Intra-Cellular Therapies (NASDAQ: NASDAQ:ITCI) has announced a significant increase in revenues for the first quarter of 2024, driven by the strong performance of its flagship product, CAPLYTA. The company reported total revenues of $144.9 million, a 53% surge compared to the same period in 2023. CAPLYTA, indicated for bipolar depression and schizophrenia, accounted for nearly all the reported revenue, with net sales of $144.8 million.
Intra-Cellular also provided positive updates on its clinical development pipeline, including promising results from a study on Lumateperone as an adjunctive treatment for major depressive disorder (MDD). The company's financial health remains robust, with a substantial cash reserve and recent successful capital-raising efforts.
Key Takeaways
- CAPLYTA net sales reached $144.8 million in Q1 2024, marking a 53% year-over-year increase.
- Full-year guidance for CAPLYTA net sales remains between $645 million and $675 million.
- Positive top-line results from Study 501 on Lumateperone for MDD; plans to file with the FDA in the second half of 2024.
- Ongoing clinical programs include studies for various disorders, including Alzheimer's disease and Parkinson's disease.
- Strong cash position with $477.4 million in cash, cash equivalents, and investment securities after a public offering that raised $575 million.
- The company is expanding its sales force and exploring new product additions to its portfolio.
Company Outlook
- Intra-Cellular Therapies is optimistic about the continued growth of CAPLYTA sales.
- The company is preparing to submit a supplemental new drug application for Lumateperone as an adjunctive treatment for MDD.
- Studies for autism spectrum disorder and additional indications for drug 1284 are underway, with a focus on broad labeling.
Bearish Highlights
- The regulatory pathway for Alzheimer's agitation treatment is still being clarified, indicating potential challenges ahead.
Bullish Highlights
- CAPLYTA has shown strong efficacy, safety, and convenient dosing, with growing adoption among prescribers.
- The company is actively engaging in educational and marketing initiatives to further boost CAPLYTA's market presence.
- Unrestricted status on two major Medicare Part D plans enhances CAPLYTA's market access.
Misses
- There were no specific misses reported during the earnings call.
Q&A Highlights
- Intra-Cellular is in discussions with the FDA about study designs for Alzheimer's agitation treatment.
- The company has a growing base of unique prescribers for CAPLYTA, with thousands of new prescribers each quarter.
- Expansion of the sales force is planned to target a broader range of physicians if Lumateperone for MDD is approved.
In conclusion, Intra-Cellular Therapies has demonstrated a strong start to 2024, with CAPLYTA driving revenue growth and a promising pipeline of treatments in development. The company's strategic initiatives and firm financial foundation position it well for future advancements and potential market expansion. With key studies progressing and regulatory discussions ongoing, Intra-Cellular Therapies remains focused on its mission to develop innovative treatments for patients with psychiatric and neurological disorders.
InvestingPro Insights
Intra-Cellular Therapies has certainly made a splash with its Q1 2024 performance, and a deeper dive into the company's financial health through InvestingPro data and tips can give us further insights into what lies ahead for the company.
InvestingPro Data: The company's market capitalization stands at a robust $7.54 billion, reflecting investor confidence in its growth trajectory. Revenue growth has been impressive, with an 85.51% increase over the last twelve months as of Q1 2024. Despite this, the company's P/E ratio is negative at -53.34, indicating that it is not currently profitable.
InvestingPro Tips: Analysts have revised their earnings estimates upwards for the upcoming period, suggesting optimism about Intra-Cellular's financial future. However, they do not anticipate the company will be profitable this year. This aligns with the significant investments Intra-Cellular is making in its clinical development pipeline and market expansion efforts. The company's liquid assets do exceed its short-term obligations, which is a positive sign for its liquidity and ability to fund ongoing operations.
The company's stock has experienced a large price uptick over the last six months, demonstrating strong market performance and investor interest. Adding to the picture, Intra-Cellular trades at a high Price/Book multiple of 12.6, which may suggest that the stock is valued on the higher end relative to its book value.
For those interested in learning more, there are additional InvestingPro Tips available that can offer further insights into Intra-Cellular Therapies' financial health and market performance. Readers can use the exclusive coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking even more valuable analysis to inform their investment decisions.
Full transcript - Intracellular Th (ITCI) Q1 2024:
Operator: Good morning, ladies and gentlemen, and welcome to Intra-Cellular Therapies' First Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. I would like now to turn the conference over to your speaker today Dr. Juan Sanchez, Vice President, Corporate Communication and Investor Relations. Please go ahead.
Juan Sanchez: Good morning and thank you all for joining us on our first quarter 2024 earnings call. Joining me today on the call are Dr. Sharon Mates, Chairman and Chief Executive Officer; Mark Neumann, Chief Commercial Officer; Dr. Suresh Durgam, Chief Medical Officer; and Larry Hineline, Chief Financial Officer. The slides to help guide today's call are available under the Investor Events section of our corporate website. I'm on slide number two. 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 statements 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. These statements are made only as the date of this conference call and the company disclaims any obligation to update such statements. I will now turn the call over to Sharon. Sharon will begin on slide four. Sharon?
