Sharon Mates: And to continue on that, and to answer your first question, our MDD platform is composed of two studies for the treatment of — for adjunctive treatment and MDD. Having said that, we’ll see the readouts on these studies, and hopefully they’re both positive; if one is positive and one misses, it depends on why it missed and how it missed, and the FDA looks at the totality of your evidence. And that’s where you asked about the mixed features. The mixed features is not part of the adjunctive MDD program. However, what happens is the FDA does take into account the totality of your evidence. And so, an example of that is Rexulti, where they had two studies, one hit, one miss, but the FDA looks at the totality of your evidence and they then opine.
And so, I think that’s where all of our data, any data you have that we have in MDD will be looked at in our submission. So, I think the very, very strong positive data that we had in our mixed feature studies can only help us. And I’ll leave it at that.
Jason Gerberry: Got it. Okay. Thank you.
Operator: Thank you. One moment for our next question, please. It comes from the line of Ash Verma with UBS. Please proceed.
Ash Verma: Hi. Thanks for taking my questions. So, may be just a couple on pipeline, for the LAI, I think the press release mentioned that there was some sad data that you had generated. Just what did that show, and what are these four different formulations that you’re going after in this new study that you’re starting? And then for lenrispodun, so Parkinson’s can be a big market with different segmentation. Are you trying to position this as a monotherapy or adjunctive? Or is it going after the early or the late stage disease? Thanks.
Sharon Mates: Okay. Maybe, Suresh, do you want to start? Or actually, I can start with the LAI and then turn it over to you for the lenrispodun.
Suresh Durgam: Okay.
Sharon Mates: I’m sorry, guys. I appear to be losing my voice. So, we did a Phase 1 study, and what the study showed was, in fact, what we’re looking for is a formulation that is good for both a one-month and longer duration. The first study showed, first of all, we can administer it. This was a sub-cu formulation, but it would not be an ideal formulation to go forward with, certainly for greater than one month. So we went back to the drawing board, and based on what we heard about a sub-Q formulation versus other types of formulations, like IM, also based on the site of injection. And so, the four formulations that we have prepared look at both sub-Q versus IM and the site of administration, and looking at the ability to deliver the molecule over both a one-month and longer duration. So, that’s the answer to your first question, and maybe, Suresh, do you want to talk about our Parkinson’s study and the patient population?
Suresh Durgam: Yes. So, the Parkinson’s study, the lenrispodun, that study is a study in Parkinson’s disease. We are looking at populations where the primary objective is to look at efficacy of lenrispodun as administered once daily as an adjunctive treatment to existing liver topo therapy. So, the patients must be on stable doses of existing levodopa therapy, and our primary endpoint there is looking at the Hauser diary, that is, increase in on-time without troublesome dyskinesia. We also are looking at the motor aspects, MDS-UPDRS, part two of activities of daily living. In that study, we are also measuring other multiple things, one, looking at measurements in cognition. We’re also looking at several biomarkers of inflammation.
This is important for both Parkinson’s and also looking at programs outside of the CNS. And once we look at the data based on the movement measurements, cognition, and inflammation, our next studies will look into defining what the path forward will be for this program.
Ash Verma: Okay. Thank you.
Operator: Thank you. And one moment for our next question, please. And it’s from the line of Sumant Kulkarni with Canaccord Genuity. Please proceed.
Sumant Kulkarni: Good morning. Great to see all the progress, and thanks for taking my question. I’m going to ask a bigger picture one. On your MDD program, you’re clearly putting a lot of resources behind it. So, for the benefit of investors, what would be the latest and most accurate characterization from within the company on whether you view the addition of the MDD indication as a nice to have for lumateperone given the size of the market and unmet need, or is it more of a strategic imperative for the company?
Sharon Mates: Hi, Sumant. That’s an interesting question. Maybe, I don’t know, Mark, would you like to start from a commercial perspective, and then we can chime in?
Mark Neumann: Yes, sure. That is a very interestingly phrased question, Sumant. And I guess what I would say is we believe with our current business in schizophrenia and bipolar depression, we are still in the early innings of tapping into the opportunity for CAPLYTA, and we see tremendous opportunities for continued growth in bipolar depression as we continue to penetrate that market. Certainly, MDD is equally a large opportunity with significant opportunities for growth, as I just mentioned in answering one of the previous questions, and we would certainly be excited to add that to our label and have the opportunity to bring CAPLYTA to physicians and patients in the area of MDD as well.
Sharon Mates: I have nothing to add. I think that’s a well-stated and well-stated position of the company.
Sumant Kulkarni: Thanks.
Operator: Thank you. And one moment for our last question in the queue. It comes from the line of Ami Fadia with Needham & Company. Please proceed. Good morning.
