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: Balaji Prasad - Barclays Investment Bank - Analyst
: Maybe to begin with, Mike, you recently reported your Q4 results, walk us through the key points and the highlights there, and then drill it down
further into the 2025 outlook that you see and what are the key events, milestones we should look for?
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Maybe as the business stands itself, could you provide an overview of the company too for those who are new to the story, focus on the strategic
goals to have?
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Got it. And maybe I think we have multiple things happening on the pipeline side. Let's start there. So walk us through the current state of the
pipeline, and what is it that you find the most exciting within your pipeline?
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Understood. And I would imagine, as you go through the enrollments, you would, at certain points, you'll be updating the market and your investors
about it. And so maybe starting with clofazimine, how should we think about this drug versus the existing drugs in the market? Where are the
points of differentiation for the product?
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Sure. And as regards to market itself, help us contextualize the total addressable market as you see for the product and maybe the market and then
translate that to potential revenue sides?
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Sorry?
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: All right. So as we look at the progress of the trial, one of the key events or catalyst we should be looking forward to?
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Got it. And remind us again, what is the data that you would see that would give you decision, at least create a confidence in continuing on with
the trial? And what would you like to see it as also help it commercially?
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Understood. Shifting from clofazimine to nintedanib. So remind us of where this asset stands currently, and I know you have had some interactions
with the regulatory agencies for an end of Phase I meeting. What's the update there?
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MARCH 12, 2025 / 5:30PM, MNKD.OQ - MannKind Corp at Barclays Global Healthcare Conference
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: And it's still in a slightly early stage generally for analysts like me to start modeling out the market and giving -- putting a number to the drug and
the potential opportunity, but help us understand the market opportunity for this drug.
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Understood. And maybe a final question around the pipeline side of things. What do you see as a scope for possible expansion of the pipeline? Is
that a priority for both of you? And how are we thinking about it -- related to your other goals that you have?
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MARCH 12, 2025 / 5:30PM, MNKD.OQ - MannKind Corp at Barclays Global Healthcare Conference
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Understood. Shifting more a bit towards the commercial side of things. Talk to us about Afrezza and the level of adoption you're seeing currently?
And how does the drug fit into the broader treatment paradigm?
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Sure. So the sNDA submission is still on track for the first half of the year?
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Got it. And help us understand what this means in terms of incremental market opportunity and also the overall market opportunity for Afrezza.
And where do you see the peak sales for the drug?
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Got it. Great. Changing tax slightly on the commercial side still early this morning, we had Amphastar where they speak about their collaboration
with you on BAQSIMI. So take us through that? And what does it mean, this promotional collaboration, that you have and also the implication of
this for your overall strategy?
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Got it. With a few minutes remaining, I do want to discuss some points around the balance sheet. So Chris, walk us through the current state of the
balance sheet and as the company has evolved and come to this point, what are the capital allocation priorities for 2025? How has it changed?
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Got it. So with these programs ongoing, how should the market be thinking about operating margin directions? And at what point could we also
start seeing the return on some of these investments you're planning to make?
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MARCH 12, 2025 / 5:30PM, MNKD.OQ - MannKind Corp at Barclays Global Healthcare Conference
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: Got it. Maybe final question for the session with multiple things happening and you're hitting some key event milestones over the next 6, 12 months,
a good spot to think about the longer-term vision for the company, what would the company be looking like in three years or five years from now?
Question: Balaji Prasad - Barclays Investment Bank - Analyst
: So I think that will be a good spot to leave this conversation at and look forward to updates around these -- the progress and thank you again for
joining us at the health care conference, and I wish you a very productive day of our meetings.
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