Sharon Mates: Thanks, Juan. Good morning, everyone, and welcome to today's call. We are pleased to share our results for the first quarter of 2024 and to provide updates on our clinical studies. Our team continued to deliver strong growth for CAPLYTA in our current indications of bipolar depression and schizophrenia. With the overwhelmingly positive top line results from Study 501, we achieved a major milestone as we work to expand CAPLYTA's label into major depressive disorder and establish CAPLYTA as a drug of choice for broad patient populations with mood disorders. I'll talk more about this in a moment, but first, let's start with our commercial performance. Our strong growth continued. First quarter total revenues increased to $144.9 million. As we preannounced, CAPLYTA net sales increased to $144.8 representing a 53% growth versus the same period in 2023. We are pleased with our performance and we are confident in the continued growth of CAPLYTA. Consequently, we are reiterating our guidance for full year CAPLYTA net sales between $645 million and $675 million. Mark and Larry will provide a more detailed picture of our performance later in the call. Let me highlight our most recent clinical development news. Last month, we announced robust positive top line results from Study 501 evaluating Lumateperone as an adjunctive treatment to antidepressants in patients with MDD. These results are shown in slides 7 through 10. In this adjunctive study, Lumateperone met the primary endpoint of change from baseline at Week 6 on the MADRS Total Score versus Placebo with an impressive 4.9 point reduction. The p value was less than 0.0001 with a robust Cohen's d effect size of 0.61. As you can see, statistically significant reductions in depressive symptoms as measured by the MADRS were seen at the earliest time point tested Week 1 and these improvements continued throughout the course of the trial. Lumateperone also met the key secondary endpoint of change from baseline on the clinician rated CGI-S with a p value of less than 0.0001 and a robust effect size of 0.67. The CGI-S also statistically significantly improved at the earliest time point tested Week 1. In this study, we also included a measure of the patient's voice to complement the clinician rated scales. On a patient reported measure, the Quick Inventory of Depressive Symptomatology Self Report Scale or QIDS patients reported robust reduction in their depressive symptoms. There was a robust reduction in symptoms with a p value of less than 0.0001. We are very pleased that the patient reported improvements in depressive symptoms support the clinician rated endpoints in this study. We continue to see a favorable safety and tolerability profile. Adverse events were similar to those seen in prior studies of Lumateperone as a treatment for bipolar depression and schizophrenia. Today, we are pleased to report the results of additional safety information demonstrating that mean changes in key metabolic parameters, including glucose, insulin, triglycerides and total LDL and HDL cholesterol were similar between Lumateperone and Placebo. Importantly, mean changes in weight were also similar to placebo. These strong results from Study 501 underscore the potential for Lumateperone to treat a broad spectrum of mood disorders. We have now shown Lumateperone's strong antidepressant activity in patients with MDD as an adjunctive therapy in patients with Bipolar I and Bipolar II both as a monotherapy and as adjunctive therapy in patients with MDD and bipolar depression exhibiting mixed features and in patients with comorbid depression in our schizophrenia program. The results of Study 501, coupled with Lumateperone's distinct pharmacology, reinforce our label expansion strategy and the long-term prospects for Lumateperone across mood disorders. Our second Phase III trial in MDD, Study 502, has recently completed clinical conduct. We expect to report top line results from Study 502 later this quarter. Subject to the results, we anticipate filing a supplemental new drug application with the FDA in the second half of 2024. MDD is a highly prevalent disorder with approximately 21 million adults affected every year, thus presenting a large opportunity to expand on our already approved indications of schizophrenia and bipolar disorder. MDD accounts for 30% of the approximately 68 million annual antipsychotic market prescriptions. Therefore, as seen on slide 12, the total addressable market for CAPLYTA increases to approximately 80% of the annual antipsychotic market prescriptions with the addition of an MDD indication from nearly 50% with bipolar and schizophrenia indications. We are very excited about the possibility of providing a new treatment option for these patients. Let me now provide an update on our pipeline starting with other Lumateperone programs. Our Lumateperone pediatric program 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. Patient enrollment is ongoing in the open label safety study as well as in the double-blind placebo-controlled bipolar depression study. We anticipate beginning patient enrollment in the autism spectrum disorder studies in the third quarter of this year. Additionally, we continue to advance our long acting injectable Lumateperone with the initiation of Phase I studies with additional formulations later this year. We continue to advance our other pipeline programs, including 1284. ITI-1284 is a deuterated Lumateperone and is an important drug candidate as we continue to build our neuropsychiatry franchise. This quarter, we expect to initiate patient enrollment in our Phase II clinical trial evaluating ITI-1284 as adjunctive therapy to antianxiety medications in patients with generalized anxiety disorder or GAD. There are approximately 10 million diagnosed adults in the US with GAD. It is important to note that about half of patients who receive treatment do not respond adequately to initial therapy. We believe ITI-1284 is well suited for this patient population and could offer an effective, safe and well tolerated treatment. Also later this quarter, we plan to initiate patient enrollment in Phase II clinical study in psychosis associated with Alzheimer's disease as well as a Phase II study in agitation associated with Alzheimer's disease. Our Phosphodiesterase I inhibitor program includes