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

Operator: Thank you. Your next question comes from the line of Salvin Richer [ph] with Goldman Sachs. You may proceed with your question.

Unidentified Analyst: Hey, thanks. This is Matt on first Salvin [ph]. Your highlighted NUPLAZID is recently cash flow positive, could you share what kind of margins you have right now and where you see that headed longer term? And then on the litigation — patent litigation for NUPLAZID; I think we’re expecting an update by the end of the month. Do you have any update there for us? Thank you.

Steve Davis: Yes. I’ll take the second question first. And I’ll ask Mark to answer the first one. So, the district court has not issued a decision yet. We think highly likely that the court will by the end of the year for sure. And just in terms of update or commentary; it’s litigation, there is nothing really that we have to say at this point other than I’ll just say what we said before. And that is, we believe the law is on our side and we’re highly confident in our position. So, we’re eager to get to a decision as well. Mark you want to take the…

Mark Schneyer : Yes. On the cash profitability of NUPLAZID, we generate approximately $300 million of cash flow on a fully allocated cost basis of the franchise. We expect that to continue to grow overtime, obviously on a year-to-year basis as we go through our budget plans and investment cycles on — for year-over-year, we’ll decide to the level of support and investment for the franchise with the focus being both on top line growth and near-term profitability.

Operator: Thank you. Your next question comes from the line of Sumant Kulkarni with Canaccord Genuity. You may proceed.

Sumant Kulkarni: Good afternoon. Thanks for taking my question. Assuming that NUPLAZID [ph] is successful in negative symptoms of schizophrenia, how are you thinking about potential pricing given the product is already in the market? And do you think you’re appropriately resourced from a Salesforce perspective?

Steve Davis: Two-part question. Brendan why don’t you take the second part. Actually Brendan if you can take both, if you don’t mind.

Brendan Teehan: Yes, sure. So for us, the — in terms of pricing, were not going to discuss where we are at this point other than to say we certainly will be looking at events that run into value across our portfolio of indications. When we stopped to think about resourcing, we are a CNS focused company and there is a fair amount of crossover between the treaters of negative symptoms of schizophrenia which will allow us to kind of capitalize on core resources we have within the organization. But we will obviously logically expand our footprint to cover both, the locations treating these patients and the broadened psychiatry population that tends to focus on these negative symptoms of patients.

Operator: Thank you. Your next question comes from the line of Ami Fadia with Needham & Company. You may proceed.

Ami Fadia: Good evening. Thanks for taking my question and congratulations on the strong performance of DAYBUE. Maybe just one follow-up on DAYBUE from me. Can you talk about sort of the time to approval for patients, whether they are under medical exemption or whether they are under an insurance plan where they do have them put on the formulary? And I’m trying to sort of get a better sense of where you are in the launch, as you’ve indicated that the quote from here will be more linear. Is this more to do with sort of the initial bolus [ph] of patients already getting on DAYBUE and now it’s more about really — blocking and tackling and getting — waiting for new patients to be diagnosed? If you can give any color on that. Thank you.

Steve Davis: Thanks so much for the question. Two-parter question. Brendan, you want to take the first? And Parag, the second?

Brendan Teehan: Sure, that would be great. So, thanks so much. What we’ve seen, and unsurprisingly and very similar to other rare disease launches, the initial approvals have come through letters of medical necessity, letters of medical exception; that was in the second quarter and somewhat in the third quarter. As I pointed to, we now have almost 80% of covered lives that have planned — written planned coverage for DAYBUE. And as we’ve seen, almost on a month-by-month basis, we’ve seen more in — in the same month approvals, second month approvals, third month approvals, overtime as these written plans have gone into play. So, as I think we said on our last call, by the end of the year we’d expect most of those policies that are going to be published to happen before the end of the year; we would expect to see a few more between now and the end of December.

But we are pleased with the coverage we already have and the increasing pace at which those enrollment forms are becoming prescriptions. You want to take the second piece, Parag?

Parag Meswani: Yes. Can you repeat the second question, please, if you don’t mind? Or Steve, you want to repeat that?

Steve Davis: I think it was the linearity of the adoption of DAYBUE as a function of sort of what’s happening for treatment dynamics in the fourth quarter or close to a surge?

Parag Meswani: Yes, sure. So you know, at this stage as Brendan mentioned in his prepared remarks and in the Q&A as well, through a really effective pre-launch education and connecting closely with the Rett Community with providers, we have led to a step-up in update during the first couple of quarters. At this stage, our plan for growth is to really identify physicians and patients that have a smaller number of Rett patients, and patients that aren’t having the same degree of frequency as visits in the clinics as they had in the first couple of quarters of the year. So, our goal moving forward is to establish the strong foundation that we’ve had so far in terms of demand, which is a significant breadth and depth of physician experience so far; a high number of patients and families sharing positive experience at the marketplace, and an access that has happened much faster than our initial pre-launch expectations.