The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Excellent. I do have one point of admin. If anyone has any questions in the room, please go to Rivka. She's going to -- she's got a microphone and
she can pass that microphone to you and we can have your question asked. With that said, you've had a great year so far. Stock is up 80% year-to-date
from this morning. Not many stocks you can say that and buy a pharma. However, I realize not everyone here in the room knows about your story
and I think perhaps a good place to start is to give a brief introduction about the company and highlight year-to-date.
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Excellent. And perhaps Chris, you know, we we're talking about the pipeline and the products that you -- or the product you have available. Can
you perhaps talk about the capital commitment you have on the pipeline versus what you've got on the market?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Great. And just to touch upon the rest of the year, there are a few catalysts left. That's unusual and we've only got a month left, but perhaps can
you outline this for everyone here and talk about the opportunity these could have?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Understood. And if I look at INHALE 3, how are you going to go about maximizing that opportunity first?
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NOVEMBER 12, 2024 / 6:15PM, MNKD.OQ - MannKind Corp at UBS Global Healthcare Conference
Question: Trung Nguyen - UBS Securities LLC - Analyst
: So do you think you can change people's original thoughts about the drug? Because initially, it appears that people weren't being properly dosed,
right? Is there a perception that your product is just inferior and that's, you're just going to need more promotion that you can invest in to just
change people's mind here?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: And in your comments just then on the PEDS side of things, have you talked to physicians about potentially, your products and PEDS? What's their
reception been like there? That what's the need in the PEDS?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Excellent. Okay. If we switch gears to 101 inhale clofaxin -- I think, clofazimine, for refactory MTM called by MAC, perhaps for everyone here? Can
you give us an overview of MAC, the current treatments there are, and what gives you excitement going into this area?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: And can you perhaps talk about some of the early PKPD data? What gives you excitement here? And how do you think that translates when you
get into humans?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: And it seems like you've got an aggressive plan to move from Phase 1 to Phase 3 very, very quickly. Have you spoke to FDA about the design here?
And how are you thinking about recruitment?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: And on the cost side of things, how should we think about costs building as this trial comes on board? Have you, have you mentioned how much
something like a Phase 3 study could have lost?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Okay. Excellent. And 201 perhaps a very similar question about IPF the disease, the augment need that's there and your excitement about the
opportunity in IPF.
Question: Trung Nguyen - UBS Securities LLC - Analyst
: In the Phase 1 that you just recently discussed, there was, is it two or three doses that you tried?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Okay. Interesting. And your meeting with FDA first quarter of next year, how should we think about timelines if it was for a phase, if they said, look,
you need to do a Phase 2 and then subsequently a Phase 3 and then if you went into straight 2, 3?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Yeah, understood. And what do you think are the points that you need to agree with FDA on to get this thing approved? What's the key things you
think that you're going to have the most negotiation with FDA?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Okay, excellent. Let's switch gears to Tyvaso. Obviously, it continues to be a very key strategic product here. One area where I think there's a bit of
confusion on the street is on manufacturing and the cost base here. And if cost keeps going up, you know, how does that relate to the proportion
of cartridges sold? So how should we think about that manufacturing going forward come 2025?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: So you are studying Tyvaso in IPF, the TETON studies. I think that's how you pronounce it -- TETON. They're evaluating the nebulizer, not your DPI.
So perhaps can you explain why they've gone with the nebulizer and your excitement for the IPF opportunity?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: So you don't think that bridging study, there's going to be no complications there? Have you spoken to the FDA about that?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Okay. Brilliant. Chris perhaps can we catch up on where you are in terms of expanding manufacturing capacity for the DPI? I mean, obviously you've
expanded into a second production site at your existing manufacturing site. So is there any numbers you can kind of give us around this expansion?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Okay, excellent. And can we talk about the catalyst for 2025 as we exit 2024? Where should investors be looking at for potential points of inflation
for you guys?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: And Chris, as the CFO, what are your priorities for come 2025?
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Excellent. And we'd love to have you here again next year. One of the things that I'm asking all of the companies that I've got on stage is, come this
time next year, what are the three things you have hoped to have achieved by then? And I'll put you on the hook for that and start next year.
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Excellent. Well, I'll lead with that at the start of next year.
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Thank you, gentlemen. Thank you for coming.
Question: Trung Nguyen - UBS Securities LLC - Analyst
: Hope you have a good rest of the day.
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