Lenrispodun and ITI-1020. Our Phase II study with Lenrispodun in Parkinson's disease is ongoing and top line results are expected in 2025. Besides motor symptom improvement, we are exploring the effects of Lenrispodun in cognition, a key non-motor manifestation of the disease and measuring biomarkers of neuroinflammation to help inform next steps. Our second PDE1 product candidate, ITI-1020, is being developed for oncology indications. We are currently conducting a Phase I single ascending dose study with ITI-1020 and healthy volunteers. I'd also like to give a quick update on our earlier stage programs. We're exploring ITI-333 to treat opioid use disorder and pain. Our multiple ascending dose study and a positron emission tomography study are both ongoing. Finally, last year we introduced a portfolio of non-hallucinogenic psychedelics for the treatment of mood, anxiety and other neuropsychiatric disorders. ITI- 1549, the lead candidate is advancing preclinical development and we expect to begin clinical testing in 2025. A scientific poster describing the preclinical advancement of ITI- 1549 will be presented next week at the Society of Biological Psychiatry Annual Meeting. In this poster, we further describe the novel mechanism of action of ITI- 1549. We also demonstrate improvement in preclinical models of anhedonia and a reduction in symptoms of anxiety. We look forward to sharing this information following our poster presentation. We are in a strong financial position to maximize the opportunities ahead of us with CAPLYTA and we continue to build our robust pipeline. We ended the first quarter with approximately $477.4 million in cash, cash equivalents and investment securities. In April of 2024, we received approximately $575 million in gross proceeds from our public offering of common stock. Additionally, we have no debt. I'll now turn the call over to Mark to further discuss this quarter's CAPLYTA performance. Mark?
Mark Neumann: Thanks, Sharon, and good morning, everyone. CAPLYTA's strong performance continued in Q1 of 2024 with robust year-over-year growth in total prescriptions of 39% despite typical first quarter seasonal dynamics as well as the industry disruption caused by the Change Health cyberattack that occurred during the quarter. CAPLYTA's growth continues to be driven by strong uptake in bipolar depression, where it has solidified its position as the first and only treatment option indicated for patients with Bipolar I and Bipolar II depression as monotherapy and as adjunctive therapy with lithium or valproate.. We also continue to see steady growth in schizophrenia. We continue to expand our prescriber base, which now stands at more than 39,000 healthcare providers since launch. Physicians appreciate CAPLYTA's proven efficacy, favorable safety and tolerability profile and convenient once daily dosing with no titration required. Beyond a compelling product profile, the team's commercial execution continues to be very strong. Our sales team is currently educating our prescriber base, which includes psychiatrists, nurse practitioners and primary care physicians. Our sales efforts are complemented by a comprehensive marketing program, including extensive peer-to-peer medical education programming, digital promotion and a broad national consumer advertising campaign delivered through television and social media. We're very pleased to have just launched a new consumer TV advertisement, which depicts the experience of people living with bipolar depression and the benefits CAPLYTA may provide them. We also continue to enjoy a strong market access position with broad access with over 99% of lives covered in Medicare and Medicaid and about 90% of lives covered in commercial. In early Q4 2023, CAPLYTA gained unrestricted status on two of the largest Medicare Part D plans. We are pleased with the initial results of these changes and expect to see the full impact of these changes throughout 2024. As Sharon mentioned, the commercial opportunity for CAPLYTA within its current indications is large and represents nearly half of the approximately 68 million annual antipsychotic prescriptions in the US. We will continue to invest behind the brand, build on our strong momentum and fully optimize the current opportunity as we further penetrate the bipolar depression and schizophrenia markets. In closing, we are pleased with CAPLYTA's strong performance. CAPLYTA has a very compelling product profile and we are well positioned for continued growth both in the short-term and the long-term as we work to establish CAPLYTA as a first choice treatment across mood disorders. We look forward to continuing to update you on the success of CAPLYTA. I'll now turn the call over to Larry to further discuss our financial performance. Larry?
Lawrence Hineline: Thank you, Mark. I will provide highlights of our financial results for the first quarter ending March 31st, 2024. In the first quarter, net product sales of CAPLYTA were $144.8 million compared to $94.7 million for the same period in 2023, representing a year-over-year increase of 53%. Our net sales growth in the first quarter was primarily driven by increased prescription demand and to a lesser extent higher inventory levels. Our gross to net percentage in the first quarter increased to the mid-30s consistent with our guidance. We expect our gross to net percentage to remain in the mid-30s for the remainder of the year. We believe underlying demand for CAPLYTA will remain strong and we are reiterating our full year 2024 CAPLYTA net sales guidance of $645 million to $675 million. Selling, general and administrative expenses were $113.1 million for the first quarter of 2024 compared to $98.9 million for the same period in 2023. Research and development expenses for the first quarter of 2024 were $42.8 million compared to $38 million for the same period in 2023. Our financial position remains strong. Cash, cash equivalents and investment securities totaled $477.4 million at March 31st, 2024 compared to $499.7 million at December 31st, 2023. In April 2024, we completed a public offering of our common stock in which we sold approximately 7.9 million shares for aggregate gross proceeds of $575 million and net proceeds of approximately $543 million. This concludes our prepared remarks. Operator, please open the line for questions.
