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spk13: Good morning, and welcome to Intracellular Therapy's first quarter financial results conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand has been raised. To lower your hand, press star 1-1 again. Please be advised that today's conference call is being recorded. I would now like to turn the conference over to Dr. Juan Sanchez, Vice President, Corporate Communications and Investor Relations. Please go ahead.
spk12: Good morning and thank you all for being here today. Joining me on the call today are Dr. Sharon Mates, Chairman and Chief Executive Officer, Mark Newman, Chief Commercial Officer, Dr. Suresh Dorgan, Chief Medical Officer, and Larry Heinlein, Chief Financial Officer. As a reminder, During today's call, we will be making certain forward-looking statements. These forward-looking statements are based on current information, assumptions, and expectations. Those are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statement. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to place any reliance on these for looking at payments and the company disclaims any obligation to update such payments. I will now turn the call over to Sharon.
spk02: Thanks Juan. Good morning everyone and welcome to today's call. Following a strong performance last year, 2023 is off to a great start. During the first quarter, Our team delivered strong growth for Keplida and made important progress on the clinical development front. Just a few weeks ago, we announced robust, positive, top-line results from study 403, evaluating lumotepirone in patients with major depressive disorder, or MDD, exhibiting mixed features, and in patients with bipolar depression, exhibiting mixed features. I will talk more about this in a moment. Let's start with our performance with Keplida in Q1. Demand for Keplida and prescriber adoption has been strong. Total prescriptions increased by 159% compared to first quarter of 2022 and increased 16% sequentially in Q1 2023 compared to Q4 2022. First quarter total revenues increased to $95.3 million Our strong prescription growth drove Caplida net revenues of $94.7 million, a 173% growth versus the same period in 2022. We are very pleased with our performance in Q1 and reiterate our prior guidance for full-year Caplida net sales between $430 and $455 million. We are confident in continued growth and the future potential of Caplida. We continue to receive very positive feedback from both prescribers and patients. Physicians cite Keplita's clinical profile and efficacy for a broad range of patients with bipolar depression and schizophrenia. Importantly, patients often highlight improvements in their symptoms and Keplita's favorable side effect profile. This positive feedback further reinforces our belief that Keplita is helping to change the lives of patients. On the clinical front, we continue to expand our Keplida development programs and advance our other pipeline programs. Let's start with our most recent news. In March, we announced robust positive top-line results from study 403. These strong results further validate the potential for Lumotepirone to treat a broad spectrum of mood disorders In this study, we evaluated Lumetepirone 42 milligrams as monotherapy for the treatment of major depressive episodes in patients with MDD exhibiting mixed features and in patients with bipolar depression exhibiting mixed features. Lumetepirone demonstrated a statistically significant and clinically meaningful reduction on the Madras total score compared to placebo at week six, the primary endpoint of the study. This result was demonstrated in the combined patient population of major depressive disorder with mixed features and bipolar depression with mixed features. The drug placebo LS mean difference was 5.7 points with a p-value of less than 0.0001 and the effect size was 0.64. The strong results were consistent for the individual patient populations as well. For the MVD patient population with mixed features, the effect size was 0.67. And for the bipolar depression patient population with mixed features, the effect size was 0.64. The p-value for each of these individual populations was less than 0.0001. Lumotepirone 42 milligrams also met the key secondary endpoints by demonstrating a statistically significant and clinically meaningful reduction in the clinician's global impression scale or CGI compared to placebo at week six in all populations evaluated. Consistent with prior trials, Lumetepirone was generally safe and well tolerated. Patients experiencing depressive episodes with mixed features have more severe illness with higher recurrence rates, comorbidities, and rates of suicide and suicidal ideation. In addition, patients with MDD and mixed features respond poorly to antidepressants. These study results provide important data about the efficacy, tolerability, and safety profile of Lumitecheron for these difficult to treat conditions. These results build on the data we reported in our post hoc analysis of study 404 on the subset of patients with bipolar depression exhibiting mixed features. We are pleased to announce that this analysis has just been published in April in the Journal of