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: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: To start, maybe, Rich, you could just like level set for us for those that might not be familiar that are listening in, can you just give us an
overview of Catalyst and each of your product candidates?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Thank you, Rich. That was a really good overview. Lots to go off of there. Maybe just -- let's just talk about the overall strategy for the
commercial engine first. As you think about the next 12 months, how do you expect that to evolve in terms of your priorities as you
commercialize your three products?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: And that's from the SUMMIT Study that you're --
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Got it. Okay. That's helpful clarification. So for the Phase 1, when you say additional indications outside of DMD, are we staying in the
neuromuscular space? Or could we expand beyond that?
I mean there are plenty of diseases where steroids are still make a foundation of the treatment paradigm. So how large is the spread for
AGAMREE potentially in your view?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Got it. Okay. And so then when you think about AGAMREE and its penetration into the market, you have some of this data that you just
mentioned from Santhera. You have the SUMMIT Study that you'll be able to rely on when that data starts to roll out. I guess how should
we anticipate the launch to grow over time? Like what does that curve look like potentially?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Right. And in terms of the data that we'll see out of SUMMIT over time is the behavioral piece, I think you've said in the past is likely to be
one of the first data readouts. I guess when you have that in hand, how does that help to just drive the launch further in terms of the breadth
you're looking for -- or the depth, excuse me.
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: I see. Okay. And how should we think about just the overall peak market opportunity for AGAMREE now that you've had almost two years
launched coming up, I believe. I guess what have you learned? And what should we think about the peak opportunity of this drug?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Got it. No, that's super helpful context. And then I think you mentioned this as well, Rich, about the potential immunosuppression for a gene
therapy as well. I'm wondering like where does that stand? And where could we maybe see an impact from that?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Sure.
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Yeah, absolutely. I mean it sounds like the base business that you have right now is quite strong, and there's a number of tailwinds that we
could see materialize over the next, call it, 12 to 24 months potentially, at least data-wise, maybe if not future label change.
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Yeah. No, that's a really good position for AGAMREE. Okay. So why don't we go ahead and switch over to FIRDAPSE then? I mean we started
-- you gave us a really good overview of that one as well.
Why don't we start with the Oncology segment, if you don't mind. I'm wondering all of your efforts, I think you laid out what they are quite
clearly already. But how have those been received by physicians? How is that education progressing, the efforts that you're making?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: No, that makes a lot of sense and the opportunity is there for sure. When you think about that inflection point, I think you said mid-'26, you're
obviously working to change a bunch of care pathways. Does that all -- I guess, do you get enough momentum at that point? Is that when
you expect the education to hit sort of like, I guess, an upward curve where the diagnosis rate should start increasing? And is that just like
a critical mass of these care pathways changed on your favor?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Yeah. That makes sense. And I guess just -- can you talk a little bit about that strategy, about how many of the accounts -- you mentioned
McKesson being one of the large ones. Are there any others that are on your list? I'm curious if you have like a couple of waves of targets.
And then just how are you thinking about, I guess, that as it progresses? Like how do you progress through wave one, wave two, wave
three, if they exist?
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DECEMBER 02, 2025 / 6:00PM, CPRX.OQ - Catalyst Pharmaceuticals Inc at Citi Global Healthcare
Conference
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Is there -- or would you consider sharing sort of, I guess, testing rates and how they have increased over time as like a KPI that maybe we
could track for the Oncology segment or in general?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Got it. That's super helpful. And then, just talking about the idiopathic opportunity, Rich, you said that there's still a large amount of opportunity
there. Maybe just talk about how you're going to further penetrate that segment over time and what dynamics we should be aware of for
that?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Yeah. I was going to ask how long does a patient typically stay in your patient pool? Is there an average? Or are there, to your point, a couple
of different types of patients that move through at different rates?
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DECEMBER 02, 2025 / 6:00PM, CPRX.OQ - Catalyst Pharmaceuticals Inc at Citi Global Healthcare
Conference
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Is there a dedicated MG panel that you can add VGCC testing to? Or is it just, again, individual physician-by-physician educating to remind
them they should be testing for this for every potential MG patient?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Got it. Okay. Great to hear. So then maybe let's just talk about the overall opportunity. I know you've outlined it before, Rich, but I think it's
helpful to maybe say it again. And I'm curious how you think about the overall LEMS and then segmenting it out between the idiopathic and
the oncology opportunities.
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Right. So you've settled three of the four challengers and those three settlements said 2034, correct?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: February of 2035. That's how you get to your nine. Can you talk a little bit about expectations for when that fourth challenger might have
a resolution?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Right. Okay. That's helpful. So we look forward to a resolution potentially in the future for that.
And I guess -- so I think that was great on FIRDAPSE. We talked a little bit about FYCOMPA already in the beginning of the call. But maybe
just overall for the business, FYCOMPA is sticky, and we're seeing that, but it is losing revenues over time.
We have the strong AGAMREE launch that we talked about, continued FIRDAPSE growth. I guess how do you just think about the overall
growth of the business as we move into 2026? And I'd love your thoughts on what a potential BD transaction, how that could impact growth
and just in broad terms because obviously, you can't be specific about some of these.
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Got it. Okay. That's helpful. So -- and is it -- would it still be 15% to 20% year-over-year growth as we move into '26? Or would you, I guess,
give us an update early next year?
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DECEMBER 02, 2025 / 6:00PM, CPRX.OQ - Catalyst Pharmaceuticals Inc at Citi Global Healthcare
Conference
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Okay. Okay. That's helpful. And then just -- you touched on this as well in the beginning, Rich, but just on BD and the potential opportunities
out there, can you just remind us what that ideal BD deal looks like in terms of development stage. I think you were saying you could take
a little bit of risk, late-stage development, or regulatory, but also just the peak sales potential, how much you have to deploy capital-wise?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Yeah, absolutely. And then, Mike, I've left you alone this whole session, so I want to make sure you have a question as well. Can you just
remind us just a little bit of the financial health of the company, the cash that you have to deploy and I guess, how you're thinking about as
we move into '26?
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DECEMBER 02, 2025 / 6:00PM, CPRX.OQ - Catalyst Pharmaceuticals Inc at Citi Global Healthcare
Conference
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Excellent. Okay. And then -- so Rich, I just want to turn it back to you. Any closing remarks you might have? And anything you think is really
important to emphasize for investors?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: Yeah. As am I. Well, thank you so much. It was wonderful to us having you here today, and it was a great discussion. Thank you.
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