Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q4 2022 Earnings Call Transcript

Steven R. Miller: I’ll let Jeff and Pat address anything about pricing. But with regard to the strategy, I’ll just remind you that when RUZURGI was on the market before the FDA removed it, it was approved for up to 100 milligrams. And so we will be using all the data that is in the reserve of the NDA as part of the basis of our supplemental NDA to increase the strength — to increase the maximum daily dose perhaps to 100 milligrams. And as I previously mentioned on the call, we also have a number of patients who are on the 100 milligram strength for FIRDAPSE who are taking 100 milligrams of FIRDAPSE per day, and all of that safety data will also be included. And again, as I said, all of that data as a whole, we believe, constitutes sufficient body of evidence to convince the FDA to let us apply for an increased maximum daily dosage of FIRDAPSE.

Patrick J. McEnany: And Les, with regard to pricing, remember it is dose related, and our typical patient is on about 6 — a typical adult patient is on about 60 milligrams per day, more or less. And our net price after gross to net discounts and rebates and what have you, for that patient is around $375,000. So you could extrapolate from there with regard to what the pricing might be.

Unidentified Analyst: Great, that’s very helpful. And then last one for the team, I guess, on the regulatory process in Japan, just kind of go over that, if you could. And of all goes well, how soon can DyDo enter the market in Japan and what’s the strategy for the periphery countries? Thank you.

Steven R. Miller: Well — yes, I’m limited by what I can say because our partners don’t disclose a lot to the public markets. I’ll just generally go over the process that happens in Japan. As I said during the call, they’re collecting safety data from their ongoing safety follow-up phase. Upon completion and collection of all that data, the next step is to file the NDA in Japan, which I mentioned will be in 2024. As an orphan drug, the typical review cycle time in Japan for an orphan drug NDA is about six to eight months, so I would anticipate that if their cycle time is an average that they should be approved towards the end of 2024, providing of course, their NDA is acceptable for the Japanese authorities.

Unidentified Analyst : Thank you.

Operator: Thank you. Our next question comes from Scott Henry with ROTH Capital Partners.

Scott Henry: Thank you and good morning. Congratulations on a strong year. A couple of questions. And I know you don’t want to disclose a lot, but with regards to the three patent filings, do you know if there’s a — or is there a first filer among those three?

Patrick J. McEnany: Steve, do you want to take that?

Steven R. Miller: Sure. The short answer to your question is, yes, that’s public information. It’s on the FDA’s website. The answer is that all three of them are first filers. In other words, they’re all tied for first.

Scott Henry: Okay, great. Thank you for that clarification. A couple of other questions, with the shift from the 80 milligram to the 100 milligram dose, would you expect to see some revenue creep upward per patient, I mean, often, higher doses generates higher revenue per patient, just want to make sure that is correct?

Patrick J. McEnany: Scott, I’ll turn that over to Jeff.