Q3 2024 MannKind Corp Earnings Call
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Speaker Change: Good afternoon, and welcome to the Mankind Corporation 3rd Quarter 2024 Financial Results Earnings Call. As a reminder, this call is being recorded on November 7th, 2024, and will be available for call.
Speaker Change: on the Mankind Corporation website shortly after the conclusion of this call and available for approximately 90 days.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: Joining us today for Mankind are Chief Executive Officer Michael Castagna and Chief Financial Officer Chris Prentiss. I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.
Thank you very much.
[inaudible]
Speaker Change: Thank you, Operator, and to our entire Mankind team for all the accomplishments we've had this quarter. I'd never been more excited and energized about our opportunities to grow Mankind over the coming years. Today, I'll open up with operational and pipeline highlights, followed by Chris giving a financial review with closing remarks going to Q&A.
Speaker Change: As we look at our third quarter highlights, Taivesa DPI collaboration continues to be record-setting revenue and expansion opportunities as we look at our manufacturing revenue and continued opportunities with Taivesa in IP.
Speaker Change: We're super excited by the continued strong collaboration with United Therapeutics.
Speaker Change: And now as we start to migrate from just a Tybaso, DPI and a FRESA, the pipeline is emerging as one of our focuses this year, and we're excited by the readouts in the tetanus phase one here. We just completed the phase one that we announced this week.
Speaker Change: as well as our clofazamine inhalation studies well under its way in phase three site activations where we have ongoing opportunities here in the U.S. as well as Asia as we're starting that trial.
Speaker Change: The EBU net revenue for the quarter was $20 million, or 10% versus last year.
Speaker Change: And we saw a FRESA 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.
Speaker Change: As we look in Q4, we're looking to accelerate our growth on a FresN 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 NRXs year over year.
Speaker Change: Our pre-dexter study will be reading out very shortly here at the end of Q4, and we are in a strong financial position with $268 million in cash, and we have $15 million in non-GAAP operating income for the quarter.
Speaker Change: We're leaving here in Q3 in a very strong financial position as we get ready to fund our innovation here with clofazamine 101 and 201 moving forward. Now let me bridge over to clofazamine 101.
Speaker Change: 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.
Speaker Change: We believe orophosphazamine has been a part of the guidelines since 2020, and by developing an inhalation suspension,
Speaker Change: 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 clofazamine-related side effects of skin discoloration, QT prolongation, and drug accumulation in the organs.
Speaker Change: We also believe our convenient dosing cycle of 28 days on and 56 days off will provide us a competitive advantage.
Speaker Change: Unfortunately, as we look out in the space, mankind is one of the last remaining companies outside of Inzamid investing in NTM at this point, due to the failures of several competitors this past year.
Speaker Change: I want to remind you of the ICON1 Phase 3 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.
Speaker Change: and we'll start with 28 days of treatment. We'll be off for 56 days of treatment and then 28 days on and 56 days off. After that second treatment cycle will be our primary endpoint. We're going with a single dose suspension of 80 milligrams inhaled.
Speaker Change: and a two-to-one randomization. We'll have an interim analysis after the first hundred patients, and that'll look to make sure that the trial's on track to achieve its end point, or if we have to make any adjustments based on the statistical plan that's been pre-identified.
Speaker Change: I want to remind you it's a co-primary endpoint of sputum conversion and patient-reported outcomes for the U.S., and the rest of the world is just sputum conversion. We will conduct one trial with both endpoints for the various countries in the U.S. as well as the rest of the world.
Speaker Change: We are currently 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
Speaker Change: We do have FDA Fast-Track, QIDP, and ORFIN, which provides us with 12 years of exclusivity as we get off the ground.
Speaker Change: Now, Bridgington has had an MDPI. This is an exciting opportunity for the company.
Speaker Change: When we think back, I want to remind you that Technosphere technology is mostly made up of FDKP plus our Dreamboat device.
