Q1 2024 Intra-Cellular Therapies Inc Earnings Call

May 7, 2024

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Operator: Good morning, ladies and gentlemen, and welcome to Intra-Cellular Therapies' First quarter 2024 Earnings Conference Call. [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 of Corporate Communication and Investor Relations. Please go ahead.

Speaker Change: Good morning, ladies and gentlemen, and welcome to the intra cellular therapies first quarter 'twenty 'twenty four earnings conference call. At this time, all participants are in a listen only mode.

Speaker Change: After the speaker's presentation, there will be a question and answer session.

Speaker Change: To ask a question during this session you wouldn't need to press star one on your telephone.

Speaker Change: I Didnt hear an automated message of bites in your hand, it's right.

Speaker Change: Your question. Please press star one again.

Speaker Change: Please be advised that today's conference is being recorded I.

Speaker Change: I would like now to turn the conference over to your Speaker today Doctor, One Sanchez, Vice President Corporate Communications and Investor Relations. Please go ahead.

Juan Fernando 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 Lawrence Hineline, Chief Financial Officer. The slides to help guide today's call are available on the investor events section of our corporate website. I'm on slide number two.

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 Lawrence Hineline, Chief Financial Officer.

Juan Fernando Sanchez: Good morning, and thank you all for joining us.

Juan Fernando Sanchez: On our first quarter 2024 earnings call.

Juan Fernando Sanchez: Joining me today on the call are go to Sharon mates.

Juan Fernando Sanchez: Man and Chief Executive Officer, Mark Newman, Chief Commercial officer.

Juan Fernando Sanchez: That's correct.

Sharon Mates: Hello, Peter.

Sharon Mates: Laurie <unk> 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 2. 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 previous 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 of the date of this conference call, and the company disclaims any obligation to update such statements.

Sharon Mates: The slides to help guide todays call are available on the Investor event section of our corporate website.

Speaker Change: I'm on slide number two.

Juan Fernando Sanchez: 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 of the date of this conference call, and the company exclaims any obligation to update such statements.

Speaker Change: Okay.

Speaker Change: During today's call, we'll be making certain forward looking statements. These forward looking statements are based on current information assumptions and expectations.

Speaker Change: Those statements are subject to change and involve a number of risks and uncertainties that may cause actual results could differ materially.

These and other risks are described in our previous 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 of the date of this conference call, and the company disclaims any obligation to update such statements.

Speaker Change: And those contained in forward looking Kramer.

Speaker Change: There is another risk are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports.

Speaker Change: You are cautioned not to place undue reliance on these forward looking statements.

Speaker Change: Payments are made only as the date of this conference call and the company disclaims any obligation to update such statements.

Juan Fernando Sanchez: I will now turn the call over to Sharon. Sharon will begin on slide 4.

Speaker Change: I'll now turn the call over to Sharon.

Speaker Change: <unk> 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 worked 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.

Sharon Mates: Thanks, Juan good morning, everyone and welcome to today's call.

Sharon Mates: We are pleased to share our results for the first quarter of 2024 and to provide updates on our clinical studies.

Sharon Mates: Our team continued to deliver strong growth for kept later.

Sharon Mates: In our current indications with bipolar depression and schizophrenia.

Sharon Mates: With the overwhelmingly positive topline results from study <unk>, one we achieved a major milestone as we work to expand kept lightest label into major depressive disorder and establish <unk> 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 pre-announced, CAPLYTA and net sales increased to $144.8 million, 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.

Sharon Mates: I'll talk more about this in a moment, but first let's start with our commercial performance.

Sharon Mates: Our strong growth continued first quarter total revenues increased to $144 $9 million.

Sharon Mates: As we pre-announced, cap light and net sales increased to $144.8 million, 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 Keplita. Consequently, we are reiterating our guidance for full year kept light and net sales between $645 and $675 million.

As we pre-announced, cap light and net sales increased to $144.8 million, 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 Keplita.

Sharon Mates: As we pre announced kept light of net sales increased to $144 $8 million, representing a 53% growth versus the same period in 2023.

Sharon Mates: We are pleased with our performance and we are confident in the continued growth of kept lighter.

Consequently, we are reiterating our guidance for full year CAPLYTA and net sales between $645 million and $675 million. Mark and Larry will provide a more detailed picture of our performance later in the call. Now, let me highlight our most recent clinical development news. Last month, we announced robust positive top-line results from Study 501, evaluating rumateparone as an adjunctive treatment to antidepressants in patients with MDD. These results are shown in slides 7 through 10.

Sharon Mates: Consequently, we are reiterating our guidance for full year top line net sales between $645 $675 million.

Sharon Mates: Mark and Larry will provide a more detailed picture of our performance later in the call. Now, let me highlight our most recent clinical development news. Last month, we announced robust positive top-line results from Study 501, evaluating rumateparone as an adjunctive treatment to antidepressants in patients with MDD. These results are shown in slides 7 through 10.

