ACADIA Pharmaceuticals Inc at TD Cowen Healthcare Conference Transcript

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

Question: Ritu Baral - TD Cowen - Analyst : So let's start with DAYBUE. I think most of the focus, investor focus on the name is still DAYBUE. You're expanding your salesforce by 30% to help drive patient starts, specifically outside Rett centers of excellence. Can you review for us the current penetration rates in centers of excellence as you see it, high volume institutions and community practices, respectively?

Question: Ritu Baral - TD Cowen - Analyst : So you mentioned something interesting. You said now 23 Centers of Excellence.

Question: Ritu Baral - TD Cowen - Analyst : It's 22, okay. Is there a new one or --?

Question: Ritu Baral - TD Cowen - Analyst : Yeah, okay. Is that something we should watch out for? Are there increasing centers of excellence for a broad swath of care? One thing we noticed when we were doing our tracking surveys is that there was this giant hole in the northwest. Like over here, because we were trying to survey a good geographical distribution and there seemed to be giant holes in parts of the country -- the IRS center.

Question: Ritu Baral - TD Cowen - Analyst : Exactly. Okay, great. And then going back to what you said, Catherine, about the community setting. Are you guys developing new materials, supportive care products such that that are more tailored to a community setting in managing the GI side effects? Because the more community you go, the less time.

Question: Ritu Baral - TD Cowen - Analyst : Got it, got it. In the non-COE setting, right now, is it really just the mind share question that is the gating factor? Or are they, I guess, are they hesitant to use DAYBUE because of the manpower burden of managing the patient early on in titration?

Question: Ritu Baral - TD Cowen - Analyst : Is assistance with insurance coverage and back-office support also an element of this?

Question: Ritu Baral - TD Cowen - Analyst : Is this part of the 30%?

Question: Ritu Baral - TD Cowen - Analyst : Got it. And are these doctors managing towards a different goal than COEs? I know you mentioned they want to be able to offer and they want to be able to help their patients. But what is -- I guess, as we think about dose titration, what are they dosing towards versus what Centers of Excellence dose towards?

Question: Ritu Baral - TD Cowen - Analyst : Right. That's the point of capturing up in order to even risk the time.

Question: Ritu Baral - TD Cowen - Analyst : Got it. And so going back to the COEs for a second. Are there any additional resources or support that you think makes sense to deploy towards the COEs?

Question: Ritu Baral - TD Cowen - Analyst : Got it. And then given these efforts in the expansion, how much DAYBUE growth should be expected in the second half? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 05, 2025 / 4:10PM, ACAD.OQ - ACADIA Pharmaceuticals Inc at TD Cowen Healthcare Conference

Question: Ritu Baral - TD Cowen - Analyst : Got it. Actually, that leads to a very interesting question on Q1 seasonality given the changes in Medicare, Medicaid, out-of-pocket caps, and the way that Wall Street is usually modeled Q1 -- down Q1, increased gross to net, lower percentage, lower market share due to patients switching, and also greater gross to net because of the doughnut hole. How should we think about that going forward with the redesign? Should it be an amplification of what we had previous years?

Question: Ritu Baral - TD Cowen - Analyst : We'll go back to DAYBUE in Europe in a second, but if you could address that. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 05, 2025 / 4:10PM, ACAD.OQ - ACADIA Pharmaceuticals Inc at TD Cowen Healthcare Conference

Question: Ritu Baral - TD Cowen - Analyst : Oh, because it's your second product?

Question: Ritu Baral - TD Cowen - Analyst : Got you.

Question: Ritu Baral - TD Cowen - Analyst : Okay.

Question: Ritu Baral - TD Cowen - Analyst : For 2025. And that's a lighting scale. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 05, 2025 / 4:10PM, ACAD.OQ - ACADIA Pharmaceuticals Inc at TD Cowen Healthcare Conference

Question: Ritu Baral - TD Cowen - Analyst : Got it.

Question: Ritu Baral - TD Cowen - Analyst : Understood, understood. Okay, let's move back to trofinetide or DAYBUE in the EU. You've guided to expected CHMP, I believe, in the first quarter of 2026. How is that application going? First of all, have you gotten the first round of questions back?

Question: Ritu Baral - TD Cowen - Analyst : Who are the rapporteurs?