Speaker Change: 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 radiolabeled technics 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.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: And we now have over 5,000 patients taking Taveso. When you think about that, those patients have orphan lung disease, a pulmonary hypertension, ILD, and I'm sure there's some with comorbidities of IPF and COPD.
Speaker Change: 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 201.
Speaker Change: 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. But the majority of those made up of OFEB, which is a great product that's one of two drugs only approved, but it does have severe GI side effects which limit patients' ability to stay on the product.
Speaker Change: So, as we try to think about how do we develop improved products...
Speaker Change: Really, this was the opportunity to lower the systemic exposure while maximizing lung exposure.
Speaker Change: 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, B, and A1, A2, A3, followed by multiple sending dose over seven days where we tested.
Speaker Change: A1 and A2 dosing. We really didn't need to go to A3, but we wanted to make sure it was safe and tolerable for that data to have in the future.
Speaker Change: Overall, this trial was a success. We saw no dose-limiting toxicities or dose implications on FEV1.
Speaker Change: And we also saw in our chronic tox study, no significant signals or adverse event findings that would prevent us from moving forward in a chronic administration of this product.
Speaker Change: 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 2, 3, hopefully here in 2025.
Speaker Change: This is a very exciting time for mankind as this will be two assets we have going into full-scale clinical trials Which will pave the way for future exponential growth for mankind
Speaker Change: I now want to bridge over to our diabetes business where we had the first large trial readout this year.
Speaker Change: 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...
Speaker Change: automated insulin delivery pumps, mainly Tandem and Omnipotent in this trial, as well as patients on MDI, comparing that to a single shot of Degladec or Traceeba plus a Fresa.
Speaker Change: And then at the end of 17 weeks, these patients were given a second meal challenge.
Speaker Change: And we could see in the first and second meal challenge significant improvement in post-prandial 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...
Speaker Change: for Fraser Diaglodic, or you switch to usual care. And what you see here on the next slide is we just released the 30-week data. I'm really proud to see that the longer you run a FRASA here on the top left, you can see your A1c continue to improve over time.
Speaker Change: We also continue to see more people getting the goal of almost 42% got the goal, which is unbelievable here and it's very tough disease in type 1, where the large majority of patients do not set a goal today.
Speaker Change: The second part of this study was the readout 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 Afreza We saw an improvement in A1C in those 13 weeks of taking the product
What?
Speaker Change: We were able to see twice as many people get the goal here on the right side in 13 weeks, which is important as we think about the trial and what AFREZA can do. And I'll remind you, this is people who are already on the optimized treatments they were taking. They've been with diabetes a long time. And by switching into AFREZA, we were able to drive more people to goal, which is ultimately a huge benefit to society.
Thank you for watching!
Now let's shift over to our revenues year-to-date.
Speaker Change: When we look at the EVU profitability has been our focus this year. When you think about the growth and the transformation we've had, Fresno grew 16% year over year while Vigo was slightly down. As we shifted to managing Vigo for profitability this year, away from volume, and we've been really happy with those outcomes.
Speaker Change: And on year-to-date overall for the business, you can see this year versus last year is about a $12 million improvement in bottom line contribution between managing our expenses, improving our efficiency on COGS, and continuing to drive more to the bottom line.
Thank you for watching!
Speaker Change: When we look at Q3, we're able to grow a phrasa 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 Salesforce restructuring.
Speaker Change: compounded by a shift in inventory in 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 to Fresa.
Speaker Change: And a lot of this caused 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 was also followed by a mix of faster growth in four and eight units versus 12, which is a direct reflection of our focus to grow more into type one space versus type two.
Speaker Change: 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 our earliest leading indicator of our success as we look at this quarter and next quarter on how we're going to do.
Speaker Change: In Q4, we also made a change by removing Vigo from the sales force to double down the focus on Ephraza's growth, and we increased our target incentives around hub referrals and new prescription growth as we exit this year.
