Eiry Roberts: Okay, thanks. Let me take the second part first. In terms of the educational efforts, I think it’s really important, given the fact that crinecerfont will be the first potential medication to come forward into this space in the last 60, 70 years, that whilst we have obviously a group of experts who are incredibly familiar with the current options that they have available for helping this patient population, the opportunity to fundamentally change the paradigm of treating this disease, I think is one that’s going to require us to engage heavily in educating clinicians, educating the patient population and families, and everyone else around those patients, so we will be–we are investing heavily in that already, both on the medical side and the commercial side, obviously in a compliant way ahead of our hopeful approval.
With respect to the question around the ad-com, I mean, the reason we talk about an ad-com is just because of what I said earlier, really – there hasn’t been a medication in this space for so many years, and in addition to that, obviously it may be an opportunity for the FDA to engage with experts in the field outside of those that have worked on the program. We don’t have any particular reason to believe that an ad-com would be necessary based on our data – we’re incredibly impressed with the data that we were able to generate from our Phase III program and believe that our NDA will be very clear and articulate both the benefit and tolerability of crinecerfont, and so we don’t have particular topics we’re thinking about, it’s just in order to be prepared, we’re obviously making sure that that’s in place, in the event that the FDA decides to go down that route.
Brian Abrams: Thanks Eiry.
Operator: Thank you. Our next question comes from Chris Shibutani with Goldman Sachs. Please go ahead.
Stephen: Hey team, this is Stephen on for Chris. Thanks for taking our question. I think Eric mentioned in the prepared remarks that you expect growth from all three channels of your commercial organization with regards to Ingrezza this year, so I’m just curious if you can speak about development and progress points made in the long term care channel and how meaningful we should expect revenues from that channel to be in 2024. Thank you.
Eric Benevich: Yes, so all three segments of our business are growing nicely, as I mentioned. Psych continues to drive the majority of the opportunity because that’s where the majority for the patients are being cared for with TD. Neurology and LTC are also doing quite well, and at this point, the contribution from each is pretty similar in terms of our overall business. LTC is the newest segment. As I’ve mentioned before, it’s probably the least developed segment because we really haven’t been in there as long educating the stakeholders, driving screening, diagnosis and treatment, and it continues to really be growing nicely. In such a short period of time, for it to be contributing to that level, I think it’s a testament to the investment that we made and we’re quite happy with the results.
Stephen: Great, thank you.
Operator: Thank you. Our next question comes from Josh Schimmer with Cantor. Please go ahead.
Josh Schimmer: Thanks for taking my questions. Just a couple of quick ones. First, are you seeing any shifts in market share as a result of the once-per-day Austedo launch, and then I noticed you’ve added Efmody, if I’m pronouncing that correct, to the pipeline. I think in the past, you’ve indicated that might be a product more designed for market building and establishing a sales force, as oppose to generating meaningful revenue. Are you starting to shift that perspective at all? Thank you.
Eric Benevich: Yes, I’ll take your first question. The answer is no, we haven’t seen any change in market share. It appears to us that deutetrabenazine XR is cannibalizing deutetrabenazine in terms of their overall business, so it’s more of a shift within that deutetrabenazine franchise than any kind of share gain. The other thing that I’ll say is that we didn’t see a change of market share in 2023, and we don’t expect to see any kind of change in market share, at least any kind of negative change in market share in 2024.
Matt Abernethy: Yes, the only thing that I’d add, Eric, is that the market itself has just been incredibly rich. There’s so many patients that need help with their tardive dyskinesia and great unmet need, so when you look at what we were able to achieve this year – record year-over-year growth, over $400 million, and I would just say from a class perspective this continues to be a great opportunity, and looking forward to helping more patients who need help with their tardive dyskinesia. Eiry, do you want to comment on the Efmody?
Eiry Roberts: Yes, certainly. Efmody is a steroid treatment that is currently approved in Europe for the treatment of CAH in adults, and as such, I think it potentially has some complementarity to crinecerfont. In the U.S., we do not have an approval for Efmody currently. We are reading out two trials of Efmody in the first half of this year, and based on the data from those two Phase II trials, obviously we’ll update you as to what our next plans are.
Operator: Thank you. Our next question comes from Anupam Rama with JP Morgan. Please go ahead.
Anupam Rama: Hey guys, thanks so much for taking the question. Just maybe a quick pipeline question. The AMPA potentiator in MDD, that’s one of the next catalysts you’re expecting in the first half of ’24. Maybe you could describe the study, the key end points, and what you’re looking for in this program to give you confidence to move to the next phase.
Eiry Roberts: Thanks Anupam. Yes, you’re right – in the first half of this year, we will read out the data from NBI-845, which is our AMPA potentiator as a potential treatment for major depressive disorder. This is a dose finding study. It compares two different dose levels of the AMPA potentiator to placebo, using a pretty standard primary end point of the MADRS score at week 4, and the goal here with this mechanism of action, obviously since its potentially ketamine-like yet through a downstream mechanism associated with NMDA, is that we actually would see a more rapid onset of anti-depressant activity than is seen usually with SSRIs and other treatments. We are looking at MADRS as the primary end point, but we have multiple other secondary end points within this dose finding study which allows us to look at function and quality of life, as well as the other psychiatric end points, and so in essence we’ll be looking at the totality of the information coming out of this dose finding study to make a decision as to whether to proceed.
Anupam Rama: Thanks so much for taking our question.
Operator: Thank you. Our next question comes from Carter Gould with Barclays. Please go ahead.
Carter Gould: Good morning, thanks for taking the question. Maybe another one for Eiry. It was brought up a little bit at the analyst day but, frankly, kind of got overshadowed by some of the other updates, and that is the next-generation VMAT2 inhibitor. Can you just talk about–obviously the ATS study is ongoing, and you’ve talked a little bit about how that will–you know, the impact of that. Can you just maybe lay out your expectations and the progress you expect on this broader effort and VMAT2 follow-ons over the course of the next 12 to 18 months?
Eiry Roberts: Yes, so we are just entering the clinic with NBI-890, which is the VMAT2 follow-on, and obviously given the depth of knowledge that we have of this VMAT2 mechanism, this is a really important mechanism and platform for us. Valbenazine is an amazing medication in terms of its profile that Eric alluded to earlier, and so we have had to keep the bar really high in terms of the ability to differentiate with next-generation molecules coming into the clinic. We haven’t talked too much about the profile of this VMAT2 inhibitor yet. We will obviously do that as we generate Phase I data, but we would seek to differentiate with this molecule, both in terms of potential indications that we would go into but also in some of the characteristics of the molecule itself, that might lend itself to other areas such as long acting intramuscular injection or the approaches that are important in the neuropsychiatric arena.
Operator: Thank you. We’ll take our next question from Akash Tewari with Jefferies. Please go ahead.
Ivy: Good morning. Thanks for taking our question. This is Ivy [ph] on for Akash. On your Phase II schizophrenia trial for M4 agonist, 568, I guess that will be reading out this year. It sounds like you are prioritizing safety over efficacy. How much efficacy are you willing to maybe give up here in comparison to other competitors, like KarXT, in order to move forward into Phase III study? Thanks.