Clinical Psychiatry. We plan to meet with the FDA later this year to discuss our study results and determine the next steps for the program. Our Lumetepirone program extends across several major neuropsychiatric conditions, including MDD. We have an ongoing registration program evaluating Lumetepirone as adjunctive treatment for major depressive disorder in patients who partially respond to antidepressants. Subject to the results of our ongoing studies, we expect to file an SMDA in 2024. We have continued, we've also continued to invest in our Lumetepirone long-acting injectable program, having completed a phase one study evaluating one formulation and completed preclinical studies evaluating several formulations which can deliver drugs for one month or longer. The goal of this program is to develop formulations that are effective, safe, and well-tolerated with treatment durations of one month or longer. We plan on progressing these formulations this year and next year. Beyond Lumateparone, we continue to make progress with our other pipeline programs, including ITI1284, our phosphodiesterase 1 or PDE1 inhibitors, and ITI triple 3. Consistent with our Lumetepirone program, these innovative pipeline programs focus on therapeutic areas with significant unmet patient needs. Starting with ITI1284, our deuterated form of Lumetepirone. In 2023, we plan to begin phase 2 clinical studies in patients with agitation and Alzheimer's disease patients with psychosis and Alzheimer's disease, and patients with generalized anxiety disorder, all highly prevalent conditions. Our PDE1 inhibitor program patient enrollment has been initiated in our Phase II proof-of-concept study for lenbospodin, which is being developed for the treatment of motor symptoms in patients with Parkinson's disease. Changes in cognitive measures and inflammatory biomarkers will also be assessed. Extensive evidence supports the involvement of neuroinflammation in the development of Parkinson's disease. We have shown that lenrasposin acts to reduce neuroinflammation by directly modulating intracellular signaling pathways in cells in the brain called microglia. A similar pathway may be involved in controlling immune cell function, particularly macrophages in non-CNS tissues, including certain solid tumors. We have an active IND for our newest PDE1 inhibitor, ATI1020, which is being developed as a novel immunotherapy for oncology indications. Clinical conduct has begun in a single ascending dose study in normal healthy volunteers to establish a safe and tolerable range of doses for further study. The potential of the safe and well-tolerated small molecule as part of the treatment armamentarium for cancer indications is an exciting prospect and we look forward to advancing this program. Finally, we continue to develop ITI-333, our 5-HT2A receptor antagonist and new opioid receptor partial agonist for the treatment of opioid use disorder and pain. In Q1, we began clinical conduct in a multiple ascending dose study in healthy volunteers evaluating pharmacokinetic safety and tolerability of the molecule. Our neuroimaging study is ongoing. Our company is in a strong financial position, ending the quarter with $540.5M in cash, cash equivalents, and investment securities. Additionally, we have no debt. As a company, we remain deeply committed to our goal of developing effective and innovative treatments that improve the lives of patients. We continue to take steps forward to achieve this goal. We believe we have significant growth potential in CapLIDA and the rest of our pipeline, and we look forward to continuing our progress. I will now turn the call over to Mark to further discuss CapLIDA's performance and commercial opportunity. Mark?
spk10: Thanks, Sharon, and good morning, everyone. As Sharon noted, CapLIDA is off to a great start in 2023. registering sequential quarterly growth in total prescriptions of 16% versus Q4 of 2022, and year-over-year growth of 159% versus the same period last year. Capilita generated this impressive performance despite facing typical first-quarter headwinds and an overall antipsychotic market that grew total prescriptions only modestly. Additionally, weekly new patient starts of Capilita are now five to six times higher than they were prior to our label expansion in bipolar depression. This growth is being driven by continued strong underlying demand and prescriber adoption of Capilita as we saw consistently strong monthly increases in Q1 in both the breadth of our prescriber base as well as the depth of prescribing. By the end of the first quarter, Capilita's prescriber base had grown to more than 25,000 unique prescribers adding close to 4,000 new first-time prescribers in Q1, including over 1,400 in March alone, as we continue to penetrate the prescriber adoption curve. We believe the fundamentals of a healthy launch are evident, and we are highly confident that Capilita will continue to experience strong growth throughout this year and beyond. The market opportunity for Capilita is large, and we believe this is just the beginning with plenty of room for long-term growth. There are several reasons for this. First, Keflaida is approved in large patient populations, including