Operator: Thank you. One moment for our next question. And our next question comes from the line of Jessica Fye from J.P. Morgan Chase. Your question please.
Unidentified Analyst : Hey guys, this is Masan on for Jessica. Congratulations on the fantastic guide. Could you provide your latest expectations on when we can hear the top line results from the adjunctive MDD trials and can you talk about — give us a little bit color on the reasonings for starting another adjunctive trial this year? Thank you.
Sharon Mates: Yeah, sure. This is Sharon and I’ll start and then I’ll ask Suresh if he wants to add. We guided you to a filing of an SNDA in 2024 for our adjunctive MDD and that’s based on studies 501 and 502 and 503. We have said that, I think was your other question, just repeat your other question for me please. Operator, anybody there.
Operator: You may proceed.
Mark Neumann: She may have disconnected Sharon.
Sharon Mates: Oh, she got disconnected. Okay. Well, I think her question was, why are we — just does anybody want to paraphrase it or should we just go on to the next question, and then we’ll come back to it. Hopefully she re-engages.
Operator: Certainly one moment for our next question. Our next question comes from the line of Umer Raffat from Evercore ISI. Your question, please.
Michael DiFiore: Hi, guys, this is Mike DiFiore in for Umer. Thanks so much for taking our questions and congrats on the quarter and progress. Just two for me; one clinical one commercial. The clinical one regarding your mixed features trial, I know, top line results are due sometime this quarter. But at a recent broker conference, you mentioned that the placebo group index patients may be very different from what we’ve seen in depression patients. So how do we think about that, is our depressed patients — patients were being treated as adjunct of depressed patients, since they’re already experiencing a partial response could we expect a greater placebo response in these patients, just any thoughts on how to frame that? And the commercial question is regarding your guidance, it seems pretty conservative.
At the high point, your guidance that assumes roughly around 80 new prescriptions adds added every week on average, which seems pretty doable. I think since the beginning of the year, there’s been around an average of 200 prescriptions added weekly, just any thoughts along those lines? Thanks.
Sharon Mates: So let’s start with the commercial question. And I’ll ask Mark, do you want to take that and then we’ll go to Suresh or I’ll take the — one of us will take the clinical question.
Mark Neumann: Yeah, Mike, I don’t know that I have much more to add other than what we’ve said that we have a high degree of confidence in the continued growth of CAPLYTA and we set the range at what we thought was the appropriate range, given the growth that we’ve been seeing. So overall, I would just say we’re — we have a high degree of confidence that we’ve got the range, right.
Sharon Mates: Okay. And also on the clinical question on placebo, I think all studies have placebo effects. I’m really not certain there would be any more or less here than any other study. But I’ll ask Suresh, if he wants to comment any further.
Suresh Durgam: Yes, good morning. These are different populations. One is the mixed future study is the monotherapy study. And the adjunctive treatment study is adjunctive to other antidepressants. That is patients who are already partially responded to the antidepressant. These are two different populations and there are several differences within the populations. Also that each individual study has its — comes with its own set of issues that is the patients, what kind of patients deviated they are coming from, what concomitant medications they have been on. All these play a role in determining how the study reads out. So you cannot make comparisons between one study to another especially when they are not similar designs when there are two different populations. And that’s the reason why you had to look at those in two different sets of individual studies.
Michael DiFiore: Got it, thank you.
Operator: Thank you. One moment for our next question. And our next question comes to the line of Marc Goodman from SVB Leerink. Your question please.
Marc Goodman: Yes, good morning. Can you give us a little more color on these Phase 2 programs for 1284 AD agitation, AD psychosis, how are these patients different and what endpoints you’re looking at that will be different here in the anxiety one? And then just very just quickly, the sales reps that were added to 50 reps, are they getting added in 2023 or were any of them added in the fourth quarter? Thanks.
Sharon Mates: Suresh, do you want to take the definition versus versus psychosis?
Suresh Durgam: Yes. So for the 1284 OTD we are progressing with studies in three different indications. One, the first one is agitation in Alzheimer’s disease. This is purely looking at patients who have agitation. It’s common for other MS patients to have behavioral symptoms, both agitation and psychosis. But there are different indications and they have different endpoints. So the first study we would be looking at the agitation part of the study. And regarding the details of the endpoints and the study designs, as we come closer to starting the trial, we will let you know. In terms of the next indication that is talking about psychosis in Alzheimer’s disease, that endpoints also are different from this basically looking at psychotic symptoms within the Alzheimer’s patients who have Alzheimer’s disease.
And that study also is going to start this year. And the GAD, generalized anxiety disorder, and there has been as we have indicated in our call, that there is a lot of treatment failures and patients only respond partially to some of the drugs. And there is still an unmet need in this population. And adding this drug to those populations will help with treating the anxiety symptoms, and there is a big unmet need. And the details of all of individual designs of these studies will be communicated once the study is closed at the start.
Operator: Thank you one.
Marc Goodman: Sharon, there is a question for Mark.