Speaker Change: Given the outcomes of the INHALE-3 and the outcome in INHALE-1 pediatric results, we expect to continue to shift the FRESA from a profitability mindset to a growth mindset in 2025 and beyond.
Speaker Change: As we look here, I want to remind you of the Pediatric Opportunity. There are over 300,000 kids living with type 1 diabetes.
Speaker Change: This was a 52-week primary study on Inhale-1, ages 4 to 17. Very little were type 2, majority were type 1, and the primary endpoint is at 6 months. And the data will be coming in here before the end of the year, so we'll be able to update shareholders. And we would expect a pre-NDA filing meeting in the first half.
Speaker Change: As the 12-month data will come out roughly late Q2 next year, and the filing would happen 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 want to see the 12-month data before we file.
Speaker Change: So as we look out, we've got INHALE-3 coming with the label change, hopefully on Figure 1, as well as INHALE-1 readout. And we're also, you're going to be seeing an IIT we're funding and gestational diabetes very shortly. So we continue to look at AFREZA's multitude of growth opportunities in the coming years.
Speaker Change: And let me stop there and turn it over to Chris to give us an update on our financials.
Chris 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 at the FTC.
Chris Prentiss: As Mike mentioned, our business demonstrated robust double-digit revenue growth compared to last year, led by revenues related to DiVaso DPI.
Chris Prentiss: 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.
Chris Prentiss: Looking at the details, Taiveso DPI 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.
Chris Prentiss: On United Therapeutics Q3 earnings call, they noted the revenue growth was due to additional patients and an increase in price.
Chris Prentiss: They also commented that referrals and start patterns remain very robust.
reinforcing their confidence in the durability of the growth profile.
Chris Prentiss: Collaboration and services revenue was $23 million, a 78% increase from the third quarter of 2023.
Chris Prentiss: For the nine-month period, we recorded $74 million, a 108% increase compared to the same period in 2023.
Chris Prentiss: The increase over the prior year period was primarily attributable to increased manufacturing activities for Tybaso DPI.
Chris Prentiss: Collaboration and services revenue consists primarily of manufacturing revenue based on production activities sold through to UT and a recognition of deferred revenue.
Chris Prentiss: 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.
Speaker Change: A FRESA net revenue for the third quarter was $15 million, a 12% increase due to higher demand and improved growth to net.
Speaker Change: During the nine-month period, AFRESA revenue was $46 million, a 16% increase over the same period last year.
Speaker Change: This increase was due to higher demand, a price increase, and improved growth to net.
Speaker Change: VGO net revenue was approximately $5 million for the third quarter, an increase of 5%, and a nine-month period was approximately $14 million, a decrease of 6%.
Speaker Change: This is due to lower product demand, partially offset by improved gross net adjustments, and increased price.
Speaker Change: 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.
Speaker Change: These revenues, and our management of the commercial business, have led to results on the bottom line.
Speaker Change: 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.
Speaker Change: This compares the GAAP net income of $2 million in the prior year quarter and non-GAAP net income of $4 million.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: 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 achieve net income of $20 million for the year-to-date period and $45 million non-GAP.
Speaker Change: 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.
Thank you, Chris.
Mike: 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 NHEL 1, which we fully expect to share with the street here by the end of the year.
Mike: We're looking forward to closing out the year. As we look at the first half, we have several key regulatory updates coming around 2.01 with another Phase I meeting.
Mike: Tybasa DPI and the spray dry expansion hopefully coming online. One-on-one continued site activations around the world and patient enrollment and screenings continuing.
Mike: We'll also be having discussions with the agency on our INHALE-1 readout and our INHALE-3 data label change as we go forward.
Mike: The next adventure of the company is extremely exciting as we look at our key value drivers going forward.
Mike: We have 101 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, will be a very robust opportunity in the coming years.
Mike: 201, as we move that one forward, we think this has a real opportunity to help impact the patient's lives and impact with IPF who suffer every day from severe diarrhea and GI side effects.
