ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) Q3 2023 Earnings Call Transcript

Steve Davis: Yes, thanks so much. I’m going to ask Parag Meswani to take the first question and Brendan on the second question. Parag?

Parag Meswani: Sure. Thanks for the question. So, what I’ll say at the outset is that overall physician feedback regarding DAYBUE is encouraging and points to a high level of caregiver interest regardless of age, gender, weight range, so on and so forth; so we feel very confident about their view of the product profile. In terms of diagnosis rates, we don’t really see any variance or differences as to when patients are diagnosed. What we do see our differences when patients are coming in for their follow-up. One of the things that Brendan mentioned in his prepared remarks is that there is a different cadence of when patients are going in to see their clinicians. And overtime, we expect that to accelerate as more patients become familiar with DAYBUE and DAYBUE’s product profile.

Steve Davis: Thanks, Parag. Brendan, ex-U.S.?

Brendan Teehan: So for outside the United States, we are obviously excited about the opportunity to be able to bring Trofinetide to a broader audience. Our first progress will be in Canada. As we’ve described, we’re already in conversations to bring DAYBUE to Canada in the next 18 months. We’ve also began our conversations with regulators and taking scientific advice in Europe, and are also prepping for Japan. We will look opportunistically at the rest of the world as well for opportunities for us to continue our global expansion from there.

Operator: Thank you. Your next question comes from Jeff [ph] with Morgan Stanley. Please proceed.

Unidentified Analyst: Thanks for taking my question. You said that centers are treating existing prevalent patients during planned clinic days. So I guess with the expectations of more linear trajectory going forward, have the number of clinic days remain stable or are they starting to decrease the center’s work through existing prevalent patients? Thanks.

Steve Davis: Thanks for the question, Jeff. Parag, you want to take that?

Parag Meswani: Yes, happy to take that question. So, I would say that it is variable. We know there a number of centers of excellence have actually increased their clinic days as a consequence of the approval of DAYBUE; some have gone from a clinic day a month to a clinic day a week. Others don’t have the infrastructure yet. As Brendan mentioned before on the payer question, there may be just one or two clinicians who are responsible for everything from clinic visits to payer access issues and managing clinical trials as well. So overtime, we are seeing more and more clinic days being added, we’re encouraging that and facilitating those sorts of connections through centers of excellence and through the community as well. But this is a new muscle ability to flex in many ways as more patients are being treated and seen, clinic days are being added to meet the demand that’s coming in through the clinic doors.

Operator: Thank you. Your next question comes from a line of Charles Duncan of Cantor. Please proceed.

Charles Duncan: Hey, good afternoon. Steve and team, congrats on a great quarter for DAYBUE. I think I’ll ask a couple of questions on the pipeline since other good questions have been asked. On the commercial — on the pipeline, first of all, question regarding ACP101; helpful context in terms of number of patients. Can you give us a sense of how quickly you would anticipate that study to enroll? And for ACP204, I guess I’m assuming that they’re going to be primarily Alzheimer’s disease patients that are later on in their journey? And how will you confirm that they’re Alzheimer’s patients versus other etiologies or is that not an issue for you for the conduct of this study? Thanks.

Steve Davis: Thanks, Charles. As tempting it is to answer the first question, we just typically don’t comment on projected enrollment until we get into — actually get some enrollment experience; so we’ll have to get back on that. And then I’ll ask Doug to answer the second question regarding Alzheimer’s patients.

Doug Williamson: Yes. And it’s a great question Charles because that’s actually a conversation we had with the FDA. And their Outcomes Assessment Group are increasingly interested in validating the diagnosis of Alzheimer’s; so we’ve agreed with them that we’ll conduct a biomarker — blood-based biomarker into the diagnostic procedure to just add extra — an extra level of certainty that we’re getting the diagnosis correct.

Operator: Thank you. Your next question comes from the line of Ash Verma [ph] with UBS. Please proceed.

Unidentified Analyst: Hi, thanks for taking our questions. So just in terms of persistency on DAYBUE, I wanted to get your thoughts on how you think this could trend overtime? I mean, we — it’s very encouraging to see this four month data and get this type of granularity but how do you think this might look at like 6, 9 or 12 months? And any updates on the LILAC-2 study? And would that be a more representative data point for what we’re seeing in the real world? Thanks.

Steve Davis: Yes, thanks so much. I’ll take the first question and ask Kathie to take a second. So with respect to the first question, it’s early still. We do have as we’ve mentioned 800 patients with therapy, so now we have a meaningful amount of data on multiple parameters, including persistency. So we have a strong number of patients that have completed four months of therapy and as we go forward we’ll continue to monitor this and update. We have obviously not as many patients at five months ago before and six months and five, etcetera. But I would say that as we look at the data that we have, with this separation between where we’re — what we’re seeing in the real world, and what we’re seeing from the LILAC-1 open label rollovers, which again, as we said we think is the best clinical trial comparison because those are patients starting therapy knowing they’re starting on DAYBUE; we continue to see the separation.