Operator: Thank you. [Operator Instructions] The first question comes from Jessica Fye with JPMorgan. Your line is open.
Jessica Fye: Hey, guys. Good morning. Thanks for taking my question. So I was wondering with a demonstrated commercial track record and a robust balance sheet, I'm curious how you think about the possibility of adding another product to the bag and how you think about the right time to do that, i.e., if it's something you wouldn't want to do simultaneous with the MDD launch, for example, or if you think there is the organizational capacity to do both at the same time? Thank you.
Sharon Mates: Hi, Jessica. This is Sharon. Thanks for the question. So, yes, we're always looking for new opportunities. And as you said, with our robust balance sheet, that certainly allows us to contemplate opportunities that are marketed products. As to, I'll let Mark speak, but I know, what he's going to tell you about. You probably don't want to launch simultaneously two new products. However, we do certainly have the bandwidth that we could stagger these and have the two products in their launch phases simultaneously. Mark, did you want to add anything to that? And we're very excited to do that and we keep looking for new products to add.
Mark Neumann: Yeah. No, Sharon. Yep. I think you've got it right. Certainly, we have the capacity and the capability of doing it. I think when you have a product as strong as CAPLYTA, you want to make sure that the focus stays there, and we continue to execute well. So as we look at these opportunities, we look for strategic fits. We look for products that have compelling product profiles and would be a good fit with the call points that our sales force currently has in their call universe. So we look at all those things. And up until this point, we haven't found the right fit. But as Sharon said, we would certainly welcome another product into the portfolio and certainly have the capacity and the capability to do that.
Operator: One moment for the next question. The next question comes from Brian Abrahams with RBC Capital Markets. Your line is open.
Brian Abrahams: Hi there. Good morning. Thanks for taking my question. I'm curious if you could talk about any initial KOL feedback that you received on the MDD data and where CAPLYTA could potentially fit in? And I guess along those lines, I'm also curious how the top line MDD data may have impacted or maybe impacting uptake in bipolar depression, if you're seeing any pull throughs or sort of early shifts in use patterns there? Thanks.
Sharon Mates: Great. Hi, Brian. Thanks for the questions. And maybe, Suresh, would you like to start I'll just give you an overall on the KOLs. It's been -- it's been very gratifying to hear their responses and their enthusiasm of CAPLYTA. Suresh is at APA. I think he's sitting in some room off to the side right now. So maybe, Suresh, do you want to say whether you've had any further feedback and what your conversations with KOLs are?
Suresh Durgam: Yes. In terms of the conversations with KOLs, I have met several KOLs here at the APA, and the feedback on our data on 501 study is very, very positive. And also with the robustness of the data showing in all endpoints, both, the primary and key secondary endpoints and also the self-rated patient-rated scale. So they were very happy to see that results and are looking forward for the second study.
Sharon Mates: And as to, the uptake on if there's any pull through, I think, I'm not sure. Mark, are you comfortable speaking to that?
Mark Neumann: Yes, sure, Brian. I think it's far too early to see an impact of the most recent results on prescribing, as you say, within bipolar depression. Typically, any kind of lift that you might get on your current indications usually comes after data is presented in the scientific literature. And I know Suresh and his team are working hard on that for future presentations of the data. But at this point, I don't think we've seen any kind of material lift in our existing indications from presentation of the data.
Brian Abrahams: Got it. That's all really helpful. Thanks so much.
Sharon Mates: And just to say that we hope to be presenting the 501 data at Medical Meetings later this year.
Operator: One moment for the next question. The next question comes from Andrew Tsai with Jefferies. Your line is open.
Andrew Tsai: Hey, good morning. Thanks for taking my question. Maybe on MDD, since we're one or two months away from second half 2024. Is a Q3 filing a possibility after the second dataset reads out or should the street be thinking Q4 at this juncture? And then in the scenario in which the second dataset did look different, would you still look to file in second half or is there a scenario in which you waited for the third dataset later in 2025 before filing the sNDA? Thank you.
Sharon Mates: Thanks. I didn't write down your questions, so I hope I remember all of them. So first on, I think, on our potential filing later this year in the second half, what that would be. So we've said that our readout of 502 was going to be late in the second quarter. So you can anticipate that, that most likely means June. So then you'd have to drop everything into shelves that are being created and put all the data together. So when we say a filing in the second half, I would tell you Q3 is aggressive, not doable, but aggressive. So that's the answer to that question. And then you asked, oh, about, what is our filing strategy. And I think, first of all, we need to see the data, which we will do soon. We do believe in the very robustness of our package as it exists now. So I think we are working very hard on timeline of we will be submitting our application in the second half of this year.
