Q4 2023 Intra-Cellular Therapies Inc Earnings Call

Participants

Juan Sabchez; VP, Corporate Communications & IR; Intra Cellula Therapies Inc

Sharon Mates; President & CEO; Intra Cellular Therapies Inc

Mark Neuman; Chief Commercial Officer; Intra Cellular Therapies Inc

Lawrence Hineline; CFO & Senior VP; Intra Cellular Therapies Inc

Suresh Durgam; Chief Medical Officer; Intra Cellular Therapies Inc

Andrew Tsai; Analyst; Jefferies

Brian Abrahams; Analyst; RBC Capital

Jessica Fye; Analyst; JP Morgan

Michael Riyadh; Analyst; Morgan Stanley

Umer Raffat; Analyst; Evercore

Marc Goodman; Analyst; Leerink Partners

Joseph Tommy; Analyst; TD Cowen

David Amsellem; Analyst; Piper Sandler

Jason Gerberry; Analyst; Bank of America

Ash Verma; Analyst; UBS

Sumant Kulkarni; Analyst; Cannacord Genuity

Ami Fadia; Analyst; Needham & Company

Charles Duncan; Analyst; Cnator Fitzgerald

Presentation

Operator

Good morning, ladies and gentlemen, and welcome to Intra-Cellular Therapies Fourth Quarter and Year End Financial Results Conference Call. At this time, all participants are in a listen only mode. (Operator Instructions) Again, as a courtesy to other analysts, please limit your questions to one. Please note that today's conference 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.

Juan Sabchez

Good morning, and thank you all for joining us on our fourth quarter and full year 2023 earnings call. Joining me on the call today are Dr. Sharon Mates, Chairman and Chief Executive Officer; Mark Newman, Chief Commercial Officer; Dr. Suresh Burton, Chief Medical Officer, and Laurie Hineline, 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. These 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 statements.
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 undue reliance on these forward-looking statements and the Company disclaims any obligations to update such statements, Sharon?

