Catalyst Pharmaceuticals Inc at Bank of America Global Healthcare Conference Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Jason Gerberry - Bank of America - Analyst : So we can kind of jump into the discussion of the existing assets and you know where you're headed in terms of ramping and where those products can take you and what the future looks like in terms of strategy and capital deployment as well. So maybe Richard coming out of one cuue, I don't know if there's any kind of high points you'd want to flag as it pertains to, where the company come. You've been with the company a little over a year now, right, and kind of where you see the company. Having come in that time frame and where you see it evolving too. Well, yes.

Question: Jason Gerberry - Bank of America - Analyst : So. Taps and gamma for your growth anchors looking forward for by Kapa we'll have some natural erosion, as you mentioned with the generics and so we'll focus on fertaps and gamray I guess interestingly with with FerdAs, as you said, kind of mid-teens growth that you're achieving products been on the market for a decent amount of time north of $300 million in sales. You've talked about this being a billion dollar market opportunity. I'm wondering if you could. Sort of frame where we are at in terms of the life cycle of this product, a lot of rare orphan drugs do take time to patient find to build these markets. Oftentimes we see a lot of rare orphan drugs eventually get to 50 to 60% penetration rates. So do you feel like The patients are out there, they're diagnosed, or they, there needs to be more effort to get more patients into the treatment pool. What are some of the battles and some of the key levers that will make this truly a billion dollar market opportunity to keep that mid-teens growth sustainable?

Question: Jason Gerberry - Bank of America - Analyst : So what does that look like on the idiopathic side? Does that look like those doctors who see one patient in their life now start to see 2, and that more patients may be kind of funneling maybe patients incorrectly diagnosed with that myasthenia gravis, for example, and that might constitute half of your incremental growth to that billion dollars dollar target, and the other half may come from. The cancer side. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. PRELIMINARY MAY 14, 2025 / 3:00PM, CPRX.OQ - Catalyst Pharmaceuticals Inc at Bank of America Global Healthcare Conference

Question: Jason Gerberry - Bank of America - Analyst : Okay, so shared growth is maybe split between the two opportunities. Is that a fair way to summarize it? Okay, so let's see, so. Is there a meaningful difference in say the cancer limbs versus the idiopathic? I would imagine there is in terms of the duration of treatment with IDEO. I imagine you may get a patient for life, whereas with cancer limbs you get a patient that is more of an incidence based market. It.

Question: Jason Gerberry - Bank of America - Analyst : You said roughly 18 months for.

Question: Jason Gerberry - Bank of America - Analyst : Okay, and then. Thinking about the time to getting maybe to grow this to a billion dollar market and if you continue this kind of mid-teens growth, over 8 or 9 year period, you could get there, but you see kind of eventually as you get to bigger numbers, maybe a growth slowdown and with the IP settlements to 2035 that may play a key role in just giving you a longer runway to get to that number. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. PRELIMINARY MAY 14, 2025 / 3:00PM, CPRX.OQ - Catalyst Pharmaceuticals Inc at Bank of America Global Healthcare Conference

Question: Jason Gerberry - Bank of America - Analyst : Yeah, okay, so you have this current like queue of patients that you guys have characterized as 500 or so patients that you've identified, they're not on treatment. You just where are those patients at in terms of their diagnostic workup and identification and probability of getting treated and and my understanding is I think they are more heavily skewed to ADO right and so the A Cancer lambs rollout story sounds like more of a 2026 plus.

Question: Jason Gerberry - Bank of America - Analyst : Maybe for Steve. The litigation, I think you guys have an estimate for or 1 2026 for when the litigation with the other two challengers could make it to litigation just a status update there. Yeah. Steven Miller - Catalyst Pharmaceuticals Inc - Executive Vice President, Chief Operating Officer, Chief Scientific Officer So far the judge has not actually scheduled the trial for this case. The dates you gave are Actually the latest we would expect it to happen because the stay ends in May of 2026 and the judge is going to TRY to make sure that this case is resolved one way or the other by May of 2026, which means the trial has to be toward the end of the year or beginning of next year. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. PRELIMINARY MAY 14, 2025 / 3:00PM, CPRX.OQ - Catalyst Pharmaceuticals Inc at Bank of America Global Healthcare Conference And I'll point out also that we have settled with two of the litigants. We do have conversations with the others from time to time and certainly if they have something that's of value to the shareholders, we're going to act on it. So.