bipolar depression, a highly prevalent mood disorder affecting more than 11 million Americans. There is a significant remaining unmet medical need in bipolar depression with frequent medication switching in the class as prescribers search for the optimal balance of efficacy and tolerability for each patient. Cathleida has a compelling product profile and is proven effective in bipolar depression and schizophrenia with a favorable safety and tolerability profile with weight, metabolic changes, EPS, and akathisia, all similar to placebo in our clinical trials. These are powerful reasons to prescribe. Our bipolar depression label, which includes the use of Cathleida as both monotherapy and as adjunctive treatment in bipolar I and bipolar II depression, puts us in a strong competitive position in this marketplace. While the prevalence of Bipolar I and Bipolar II disorders are similar, the Bipolar II patient population remains underdiagnosed. This patient population represents an important opportunity for Kaplida, as there is only one other drug approved for Bipolar II depression. As part of our marketing efforts, we are increasing awareness and the importance of treating Bipolar II disorder. Secondly, the prescriber base for antipsychotics is large with tens of thousands of prescribers. As I mentioned before, we've been consistently increasing both the breadth and the depth of this space, adding significant numbers of unique prescribers and expanding the average number of prescriptions per prescriber. The recent increase in the size of our sales organization allows us to connect more frequently with our highest volume prescribers, as well as continuing to expand our reach thereby increasing our market share and penetration. We are investing behind the brand to optimize the growth of Capilita and have a comprehensive commercial plan complementing our sales efforts with peer-to-peer medical education programs, digital promotion, and our Let in the Light direct-to-consumer national advertising campaign. Together, these efforts are raising awareness amongst prescribers and patients about the unmet need in Bipolar I and Bipolar II depression and educating physicians and potential new patients about the benefits of cathelitis. Finally, our extensive market access coverage across all three payer channels and our comprehensive LidaLink patient support offerings complement our promotional efforts. In Q1, we strengthened our market access position to now cover approximately 90% of commercially insured lives and have continued to maintain greater than 98% coverage in the Medicare Part D and Medicaid channels. Our experienced commercial team is proud of our progress to date, and we remain focused on supporting the needs of our physicians and patients and delivering sustained prescription and revenue growth throughout the year. Now, I'll hand the call over to Larry to detail our financial performance. Larry?
spk20: Thank you, Mark. I will provide highlights of our financial results. Total revenues were $95.3 million for the first quarter of 2023 compared to $35 million for the same period in 2022. Net product sales of Capilita were $94.7 million in the first quarter of 2023 compared to $34.8 million for the same period in 2022, representing a year-over-year increase of 173%. In the first quarter, Capilita net sales increased 8% over the fourth quarter of 2022, and total prescriptions grew 16% sequentially. Our gross-to-net percentage was in the low 30s, reflecting more favorable-than-anticipated payer dynamics, including lower-than-anticipated copay assistance costs due to more favorable formulary placement and lower managed care rebates. We expect our gross-to-net percentage to increase towards the mid-30s for the remainder of the year. During the quarter, there was a modest decrease in days on hand of Capilita at the wholesale level. As we expect underlying demand for capital items to remain strong, we are reiterating our prior full-year 2023 capital item net sales guidance of $430 to $455 million. Selling general and administrative SG&A expenses were $98.9 million for the first quarter of 2023, compared to $75.5 million for the same period in 2022. This increase is due to increases in marketing and advertising costs. research and development R&D expenses for the first quarter of 2023 were $38 million compared to $29 million for the same period in 2022. This increase is primarily due to higher LumaTeperone project costs and to a lesser extent non-LumaTeperone project costs. Cash, cash equivalents and investment securities total $540.5 million at March 31st, 2023 compared to $593.7 million at December 31st, 2022. For 2023, we continue to estimate full-year SG&A expenses to range between $420 and $450 million, and full-year R&D expenses to range between $195 and $220 million. This concludes our prepared remarks. Operator, please open the line for questions.
spk13: As a reminder, to ask a question, you will need to press star one one on your telephone. And due to time constraints and to give everyone a chance to ask a question, we ask that you please limit yourself to one question. One moment, please. And our first question comes from the line of Jessica Fai with JPMorgan.
