as a result of that to me was step one on this space.

After which, the Part 1 research was actually seeking to see what — if any GI uncomfortable side effects might have occurred? Or was there something associated to OFE kind uncomfortable side effects that may give us concern or not less than confirming our thesis that they need to be minimal, which is what we anticipated they usually have been. After which, the second a part of that’s whereas they have been wholesome volunteers, it was the primary time we’re actually placing Nintedanib in a wholesome volunteer lung. And we’re fairly assured in FTKP, as I said earlier within the name, however demonstrating that there was no opposed response to Nintedanib. We will clearly see within the Part 1, whether or not it is the management arm or the, I will name it, placebo or the lively, there was no indicators or any issues for that.

In order that’s actually shapes us up for the Part 2. We all know the FDA of their preliminary feedback wished a dose vary discovering research. So that is what we’ll go to them with subsequent 12 months. So we try to get to both a Part 2/3 bridge and even simply go to our single dose that we need to goal and see whether or not we might down dose if any person had tolerability points.

However till we meet with the FDA, I believe it is all — we won’t actually predict the place their heads are gonna be, and we’ve got an excellent rationale, however whether or not they agree or disagree is the query. In order that’s the place we’re. We count on to get there, hopefully, in Q1, and we’ll present updates as we meet with them.

Andreas Argyrides — Analyst

Congrats on all of the progress.

Operator

And our subsequent query shall be coming from Olivia Brayer of Cantor Fitzgerald. Your line is open.

Olivia Brayer — Analyst

Hey, good afternoon. Thanks for the query. What extra are you able to inform us about MNKD-201’s profile simply by way of any differentiation you have seen to date? You guys are, clearly, not the one ones growing an inhaled model of the drug. And did you guys take a look at PK because it pertains to the oral formulation? In that case, any comparisons there?

Michael E. Castagna — Chief Government Officer and Director

Certain. I believe, the — I believe, to start with, we’re in all probability in a pace to maneuver this into sufferers in a much bigger means. And I imagine we’ve got the flexibility to do this within the dry powder formulation by way of CMC is just about prepared, in addition to our trial design. So it is actually simply getting this to the FDA.

I believe, by way of one can ask, is there a distinction in a nebulizer versus a dry powder. We in all probability have just a little little bit of a bias towards dry powder given our firm historical past and background and the success of Tyvaso DPI and what we noticed there over their nebulizer. In order that’s actually our — additionally our key factors of differentiation as we go ahead. I believe there’s all the time sufficient room available in the market for 2 gamers.

So it is actually about making a distinction within the sufferers’ lives and letting competitors compete. However we predict that this illness requires hopefully some innovation that we will convey to {the marketplace}. When it comes to the medical differentiation, as chances are you’ll or could not understand, these sufferers take immense quantities ofmodium simply to attempt to keep on OFEV. And that shall be a number of the stuff we take a look at is will we cut back the quantity ofmodium will we cut back diarrhea.

Our proposal to the FDA is a mix of naive and skilled sufferers. So hopefully, we’ll have the ability to see GI facet impact from OFE versus us in that profile. Once more, the FDA might change our trial design, and we might focus solely on skilled sufferers doubtlessly. However in any other case, we predict the administration just isn’t gonna be the largest burden by way of a tablet versus inhaled, however the facet impact profile of OFEV is admittedly what we’re going after.

And hopefully, we will get greater lung focus. We did measure plasma PK on this trial, to not examine it to OFEV, however simply to sort of triangulate to our animal fashions to see the place we have been. And that information remains to be coming in as we communicate. So we’ll have that full evaluation earlier than we go to the FDA.

Olivia Brayer — Analyst

OK. Understood. After which, simply by way of sort of information disclosure for measuring plasma and PK, is the — ought to we count on to see that someday subsequent 12 months? Or is that one thing that you’re going to simply go to the FDA with and never essentially current at a medical assembly or publish?

Michael E. Castagna — Chief Government Officer and Director

I do not need to speculate but as a result of I do not know what the info says relative to our animals and the way would we triangulate that or put some info on the market. I do assume individuals have been asking across the bleomycin research on this. And so, we’ll take into consideration how we will convey some extra articulation of our confidence as we go ahead and what that trial design seems to be like and the info behind the assist round that. So — and that is in all probability the one space I believe we’re nonetheless having some inside dialogue on, which is do you do a smaller Part 2 simply to get the efficacy information so individuals might see that sooner.

After which, that can take just a little bit longer of a Part 2 than a Part 3, however it might give individuals extra certainty. And so, these are a number of the discussions between the FDA and our inside medical growth workforce.

Operator

And our subsequent query shall be coming from the road of Faisal Khurshid of Leerink Companions. Your line is open.

Faisal Khurshid — Analyst

Hey, guys, thanks for taking the query. I simply wished to ask if you happen to might say just a little bit extra across the opposed occasion profile that you simply noticed within the Part 1 for the inhaled nintedanib. Like with the FEV drop and cough occasions, might you inform us just a little bit extra like what’s your speculation round what triggered that? Like is that excipient associated? And simply something round like sort of time course of these occasions? And simply any extra perception you can provide round that?

