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: Olivia Bryer - Cantor Fitzgerald - Analyst
: Michael, I'm sure most of the room is familiar with the story, and you guys obviously have a lot going on. I think the story is going through a
significant transition right now with the company. So maybe just to kick things off, set the stage with where the company is today, some of the
progress that you guys have been excited about and what we should be looking forward in 2024 in terms of strategic priorities and some of the
progress that the company is making some strides.
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Yeah, it's a great plan. I mean, you guys do have a lot going on. Do you feel like there's an appreciation when you have some of these conversations
with investors, that there is more beyond Tyvaso. I mean, has that conversation started to shift more and more around the pipeline?
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Yeah, understood it's --
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Yeah. It is exciting. It's great to hear. Well let's just dive right into Tyvaso DPI. I mean obviously, that's been a topic du jour for a lot of people.
And I recognize that the pipeline is starting to get more airtime, but that is something that you guys have talked about as one of your biggest
growth drivers. That is something that has started to gain momentum. Congrats on a great quarter last quarter, and maybe just talk to us about
where Tyvaso fits into the growth strategy for the company more broadly?
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Yeah. And then from a supply capacity perspective, I mean, it's a great point, right? You guys have had a number of learnings as the launch has
played out. I'm sure you'll have more learnings, like you said, in Q3 and into Q4. And I know that you guys have been very focused on making
improvements in being able to supply more and at a faster rate.
So maybe talk to us about some of those improvements that you have been able to successfully make. What are some improvements that you plan
to make going forward? And then really, how quickly can that start to impact the top line and ramp up on from a growth trajectory?
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Yeah. And then last question on capacity is just you know, I hate to ask you to put a time on it, but when do you think or at one point, will you guys
get to a point where you can start to have some backfill and really start to build inventory?
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Okay.
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Okay. Sure. Understood. And you guys are partnered with United, and I know that's been a fantastic partnership for you guys. And this is a question
you probably get asked all the time and are probably tired of answering it.
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SEPTEMBER 27, 2023 / 3:30PM, MNKD.OQ - MannKind Corp at Cantor Fitzgerald Global Healthcare Conference
But United has been pretty vocal about wanting to build out another manufacturing facility. What do you think of their strategy? And how does
that potentially impact some of the progress that you guys will be able to make going forward?
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Yeah, well it sounds like you guys are in a great position and the Danbury factory is beautiful. If you guys haven't been, I was just up there recently.
Thanks for the tour, lot of hard hats. It was a lot of fun.
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Yeah, well, we're looking forward to all the progress of the launch. And Perfect segue, maybe we'll dive into your diabetes business a bit. Obviously,
diabetes has been a very interesting rapidly evolving fields, there's a lot of innovation going on.
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SEPTEMBER 27, 2023 / 3:30PM, MNKD.OQ - MannKind Corp at Cantor Fitzgerald Global Healthcare Conference
So how do you think about MannKind fitting into the broader diabetes space? And when you think about positioning the company for success,
given that there is competition out there. Where does MannKind fit into the broader diabetes space?
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Yeah, understood. And we'll get into your pediatric study in a minute. But outside of pediatrics and when you really look at the adult space. I guess
the question is how do you think about growth being driven by adults versus pediatrics?
And are there things that you all can proactively do before hopefully getting approval in pediatrics? I know you talked about marketing is and just
physician awareness is maybe the biggest bottleneck that you guys are facing. So is there something that you can do to accelerate adoption in the
meantime?
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Yeah, and remind us what the next updates are. I know you have INHALE-1 pediatric data coming out pretty soon. I know you have INHALE-3 also
right around the corner. So what are you know what can we -- when can we expect to see some of those?
I hate to ask the timeline question again, but I am a have a sell-side analyst.
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Good luck. And then beyond that, what should we be looking for? Maybe help set expectations into those data.
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Yeah. And the importance of dosing correctly, it's an interesting point. Is there a way that you all can control for that or at least proactively get
ahead of it?
I don't know if there are [teachings] that you can do with certainty PI's or whatever it may be just to help increase chances of success for this study?
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Yeah, understood. Well definitely looking forward to all the progress with Afrezza business as well. And you do have these two big commercial
franchises. Currently, I know you guys are building out a pretty active pipeline. So maybe just to kick things off, how do you weigh investing in the
commercial business, current commercial products, marketing, things like that versus wanting to invest heavily in your R&D engine and next leg
of growth, so to speak?
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Absolutely. And then I think there's a lot of interest in your, what is it? MannKind 101, MNKD, how do you pronounce that?
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Yeah, which is your inhaled clofazimine program. I know you guys have talked about this as a potentially big commercial opportunity for you. I
know it's a very important driver going forward, and I know you guys are filing an IND moving directly into Phase 3. So what is the -- what's the
next step for that program?
How do we get there? And for investors that maybe haven't done a lot of work in the space or a lot of work around that asset, specifically, what
gives you a level of confidence that you can move directly into Phase 3 and ultimately through the regulatory path.
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SEPTEMBER 27, 2023 / 3:30PM, MNKD.OQ - MannKind Corp at Cantor Fitzgerald Global Healthcare Conference
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Your hands not like Orange. So you must not be --
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: And that's still been the feedback from FDA?
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: So in terms of timelines, the expectation to file by end of year is it --
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Okay great and then move directly into Phase 3 (multiple speakers)
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Yeah, great. Well, I know we're out of time, but let me just ask you one last pipeline question that you guys do have another interesting pipeline
asset 201.
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: I think that could be a very interesting program down the road, maybe sooner than later. How big of a strategic focus has that been? And how
quickly could you physically move some of a program like that forward?
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Sure. We'll we're looking forward to the progress of that program. And really everything I mean, you guys clearly have a lot going on and I think
sometimes people don't always appreciate how many shots and goals you guys truly have.
Question: Olivia Bryer - Cantor Fitzgerald - Analyst
: Of course, yeah. Sounds like you guys are turning things around. So we're looking forward to all the progress next year. Thanks so much, Michael.
Great having you here today.
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