spk00: Hi. Good morning. This is for Jessica. Thank you for taking our question. You talked about the GTNs in 1Q being in a low 30% range. Can you talk about how do you see it going into 2Q? Is it likely to improve sequentially? And secondly, given that the third trial in Adjunctive MDD, the study 505, is underway now, would you be able to provide us with any timelines on how to think about the data readouts? Thank you.
spk02: Thanks for your questions. I think I got both of them. I think the beginning, the first question was on gross to net, and I'll ask Larry to take that one. And then if I have it right, your second question is on starting on study 505. I might ask you to repeat that one, but first let's do the gross to net. So Larry, do you want to take the gross to net question, please?
spk20: Yeah, I do. I think you asked why is the gross to net percentage going to increase or decrease as we go forward. I didn't quite hear that.
spk02: Yeah, I think you said about the increasing. Yeah, right.
spk20: Yeah, sure. Well, as I mentioned in our prepared remarks, our gross to net was lower in the first quarter. However, we do expect the gross to net to increase in the second it towards the mid-30s from the low 30s that we experienced in the first quarter. And this is primarily due to increased volume going through the commercial channel as well as increased commercial coverage.
spk02: Okay. And could you repeat the second part of the question on 505, please?
spk00: Yeah, sure. Just thinking about the timeline for data readout from the three adjunctive NBD trials.
spk02: Okay, so for the 1st, 2 MVD trials, we've said that we expect that should they be successful, we would be filing in 2024. so obviously readout is earlier than that for 505. we've said that that that would take more time. Clinical conduct has started. And obviously, it would take longer. It would probably take another year. So we would expect that we would be concluding that study and be ready to do our filing in 2025. Thanks. Next question, operator, please.
spk07: you and our next question comes from the line of Brian Abraham with RBC capital markets oh yeah it's Leonid on for Brian thanks for taking our question congratulations on the strong quarter I wanted asked on the mixed features indication just how much more education do you think that needs there needs to be done to I guess some of the K wells up to speed on how to best treat these patients you know are you finding there any differences in the familiarity with mixed features across geographies or treatment centers. And I guess, what's the best way to position Kaplita in the mixed features population, you know, across lines of therapy or, you know, first switch? Thanks.
spk02: Yeah, thanks, Leonid. These are great questions, and I'll start, and I'll ask if Suresh wants to add anything. I think that with the publication of the DSM-5, which now is, you know, some years ago, I think there's been an increasing awareness and an increased desire to be able to treat these patients. Bipolar depression with mixed features was included in the DSM-IV, but it was a looser definition. I mean, that's not a technical term, but a looser definition than in the DSM-V. And there wasn't any specifier or clear definition. in the DSM-IV for mixed features in MVD. So again, with the DSM-V, I think that that has allowed the clearer definitions and that there has been an increase in physician awareness and wishes to be able to treat these patient populations. These are not small patient populations. about on average about a third of each of these patient populations have mixed features. They're difficult to treat patients. They have higher rates of suicide and suicidal ideation. So these are important patient populations to treat. As to whether or not there are differences in geographical regions, I am not aware of that, but maybe I'll ask Suresh if he has anything he wants to add to that.
spk06: In terms of the geographical distribution, no, I don't think there is any differences. It is seen, you know, this is, as you said, it's about a third of the patient population, a little bit on the lower side for the MDD, but a little bit higher side on the bipolar depression set space. And since 2013, since it's been officially established, a specifier within the DSM-5, prescribers have been getting more and more used to this, and we continue to educate the prescribers.
spk02: So, also, I think it's important to note that our data was extremely robust, and healthcare providers are very interested in these results. To that end, of course, we're working on a publication as well as all the other measures that we've described to you.
spk07: Got it. Thanks so much.
spk13: Thank you. And our next question comes from the line of Andrew Tsai with Jefferies.
spk19: Hi. Good morning and congrats. Another great quarter. Thanks for taking our questions. So I wanted to ask on MDD today. First one is, what is it power to show for Capilita versus Placebo and Madras, or what are you expecting the minimum delta to be for Capilita to be clinically meaningful? I'm just curious if we should be thinking any differently from the mixed features indication. And then secondly, also for MDD, would you consider waiting to top line the data until both of them, both of the first two have completed? Would you be open to top lining the data in more of a piecemeal fashion, one at a time? Thank you.