Andrew Tsai: Great. Thank you. Thank you.
Operator: One moment for the next question. The next question comes from Charles Duncan with Cantor. Your line is open.
Charles Duncan: Good morning, Sharon and team. Congrats on a strong commercial performance in the quarter as well as recent data. I had a two part question. One is, if CAPLYTA is approved as adjunctive therapy in MDD, can you provide us a little color on what you would anticipate sales force sizing to be and if eventual demand for the product in that market could drive the franchise to profitability? And then with regard to 502, could you remind us of the sample in terms of it being comprised of number of patients from clinical sites other than from 501? Thanks.
Sharon Mates: Mark, do you want to take the first part and then Suresh the second part?
Mark Neumann: Yeah. Sure. Hi, Charles. Yes, what we said in the past about sales force size with an eventual approval in MDD is that we certainly would expect to significantly increase the size of our sales force. As you know, currently, our sales force has a target audience of about 43,000 physicians, the vast majority of them being psychiatrists and the nurse practitioners that support them. So we have very good coverage of the psychiatry community. We do have a segment of primary care that we currently call on. Those are primary care physicians who are comfortable treating bipolar depression and are high volume prescribers of antipsychotics for that condition. But as we contemplate an approval in MDD, the expansion would come by a much larger target audience within the primary care community. There aren't many more psychiatrists that we don't already call on for our current indications, but it would be for an expansion into primary care As we get closer to the timing of a potential approval, we'll come back to you with more details about the specific size and timing that we would be executing against.
Sharon Mates: Okay.
Mark Neumann: And Suresh, I think, there's a second part. Yes.
Suresh Durgam: Yes. In terms of the sample size, it's very similar sample size for 502 compared to 501. And in terms of the clinical sites, there is no overlap of sites. But however, we tend to include about 30% of patients coming from US. And about the remaining coming from ex-US sites.
Sharon Mates: So there's some [Technical Difficulty] some site overlap.
Suresh Durgam: Yes.
Sharon Mates: Because you don't be competing with yourself when you're enrolling patients.
Charles Duncan: Got it. Makes sense. Thank you.
Operator: One moment for the next question. The next question comes from Marc Goodman with Leerink Partners. Your line is open.
Marc Goodman: Yes. On ITI-214, can you remind us of the differentiation in this product and how you look to kind of break into the Parkinson's market, which is a tough market over the past decade for new products? And Larry, could you also just tell us what the inventory change was in the quarter? Thanks.
Sharon Mates: Okay. Suresh, do you want to start with talking about 214?
Suresh Durgam: Yes. 214, that is the Lenrispodun. We have an ongoing study in Parkinson's disease and that is a proof-of-concept study. In that study, we are evaluating several things. One, evaluating the motor symptom improvement. We're also evaluating cognition measures as well as biomarker for inflammation. So based on the data from that, we will decide on the next steps, looking at the data we'll read from that. That that study is a four week study. It's the, the primary endpoint is the Hauser diary. We're looking for increase in on time without troublesome dyskinesia. And the key secondary is the MDS-UPDRS Part II, which measures motor aspects of experiences of daily living. And we also as I indicated, one of the things we are looking there is looking for biomarkers, for inflammation in that study.
Sharon Mates: And to the second part on inventory, Larry, do you want to take that?
Lawrence Hineline: Yes, sure. During this quarter, we experienced strong prescription growth that's continued over the last several quarters. And in this quarter, this prescription demand was the primary driver for revenue. There was, to a lesser extent, an inventory increase for this quarter, but the primary driver was Scripps.
Marc Goodman: Can you quantify the inventory change?
Lawrence Hineline: No, we've not given that sort of granular detail before and it's difficult to do.
Marc Goodman: Okay.
Operator: One moment for the next question. The next question comes from Umer Raffat with Evercore. Your line is open.
Michael DiFiore: Hi, guys. This is Mike DiFiore in for Umer. Thanks so much for taking my question and congrats on all the success. Just two quick ones from me. Any updated thoughts on pursuing a monotherapy indication for MDD given CAPLYTA's improved safety profile compared to second generation atypical antipsychotics? I'm asking because Seroquel pursued this in the path and although it was efficacious, the FDA didn't approve the monotherapy indication for MDD due to safety concerns. And my follow-up is on the, I guess, separate follow-up is on the PDE1 program. Just a quick observation, last quarter, they said the top line was expected in one half '25 now. This quarter is just 2025. So I was wondering if there's any sort of recruiting or trial delays on that front. Thank you.
Sharon Mates: Okay. Suresh, do you want to take that?
Suresh Durgam: In terms of the, yeah, you can start Sharon and I can.
Sharon Mates: No. Go ahead.
Suresh Durgam: Okay. In terms of the study itself, their recruitment is slower and we are.
