Q1 2025 MannKind Corp Earnings Call
Call is being recorded on May 8th, 2025, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call and available for approximately 90 days.
This call will contain forward-looking statements. Search forward-looking statements are subject to risks and uncertainty which can cause actual risks to differ materially from these stated
For further information on the company's risk factors, please see the form 10Q for the quarterly period ended March 31st 2025 on file with the SEC, the earnings release and the slides prepared for this presentation.
Speaker Change: Joining us today for MannKind, a Chief Executive Officer, Michael Castagna, and a Chief Financial Officer, Chris Prentiss. I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.
Speaker Change: Thank you everyone for joining us this morning. Today joining me is Chris Prentiss, our chief financial officer. We'll be going through operational pipeline highlights, our financial review, and some of my remarks at the end.
Speaker Change: As we've engaged with the investment community over the last several months, our discussions highlight that investors, especially in these uncertain times,
Speaker Change: are seeking commercial stage companies that have a profile of growing revenue, promising pipeline and a strong financial position combined with a very little debt that we have going forward. I'm proud to share that this depicts where MannKind is today and are excited by our five key pillars of growth above. Let's go.
Dr. Prasad Prasad Prasad Prasad Prasad Prasad
Now I'm going to highlight our Q1 2025 key points.
Speaker Change: Our Underground Business Group, 20% on Unarxes and 14% on TRXs, we have filed for a label change for our adult, which is a 2X round-down conversion. We expect that to be hopefully approved in Q4 of this year. We plan to file the pediatric expansion in mid-2025.
Faisal Khurshid
Speaker Change: Our tabasos collaboration remains strong. I'm sure many of you have listened to the UT call. We are excited about our great partnership together, which resulted in Q1 world he revenue of $30 million and manufacturing revenue of $29 million in dollars.
Speaker Change: In terms of co-phasming and attending, I will highlight those later in this call and our financial results were very strong for the quarter and we had non-gas income of 22 million or 43% growth over last year. Now let me bridge to our diabetes business.
Speaker Change: Since we may have spoke, we had a very successful ATT showing with multiple K-Welener
Speaker Change: Unlike anything before, due to the positive inhale-free data and the excitement that is building in the pediatric opportunity, all of this gives us reason to believe the steps we have taken and continue to take set the stage for Frieza to realize its true potential.
Speaker Change: After leaving ATTD and interacting with hundreds of U.S. and international customers from around the world, the global expansion and demand opportunity is real as evidenced by a booth at ATTD which was non-stop with traffic over the three days we were there.
Speaker Change: Additionally, I have met many U.S. customers in my travels around the U.S.
Speaker Change: and I no longer hear the objections I used to and now what I hear is why don't we increase patient requests? Why is it not top of mine with our sales force?
Speaker Change: We're very excited. We believe Pediatrics is a real opportunity to cause an inflection in a Fresaf. Additionally, we recently had a payer at board that also described how they would probably allow pediatrics to go through relative to the history where they would block a Fresaf to inject a blunt form.
Speaker Change: Now, as I look at the performance driven by a strong NRX growth, we've really seen this improvement, but what's more important is a 26% year-over-year growth in our top 50 prescribers, top 50% of our prescribers. We're very pleased with the early indicators here and continue to go deeper on our call list to increase the number of prescribers we can target.
Speaker Change: Our TRX activity is consistent with our gross revenues, and while net sales have created relatively in line with the prior year, this is due to one-time adjustments of our gross tenant and Q1 and ordering patterns at the end of 2024.
Speaker Change: Data since the last end of the last quarter continues to give us confidence that our messages are resonating and our team is on the right path to continue making impacts.
Faisal Khurshid,
Now, I'll bridge over to the orphan lung opportunity.
Speaker Change: First, on Tavesu DPI, this revenue coming in from the United Therapeutics will provide the non-delutive pipeline funding that we need to move Tavesu, sorry, Khofazamine, MannKind 101 forward as well as the tenant of our MannKind 201.
Speaker Change: What's really encouraging is we had about 1.1 billion of Tavasa DPI-related revenue from the United Therapeutics in the previous four quarters. And we receive, obviously, 10% of royalty on those sales.