Question: Jason Gerberry - Bank of America - Analyst : And so when you launched, there was obviously at the time or when you got the asset the loss of generics hadn't been commercially available now they are commercially available. And so one of the questions around payer access and step edits, would you have to step through one or two generics, and I believe you're at one generic step through right for most plants.

Question: Jason Gerberry - Bank of America - Analyst : So is the criteria then typically a lifetime have you ever been on? Generic and thus if you have and you check that box, then you can get a gam. Great.

Question: Jason Gerberry - Bank of America - Analyst : But do we know? At the moment, are the new starts stepping through, or are they forced to step through or not?

Question: Jason Gerberry - Bank of America - Analyst : Yeah. And what drives that is it things like the. The summit. I think.

Question: Jason Gerberry - Bank of America - Analyst : Yeah, because it would seem like you know for long term growth and you know getting patients who are on therapy for a long period of time, getting earlier is better.

Question: Jason Gerberry - Bank of America - Analyst : Okay. You mentioned the potential queuing effect dynamic coming into the start of the year. And you had the unfortunate patient death on gene therapy. How has that affected gene therapy adoption and the dynamic with steroid switching?

Question: Jason Gerberry - Bank of America - Analyst : Okay. And maybe for Steve just thinking about Summit and how important that ultimately will be to the use case for gamma ray and talk about the cadence of data generation that will come out of this and when investors will get a lot of sight on new data sets that are generated and what what what what are the important objectives here to inform clinicians. Steven Miller - Catalyst Pharmaceuticals Inc - Executive Vice President, Chief Operating Officer, Chief Scientific Officer Well, I'll start with the important objectives. The important objectives are to get additional safety information out to the treating physicians so that they know what the advantages of a gamma are relative to other potential therapies for patients. And we're looking at cardiovascular safety, bone health, stature, aggression, and other psychological changes, as well as just a number of other clinical characteristics of these patients. Now with regard to the cadence of the data, it is an open label study. Visibility to the data. It is a trial that's what's called a natural history control trial as well. And so we will, because we have access to the data, we will periodically put data in the public domain approximately about once a year. But remember it's still recruiting now, so I would anticipate that the first data probably would be sometime in 2026. That date would be dated with descriptive statistics that would be released to conferences and things like that and burnouts published as well. Yeah, the comparisons against natural history will be done only when we think that there's a significant increase in a particular endpoint that we're watching, because every time you do that comparison, you spend a little bit of alpha and decrease your chance of achieving statistical significance. But the important takeaway from doing that analysis is when you do that natural history comparison, that is of sufficient control to submit to the FDA to request changes to our insert sheet and get important safety information put onto the answer sheet for the product, okay.

Question: Jason Gerberry - Bank of America - Analyst : Just. I realize it is difficult to answer many questions around the recent executive order pertaining to most favored nations and I guess like one way that investors are just looking at companies with high sales in the US and high government exposure, in the absence of certainty as to exactly where you know it may pertain. So I guess how would you kind of educate investors in terms of your, I believe you got more higher Medicaid exposure on a gara versus high Medicare exposure on FIDAs, just dimensionalizing that and I guess the dynamics with OUS reference pricing points in OECD countries.

Question: Jason Gerberry - Bank of America - Analyst : Are you outlined, I think the delta, is it a delta US versus that 50 to.

Question: Jason Gerberry - Bank of America - Analyst : And the German price point of 50 is is subject to renegotiation, right? It's not like a.

Question: Jason Gerberry - Bank of America - Analyst : So you control pricing of.

Question: Jason Gerberry - Bank of America - Analyst : Okay. Alright, and then maybe just thinking about BD in the last two minutes here. I know it's been historically something that the company has done a deal maybe once every couple of years, right? Gam being the last one. Do you feel like the company is at a position to take on another asset? Absolutely.

Question: Jason Gerberry - Bank of America - Analyst : Do you feel like a lot of what is going on in the macro will presage a consolidating environment? There is a lot of biotech companies out there, right, that it is a challenge to subsist on a on a standalone basis in capital intensive spaces and rates are not dropping like a rock either. So.

Question: Jason Gerberry - Bank of America - Analyst : In terms of like confidence in getting something done this year. I mean, do you feel like All the assets that maybe you're looking at there are, there is always a question of are sellers willing to sell, especially in these periods of macro uncertainty, or is there a weed out mentality and we feel like we are being unfairly valued maybe because of what is going on in the market which will pass and so that it becomes a difficult environment for the bid. Dynamic.

Question: Jason Gerberry - Bank of America - Analyst : We're out of time, so gentlemen, thanks so much for joining.