Sharon Mates: Wait a minute. Wait, wait, wait. The 214. The first part of the question was an update on monotherapy for MDD and that Seroquel did try for monotherapy. And as you correctly pointed out, Mike, that the FDA was concerned about their metabolic consequences et cetera. I think that we're evaluating all of this and obviously, as you know, there isn't the safety concerns that one sees with Seroquel with Lumateperone. So we're looking at that. There are a lot of -- there are a lot of things to look at. It's also different times than when Seroquel was first approved. On the PDE program, we -- recruitment has gone slower than we originally thought. That could be because of studies that are ongoing. It could also be because we try to ensure that we get in appropriate patients et cetera. But we still are in 2025 in our timelines. So we've just left out saying first half, second half or anything, which I don't think we had said before either. Maybe we did. I can't remember. So I think it is 2025. And, also, you're correct that or actually, I think the speaker before you was correct in talking about that Parkinson's is a crowded market, but we think that we're getting or we should be getting some very good data on the use of these PDE1 inhibitors in neuroinflammation and that should help inform us both on taking forward 214 in Parkinson's disease and in taking forward other molecules within the PDE1 space into several different arenas. With that, Suresh, did you want to add anything else? I'm sorry. I didn't mean to cut you off.
Suresh Durgam: No. In terms of the 501 study, yeah, the MDD program, that's true. That's again we'll be looking at the data and then we'll figure it out what to do next steps for the monotherapy.
Michael DiFiore: Very helpful. Thanks so much.
Operator: Please standby for the next question. The next question comes from Jason Gerberry with Bank of America. Your line is open.
Jason Gerberry: Hey, guys. Good morning and thank you for taking my question. On ITI-1284, I'm not seeing this on CT.GOV yet, but maybe I'm missing something. But just generally trying to get a sense, how big are these trials? How many dose arms? Are these going to be like 12 week treatment period to get proof-of-concept and figure out dose? And just trying to get a rough sense of time line here ultimately. And then just as my follow-up, if I can squeeze it in. I didn't hear an update on mixed features. I think you guys were waiting for the minutes, which tend to come like I think 30 days after the meeting. So just curious if there's a mixed features update. Thanks.
Sharon Mates: I'll start with the second part, and then I'll ask, Suresh to chime in on the first part. So we did update you on the mixed features and said that we would come back to you after, our readout of 502, and as we continue to put together our strategy for mixed features in MDD. So stay tuned. Hopefully, in the near future, we'll have some updates for you, on the mixed features. And I'll give you the short answer on 1284 as we will be posting, these studies, we said, before the end of this quarter. And I'll leave it to Suresh to talk to you about the design and powering of these studies.
Suresh Durgam: Yes. Regarding the 1284 studies, we have three programs right now. That is the GAD program, the psychosis in Alzheimer's disease, and agitation in Alzheimer's disease. The first study we will be starting is the GAD program. That is a fully powered study, as a registrational study. It's as an adjunctive treatment, and it is, sample size would be somewhere in the range of about 600 patients. It's going to be three arms, placebo versus two doses. Again, the details once we start the trial, soon in the next few, we will be posting that online for the ClinicalTrials.gov. Similarly for the agitation and psychosis in Alzheimer's, those are Phase II studies, but are powered as registrational studies. Those details also will be posted as soon as we start the studies. And they are intended to start this in the second quarter.
Jason Gerberry: Got it. Thank you.
Operator: Please standby for the next question. The next question comes from Sumant Kulkarni with Canaccord. Your line is open.
Sumant Kulkarni: Hi. Thanks for taking my question. Sorry about the two parter. So on the last MDD data focused call, I know you'd requested me to hold off on this question until this update, so I'll ask it now. 1284, are you planning to specifically develop that product in the various sub indications of depression? And on Lumateperone for autism spectrum disorder, I'm asking because unmet need is high. How is the company thinking about dosing for pediatric patients? Is there a weight based dosing paradigm or will it be as simple as the product that's out there in the market right now in terms of logistics around dosing? Thanks.
Sharon Mates: Suresh, you want to take the second part and then I'll need you to repeat the first part.
Suresh Durgam: Yes. Regarding the second part about the autism in for Lumateperone, we are going to be starting those studies for irritability in autism. And regarding the dosing, we are looking at we have to finish first finish the PK studies, for the lower age group, between 5 to 10 years old. Based on the PK exposure levels that comes from that study, we will be deciding on the dosing for those patients. For patients in the upper age group, it will be similar to what, it is in in adults. For example, from 13 to 17, it will be -- it will be similar to 42 milligrams. So the lower age groups, we have to figure out by the PK studies.
Sumant Kulkarni: Got it. And the first part was on 1284, we know you're developing it for Alzheimer's disease psychosis and agitation and generalized anxiety disorder, but are there any specific plans to develop that within the depression context?
Sharon Mates: Yes. Well, we are contemplating other indications within 1284, but let us get these studies started first and then we'll come back to you with the other studies that we'll be doing.
Sumant Kulkarni: Thank you.
Operator: One moment for the next question. The next question comes from Jeffrey Hung with Morgan Stanley. Your line is open.
