Suresh Durgam: Not at this time, no. Thank you.
Operator: Thank you. [Operator Instructions] Our next question comes from the line of Charles Duncan of Cantor Fitzgerald. Your line is open.
Charles Duncan: Yes. Hi, Sharon and team. Thanks for taking our questions and let me add my congratulations on a really nice quarter and appreciate the guidance increase. I had a commercial question and then one R&D question. Mark for the commercial question, when you consider the guidance and contemplate next year. I guess, I’m wondering what would be the key thing that you would be looking for? Would it be new patients or increasing persistence, perhaps even within the bipolar community? And then I’ll ask my pipeline question.
Mark Neumann: Yes. Thanks, Charles. And the answer is both. And certainly, we’ve been pleased with the pace at which we’ve been adding new patients in bipolar depression for CAPLYTA. And in fact, earlier this week, when we got our NBRx data, new to brand prescription data, we hit a new all time high, which is the best reflection of how many new patients are being added to your brand. We expected to see that following some of the typical summer seasonality that we see. And so that’s a really good sign to us that the fourth quarter is off to a good start, and we would see that continuing into next year as well. And of course, we – the new patients come with existing prescribers, but they also come with new prescribers that we’ve also been doing, I think, a really good job of adding new first time prescribers to our prescriber base.
And as I mentioned in the prepared remarks, we now have over 32,000 unique prescribers of CAPLYTA. In each quarter, we’re adding significant numbers of new prescribers to that base. So we would see all of that momentum continuing through the fourth quarter and into 2024 as well.
Charles Duncan: Okay. And then relative to the pipeline, I guess, I’m wondering about deuterated lumateperone, quite intriguing target product profile there. Is it included in the IP that was recently extended? I guess, it’s for the 839 patent. Sharon, and if not, are there, call it, non-obvious observations on its PK/PD that may be patentable that you can imagine.
Sharon Mates: Yes. The ITI-1284 is an NME. It’s a new molecular entity with its own patent portfolio. So it has a totally unique patent portfolio with a unique patent coverage. So you should look at that as a totally separate molecule.
Charles Duncan: Okay. Helpful. Thanks for taking…
Sharon Mates: I’ll leave that. Yes.
Mark Neumann: Yeah, thanks.
Operator: Our next question comes from the line of Umer Raffat of Evercore. Your line is open.
Umer Raffat: Hi, guys. Thanks so much for taking my question and congrats on a great quarter. Two for me. Number one, clarify the reasons for your lowered OpEx spend expectations this year. And secondly, CAPLYTA TRx trends have been positive since Labor Day, showing positive week on week growth in three the last five weeks. And was just wondering if this was driven by any special promo activities and could we expect these trends to continue, given the favorable change of coverage in two of those Part D plans that you mentioned before? Thank you.
Sharon Mates: Great, thanks. I’ll ask Larry, do you want to take the first question and then Mark will take the next question. Okay, thanks.
Larry Hineline: Yes. Right. The decrease in R&D is primarily driven by the time – I’m sorry. Okay. Yes. Operating expenditures we’ll start with R&D first is driven by the timing…
Sharon Mates: This quarter of OpEx, which he asked about, please.
Umer Raffat: No, I asked about the reason behind the lowered operating expenses, expense with guidance, what’s driving right. Thank you.
Larry Hineline: Yes. Okay. Well, the reduction in the operating expenditures are in two areas – two primary areas, research and development, okay, which is driven the lower expectations are driven by the timing enrollment of clinical trials in our early stage programs. All right. And as far as DNA is concerned, we’ve been pretty disciplined with our OpEx spends there and while still achieving the strong results that we’re seeing on top line revenues. So I think those are the explanations that especially SG&A, we run a tight ship here and it’s across the board sort of reduction. Hopefully, that answers your question.
Umer Raffat: Thank you. Yeah.
Mark Neumann: Hi, Umer, it’s Mark. I can take the second part of your question, and yes, we have been pleased, but not surprised at the reacceleration of our growth in total prescriptions. Each year, you see the summer seasonality in Q3, which suppresses some of the growth. As I mentioned in my prepared remarks, there was zero growth in the overall market. We were able to drive 7% growth and continue to penetrate the market. And now, as we got past Labor Day, we’re seeing new all time highs in TRx, we’re seeing them in NBRx. And we believe that’s reflective of the overall market recovering in the fourth quarter, as it tends to do each year. But also, I think you mentioned some of the activities. Certainly, our salesforce execution has been very strong.
You’re aware that at the beginning of the year, towards the middle end of the first quarter, we added 50 new sales representatives. It typically takes about six months for them to get fully up to speed and fully optimized. And those 50 are now really just hitting their stride. So we expect an even greater contribution from them this quarter. And as we go into 2024, our ongoing DTC efforts continue to be very effective, bringing new patients into CAPLYTA. And then lastly, the two payer wins that I mentioned in my remarks, we do expect that to drive additional volume, but like other things, it does take a little while for that to be fully realized. We expect some of that benefit in the fourth quarter, but we’d really expect the full benefit of that in 2024.
So I guess, to summarize, we are pleased in the reacceleration in the growth. We expect that to continue this quarter and then really expect to carry that momentum over into 2024. So I hope that answers your question.
Umer Raffat: Yes, it does. Thanks so much.
Operator: Thank you. Our next question comes from the line of Jeffrey Hung of Morgan Stanley. Your line is open.
