Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) Q3 2023 Earnings Call Transcript

Another way to characterize it is clearly the strong growth that we’ve seen for the last 18 months is being driven by bipolar depression. We continue to grow the schizophrenia business. It’s an important business to us. It’s obviously important for patients, and we continue to grow that business. But the real explosive growth that you’ve seen is coming from bipolar depression. And then a third way even to characterize it is, as you suggest in – and we have been very pleased that both of those metrics continue to increase with the pace not falling off at all as we go quarter-over-quarter. So we’re now into our seventh quarter of the bipolar depression launch. We continue to add significant new numbers of first time prescribers of CAPLYTA, as you mentioned, now over 32,000.

And that’s just a matter of working up the adoption curve. All physicians fall somewhere on the adoption curve for new medicines. Some start it very early, some wait quite a bit longer to try a new medicine for the first time, and many of them fall within the middle. And it’s really just the day-to-day effort in our promotional activities, communicating the message about the benefits of CAPLYTA and continuing to get new prescribers. And in addition to that, each of those prescribers then finding additional appropriate patients for CAPLYTA and increasing the depth. And what I would say about the depth is each quarter, quarter-over-quarter, that depth continues to increase at a similar pace. So overall, we’re very pleased with all of the metrics that we follow in terms of what it says about not only the current growth of CAPLYTA, but what we see as continued robust growth into the future as well.

Ami Fadia: Great. Thank you. And if I may ask just another follow-up on mixed features. You talked about mixed features patients exhibiting anxious distress. What percent of the population is that, and would one of your avenues of discussion the FDA be to perhaps focus on that subset of the population, or would you still be looking for a label in mixed features patients?

Sharon Mates: Hi Ami, maybe I’ll ask Suresh to take that question.

Suresh Durgam: Yes. So in terms of anxious distress, there is a lot of overlap between anxious distress and mixed features. Patients with major depressive disorder or bipolar depression have mixed features and also anxious distress. A larger percentage of patients have anxious distress and mixed features, and there is also an overlap between these two. Our focus right now at the FDA will be talking about mixed features. However, we are also looking at the anxious distress. Once we finish talking about mixed features, we will be evaluating the next steps for anxious distress.

Ami Fadia: Got it. Thank you.

Suresh Durgam: Thank you.

Operator: Thank you. [Operator Instructions] Our next question comes from the line of Ashwani Verma of UBS. Your line is open.

Unidentified Analyst: Hi. This is [indiscernible] on for Ash. Thanks for taking our questions. For our question, it’s for CAPLYTA. What level of contracting do you currently have and in the long run, how much more can contracting play a part? Thank you.

Sharon Mates: Mark, you want to take that?

Mark Neumann: Yes, sure. Yes, I can take that, Sharon. So in terms of the breadth of our coverage and number of covered lives, our Medicare and Medicaid has very broad coverage at over 98% of covered lives. In the commercial channel, we have approximately 90% covered lives. And so across all three channels, we’re pleased with the coverage that we have, which means that the vast majority of patients have access to CAPLYTA. There’s also the – what we call the quality of coverage, which is whether when these patients are covered, whether they’re covered in an unrestricted way, whether there’s a step edit or in some cases a prior authorization. And so as we look forward, we will always look at opportunities to take a look at the price and volume trade-off.

If we see an opportunity with a particular payer, where perhaps we want to move from a prior authorization situation to an unrestricted status and we believe that the rebate level is appropriate, then that’s a decision that we’ll take. So for example, at the end of the third quarter, as I mentioned in my prepared remarks, there were two large Part D payers that we were able to move CAPLYTA from a prior authorization and two step edits to unrestricted status. And we believe that that will bring in significantly increased volume with those payers and contribute to revenues as we head through the fourth quarter and into next year. So while we are very pleased overall with where we stand with our market access situation, we’ll continue to look at individual opportunities at the margins to continue to improve that.

So I hope that answers your question, maybe a little bit more background than you were asking for in your question, but I thought it was important just to provide some of the details for you there.

Operator: Thank you. Our next question comes from the line of Graig Suvannavejh of Mizuho Securities. Your line is open.

Graig Suvannavejh: Good morning. Thanks. It’s Graig Suvannavejh at Mizuho. Congrats on all the progress in the quarter. My question is regarding the mixed features opportunity, I think you had mentioned that you were hoping to get on the FDA calendar this quarter or perhaps early next quarter. I was just curious as to the time with which, since you have the data in hand, which I believe, if I recall correctly was late March and just kind of the sequence and the timing as to I guess the time it’s taking to be able to get in front of the FDA and whether that’s related to additional analyses that you wanted to do in prep for that meeting. It’s just a little longer than perhaps I would have expected. And then maybe the corollary question is regarding as to again the strategy there, are you – just to clarify, are you looking for a formal indication in mixed features to put on the label, or is it really more about getting the data from Study 403 incorporated perhaps and reflected in the label versus a formal indication?

Thanks.

Sharon Mates: Hi, Graig. So let me try and take that and then I’ll ask if Suresh wants to add anything else. We did say in our prepared remarks that we do have – that we have requested a meeting. So we do have a meeting request in to the FDA and we do expect to meet with them the end of this year, early next year. So that is done. We also said that we do believe that our label right now for bipolar is extremely broad and does include a broad patient population. And as you know, we don’t have a label today in MDD patients. So I think that the real focus of this discussion is going to go there and that we are presently looking further into the data that we have in anxious distress. And we will have more to say about that as we – as our position there evolves and as the data directs us to describe the data.

So I think that answers your question. And I think in terms of what the next steps are, I think that now we’ve submitted the request, we’ll have the meeting, and we’ll update you once we have that meeting. Okay.

Operator: Thank you. [Operator Instructions] Our next question comes from the line of Jason Gerberry of Bank of America. Your line is open.