Mike: As we think about titrates or DPI, it's hard for us to control that revenue stream, but we try to give you clarity that we continue to see very strong demand growth and manufacturing opportunities, and that for every 10,000 patients here is roughly $300 to $350 million in revenue to mankind.
Mike: With the upcoming readouts next year of T-TOM 1 and 2, we're going to be extremely excited about this IPF opportunity, as well as T-TOM TPS. Looking forward to continue to leverage the manufacturing scale that we've built up, as well as the opportunity to help a whole other area of patients suffering from IPF.
Mike: Within the endocrine space, I want to remind you that 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.
Mike: a substantial opportunity in children to make their lives hopefully better than what they go through today.
Mike: The INHALE-3 study we'll 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.
Mike: We're looking forward to bringing all this forward and landing us in a continued growth opportunity in the years to come.
Mike: We'll have several opportunities to share scientific and investor updates here in Q4 as well as Q1 next year.
Mike: Starting off with the UBS Global Healthcare Conference next week. We'll be there on Tuesday Followed by an opportunity we were invited with Oppenheimer here in December 12th in New York for the Rare Disease Summit
Mike: And we'll also be attending the ATTD conference where we already had several abstracts and presentations accepted around our InHAL3 data and possible InHAL1 as we find out more notifications being acceptance.
Mike: 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.
Mike: 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.
Speaker Change: Thank you. If you would like to ask a question please press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised.
Speaker Change: If you would like to remove yourself from the queue, please press star 11 again. We also ask that you wait for your name and company to be announced before you proceed with your question. One moment for the first question.
Speaker Change: And our first question will be coming from Andreas Agouridis of Oppenheimer. Your line is open.
Thank you for watching!
Speaker Change: Thanks, Alberta. Thanks, guys, and congrats on all the progress this quarter. We've got two questions from us.
Speaker Change: Can you just give us a little bit more detail on the Phase 1 and how that helps inform the Phase 2-3 design, what you may have seen from an efficacy standpoint, and then maybe a little bit more detail on the timeline if you could. I appreciate that. Thank you.
Sure.
Speaker Change: Thank you, Andres. I think it came in a little blurry, but I think I heard your first question was on one-on-one around arrow case penetration and where does
Speaker Change: 101 fit in? And as we look at the landscape, I think the first thing is hopefully displacing our case in the refractory population as the administration and hopefully tolerability of 101, if it works, efficacy-wise, should sustain the ability to do that very well.
Speaker Change: The second area is we are down to final formulation selection very shortly on 101 and Mid to long term we also expect to bring a dry powder formulation out that would help penetrate earlier lines of treatment
Speaker Change: And so, our ultimate goal is to be used first line and second line or factory between a dry powder and a nebulizer. Just the nebulizer was the faster way to market, and so they're right on top of each other in the grand scheme of things, but that's generally where we expect.
Speaker Change: to be able to compete in early and late lines of treatment in NTM.
Speaker Change: We'll get further updates in terms of that strategy and bridging study or new study, naive study, et cetera, sometime in 25.
[inaudible]
Speaker Change: The 201 details on how that informs us, I think the first thing was making sure the chronic tox data was okay.
Speaker Change: because that, to me, was the first step in this area. And then the...
Phase 1 study was really looking to see what
if any GI side effects could have occurred.
Speaker Change: Or is there anything related to OFEB-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 they were.
Speaker Change: And then the second part of that is, while they were healthy volunteers, it was the first time we were really putting Netentib in a healthy volunteer lung, and we were pretty confident in FTKP, as I stated earlier in the call, but demonstrating that there was no adverse reaction to Netentib. We could clearly see in the Phase I, whether it's the control arm.
Speaker Change: or the, I'll call it placebo, or the active. There was no indicators or any concerns.
Speaker Change: for that. So that's really what shapes us up for the phase two.
Speaker Change: 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 two, three bridge or even just go into our single dose.
Speaker Change: that we want to target 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 can't really predict.