spk02: So I will start and I'll ask Suresh to fill in. So first, on what we're expecting on all of these mood disorders, we are using the Madras as our measure for our primary endpoint, the change from baseline on the Madras score. And as you know, typically that's within a two to four point range. And you look towards the mid or higher range for monotherapy studies, and you look to the lower range for an adjunctive study. And when you think about that, it makes sense because on an adjunctive treatment, these patients are already being helped, they're just not being helped optimally. So you look towards the lower end for for the change in madras in in adjunctive studies so that's the first question you asked the second one is on when these studies read out will we read them both out together or will we read them out separately and I think we will see in the timing of when they finish as you know they did not start together. They started sequentially. One started a little bit before the other one. So I think we'll see when they conclude. If they conclude separately, then we'll report them out separately if there's a long time or any period of time between the two. And if they're close together, then we'll report them out together. I think we're not prepared to give any further granularity on that yet. And I think that covers it unless I missed something. Suresh, did I miss anything?
spk19: No, I think you did. Yeah, thank you, guys. That makes perfect sense.
spk14: Thank you.
spk13: And our next question comes from the line of Charles Duncan with Cancer Fitzgerald.
spk21: Yes, good morning, Sharon and team. Let me add my congratulations on a really nice quarter. I did have a multi-part question. One part is on commercial, and I'm wondering if Mark could speak to any observations on persistence that he's seen in the BPD versus, say, the schizophrenia population, and if the guidance includes any change in pricing
spk10: assumed uh later on this year mark yeah sure yep sure hi charles uh yeah so the we continue to see a very strong compliance and persistency profile with capitalida which began with schizophrenia and has continued on through bipolar depression we think that's down to among other things the very favorable safety and tolerability profile that we have in our clinical trials and what is being replicated in the real world with physician and patient experience. So that continues to go well. And the second part of your question, yes, we have built in all of our assumptions into the guidance that we've provided for this year. And as Larry and Sharon both addressed, we've reiterated that guidance for the remainder of the year. Okay.
spk14: Thanks.
spk02: Operator, our next question.
spk13: Thank you. And our next question comes from the line of Jeff Hung with Morgan Stanley.
spk09: Thanks for taking my question. For your PDE1 inhibitor portfolio, can you talk about the differences between 214 and 1020 and how those differences lend the candidates to be better suited for different indications? Thanks.
spk02: Okay. So, the two molecules we're testing, 214 and 1020, are different molecular entities. They're both new molecular entities, but they differ from each other. We have several different scaffolds within the PDE1 inhibitors, and that affects the potency of these molecules. And they have been purposely designed to have different potencies and to, and in their ability to penetrate the blood brain barrier and some other aspects as well. But I think this is what we've said publicly to date. So we're very excited about both of these molecules. And as we go forward, I think we'll be talking more and more about them.
spk14: Thank you. Thank you.
spk13: Thank you. Our next question comes from the line of Sumant Kulkarni with Cancord Genuity.
spk03: Good morning. Thanks for taking my question. It's nice to see all the progress at the company. So on mixed features, is there any way to proactively gauge how doctors and physicians and patients might be perceiving the high-quality data sets that you have on hand already? And on that note, when you meet the FDA, I know you're going in to seek feedback from But do you proactively expect to request a potential for an SNDA submission on the back of very high quality data?
spk22: Yeah, I'm not quite sure who to address that to. Suresh, do you want to start?
spk06: Yes. Yes, the data we have seen with our 403 mixed features study is strong, both in the combined populations of bipolar depression with mixed features as well as the MDD with mixed features, and also the individual patient population with MDD with mixed features, and individual population of bipolar depression with mixed features. As we have indicated earlier, we are putting a package together to go to the FDA and discuss, and we will update you on our next steps on what the steps would be from the FDA. And we are also planning to this great data to be published and we're working on a publication right now to publish as soon as possible.
spk02: And we'll also be going to a medical meeting both later this year as well as next year. So I think we're educating the physician community with the data.
spk15: Thank you.
spk02: And we'll get a great reception to it as well.
spk13: Thank you. And our next question comes from the line of Mark Goodman with SVB Learing.