Sharon Mates: 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.

Speaker Change: Let me highlight our most recent clinical development news.

Speaker Change: Last month, we announced robust positive topline results from study <unk> hundred one evaluating <unk> as an adjunctive treatment to antidepressants in patients with M. D D.

Speaker Change: These results are shown in slide seven through 10.

Sharon Mates: In this adjunctive study, Lumetepurone met the primary endpoint of change from baseline at week six on the MAGIS total score versus placebo with an impressive 4.9 point reduction. The p-value was less than 0.0001, with a robust cones VFX size of 0.61. As you can see, statistically significant reductions in depressive symptoms, as measured by MADRS, were seen at the earliest time point tested, week 1, and these improvements continued throughout the course of the trial.

Speaker Change: In this adjunctive study <unk> met the primary endpoint of change from baseline at week six on the Majerus total score versus placebo with an impressive $4 nine point reduction.

Speaker Change: The P value was less than zero point zero zero zero.

Speaker Change: Zero, one with a robust <unk> effect size of 0.61.

Speaker Change: As you can see statistically significant reduction in depressive symptoms as measured by the Madras we're seeing at the earliest time point tested week, one and these improvements continue throughout the course of the trial.

Sharon Mates: LUMATEPERONE also met the key secondary endpoint of change from baseline on the clinician-rated CGI-F 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.

Speaker Change: <unk> 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.

Speaker Change: The CGI S also statistically significantly improved at the earliest time point tested weak one.

Sharon Mates: 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.

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.

Speaker Change: In this study we also included a measure of the patient voice to complement the clinician rated scales.

Speaker Change: On a patient reported measure the quick inventory of depressive symptomatology self report scale or Quids patients reported robust reduction in their depressive symptoms.

Speaker Change: 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.

Speaker Change: We are very pleased that the patient reported improvements in depressive symptoms support the clinician rated endpoints in this study.

Speaker Change: We continue to see a favorable safety and Tolerability profile.

Sharon Mates: Adverse events were similar to those seen in prior studies of lumateparone 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 lumateparone and placebo. Importantly, mean changes in weight were also similar to placebo.

Speaker Change: First events were similar to those seen in prior studies of <unk> as a treatment for bipolar depression and schizophrenia.

Speaker Change: Today, we are pleased to report the results of additional safety information demonstrating that mean changes and key metabolic parameters, including glucose insulin triglycerides and total LDL and HDL cholesterol were similar between <unk> 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.

Speaker Change: Importantly, when changes in weight were also similar to placebo.

Sharon Mates: These strong results from Study 501 underscore the potential for lumateparone to treat a broad spectrum of mood disorders. We have now shown Lumecaparon's strong antidepressant activity in patients with MDD as an adjunctive therapy, in patients with bipolar I and bipolar II, both as monotherapy and as adjunctive therapy, in patients with MDD and bipolar depression exhibiting mixed features, and in patients with comorbid depression in our The results of Study 501, coupled with Lumetepiron's distinct pharmacology, reinforce our label expansion strategy and the long-term prospects for Lumetepiron 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.

Speaker Change: These strong results from study <unk> hundred one underscores the potential for <unk> to treat a broad spectrum of mood disorders.

Speaker Change: We have now shown on the Tempur on strong antidepressant activity in patients with M. D. As an adjunctive therapy in patients with bipolar one and bipolar two.

Speaker Change: Both as a monotherapy and as adjunctive therapy in patients with MD D and bipolar depression exhibiting mixed features and in patients with comorbid depression in our schizophrenia program.

Speaker Change: The results of this study 501, coupled with limited loans distinct pharmacology reinforced our label expansion strategy and the long term prospects for luma kept around across mood disorders.

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.

Speaker Change: Our second phase III trial in M. D. D study 502 has recently completed clinical conduct we expect to report topline results from study <unk> later this quarter.

Sharon Mates: 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 prescription.

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.

Speaker Change: Subject to the results, we anticipate filing a supplemental new drug application with the FDA in the second half of 2024.

Speaker Change: <unk> 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 prescription. 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 Lumeteperone 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.

Speaker Change: MVD accounts for 30% of the approximately $68 million annual anti psychotic market prescriptions.

Sharon Mates: Therefore, as seen on slide 12, the total addressable market for Keplita 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 Lumeteperone 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.

Speaker Change: Therefore as seen on slide 12, the total addressable market for capital Ida increases to approximately 80% of the annual anti psychotic market prescriptions with the addition of an MDT indication from nearly 50% with bipolar and schizophrenia indications.

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 2 double-blind placebo-controlled studies in irritability associated with autism spectrum disorder.

Speaker Change: We are very excited about the possibility of providing a new treatment option for these patients.

Sharon Mates: 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. Additionally, we continue to advance our other pipeline programs, including 1284.