Sharon Mates

Thanks, and good morning, everyone, and welcome to today's call. We are excited to share our results for the fourth quarter and the full year 2023. This past year was defined by strong and consistent growth throughout our company. We achieved major milestones as we establish capital-light as a key treatment option for broad patient populations with bipolar depression and schizophrenia. We also advanced our pipeline programs and look forward to announcing top line results in our major depressive disorder study Study 501 and Study 502 full year 2023, total revenues were $464 million.
Capital-light and net sales in 2023 were $462 million compared to $249 million in 2022, representing an 86% increase. Similarly, total scripts grew by 85% in 2023 compared to 2022. Demand for capital-light remains strong. Our well executed commercial efforts continue to drive prescription growth from both new and existing prescribers.
We anticipate continuing strong demand for litter based on positive momentum, I am pleased to report that we expect full year 2020 for light and net product sales to be in the range of $645 to $675 million. Mark will elaborate on our commercial performance and plans for this year in a moment, and then Larry will share additional details regarding our financials. We continue to strategically invest in our pipeline, and we anticipate further advancements in several of our late mid and early stage clinical programs in 2024.
I'd like to share more specifics regarding our plans for expanding CAP lighted beyond its current indications, we have two upcoming Phase top3 line readouts for the use of lumateperone as an adjunctive treatment in major depressive disorder or MDD. Our 501 study is fully enrolled and most patients had completed treatment.
We allowed the small number of patients who are in screening when we reached our previously determined enrollment targets to continue and be randomized to the double-blind treatment phase of the study. The rationale for allowing these patients to continue to participate in the double-blind treatment is that we believe that ethically if the patient has participate in the screening process and qualify for enrollment, they should be allowed the possibility of receiving treatment as a result, we expect to report top line results from Study BO. one in April of this year rather than late, we remain on track to report top line results from Study five oh two late in the second quarter of this year.
Subject to those results, we continue to anticipate filing a supplemental new drug application with the FDA in the second half of this year. We have a high degree of confidence in our MDD program as we have previously shared multiple lines of evidence support this confidence starting with LeuTech loans mechanism of action simultaneously modulating serotonin, dopamine and glutamate systems. Importantly, we have significant clinical evidence in several patient populations, including patients with schizophrenia with co-morbid depression, patients with bipolar depression and patients with MDD exhibiting mixed features. Of note, cap light is the only antipsychotic approved for both bipolar one and bipolar two depression, both as monotherapy and as adjunctive therapy.
We remain very excited by the possibility of helping millions of patients with MDD. The significant uptake of the last two antipsychotics approved for adjunctive treatment in MDD underscores the continued unmet need and large opportunity in this market. Given the efficacy and safety profile to date, we are confident in CAP Leidos future potential in this patient population.
As we mentioned to you previously, we were expecting to have a meeting with the FDA to discuss the results of Study four oh three, particularly with respect to the MDD patient population with mixed features. I'm pleased to report that we recently had a constructive meeting, and as you know, we wait for minutes prior to making any statements regarding our interactions with the FDA. We expect to receive the minutes from this meeting later this quarter and plan to update you regarding the outcome and next steps at that time.
Beyond our MDD program, we continue to invest in our lumateperone R&D program accordingly, we have initiated our lumateperone pediatric program, which includes an open-label safety study in schizophrenia and bipolar disorder, a double-blind placebo-controlled study in bipolar depression, and two, double-blind placebo-controlled studies in irritability associated with autism spectrum disorder. Approximately 2.8% of children in the United States have offices in spectrum disorder. Irritability is a common system that pairs their daily activities with prevalence estimates ranging from about 25% to 45% of those patients.
There are only two antipsychotic approved for the treatment of irritability associated with autism spectrum disorder and two antipsychotics approved for the treatment of bipolar depression in the pediatric population. We believe lumateperone with its efficacy and favorable safety profile, if approved, can address important medical needs for these younger patients and their families, especially given the heightened concern regarding metabolic and motor issues in these patient population.
Additionally, in the first half of 2024, we will continue to advance our long-acting injectable lumateperone programs studying four different formulations.
In summary, we continue the very successful launch of capital-light and are confident in the continued robust growth throughout 2024 kept light. It is an important treatment option for patients with bipolar disorder and schizophrenia. These conditions account for about 50% of the U.S. anti-psychotic markets, nearly [68 million] scripts each year. With the potential addition of MDD, our total addressable market would expand to cover nearly 80% of the market prescriptions. In addition, we expect our development programs among younger patient populations, and I'll work with long-acting injectables to further maximize the value of our lumateperone portfolio.
Outside of lumateperone, our pipeline continues to move forward with several clinical trials underway and others commencing soon. ITI1284 is an important product candidate in our neuropsychiatry portfolio. In the first half of 2024, we plan to initiate patient enrollment in Phase two clinical trial. Starting with our generalized anxiety disorder program.
Our first study will evaluate 1284 as adjunctive treatment to SSRIs and SNRIs. Also in the first half of 2024, we'll begin clinical conduct to evaluate 88 to 84 for the treatment of psychosis in Alzheimer's disease and agitation in Alzheimer's disease in our phosphodiesterase one inhibitor program. Lendlease potent Phase two clinical trial in Parkinson's disease is ongoing, and we expect to complete enrollment in late 2024 with top line results expected in the first half of 2025.
With respect to our ITI. 1020 oncology program, our Phase one single-ascending dose study in healthy volunteers is progression. Our earlier stage development programs include ITI. triple three for opioid use disorder and pain for which a multiple ascending dose study and a positron emission tomography study are both ongoing also in development is our nonvoice and Agennix psychedelic program. This past December at the American College of neuro psychopharmacology, we presented preclinical data from our lead compound ITI1549.
We are very encouraged by the positive reception our presentation received from the scientific and medical community, and we look forward to advancing ITI1549 into human testing in late 2024 or early 2025. In 2023, we presented new capital-light data regarding our development programs at several medical and scientific meetings. We also published results in various medical journals, demonstrating our progress throughout the course of the year.
Looking ahead to 2024, we are starting off operationally and financially strong. As of December 31st, 2023, we had approximately $500 million in cash, cash equivalents and investment securities, and we have no debt. I'm incredibly proud of our team and our accomplishments, and I'm excited to embark on our next phase of growth in 2024.
I will now turn the call over to Mark to further discuss our latest performance and our plans for 2024 more by share.