spk08: Morning. Mark, can you talk about your share of voice for CapLiner relative to VrayLar? Maybe on a percentage terms and if you feel like you've got it right and whether there's potential that you might need to take it higher or just curious how you're thinking about things relative to probably the other major competitor that's making noise out there.
spk10: Yeah, thanks, Mark. We think pretty much since the beginning, we have maintained a comparable share of voice out there across the different elements of the promotional mix. And we feel that with the quality of the profile, the clinical profile of Capilita, if we can maintain a comparable share of voice and have comparable access from a payer perspective, then that's a situation that we like a lot because we think we can win in that situation. So I think, as I mentioned in my prepared remarks, we are investing behind the brand to optimize the growth of Capilita. As you're aware, Mark, at the beginning of the year, we expanded our sales force by an additional 50 representatives that has allowed us to more frequently interact with our highest volume prescribers, but also increase our reach. Still early days with that, but we're seeing very nice progress with those representatives, and we expect that impact to build over the course of the year. We've been airing our revised and new DTC campaign, the Lead in the Life campaign, and we're liking the metrics that we're following there. So I think across the board, we feel good about the level of promotion and our ability to compete with the others in the branded category. Thanks.
spk13: Thank you. And our next question comes from the line of Jason Gerberry.
spk14: One moment, please.
spk13: And our next question comes from the line of Michael DeFior with Evercore ISI.
spk01: Hi, guys. This is Omar working for Mike. I have two here, if I may. First, as we think about sort of the bigger picture, as we think about your expansion into mixed features as well as MDD, Can you lay out for us what are the market shares? Because there may be stuff getting used off-label and mixed features right now. Can you speak to what your commercial diligence is on that, like the key players? But even more importantly on the MDD side, and perhaps if you could also give us an added layer of monotherapy versus adjunct use. And then separately, would you at any point consider possibly even exploring a monotherapy trial in MDD as well? Thank you very much.
spk02: Okay. I think you had even more than two there, Umar. But let me see if I can parcel it out and see who they go to. So I don't know, Mark, do you want to start or do you want me to start?
spk10: I mean, I can address the market share portion of the question that Umar has and then turn it over to you. I think Market share information on mixed feature Zoomers is, I think, a difficult thing to get at. What I would say is when you look at the MVD market overall, there's only a handful of products approved for MVD, as you're aware, including Rexulti, more recently, Brailar, Abilify previously. And so that you can get those market shares with those products. But the mixed features is a little more difficult to get at. So, Sharon, let me turn that back over to you then.
spk02: Well, I'll first say that, as you know, there is nothing approved in mixed features for either bipolar depression or MDD with mixed features. Having said that, I will first turn it over to Suresh to tell you a little bit more about the unmet and why we think these are large markets and to explain about why there is a need in this patient population. And then I'll come back to say a few more comments. So Suresh.
spk06: Yeah. In terms of the mixed features, you know, this is what we are studying is patients who have a major depressive episode either in bipolar disorder or in MDD. Patients who have some of the manic symptoms that don't meet the clinical threshold for full blown mania. So these patients are mixed features patients who have greater severity of illness. These patients have higher suicidal rates and also have high rates of suicide. They also have high recurrence rates and they have high comorbidities. And they are also more often they don't respond to antidepressants. And all these make these patients difficult to treat patient populations. and hence the unmet need in this particular specific population. So that's why we studied this. And with the data we have, which we have the robust data in both the MDD individual patients with mixed features and bipolar depression mixed features, we have demonstrated that lumoteprone has implications in a broad range of mood disorders across the whole mood disorder spectrum. And we are going to go to the FDA, discuss our plans for moving this forward.
spk02: So to answer your question, though, it is that we know that in MDD, we know that at least half the patients are certainly not optimally or treated such that they go into remission. So we know that there's a very broad need for new treatments in that patient population. Furthermore, we know that about a third of both the MVD patient population and the bipolar patient population have mixed features. So we know that there are robust markets for a product such as capillitis that can address the mixed feature patient populations. Oh, and then you asked a question about monotherapy treatment. And I think right now our studies are in adjunctive treatment, and we think that that's the right place to be.
spk13: Thank you. And our next question comes from the line of Jason Gerberry with Bank of America.