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.

Speaker Change: Let me now provide an update on our pipeline starting with other <unk> programs.

Speaker Change: Our alumina Chaperoned 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.

Speaker Change: Patient enrollment is ongoing in the open label safety study as well as in the double blind placebo controlled bipolar depression study.

Speaker Change: We anticipate beginning patient enrolment in the autism spectrum disorder studies in the third quarter of this year.

Speaker Change: Additionally, we continue to advance our long acting injectable <unk> with the initiation of phase one 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 anti-anxiety medications in patients with generalized anxiety disorder, or GAD. There are approximately 10 million diagnosed adults in the U.S. with GAD. It is important to note that about half of patients who receive treatment do not respond adequately to initial therapy.

Speaker Change: We continue to advance our other pipeline programs, including $12 84.

Sharon Mates: ITI-1284 is a deuterated lumateparone 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 2 clinical trial, evaluating ITI-1284 as adjunctive therapy to anti-anxiety medications in patients with generalized anxiety disorder, or GAD. There are approximately 10 million diagnosed adults in the U.S. with GAD. It is important to note that about half of patients who receive treatment do not respond adequately to initial therapy.

Speaker Change: <unk> hundred 84 is it due to rated <unk> and is an important drug candidate as we continued to build our neuropsychiatry franchise.

Speaker Change: This quarter, we expect to initiate patient enrollment in our phase II clinical trial evaluating ITI 284, as adjunctive therapy, antianxiety medications and patients with generalized anxiety disorder or <unk>.

There are approximately 10 million diagnosed adults in the U.S. 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 a 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-1 inhibitor program includes LENRISPODUN and ITI-1020. Our Phase II study with LENRISPODUN for Parkinson's disease is ongoing, and top-line results are expected in 2025. Besides motor symptom improvement, we are exploring the effects of LENRISPODUN on cognition, a key non-motor manifestation of the disease, and measuring biomarkers of neuroinflammation to help inform next steps.

Speaker Change: There are approximately 10 million diagnosed adults in the U S with J D.

Speaker Change: It's important to note that about half of patients who received treatment do not respond adequately to initial therapy.

Sharon Mates: 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 a phase two clinical study in psychosis associated with Alzheimer's disease, as well as a phase two study in agitation associated with Alzheimer's disease. Our phosphodiesterase-1 inhibitor program includes lenrispodin and IPI-1020. Our Phase II study with Lenros-Poten for Parkinson's disease is ongoing, and top-line results are expected in 2025. Besides motor symptom improvement, we are exploring the effects of lenrospotent on cognition, a key non-motor manifestation of the disease, and measuring biomarkers of neuroinflammation to help inform next steps.

Speaker Change: We believe ITI 12, 84 is well suited for this patient population and could offer an effective safe and well tolerated treatment.

Speaker Change: 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 at Phase II study in agitation associated with Alzheimers disease.

Our phosphodiesterase-1 inhibitor program includes LENRISPODUN and ITI-1020. Our Phase II study with LENRISPODUN for Parkinson's disease is ongoing, and top-line results are expected in 2025. Besides motor symptom improvement, we are exploring the effects of LENRISPODUN on cognition, a key non-motor manifestation of the disease, and measuring biomarkers of neuroinflammation to help inform next steps.

Speaker Change: Our phosphodiesterase one inhibitor program includes language potent at ITI <unk> 'twenty.

Speaker Change: Our phase II study with landlords potent 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 on cognition, a key non-motor manifestation of the disease, and measuring biomarkers of neuroinflammation to help inform next steps.

Speaker Change: Besides motor symptom improvement, we are exploring the effects of lenders potent and cognition are key non motor manifestations of the disease and measuring biomarkers of neuro inflammation to help inform next steps.

Sharon Mates: Our second PDE1 product candidate, IT-1020, is being developed for oncology indications. We are currently conducting a Phase I single ascending dose study with ITI-1020 in healthy volunteers. I'd also like to give a quick update on our earlier stage program. We're exploring ITI-333 to treat opioid use disorder and pain. Our multiple Ascending dose study and the 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.

Our second PDE1 product candidate, IT-1020, is being developed for oncology indications. We are currently conducting a Phase I single ascending dose study with ITI-1020 in healthy volunteers. I'd also like to give a quick update on our earlier stage program. We're exploring ITI-333 to treat opioid use disorder and pain. Our multiple Ascending dose study and the positron emission tomography study are both ongoing.

Speaker Change: Our second PD, one product candidate ATI 2020 is being developed for oncology indications.

Speaker Change: We're currently conducting a phase one single ascending dose study with ITI <unk> in healthy volunteers.

Speaker Change: I'd also like to give a quick update on our earlier stage programs.

Speaker Change: We're exploring ITI <unk> to treat opioid use disorder and pain.

