Okay, well, thank you guys for joining us. Pleasure to have ITCI management. I feel like, over the course of the years, tracking the story, it seems like it's tracking exactly where that Phase II data was, tracking in terms of the safety profile, and now it's playing out commercially as well. So, thank you guys for being here, and I'll, Sharon, I'll let you kick things off. We'll jump right into the story. Great. So, I think most people know our story. So, I don't have to go through the whole history. However, that we started the company in 2002, and our first product, that we received approval for in December of 2019, and launched in March of 2020, just as the world shut down, was for Caplyta for the treatment of schizophrenia. In 2021, we received an approval, for our first expansion of Caplyta, and that's for bipolar depression. And we were off to the races, contributing to the revenues that we see today. We've guided you to $665 million-$685 million for the year, and we are on track for that. And we recently completed our studies in major depressive disorder as adjunctive treatment, and we just announced this morning that we have recently submitted our sNDA, for the approval as adjunctive treatment in MDD. We continue on with our pipeline as well, with 1284 product, which is a deuterated lumateperone in clinical trials for GAD, psychosis in Alzheimer's, and agitation in Alzheimer's, and we have an LAI program as well, with lumateperone, and we have other products coming down the pike as well that I'm sure we'll get into. Excellent. So, there's a lot of layers to that, and I want to get into each of them, but I think, Sharon, one of the most critical things coming up next from the story perspective, to me at least, is perhaps not even the MDD. It's actually that, you guys are approaching profitability, and there's a whole new set of investors that could potentially be very interested in the story and understanding where this is going, if just from the ownership perspective, so I guess my first question is, is it reasonable to assume somewhere between, and that's not guidance, but somewhere at some point next year, 2Q, 3Q, what have you, you're approaching that break-even on the quarter? So, you know, we do things as we get very comfortable. Right. And so, for instance, as you know, when we initially launched, etc., we didn't give you guidance on our revenues. Then, as we became very, very comfortable on our achievement of revenue milestones, we started giving you guidance there. So, we haven't yet given you guidance on profitability. I'm going to turn it over to Sanjeev as our CFO. Yeah. So, Umar, I'm relatively new, but what I've seen thus far is Sharon, management have been very disciplined in investing. And the way I see right now, the company's very well capitalized, as you know. We have resources. Our priority near-term is obviously maximize Caplyta top line, you know, with the existing indication, launching successfully MDD, which will require investment, and prosecuting the pipeline. We got impressive programs on that. So, we focused on that. Clearly, profitability is a goal that we have, but right now the priority is investment, and we'll talk more about that when we give guidance for next year. Okay. So, and this is exactly the direction I was going, because theoretically, if you just follow the cadence of launch, at least in my mind, it could be hitting break-even in 2Q, which then means 3Q and 4Q are profitable. But what I was really driving towards was, to me, what that means is, in the guidance, it could look like it's EPS neutral to slightly positive, and that guidance comes in February. So, I guess, how would you sort of prepare the street for that? Maybe even just speak to some of those investments you guys have in mind. I think I don't want to get ahead of what the guidance is. I think the way to simply think about it, as you talked about, is the top line will continue to grow, with the existing indication that we have, and then with the launch of MDD in the second half of the year. That obviously will be reflected in that. And as far as the expenses are concerned, you have the cadence that you see this year, including the investment that we did, with the expansion of 150 field force for primary care. And then, as we also talked about, that we're going to be second phase of the expansion that we would do next year. We'll put all those aspects in mind, including the investment in the pipeline, and come back. Again, we don't give quarter-by-quarter guidance, Umar, as you can imagine. But we'll talk a little bit about, you know, what that would mean in terms of next year and going beyond that. Got it. Okay. Excellent. So I just want to make sure I have it right. Current run rate $700 million, consensus expectations for next year's $935 million. Based on the current OpEx trends, a $935 million should be about break-even, but I think the point you're leaning into is there's a sales force expansion. There's also some additional R&D investments you guys have in mind as well. So, for that