Michael Riad: Hi. This is Michael Riad on for Jeff Hung. Thank you for taking our question. Thinking more generally about the results from Study 501 versus 403. How important is it to get DSM-5 classifiers into the label versus a more broad label like adjunct MDD? I guess I'm just trying to ask what happens more regularly in standard clinical practice and to what extent do classifiers influence treatment decision? Thanks so much.
Sharon Mates: So I think our broad label, is obviously what we always aim for and what we're doing is exploring value of having anything, you know, specific in any label that we have. And, again, as we -- as we get the 502 readout, we'll come back to you with further updates on exactly what it is that our strategy is now and will be. Mark, did you want to add anything to that?
Mark Neumann: No, I think that's good.
Sharon Mates: Okay.
Operator: One moment for the next question. The next question comes from Graig Suvannavejh with Mizuho. Your line is open.
Charles Wang: Good morning, everyone. This is Charles Wang on for Graig. Thanks for taking our question. Given Study 501 indicated a very strong placebo adjusted effect size of 4.9. Does the company expect to see similar efficacy in Study 502?
Sharon Mates: Yeah. That was a point change. That wasn't the effect size, but the effect size was very strong as well. And I think what you're looking for, the studies are powered to show actually, this study was powered to show a two point change, because in adjunctive studies, typically, you are at the lower end of the two to four point change in the MADRS that you're seeing. So I think we're very close to the data. We hope very much that we have as strong a readout as we saw in 501, but no two studies are alike. And you can, as you know, if you look at precedent at other studies there you know no two studies are exactly the same even within a program. So we look forward to seeing the data and we'll update you as soon as we get it. Suresh, did you want to?
Charles Wang: Okay. Thank you.
Sharon Mates: Sorry. You okay?
Suresh Durgam: No. That's correct. Yeah, I would agree with that.
Sharon Mates: Okay.
Operator: One moment for the next question. The next question comes from Troy Langford with TD Cowen. Your line is open.
Troy Langford: Hi. Congrats on all the progress this quarter and thanks for taking our questions. Just on the CAPLYTA commercial performance, do you think we've already seen the majority of the impact of the expanded sales force? Or do you think we could see this impact play out gradually over the course of the rest of this year? And how long do you think it will take for us to see the impact of the new TV ad on CAPLYTA sales trajectory?
Sharon Mates: Mark?
Mark Neumann: Yes, sure. I can take that. Yes, I think, we are -- we've been very pleased with the impact that the additional 50 representatives that we brought on a little over a year ago, typically it takes up to six months for representatives to see an optimized performance in their territory. So I think they're hitting on all cylinders now and I think you can expect a continued impact from them as you can with all of our representatives in all of our territories. And in terms of the DTC impact, we've been continuously running our DTC with the Let in the Lyte campaign. As I mentioned in the prepared remarks, we're very pleased to have just very recently launched a new campaign that builds on the Let in the Lyte campaign, and we would expect to see the impact of that over the course of the year as well. We've been pleased with the response that we've seen in all of the metrics that we track for our DTC programs and we're very pleased to be able to refresh the creative campaign. So keep an eye out for that in the coming weeks and months.
Troy Langford: Great. Thanks for the color.
Operator: One moment for the next question. The next question comes from Ash Varma with UBS. Your line is open.
Ashwani Verma: Hi. Good morning. Thanks for taking our question. So just quickly on the pipeline, ITI-1500, the psychedelic, just wanted to understand like what's the base molecule you're pursuing here? What is the target that it is hitting? Just mechanistically, if you can talk about like what is the value proposition that would be great? Thanks.
Sharon Mates: Yes, thanks. The first part of your question got a little muffled, so I may need to ask you to repeat it. But I think you are asking about, the mechanism, of the 1500 series and where it comes from. It is the entire program has been developed in-house, has been discovered, the scaffolds and have been discovered and worked on internally going based off of our many years of knowledge in serotonin biology and in particular in 5-HT2 biology. So that's what these molecules have been, molded around, and we are very excited because they are agonists, but they do not have the hallucinogenic activity in animals. And, also, they do not have the cardiovascular side effects that you see with 5-HT2 agonists in general. So we're very pleased with that.
Operator: [Operator Instructions] Please standby for the next question. The next question comes from Ami Fadia with Needham. Your line is now open.
Ami Fadia: Hi. Good morning. Thanks for taking my question. I had a quick follow-up on ITI-214. You mentioned you're going to collect some biomarker data on information. Could you elaborate a little bit more about how that could translate into differentiation versus existing treatment options within Parkinson's? And also in the past, you've talked about potentially looking at impact on movement and cognition. Could you sort of remind us if there are ways in which you're going to be measuring that in the four week study? Thanks.
Sharon Mates: Suresh?
Suresh Durgam: Yes. In terms of the 214 Parkinson's study, that is a proof-of-concept study. As indicated, we are looking at the moment scale, cognition and inflammatory biomarkers. Your question specifically regarding the cognition. We are measuring what is called, symbol digit modalities test. This measures the processing speed with a simple substitution task that essentially to detect the cognitive dysfunction. And this scale is similar to the DSST version, but for Parkinson's patients, this is a better version of that, for Parkinson's patients. In terms of the biomarkers, we are testing biomarkers for inflammation. IL-6, IL-18, CCL are being tested and other biomarkers are tested to see the effect on these biomarkers. And in terms of the utility of that, that will help for us in our other indications we are pursuing, in inflammation that will help us figure out what other things we can do with that.