Speaker Change: Our multiple ascending dose study and 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 demonstrate improvement in preclinical models of anhedonia and a reduction in symptoms of anxiety

Speaker Change: Finally last year, we introduced a portfolio of non hallucinogenic psychedelics for the treatment of mood anxiety and other neuropsychiatric disorders.

Sharon Mates: ITI 1549, the lead candidate, is advancing preclinical development, and we expect to begin clinical testing in 2025. A scientific poster describing the preclinical development 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 and demonstrate improvement in preclinical models of anhedonia and a reduction in symptoms of anxiety

Speaker Change: <unk> 49, the lead candidate is advancing preclinical development and we expect to begin clinical testing in 2025.

Speaker Change: A scientific poster describing the preclinical advancement of ITI <unk> dollars 49 will be presented next week at the society of biological Psychiatry annual meeting.

Speaker Change: In this poster we further describe the novel mechanism of action of ITI <unk> 49, we also demonstrate improvement in preclinical models of anhedonia and a reduction in symptoms of anxiety.

Sharon Mates: 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?

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.

Speaker Change: We look forward to sharing this information following our poster presentation.

Speaker Change: We are in a strong financial position to maximize the opportunities ahead of us with cap lighter and we continued to build a robust pipeline we.

Speaker Change: We ended the first quarter was approximately $477 $4 million in cash cash equivalents and investment Securities. In April 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?

Speaker Change: I'll now turn the call over to Mark to further discuss this quarter's kept lighter 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 Cyber Attack that occurred during the quarter. CAPLYTA's growth continues to be driven by a 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.

Mark Neumann: Thanks, Sharon and good morning, everyone.

Mark Neumann: Capital either strong performance continued in Q1 of 2024 with robust year over year growth in total prescriptions of 39% despite.

Mark Neumann: Despite typical first quarter seasonal dynamics as well as the industry disruption caused by the change health cyber attacks that occurred during the quarter.

Mark Neumann: CAPLYTA's growth continues to be driven by a 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.

Mark Neumann: Capillatus growth continues to be driven by the strong uptake in bipolar depression, where it has solidified its position as the first and only treatment option indicated for patients with bipolar one and bipolar depression, as monotherapy and adjunctive therapy with lithium or valproate.

Mark Neumann: 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 Kefalite's proven efficacy, favorable safety and tolerability profile, and convenient once-daily dosing with no titration required.

We also continue to see steady growth in schizophrenia.

Mark Neumann: 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.

Mark Neumann: We continued to expand our prescriber base, which now stands at more than 39000 healthcare providers since launch.

Mark Neumann: Physicians appreciate capillatus proven efficacy favorable safety and Tolerability profile and convenient once daily dosing with no titration required.

Mark Neumann: 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 that depicts the experience of people living with bipolar depression and the benefits Capileta may provide.

Beyond a compelling product profile, the team's commercial execution continues to be very strong.

Mark Neumann: Beyond the 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 that depicts the experience of people living with bipolar depression and the benefits Capileta may provide.

Mark Neumann: Our sales team is currently educating our prescriber base, which includes psychiatrist nurse practitioners and primary care physicians.

Mark Neumann: 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 that 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 to 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 2 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.

Mark Neumann: 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 capital Ida may provide them.

Mark Neumann: We also continue to enjoy a strong market access position with broad access to over 99% of lives covered in Medicare and Medicaid and about 90% of lives covered in commercial. In early Q4 2023, Capilita 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 2020.

Mark Neumann: 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.

Mark Neumann: In early Q4, 2023 capital light gained unrestricted status on two of the largest Medicare part D plans.

Mark Neumann: We are pleased with the initial results of these changes and expect to see the full impact of these changes throughout 2024.

Mark Neumann: 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 U.S. 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 market. 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?

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 U.S. 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 market.

Mark Neumann: As Sharon mentioned, the commercial opportunity for capital either within its current indications is large and represents nearly half of the approximately $68 million annual antipsychotic prescriptions in the U S.

Mark Neumann: We will continue to invest behind the brand and 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?

Speaker Change: In closing we are pleased with capital light as strong performance.

Mark Neumann: <unk> 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 capital Ita as a first choice treatment across mood disorders.

Mark Neumann: We look forward to continuing to update you on the success of capital items.

Mark Neumann: I'll now turn the call over to Larry to further discuss our financial performance Larry.

Lawrence J. 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 net percentage in the first quarter increased to the mid-30s, consistent with our guidance.

Larry: Thank you Mark I will provide highlights of our financial results for the first quarter ending March 31 2024.

Larry: In the first quarter net product sales of capital either 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 net percentage in the first quarter increased to the mid-30s, consistent with our guidance. We expect that gross 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.

Mark Neumann: Our net sales growth in the first quarter was primarily driven by increased prescription demand and to a lesser extent higher inventory levels.

