ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) Q4 2022 Earnings Call Transcript

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Eddie Hickman: Hey. This is Eddie on for Yatin. Congrats on the quarter. Do you expect any impact on the trofinetide filing or review now that Billy Dunn has departed? And do you expect to have any restrictions or limitations on the label or have to complete any post-marketing studies after potential approval? Thanks.

Steve Davis: Yeah. Yeah. I will take the first part of that. We don’t anticipate any impact from Billy Dunn leaving FDA. We — as you might expect, we reached out the FDA today, heard back and they expressly confirmed that we should not — this should not have any impact on our application. Dr. Buracchio has been acting Deputy Director of the Office of Neuroscience for some time and will continue with that role, as well as the Director of the Neurology 1 Division. So I understand the reason for asking the question, but we don’t think it will have any impact on our application.

Eddie Hickman: Okay.

Kathie Bishop: And second part of the question with respect to, I think, you talked about post-marketing requirements and labeling. Since we are under review, we don’t comment on that at this point.

Eddie Hickman: Got you. Do you think you could clarify how many LILAC-2 patients you currently have on drug?

Kathie Bishop: Yeah. So the LILAC-2 study is currently ongoing. So at this time we can’t get into any further specifications rather than what I mentioned in the prepared remarks.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Gregory Renza from RBC Capital.

Gregory Renza: Great. Thanks, Steve, and congrats on the progress. Thanks for taking my question. Steve, maybe just a question on perhaps longer term or even post the March PDUFA for trofinetide, just on the premise of a potential trofinetide approval and entering the market, how does that shape your prioritization of your pipeline and maybe looking externally as you and Brendan certainly mentioned trofinetide as foundational to Rett patients, I am curious if you have any input on whether it’s the ASO program or others that you think are important to tack on to or at least to think about when it comes to serving these patients? Thanks so much.

Steve Davis: Great. I am sorry I didn’t hear the — I heard the first part relating to what impact it would have on our portfolio just, I didn’t hear the second part of the question.

Gregory Renza: Yeah. Just with respect to what’s in your pipeline, the ASO program and how you are thinking about the pipeline and external, how an approval would shape your prioritization and focus there? Thank you.

Steve Davis: Yeah. Okay. Thanks much. So the short answer is it wouldn’t. I think that we have always viewed — since we have data from study with trofinetide where we have both co-primary endpoints, recognize a very dramatic unmet need. We have felt like this is a drug that’s needed and with a high lack of approval. So we find our business accordingly. We will continue — we are very excited about other assets we have including our early assets and including the programs we have partnered the Stoke Therapeutics that you referred to. From a business development perspective, our strategy remains the same, as we have described for the last couple of years and that is — it’s a very important part of our business. As we have described in the most recent quarters, the fluctuations in the capital markets have significantly impacted business development opportunity set and that really works to the advantage of companies like us, companies that have strong balance sheets, established revenues and don’t go back to the capital markets versus those that do, and so as a consequence of that, we are seeing opportunities to continue to improve, but we are well positioned to leverage that.

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