Josh Schimmer: Thank you.
Operator: Question comes from Carter Gould with Barclays. Please go ahead.
Leon Wang: Hi. This is Leon on for Carter. Congrats on a great quarter. Our question just is relating to CAH. We’re wondering, will it be an appropriate medical meeting to share the data, essentially, do we — should we expect this maybe around middle of the year, perhaps at end of or could we see this publication published ahead of time? Thank you.
Eiry Roberts: A couple of comments on that. First of all, when we shared the data a month or so ago now, we shared probably approximately 5% or less than 10% of the information that we were generating. And so right now we’re working on pulling together all of the remaining information from the trial and all the data that were generated. And then our goal will be to pull that together for publication and presentation as rapidly as possible, in parallel, obviously, with preparing for the NDA submission, which we will do next year. And so I think the key message — the key meetings in the endo space include endo that you alluded to together with additional pediatric meetings in both the U.S. and in Europe. Most of those fall in from around April time next year and those are most likely to be the meetings that we would be targeting for presentation with a full publication running in parallel with that.
Leon Wang: Thanks. Appreciate it.
Operator: Our next question comes from Anupam Rama with JPMorgan. Please go ahead.
Anupam Rama: Hey, guys. Thanks so much for taking the question and congrats on the quarter. So while you guys didn’t pre-announce 4Q INGREZZA sales or provide forward year guidance last year at the JPMorgan Health Care Conference. You have taken this strategy in the past. So just wondering what we should be expecting this year in terms of the conference? Thanks so much.
Kevin Gorman: Yeah. Hi, Anupam. Nice to hear from you. You should expect similar to last year that we’re not going to be providing a Q4 update from INGREZZA sales perspective at the JPMorgan Conference in January and we’ll be providing that information during our February earnings call where we’ll provide a full financial picture, including INGREZZA sales guidance, Q4 performance and what we expect for 2024. But we are looking forward to seeing you and spending time with you and covering a lot of ongoing associated with our pipeline.
Anupam Rama: Thanks so much.
Operator: Question comes from Jay Olson with Oppenheimer. Please go ahead.
Jay Olson: Oh! Hey. Congrats on another impressive quarter. Can you talk about lifecycle management plans for INGREZZA, especially since you settled with Teva and Sanofi for 2040 and you currently have two new indications in clinical development? Are there additional new indications you might pursue for INGREZZA considering the extended runway, which could go well beyond consensus estimates? Thank you.
Eiry Roberts: Thanks, Jay. We continue to look at opportunities for INGREZZA in serving different patient groups on an ongoing basis, both from the insights that we gain from our medical team in the field and also, obviously, in the clinical development setting. However, at the moment, given the breadth of everything else that we have going on in our proof — in our pipeline, we are focused on two key indications, as you mentioned, which is adjunctive treatment of schizophrenia and dyskinetic cerebral palsy. And we’ve focused on those two given that they had the highest likelihood of being successful taking dyskinetic cerebral palsy first, I think, in the context of the really strong data that we generated both in tardive dyskinesia and now in the Chorea of Huntington’s with dyskinetic cerebral palsy being the most common childhood movement disorder in the United States.
We believed it was appropriate for us to be pursuing an indication in that setting and we have a Phase III program currently ongoing, both in the U.S. and outside the U.S. And then for adjunctive treatment of schizophrenia, it was a combination of three things that drove us to that indication. The first was obviously the very key safety and tolerability profile that we had for INGREZZA in patients with schizophrenia already from our tardive dyskinesia experience. Secondly, with some preclinical data that we had showing potential adjunctive therapy might be beneficial from an additive or synergistic perspective on efficacy. And then thirdly, obviously, what we were hearing from the field. So we are focused on those programs right now and getting to data as rapidly as possible on each of those.
But we do continue to look at other opportunities, obviously, on an ongoing basis.
Kevin Gorman: And what I would add to that is that, as we said, we’ve got a long runway with this medication. We feel confident in our patent position out to at least mid-2030s, and as you’ve seen that with our end of negotiations with two of the four parties, we’ve settled into the late 2030s with them. So the only other thing I would add is that, while INGREZZA has, as I said, a very long runway still left to it, our research group is highly focused on maintaining our leadership in movement disorders and in tardive dyskinesia.
Jay Olson: Super helpful. Thanks for taking the question.
Operator: And our next question comes from Brian Skorney with Baird. Please go ahead.
Unidentified Analyst: Hey, guys. This is Charlie [ph] on for Brian. Thanks for taking our question and congrats on the quarter. So I wanted to ask about the anhedonia asset, which I believe you are still on track to give us data on in the fourth quarter. What exactly should we be looking at in terms of a clinical bar here and what data have you generated so far that gives you confidence in this asset that it’s differentiated from previous assets that have struggled to get a strong efficacy signal? Thank you.
Eiry Roberts: Yeah. Thanks, Charlie. So the, yes, we are on track to read out the data from this anhedonia Phase II study in this quarter. This is actually an orphan GPCR and GPR139 molecule. So although we understand a great deal about the biology of where this target is located in the habenula and that gives us confidence around the potential use in anhedonia, obviously, there’s been very little research that’s been successful in the field of anhedonia. And it’s a very difficult symptom set within the range of symptoms experienced by patients with major depressive disorder. And so in that context, this proof-of-concept initial study in Phase II in 88 patients is focused not only on looking at the potential impact of 846 on the anhedonia scales themselves, the DARS [ph] scales, but also on the depression scales.
And so we will be interested when we read out the data to understand whether 846 has an antidepressant effect alone or whether that effect is predominantly on the scales of anhedonia. In terms of setting a bar, this is a proof-of-concept signal seeking study, we will be looking at the totality of the data both from an efficacy and safety perspective and we look forward to sharing the information when we have it available.