Mark Neuman

Good morning, everyone. It's great to be with you today. 2023 was a year of tremendous progress in establishing capital-light as a leading treatment option for patients with bipolar depression and schizophrenia, setting the stage for continued robust growth in 2024 and beyond. We continue to work our way up the physician adoption curve adding more than 15,000 new first-time prescribers of CAP later during the year and growing the breadth of our cumulative physician prescriber base since launch to over 36,000 by the end of the year.
We also saw consistent quarter-over-quarter increases in the depth of prescribing as existing prescribers identified more and more patients who are appropriate for capitalized treatments. This progress was driven by our comprehensive promotional activities, including the expansion of our sales force executed in Q2 of 2023, extensive peer-to-peer medical education programming and robust digital advertising, complementing our professional promotion was a comprehensive consumer and patient campaign featuring broad national advertising through television and social media to enhance awareness among the 11 million adults with bipolar disorder and to communicate the potential benefits of capital-light for these patients.
For the year, cumulative posted strong growth, increasing total prescriptions by 85% in 2023 versus 2022 and finishing the year with significant momentum, accelerating growth in total prescriptions to 10% sequentially in Q4 versus Q3, we are well positioned to drive continued robust growth throughout 2024. Castlight has a very compelling product profile that features strong efficacy and a favorable safety and tolerability profile in our clinical studies capitalizes metabolic parameters, which include changes in weight, cholesterol and glucose are all similar to placebo.
Equally important movement disorders like EPS. and akathisia are also similar to placebo. Capital-light as favorable profile is very important as these side effects can often lead to poor patient compliance and drug discontinuation. Another real benefit we hear from physicians is that they can start their patients at the effective dose without having to titrate instead of waiting days or weeks to complete that process. Physicians also appreciate the convenience of calculators one fairly in 2024.
We will continue to invest in optimizing the growth of capital-light with several enhancements to our comprehensive promotional plan. As I mentioned previously, we added approximately 50 additional sales representatives late in Q1 of 2023, and those representatives are now firmly established and contributing significantly to our growth. We've also had consistently favorable results from our comprehensive direct-to-consumer platform, and we will continue these efforts throughout 2024 with a new creative campaign being introduced in Q2.
Finally, we continue to enjoy a strong market access position with over 99% of Medicare and Medicaid lives covered about 90% covered commercial lives. As I mentioned in our last call, from the end of Q3 2023 and the beginning of the fourth quarter, we negotiated an improvement in the utilization criteria for capital lighter with two of the largest Medicare Part D payers. We were able to move capital data from a prior authorization and two generic steps to unrestricted status with these plans we've already seen some initial benefits from this in the fourth quarter, and we expect to see the full impact of these changes this year.
In summary, we made tremendous progress with Castlight in 2023. And we are confident that Castlight is favorable product profile and our incremental promotional investment behind the brand will result in a robust year of capital-light growth in 2024. And I'll now turn the call to Larry to discuss our financial performance. Larry?

Lawrence Hineline

Thank you, Mark. I will provide highlights of our financial results for the fourth quarter and year ending December 31st, 2023, and our outlook for 2024. In the fourth quarter, net product sales of Caballito were $131.5 million compared to $87.4 million for the same period in 2022, representing a year-over-year increase of 50.4%. Our increase in net product sales was primarily driven by strong underlying prescription growth, a 55% increase versus the same quarter in 2022 and a 10% sequential increase over the third quarter of 2023.
This increase was partially offset by a higher gross to net percentage in the fourth quarter. That was at the high end of the low 30s. Still in line with our prior guidance for 2024, we expect cap light as gross to net percentage to be in the mid 30s throughout the year. Q4 inventory levels in the trade measured by days on hand of capital-light at the wholesale level remain consistent relative to the prior quarter. For the full year 2023, total revenues were $464.4 million compared to $250.3 million in 2022.
Net product sales of calculator were $462.2 million for the full year 2023, in line with our guidance. This represents an increase of 85.5% compared to 2022. Sg&a expenses were $409.9 million for the year ended December 31st, 2023, compared to $358.8 million for the year ended December 31st, 2022. R&d expenses were up $180.1 million for the year ended December 31st, 2023, compared to $134.7 million for the year ended December 31st, 2022.
Turning to our outlook for 2024. As Sharon mentioned, we expect calculated net product sales to be between $645 and $675 million, reflecting continued strong demand for 2024. We estimate SG&A expenses to range between $450 and $480 million, which includes approximately $38.6 million of non-cash share-based compensation expense. This reflects our commitment to continuing to effectively and efficiently support capital-light commercialization through investments in our sales organization and marketing activities.
For 2024, we estimate R&D expenses to range between $215 and $240 million, which includes approximately $22.5 million of noncash share-based compensation expense. Our R&D guidance reflects investments to support our broad pipeline in 2024. We anticipate that a large portion of our total R&D expenditures will be related to our lumateperone development programs as we continue to explore the use of lumateperone in additional patient populations.
Our financial position remains strong. Cash cash equivalents, investment securities and restricted cash totaled $499.7 million at December 31st, 2023. This concludes our prepared remarks. Operator, please open the line for questions.

Question and Answer Session

Operator

Thank you. (Operator Instructions)
Andrew Tsai, Jefferies.

Andrew Tsai

Thanks. Good morning. Congrats on the strong execution and the continued progress. So on for me, I wanted to ask on MDD today, what is your guys' latest thinking in terms of what we can expect to see in the top line release in April? And then on understanding as a two point placebo adjusted change should be a good efficacy result. But is there anything else you would encourage the street to also look for as we think about capital as potential differentiation in adjunctive MDD such as response rates and remission rates, safety profile, anything else? Thank you

Sharon Mates

Thanks so much for the question, Andrew and kind words, this is Darren, and I'll start off and then I'll ask Suresh has anything he wants to add. And so typically in our top line data, what we do put out is all of the information that we have at that point. And as you know, these are large studies that we do. And so we don't get all of the top line data all of the data at one moment in time and since we know how anxious both we and the Street are, we put the data out when we get it. So we certainly expect the primary endpoint, which is change from baseline on matters. And we'll also put out any other data that we have at that point.
And you're right, that typically in these studies, you expect to see a two to four point change on the moderates. But on an adjunctive study, you expect to be at the lower end, whereas the monotherapy studies you expect to be at the higher end. So that's what we're expecting. We power our studies to approximately 90% on. And so and we obviously, as I said in our prepared remarks, we have confidence and both in our program in the studies and on our lumateperone performance in these studies.
So with that, I don't know, Suresh, do you have anything you want to add a lot of the Sun you have prepared or tenants. Thank you.

