Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) Q1 2024 Earnings Call Transcript

Sharon Mates: Sure. Thanks for the question. I’ll start and then I’ll ask Suresh if he wants to add anything. You’re correct. It’s not a well-worn regulatory pathway, but the pathway is becoming clearer and clearer. With the approval of REXULTI in Alzheimer’s agitation, we know, what — are allowed. We also, you know, the FDA has been refining their requirements, et cetera. So I think that the study that we’re doing that Suresh told you about, it is a Phase II study powered as a Phase III study. So we look forward to that data. And then and by the way the study has been we’ve gone back and forth with the FDA. We — they are completely apprised and have had input into how you do these studies and what you do and what scales you use in these studies, how you use them.

So I think that and the randomized withdrawal is something that is oftentimes used. And again that is with would be with discussion with the FDA, as we go forward, should we choose to want to use that paradigm. Suresh, did you want to add anything?

Suresh Durgam: Just again to reiterate that the path, as you said, you know, while it is not fully there, but at least with the breadth of proposal, there is a path forward, from that angle. We have to see if other designs would be — would be okay with FDA at this point.

David Amsellem: Okay. Helpful. Thank you.

Operator: And our last question will come from Joel Beatty with Baird. Your line is now open.

Joel Beatty: Thanks for taking the question. For CAPLYTA sales, how much growth is coming from new first time prescribers versus greater depth from existing prescribers?

Sharon Mates: Mark, do you want to take that?

Mark Neumann: Yes. Sharon, I can take that. So we’re seeing a nice balanced contribution both of increasing new prescribers as well as depth of prescribing over time. As I mentioned in my prepared remarks, we now have over 39,000 unique prescribers of CAPLYTA. That continues to grow at a strong rate each quarter. We’re adding 3000 to 4000 new first time prescribers every quarter and we really haven’t seen that slowdown over the quarter. So we look at our depth and our breadth metrics for the launch and we’re very encouraged by what we’re seeing there. So we continue to put effort toward both getting new prescribers of CAPLYTA as well as increasing the depth of prescribing for each of those prescribers.

Joel Beatty: Thank you.

Operator: At this time, I would now like to turn the call back over to Sharon for closing remarks.

Sharon Mates: Well, thanks, everyone, for participating on today’s call, and thanks for all of your questions as well. We look forward to updating you on our MDD studies as well as on our other studies. We think it’s a very exciting time for ITCI and we look forward to continuing to help patients and to develop new medicines to treat patients. With that, I can ask the operator to please disconnect. Thanks very much. Bye-bye.

Operator: This concludes today’s conference call. Thank you for your participation. You may now disconnect.