Michael E. Castagna — Chief Government Officer and Director

Yeah. There was no — I believe within the seven-day half, we glance to see, did it worsen over the seven days? Did individuals have it on Day 1, have it on Day 7. The underside line is there was no actual issues across the drop or the importance of the drop or it did not proceed to worsen. In truth, nobody discontinued due to it.

So individuals that will have gotten on Day 1, could not have had it on Day 7. Some individuals did not have it on Day 1, bought on Day 7. So there was no consistency about when or the way it appeared. There’s one factor I will spotlight for you that I believe is vital is these sufferers needed to do an FEV1, I believe, like each quarter-hour roughly.

So there was like 4 to 5 FEV1s within the hour to 2 hours publish dosing. And so, that itself would have plenty of irritation of the lung. And that is one thing that the FDA wished. So we did it, however I am undecided it’ll inform us a lot.

We’ll take a look at the abstract of all that information. However there was plenty of, I will say, administration of FEV1 all through the time interval of measurement. And so, we’re taking a look at whole FEV1 drops from the preliminary dose right through two hours, and that is after repeated FEV1s per affected person. So there’s plenty of information drawn, quite a bit to nonetheless be summarized, however there was nothing on the highest degree after we appeared on the information that was of concern or consistency, I will say.

And it appeared to occur in each the management, in addition to the lively arm. So there wasn’t something particularly round nintedanib that we might say can be. So I believe it is rather more round placing dry powder into the lung than something and the frequency of FEV1 testing that was required.

Faisal Khurshid — Analyst

Yeah, that appears like a piece out. Simply to make clear, the placebo arm was like only a straight excipient with out nintedanib. So it is the identical sort of dry powder inhalation simply with no lively drug?

Michael E. Castagna — Chief Government Officer and Director

Yeah, FTKP is the excipient.

Operator

Our subsequent query shall be coming from the road of Gregory Renza of RBC Capital Markets. Your line is open.

Anish Nikhanj — Analyst

Hello, Mike and workforce. It is Anish on for Greg. Congrats on the progress this quarter. Simply firstly, on 101, what is the broader worth proposition from a cost-effective standpoint for sufferers and physicians to make use of MannKind 101 over ARIKAYCE and even oral clofazimine in NTM.

Perhaps in case you have some early ideas on the place you’d wish to land on out-of-pocket price. After which, Justin keying in on Tyvaso or Tyvaso DPI and the TETON IPF and PPF research, would possibly 201 even be clinically usable in PPF? I do know there’s some analysis on the market. Simply wished to get your ideas.

Michael E. Castagna — Chief Government Officer and Director

Yeah, no, thanks. I do assume that is — as we noticed one other firm switched from IPF to PPF. I believe, we’ll see some leads to IPF subsequent 12 months with the TETON 1 and a couple of. So I believe there is a chance there, to your level.

A few of that shall be we might count on to get, in my thoughts, extrapolation of indication. So if we take a look at what nintedanib has indicated for, I believe it is actually selecting the correct inhabitants with the best trial to get the best endpoint. And I believe as a part of our request with the FDA, similar to we bought ILD with Tyvaso DPI, we might hope to get extrapolation with that focus. So that may be our first concentrate on that.

However to your level, perhaps we might go after PPF as a substitute of IPF if we actually wished to. And I believe that is nonetheless an ongoing dialogue, however I believe plenty of that is the larger inhabitants of IPF and the predictability of enrollment in that trial. I will bridge over to your 101 query on the model worth proposition. So I believe once you take a look at clofazimine, it is in all the rules, docs actually like it.

Our workforce is over in Asia proper now in Australia activating websites and kicking off the investigator conferences over there. And clofazimine has rather more wider use, I will say, in these markets. And so, the receptivity of our nebulizer type could be very excessive and the assumption in clofazimine as a therapy for NTM could be very excessive. And when you concentrate on the couple of uncomfortable side effects of clofazimine, particularly, oral formulation, you are getting pores and skin discoloration, QT prolongation and doubtlessly organ accumulation.

So these are three issues you do not need that with the decreased dose within the systemic circulation, however higher focus within the lungs, we might see a greater worth prop. After which, mix that, I believe with ARIKAYCE. ARIKAYCE is an aminoglycoside, so it is bought ototoxicity by nature. And I do imagine these shall be clinically differentiated, particularly as you get to infectious illness docs and hospitals who’re used to coping with these items.

I believe there will be a medical differentiation, doubtlessly a security. Once more, we bought to get trial outcomes earlier than we get too excited. However I believe conceptually, that is the place our heads are. After which, you get to the dosing administration.

Day by day, cleansing a tool for six months to 18 months of your life is a burden. And that is one of many causes we selected the dosing we did with clofazimine, which is 28 days on and 56 days off. One is using a nebulizer and the PK/PD of the product permits us to in all probability get that lengthy. After which, the second is the co-pay burden on the affected person.

