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: Sam Jones - Morgan Stanley - Analyst
: Great. Yeah, fantastic. And we'll definitely dive into a lot of the details around that. I guess you've made a lot of progress year to date. Is the kind
of things that you would highlight particularly?
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SEPTEMBER 06, 2024 / 11:00AM, MNKD.OQ - MannKind Corp at Morgan Stanley Global Healthcare Conference
Question: Sam Jones - Morgan Stanley - Analyst
: Great. So yeah, maybe we start with the orphan lung portfolio and the Tyvaso DPI. So you've had a lot of success of the program, I guess just ground
us in the kind of the product where you're approved currently in the relationship with United?
Question: Sam Jones - Morgan Stanley - Analyst
: Absolutely. And maybe just touching on the technology, specifically tightness kind of talk about how that's differentiated and how that translates
into kind of benefits for patients?
Question: Sam Jones - Morgan Stanley - Analyst
: Right. Yeah, and maybe kind of talk about the future of Tyvaso DPI kind of what are the indications as expanding into the timing of that?
Question: Sam Jones - Morgan Stanley - Analyst
: Fantastic. And maybe just a little bit on manufacturing and I know there's been a lot of investment on the manufacturing side. How should we
think about kind of capacity going forwards for the current indications, future indications and kind of how you split that with United?
Question: Sam Jones - Morgan Stanley - Analyst
: That's fantastic. So maybe pivoting to the pipeline you have a long pipeline. You've had great momentum this year with MNKD-101 and MNKD-201
getting [INDs] approved initiating a Phase 3 and Phase 1 trial, respectively, and you've got fast track designation with 101. Maybe kind of just high
level starting with kind of how do you think about the pipeline generally kind of balancing breadth versus focus, derisk targets, speed of development,
et cetera?
Question: Sam Jones - Morgan Stanley - Analyst
: Great. And so maybe spending some time on 101 kind of why NTM, what does that market look like today?
Question: Sam Jones - Morgan Stanley - Analyst
: Great. And you're in a Phase 3 currently, maybe just kind of touch upon the program design and you kind of touched upon it, but the kind of
geographies that you're thinking about as well?
Question: Sam Jones - Morgan Stanley - Analyst
: Yeah. And how is enrolment going kind of anything you confer from kind of enrolment today?
Question: Sam Jones - Morgan Stanley - Analyst
: Great. Yeah, no, we'll definitely stay tuned on progress there. Maybe shifting over to MNKD-201, maybe just level setting kind of give a quick
overview of the programming and current status there.
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SEPTEMBER 06, 2024 / 11:00AM, MNKD.OQ - MannKind Corp at Morgan Stanley Global Healthcare Conference
Question: Sam Jones - Morgan Stanley - Analyst
: Great. And obviously, IPF is a large market with the current commercial products and there's a lot of assets in development as well. I guess how do
you see 201 fit in the landscape? And obviously, Tyvaso DPI obviously in development as well?
Question: Sam Jones - Morgan Stanley - Analyst
: Great. And I guess, thinking about data, not necessarily what you're going to see from the Phase 1, but kind of as you think about success for 201.
How do you think about that in terms of kind of efficacy or safety? Do you think you need to see better efficacy current product or are you just
looking for similar efficacy and better tolerability?
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SEPTEMBER 06, 2024 / 11:00AM, MNKD.OQ - MannKind Corp at Morgan Stanley Global Healthcare Conference
Question: Sam Jones - Morgan Stanley - Analyst
: Great. You touched on the Phase 1, maybe just you have the Phase 1 kind of coming out later this year, kind of what are the next steps post that
path forward?
Question: Sam Jones - Morgan Stanley - Analyst
: Great. And obviously you've got a lot going on with 101, 201. I guess how should we think about the pipeline going forward in terms of kind of
looking to grow that potentially or kind of how you're thinking?
Question: Sam Jones - Morgan Stanley - Analyst
: No, absolutely. And I maybe we shift from away from the pipeline and kind of over to the endocrine business and Afrezza. This is a different leg of
the stool, I guess compared to the orphan lung business. Maybe just start with an overview and kind of, I guess, how you see endocrine and orphan
lung sitting together and how that kind of gives you a good mix in the business?
Question: Sam Jones - Morgan Stanley - Analyst
: Yeah, fantastic. Maybe spending some time on those trials, maybe starting with INHALE-3. You had out data recently and then as you mentioned,
you had the 30 week data coming up. I guess maybe to kind of orient us on the data what that showed any feedback you've had from the data.
Question: Sam Jones - Morgan Stanley - Analyst
: Great. And I guess, how do you see that translating into kind of impact with patients and payers and prescribers and kind of adding to the growth,
frankly, going forwards.
Question: Sam Jones - Morgan Stanley - Analyst
: Yeah. And I guess how do you think about that you've got the data coming up in Q4, I think kind of what are you expecting for the data there?
Question: Sam Jones - Morgan Stanley - Analyst
: Right. Maybe just touching on kind of financials quickly. You're profitable year to date through June 30 strong cash position. You've done a few
things earlier in the year to kind of tally up the capital structure, the royalty monetization. Maybe just how do you think about capital structure and
how you think about capital deployment going forward as well?
Question: Sam Jones - Morgan Stanley - Analyst
: Yeah. No, fantastic. And we've touched upon a lot of stuff across the business, the pipeline, the data readouts that you've got coming up. Maybe
just to close kind of what are the key things that we should be focused on in the next 12 months for MannKind.
Question: Sam Jones - Morgan Stanley - Analyst
: Great. Yes, no, well, congrats on all the progress and exciting things ahead for MannKind. Thanks very much for joining us, Mike.
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SEPTEMBER 06, 2024 / 11:00AM, MNKD.OQ - MannKind Corp at Morgan Stanley Global Healthcare Conference
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