Ami Fadia: Good morning. Thanks for taking my question, and congrats on all the progress. My question is more of a clarification question on your comments on the MDD regulatory plan. Would you say that if one study hits and the other misses, you would still go in for a regulatory submission without waiting for the third one to read out? And then also just going back and thinking about mixed features, what’s your latest thinking about the regulatory path forward, and could you use some of the data from the MDD studies that are going to be reading out to pursue a specific label in mixed features? Thank you.
Sharon Mates: Hi, Ami. Thanks for the question. I think it’s a little too early to comment on how we’re going to proceed until we know what the data is, okay? I will tell you that obviously two positive studies we proceed as planned, one positive study and one negative study. Again, it really, really depends. It really depends on what happened, why you missed, whether or not — and we would — we always submit all of our data to the FDA as soon as we can. So, I think it’s a little bit too soon to answer your questions on what happens if, because it depends on what the data says. And I think we can leave it at that. There may have been — was there another question in there, or are we good?
Ami Fadia: My question was also regarding mixed features and what your latest thinking there is.
Sharon Mates: Well, as we said in our prepared remarks that we did have a very constructive meeting with the FDA, and as always, we wait for our minutes. And once we have our minutes, we’ll come back to you.
Ami Fadia: Thank you.
Sharon Mates: Operator, may be another question?
Operator: Yes, we have time for one more question. One moment, please. And it’s from Charles Duncan with Cantor Fitzgerald. Please proceed.
Charles Duncan: Hey, good morning, Sharon, and team. Congrats on a good year, and thanks for taking our questions. I’m hopping between calls, so sorry if this has already been addressed. But I wondered what your perspectives were with regard to the possibility of muscarinic agonists being approved for monotherapy in schizophrenia later on this year. And I guess monotherapy in schizophrenia later on this year. And I guess, I’m wondering if you could provide us a little bit of color on your preparation in terms of differentiation of CAPLYTA relative to those candidates and how you’re, addressing the prescriber base at this point.
Sharon Mates: Mark, do you want to take that?
Mark Neumann: Yes, sure, Charles. So, we have a great deal of confidence in the product that we have in CAPLYTA. We feel across both schizophrenia and bipolar depression, we see very strong efficacy, a very favorable safety and tolerability profile, and a dosing regimen that physicians and patients really like. And our focus is on educating physicians and patients to make sure that they’re aware of CAPLYTA, they understand the potential benefits of CAPLYTA for their patients, and so that’s where we put our energy. New products potentially being added to the mix for physicians is always a good thing. For patients, as you know, in this category, there’s a tremendous amount of churn, what we call churn, meaning patients try one therapy often prior to CAPLYTA.
They would experience side effects either on the movement disorder side or on the metabolic side, and so they cycle through multiple different products. So, for them to have another option to choose from is always a good thing for patients. I would say for us, more and more of our business, as we’ve talked about in the past, is coming from bipolar depression, and in the future with a successful MDD study, as we just talked about would be coming from that area as well. So, we don’t see a significant impact on the CAPLYTA business of any new entrants coming into the market. So, I hope that addresses your question, Charlie.
Charles Duncan: Yes.
Sharon Mates: Right, and I would like to just add to that that we — I agree, and we as a company think that any new product that can help patients is great for patients, and as Mark said, especially in schizophrenia, these patients cycle through these products. It is part of the disease state. So, we think it can be a benefit to patients, and that’s terrific. Now, having said that, there are 2.4 million patients with schizophrenia, there is four to five times that patient size in bipolar depression, and there are even more patients with MDD, and our business is growing in the bipolar space, and we expect that to continue. So, as Mark said, as a summary statement, we really do not expect this to really impact our business at all.
Charles Duncan: That makes sense, Sharon, and Mark, and it doesn’t appear that those agents impact depression at all. So, clear differentiation. One quick point of clarification, though, given what’s going on with regard to acquisitions, I think I know the answer to this question, but the small royalty that you pay to Bristol-Myers that is paid to that company without any input on their part, you just send them a check. They have no role in marketing CAPLYTA at this point, right?
Sharon Mates: They have no role in marketing CAPLYTA.
Charles Duncan: Okay. Thanks.
Operator: Thank you. And with that, ladies, and gentlemen, we conclude the Q&A answer period. I will turn to Dr. Sharon Mates for final comments.
Sharon Mates: Thank you, everyone, for joining us. I know that we’re a little bit over in time, so I’ll make it very brief. I think we are very proud of our performance during 2023, and we’re really looking forward to 2024 and look forward to updating everybody as we go forward. So, thanks again for joining the call. And with that, Operator, you can disconnect.
Operator: Thank you everybody for joining our call today. You may now disconnect.
