Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) Q3 2023 Earnings Call Transcript

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Jason Gerberry: Hey, guys, thanks for taking my questions. Just on the earlier comments about MDD and sort of the target prescriber footprint, if you will, I was taken by the comment about a significant increase, and I guess I would have thought that with atypicals getting used maybe in a later line patient, that this would have been the domain of the psychiatrist. And so maybe, mindful you’re not going to specifically tell us how much that increases the prescriber footprint by, but you did say significant. So I just wanted to confirm that that would be a pretty meaningful step change in terms of the number of prescribers that you have to reach if MDD was added to the label. Thanks.

Mark Neumann: Yes. Thanks, Jason. It’s always difficult to get the right characterization of that because as I’ve said, we’re not at a point where we’re providing the specific numbers of what that expansion might look like. But let me try to clarify again. The 43,000 prescribers that we currently have are predominantly psychiatrists and nurse practitioners who treat the predominant number of schizophrenia and bipolar depression patients. There is a segment of primary care physicians that we currently call on those primary care physicians are comfortable treating bipolar depression. They don’t treat much schizophrenia. So we never really targeted them for schizophrenia, but they are comfortable treating bipolar depression, and their prescribing habits look very similar to the psychiatrist in bipolar depression.

That’s not the majority of primary care physicians, but there is a segment that is like that, and we currently target those primary care physicians. As we contemplate an approval in MDD and we look at the prescribing habits of other segments of primary care physicians, that’s where that segment expands. And so any expansion in our target audience would be to go after primary care physicians. And then the question just becomes how deep do you go into primary care? And that’ll determine the number of prescribers that you add to the target list, and that will determine how much of a sales force expansion we would have in order to cover those primary care physicians. And as we get closer to the MDD potential approval and launch, we’ll come back to you with more details about that.

Operator: Thank you. [Operator Instructions] Our next question comes from the line of Corinne Jenkins of Goldman Sachs. Your line is open.

Corinne Jenkins: Yes. Good morning, everyone. Maybe one on the 1284 program. Just when should we anticipate kind of clinical data from those? And then are you thinking you’d pursue all of those programs if they showed activity, or are there kind of criteria you’re using to evaluate go/no-go decisions or any constraints on kind of the number that you could pursue into Phase 3? Thanks.

Sharon Mates: Hi Corinne, thanks for the question. So first on 1284, we will be going into I mean we started the programs and we expect clinical conduct to begin next year. As to whether we would pursue all three indications, I think that will be dependent on what the data shows from these studies, right? I mean, if we have great data from all three, yes, we’ll pursue all three. If we – if it looks like there’s a better opportunity in two out of the three, we would do that. So I think it’s a little early to say how many of these will be pursuing full blown Phase 3 programs on, but we’re very encouraged by what we’ve seen to date and very enthusiastic about these programs. And we’ve now outlined for you the GAD what that program is going to look like in terms of the first study, who will be enrolled.

Operator: We are out of time for questions for today. I’d like to turn the call back over to Sharon Mates for any closing marks.

Sharon Mates: So thank you, everybody for participating today. As you can see, I think we had a very strong quarter, and we’re very pleased with the progress we’ve been making on all fronts both on CAPLYTA and on our pipeline. I think that we have demonstrated and we talked a little bit about the uniqueness of the way that we develop our drugs, that we not – we look not only at the cell surf, but look downstream of the receptor as well, and how that has been driving our development programs actually from the start of the company. And so we’re very enthusiastic about our pipeline and about our research as well as on continuing to advance CAPLYTA. So with that, I think operator, we – just to say we look forward to updating you as we go forward. And with that, operator, you can disconnect the call. Thanks.

Operator: Thank you. Ladies and gentlemen, this does conclude today’s conference call. Thank you for participating. You may now disconnect. Have a great day.

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