ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) Q4 2022 Earnings Call Transcript

Operator: Thank you. We have time for one more question. Our next question comes from the line of Kyle Qian from Canaccord Genuity.

Kyle Qian: Hello. This is Kyle speaking on behalf of Sumant Kulkarni. Thanks for squeezing us in. In terms of answering negative symptoms of schizophrenia given you have a positive Phase III already, what point do you expect to learn from the FDA as to exactly what your second Phase III trial may need to show? And related to that, will a trend be enough given no product has ever been approved specifically for this indication? Thanks.

Steve Davis: So you were muffled a little bit. I think I got the question. Let me just try — if I don’t answer everything you asked, let me know. There’s nothing approved to treat the negative symptoms of schizophrenia. In terms of where we stand, so we, again, as Doug mentioned in our prepared remarks, we have something very unusual in this space. It’s been a very difficult space for decades. It’s long been talked about as the most significant unmet need in schizophrenia. So it’s very rare to have a positive pivotal study, which we have in the case of ADVANCE-1. So we are running our second study now, ADVANCE-2. We should complete enrollment there in the middle of this year and then have results early next year. So, at that point the two positive pivotal studies, if ADVANCE-2 successful, we will plan to submit on that basis and we follow the difficult path there where we would have a pre-submission meeting with FDA, we would submit and then go through the normal review process.

Did that answer both of your questions?

Kyle Qian: Yes. So in the second Phase III, will a trend be enough, given no product has been approved indication as if the primate did not hit?

Steve Davis: Well, I think, we — at this point, we just need to complete the study and get the results. We are eager to do that. As Doug mentioned, having very strong results at the dose that we are testing now in ADVANCE-2 and our ADVANCE-1 study certainly gives us every means for optimism here. And the two things that I have pointed out that are different between ADVANCE-1 and ADVANCE-2 both should improve, we will probably have success. So I think until we actually open the outlook, which we are going to do, there’s not a lot more news to take .

Kyle Qian: Okay. Thanks.

Steve Davis: Yeah. You bet.

Operator: Thank you. Mr. Davis, please proceed to closing remarks.

Steve Davis: Yeah. Great. Thanks much, Operator. Thanks again everyone for joining us today. This will be a very significant year for us. We are eager to get to March 12 as I mentioned and we look next quarter.

Operator: Thank you for your participation in today’s conference call. This concludes the presentation. You may now disconnect. Good day.