Mark Neumann: Yeah. Sure. Hi, Charles. Yes, what we said in the past about sales force size with an eventual approval in MDD is that we certainly would expect to significantly increase the size of our sales force. As you know, currently, our sales force has a target audience of about 43,000 physicians, the vast majority of them being psychiatrists and the nurse practitioners that support them. So we have very good coverage of the psychiatry community. We do have a segment of primary care that we currently call on. Those are primary care physicians who are comfortable treating bipolar depression and are high volume prescribers of antipsychotics for that condition. But as we contemplate an approval in MDD, the expansion would come by a much larger target audience within the primary care community.
There aren’t many more psychiatrists that we don’t already call on for our current indications, but it would be for an expansion into primary care As we get closer to the timing of a potential approval, we’ll come back to you with more details about the specific size and timing that we would be executing against.
Sharon Mates: Okay.
Mark Neumann: And Suresh, I think, there’s a second part. Yes.
Suresh Durgam: Yes. In terms of the sample size, it’s very similar sample size for 502 compared to 501. And in terms of the clinical sites, there is no overlap of sites. But however, we tend to include about 30% of patients coming from US. And about the remaining coming from ex-US sites.
Sharon Mates: So there’s some [Technical Difficulty] some site overlap.
Suresh Durgam: Yes.
Sharon Mates: Because you don’t be competing with yourself when you’re enrolling patients.
Charles Duncan: Got it. Makes sense. Thank you.
Operator: One moment for the next question. The next question comes from Marc Goodman with Leerink Partners. Your line is open.
Marc Goodman: Yes. On ITI-214, can you remind us of the differentiation in this product and how you look to kind of break into the Parkinson’s market, which is a tough market over the past decade for new products? And Larry, could you also just tell us what the inventory change was in the quarter? Thanks.
Sharon Mates: Okay. Suresh, do you want to start with talking about 214?
Suresh Durgam: Yes. 214, that is the Lenrispodun. We have an ongoing study in Parkinson’s disease and that is a proof-of-concept study. In that study, we are evaluating several things. One, evaluating the motor symptom improvement. We’re also evaluating cognition measures as well as biomarker for inflammation. So based on the data from that, we will decide on the next steps, looking at the data we’ll read from that. That that study is a four week study. It’s the, the primary endpoint is the Hauser diary. We’re looking for increase in on time without troublesome dyskinesia. And the key secondary is the MDS-UPDRS Part II, which measures motor aspects of experiences of daily living. And we also as I indicated, one of the things we are looking there is looking for biomarkers, for inflammation in that study.
Sharon Mates: And to the second part on inventory, Larry, do you want to take that?
Lawrence Hineline: Yes, sure. During this quarter, we experienced strong prescription growth that’s continued over the last several quarters. And in this quarter, this prescription demand was the primary driver for revenue. There was, to a lesser extent, an inventory increase for this quarter, but the primary driver was Scripps.
Marc Goodman: Can you quantify the inventory change?
Lawrence Hineline: No, we’ve not given that sort of granular detail before and it’s difficult to do.
Marc Goodman: Okay.
Operator: One moment for the next question. The next question comes from Umer Raffat with Evercore. Your line is open.
Michael DiFiore: Hi, guys. This is Mike DiFiore in for Umer. Thanks so much for taking my question and congrats on all the success. Just two quick ones from me. Any updated thoughts on pursuing a monotherapy indication for MDD given CAPLYTA’s improved safety profile compared to second generation atypical antipsychotics? I’m asking because Seroquel pursued this in the path and although it was efficacious, the FDA didn’t approve the monotherapy indication for MDD due to safety concerns. And my follow-up is on the, I guess, separate follow-up is on the PDE1 program. Just a quick observation, last quarter, they said the top line was expected in one half ’25 now. This quarter is just 2025. So I was wondering if there’s any sort of recruiting or trial delays on that front. Thank you.
Sharon Mates: Okay. Suresh, do you want to take that?
Suresh Durgam: In terms of the, yeah, you can start Sharon and I can.
Sharon Mates: No. Go ahead.
Suresh Durgam: Okay. In terms of the study itself, their recruitment is slower and we are.
Sharon Mates: Wait a minute. Wait, wait, wait. The 214. The first part of the question was an update on monotherapy for MDD and that Seroquel did try for monotherapy. And as you correctly pointed out, Mike, that the FDA was concerned about their metabolic consequences et cetera. I think that we’re evaluating all of this and obviously, as you know, there isn’t the safety concerns that one sees with Seroquel with Lumateperone. So we’re looking at that. There are a lot of — there are a lot of things to look at. It’s also different times than when Seroquel was first approved. On the PDE program, we — recruitment has gone slower than we originally thought. That could be because of studies that are ongoing. It could also be because we try to ensure that we get in appropriate patients et cetera.
But we still are in 2025 in our timelines. So we’ve just left out saying first half, second half or anything, which I don’t think we had said before either. Maybe we did. I can’t remember. So I think it is 2025. And, also, you’re correct that or actually, I think the speaker before you was correct in talking about that Parkinson’s is a crowded market, but we think that we’re getting or we should be getting some very good data on the use of these PDE1 inhibitors in neuroinflammation and that should help inform us both on taking forward 214 in Parkinson’s disease and in taking forward other molecules within the PDE1 space into several different arenas. With that, Suresh, did you want to add anything else? I’m sorry. I didn’t mean to cut you off.
Suresh Durgam: No. In terms of the 501 study, yeah, the MDD program, that’s true. That’s again we’ll be looking at the data and then we’ll figure it out what to do next steps for the monotherapy.
Michael DiFiore: Very helpful. Thanks so much.
Operator: Please standby for the next question. The next question comes from Jason Gerberry with Bank of America. Your line is open.
