Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q1 2023 Earnings Call Transcript

Les Sulewski: Got it, okay. Then if we normalize Fycompa sales for the full three months run rate, that would imply a very strong quarter, probably more so than what everyone on the street expected, let’s say. Can you provide any color that you think drove that upside, and can we expect the remaining quarters to be similarly strong? If we do a normalized run rate, something around $40 million per quarter, does that seem reasonable or is that a high number?

Patrick McEnany: That’s a great question. I’ll let Jeff take that as well.

Jeff Del Carmen: Sure. One quick thing is with any integration, you have to allow for a transition period. What we’re doing is we feel like we’re going to be much more efficient with our sales force. We’re taking about 40% from a size perspective our number of field personnel versus what was previously used for Fycompa and larger territories, but with that, we want to allow for that transition period to take hold, and that’s why we’re very confident in the flat 2023 versus 2022.

Patrick McEnany: Let me add to that, Les, as Jeff pointed out in your earlier question, this is more of a retail product and as a result, your rebates and your re-authorizations and things like that also are affected in the month of January, and so I don’t think you can merely take those two months and extrapolate for the full year. I think that would be a mistake, and I think right now for the moment, and if that changes we’ll certainly provide an update on the guidance, but I think we’re still very comfortable sitting with that 130 for this year.

Jeff Del Carmen: Correct, and we are very confident that we can demonstrate growth in 2024 with Fycompa.

Les Sulewski: Guys, thank you for the color. Good luck on the progress. Thank you.

Patrick McEnany: Thank you.

Operator: Thank you. Our next question is from Joe Catanzaro with Piper Sandler. Please proceed with your question.

Joe Catanzaro: Hey everybody, thanks so much for taking my questions. Maybe first one from me, just wondering if you can comment on the cadence of new patient enrollments in the quarter and the split you’re seeing between non-tumor LEMS and tumor LEMs and whether that dynamic is changing in any way with some of your efforts in oncology. Then with regards to your comments on further global expansion opportunities, wondering if we should think about that in the same way you’ve sort of struck a collaboration with DyDo in Japan, and then maybe related to DyDo, are there any milestones associated with the completion of their Phase III and subsequent NDA filing? Thanks.

Patrick McEnany: Sure. Jeff, do you want to take the first question?

Jeff Del Carmen: Hi Joe, thanks for the question. The cadence of new patient enrollments in Q1 exceeded forecasts, so we had a strong new patient enrollment there in Q1 and we continue to see that strong cadence here thus far in Q2. As far as the mix goes, we saw, we estimate, about a 25% of our new enrollments in Q1 are tumors LEMS patients. Keep in mind that some patients come in with that tumor LEMS ICD-10 code, but there are some patients that come in that are LEMS patients and then over–so we have to make an assumption, so over the next two years as they get their scans, they will be diagnosed with it. Based on all those factors, we’re estimating that we’re about 25% mix of our total enrollments are tumor LEMS.

Patrick McEnany: And Joe, with regard to our global efforts, yes, the DyDo Pharma transaction for Japan serves as a really good model for other territories in Asia and South and Central America. With regard to milestones, there is an undisclosed milestone based on filing and acceptance by PMBA.

Joe Catanzaro: Okay, got it. That’s all helpful. Thanks for taking my questions.

Patrick McEnany: Sure, thanks Joe.

Operator: Thank you. Our next question is from Charles Duncan with Cantor Fitzgerald. Please proceed with your questions.