spk11: Hey, guys. Thanks for taking my questions. Sorry about the issue there. On mixed features, just a follow-up here. I guess I struggle to see why there wouldn't be a knock-on effect to cap lighter revenue, just given that these physicians, while technically mixed features is off-label, couldn't diagnose these patients as bipolar. And as you go to FDA, it seems like No approved mixed feature drug. You've laid out a strong case about elevated morbidity with these patients, and you don't have single trial site contribution to efficacy. So what are the counterarguments to why you shouldn't be able to get approved with a single study?
spk02: Yeah, I think it is our policy to never opine for the FDA to say that we are putting a package together. We're going to speak to them. I would tell you that right now we do have a broad label in bipolar depression, and we're very excited about the label that we have in bipolar depression right now. And so I think that stay tuned. There's a lot more to come, including a lot more data on our programs that are in the clinical studies. So we'll get back to you as soon as we have more information.
spk14: Okay.
spk13: Thank you. And our next question comes from the line of Ash Verma with UBS.
spk18: Hi. Good morning. Thanks for taking my question. So for MDD, anything you can share on the enrollment for the 501 and 502 trials? Seems like based on CD.gov, all the sites for 501 have been enrolling since last one year. But for 502, I think you still have a few sites that haven't opened enrollment.
spk02: Yeah. Thanks for your question, Ash. It has not been our practice to discuss enrollment other than it's going well. And I think there's a reason for that, because your enrollment can go well, and then it cannot go well, or it can go the other direction. And we don't want to mislead anybody. So we leave it at the fact that enrollment is ongoing. We do tell you we're not seeing any surprises. And so I think that we'll let you know more as we go forward with the program. Great. Thank you.
spk13: Thank you. One moment, please. And our next question comes from the line of Ami Fadia with Needham & Company.
spk05: Hi. Good morning. This is Eason Leon for Ami. Congrats on the quarter and thanks for taking our question. piggybacking off of a previous question, do you anticipate the mixed features data to help drive growth in BPD this year? And just curious if there are, you know, potential tailwinds, you know, this year, even without a specific mixed features label, and if this is contemplated in your capillitis sales guidance. Thank you.
spk02: Yeah, I can tell you that good news, good data is always good news, and it allows for us to continue to drive awareness of Kaplida. It is important to always present your data at medical meetings and to continue to drive the awareness of your products with the physician community. So we're doing that. I think our sales guidance is based on Kaplida for its approved indications and our position in the marketplace right now. Mark, do you want to add anything to that?
spk10: No, I think that covers it, Sharon.
spk02: Great. Thanks for the question.
spk13: Thank you. Our next question comes from the line of David Amsalim with Piper Sandler.
spk17: Thanks. So I had a commercialization question for Mark. I know you have the current Salesforce expansion, but I wanted to ask you, longer term, how you're thinking about the expansion of the sales infrastructure to support MDD? How are you thinking about the general practitioner audience that you're going to need to cover? And maybe give us a sense of what your biggest competitor here, I guess it would be Abby with Raylar, what kind of resources they have in terms of headcount for that product, just to give us a way of sizing up how we should think about your commercial organization longer term. Thank you.
spk10: Yeah, thanks, David. Good questions. And let me give you a little bit of background. So currently, Our Salesforce has a target audience size of about 43,000 physicians, mostly made up of psychiatrists and nurse practitioners that support those psychiatrists, but also a segment of primary care as well. Now, those 43,000 physicians account for about 90% to 95% of all the branded antipsychotic prescriptions written for schizophrenia and for bipolar depression. And the primary care segment that's included currently are those primary care physicians who are comfortable treating bipolar depression and are high-volume prescribers of branded antipsychotics for those patients. That doesn't mean that every primary care physician out there is comfortable treating bipolar depression. And those that aren't, they're not part of our current target list. So we have 43,000. that we feel with the size of our sales force, we have very good coverage of those 43,000. Now, as we play forward to MDD and we think about the opportunity there, the good news is that virtually all those 43,000 physicians who are treating schizophrenia and bipolar depression, they also treat a lot of MDDs. So we will have built up and be able to leverage the awareness that we've built up about Kaplida with those 43,000 physicians and assuming approval in MDD would then be able to transition to messaging about MDD as well. Now, there is another segment of primary care physicians that we believe are not comfortable treating either schizophrenia or bipolar disorder, but they do treat a lot of MDD, and they do write for branded oral antipsychotics, and it would be that segment of physicians that we would look to expand our sales force in order to get the appropriate amount of coverage on them to optimize our growth in that indication as well. So we're still a little ways away for that, and we'll continue to update you guys as we get a little bit closer to that opportunity.