Speaker Change: We recorded $29 million in manufacturing revenue in Q1 and we await the read- the read-ups of the T-TOM 1 and 2 trials that United Therapeutics is conducting.
Thank you for watching!
[inaudible]
Speaker Change: As I looked at the NTM market, we get very excited that this market would likely exceed $1 billion by the end of the decade. Our focus on the US and Japan, which have the highest addressable populations, and this disease continues to grow 7% year over year.
Speaker Change: We see a large market opportunity with one branded treatment in the US and Japan. We believe MannKind will be the next potential launch with Klafazamine as we look out.
Speaker Change: Current NTM therapies have the limitations in efficacy safety and tolerability.
Speaker Change: As we look at the drug combinations, they have low efficacy and high systemic toxicity. These are very severe and cause long-term consequences for patients. And if frequent dosing, these are almost like TB-like regimens and or nebulizers that contribute to patient fatigue and low adherence to therapy.
Speaker Change: Now let me bridge over to the Inhale Development rationale for inhale cliff as I mean. The first thing we were trying to do is make sure we maximize the anti-micobacterium activity at the sight of infection by bypassing the GI track and minimizing systemic exposure to hopefully improve the tolerability profile. [inaudible]
Speaker Change: Oracle Fasmin is recommended by the clinical guidelines and we've done some pre-work to really have comfort in the animal studies as we move forward in the progress of human development.
Speaker Change: Additionally, because COVID-19 has a long half-life, we've been able to create a very chameleon dosing cycle, but the drug holiday meaning they take the product for 20 days and load the lung, and then 56 days off, and we hope this will alleviate the patient's human burden as well as non-compliance.
Now, let me update you on our MannKind 101 study
Speaker Change: First, 85% of our sites have been activated across four countries
Speaker Change: Two, we've had 55 patients randomized with minimal dropouts and patients are now starting to move past the six-month time point rolling over to extension. And as of today there's been no down-dosing to a lower dose. So we believe people are tolerating the product and this is an indication of the direction the product hopefully will go.
Speaker Change: We remain confident in achieving 100 patients in their internal analysis enrolled by the end of the year, and even once we hit that number we will continue to enroll so that when we get that readout in 2026, if it says we need it more patients hopefully we'll hit that mark by the time we get to that data point.
Now I'll bridge over to IPF.
Speaker Change: What does he don't know IPF? It's a progressive and fatal disease, 80% of people will die within the first five years of diagnosis. There are only two drugs approved and the majority of the patients cannot tolerate either one of those products, hence why we continue to move this forward and believe there's a real opportunity to help patients.
Speaker Change: We believe in the 10 that will be the background of therapy as new combinations continue to come out and get approved over the coming years.
Speaker Change: We previously talked about our phase one study which was complete and it meant its safety intolerability objectives and healthy volunteers.
Speaker Change: We had no serious A.E.s and A.E.s typically seen with the tentative such as diarrhea have not shown up, and we expect they continue to develop this in the next phase of development in a global trial, and I look forward to sharing those details at a future meeting. I'll now turn over to Chris. I'll now turn over to Chris.
Chris Prentiss: Thanks, Mike, and good morning, everyone. I will now discuss our first quarter of 2025 financial results. For a summary of our financials, please review our press release issued before this call and our Form 10Q which is now on file with the FCC.
Chris Prentiss: Before we get into the details of the quarterly results, I want to highlight our revenue growth over the last five years as we compare the trailing four quarters on an annual basis.
Chris Prentiss: It demonstrates impressive growth across our three revenue categories over this time frame, a testament to the extraordinary work of our team.
Chris Prentiss: Looking forward, we expect our royalty revenue to continue to grow based on the impressive performance of Tavaso DPI.
Chris Prentiss: We expect our collaboration and services revenue to remain relatively flat on an annual basis in the near term, due to production scale up in efficiencies, and will fluctuate over time based on UT's production orders.
Chris Prentiss: The commercial metrics that are unfolding give us confidence and excitement for the future of a phrasa and we anticipate change in its growth trajectory, especially if we are able to gain approval for a pediatric indication.
Thank you for watching!