Speaker Change: where their heads are going to be. 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 right after we meet with them.
Speaker Change: Appreciate the color and congrats on all the progress and I'll hop back in a few things.
Thank you.
Thank you. One moment for the next question.
Speaker Change: And our next question will be coming from Olivia Brer of Canter Fitzgerald. Your line is open.
Olivia Brer: Hi, good afternoon. Thank you for the question. What more can you tell us about MNKD 201's profile just in terms of any differentiation you've seen so far?
Olivia Brer: You know, you guys are obviously not the only ones developing an inhaled version of the drug. And did you guys look at PK as it relates to the oral formulation? If so, any comparisons there?
Sure, I think the...
The
Olivia Brer: 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 terms of
Olivia Brer: and what we saw there over their nebulizer. So that's really also our key points of differentiation as we go forward. I think there's always enough room in a market for two players. So it's really about making a difference in the patient's lives and letting competition.
Olivia Brer: compete, but we think that this disease requires hopefully some innovation that we can bring to the marketplace.
Olivia Brer: In terms of the the clinical differentiation, you know, as you may or may not realize these patients You know take immense amounts of modium just to try to stay on OFEV
Olivia Brer: from OFEB versus us in that profile. Again, the FDA could change our trial design and we would focus only on experienced patients potentially.
Olivia Brer: But otherwise, we think the administration is not gonna be the biggest burden in terms of a pill versus inhaled, but the side effect profile of OFEV is really what we're going after. And hopefully, we can get higher lung concentration. We did measure plasma.
Olivia Brer: PK in this trial. Not to compare it to OFEB, but just to kind of triangulate to our animal models 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.
Speaker Change: Okay, understood. Thanks, Micah. And then just in terms of kind of data disclosure for measuring, you know, plasma and PK, 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 present at a medical meeting or publish?
Speaker Change: I don't want to speculate yet because I don't know what the data says relative to our animals and you know how would we triangulate that or put some information out there. I do think people have been asking around the bleomycin study and this and so I will think about how we can...
Speaker Change: bring some more articulation of our confidence as we go forward and what that trial design looks like and the data behind the support around that.
So.
Speaker Change: And that's probably, you know, the one area I think we're still having some internal discussion on, which is...
Speaker Change: do you do a smaller phase two just to get the efficacy data so people could see that sooner? And then that'll take a little bit longer of a phase two than a phase three, but it would give people more certainty. And so those are some of the discussions between the FDA and our internal clinical development team.
Okay, great. Thank you. I appreciate the color.
Okay.
Thank you. One moment for the next question.
Speaker Change: And our next question will be coming from the line of Fizal.
Hershey of Lerink Partners. Your line is open.
Speaker Change: 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 in F&B. One I think like every 15 minutes roughly so there was like four to five F&B ones in the hour to two hours post dosing and so that itself would have a lot of irritation or alone.
Speaker Change: And that's something that the FDA wanted so we did it but not sure it's going to tell US much we'll look at the summary of all that data.
Speaker Change: But there is a lot of I'll say administration of Seb, one throughout the time period of measurement.
Speaker Change: And so we're looking at total F&B one drops from the initial dose all the way through two hours and that's after repeated F&B ones.
Speaker Change: Patient so there's a lot of data drawn a lot to still be summarized.
Speaker Change: But there is nothing at the highest level that when we looked at the data that was a concern 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 specifically around the tenant that we would say.
Speaker Change: There is also I think it's much more around putting dry powder in the lungs than anything and the frequency of a few on testing that was required.
Speaker Change: Yes, and it sounds like a workout.
Speaker Change: Just to clarify the placebo arm was like just the straight excipient without the Nintendo switch. It's the same kind of dry powder inhalation doesn't know active drug.
Speaker Change: Yes, its SDK P.
Speaker Change: As the excipient.
Speaker Change: Got it great. Thanks for taking the questions.
Speaker Change: Okay. Thank you.
