ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) Q4 2023 Earnings Call Transcript

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Operator: One moment for our next question. Our next question comes from Marc Goodman with Leerink. Your line is open.

Marc Goodman: Yes. For DAYBUE, just a little bit more color. Can you help us with dosing what’s the dosing for most of these patients relative to the target dose? And then also like average age and weight of the patients, if you can help us with that? Thanks.

Steve Davis: Sure. Before we answer that question, there is a question of profitability that [indiscernible] we didn’t answer. So Mark, do you want to take that?

Mark Schneyer: Yes, happy to. I think just on the previous question, the simple answer is, can we make a launch and investment in negative symptoms of schizophrenia profitable? Simple answer is yes. Obviously, we will be mindful of the potential ranges for exclusivity for remaining for pimavanserin. So our launch will be a little different than if we knew that we would have a much, the longer-dated life. But if we, as we get into 2030 and beyond, we can adjust investment and also keep in mind there’s a significant number of synergies between negative symptoms of schizophrenia and Parkinson’s disease psychosis. So we’re not starting from scratch and all together we can make this franchise profitable to ACADIA in a variety of ranges for ultimate exclusivity for the molecule.

Steve Davis: Thanks, Mark. Okay, Brendan, two questions.

Brendan Teehan: Yes, sure. Marc, thanks for the question. In terms of dosing, we think in terms of compliance to the label dose, it’s a weight-based product. The average compliance to dose is in the 75% to 80% range at this point. You also asked questions about weight and age. The weight has remained in the low 30-kilogram range between 32 mg to 34 mg and the age is in the mid-teens, about 16 for an average age.

Operator: One moment for our next question. Last question comes from Yatin Suneja with Guggenheim. Your line is open.

Yatin Suneja: Just two quick ones from me. Could you comment on gross to net, where you are on DAYBUE if you can also characterize the OUS opportunity in dollar perspective? And then are you willing to say anything on NUPLAZID from Q1 sales perspective? How should we think about seasonality there, similar to what you have experienced in the past few years or a little bit different?

Steve Davis: Okay. I think it’s going to be Mark, Brendan, Mark.

Mark Schneyer: Yes. On gross to net, maybe I’ll do a go-forward and a look back on DAYBUE. I think going forward, we expect gross to net to be in the 20% range for DAYBUE, and it shouldn’t really fluctuate quarter-to-quarter. When we look backwards, it was a little lower over the course of the entire year. So it was 17.7% through fiscal year 2023. And we did have favorability to that in the fourth quarter and the gross to net for DAYBUE was 15.4% in the fourth quarter last year.

Brendan Teehan: From just thinking about DAYBUE outside the United States, obviously, we see a tremendous opportunity I would speak to it in terms of the prevalent population, which is slightly larger than the United States and EU, Canada, where we’ll be first is on the order of 600 to 900 patients. And then Japan is likely between 1,000 and 2,000 patients. So in terms of value, I think I spoke a little bit to what we see which is you can take a look at our U.S. pricing and you can look at other rare disease products that launched in the U.S. to see their proximity to a U.S. price for their EU approach. And I think there is a narrower band that existed for a broad range or broad education products. It’s too early for us to really talk about what a price for per EU nation will be at this point, but that should give some sense of direction.

Mark Schneyer: And then on NUPLAZID, I think dynamics should be consistent this year, except for the gross to net dynamic that I mentioned for the fourth quarter. So we gave kind of seasonal dynamics in across the quarter should be the same in terms of volumes. And then I gave the gross to net guidance for the first quarter, just to make sure people can think in the right range as we go through the Medicare Part-D dynamics for the first quarter, and there’ll just be less of that in the fourth quarter of this year just due to the anticipated Medicare Part-D redesign in 2025.

Operator: That concludes the question-and-answer session. I would like to turn the call back to Steve Davis for closing remarks.

Steve Davis: Great. Thank you, operator. Thanks again, everyone, for joining us today. We look forward to updating you on our progress next quarter.

Operator: Thank you for your participation in today’s conference. This does conclude the program. You may now disconnect.

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