Chris Prentiss: Our overall revenues in the first quarter grew 18% led by revenues related to Taipei so DPI. Taipei so DPI royalties contributed 30 million in the first quarter an increase of 32% over the same quarter last year.
Chris Prentiss: Collaboration and Services revenue consists primarily of manufacturing revenue based on production volumes sold through to UT and the recognition of deferred revenue. We recorded revenue of 29 million in the current quarter and 18 percent increase from the prior year quarter.
Chris Prentiss: A Prasad Nat revenues for the first quarter were 15 million, a 3% increase over the prior year.
Chris Prentiss: It's important to note that the first quarter of 2024 benefited from a one-time favorable adjustment to gross denotes. Additionally, the current quarter was negatively impacted based on the timing of shipment at the end of the year.
Chris Prentiss: As we look at the performance of Afreza, we are encouraged by the growth and new and recurring prescriptions over the prior year and expect this trend to continue.
Chris Prentiss: Vigo Net Revenue was approximately 4 million for the first quarter, a 6% decrease driven by lower product demand.
Chris Prentiss: As discussed on previous calls, the sales force is no longer actively promoting VGO as of the fourth quarter of 2024.
Chris Prentiss: For the first quarter of 2025, we reported net income of 13 million or 4 cents in earnings per share, a 24% increase compared to 11 million or 4 cents per share for the first quarter of 2024.
Chris Prentiss: On a non-GAAP basis, we reported 22 million of net income, or 7 cents of earnings per share for the first quarter, compared to 15 million of non-GAAP net income, or 6 cents per share for the same period in 2024, a 43% increase.
Chris Prentiss: We started the year strong. Our operational results combined with our quarter end cash and investments of 198 million will allow us to continue investing in our differentiated pipeline and execute on our objectives, including driving commercial growth.
Chris Prentiss: Mike and I will be at the RBC and Jeffries conferences over the next month and we look forward to engaging with all of you there.
Thank you, Chris.
Chris Prentiss: Quickly I'll talk about some anticipated catalysts over the first and second half of this year. As we look ahead, there are a series of catalysts on our pillars here to highlight a few.
Chris Prentiss: In Hill 1, we just had our last patient and role last week and last visit, and now we can lock the database and get top line results here shortly and submit the SPLA in the next few months.
Chris Prentiss: for MannKind 101 to key metric retractions in-term enrollment target, which we expect to meet by year end and on 201 is continued to finalize details behind our global trial and work with your zeros to get a proposal to kick this off in the second half of 2025.
Faisal Khurshid
Chris Prentiss: As we look to continue to build shareholder value in 2025 and beyond, obviously there's a pillar of Tabaso DPI and for every 10,000 patients covered on insurance, we'll see 350 million revenue between manufacturing
Chris Prentiss: We know there's a big opportunity here in T Tom 1 and 2 and want to actually await those results from United Therapeutics as well as the bridging work that has to be done in order to get that into IPF patients.
Chris Prentiss: With the endocrine business, we previously talked about what the opportunity of pediatrics means. It's a long-term strategy we've been pursuing as we ran the endocrine business for profitability versus significant growth. We now believe that every 10% share end kids will represent about $150 million in net revenue to mankind.
Chris Prentiss: As we look out, the inheld free data continues to be educated out there in the marketplace and present it, and the international opportunity continues to grow.
Chris Prentiss: and as we close out here on 101 and 201, 101 is a significant unmet need here in NTM.
Chris Prentiss: And every 1,000 patients, we believe would be $100 million in that revenue.
Chris Prentiss: And on 201, the market is so large, we just need to make sure we have a product that works to help these patients who really have very little options to extend her enhanced her life.
Chris Prentiss: We are looking forward to continue to build upon these catalysts a big MannKind, a great opportunity.
Chris Prentiss: in June . We look for these opportunities to discuss and present our new data, and with that said Operator, we'll now turn our call over for Q&A.
Chris Prentiss: Thank you. At this time, if you would like to ask a question, please click on the raise hand button which can be found on the black bar at the bottom of your screen.
Chris Prentiss: When it is your turn, you will receive a message on your screen from the host, allowing you to talk and then you will hear your name called.
