Hi, everyone. We're starting with our next session. I'm Andrew Tsai, senior biotech analyst at Jefferies. I have the Intra-Cellular team with me today. Thanks for tuning in. To my direct left, Sharon Mates, Chairman, President, and CEO. To her left, Mark Neumann, CCO, and to his left, Juan Sanchez, IR, Head of IR. Welcome. Thank you. Thank you. Did you want to maybe level set what Intra-Cellular is briefly, what you're working on, what milestones we can look for over the next 6-12 months? Sure. So thanks a lot. First, it's great to be here. Before we start, though, we should tell you that we will be making forward-looking statements, and I refer you to our SEC filings and to our website for continuous updates on the company. Having said that, let me just start with a brief overview of the company. We started the company in 2002 to commercialize technologies out of Paul Greengard's laboratory, at Rockefeller, where he focused his career on showing, "Don't just look at the outside of cell surfaces, at receptors. Look downstream and look at the interactions intracellularly and between cells." And that's what the focus of the company has been, and that's why the name of the company, Intra-Cellular Therapies, because we don't just look on the cell surface, we look downstream. So fast-forward now to 2019, where we received our first approval for our first product, and the generic name is lumateperone, and the trade name is, CAPLYTA. So our first indication was for CAPLYTA, for the treatment of schizophrenia in adults in 2019. In December, we received approval, and we launched in March. You may remember March 2020 was a big time in the world with COVID, and we were launching just as the world was shutting down. So we actually pivoted at the very last minute to a completely virtual launch, and we were, in fact, very successful, even in the face of COVID, with Mark as the head of commercial and then, his team in launching. Then, in December 2021, we received our second approval for CAPLYTA, and that's for the treatment of bipolar depression. And we have seen a very robust trajectory with our scripts with the approval of bipolar depression, which makes a lot of sense because about 2.4 million adults have schizophrenia, and 4-5 times that size is the patient population for bipolar. So you see this hockey stick-like trajectory, and we've continued to see that. Last year, we had an 85% increase over 2022 in our revenues, 86% increase, sorry, and we... That resulted in about $462 million in revenues. For this year, we have guided you to $645 million-$675 million in revenues. So a very robust trajectory, and we're very pleased to be helping patients with CAPLYTA. Okay. So you probably, if I could go just tell you about... 'cause it'll be your first question, probably, is, as you know, we're looking at our next label expansion, and that's into the treatment adjunctively for MDD. And we had a first readout, and that readout was incredibly robustly positive, with very large effect sizes. In fact, we've done several different studies looking at depression, depressive episodes in different patient populations, and each one is very robustly positive. Therefore, we believe that CAPLYTA is the drug of choice or can be a drug of, the drug of choice across many mood disorders. So, do you want me to hold the pipeline for later? Sounds good. Okay, I'll hold the pipeline. Great. Sounds good. Okay. Sounds good. All right. Okay, well, we'll spend a couple minutes with the current launch in schizophrenia and bipolar depression. So, we've obviously seen a continued quarter-over-quarter growth trajectory all this time, so congratulations. TRx, NB Rx on a weekly basis, record high. So what inning do you think we are in, and why? Yeah, I can take that, Andrew. So I think we're in the early innings of our bipolar depression launch. I mean, we're two years out, but the unmet need is very significant and still remains, and as Sharon was saying, if you've seen the trajectory of our prescription growth, the slope really hasn't changed at all. It continues to be very strong, very robust. A couple of the metrics that we look at on a regular basis are the breadth of our prescriber base, how many new first-time prescribers are we adding each month, each quarter? And then the depth of their prescribing, how much is each one of those prescribers prescribing? Both of those, quarter-over-quarter, have been very robust. We continue to add 3,000-4,000 new first-time prescribers of CAPLYTA every quarter, and that's been very consistent, and the depth of prescribing continues to grow as well. In my experience with the launch, when you're two years out, and you're still moving both of those in that direction, that's a sign of a very healthy launch. We feel very good about the launch, and we think we're still in the early innings, and there's still a tremendous amount of opportunity. Mm-hmm ... for growth. Thanks. And what would it take to see an acceleration of the acceleration? Is it more DTC ad, you know, more awareness, payer