reason, we should keep the OpEx, don't hold the OpEx sort of steady where the current levels are at because of some of these additional investments. That's right, and again, more to come on when we talk about this, and we'll explain to you all, the rationale behind that. Okay. Got it. Excellent. Mike, anything on this before we, just before we move on? Okay. Maybe let's start to get a little more product-specific then. And I guess, the, the first one for me is, as I think about the current run rate of $700 million and heading towards next year, A, can you remind us, is there any relevance from an IRA impact perspective? B, it doesn't look like a muscarinic should be relevant from a trajectory perspective, but could you sort of give us some perspective on that as well? And then obviously I want to get into MDD, but just break it down into those three buckets. So, I'll talk about the IRA, and then you can take it. Sure. Umar, there are multiple layers of IRA, as you can imagine. Two things that are going to impact this year and next year, they're all kind of have been thought about and factored into that. One is obviously the inflation penalty, which gets, you know, kicked off in the Q4 of this year. That's kind of reflected in that. And then next year, we will have the Medicare Part D redesign phase and discount, because we're a small manufacturer biotech from CMS perspective. We'll have 1% on the initial coverage discount and the 1% on catastrophic, which obviously will be factored into as part of our guidance. And has been taken into account on all of our projections. Yep. And then, Umar, on the new muscarinic product, still early days, but as we've said, we don't expect a significant impact on Caplyta trajectory of the launch, really for two reasons. One, schizophrenia is the smallest of all the indications for the antipsychotics. It's the kind of indication where no one product dominates. There's a lot of churn of patients and switching that goes on. Secondly, as the antipsychotics, including Caplyta, add more indications, mood indications, as we have in bipolar depression, as we'll have in MDD, the vast majority of the growth comes from those two areas. So, for example, if you look at Vraylar as an analog, with their three indications, less than 10% of their scripts come from schizophrenia. The vast majority come from MDD and bipolar, and Caplyta is very much on that same trajectory, and we would expect to see that continue as well. So, is schizophrenia less than 10% for Caplyta right now? No, no, Vraylar. Vraylar. For Caplyta, we're getting down around 15%. And it's been dropping ever, as you can imagine. The real explosive growth that you've seen is coming from bipolar depression. Schizophrenia is growing. It's growing nicely, but the real explosive growth is coming from bipolar depression. So, as that grows, the contribution of schizophrenia becomes less and less over time. Right. Sharon, I remember one thing we've discussed on some of the phone calls we had over the years was the, just the side effect profile, some of the feedback you got from some of the Allergan folks you guys hired back in the day. And that side effect profile, obviously very relevant clinically, certainly relevant in schizophrenia, more relevant in bipolar, but I think it's by far the most relevant in the indication you don't have yet, which is MDD. Wouldn't that mean, and we've kind of seen this going from schizophrenia to bipolar at the curve accelerated, wouldn't that mean that a potential next inflection could happen again? Because that's the indication where even, Abilify is at the very lowest dose. Right. We do think that we will see another hockey stick trajectory with the approval of MDD, and if you look at our 501 and 502 studies, the studies in adjunctive treatment in MDD, you did see a continuation of the very favorable safety and tolerability profile in MDD patients that we saw in bipolar patients and that we saw in schizophrenia patients, so we are very excited about the increase in the trajectory that we should see yet again, like when we went from schizophrenia to bipolar. We think it may even be more steep going from bipolar into MDD. Got it. And if I may, perhaps, if I just look at the year-over-year for Caplyta right now, you guys were at a $500 million run rate in 3Q last year, about a $700 million run rate in 3Q this year. Linearly, that implies next year should be $900 million, which is kind of where the consensus is. But if there is that inflection, the hockey stick, that should imply Caplyta could top $1 billion, and it kind of ties back into some of the profitability metrics as well, which is why in the back of my mind, I'm thinking, technically, next year's an EPS positive year for you guys. So, how do we marry the Caplyta hockey stick with sort of where, things could track from a P&L perspective? So, we're very excited about the trajectory and the growth of the business. We're also continuing to invest in the business. So, I would tell you that, again, we'll give you more guidance next year, but