Chris Prentiss: Please accept, unmute your audio and ask your question. We will wait a moment to allow the cuter form.
Faisal Khurshid,
Faisal Khurshid, Faisal Khurshid
Speaker Change: Our third question comes from Faisal Khurshid from Learing. Faisal, please unmute your line and ask your question.
Chris Prentiss: Hi, this is Heidi on Professor. Thanks for taking our question. Regarding MannKind 201, can you provide some initial thoughts on what a Phase 2-3 trial design for MannKind 201 could look like, and any feedback you received from the FDA? And did they align on a seamless study design? Thanks.
Speaker Change: Hi, thank you for the question. We aren't given too much guidance yet on the feedback from FDA. What I can say on the Phase 2, 3 design was more for a global...
Speaker Change: Trial, so I think that'll be more of a question as we get to XUS authorities.
Speaker Change: I think on the trial design, we are thinking of several dose arm trial compared to placebo and I think there's a few last minute discussion points we're having around. Is it on top of a preventive zone or a naive patients or patients that are produced to treat it but not tolerating?
Speaker Change: Existing products. So that's probably the extent we can share at this point.
God, thanks so much.
Speaker Change: Thank you. Our next question comes from Olivia Brayer from Cantor, Olivia please unmute your line and ask your question.
Olivia Brea: Good morning guys, thank you for the question. I wanted to follow up on your IPF study, especially because it relates to end points.
Olivia Brea: Maybe it's a little premature to ask, but are you guys looking to measure FEC in that study and maybe just any comments around whether you're hoping to actually show improvement from baseline versus the Delta from the placebo arm?
Speaker Change: and then also if there's anything you can tell us with respect to those levels and then I've got a follow-up question on that detail.
So, I think we will be looking at.
Speaker Change: A couple of different doses. We're still finalizing the protocols you can imagine, but
Speaker Change: Conceptually, we're looking at a couple doses and I think the question is, do you combine those doses for analysis versus placebo? Where do we look for a dose response by the highest dose versus mid or low? That's generally where we're going at this point.
Speaker Change: We are looking for Adelta Fumposibba, we're not scaling it for a statistical end pointer powering it to have a distinct difference.
Speaker Change: in terms of, you know, should it be 100 delta versus 50, but we are looking to get enough patients enrolled so that we can see a delta to have comfort as we go on the phase three with that efficacy could look like as we scale the next generation, the next part of the trial.
Speaker Change: Okay, understood. And then obviously, Taipei, so IPF data coming up in a few months for the nebulizer. I know they've talked about a potential bridging study for DPI.
Speaker Change: Do you know at this point if that would be an inferiority study between the two, DPI and the Nebulized Formulation and anything you can tell us at this point in terms of timing around when that could kick off and how long that could realistically take?
Speaker Change: I think it's too premature to comment yet. I think UTNUS will be meeting very surely to discuss these things and we'll have some insights from the IPF meeting we had for two or one that I think will feed into the TAVASO discussion as well.
Speaker Change: I think give us another quarter or two, I don't know, waiting for the Teton [inaudible]
Speaker Change: Two results are one of the first focuses and obviously get that read out but in the second focus they have some preliminary ideas and I think we'll have a solid plan. I think we believe it will be a breeze like study as opposed to a large scale trial so I think that's the direction I've heard from UT but again I would...
Speaker Change: Deferred them to comment for their initial faults, but that's generally the comments I've heard.
Speaker Change: Okay, understood. Thank you guys. We're off in the corner today. Thank you
Speaker Change: Thank you. Our next question comes from Gregory Renza at RBC. Gregory, please unmute your line and ask your question.
Anishan: Good morning my team, it's Anishan for Greg, congrats on the progress this quarter and thanks for taking our questions just a couple from us
Anishan: First on the label update for adults that you spoke about, maybe if you could just give some color on the rationale behind the update and how you're thinking about the Delta in uptake in adults.
Anishan: And second, just given the macro backdrop, how are you thinking about the potential impact of supply chain for a phrasa, the manufacturing of Tavae's DPI, and even longer term that on 101 and 201, just as we think about APIs, parts related to technosphere, dry powder, et cetera. Thanks so much.
Sure.