Operator

Brian Abrahams, RBC Capital Markets.

Brian Abrahams

I'm Hey, congrats as well from my end on all the continued progress. Just maybe continuing on MDD. Can you talk maybe give us a little bit more of a sense of the degree of, I guess of over enrollment you may have in the study how that might impact powering. And then I guess, how you're thinking about as these results have come out of it during the second quarter where the most differentiation potential that could be here in terms of positioning relative to some of the other adjunctive atypicals in this space? Thanks.

Sharon Mates

So Mr. Sharon, again, and I'll start with regards to ARM. Yes, as we've said, no patients come into screening and we did believe that some patients who are in screening who passed through successfully through the screening process should be allowed to enter on. Typically you plan your studies so that on you will have at least the number of patients when whenever you put a protocol in place, you say approximately like we had approximately 470 patients a week. We screen appropriately for that and we had patients come through. So it's a small number of patients.
It's typically under 5% that you over involved. And that is what fits the bill here that we allowed to come in that you older screen and if a passion allowed to go in. So that is what we have. But of course, you do need to wait for them to complete just a couple of weeks later that they are bum coming through finishing up the study. And that's why the study will read out in April rather than in March.
So I think I don't know, Suresh did you want to add anything to that?

Suresh Durgam

Yes. I think the third asking about the powering for this, I'm not going to be any powering applications because the number is still small. So I wouldn't I would not expect any accounting implications.

Sharon Mates

Right. And on differentiation, you also asked about that, and I think that I think cat litter has demonstrated its efficacy and favorable safety and tolerability profile. And with that, we think that there is a real need in the marketplace for additional agents and that kept light I can perform well in this marketplace.

Brian Abrahams

Thank Sharon.

Operator

Jessica Fye, JP Morgan. Please proceed.

Jessica Fye

Hey, guys. This is Nelson on for Jess. Congratulations on the strong guidance for Keppel Data in 2024. Can you walk us through some of the assumptions that underlie the guidance? And what does it mean in terms of patient penetration? And then how do we think about the gross-to-net dynamics in 2024?

Sharon Mates

So maybe I'll ask on Mark, if you want to talk to the first part. And then Larry, if you want to talk to the gross to net.

Mark Neuman

Yes, sure, Sharon. So the guidance that we put out, the main driver of that guidance is the underlying strong demand trend that we see in the business and the continued demand for cap light up. So any variation around that trend is really where you get the range in the guidance. We expect to continue to penetrate both the schizophrenia and bipolar depression market, where we focus both on increasing the breadth of prescribing our prescriber base.
As I mentioned in my prepared prepared remarks, and last year, we added over 15,000 new first-time prescribers of CAP lineup. We expect to see that continue in 2024 as well as at the same time across the entire prescriber base of what is now over 36,000. We expect to continue to see increased depth of writing as these existing prescribers get more experience and they find more and more patients that are appropriate for cap light up on. So those are the main factors that go into the guidance range that we provide. And I think you also had a question on how to think about gross to nets for 2024. So for that, I'll turn it over to Larry.

Lawrence Hineline

Yes. Thanks, Mark? Yes, the gross to net in 2024 is going to be and we project to be in the mid 30s, and that's compared to the low 30s that we saw in 2023. Now there are several primary drivers for this increase where we have increases in volume going through the commercial channel as a result of the strong uptake in the bipolar program, plus there also been recent improvements in Medicare Part D coverage. So those two are the main drivers for that. The increase from the low 30s to the mid 30s.

Sharon Mates

Am I right this answer the question?

Jessica Fye

Yes. Operator, why don't you go ahead with that Next call, please.

Operator

Jeff Hung, Morgan Stanley.

Michael Riyadh

Hi, this is Michael Riyadh on for Jeff Hung. Thank you for taking our question on for adjunctive MDD. To what extent is the background ADT influence the placebo effect? And how should we be thinking about placebo response variability between Study 501, 502, 505 are the three studies balanced in terms of the background regimen. Thanks so much.

Sharon Mates

Suresh, would you like to add to that?

