Mark Neumann: Yeah, Mark, I can answer the sales representative timing question. All of the representatives were brought on in 2023. So they had start dates, in a couple of ways in the latter part of January and pretty much for the month of February had been on boarded and getting trained up. And only recently in the last week or two have they been out in the field selling. So that’s the timing.
Operator: Thank you. One moment for our next question. Our next question comes from the line of Ami Fadia from Needham. Your question, please.
Ami Fadia: Hi, good morning. Thanks for taking the question. Can you share with us the rationale for initiating a third adjunctive MDD study and why stay sharp prior to the readout of the ones that are ongoing? And then just with regards to the mixed feature study that we’re going to read out soon, help us understand sort of what you think that you need to be able to demonstrate, to move ahead and seek sort of registration, seek approval in that indication. You have indicated in the past that data will drive further discussions with the FDA. What I’m trying to understand, you think that maybe at least in — they had run a study, but then they did not end up getting approval, it appeared to us that the bar was probably high to seek an approval in that patient subset, so we’ll be pleased to get your thoughts on that? Thanks.
Sharon Mates: Okay. I don’t know Suresh, do you want to start and then I can chime in.
Suresh Durgam: Yes, regarding the first question you asked about why starting the third study. In deciding when to start the third study when you look at the landscape, including how many studies are being run right now and what countries they are running and what have been conducted, we believe this is the appropriate time to initiate this study. And major depressive disorder in adjunctive treatment is a great near-term opportunity. Similar to our clinical development strategies followed in our other mood disorders program, for example, the bipolar depression program, it is prudent to add additional trials. It’s a good decision and it highlights our commitment to expanding applied kind of integration. In terms of the second question about the mixed features, as we have indicated, the readout of the study we’re expecting in this quarter, and the readout will depend on how strong the results are.
As we have indicated in the previous times, it depends on what the results show and we will have to go to the FDA and discuss presentable data, that’s what we have indicated to the FDA. Once we go and discuss based on the results, we will know the next path. I want to also remind that there has not been a path established for approval in mixed features. While there is path established for adjunctive treatment the mixed features approval, there is no one with that indication, especially for the bipolar depression with mixed features or MDD with mixed features. Now, there is not an indication for that yet. So we would like to discuss that with the FDA. And our strategy is mainly to expand across the mood disorder spectrum, both in unipolar and bipolar disorder.
I think you had a question about other some — some other company doing this study and not having an approval, but I cannot speak to that, because I don’t know what relations were made internally.
Ami Fadia: Understood, thank you so much.
Operator: Thank you. One moment for our next question. And our next question comes from the line of Charles Duncan from Cantor. Your question, please.
Charles Duncan: Yeah, from Cantor. Thanks, Sharon and team for taking our question. And congratulations on a transformative year last year. I think these are or this is a commercial question with two parts. One is actually related to the last question in terms of the mix feature readout and strategy. We recently conducted a KOL call that suggested — the KOL suggested that even a date of publication would be picked up by prescribers, and I know that you would mark it off label. But do you think that the label could encompass prescribing in mixed features patients? And the second part is, what are you doing to prepare for the coming wave of muscarinic modulators, is mono therapy and schizophrenia or do you think that that’s a non-event for your commercial franchise?
Sharon Mates: Mark, do you want to start or do you want me to?
Mark Neumann: Why don’t you go ahead and start and I’ll add some color if necessary, Sharon.
Sharon Mates: Okay, I’ll start with the label and I think that really what we need to do, and you’re right, we do not promote anything off label. So what we would do is we’re going to wait and we’re going to see the data. And we are going to go to the FDA with the data and assuming that it’s very good, which we’re of course hopeful for that might guide us towards a particular path. We will publish the results and again, we’re hopeful that the data is very good. And physicians can read the papers. And I guess on — I think it’s a little premature to talk about and comment on label expansion based on these results, because we don’t know the results. On the , I don’t think again. So our first approval wasn’t specifically our next approval and the direction of the company is schizophrenia is important, but mood disorders are much larger populations and the indications that we are moving in with our expansion.
We do think that — so we do think that anything that’s approved for patients with schizophrenia is a good thing. We look for anything that can help patients. Remember patients cycle through all of these drugs and we would look forward. We don’t expect there to be any negative impact on us at all. First of all, they’re still in the future. But we — all I can say is we look forward to having more options to treat patients. Mark, do you want to add anything to that?
Mark Neumann: No, I think that’s great.
Charles Duncan: Thanks, Sharon, for the color.
Operator: Thank you. One moment for our next question. And our next question comes from line of Jason Gerberry from Bank of America. Your question, please.
Jason Gerberry: Hey, good morning, guys. Thanks for being my question. So, just wanted to drill in a little bit more on the selling and marketing investments step up, and really is sustained sales growth contingent on this sort of level of investment or is there a possibility as we get into 2024, you can level off that investment and really kind of leverage this big step up in selling and marketing investment that we’ve seen in the last two years? And then as I look at like 2022, half of the script growth came from nurse practitioners, roughly. And so it’s a broader trend we see in mood disorder drugs in general. So just wondering if there’s a connection at all, to this sort of dynamic and the step up in selling and marketing investment?
Mark Neumann: Yeah, I can take that Sharon. Yeah, so when we made the decision to expand the sales force, what we were seeing is very strong demand for CAPLYTA, very positive reception in the marketplace. And as we analyze the data, we saw there was an opportunity to continue to fuel incremental growth. We’ve been pleased with the growth that we’ve been seeing but as we always do with all of our investments, we’re good stewards of the investment dollars that we have. And we always look for opportunities that might yield even incremental growth for us. And so in adding these 50 additional neuroscience specialists, what it will allow us to do is more frequently connect with high volume prescribers and also expand our reach deeper into our target audience.
And you mentioned NPs and PAs, and we would agree with you, certainly over the last couple of years NPs and PAs in disease states, like schizophrenia and especially bipolar depression, have become a very important audience for us. They are very much a part of our target audience and will continue to reach out to them to educate them on the disease and the benefits of CAPLYTA. So hope that answers your question, Jason.
Operator: Thank you. One moment for our next question. And our next question comes from the line of David Amsellem from Piper Sandler. Your question, please.
David Amsellem: Hey, thanks. So I wanted to ask you about LAI limits up around and get your thoughts behind the rationale there. My understanding is that the LAIs are primarily in the schizophrenia and bipolar, more mania population. So, as you’re leaning more and more into depression and bipolar depression, and then MDD, how do you think about the significance of an LAI form of lumateperone and I guess, in the grand scheme of things in your pipeline, how important is it? Thank you.