Anishan: A lot of questions wrapped up there, I'll try to hit them all.
Anishan: I think on the dosing, we are looking to, we know from all the data we've given, we've published and presented, that a better conversion dose leads to better time and range, better control in the first two hours. So we're hoping that that label change will be approved here in Q4.
Anishan: There's another part of label change that we're asking for that we'll see if that happens as well that we should help us commercially.
Anishan: I think on the adult uptake, we are looking to scale faster where we are, even with the current footprint but maybe expanding that footprint as we go into the second half
Anishan: So we do believe there's upside growth in the execution on the both sides.
Anishan: But the real focus of the team right now is preparing for peeds and getting the core functional parts of the launch in place now that we're being with the board very shortly.
Anishan: On the supply chain, given that we're predominantly US manufactured, we don't anticipate much impact from terrorists. Maybe I'll let Chris come in on a couple of those.
Chris Prentiss: are all manufactured out of our Connecticut facility. So there are certainly certain materials that are purchased from other places throughout the world.
Chris Prentiss: The tariff situation is still evolving, I think it's fair to say, but what we are aware of right now, we feel good that our key products are either exempt at this point in time, or we are in a good position to manage through it.
Chris Prentiss: We had several quarters of VEGO supplies here in the U.S. We were able to slow down shipments there just to kind of see where this goes to minimize any impact. But we do believe VEGO will be exempt from tariffs if it does go forward as is. So we feel pretty good, well minimal impact overall, but again, time will tell, today's situation for all of us.
Great, thanks, I appreciate it.
Speaker Change: Thank you. Our next question comes from Andreas. Andreas, please could you unmute your line and ask your question.
Thank you for watching!
Andreas: All right, good morning. Thanks for taking your questions. Lots of focus on IPF.
Andreas: Clinical Development Treatment Landscape. Can you give us a sense of where you see 201 and even some color on DPI and sitting in the in-the-treatment landscape? Then have a quick one follow-up after that, thanks.
Andreas: Yes, but I don't think we're asking about one or one that I'll hold back.
Andreas: On the 201, I think as we look out, the landscape obviously is challenging, meaning the client had an abysmal failure in Q4.
Andreas: A real focus is on how do we expand the opportunity to help more patients and hopefully bring a tolerable you know, O-Five-like regiment to market, we believe.
Andreas: and Helena Techno could be a background of therapy for the other new drugs coming. So we think about
Andreas: or the new BI launch or the Pristomires one. You know, if these products make it to market I will be very excited because we do believe that we use in combination and that combo treatments will hopefully provide better efficacy for patients assuming they get the tolerability, which I think has been
Andreas: The right limiting issue to date is the two drugs out there are not very tolerable and when you combine them you're getting overlapping toxicity so to have something that we think could provide some efficacy.
Andreas: potentially equivalent dose or higher doses, then how do we then think about that in combination with the new treatments coming and I think that's really evolving quickly over the next year to as our trials move to phase 2-3.
Andreas: And it's also creating one of the why I don't want to come at too much in the study design because
Andreas: We're trying to think through what do you do as these new agents come online over the next one in two years and how would you add those into the trial or add an
Andreas: Can you run a placebo trial? Can you run a naive trial? Can it be on top of background? And in the case of the tent, it doesn't make sense always to have it on top of background therapy because one of the drugs you're trying to replace would be or O5. So I hope it helps give you some color.
Andreas: Yeah, and then obviously, you know, when it comes to inhale therapies, the delivery is paramount and, you know, we can tend that device.
Andreas: Plays a key role in that. How are you guys thinking, just broadly, maybe it's too soon or, you know, you do have a lot on your place, but how are you thinking about opportunities to collaborate with other companies on the delivery side of things? Yeah, thanks.
Andreas: So I think on 201, you know, obviously our device platform has been very successful in the pH and pH ILD market.
Andreas: I would say that diabetes market, the device platform is not a reason it's not successful so we're planning to use the same device platform for 201 and you know that device has been used quite widely now amongst pulmonologists [inaudible]
Speaker Change: Thank you for joining us. We'll see you in a minute. Bye. Bye. Bye. Bye. Bye. Bye. Bye.