Suresh Durgam

Yes. So yes, so in this program for MDD with adjunctive treatment for MDD, we have allowed SSRIs, SNRIs and other antipsychotics, 100% to be the background and the holidays that are approved are allowed into this. So the background in terms of you're talking about the placebo response again in all CNS trials and MDD trials, in particular, placebo response. We tried to mitigate it by taking several measures. So this is no different than this study. Also that we are taking measures and allowing for proper delegates of patients, making sure that they have a CVOT that are coming in.
And so we have taken those measures in terms of the placebo response in terms of individual mitigations, we group them based on SSRIs and SNRIs. Individual medications will not be taken into account and just be taking into account from a class platforms and all of the the whole program has been done the same way.

Operator

Umer Raffat, Evercore.

Umer Raffat

I guess this is mighty fee-oriented for all right. Thanks a lot for taking my question and congrats on all the progress in 2023, two from me. One is a variation of the question just asked on study fiber. One for the advent of MDD trials seem to have a little bit more diverse set of ex U.S. countries participating comparative study five oh two. And my question is, could there be any local regional differences in the way medicine is practiced that makes you more or less confident that some of the study fiber to it would be successful given that both trials are designed exactly the same and have a follow-up.

Sharon Mates

Yes. So this is Sharon on. Thanks for the question, Mike. And I'll start and I'll ask Suresh if he wants to fill in. We plan all of our studies the same way that our late-stage global studies. And that is and you look at the different countries and we plan for the U.S. to have a proportion of patients and for ex U.S. have a proportion of patients. And that proportion of patients is typically around 30% US and then ex U.S. arm, it does. And and this is no different.
So fiber one and five oh two are the same as that I don't know. I didn't quite get your part of the question where you seem to think there's a difference because there isn't any difference on some of the countries are different, it's ex U.S. and U.S. patient populations as per and what is common practice and what in discussions with the FDA, what they like.

Umer Raffat

Perfect kind of. That's helpful on I'm sorry, do you have anything more to add?

Sharon Mates

I don't know, Suresh, did you have anything to add?

Suresh Durgam

in terms of again, that's still, you know, we have got 30% coming from U.S. and ex U.S. And the question about different countries, but these are all standard practice guidelines. So that's pretty much absorbed throughout the world. So in terms of the practice guide guidances and other factors, we look into that and we select countries that have similar objectives for patents where I kind of touched on before,

Sharon Mates

I couldn't I couldn't hear what Suresh said it, but just to make clear, we aim for around 30%, give or take a percent or two on either side.

Michael Riyadh

Got it. That's helpful. And my follow-up question is and forgive me if I missed this. Have you met with the FDA to discuss the mixed features data in context of the broader adjunctive MDD indication as? And if so, would you be able to offer any commentary or color there? Thank you.

Sharon Mates

Yes, thanks, Mike. Yes, in our prepared remarks, I did say that we did recently have a meeting and with the FDA and that it was a constructive meeting. And that, as is our practice, we always wait for the FDA minutes before we say anything And so once we have the minutes, we will further update you on our funding program. And on I'm of the meeting

Operator

Marc Goodman, Leerink Partners.

Marc Goodman

Assessment is my question is really on local mark. Congrats on the quarter. So could you maybe talk about a couple of modest growth trajectory moving into first quarter 24? How should we think about a sequential growth versus fourth quarter given the seasonality and maybe additional color on the DTC campaign, your plan in 2024? Thanks.

Mark Neuman

Thanks, Mark, you want to take that, please? Yes, sure. Thanks for the question, um, so we had very strong fourth quarter, accelerating our total prescription growth at the 10%. So we come into the year in 2024 with some significant momentum in that regard. Typically, as you allude to in the first quarter, you see some typical headwinds associated with some patients switching on have market access plans.
When you have a product like ours with an increasing portion of the business coming through the commercial channel. You also have increased co-pay assistance required as patient deductibles reset for the year. And then typically that decreases over the course of the year.
So we feel very good about the momentum we have, the underlying business, the demand in the business, the reception that physicians have had to the product and the feedback that they provide to us on their experience and the patients' experience. But yes, typically in the first quarter, you do see some some headwinds. And then in the second quarter, you see a reacceleration in growth. So that's in general how I would how I think about the upcoming QUARTERS.

Operator

Joseph Tommy, TD Cowen.

Joseph Tommy

Good morning. Thank you for taking my question and congrats on the quarter. And maybe just if you could talk a little bit on the expected size of the sales force expansion that will be necessary if the MDD. indication is allowed to move forward under the label. I know we've heard some success in MDD in the primary care setting. So would you look to expand a little bit more there and is any of your expense guidance for 2020 for earmarked for an expansion for MD. deal, would that be more of a 2025 move?

Sharon Mates

Thank you, Mark. Would you like to take that?