access? How do you get sales to accelerate even further? Yeah, so I think as with any product in any category, it comes down to the product. It's how well you execute, and it's the promotional effort that you put behind it. We have a very, a strong, compelling product profile, from a safety and efficacy perspective, as well as dosing convenience. The team, from a commercial perspective, has been executing flawlessly throughout the launch, that will continue. Earlier this year, Andrew, I think you're aware, we've been doing DTC for quite some time. We launched a new campaign towards the end of the first quarter. And while it's too early for quantitative metrics, the qualitative feedback on that has been very strong, so we expect to see some additional growth coming out of that. We're in very good shape from a market access perspective, broad coverage with over 99% covered lives in both Medicare and Medicaid, and about 90% in the commercial channel. So we feel very good about that. So we think we're hitting on all cylinders, and we've got a lot of good promotional activity, both on the professional side with physicians and educating them, as well as direct to consumer with our DTC ads, our social media, et cetera. Great. And for Q2, scripts, I think, are tracking up maybe 8% quarter-over-quarter. It's a acceleration from Q1. So, are you comfortable where consensus is? I think that's 159, based on my- So, you're right. We have seen a re-acceleration in the second quarter of our script growth, and that's something that you see typically in this class and many classes. You usually have a good fourth quarter, where we grow at 10%, our TRXs. First quarter, you hit some headwinds with the typical seasonal issues with payers. But we still grew at about 5% when the overall market barely grew, so we were pleased with that. And now in the second quarter, we've seen a re-acceleration. I actually think it was closer to 10% now quarter to date. Mm. We're tracking very well on that as well, with a few weeks left to go here in the quarter. Okay. You reiterated that your full year guidance back in Q1, you know, Q2 is looking pretty good, and so can we expect you to at least revise it in some shape or form in the upcoming Q2 EPS? I think, I think we'll wait till we do our Q2 numbers to have anything to say. There's a lot of dynamics going on in the marketplace, so I wouldn't, I, I think- Makes sense. Till we have all our numbers, we're not saying anything. Okay. Launch is going great. Now, we have MDD phase III data coming. So in terms of the opportunity, you know, I think you've guided how ultimately bipolar depression will make up 90% of CAPLYTA scripts or sales, at peak within those two indications. You know, is it safe that with major depression, maybe. I don't know. Do you think you can get more sales in MDD than you can get from bipolar depression, ultimately? What I would say, Andrew, is it's possible. Both bipolar depression and MDD represent very significant opportunities for CAPLYTA. They're very similar in many ways in that they're both very large patient populations, much larger than the schizophrenia patient population, which is about 2.4 million U.S. adults. Bipolar disorder is about 4x-5 x the size of that, about 10 or 11 million U.S. adults. MDD is still larger still by a multiple of two, so you have about 21 million U.S. adults suffering with major depressive disorder each year. However, some of that 21 million patients, their unmet need is met with SSRIs and SNRIs. So we personally think about the MDD opportunity in about the same ballpark as bipolar depression, so they're both very large, very significant opportunities. If you look at the prescriptions in antipsychotics, there's about 68 million prescriptions each year of antipsychotics. MDD is the largest of that, at about 30%. Bipolar depression is not far behind, it's in the upper 20s. So from a prescription perspective, you see they're about the same size. Now, MDD is growing. Mm. It's the fastest growing. Bipolar is growing. MDD, with the launch of Vraylar a little over a year ago, they've done very well. For us, what that tells us, it's a very good sign that it validates what we believe is that there still remains a very significant unmet need in MDD. Right. And speaking of Vraylar, I think, the company has guided Vraylar to do $1 billion in MDD alone so far. Given CAPLYTA's profile and how it, in my opinion, does look better than Vraylar, wouldn't it be safe to assume you can do more than Vraylar in MDD? We don't guide longer term with kind of peak revenues. What I would say is, and I'm sure we'll get to it a little bit later, the results of Study 501 in MDD were very robust. We feel very good, even exceeded our own expectations of what that was gonna look like. There's a big opportunity, and our ambition is always to do as well as we can, and so we'll certainly be trying to beat that mark. Okay. In addition to the efficacy profile, the safety profile continues to be very much like placebo and very benign, and we think