Question: Ritu Baral - TD Cowen - Analyst : Okay. With the Netherlands having extensive experience with rare disease.

Question: Ritu Baral - TD Cowen - Analyst : Great. As we think about Centers of Excellence and concentration care in the EU versus US, how should we be thinking about that?

Question: Ritu Baral - TD Cowen - Analyst : Where is the UK?

Question: Ritu Baral - TD Cowen - Analyst : Got it. Pre-launch activities, what do you have going on in Europe? And what geographies will you be concentrating commercial investment in?

Question: Ritu Baral - TD Cowen - Analyst : And what geographies is that allowed in? I think it's France and Italy. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 05, 2025 / 4:10PM, ACAD.OQ - ACADIA Pharmaceuticals Inc at TD Cowen Healthcare Conference

Question: Ritu Baral - TD Cowen - Analyst : Germany has a managed access program?

Question: Ritu Baral - TD Cowen - Analyst : For the part of it that is charged, will you be keeping, like will you be keeping a reserve on the revenues?

Question: Ritu Baral - TD Cowen - Analyst : So there's no clawback in the majority of these?

Question: Ritu Baral - TD Cowen - Analyst : Got it. And then as you approach these health technology assessments, will the patients on these expanded access programs and your relationships with the KOLs assist in final pricing procedures?

Question: Ritu Baral - TD Cowen - Analyst : Got it. Great. So we're going to move on to -204. Unfortunately, we have less than 10 minutes left already. Yeah, we're going to move on to -204. So this is your next-generation NUPLAZID, essentially, a 5-HT2A agonist in development for ADP and now also Lewy body dementia. Can you walk us through the design of the seamless Phase 2/3 ADP study and timelines for enrollment and data as you see them right now?

Question: Ritu Baral - TD Cowen - Analyst : Got it. What informed your decision to use tau-based serum biomarkers during patient enrollment?

Question: Ritu Baral - TD Cowen - Analyst : Got it. Can you talk to the buy-in that you have from FDA on the SAPS+HD? And can you talk a little bit about powering of the study?

Question: Ritu Baral - TD Cowen - Analyst : Got it. And the effect size and powering?

Question: Ritu Baral - TD Cowen - Analyst : So could the prior pima studies provide a their assumption of what placebo is expected in these studies?

Question: Ritu Baral - TD Cowen - Analyst : Got it. Well, HARMONY was a randomized withdrawal study. Why not pursue randomized withdrawal with -204?

Question: Ritu Baral - TD Cowen - Analyst : Got it. How do you think of the three studies as registrational studies? You're basically saying if one Phase 3 fails that you could file on Phase 2/3 together as the two pivotals. First of all, is that correct? Like is the Phase 2 generate all the data points needed? And also, within the trials, are you generating any sort of durability data that FDA might be looking for?

Question: Ritu Baral - TD Cowen - Analyst : Exploratory efficacy, so you're still taking the SAPS+HD out that long?

Question: Ritu Baral - TD Cowen - Analyst : Are there any requirements from FDA or questions from FDA on that 12-month SAPS+HD data?

Question: Ritu Baral - TD Cowen - Analyst : Got it. All right. I've left myself one minute on DAY -- sorry, NUPLAZID, and one minute on ACP-101. Let's do 101 first, lightning round. This is your Prader-Willi compound. Can you quickly review where you are on Phase 3 enrollment and the key efficacy endpoints and when that data will come?

Question: Ritu Baral - TD Cowen - Analyst : And that is caregiver-based, correct?

Question: Ritu Baral - TD Cowen - Analyst : Got it. And then in our last minute, there's a new NUPLAZID DTC campaign.

Question: Ritu Baral - TD Cowen - Analyst : We see sort of renewed growth, which, at least from the investment community sort of came out of nowhere. How do we see those two interplaying and what's going to drive continued growth?

Question: Ritu Baral - TD Cowen - Analyst : I know consensus had not modeled significant growth going forward. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 05, 2025 / 4:10PM, ACAD.OQ - ACADIA Pharmaceuticals Inc at TD Cowen Healthcare Conference

Question: Ritu Baral - TD Cowen - Analyst : Great. Well, thank you so much, Catherine, Ponni, Mark, for joining us. It was very helpful.