Michael Riad: Hi. This is Michael Riad on for Jeff Hung. Thank you for taking our questions, and congrats on all the progress. We have two. First, on the long acting injectable, the company is looking at four more formulations to begin single ascending dosing first half next year. How do the four formulations differ from the one you already took through FAD? And what criteria will you be evaluating beyond treatment duration to compare? Thanks. And I have a follow-up.
Sharon Mates: Yes, this is Sharon, and I’ll take that one. So the different formulations, look at exactly that there are different vehicles, and we’re also looking at different sites of injection. So I think that – and what we’re looking at is a sustained PK profile of either one month or greater, in particular two months, as well as a clean safety and tolerability profile.
Michael Riad: Thank you. That’s very helpful. And then on the second one, so you’re seeing antidepressant effects of lumateperone across a broad spectrum of mood disorders, schizophrenia, bipolar depression, MDD, mixed features, and now anxious distress. But a shared outcome for a lot of these patients is that they are either refractory or only partially respond. So in that context, what do you think is giving luma’s ability to broadly deliver antidepressant effects, specifically when traditional SSRIs? So thanks so much.
Sharon Mates: Yes, thanks for the question. I think that it’s a confluence of many different factors, and in particular, it’s the mechanism of action that we believe this drug is acting by. So, unlike other antipsychotics, this drug does have SSRI activity, but it’s not solely the SSRI activity that is at work here. In fact, we have shown through our Intra-Cellular signaling pathways work, which is what we really formed the company on is to not only look at cell surface receptors, but to look downstream of the receptor. We show that through Intra-Cellular signaling, through the D1 receptor, we believe that we are a partial agonist, and we’ve shown how we proceed down the mTOR pathway and that we affect the glutamate system.
So we think that that is very exciting and very helpful in treating depression as well as we have with very rapidly saturate the 5-HT2A receptor, which we know boosts the activity of other receptor biology. So, in fact, we are boosting the activity that we see in both D1 pathway as well as in the SSRI, which, again, the unique opportunity here is the 5-HT2A antagonism that we have, and then the serot reuptake inhibition, which allows for more serotonin to be in the cleft. So it’s a very unique profile of the molecule that we believe leads to the antidepressant effects. And not to forget about the D2 two receptor activity, which acts, we believe as a partial agonist presynaptically and postsynaptically as an antagonist. So that’s important for bipolar, it’s important for schizophrenia, it’s important for several other psychiatric indications as well.
Michael Riad: Thank you. That’s really helpful. I appreciate the response. Thanks.
Operator: Thank you. [Operator Instructions] Our next question comes from the line of Marc Goodman of Leerink. Your line is open.
Marc Goodman: Yes. Good morning, Larry, the IQVIA daily capture rate seems to open down. I was just curious if you’ve noticed that and if there was a reason for that. Anything you can help us with there? Because the prescriptions just seem to be not driving what we would think to be driving the sales in the quarter. But you told us the gross-to-nets didn’t change much. Obviously inventory didn’t change much. So it’s got to be this IQVIA data that we’re looking at. So I’m just curious if you had any comment on that. And then, secondly, you mentioned the ITI-1500. You talk about data we’re going to see and what meeting you’re talking about that’s going to happen before the end of the year. Thanks.
Sharon Mates: Sure. So maybe to start you off, maybe I’ll ask Mark to address to start out on what we’re seeing about the capture rates and then ask Larry to chime in if he has anything to add to that. And then if I remember by that time you may need to remind me, I’m come back to the 1500 series. Mark?
Mark Neumann: Yes, Sure, Sharon. And yes, thanks, Marc for the question. Yes. What I would say, Marc is the – as with previous quarters, the primary driver of our revenue growth in the third quarter was driven by strong underlying demand and the growth that we’re seeing in prescriptions. As Larry mentioned in his prepared remarks, gross-to-net remained in the low-30s and it was comparable quarter-over-quarter. And regarding inventory, the days on hand of CAPLYTA at the wholesale level remained stable during the cover and that maintained the channel inventory at adequate levels to meet the growing demand that we see in the marketplace. So I think when you put all three of those factors together that helps to explain what we’re seeing in terms of the overall revenue growth that we see for CAPLYTA in the quarter. Sharon, I’ll turn it over to you for the second part of the question.
Sharon Mates: So on the 1500 series, as you know these are non-hallucinogenic psychedelics that we’ve been developing. This is all in-house developed where they’re new molecular entities, they’re not modifications of the present psychedelics. The – I think there is only one medical meeting left this year. I’m not sure they’re not happy for people to announce things. But it is AT&T at the end of the year that we’ll be presenting there. So – and we will of course make the information available to you after that.
Operator: Thank you. [Operator Instructions] Our next question comes from the line of Ami Fadia of Needham & Company. Your line is open.
Ami Fadia: Hi, good morning. Thanks for taking my question, and congratulations on the strong quarter. I had a question about just where the demand for CAPLYTA is coming from and if you could throw some light into it. You talked about the total prescriber base now reaching about 32,000 physicians of the 43,000 that you’re targeting. Can you talk about sort of the potential of expanding into the remaining 9,000 or so and also more importantly, the depth of prescribing and maybe any commentary you can provide around what is the current average number of prescriptions per physician and where is the potential for it to go to.
Mark Neumann: Yes. Sure, Ami, so thanks for your question. Yes, was – so there’s a lot of different ways to characterize where the demand is coming from. And what we’re pleased about with the launch of CAPLYTA is that the product is not being niched in any particular area and by that I mean we’re seeing new patient starts as well as switches and add-ons. We’re seeing switches come from branded products and generic products. We’re seeing use of CAPLYTA across all lines of therapy. As you know in this category there’s a lot of switching of agents. So many of these patients have already been on one or two or three antipsychotics and CAPLYTA is getting used in each one of those situations. And in fact, what we hear from physicians is as long as the patient’s insurance will allow first line use, they would prefer to use it that way because of the favorable safety and tolerability.