that is an advantage for patients. Right. And so we're gonna get that data later this month. I think the investors generally know what to expect. So let's just say it were positive. What? Walk us through what happens next. You'll talk to the FDA right after, and then file MDD? Maybe walk us through your plan. Right. So as with every program, once you get your data, you meet with the, you put it together into a package. You meet with the FDA, and we, our plans are to file this year, so in the second half of this year. Hmm. Is there any scenario that you can imagine where you would delay the sNDA filing in the second half? Not at the moment. Mm-hmm. ... I I think we've, we're really on target to be filing the second half of this year. Okay. I think, you know, mixed features, I think you wanted to talk to the FDA again after the major depression data sets have all read out or both read out. Are you trying to leverage the mixed features data set to support the sNDA package in adjunct MDD, or are you still trying to get a standalone indication for mixed features? We're still weighing all the opportunities there with mixed features, and just to remind you, in bipolar depression, it's, it is encompassed within our label for mixed features in bipolar depression, but we have no label for MDD, hence the questions of where are you going with it? And I think that's why we wait for the data, then we'll go and talk to the FDA. Okay. And, arguably, you're experts in controlling for placebo, running these types of depression studies. How do you take advantage of that expertise? Are there other indication areas you're exploring for CAPLYTA? Yeah. So I'm very pleased that Wall Street thinks we're experts at controlling placebo. I would caution everybody, okay? Okay. I made that mistake earlier in our existence, where we had a study that was really terrific. We controlled placebo, et cetera, et cetera, and then you have other studies where you're not quite as good. So I think we try our best. We put in as much as we can to ensure that we get correct patients, in other words, that they're real patients, not just someone who is in it for, you know, to be treated. And so far we've been able to do a very good job, and we're very, very pleased with that. But I would tell you, I think we in our own minds have complete confidence that lumateperone is a treatment for mood disorders and for schizophrenia as well. And I think we've shown that in... We've shown efficacy in schizophrenia patients. We've shown efficacy in patients with schizophrenia who have comorbid depression. We've shown it in bipolar depression. We've shown it in patients with mixed features, with major depressive episodes, in MDD or in bipolar disorder, and we showed it in adjunctive treatment in MDD. So we've shown it across the spectrum, and the whole question really is that, it, it's not, is this an effective treatment? It's, can you control your placebo response? And as we know, in the real world, patients aren't getting placebo. So we're very confident in the use of CAPLYTA, and in its safety profile. But as we all know- Mm-hmm ... you have to demonstrate it, so we're waiting for the next study results. Right. And, I mean, would you consider pursuing additional opportunities, indication areas for CAPLYTA, or do you stop here after MDD? No, we always consider, and we have a very robust pediatric program in both bipolar depression, as well as we have one in irritability in autism. Mm ... and, also some other studies. So we definitely are pursuing other indications as well. Right. And one thing that was recently, separate topic, relatively new, is you want to find new assets to potentially acquire. So maybe walk us through the urgency to do something here, and how much firepower do you have? So first and foremost, we focus on CAPLYTA and the expansion and indications for CAPLYTA. So both from the commercial opportunity presently and pre-commercial activities for new indications for CAPLYTA. We're very, very well-financed. We have no debt. Prior to a recent raise, we had almost $500 million on our balance sheet. Now we have $1 billion on our balance sheet. So we're very well capitalized, and so your answer to firepower is, yes, we have a lot of firepower. But I think first and foremost is CAPLYTA, and then secondly, we would like to add, and, and this is no different from anything we've said for two years now, guys, okay? I think this is normal course of business. You're always looking at improving your asset class and, or adding to your asset class. I think we, we have a very, very robust pipeline, and I think, and we're very proud of that pipeline. But as everybody knows, pipelines take time. So if we could find an asset that Mark's group could just put in their bag and go ahead with it and run with it, that would be terrific. We have not been successful at doing that lately, and so nothing, you know... we're very happy to keep going the way we are. Right. Okay, and something later stage is the preference that's synergistic to