Mark Neumann: Our gross to net percentage in the first quarter increased to the mid <unk> consistent with our guidance, we expect our gross to net percentage to remain in the mid <unk> for the remainder of the year.

Lawrence J. Hineline: We expect that gross net percentage to remain in the mid-30s for the remainder of the year. We believe underlying demand for Capilata will remain strong, and we are reiterating our full year 2024 Capilata Net Sales Guidance of $645 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.

We expect that gross net percentage to remain in the mid-30s for the remainder of the year. We believe underlying demand for Capilata will remain strong, and we are reiterating our full year 2024 Capilata Net Sales Guidance of $645 to $675 million.

Mark Neumann: We believe underlying demand for capital item will remain strong and we are reiterating our full year 2024 cap rate and net sales guidance of $645 million to $675 million okay.

Mark Neumann: Selling general and administrative expenses were $113 1 million for the first quarter of 2024.

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.

Mark Neumann: <unk> to $98 $9 million for the same period in 2023.

Mark Neumann: Research and development expenses for the first quarter of 2024, or $42 8 million compared to $38 million for the same period in 2023.

Lawrence J. Hineline: 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

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.

Mark Neumann: Our financial position remains strong cash cash equivalents and investment securities totaled $477 4 million at March 31, 2024, compared to $499 7 million at December 31 2023.

Mark Neumann: In April 2024, we completed a public offering of our common stock in which we sold approximately seven 9 million shares for aggregate 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.

This concludes our prepared remarks. Operator, please open the line for questions

Operator: [Operator Instructions] The first question comes from Jessica Fye with J.P. Morgan. Your line is open.

Speaker Change: Thank you as a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.

Mark Neumann: Please limit to one question each please standby, while we compile the Q&A roster.

Mark Neumann: 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 the demonstrated commercial track record and a robust balance sheet.

Jessica Fye: 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.

Jessica Fye: If it's something you wouldn't want to do simultaneous with the MDT launch for example, or do you think there is the organizational capacity to do both at the same time.

Jessica Fye: <unk>.

Sharon Mates: Hi, guys, good morning. Thank you for taking the question. So I was wondering with the 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 do 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? Jessica and 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 that, I'll let Mark speak, but I know what he's going to tell you about. You probably don't want to launch two new products simultaneously. However, we certainly have the bandwidth so that we could stagger these and have 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.

Jessica Fye: Hi, guys, good morning. Thank you for taking the question. So I was wondering with the 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 do 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.

Mark Neumann: Hi, Jessica this is Sharon thanks for the question.

Sharon Mates: So yes.

Sharon Mates: We're always looking for new opportunities and as you said with a robust balance sheet that certainly allows us.

Sharon Mates: Right.

Sharon Mates:

Sharon Mates: Opportunities that our marketed products.

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. We probably don't want to launch simultaneously 2 new product. However, we do certainly have the bandwidth that we could stagger these and have 2 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.

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. We probably don't want to launch simultaneously 2 new product. However, we do certainly have the bandwidth that we could stagger these and have 2 products in their launch phases simultaneously.

Sharon Mates: As to I'll, let mark speak, but I know what.

Mark: What he's going to tell you.

Speaker Change: Got it.

Speaker Change: You, probably don't want to launch simultaneously to new product. However, we do certainly have the bandwidth that we could stagger these and.

Speaker Change: And have two products.

Speaker Change: Their launch for Asia 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, 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: Yes, Sharon, 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 salesforce currently has in their call universe.

Mark: Yes, Sharon.

Sharon Mates: Yes.

Mark: I think you've got it right.

Mark: Certainly we have the capacity and the capability of doing it I think when you have a product as strong as capital Ita 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 <unk>.

Mark: Strategic fit we look for products that have compelling product profiles and would be a good fit with the call points that our sales force.

Mark: Currently has in their call universe. So we look at all of those things and up until this point, we haven't found the right fit.

Mark Neumann: 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.

Aaron: Aaron said.

Aaron: We would certainly welcome and other products into.

Aaron: And of 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.

Speaker Change: One moment for the next question.

Speaker Change: Yes.

Speaker Change: The next question comes from Brian Abrahams with RBC capital markets. Your line is open.

Brian Corey Abrahams: Hi, there good morning, Thanks for taking my question.

Brian Corey Abrahams: Curious if you could talk about any initial kols feedback that you received on the MDT data and where <unk> could potentially fit in and I guess, along those lines I'm also curious how the topline MDT data may have impacted or.

Brian Corey Abrahams: There may be impacting uptake in bipolar depression, if youre seeing any pull throughs are sort of early shifts.

Brian Corey Abrahams: Shifts in use patterns there. Thanks.

Sharon Mates: 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 among 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 sot of early shift in issue patterns there? Great. Hi, Brian. Thanks for the questions. And maybe, Suresh, would you like to start? I'll just give you an overview of the KOLs.