Mark Neuman

Yes, sure. Thank. Thanks, Joseph, for the question. Yes. So to answer the second part of the question first, our SG&A guidance for the year for 2024 does not contemplate any material expansion in our in our sales force. We continually evaluate our marketing activities and our sales force sizing, and we take advantage of any opportunities that we see to fuel additional growth. But in terms of any major expansion, we don't contemplate that in 2024 once we have the data and we understand that we're on the track for a filing and approval, and we do expect to increase the size of our sales force to ensure that we're optimizing on capital-light, the growth opportunity we would see in MDD, which is a very significant market. And to give you a little bit of background for bipolar depression and schizophrenia.
We currently target about 43,000 physicians that are primarily psychiatrists and the nurse practitioners that support them and a smaller segment of primary care physicians who do treat a lot of bipolar depression and our high-volume prescribers of antipsychotics. They are included in our current 43,000 physician target list as we contemplate an approval in MDD.
That target list will increase significantly and it will increase mostly in the area of primary care because there are many more primary care physicians who are comfortable treating MDD with adjunctive antipsychotics who aren't very high-volume prescribers for bipolar depression and certainly not for schizophrenia, and it would be for that group of physicians that we would look to expand our sales force.
Now the 43,000 physicians that we currently call on, we'll be able to leverage them because virtually all of the 43,000 who are high-volume prescribers for bipolar depression will also be high-volume prescribers for MDT. and they'll have about four or five years of experience with the brand. And so we think we'll be able to have a really good jumping off point with that group of physicians and the extent to which we expand our sales force will be determined by how far and how quickly we want to go into primary care.
And those are the things that we have been working on. And as we get a little bit closer to the talking about our launch plans, we'll come back to you with more specifics about that. So hopefully that background is helpful for you, and I'll leave it at that for now.

Joseph Tommy

Great. Thank you.

Operator

David Amsellem, Piper Sandler.

David Amsellem

I think so just two quick ones. One is with the MDD label expansion, can you talk to and payer access and particularly how we should think about rebating with commercial plans and the gross-to-net over time with MDD in the mix. So that's number one.
And number two regarding deuterated lumateperone, I wanted to get your early thoughts on how you're thinking about the value proposition here in terms of differentiation from the legacy product, particularly on tolerability and safety, given that the current form of lumateperone was extensively pretty well tolerated and seen widely seen as pretty safe within the category. So just wanted to get your thoughts on that. Thank you.

Sharon Mates

Great. Hi, David. Thank you for the question and maybe I'll ask Mark to start out and then I'll take the 1284 and they need to ask you to repeat it. If I can't remember by them, but let's start with Mark.

Mark Neuman

Yes, sure. Thanks for the question, David. Yes, for the potential label expansion into MDD, we would expect a pretty seamless process as to the addition of MDD to the label when it comes to payer access in general with the antipsychotic category, the payers manage these products at the brand level, not at the indication level, meaning that whatever your coverage is for the existing indication, that coverage gets carried over to the new indication as well.
And that's what we experienced when we moved from schizophrenia to the label expansion for bipolar depression. And we've seen similar dynamics with competitive products who have added MDD to an already existing schizophrenia and bipolar depression on label. So we would expect that to be a fairly similar process. And it's another reason why we expect it to be able to get off to a quick start and with that potential approval in MDD.
So with that, maybe I'll turn it back over to Sharon for the second question that you had around 12 four.

Sharon Mates

Great. Thanks. Let's adjust for for those listening who may not be familiar with 1284. Let me just remind everyone that 1284 is a deuterated form of lumateperone where the carbon deuterium bonds are strategically replaced with carbon hydrogen bonds so it is a new molecular entity and it's formulated as an ODTSL. to be delivered once-a-day sublingually. And we have done a Phase one program that found that 1284 ODTSL. was very rapidly absorbed into the systemic circulation was metabolically stable and resulted in high systemic exposure.
Just on that activity, I'm sorry, yes. So we have your you are right to point out that lumateperone has a very good safety and tolerability profile. What we have seen with 1284 is that we we have seen some things in a PK profile that we think may be even more advantageous, especially as we studied it in a small population of the elderly and other populations based on PK characteristics that we think make it amenable. And that is so in the elderly populations with Alzheimer's disease and the general population with GAD. So we think and that's why we're doing these studies. So we do believe that there are some and you give advantages to 1284 over lumateperone, and we are doing the studies to confirm, and we'll keep you apprised of these studies and other results as we move forward. So thanks a lot for your question.

David Amsellem

Thanks Sharon.

Operator

Jason Gerberry, Bank of America.

Jason Gerberry

Very good morning. Thanks for taking my questions. First to share data, I wanted to clarify, so is the thinking that you only need one of these three MDD trials on coupled with your mix feature positive trial to satisfy the FDA's requirement for the and BD. filing?
I just wanted to get your sense of the confidence around that. And then for Mark, just your current kind of understanding of what's going on in the adjunctive landscape for MDD for these atypical antipsychotics is and the very large launch kind of lifting all boats, so to speak with the different atypicals or is this a market share grab game? I'm just wondering how much of a switch dynamic he's involved here with some of the Asian things?