Speaker Change: Thank you wanted to move to the next question.
Speaker Change: Yes.
Speaker Change: Our next question will be coming from the line of Gregory Zhao of RBC capital markets. Your line is open.
Speaker Change: Hi, Mike and team into niche on for Greg Congrats on the progress this quarter and thanks for taking our questions just firstly on <unk> hundred one what's the broader value proposition from an economical standpoint for patients and physicians to use mannkind want in one over Eric case, or even Oracle <unk> and <unk>, maybe if you have some early thoughts on where you'd like to land on out of park.
Speaker Change: <unk> cost and then Justin keying in on <unk>, ACO, DPI and the Teton IPF and <unk> studies might tier one also be clinical usable and PPA I know theres. Some research out there just wanted to get your thoughts. Thanks, so much.
Speaker Change: Yeah.
Speaker Change: Yes. Thank you I do think that as we saw another company switched from IPF. The PPS I think we will see some.
Speaker Change: <unk> might be up next year with the <unk>, one and two so I think there is an opportunity there to your point some of that will be.
Speaker Change:
Speaker Change: We would expect to get to my mind extrapolation of indications. So if we look at what Nintendo's indicated for I think it's really picking the right population with the right trial to get the right endpoint and I think as part of our request with the FDA.
Speaker Change: Just like we got ILD with Televisa DPI, we would hope to get extrapolation with them with that but that focus so that will be our first focus on that but to your point, maybe we could go through PPS instead of Ips. If we really wanted to and I think that is still an ongoing discussion, but I think a lot of this is the bigger population of Ips and the predictability of enrollment in that trial.
Speaker Change: Ill bridge over to your 101 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.
Speaker Change: Our team is over in Asia, right now in Australia, activating sites and kicking off the investigator meetings over there and <unk>. It has much more wider use I'll say in those markets and so the receptivity of our nebulizer form is very high and the belief in <unk> as a treatment for <unk> is very high and when you think about the couple of side effects of <unk>.
Speaker Change: <unk> in particular oral formulation youre getting skin discoloration, Qt prolongation and potentially organ accumulations. So those are three things you don't want that with a reduced dose in the systemic circulation, but better concentration within the lungs, we would see better value prop.
Speaker Change: And then combined that I think with our case our cases.
Speaker Change: So it's got OTO toxicity by nature, and I do believe those will be clinically differentiated, especially as you get to infectious disease docs and the hospitals, who are used to dealing with these things.
Speaker Change: I think there'll be a clinical differentiation.
Speaker Change: Potentially a safety again, we've got to get trial results before we get too excited but.
Speaker Change: I think conceptually that's where our heads are at and then you get to the dosing administration everyday cleaning a device for six months to 18 months of your life as a burden and that's one of the reasons. We chose the dosing with <unk>, which is 28 days on at 56 days up one is the use of a nebulizer.
Speaker Change: The PK PD or the product allows us to probably get that long.
Speaker Change: And then the second is the co pay burden on the patient and so there is no real incentive for the doctors to use I'll call nebulizer or an oral form of our products. Unlike diabetes, where there is an incentive to use an insulin pump that doesn't happen in this disease.
Speaker Change: But.
Speaker Change: Being able to.
Speaker Change: Really get that nebulizer down to once a month, which should remain one co pay to the patient and so while the overall WAC cost per month supply will probably be comparable to a three months supply I would say that duration of effect of last two to three months and the co pay will be a one month thing and that's important especially for Medicare, which is generally cost per month as we go into 'twenty.
Speaker Change: So that's kind of the value prop on the cost economic side, and the dosing and safety that we're thinking about.
Speaker Change: Great. Thanks, so much.
Speaker Change: Okay.
Speaker Change: Huge.
Speaker Change: I'm sorry.
Speaker Change: Good thank you.
Speaker Change: Question Alright.
Speaker Change: Alright. Thank you one moment for the next questions.
Speaker Change: And our next question will be coming from brands or folks.