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 among 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 sot of early shift in use patterns there? Thanks.

Speaker Change: Great Hi, Brian Thanks for the questions.

Speaker Change: 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.

Sharon Mates: Great. Hi, Brian. Thanks for the questions. And maybe, Suresh, would you like to start? I'll just give you an overall of the KOLs. It's been very gratifying to hear their responses and their enthusiasm for 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 [Inaudible]?

Suresh: To hear their responses and their enthusiasm.

Suresh K. Durgam: It's been very gratifying to hear their responses and their enthusiasm. 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 have been like?

Speaker Change: Uplighter.

Speaker Change: Suresh is at I think he is sitting in.

Suresh: Some of them off to the side right now so.

Suresh: Maybe Raj do you want to say, whether you've had any further feedback and what your conversations with kols.

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 from the 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 the results and are looking forward for the second study.

Raj: Yes in terms of the conversations with Kols I have met several kols.

Suresh: Yeah.

Raj: And the feedback on our data on 501 study is very very positive.

Raj: And also with the robustness of the data showing in all of those.

Raj: Endpoints, both the primary and key secondary end clients and also the celebrated patient data.

Raj: Our scale.

Raj: So they were very happy to see that results and looking forward for the second study.

Mark Neumann: 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? Yeah.

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?

Raj: And as to the uptake on if there is.

Raj: Any pull through.

Raj: Sure.

Speaker Change: I'm not sure.

Raj: 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 the presentation of the data.

Mark Neumann: Yeah, 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 the presentation of the data.

Mark: Yes sure Brian.

Mark: I think it's far too early to see.

Mark: An impact of the most recent results on prescribing as you say within within bipolar depression.

Mark: Typically any kind of lift that you might get on your your current indications.

Mark: Usually comes after data is presented in the scientific literature.

Mark: And I know Suresh and his team are working hard on that for future presentations of the data, but at this point.

Mark: I think we've seen any kind of material lift in our existing indications from presentation of the data.

Speaker Change: Got it that's all really helpful. Thanks, so much.

Sharon Mates: Got it. That's all really helpful. Thanks so much. And just to say that we hope to be presenting the 501 data at medical meetings later this year.

Brian Abrahams: Got it. That's all really helpful. Thanks so much.

Speaker Change: And wanted to say.

Sharon Mates: And just to say that we hope to be presenting the 501 data at medical meetings later this year.

Mark: We hope to be presenting a 501 data at medical meetings later this year.

Operator: One moment for the next question. The next question comes from Andrew Tsai with Jeffreys. Your line is open.

Speaker Change: One moment for the next question.

Mark: Okay.

Mark: The next question comes from Andrew Tsai with Jefferies. Your line is open.

Andrew Tsai: Thanks for taking my question. Maybe on MDD, since we're 1 or 2 months away from second half 2024, is the Q3 filing a possibility after the second data set reads out? Or should the street be thinking Q4 at this juncture? And then, in the scenario in which the second data set did look different, would you still look to file in the second half, or is there a scenario in which you waited for the third data set later in 2025 before filing the sNDA? Thank you.

Andrew Tsai: Hey, good morning, Thanks for taking my question.

Andrew Tsai: Maybe on MDT, since where one or two months away from second half 2024.

Andrew Tsai: Q3 filing.

Andrew Tsai: 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 data set did look different.

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 have to drop everything into shells 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.

Andrew Tsai: Would you still look to file in second half or is there a scenario in which.

Andrew Tsai: You waited for the third dataset later in 2025 before following sandy Thank you.

Sharon Mates: So first on, I think, 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 have to drop everything into shells 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.

Andrew Tsai: Thanks.

Speaker Change: I didn't write down your questions. So I hope I remember all of them.

Speaker Change: So first on.

Speaker Change: I think on our potential filing.

Speaker Change: 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 you can anticipate that that.

Speaker Change: Most likely means June so.

Speaker Change: Then you'd have to drop everything into shells that are being created and put all the data together so.

Speaker Change: When we say a filing in the second half I would tell you Q3 is aggressive.

Speaker Change: Not not not doable, but aggressive.

Speaker Change: So.

Sharon Mates: And then you ask 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 the timeline where we will be submitting our application in the second half of this year.

Speaker Change: So that's the answer to that question and then you asked about.

Speaker Change: What is our file.

Speaker Change: Filing strategy and I think first of all we need to see the data.

Speaker Change: Which we will do soon.

Speaker Change: We do.

Speaker Change: 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.

Speaker Change: In the second half of this year.

Speaker Change: Great. Thank you. Thank you.

Operator: The next question comes from Charles Duncan with Cantor. Your line is open.

Speaker Change: One moment for the next question.

Speaker Change: Yeah.

Speaker Change: The next question comes from Charles Duncan with Cantor Your line is open.