CAPLYTA? Correct. Right. Okay, and speaking of the pipeline, maybe in the last five minutes or so, just because it doesn't get as much attention, but you do have programs starting up this year. So maybe starting with the deuterated program, there's 3 indications underway for deuterated CAPLYTA in phase II starting up. Are all of those phase II studies supporting pivotal studies at the end of the day? We hope they are. So they are called phase II studies, but they are powered and designed as phase III studies. So both the patient population, the number of patients, as well as the statistical analysis are designed as phase III studies. The first of these three indications, which is for GAD or generalized anxiety disorder, will start first and will start very soon. And that will be followed by psychosis in patients with Alzheimer's disease just a couple of weeks later, and then that will be followed by agitation in patients with Alzheimer's disease. So these are all large studies because they're all powered as phase III studies. Hmm. And we're really looking forward to doing those. Great. Should the base case for The Street be expecting data for those programs maybe in 2026, or could it- could we see something in 2025? So that would be aggressive to say 2025, definitely. I think to determine the exact timing, you'll have to wait till we put it on ClinicalTrials.gov. Right. Okay. And so speaking of GAD, what can CAPLYTA potentially differentiate on relative to the existing therapies, which my understanding is SSRIs, benzos, and so forth? That's right. So only there are four SSRIs approved and one other compound approved. But and benzos are used as you've stated. So we think that deuterated lumateperone has a lot of the qualities that we've explored with lumateperone. We know that it does help in anxiety. We know that it does have... We know the mechanism of action, acting through 5-HT2A and through, very importantly, the glutamatergic pathway, and we think that that is very helpful for these patients with anxiety. Okay. And then Alzheimer's psychosis for deuterated lumateperone, what is the bar to get this drug approved here? I don't think there are any drugs approved for Alzheimer's psychosis. Is that correct? For psychosis, I think that's correct. So- For agitation, REXULTI- Mm-hmm ... just got an approval, Right ... pretty recently. And- Yes. And so within psychosis, like, what would the endpoint be? Yeah ... for you to get this approved? I'm sorry, but you're gonna have to wait till we put that on clinicaltrials.gov. Oh, okay. There has been a lot of discussion over endpoints to use for schizophrenia. I can tell you that there now is some consensus over this, and so we will be putting that on clinicaltrials.gov soon. Great. Well, we'll be patient. For Alzheimer's agitation, like you said, REXULTI just got approved. Do you think you can get better efficacy than REXULTI? Safety, I'm assuming, applies from what you've seen so far to here, but what about efficacy? I think that it's premature, but I think that, again, we think there are advantages to the deuterated compound over lumateperone, especially in the elderly population, and that's because we know we express more of the parent with the deuterated form. So we're... We've seen that in our phase I studies, which were small studies, and we're hoping to replicate that in our larger studies, where we would be hopefully replicating the same things that we saw in the phase I studies. So I think that, given our knowledge about the molecule, both from the mechanism of action and from building off of lumateperone, we think that being able to express more parent, and so you shift the ratio of your metabolites, we think that that can be very beneficial to these patients. Hmm, okay. And then, maybe last minute, is the Parkinson's disease asset, ITI-214, I think top-line data in 2025, is that correct? That's correct. How are you positioning this drug at the end of the day? Where would it be used in the treatment spectrum? So what we're looking at in the Parkinson's program, and these PDE1 inhibitors, this whole platform is really quite amazing and has many potential uses. What they all have in common, what we've been finding, is the ability to control for inflammation. So and that's across different indications. So, and we've seen that in the brain, and we now know how that's operating in the brain through the microglia, and we know that now in the periphery as well through the macrophages. So, we have molecules within the PDE1 platform for Parkinson's disease, where our primary outcome in the phase two study is improvement on time, and also we're looking at cognition. And then we also have another molecule that we're looking at right now. It's going through healthy volunteers, but will be used in a certain type of cancer patient population. So we think it's a very broad spectrum- Hmm ... and we're really looking forward to updating on that. Okay, I think that's all the time we had, but thank you so much for coming and sharing these views.