Speaker Change: Robin and.
Speaker Change: And Richard your line is open.
Speaker Change: Alright, Thanks for taking my question and congratulations on the progress during the quarter.
Speaker Change: To switch gears and talk a little bit about it frankly.
Speaker Change: Can you just talk about the growth in <unk>.
And especially the growth in terms of the breadth and depth of prescribers.
Speaker Change: And what is the unaided awareness in the market just any investment that mankind.
Speaker Change: Into afraid of data over the last year.
Speaker Change: Is this some level of anticipation of that data among your current prescribing community.
Speaker Change: And then how do we see the.
Speaker Change: Our friends at commercial footprint evolving over time, just given that backdrop, especially as we sort of move into the pediatric label and then sort of really make a move on the inhaled.
Speaker Change: I Hope I say 700 data. Thank you.
Speaker Change: Thank you Brandon I think from you there is a few questions wrapped up in there and so I would say the unaided awareness of Afrezza amongst.
Doctors is what wed expect given the investment in our narrow target.
Speaker Change: We target probably about 4000, 5000 docs any given quarter.
Speaker Change: And.
Speaker Change: The number that actually write it on a consistent basis is obviously much less 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've used the product.
Speaker Change: Got to a point this year, where we really reduced our salesforce from roughly 80 people down to 50, and so with that 40% cut we had to go narrow and deep and that strategy seems to be working were seeing growth within our targets that we are really on top of and we've seen that we've lost a little bit of scripts in the non targets I'll say or in some of those docs that we.
Speaker Change: Had to leave with a reduction in the sales force, but the hope was we would make up that drop on those that we are targeting so if those appear to be kind of making that transition as we got from Q2 to Q3 early Q4 the.
Speaker Change: The other part that we are seeing in the endocrine space and you can kind of see an influence scripts.
Speaker Change: I think the overall Trc has dropped roughly 3% to 5% in Q3 and the overall rapid acting mealtime market.
Speaker Change: And first obviously drop from Q2 Q3, a little bit and some of that is we're seeing the <unk> switch from treating diabetes to actually treating weight loss and they are just literally wholesale shifting their focus from their patient volumes and so we will see how that continues to play out I don't expect it to impact our president of dramatic way, because we have more than enough prescribers that we see.
Speaker Change: Need to help and work on.
Speaker Change: But that was some of our top prescribers, we start to see it.
Speaker Change: That's why it is important to brought in.
Speaker Change: Our commercial our commercial focus beyond.
Speaker Change: The ones that we do have.
And overall as we go forward, we want to kind of see the reactions of the inhaled three data so that came out.
Speaker Change: The third big data just came out a few weeks ago here and that data will be published in a reputable journal probably in the next four to eight weeks and so that's been accepted and then we have a bunch of presentations at <unk> and we're just starting to educate the marketplace. So we'll be looking to bring <unk>.
Speaker Change: <unk>.
Speaker Change: In 2025 to really start to get into the academic centers and fellowship trainings.
Speaker Change: Really focus a little bit more on.
Speaker Change: Getting out from underneath the the burden of sales.
Speaker Change: The safety perceptions of inhaled insulin and how do we start to put that on the table and move forward on the efficacy opportunities to help more patients.
Speaker Change: And your question, but I do think we've got a good grasp of what's going on and we feel pretty good about the direction, we're going in and our ability or desire to shift investment to grow it faster or at least put some resources behind key areas to make a difference.
Speaker Change: Great. Thank you very much and congratulations again.
Speaker Change: Thank you.
Speaker Change: 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.
Speaker Change: Thank you Lisa for moderating today, and thank you to all the Mannkind 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 will continue to give you guys updates as things come in but Theres, obviously, a lot going on all in a great way and look forward to continue to open up that communication mine.
Speaker Change: And feel free to reach out with any questions. Thank you.
Speaker Change: Thank you all for joining the conference call today, you may now disconnect. This does.
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