Charles Duncan: Morning, Sharon, and team, congratulations 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 numbers of patients from clinical sites other than from 501? Thanks.

Charles Cliff Duncan: Good morning, Sharon and team congrats on a strong commercial performance in the quarter as well as recent data.

Charles Cliff Duncan: Two part question.

Charles Cliff Duncan: One is if <unk> is approved.

Charles Cliff Duncan: Hunk of therapy, and MDT can you provide us a little color on what you would anticipate sales force sizing to be and if eventual demand towards the product in that market could drive the franchise to profitability and then with regard to five vote to could you remind us of the.

Charles Cliff Duncan: 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?

Charles Cliff Duncan: Okay.

Charles Cliff Duncan: Mark do you want to take the first part and then Soares the second part.

Mark Neumann: Yes, 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 in the psychiatric community. We do have a segment of primary care that we currently call on.

Mark: Yes, sure Hi, Charles Yes, what we said in the past about salesforce size with an eventual.

Mark: Approval in NPD is that we certainly would expect to significantly increase the size of our sales force.

Mark Neumann: Yes, what we said in the past about Salesforce size with an eventual approval in MVD is that we certainly would expect to significantly increase the size of our Salesforce. 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 in the psychiatric community. We do have a segment of primary care that we currently call on.

Mark: As you know currently.

Mark: Our sales force has a target audience of about 43000 patient physicians, the vast majority of them being psychiatrist 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.

Mark: 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 anti psychotics for that condition.

Mark Neumann: 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 for 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 this 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.

Mark: But as we contemplate an approval in MDT the expansion would come by a much larger.

Mark: Target audience within the primary care community there arent many more psychiatrists that we don't already call on for our current indications, but it would be for an expansion into primary care.

Mark: As we get closer to the timing of a potential approval will come back to you with more details about the specific size and timing.

Mark: We will be executing against.

Suresh K. Durgam: Okay and--- Suresh, I think there's a second part. Yes.

Sharon Mates: Okay and---

Mark Neumann: Suresh, I think there's a second part, yes.

Mark: Okay.

Mark: <unk> I think there's a second part.

Suresh Durgam: Yes, in terms of the sample size, it's a 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 U.S., and about the remaining coming from ex-U.S. sites.

Speaker Change: Yes in terms of the sample size.

Mark: It's very similar sample size for <unk> compared to 501.

Mark: And in terms of the clinical sites that has no overlap of sites, but however.

Mark: We tend to include about 30% of patients coming from U S.

Mark: And about the remaining coming from ex U S sites.

Suresh K. Durgam: So there's some [Inaudible] site overlap, but there's also site overlap. Yes, because you don't want to be competing with yourself when you're enrolling patients.

Sharon Mates: So there's some context site overlap.

Mark: So there is some contraction.

but there's also site overlap. Yes, because you don't want to be competing with yourself when you're enrolling patients.

Suresh Durgam: Yes.

Mark: Site overlap.

Sharon Mates: Yes, because you don't want to be competing with yourself when you're enrolling patients.

Speaker Change: Yes, because you don't see competing with yourself when you're enrolling patients.

Charles Duncan: Got it. It makes sense. Thank you.

Speaker Change: Got it makes sense. Thank you.

Operator: The next question comes from Marc Goodman with Leerink Partners. Your line is open.

Speaker Change: One moment for the next question.

Speaker Change: The next question comes from Marc Goodman with Leerink Partners. Your line is open.

Speaker Change: Yes.

Marc Harold Goodman: <unk> four 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.

Marc Harold Goodman: Decade from new products and Larry could you also just tell us what the inventory change was in the quarter. Thanks.

Marc Harold Goodman: Yes.

Suresh K. Durgam: 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 though market over the past decade from new products? And Larry, could you also just tell us what the inventory change was in the quarter? Thanks. Okay, Suresh, do you want to start talking about 2-14?

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 though market over the past decade from new products? And Larry, could you also just tell us what the inventory change was in the quarter? Thanks. Okay,

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 though market over the past decade from new products? And Larry, could you also just tell us what the inventory change was in the quarter? Thanks.

Speaker Change: Okay, <unk> do you want to start with talking about.

Sharon Mates: Okay, Suresh, do you want to start with talking about 214?

Suresh, do you want to start talking about 2-14?

Suresh K. Durgam: Yes, 214, that is 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, we are evaluating motor symptom improvement. We are also evaluating cognition measures as well as biomarkers for inflammation. So based on the data from that, we will decide on the next steps, looking at the data we read from that. That study is a 4-week study. It's-- the primary endpoint is the Hauser diary.

Suresh Durgam: Yes, 214, that is 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, we are evaluating motor symptom improvement. We are also evaluating cognition measures as well as biomarkers for inflammation.

Marc Harold Goodman: Sure.

Marc Harold Goodman: Yes.

Speaker Change: And that is under supported.

Speaker Change: Gordon.

