Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) Q1 2024 Earnings Call Transcript

Troy Langford: Hi. Congrats on all the progress this quarter and thanks for taking our questions. Just on the CAPLYTA commercial performance, do you think we’ve already seen the majority of the impact of the expanded sales force? Or do you think we could see this impact play out gradually over the course of the rest of this year? And how long do you think it will take for us to see the impact of the new TV ad on CAPLYTA sales trajectory?

Sharon Mates: Mark?

Mark Neumann: Yes, sure. I can take that. Yes, I think, we are — we’ve been very pleased with the impact that the additional 50 representatives that we brought on a little over a year ago, typically it takes up to six months for representatives to see an optimized performance in their territory. So I think they’re hitting on all cylinders now and I think you can expect a continued impact from them as you can with all of our representatives in all of our territories. And in terms of the DTC impact, we’ve been continuously running our DTC with the Let in the Lyte campaign. As I mentioned in the prepared remarks, we’re very pleased to have just very recently launched a new campaign that builds on the Let in the Lyte campaign, and we would expect to see the impact of that over the course of the year as well.

We’ve been pleased with the response that we’ve seen in all of the metrics that we track for our DTC programs and we’re very pleased to be able to refresh the creative campaign. So keep an eye out for that in the coming weeks and months.

Troy Langford: Great. Thanks for the color.

Operator: One moment for the next question. The next question comes from Ash Varma with UBS. Your line is open.

Ashwani Verma: Hi. Good morning. Thanks for taking our question. So just quickly on the pipeline, ITI-1500, the psychedelic, just wanted to understand like what’s the base molecule you’re pursuing here? What is the target that it is hitting? Just mechanistically, if you can talk about like what is the value proposition that would be great? Thanks.

Sharon Mates: Yes, thanks. The first part of your question got a little muffled, so I may need to ask you to repeat it. But I think you are asking about, the mechanism, of the 1500 series and where it comes from. It is the entire program has been developed in-house, has been discovered, the scaffolds and have been discovered and worked on internally going based off of our many years of knowledge in serotonin biology and in particular in 5-HT2 biology. So that’s what these molecules have been, molded around, and we are very excited because they are agonists, but they do not have the hallucinogenic activity in animals. And, also, they do not have the cardiovascular side effects that you see with 5-HT2 agonists in general. So we’re very pleased with that.

Operator: [Operator Instructions] Please standby for the next question. The next question comes from Ami Fadia with Needham. Your line is now open.

Ami Fadia: Hi. Good morning. Thanks for taking my question. I had a quick follow-up on ITI-214. You mentioned you’re going to collect some biomarker data on information. Could you elaborate a little bit more about how that could translate into differentiation versus existing treatment options within Parkinson’s? And also in the past, you’ve talked about potentially looking at impact on movement and cognition. Could you sort of remind us if there are ways in which you’re going to be measuring that in the four week study? Thanks.

Sharon Mates: Suresh?

Suresh Durgam: Yes. In terms of the 214 Parkinson’s study, that is a proof-of-concept study. As indicated, we are looking at the moment scale, cognition and inflammatory biomarkers. Your question specifically regarding the cognition. We are measuring what is called, symbol digit modalities test. This measures the processing speed with a simple substitution task that essentially to detect the cognitive dysfunction. And this scale is similar to the DSST version, but for Parkinson’s patients, this is a better version of that, for Parkinson’s patients. In terms of the biomarkers, we are testing biomarkers for inflammation. IL-6, IL-18, CCL are being tested and other biomarkers are tested to see the effect on these biomarkers. And in terms of the utility of that, that will help for us in our other indications we are pursuing, in inflammation that will help us figure out what other things we can do with that.

Operator: One moment for the next question. Our next question comes from Corinne Johnson with Goldman Sachs. Your line is open.

Corinne Johnson: Good morning, everyone. I wanted to circle back to your answer to Jessica’s question earlier around potential interest in asset acquisition. And I guess as you think about and evaluate the assets that are out there, what sort of parameters do you have in mind as you evaluate these opportunities? And how do you think about that development or business development in the context of not just the commercial priorities, but also your other pipeline product?

Sharon Mates: Right. I’ll start and I’ll ask Mark if he wants to add anything. So, hi, Corinne, and thanks for the question. So obviously the best case scenario would be the addition of a marketed product that our present sales force can add to their bag, so to speak. So that has — that as they’re out there, they can be speaking about both CAPLYTA and another product. Going down the run one step, if we are not successful there, which we do look and to-date, we haven’t brought in anything there, we go to adjacencies. So marketed products that may require adding another sales force, but it really depends on the product and the size of the sales force that you would need. And then we also look at late stage development assets, and we’ve been moving earlier and earlier.

And you’re absolutely right in implying or suggesting or asking a question of how do you then prioritize bringing in an early stage product to our own pipeline? And I have to tell you every time we evaluate something that’s, early stage, that’s exactly what happens. We need to weigh it against what we already have and you can’t just keep adding early stage programs. So it would probably displace one of our own early stage programs. So you’re always weighing these things. And, you know, we do look across the spectrum now, from the marketed products that I gave you the order that we look at these all the way down to early stage programs.

Corinne Johnson: Thanks. That’s super helpful. Appreciate it.

Operator: One moment for the next question. The next question comes from David Amsellem with Piper Sandler. Your line is open.

David Amsellem: Hey. Thanks. So I wanted to drill down a little more deeply on the deuterated lumateperone, program. I’m particularly interested in your thoughts on the path forward in Alzheimer’s agitation with one product already approved for this for the — for the setting in Axsome’s Auvelity in late stage development. But I’m just wondering out loud, you’ve got a couple of randomized withdrawal studies, that, Axsome’s running on or has run on Auvelity, but then you also have more regular randomized studies. I’m just trying to get a sense from you or how you’re thinking about what you’re going to need to do to move AD agitation through just given that it’s not exactly a well-worn regulatory pathway? Thank you.