Neurocrine Biosciences, Inc. (NASDAQ:NBIX) Q4 2022 Earnings Call Transcript

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What we’ve seen from valbenazine in the tardive dyskinesia space is that the combination of antipsychotics and valbenazine is very safe and well tolerated in patients with schizophrenia. And coupling that with some preclinical information that showed synergy of effect in this patient population and also anecdotal data from the field that made us confident to go into a program that would allow us to understand whether patients with schizophrenia who are failing to get maximum response from their current treatment could actually benefit further in terms of both their positive and potentially negative symptoms by the addition of valbenazine. The second therapy that we have is luvadaxistat, which is in Phase 2 development. That is a DAAO inhibitor, comes from our Takeda collaboration, and that seeks to address the important cognitive deficit that is seen in patients with schizophrenia, particularly younger patients, given that this is a developmental disorder.

And so from that perspective, luvadaxistat, we had a signal in our Phase 2 study that was intriguing to us in terms of the impact on the Braxton scores measures. And so we believe that there is opportunity there that we want to further progress and further explore in Phase 2. And so we have a replicate study going on right now. And then the third and most recent addition to our pipeline is the M4 selective agonist 568, and we’re very excited about this opportunity to treat patients with acute psychosis. And we started a Phase 2 study with this mechanism late last year, and that is really enrolling very well. And as you know, this is now a validated mechanism for the treatment of acute psychosis through recent trials that have read out in Phase 2 and Phase 3.

So across the board, we think there’s a space for all of these different approaches since they each address a different aspect of schizophrenia. And given that this is a lifelong disorder for individuals from a young age right through their life, we do believe that there’s opportunity for these things to coexist if we’re successful in the clinical trials.

Chris Shibutani: Thank you.

Operator: And we’ll take our next question from Carter Gould with Barclays. Please go ahead.

Carter Gould: Good morning. Thank you for taking the questions. And I appreciate all the color on the long-term care segment. Maybe just to follow up there, can you maybe just give a little bit more detail on some of these operational hurdles and kind of Neurocrine’s efforts to kind of help the centers on that front? And just sort of what gives you confidence that’s surmountable in the next couple of quarters as you alluded to? Thank you.

Eric Benevich: Yes. As I mentioned on my initial commentary, LTC is a new segment for INGREZZA. However, it’s an opportunity that we’ve been looking at really since before we launched back in 2017. So we’re excited to be in a position where we’ve actually put a team in place to really explore that opportunity in LTC. We estimate that 10% to 15% of all TD patients are in an LTC setting. And I mentioned in my commentary that it is a more complex environment. And what I mean by that is that many of these care centers function on a day-to-day basis being run by nursing staff and the prescribers, whether it’s the medical directors, the consultant psychiatrists or nurse practitioner, they rotate through. So they’re not there on a 24/7 basis.

They’re coming through maybe every other week or every third week. And so really what that requires is for our folks to work closely with the staff in these facilities to educate them on tardive dyskinesia, help them to recognize the abnormal movements, potentially distinguish them from other drug-induced movement disorders and importantly, identify and flag residents that need further evaluation from the MD or from the nurse practitioner. And so ultimately, it takes a team approach in long-term care, and you really need to understand that environment not only in terms of the dynamics within the facility and who their prescribers are, also the role of the LTC pharmacy. And so we’ve been building our understanding of where the opportunity is.

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