Sharon Mates

Craig, maybe I'll ask Mark to start and then I'll come in.

Mark Neuman

Yes, sure, Jason. The dynamics that we're seeing in the MDD. space for adjunctive antipsychotics is very encouraging to us in terms of the potential opportunity for capital light in the future. And by that I mean, Brailer has had a very successful launch in MD. We significantly growing that market, which is not a surprise to us, but rather is confirmation of what we believe to be a very significant unmet medical need in MDD for an adjunctive antipsychotic with a good efficacy and safety profile.
So we don't believe it's a share grab on Rexulti. His business does not seem to have been impacted significantly by the launch in Bangalore. So we think we're seeing a lot of market growth there. And with successful studies and a successful filing and approval when we get to the market, we see that as a very, very robust opportunity for Castlight

Sharon Mates

And to continue on that. And to answer your first question, our MDD. platform is composed of two studies and for the treatment of a for adjunctive treatment in MDD. Having said that, we'll see the readouts on these studies and hopefully they're both positives to it. One is positive and one and Mrs. And it depends on why it missed and how it missed and the FDA looks at the totality of your evidence, and that's where you asked about the mixed features and mixed features is not part of the adjunctive MDD program.
However, what happens is the FDA does take into account the totality of your evidence. And so and an example of that is Rexulti where they had two studies, one one hit, one missed the FDA looks at the totality of your evidence and they then Alpine. And so I think that's where all of our data, any data you have in that we have an MDD. will be on looked at in our submission. So I think the very, very strong positive data that we had in RA future studies can only help, and I'll leave it at that if I've got it.

Jason Gerberry

Okay. Thank you.

Operator

Ash Verma, UBS.

Ash Verma

Thanks for taking my questions. Maybe just on a couple on pipeline, though for the L.A. I think the press release mentioned that there was some of that data that you had generated. Just wondering what did that show and what are the what are these four different formulations that you're going after in this new study that you're starting and then for a lender Sporlan, so Parkinson can be of a big market with different segmentation. Are you trying to position this as a monotherapy or adjunctive or is it going after the early or the late stage disease? Thanks.

Sharon Mates

Okay. Maybe Suresh do you want to start on? Our people are actually I can start with the LAIs and then turn it over to you for the lenders potent. Okay. I'm sorry, guys, I appear to be losing my voice you. So we did a Phase one study and what study showed was fact and what we what we're looking for is a formulation that is good for both the one month and longer duration on the first study. And so first of all, we can administer it. This was a subcu formulation, but it would not be an ideal formulation to go forward with and certainly for greater than nine months.
So we went back to the drawing board and based on what we heard about a subcu formulation versus and other types of formulations like I am also based on <unk> site of injection. And so the four formulations that we have prepared on look at both given the subcu versus Iams and site of administration and looking at the ability to deliver on the molecule over both one month and longer duration. So that's the answer to your first question and maybe Suresh, do you want to talk about our Parkinson's study and the patient population?

Suresh Durgam

Yes. So the Parkinson's study them an index for them and then this quarter and that study is a study in Parkinson's disease. We are looking at populations where the primary objective is to look at efficacy of windows for them as administered once daily as an adjunct to treatment, our two existing levodopa therapy. So the patients must be on stable doses of existing levodopa therapy. And our primary endpoint there is looking at the Hauser diary that is increase in on-time without troublesome dyskinesia.
We also are looking at the motor aspects, MDS-UPDRS opto of activities of daily living industrially. We are also measuring other multiple things. One, looking at measurements and cognition, but also looking at several biomarkers of inflammation. This is important for both Parkinson's and also looking at programs outside of the CNS. And once we look at the data were based on the moment measurements, cognition and inflammation are necessary as we look into defining what path forward will be further strengthened.

Ash Verma

Okay. Thank you.

Operator

Sumant Kulkarni, Canaccord Genuity

Sumant Kulkarni

Great to see all the progress, and thanks for taking my question. I'm going to ask a bigger picture one on your MDD program, you're clearly putting a lot of resources behind it up. So for the benefit of investors, what would be the latest and most accurate characterization from within the Company on whether you view the addition of the MDD indication as a nice to have for lumateperone given the size of the market and unmet need? Or is it more a strategic imperative for the Company on Hikma?

Sharon Mates

That's an interesting question. And maybe I don't know, Mark, would you like to start from a commercial perspective and then we can chime in.

Mark Neuman

Yes, sure. That is a very interesting. Interestingly phrased question, Tim, on and I would I guess what I would say is and we believe with our current business in schizophrenia and bipolar depression. We are still in the early innings of tapping into the opportunity for capital light, and we see tremendous opportunities for continued growth in bipolar depression as we continue to penetrate that market. Certainly, MDD. is equally a large opportunity and with significant opportunities for growth, as I just mentioned in answering one of the previous questions, and we would certainly be excited to add that to our label and have the opportunity to bring capital either to physicians and patients in the area of MTD. as well.