And so, there isn’t a actual incentive to the docs to make use of, I will name it, nebulizer or an oral type of a product not like diabetes the place there’s an incentive to make use of an insulin pump that does not occur on this illness. However having the ability to actually get that nebulizer all the way down to as soon as a month, which ought to stay one co-pay to the affected person. And so, whereas the general WAC price for month provide will in all probability be akin to a three-month provide, I might say that that period of impact will final you as much as three months, and the co-pay shall be a one-month factor. And that is vital, particularly for Medicare, which is usually capped per 30 days as we go into ’25.

In order that’s sort of the worth prop on the associated fee financial facet and the dosing and security that we’re fascinated with.

Operator

And our subsequent query shall be coming from Brandon Folkes of Rodman. Your line is open.

Brandon Folkes — Analyst

Hello. Thanks for taking my query, and congratulations on the progress through the quarter. I really need to swap gears and discuss just a little bit about Afrezza. Are you able to simply discuss concerning the development in Afrezza and kind of particularly the expansion by way of the breadth and depth of prescribers? And what’s the unaided consciousness on the market available in the market simply within the funding that MannKind has put into Afrezza information during the last 12 months.

Is there some degree of anticipation of that information amongst your present prescribing group? After which, how will we see the Afrezza industrial footprint evolving over time simply provided that backdrop, particularly as we kind of transfer into the pediatric label after which kind of actually make a transfer on the inhaled information?

Michael E. Castagna — Chief Government Officer and Director

Thanks, Brandon. Good to listen to from you. There’s just a few questions wrapped up in there. And so, I might say, the unaided consciousness of Afrezza amongst docs is what we might count on given the funding in our slender goal, that means we goal in all probability about 4,000 to five,000 docs in any given quarter.

And the quantity that really write on a constant foundation is, clearly, a lot much less. And so, that will get you to our focus, which isn’t broadening prescribers proper now. It is really going deeper with the present prescribers who’ve used the product as a result of we bought to some extent this 12 months the place we actually decreased our gross sales pressure from roughly 80 individuals all the way down to 50. And so, with that 40% minimize, we needed to go slender and deep.

And that technique appears to be working. We’re seeing development inside our targets that we’re actually on high of. And we have seen that we have misplaced just a little little bit of scripts within the non-targets, I will say, or in a few of these docs that we needed to depart with the discount within the gross sales pressure. However the hope was we might make up that drop on those who we’re concentrating on.

In order that does seem like sort of making that transition as we bought from Q2 to Q3 to early This fall. The opposite half that we’re seeing within the endocrine area, and you’ll sort of see the insulin scripts, I believe the general TRx has dropped roughly 3% to five% in Q3 within the general rapid-acting mealtime market. And Afrezza, clearly, dropped from Q2 to Q3 just a little bit. And a few of that’s we’re seeing the endos swap from treating diabetes to really treating weight reduction.

They usually’re simply actually wholesale shifting their focus and their affected person volumes. And so, we’ll see how that continues to play out. I do not count on it to impression Afrezza in a dramatic means as a result of we’ve got greater than sufficient prescribers that we nonetheless want to assist and work on. However that was a few of our high prescribers.

We begin to see, and that is why it is very important broaden our industrial focus past those that we do have. And general, as we go ahead, we need to sort of see the response to the INHALE-3 information. In order that got here out — the 30-week information simply got here out just a few weeks in the past right here. And that information shall be printed in a good journal in all probability within the subsequent 4 to eight weeks.

And so, that is been accepted. After which, we’ve got a bunch of shows at ATTD, and we’re simply beginning to educate {the marketplace}. So we’ll be seeking to convey MSLs out in 2025 to actually begin to get into the educational facilities and fellowship trainings and actually focus just a little bit extra on getting out from beneath the burden, I will say, of the protection perceptions of inhaled insulin and the way we begin to put that on the desk and transfer ahead on the efficacy alternatives to assist extra sufferers. So it is quite a bit in your query, however I do assume we bought an excellent grasp of what is going on on, and we really feel fairly good concerning the path we’re going and our means or need to shift funding to develop it quicker, not less than put some sources behind key areas to make a distinction.

Brandon Folkes — Analyst

And congratulations once more.

Operator

And this does conclude the Q&A session for at the moment. I want to flip the decision again over to administration for closing remarks. Please go forward.

Michael E. Castagna — Chief Government Officer and Director

Thanks, Lisa, for moderating at the moment, and thanks to all of the MannKind workforce and our shareholders. We have had an awesome 12 months to date. We will shut the 12 months sturdy and looking out actually ahead to 2025, and we’ll proceed to present you guys updates as issues are available. However there’s, clearly, quite a bit occurring, all in a good way, and we stay up for proceed to open up that communication line and be at liberty to achieve out with any questions.

Thanks.

Operator

[Operator signoff]

Period: 0 minutes

Name members:

Michael E. Castagna — Chief Government Officer and Director

Christopher B. Prentiss — Chief Monetary Officer

Mike Castagna — Chief Government Officer and Director

Andreas Argyrides — Analyst

Olivia Brayer — Analyst

Faisal Khurshid — Analyst

Anish Nikhanj — Analyst

Brandon Folkes — Analyst

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