I think that, just to remind you that we will continue to invest in the business. Is it more than a $100 million investment from an OpEx perspective? We're not giving you that guidance yet. The important thing to note, the revenue is going to be for a shorter period of time because of the MDD launch. Then you have to incur some of the expenses for the larger part of the year for next year because of the way the launch is set up. Without giving you guidance, that's a good way of thinking about numbers. Got it. Sharon, I want to just drill down on the $5 billion long-term guidance you guys provided on your pre-2Q call. Continues to get a lot of attention. Market opportunity, we said within five years. Market opportunity. Forgive me. Not guidance. Yeah. Just before I get into details about this, just want to remind folks, what are the assumptions behind that, if you can? Why don't I ask Mark to do that? Yeah, so at a high level, Mike, what it reflects, I think, is our confidence that we will be a leading option in the mood disorders over time, so very strong contributions from both bipolar depression as well as MDD. Drilling down a little bit further, bipolar depression, you know the trajectory that we're on. We see that trajectory continuing in that way, continuing to make market share gains so that over this time period in bipolar depression, we become one of the two top agents in bipolar depression. For MDD, now that we have the results from Study 501 and 502, we had the opportunity to take those results out into some very rigorous quantitative market research, and what we heard back was what our belief was, is that this represents a best-in-class profile in MDD. And so, the forecast for MDD reflects the fact that we believe this is a best-in-class profile and therefore will become the market leader in MDD for branded antipsychotic, use adjunctively. Schizophrenia is much less of a contributor for the reasons that we talked about before. And when you pull all that together, we're very comfortable saying that within 10 years, we think this will be at least a $5 billion opportunity. I think it was on your pre-Q call. I think one of the assumptions behind were baked into that $5 billion number. You said that you assumed that net selling price would improve over time. And my question is, how could that improve or to what extent can it improve if there's greater expansion into the commercial segment? You know, just thinking about that, if anything, wouldn't net price deteriorate as you expand greater into the commercial segment? So two different things. They get to the same point. So one is the expansion of the commercial. So you're right. With the MDD approval, more commercial channel would be affected by that, and that will have a moderate impact on the gross-to-net over a period of time. Right? Not going to have an immediate impact, but we'll have a moderate gross-to-net impact over a period of time. So, that's one factor. But the second factor is with the modest price increases that we anticipate and the gross-to-net changes that are going to happen, you will see a net selling price increase in the near-term future. So, you will see a gross-to-net going up, also the net selling price going up in the near future. I see. Okay. Also, remind us, what's the current and expected Medicare versus commercial sales split, if you could comment on that? Commercial is the largest right now, but quickly followed by Medicare, and then the least amount of that is Medicaid, in terms of what that is. Yeah, the other way around. I'm sorry. Commercial is the largest, and then Medicare is the second largest, and then Medicaid is the last on that, and then as we go forward with the MDD indication, commercial will become a bigger piece of that, and that's what we've seen in case of Vraylar, and that's what we have factored in as we thought about a $5 billion opportunity in over 10 years. I see. Also, does this $5 billion figure also assume significant switching from Vraylar to Caplyta or for any other competitive antipsychotic too? Not, not inordinately. Yeah, there, there will be switches, over time, but, as I said, the, what we believe Study 501 and 502 demonstrated is a best-in-class profile, and that means that Caplyta will become the market leader in MDD. So, as a physician is dissatisfied with, the patient's, response to, an SSRI or an SNRI, and they've made that decision to add an antipsychotic adjunctively, we think Caplyta will be that first choice because of its profile. So, there will be some switching, but it'll be new patients as well. I see. May I just quickly ask? I realize obviously you guys are only marketing to the indications, but is there any off-label usage happening in the commercial marketplace already? Just trying to think about, could there be any MDD use already happening based on the data you've put out? Yeah, you see that. You see spontaneous use by physicians. What I would say though, if you look historically at what happens when you have a product that's in the market and then you have impressive