Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) Q4 2022 Earnings Call Transcript

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Ash Verma: Sure, yeah. So just on mixed features, this is feedback that we have heard from physicians that patients are now specifically treated for this indication, at least not extensively. Do you agree or disagree to that and any example that you can give on other psychiatry indication that went through a path of being undertreated to becoming a bigger market?

Sharon Mates: Sure. So I would agree with you that — I do think that many psychiatrists do understand mixed features and see patients and treat those patients with whatever they think might be beneficial that’s currently available. But you’re right, there is no label for it. Until the DSM 5, MDDD with mixed features wasn’t even specified. And bipolar depression was a much looser definition. So DSM 5 has allowed physicians to see a tighter definition and to be more educated. We agree with you that it is an education process just like bipolar II. Physicians see bipolar II patients, they know it when there’s nothing to treat patients with, it’s more difficult. So having the label for bipolar II is very helpful to physicians. And we would look forward to educating on this indication as we go forward.

So we think there’s a lot of opportunity here for education and to expand the awareness of the disease. I think, bipolar II is a great example where it’s now quite well defined with only a few treatments. I don’t know, Suresh if you have any other examples off the top of your head.

Suresh Durgam: Other examples, not exactly the same, or at least something closer to that would be, if you think about the psychosis in Parkinson’s disease, there was nothing approved. But once that is there, that took off. Similarly, cardio dyskinesia, it’s a market that Eurokind has done extensively well with. Again, they have done a lot of educational campaign to highlight that, importance of that.

Sharon Mates: Those are great points Suresh. Thank you. Okay, operator, I think that it’s time for us to wrap up, one more question.

Operator: Certainly then. One moment for our final question. And our final question for today comes from the line Corinne Jenkins from Goldman Sachs. Your question please.

Unidentified Analyst : Hi, this is Sadaf on for Corinne. Just a couple from us. I believe you guided GAD to the mid-30s range for 2023, but what you anticipate in terms of cadence over the course of the year?

Mark Neumann: Yeah, hi, hopefully I heard you, it was in — you were asking the gross to net the guidance for the year and a cadence for that, is that what you said?

Unidentified Analyst : Yeah.

Mark Neumann: Yeah. I think our guidance, gross to net will fluctuate as it does throughout the year. But I think, you can be as — we’re comfortable in our mid-30s guidance here, I can’t give any more granularity to that.

Unidentified Analyst : Got it. Okay, thanks. And on just the second question, was that for MDD data, could it come as early as your end, or should we expect that in 2024?

Sharon Mates: So, what we’ve said on the MDD is that we expect to file in 2024. And that’s I think the guidance that we’re giving.

Unidentified Analyst : Got it. Okay. Thank you.

Sharon Mates: Okay, operator I think with that it’s time for us to wrap up and we thank everybody for joining us today. We think 2022 was a terrific year for us and for the launch of CAPLYTA in bipolar depression. We look forward to more progress this year in 2023, and we look forward to update you on a quarterly basis. So thanks everybody for participating and operator, you can now disconnect.

Operator: Certainly. Thank you, ladies and gentlemen for your participation in today’s conference. This does conclude the program. You may now disconnect. Good day.

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