ACADIA Pharmaceuticals Inc Q3 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Gregory Renza - RBC Capital Markets, LLC - Analyst : Great. Good afternoon, Catherine and ACADIA team. Congrats on the progress. Catherine, welcome aboard, and thanks for taking my questions. Maybe to start, maybe I'll refrain from asking a question about Ryan Reynolds, but could you give us some interesting color on the rationale and what you saw the attractiveness of joining ACADIA? Your mention of business development and certainly the early-stage pipeline, I'm sure, is of interest to us. Just wondering if you could just add a little more color about how break down the strategic framework. What the capabilities are for ACADIA to sort of welcome in some of those business development assets as well as really nominating and fleshing out the early-stage pipeline that was of interest to you?

Question: Gregory Renza - RBC Capital Markets, LLC - Analyst : That's helpful. Thank you. And maybe a question for Brendan. Just on the latter part of 2024 with respect to DAYBUE. And as you think about coming into the holiday season and we reflect on some of the December to January to February patient visits and DAYBUE utilization from patients and families, now how should we be thinking about some of the patterns when it comes to us entering Thanksgiving and the December holiday season and how it relates to transitioning to 2025? Thanks again, guys, and congrats.

Question: Gregory Renza - RBC Capital Markets, LLC - Analyst : Fantastic. Thanks so much.

Question: Jason Butler - Citizens JMP Securities, LLC - Analyst : Hi. Thanks for taking the questions and congrats on the quarter. I guess just a couple on NUPLAZID. Can you give us a sense of the profile of patients that are initiating therapy now in the context of the branded and unbranded campaigns? I guess -- and also in terms of the label change. Are you seeing more older patients initiated on therapy versus -- to what extent are you seeing patients come on board earlier in the diagnosis or early in the psychosis symptoms?

Question: Jason Butler - Citizens JMP Securities, LLC - Analyst : Okay, great. Thanks for taking the question.

Question: Basma Radwan - Leerink Partners LLC - Analyst : Hi, this is Basma on for Mark. We have a question regarding DAYBUE. Regarding the 50% or 60% of the patients remaining on therapy. Do we know the proportion of patients who respond to the treatment and actually demonstrate clinical benefits? Should we assume that all of them at this point are responders and basically benefit from the therapy? And on the flip side, I wonder if you could provide us with more color on the discontinuation data and share with us what is the key factor that really drives the discontinuation of therapy? Is it the A profile or is it the lack of treatment effect? Thank you.

Question: Caroline Pocher - J.P. Morgan Securities LLC - Analyst : Hi, team. This is Caroline Pocher on for Tessa Romero with JPMorgan. Thanks for taking our questions. So first, in your prepared remarks, you had mentioned that the DAYBUE launch is now at steady state of new patient flow. We were just curious if you could just clarify this statement. Does this mean steady net adds? And then you mentioned it will be a focus to grow this over the next few quarters. Is there anything that has fundamentally changed in your strategy to accelerate new patient starts? And are you considering changing or pivoting any facets of the launch strategy going forward? Thank you.

Question: Caroline Pocher - J.P. Morgan Securities LLC - Analyst : Great. Thank you so much.

Question: Joel Beatty - Robert W. Baird & Co. Incorporated - Analyst : Hi. Thanks for taking the question. What do you think of the ratio of the patients on therapy to the number of unique prescribers? And I guess what I mean is that looks like there's been about 1,500 patients who have started therapy at some point with about 800 unique prescribers. So that's a little bit less than two patients per prescriber and perhaps I would have expected it to be a little bit more concentrated.

Question: Joel Beatty - Robert W. Baird & Co. Incorporated - Analyst : Thank you.

Question: Keith Tapper - BMO Capital Markets Corp. - Analyst : Thanks, and good afternoon, team. And thanks for taking my question. Welcome and congratulations to Catherine. Obviously, a [benefit] for ACADIA. So for DAYBUE, could you remind us what to expect from the Canadian approval maybe in '25 and '26 in terms of launch expenses, material impact to revenues if all goes well? And then, have you guided for time lapse revenues in Europe and Japan? And then separately, I know it's early, but could you talk about 2591, which you have rights to in Fragile X? Is it a similar strategy versus DAYBUE, the drug itself? I know your partner Neuren showed interesting data, obviously in different indications. Anything you can share would be helpful there. Thank you.

Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst : Hi. Good afternoon. Thanks for taking my questions, and Catherine, a welcome from me as well. I wanted to get your thoughts about how to think about the European launch. In your previous role, you did handle ex-US launches. Are there certain rules of thumb to be aware of as it relates to rare disease launches in Europe that you can share with us today? And can you talk to us about your general plan forward in that region? Thanks.

Question: Jeff Hung - Morgan Stanley & Co. LLC - Analyst : Thanks for taking my questions. For ACP-204, just wondering if there's any updates on whether EU regulators have agreed to your master protocol? And can you just remind us of the strategy there? Thanks.

Question: Jeff Hung - Morgan Stanley & Co. LLC - Analyst : Thank you.

Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst : Hey, good afternoon. Catherine and team, thanks for taking our question. And Catherine, congrats on the new opportunity with ACADIA. I had a quick question regarding ACP-204. In terms of the data release protocol, I guess I appreciate the master protocol in terms of facilitating enrollment, but I'm a little bit confused as to whether or not you'll be releasing any information from Phase 2 in terms of efficacy, et cetera, as the enrollment of the Phase 3s are ongoing. So please provide a little color there. Thanks.

Question: Jay Olson - Oppenheimer & Co. Inc. - Analyst : Thank you for providing the update and thanks for taking our question. For Catherine, could you please talk about your due diligence and any key considerations that you were contemplating as you considered taking on the role of CEO at ACADIA? And then also, maybe elaborate on your longer-term vision for ACADIA. Where would you like to see this company go in the future?

Question: Sumant Kulkarni - Canaccord Genuity LLC - Analyst : Good afternoon. Thanks for taking our question. Another one on DAYBUE. Other than patients being at centers of excellence versus not, what's your understanding of the key bottleneck that may be preventing new patients from starting DAYBUE? And what's the main variable you need to focus on to see an inflection on DAYBUE sales from current levels?