Operator: One moment for the next question. Our next question comes from Corinne Johnson with Goldman Sachs. Your line is open.
Corinne Johnson: Good morning, everyone. I wanted to circle back to your answer to Jessica's question earlier around potential interest in asset acquisition. And I guess as you think about and evaluate the assets that are out there, what sort of parameters do you have in mind as you evaluate these opportunities? And how do you think about that development or business development in the context of not just the commercial priorities, but also your other pipeline product?
Sharon Mates: Right. I'll start and I'll ask Mark if he wants to add anything. So, hi, Corinne, and thanks for the question. So obviously the best case scenario would be the addition of a marketed product that our present sales force can add to their bag, so to speak. So that has -- that as they're out there, they can be speaking about both CAPLYTA and another product. Going down the run one step, if we are not successful there, which we do look and to-date, we haven't brought in anything there, we go to adjacencies. So marketed products that may require adding another sales force, but it really depends on the product and the size of the sales force that you would need. And then we also look at late stage development assets, and we've been moving earlier and earlier. And you're absolutely right in implying or suggesting or asking a question of how do you then prioritize bringing in an early stage product to our own pipeline? And I have to tell you every time we evaluate something that's, early stage, that's exactly what happens. We need to weigh it against what we already have and you can't just keep adding early stage programs. So it would probably displace one of our own early stage programs. So you're always weighing these things. And, you know, we do look across the spectrum now, from the marketed products that I gave you the order that we look at these all the way down to early stage programs.
Corinne Johnson: Thanks. That's super helpful. Appreciate it.
Operator: One moment for the next question. The next question comes from David Amsellem with Piper Sandler. Your line is open.
David Amsellem: Hey. Thanks. So I wanted to drill down a little more deeply on the deuterated lumateperone, program. I'm particularly interested in your thoughts on the path forward in Alzheimer's agitation with one product already approved for this for the -- for the setting in Axsome's Auvelity in late stage development. But I'm just wondering out loud, you've got a couple of randomized withdrawal studies, that, Axsome's running on or has run on Auvelity, but then you also have more regular randomized studies. I'm just trying to get a sense from you or how you're thinking about what you're going to need to do to move AD agitation through just given that it's not exactly a well-worn regulatory pathway? Thank you.
Sharon Mates: Sure. Thanks for the question. I'll start and then I'll ask Suresh if he wants to add anything. You're correct. It's not a well-worn regulatory pathway, but the pathway is becoming clearer and clearer. With the approval of REXULTI in Alzheimer's agitation, we know, what -- are allowed. We also, you know, the FDA has been refining their requirements, et cetera. So I think that the study that we're doing that Suresh told you about, it is a Phase II study powered as a Phase III study. So we look forward to that data. And then and by the way the study has been we've gone back and forth with the FDA. We -- they are completely apprised and have had input into how you do these studies and what you do and what scales you use in these studies, how you use them. So I think that and the randomized withdrawal is something that is oftentimes used. And again that is with would be with discussion with the FDA, as we go forward, should we choose to want to use that paradigm. Suresh, did you want to add anything?
Suresh Durgam: Just again to reiterate that the path, as you said, you know, while it is not fully there, but at least with the breadth of proposal, there is a path forward, from that angle. We have to see if other designs would be -- would be okay with FDA at this point.
David Amsellem: Okay. Helpful. Thank you.
Operator: And our last question will come from Joel Beatty with Baird. Your line is now open.
Joel Beatty: Thanks for taking the question. For CAPLYTA sales, how much growth is coming from new first time prescribers versus greater depth from existing prescribers?
Sharon Mates: Mark, do you want to take that?
Mark Neumann: Yes. Sharon, I can take that. So we're seeing a nice balanced contribution both of increasing new prescribers as well as depth of prescribing over time. As I mentioned in my prepared remarks, we now have over 39,000 unique prescribers of CAPLYTA. That continues to grow at a strong rate each quarter. We're adding 3000 to 4000 new first time prescribers every quarter and we really haven't seen that slowdown over the quarter. So we look at our depth and our breadth metrics for the launch and we're very encouraged by what we're seeing there. So we continue to put effort toward both getting new prescribers of CAPLYTA as well as increasing the depth of prescribing for each of those prescribers.
Joel Beatty: Thank you.
Operator: At this time, I would now like to turn the call back over to Sharon for closing remarks.
Sharon Mates: Well, thanks, everyone, for participating on today's call, and thanks for all of your questions as well. We look forward to updating you on our MDD studies as well as on our other studies. We think it's a very exciting time for ITCI and we look forward to continuing to help patients and to develop new medicines to treat patients. With that, I can ask the operator to please disconnect. Thanks very much. Bye-bye.
Operator: This concludes today's conference call. Thank you for your participation. You may now disconnect.
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