spk14: Great. Thank you.
spk13: Thank you. One moment, please. And our next question comes from the line of Corrine Jenkins with Goldman Sachs.
spk16: Good morning, everyone. Maybe a bit of a follow-up to that last question. You mentioned there was something like 4,000 new prescribing physicians in the quarter. Could you provide any color on the population where you're seeing that momentum versus who you saw kind of come in as early adopters? And then on a related basis, you just said there was about 40,000 target physicians versus, I think, 25,000 you're currently seeing. seeing prescriptions from. Is that 43,000 a step up with the recent Salesforce expansion or is that your target previously?
spk10: Yeah, good questions, Corinne. I think the answer to both of those questions is found in just in general how different physicians adopt new medicines as they come to market. You have a whole range of adoption characteristics by physicians. There are certain physicians that adopt a new medicine very quickly. They're the ones who want to be the first to prescribe it when it comes on the market. That's the minority of physicians. You also have at the other end of the spectrum, physicians who take much longer to get comfortable prescribing any new medicine and they want to wait to see what the experience is before they prescribe it. That's also the minority of physicians. The majority are in the middle of the bell curve that have different timeframes for when they're comfortable adopting a medication. So for us, what we see is the kind of typical adoption of a new medicine. And what's been very encouraging to us are the numbers that you just referenced that I think now we're probably six quarters into our bipolar launch. And we see no slowdown in the rate or the pace of adding new first-time prescribers to the product. And at the same time, we're also increasing the depth of prescribing quarter over quarter, and there's been no slowdown in that either. So those two metrics are very positive signs to us that there is an awful lot of room for growth for Capilita, and we'll continue to see very robust prescription growth through the remainder of this year and into the future as well.
spk15: Thanks.
spk14: Thank you. One moment, please.
spk13: And our next question comes from the line of Greg Savinovich with Mizuho Securities.
spk04: Nailed it. Hey, good morning. Thanks so much for taking my questions. Congrats, Sharon, to you and the team for another strong quarterly performance of Kaplita. I actually have a question on 1284. I don't think I've asked a question before on this pipeline opportunity. I see that you're going to initiate a phase two program across a number of indications. And in particular, I was wondering about your thoughts around the agitation in Alzheimer's disease patient opportunity. You know, we just saw the positive outcome for Rick Salty, you know, just a few weeks ago, but I'm just wondering how you see either the TPP for Lumateprone in this patient population and maybe how you qualitatively see and perhaps quantitatively see the market opportunity for this product? Thanks.
spk02: Thanks for the question, Greg. I don't know, Suresh, do you want to start or would you like for me to start?
spk06: Yes, I can start. Yes, we are planning on starting several studies with 1284, first one being the agitation in Alzheimer's disease patients. And regarding the studies itself, as we come closer to starting the study, which we are planning to do this year, and we will let you know the designs and the details of the study once we come closer to that study.
spk02: So I can add to that, and you commented on the BREX adcom, and we were very pleased to see endorsement by the panel for the use of antipsychotics in this patient population. We do think that our product profile for 1284 would benefit patients with agitation. We are currently tweaking the protocols. I think that one always tries to learn from those that present data and we think that we are currently based on what we heard at that adcom, tweaking our protocol to reflect both what we heard by the committee and by the agency as well as making sure we're maximizing what we think can be a benefit to patients. So we'll update you as soon as possible.
spk04: Okay, thanks, Sharon.
spk13: Thank you. I would now like to hand the call back over to CEO Sharon Mates for any closing remarks.
spk02: Thank you, Operator, and thank you, everybody, for joining us today. I think we're very pleased with our strong performance that we saw in Q1. As Mark mentioned to you, we look forward to increasing the depth and the breadth of the prescribing of Keplida, as well as the moving forward of our pipeline programs. So with that, we look forward to speaking with you next quarter. And with that, operator, you can disconnect.
spk13: Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect.
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