study results like the ones that we saw in 501 and 502, when the press release goes out, you guys all know about it, we know about it, the average prescribing physician doesn't have enough information to really act on it, right? As that information begins to get into the scientific literature, is presented at conferences, in publications, then they have the full data set and they can make decisions on their own. But where the real trajectory change that Sharon was talking about occurs is once you get approval, you put the full force of promotion behind it, that's when you see the real hockey stick-like trajectory. So, is there some spontaneous use in MDD? Yes. Will that continue? Probably. Certainly not something we promote to. We think the real impact will be, as Sanjeev was saying, later in the year, next year, as we get approval and launch, in MDD, that's when you could expect to see the real trajectory change. So, I want to maybe quickly switch to sort of beyond Caplyta and its current indications. There's obviously a pipeline, but even ahead of that, from a patent situation, it looks like 2029 patent is very much locked in. I know we've discussed some of the patents that go out into late 2030s, which are composition patents, but more specifically, they look like they're on the crystal form. And I sometimes wonder if those are the types of patents that generics could at least try to litigate around, try to carve around, things like that. I guess how are you guys thinking about it in terms of the realistic timeframe on IP durability? We have IP listed in the Orange Book through the end now of 2040, and we stand behind those patents. We think that you've probably seen we've just had several patents added to the Orange Book, and I think that we're very confident in the patent portfolio through 2040. Got it. Sharon, remind me, where at 2034 was that where you guys were you guiding investors to previously? No, we never guided you to anything other than our Orange Books. What we've said is others have made some speculation, but that also was prior to some patents issuing as well. And so, we stand behind, we have always stood and we continue to stand behind all of our Orange Book listed patents. Okay. I guess if we take that a step forward, then wouldn't that mean if 2039 is good, which we can discuss or debate whether solid crystal form would hold in the courts, wouldn't that mean the deuterated, which might also have generally similar IP, then you could presumably route some of those indications on existing Caplyta, not necessarily do the deuterated? How do you think about that dynamic? I'm not sure I understand the question. Are you asking if we're then going to? Deuterated is similar IP timeframe as well, right? There'll be more patents listed when we get an approval, and as they issue on the deuterated form. When is the first trial readout on deuterated? We are in trials for their Phase II trials. They are powered and sized like Phase III trials, for GAD, for psychosis and Alzheimer's, and for agitation and Alzheimer's. I think they'll finish. They'll read out in 2027. In 2027. And also, Sharon, I feel like, especially given the size of the. Let me make sure that's right. That's correct. That's correct. Okay. Thank you. I was thinking 2027, 2028, but are they registrational or are they? They, we've called them a Phase II, but they are sized and powered as Phase III, and they can serve, we believe, as registration studies if positive. Got it. In other words, they're each over 700 patients. When can we expect a readout on your long-acting injection? Because that could be very relevant for the tail value as well. The long-acting injectable is with Caplyta, with lumateperone, and we have four different formulations in a Phase I study now, and we've pitted them against each other. We will, over the course of 2025, be whittling down those. We'll be comparing the PK values of these different formulations to each other and carrying, hopefully we'll whittle it down to two or one, sometime next year. We also have other formulations in development, some on our own and some with others, and we'll see how they go. Got it. One final question for me, Sharon, regarding ITI-1284, the deuterated lumateperone. I noticed that the PET receptor occupancy study is still ongoing, yet Phase II trials have commenced. So, all of which test the 10 milligram and 20 milligram. So, what makes you confident that you're testing the optimal doses prior to completion of this PET occupancy study? So, based on preclinical studies, you have behavioral studies, and we also have a lot of experience with lumateperone and what that occupancy was. Now, just to remind you, all of the occupancy dogma went out the window with lumateperone because, as you might remember, no matter how high we pushed the dose, we got to a point where you couldn't keep increasing the occupancy. So, what we're looking to see is, you know, where we are on that curve, and how close we are. I see. Well, I think we're about time. Team, this has been immensely helpful.