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

Pete Stavropoulos: Hi, this is Pete Stavropoulos on for Charles. Hi Pat and team. Congratulations on all the progress for the quarter. First question is there’s greater than 800 LEMS diagnosed patients that are being treated with Firdapse, but wondering what you can say or what that number suggests in terms of penetration into the total LEMS opportunity, and are there any specifics you can give into penetration as a result of the oncology outreach efforts?

Patrick McEnany: I’ll turn that to Jeff, Pete.

Jeff Del Carmen: Hey Pete. What we’re seeing right now is about a 25% penetration of current patients that are still living and diagnosed with LEMS, so that’s what we’re seeing – it’s about a 25% penetration. As far as–what was your other question, Pete, about that with the tumor LEMS patients, what we think we can get as far as penetration?

Pete Stavropoulos: Yes, actually I was asking what do you think the oncology efforts, outreach efforts has been impacting–?

Jeff Del Carmen: Okay, excellent. What I can say there is the unfortunate news for small cell lung cancer LEMS patients is that greater than 80% of these patients are undiagnosed, and so it’s up to us to help these patients get diagnosed so that they can get benefit from the treatment with Firdapse. We’ve seen an uptick recently, just a slight uptick in 25% or so into the percent of our new enrollments that are small cell lung cancer LEMS patients, but we’re hopeful that we can get to about 30% of the mix will be the tumor LEMS patients. That’s what our all-out efforts are geared towards.

Pete Stavropoulos: Okay, and of the patients on Firdapse, can you provide any–you know, the proportion of or any color about patients who would like to go from 80 milligrams in the up dose to 100 milligrams?

Jeff Del Carmen: Yes, right now there are 40% of our current patients are on 80 milligrams or higher. We know that LEMs is a progressive disease, and also hearing from patients and physicians and from former Ruzurgi patients that were higher–that patients will benefit from a higher dose, some of these patients felt. We feel like there will be–that’s a huge benefit again to these LEMS patients. Also, we do see some physicians that–and patients that don’t want to go to the max dose, so when you have a cap of 80, those patients that are at 60 or even 70 milligrams don’t want to go to 80 milligrams because that’s the max dose, so now having 100, that allows for some of these patients to also benefit from a higher dose if that’s what is necessary to help treat their disease.

Pete Stavropoulos: All right, thank you. One question, I guess, on Fycompa. What’s the potential for developing Fycompa in the rare epilepsy indications, and if I heard you correctly, you mentioned earlier in the call that epilepsy is evolving into a precision medicine approach. Are there any specific epilepsies you believe Fycompa can be utilized in?

Patrick McEnany: There have already been seven different rare epilepsies that were identified in a recently published paper, that we did a press release on not too long ago. With regard to other rare epilepsies that may develop, the current label for Fycompa actually contains a fairly broad description of clinical characteristics of epilepsies that can be treated with the drug. If a specific rare epilepsy presents with those clinical characteristics, a physician would be able to prescribe Fycompa on label for that rare epilepsy and determine whether or not the patient responds well to that. But as I said, there’s already seven that have been identified. Because of the relative maturity of this product, we do not anticipate doing any formal clinical trials to update the label to specifically call out specific rate epilepsies, but our team of MSLs will continue to provide any information that is relevant for the treatment of rare epilepsies to the physician community with Fycompa.

Pete Stavropoulos: Okay, thank you for taking our questions, and congratulations on the quarter once again.