Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q1 2024 Earnings Call Transcript

Charles Duncan: Got it. Thanks, Rich, for the added color. That’s helpful.

Richard Daly: Thanks, Charles. Thank you.

Operator: And our next question comes from the line of Jason Gerberry with Bank of America. Please proceed with your question.

Jason Gerberry: Hey, guys. Thanks for taking my question. One BD question for me and then one AGAMREE question just on BD front. I’m just curious if there’s a general profile range in terms of size of deals on stage development that you look at. Would you be willing to bring in an asset that wouldn’t deliver sales and profit in the short term and how FIRDAPSE litigation outcomes sort of shape your M&A aperture? And then, on AGAMREE, maybe a little surprised just to hear lifecycle management discussion this early in the launch, is this something that you update in the second-half that could be beneficial within the IP window of AGAMREE or the regulatory exclusivity window of AGAMREE or something that’s kind of a longer-term IP extending approach? If you can comment on that, that’d be great. Thanks.

Richard Daly: Thank you. Thanks for the questions. So, on the BD size and opportunity, so we would look for things at this point in our company’s lifecycle for things that are immediately accretive or nearly immediately accretive. We would want to take advantage of the balance sheet that Mike talked about in the call. So, when we think about size and opportunity, we would want to be really thoughtful. We’d want to look at things that could add to the company’s balance sheet immediately. So, I think we would stay within ourselves, if you will. I don’t want to commit to a size at this point in time. I think we would, again, assess, but really looking at those things that are very close to market or are on market. And again, to continue to build the breadth of our capabilities so that we can continue to build and look at larger opportunities in the future as a buy and build company, that’s what we want to do.

We want to build our presence in the market. On the — how the FIRDAPSE litigation colors our thought on that, right now, Steve can speak to the timing of that, but we assume that we’re going to have a significant runway with FIRDAPSE and FIRDAPSE sales, and so we have an opportunity to build our portfolio, and we’re going to take full advantage of that as we can do that for the time being. Regarding lifecycle management, we believe now is the time to be looking at opportunities for AGAMREE to build a portfolio of applications for the product in rare and orphan conditions that require a steroid. We want to be that steroid of choice. And in the companies I’ve worked in in the past, typically companies wait too long to think about those things.

And so, to your point about, is it going to be something that’s applicable within the window of IP for a AGAMREE, that’s exactly the point. That’s what we’re trying to do is make sure that we can get the studies done, identify those opportunities, get the studies done, and then take advantage of it and create value for patients and create value for shareholders as well. Is that helpful, Jason?

Jason Gerberry: Yes. Thank you.

Richard Daly: Thanks. Thanks.

Operator: Our next question comes from the line of Samantha Semenkow with Citi. Please proceed with your question.

Unidentified Analyst: Good morning. This is [Eric] (ph) on for Sam. Thanks for taking our questions. What do you think is driving the high percentage of patients switching from prednisone in your early launch, and how do you see that evolving as this progresses?

Richard Daly: Thanks for your question. We do think that the conversion from prednisone over to AGAMREE is basically because of the safety profile. And many of these patients have been on prednisone for a significant amount of time and have seen or experienced those side effects. And they’re looking to — they transitioned over to AGAMREE to benefit from the more positive safety profile. So, over time, we do expect this mix to be about what it is today, which is very encouraging. Initially during planning and forecasting, we expected the initial launch to be primarily from the EMFLAZA patients or those patients that were used to being on a branded corticosteroid. We are encouraged by this because now we’re now opened up to the entire corticosteroid market for boys living with DMD. And that’s what we’re seeing and that’s what we expect moving forward.

Unidentified Analyst: Thank you.

Operator: Our next question comes from the line of Joe Catanzaro with Piper Sandler. Please proceed with your question.

Joe Catanzaro: Hey everybody. Thanks so much for taking my questions. I have a few on AGAMREE. If I recall correctly, I think you had said there were about 28 patients in the EAP program. I’m wondering if you could just sort of speak to what percent of those patients have been able to transition to commercial reimbursed drug. And then, maybe if you could also sort of speak to the current cadence of intake forms, maybe how the current rate compares to your pre-launch experience where you indicated there was a sort of indication of significant pent-up demand. So, wondering if current cadence of intake forms sort of continues to point to that pent-up demand. Thanks. And I have maybe one follow-up.

Richard Daly: Jeff, do you want to take that?

Jeffrey Del Carmen: Sure. So, I can point to first about the cadence of the enrollments. We started accepting pre-commercial launch enrollments in December, and we saw significant pent-up demand. We also knew at that time that there were the Centers of Excellence that were waiting for an announcement of the official commercial launch date. So, they were holding some enrollments until that announcement. Post-announcement, we started really seeing volume increase that validated our confidence in the launch. And since the commercial launch, we continue to see steady enrollments that are steady at a high level, higher than what we had forecasted, which is very encouraging. And Joe, can you remind me of your first question about, AGAMREE?