Speaker Change: Treaters in that space, so we think that's an advantage of having a clinical experience with the device and...
Speaker Change: The training that it'll just blend into those centers, on the case of Khufazamine, we'll start with a nebulizer, a jet nebulizer that is pretty widely utilized in this patient population already because they have other products that are nebulizing.
Speaker Change: But we have a dry powder version that we are looking to hopefully fit into the dream build platform. And so as we look out, you know that that's one of our core focuses. I'm not sure we need. [inaudible]
Speaker Change: Other device platforms are usually off the shelf and not many of them have been scaled successfully, but we'll keep always open to ideas for innovation and patient support.
Speaker Change: All right, appreciate and congrats on the quarter. I'll jump back in the queue. Thank you
Speaker Change: Thank you so much. Our next question comes from Yun Zhong, from Wedbush. Yun, please unmute your line and ask your question.
Faisal Khurshid,
Thanks for watching!
Speaker Change: I think it's a combination where you just said the new data combined with the execution of the sales force so we started a
Speaker Change: A strong education campaign around October time frame on the inhale three data set.
Speaker Change: and I would say we had several speaker events and national events that led to a strong Q4.
Speaker Change: and Q1. We didn't make any major changes to our sales force. We did increase our...
Speaker Change: Salesforce a little bit in terms of having more feet on the ground. We did increase our share of voice at the AT-2D conference, which I think were good investments.
Speaker Change: and hopefully those will continue to propel us as we come into Q2 and Q3.
Speaker Change: We're hearing good feedback, we're hearing less resistance, we're hearing good managed care coverage this year. So I'd say overall for Fresna, I'm very optimistic that we'll continue to see nice progress, especially as the new team comes on board and starts to make the changes they're making and those flow out through the field and through customers.
Thank you.
Speaker Change: Would you say the the tradition will be the same poor kid education?
Speaker Change: Say that again, I'm sorry, I heard pediatric patients. Right, so go into pediatric potential launch and what would be your strategy, just like the same as you took for the dial patient.
Speaker Change: Um, I think the strategy of a patient is actually very different. 80% of the patients retreated in a children's hospital or academic medical center.
and that will take a very different launch strategy.
Speaker Change: as we go forward and I think you'll be hearing some of that roll out as we get to the next quarter. We have a pretty comprehensive plan we're working on and I think that will be shared once it's approved by the board but at this point it is not going to be the same as the adult side we expect that to be a very different.
Speaker Change: Launch and a launch trajectory from where we are in adults.
Thank you very much.
Thank you.
Anthony Prasad.
Speaker Change: Thank you. Our next question comes from Anthony Patron from Mizuhau, Anthony, please unmute your line and ask your question
I'm sorry. I'm sorry. I'm sorry. I'm sorry. I'm sorry.
Speaker Change: and your thoughts on it here, and obviously the PEG, you have a caregiver.
Speaker Change: tends to be a slightly more diligent sort of patient population relative to adult. So maybe just your thoughts here on what adherence looks like in pediatric diabetes.
Speaker Change: and really what the uptake could be. I would imagine maybe there's a potential for a more rapid uptake in peace versus adults and all the follow-up.
Speaker Change: Yeah, that guy I think, nice to hear you and thank you for your initiation there.
Speaker Change: The Pete side to your point has different dynamics than the adult side. Number one, I think Pete Endos are much more progressive doctors.
Speaker Change: and they're more used to trying new technologies. An example is that you just have a group of patients who have parents.
Speaker Change: that are very active in their kids life. Anyone who has kids knows you're going to fight for your children more than anything in the world. And when it comes to newly diagnosed children, you're dealt with a life sentence, unfortunately. And you're going to, you know, I think that's really a strong opportunity with the phrases who really wants to.
Speaker Change: Learn how to count carbs, inject insulin multiple times a day. Where about iPhone, nocturnal, dead and bed? These are not fun things as a parent. Here in the stories of parents sleeping next through the trials, they're afraid they're going to go into the seizure at night. These are all the things that go through pediatric...
Speaker Change: Diabetes, and so we do think having something like a fresco which we've seen over time has less hypos in our pivotal trials.
