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: Andreas Argyrides - Oppenheimer & Co. Inc. - Analyst
: Congrats on all the progress this quarter. Two questions from us. Regarding 101, can you just give us a sense in thinking about Arikayce and the
number that you provided, what percentage penetration that is of the market? And then where does 101 fit in that and how much bigger can it
be?
And then for 201, 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 see
from an efficacy standpoint? And then maybe a little bit more detail on the timelines, if you could. I appreciate that.
Question: Olivia Brayer - Cantor Fitzgerald & Co., Inc. - Analyst
: What more can you tell us about MNKD-201's profile just in terms of any differentiation you've seen so far? 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?
Question: Olivia Brayer - Cantor Fitzgerald & Co., Inc. - Analyst
: Okay. Understood. And then just in terms of kind of data disclosure for measuring plasma and PK, is the -- should we expect to see that sometime
next year? Or is that something that you'll just go to the FDA with and not necessarily present at a medical meeting or publish?
Question: Faisal Khurshid - Leerink Partners LLC - Analyst
: I just wanted to ask if you could say a little bit more around the adverse event profile that you saw in the Phase 1 for the inhaled nintedanib. Like
with the FEV drop and cough events, could you tell us a little bit more about your hypothesis around what caused that? Like, is that excipient-related?
And just anything around like kind of time course of those events? And just any more insight you can give around that?
Question: Faisal Khurshid - Leerink Partners LLC - Analyst
: Yes. That sounds like a workout. Just to clarify, the placebo arm was like just a straight excipient without nintedanib. So it's the same kind of dry
powder inhalation just with no active drug?
Question: Brandon Folkes - Rodman & Renshaw LLC - Analyst
: Congratulations on the progress during the quarter. I actually want to switch gears and talk a little bit about Afrezza. Can you just talk about the
growth in Afrezza and sort of especially the growth in terms of the breadth and depth of prescribers? And what is the unaided awareness out there
in the market just in the investment that MannKind has put into Afrezza data over the last year? Is there some level of anticipation of that data
among your current prescribing community?
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NOVEMBER 07, 2024 / 9:30PM, MNKD.OQ - Q3 2024 MannKind Corp Earnings Call
And then how do we see the Afrezza 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 inhale -- (inaudible) inhale data?
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