Sharon Mates

I have nothing to add. I think a well stated well stated position of the Company.

Sumant Kulkarni

Thanks.

Operator

Ami Fadia, Needham & Company.

Ami Fadia

Good morning. Thanks for taking my question and congrats on all the progress. And my question is more of a clarification question on your comments on the MDD regulatory plan. Would you say that if one study hits and the other misses you would still go in for a regulatory submission without waiting for the code one to read out? And then also just going back and thinking about mixed features, what's your latest thinking about the regulatory path forward? And could you just use some of the data from the MDD studies that are going to be reading out to pursue a specific label in mixed features? Thank you.

Sharon Mates

Yes, hi, Ami. Thanks for the question. And I think it's a little too early to comment on how we're going to proceed until we know what the data is. So okay. I will tell you that obviously, on two positive studies, we proceed as planned one positive study and one negative study. Again, it really really depends on it really depends on what happened and why you missed whether or not we would we always submit all of our data to the FDA as soon as we can.
So I think it's a little bit too soon to answer on your questions on what happens just because it depends on what the data says, and I think we can leave it at that.

Ami Fadia

And there may have been Was there another question in there or we could of my question was also regarding mixed features and what your latest thinking there is.

Sharon Mates

Well, as we said in our prepared remarks that we did have a very constructive meeting with the FDA. And as always, we wait for our minutes. And once we have our minutes, we'll we'll come back.
Yes. And operator, I think may be other question.

Operator

Charles Duncan, Cantor Fitzgerald.

Charles Duncan

A good morning, Sharon and team. Congrats on a good year and thanks for taking our questions. And I'm hopping between calls. So sorry if this has already been addressed, but I wondered what your perspectives were with regard to the possibility of muscarinic agonists being approved for monotherapy in schizophrenia later on this year. And I guess I'm wondering if you could provide us a little bit of color on your preparation in terms of differentiation of cap lighter relative to those candidates and how you're, you know, addressing the prescriber base at this point?

Sharon Mates

Mark, do you want to take that?

Mark Neuman

Yes, sure, Charles. So we have a great deal of confidence in the product that we have in Caballito. We feel across both schizophrenia and bipolar depression. We see very strong efficacy a very favorable safety and tolerability profile and the dosing regimen that physicians and patients we really like and our focus is on educating physicians and patients to make sure that they're aware of capital item, they understand the potential benefits of capital-light for their patients.
And so that's where we put our energy on new new products potentially being added to the mix for physicians is always a good thing for patients, as you know, in this category. And there's a tremendous amount of churn, what we call churn, meaning patients on trial one therapy often prior to capital-light, I would experience side effects either on the movement disorder side or on the metabolic side. And so they cycle through multiple different products.
So for them to have another option to choose from is always a good thing for for patients, I would say for us and more and more of our business, as we've talked about in the past is coming from bipolar depression and in the future with the successful MDD study, as we just talked about, would be coming from that area as well. So we don't see a significant impact on the cap line of business of any new entrants coming into the into the market. So I hope that I hope that addresses your question, Charles.

Sharon Mates

Right. And I'll yes, I'll just add to that went on and we've agreed upon and we have the company and any new product that can help patients. And it's great for patients and as Mark said, especially in schizophrenia, these patients cycle through these product, but as part of the disease state plan. So we but we think it can be a benefit to patients and that's terrific. Now having said that, there are 2.4 million patients with on schizophrenia. There's four to five times that patients live in bipolar depression, and there are even more patients with MDD and on our business is growing in the bipolar space, and we expect that to continue.
So as Mark said in the summary statements, we really do not expect this to really impact on our business at all.

Charles Duncan

That makes sense, Sharon and Mark, and it doesn't appear that those agents impact depression at all. So clear differentiation. One quick point of clarification, though, given what's going on with regard to acquisitions, could I think I know the answer to this question, but the small royalty that you pay to Bristol-Myers that is paid to gas company without any input on their part. You just send them a check. They have no role in in marketing calculate at this point.

Sharon Mates

They have no role in marketing compliance.

Charles Duncan

Okay. Thanks.

Operator

Thank you. And with that, ladies and gentlemen, we conclude the Q&A answer period. I will turn to Dr. Sharon Mates for final comments.

Sharon Mates

Thank you, everyone for joining us, Charles, I know that we're a little bit over in time, so I'll make it very brief, and I think we are very proud of our performance during 2023. And we're really looking forward to 2024 and look forward to updating everybody as we go forward. So thanks again for joining the call. And with that, operator, and you can disconnect.

Operator

Thank you, everybody, for joining our call today. You may now disconnect.