Speaker Change: It, um, the one set and all set of action allows you to predict a little bit more of your control and use the CGM these days I think we'll give parents some comfort when they start to get used to the appreza profile so I think then that what that means is a consumer approach will be important impedes.
Speaker Change: And whether that's the parents in educating them and over the kids that are teenagers and camps, that's a whole different game than we've had to deal with in the Fresza adults.
The doctors themselves, I mean, I've met...
Speaker Change: I don't know, at least 10, 15 of them in the last two months here. They are very open to a Freser. Once they solve a lung safety data, that was a number one question coming into
Speaker Change: and that lung safety data looks very strong over to the 26 and 52 weeks. So I think that question is off the table in terms of any concerns of lung safety or any impact of a presence there. So that's also the important point for launch.
Speaker Change: and the last one is your communal compliance.
That's one of our surprises in the Eiffreza trial was…
Speaker Change: How well, especially the teenager said, they're hormonal, they're taking high doses, they...
Speaker Change: Are rebellious in some cases? They're worried about weight gain of insulin. We saw very high success rates in that population and so I think your average diagnosis is around 12 years old.
Speaker Change: and those kids are going through major hormonal changes between 12 and 15.
So we think that...
Speaker Change: You know, so far people will probably more likely adhere to a phrasa
Speaker Change: where the younger kids may have some challenges in the schools and the nurses' administration. We'll continue to work on programs to support that.
Speaker Change: where the teenagers can take the product themselves and carry it.
Speaker Change: much easier for them to control their shoulders. So that's generally what we see in field on their phrasal peeds and some of the high level thoughts on the launch.
Speaker Change: Very helpful, and pipeline, this is more of a totality question.
Speaker Change: and then you take 101 Club Fasemene 201 in IPF, both you and your partner go for same indication, and just look at it in a blue sky scenario.
Speaker Change: It's a heck of a lot of technosphere devices, if it all comes to fruition. So just a recap on the Dan Berry capacity, if the blue sky scenario plays out over the next five years, would you need a growth cat-backs in injection? Thanks.
Speaker Change: You know, I think we can all thank Alman for dreaming big. He built a huge skill facility for diabetes and as you know, that disease is 30 million people just in the US, let alone.
Speaker Change: 3-500 million worldwide. So when you think about capacity of device manufacturing we have a very high capacity to scale up there if needed and I don't expect any major capex.
Speaker Change: on the filling equipment lines we believe 201 can be fit into the current facility we already built and whether that's...
Speaker Change: Access Compacity on the Fresal Line, or an old production line as we scale up the dive. And we have another line that's idle. So we have plenty of equipment to fill cartridges for 201, if that continues to grow, as well as the Fresas. So we're not. [inaudible]
to worry about the capacity there.
Speaker Change: and then on 101, you may have been out of notice over the last couple quarters, but we actually have been building out the manufacturing capacity there in Danbury, the equipment's been coming in, we're actually doing a field application test this week, and that is already being built and in our CAPEX run rate so, so I think most of the pipeline is going to be fine.
Speaker Change: and CapEx is already behind us. I'm sure there will be small things here in there at Chris, but I don't have any major coming in the next five years unless we were to buy something that needed something that would be different but where we are today, I think we don't need to build another plant in the next five years and we have plenty of capacity to support the growth of the company.
Faisal Khurshid,
Thank you.
Faisal Khurshid,
Speaker Change: Thank you. That concludes the question and the portion of today's call. I will now hand the call back to the MannKind team for closing remarks.
Speaker Change: Thank you, everyone, for all your interest in MannKind, the questions here. We're really proud of the work we've done to a great discussion. We got a great direction we need to go. On 101, the pipeline with Profazami, which we were nervous to how fast or slow that trial would go. As you can see, the trial has done very well in terms of enrollment and we remain on track there.
Speaker Change: and then the Peds for Fresno's on track to be fouled here in mid-year. So everything is going in the right direction. The tariffs obviously are impacting the overall economy, but for MannKind we believe we can navigate through those headwinds.
Speaker Change: and we got a great company for investors and a great company for employers, employees and patients so thank you again for everything and look forward to talking to you soon at the upcoming conferences or on the next quarter of the call. Talk soon.
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