Speaker Change: We have an ongoing study in Parkinson's.

Marc Harold Goodman: <unk> disease.

Gordon: And that is a proof of concept study and that study we are evaluating several things one evaluating the motor symptom improvement.

Marc Harold Goodman: I'll tell you evaluating cognition measures as well as biomarker inflammation. So.

So based on the data from that, we will decide on the next steps, looking at the data we read from that. That study is a 4-week study. It's-- the primary endpoint is the Hauser diary. We're looking for an increase in on-time without troublesome dyskinesia. And the key secondary is the MDS-UPDRS Part 2, which measures motor aspects of experiences of daily living. And we also, as I indicated, one of the things we are looking at is looking for biomarkers for inflammation in that study.

Marc Harold Goodman: So based on the data.

Marc Harold Goodman: The data from that we will decide on the next steps.

Marc Harold Goodman: Looking at.

Marc Harold Goodman: The data we read from that.

Marc Harold Goodman: The study is a four week study.

Suresh K. Durgam: We're looking for an increase in on-time without... Troublesome Dyskinesia. And the key secondary is the MDS-UPDRS Part 2, which measures motor aspects of daily living. And also, as I indicated, one of the things we are looking at is looking for biomarkers for inflammation in their study.

Marc Harold Goodman: The primary endpoint is the housing variety, we're looking for increase in on time without troublesome dyskinesia.

Marc Harold Goodman: And then secondly, the Mds <unk> part two.

Marc Harold Goodman: Just more of a aspects so for expedience 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.

Marc Harold Goodman: And we also as I indicated.

Marc Harold Goodman: One of the things we're looking at that is looking for biomarkers for inflammation in that.

Marc Harold Goodman: Sure.

Lawrence J. Hineline: And to the second part on inventory, Larry, do you want to take that? Yes, sure.

Sharon Mates: And to the second part on inventory, Larry, do you want to take that?

Marc Harold Goodman: And the second part on inventory, Larry do you want to take that.

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]. Can you quantify the inventory change? Now we've not given that sort of granular detail before, and it's difficult to do.

Lawrence J. 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].

Lawrence J. 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 this quarter, but the primary driver was prescriptions. Can you quantify the inventory change? Now we've not given that sort of granular detail before, and it's difficult to do.

Marc Harold Goodman: Sure.

Larry: During this quarter, we experienced strong prescription growth that's continued over the last several quarters and in this quarter.

Larry: Prescription demand was the primary driver for revenue there was to a lesser extent in inventory.

Marc Harold Goodman: Increase.

Larry: For this quarter, but the primary driver was scripts.

Speaker Change: Can you quantify the inventory change.

Can you quantify the inventory change? Now we've not given that sort of granular detail before, and it's difficult to do.

Marc Goodman: Can you quantify the inventory change?

Speaker Change: No we've not we've not given that sort of <unk>.

Lawrence J. Hineline: No, we've not given that sort of granular detail before, and it's difficult to do.

Speaker Change: Granular detail before and it's difficult to do.

Speaker Change: Okay.

Operator: One moment for the next question. The next question comes from Umer Raffat with Evercore. Your line is open.

Speaker Change: One moment for the next question.

Speaker Change: The next question comes from Omar <unk> with Evercore. Your line is open.

Mike 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 end-psychotics? I'm asking because SEROQUEL pursued this in the past, and although it was efficacious, the FDA didn't approve the monotherapy indication for MDD due to sage concerns.

Speaker Change: Hi, guys. This is Mike <unk> in for Omar. 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 NPD given kept lot has improved safety profile compared to the second generation atypical antipsychotics I'm asking because seroquel pursued this and the path.

Speaker Change: Although was efficacious.

Speaker Change: <unk> didn't approve the monotherapy indication for <unk> due to safety concerns.

Sharon Mates: And my follow-up is on the, I guess separate follow-up is on the PDE-1 program. Just a quick observation. Last quarter, they said the top line was expected in 1 half 25. Now, this quarter is just 2025. I was wondering if there's any sort of recruiting or trial delays on that front. Thank you.

Speaker Change: My follow up is on the I guess separate follow up is on the PD One program just a quick.

Speaker Change: Observation.

Speaker Change: Last quarter. They said the topline was expected in one half 'twenty five now this quarter is just 2020 I was wondering if there's any sort of recruiting or trial delays on that front. Thank you.

Speaker Change: Okay.

Sharon Mates: Okay. Suresh, do you want to take that?

Speaker Change: Suresh do you want to take that.

Unknown Speaker: In terms of--yes, you can start, Sharon, and then I can. go ahead.

Suresh Durgam: In terms of--yes, you can start, Sharon, and then I can.

Suresh: In terms of.

Sharon Mates: Yes, go ahead.

Suresh Durgam: Okay. In terms of the study itself, their recruitment is slower and we are---

Suresh: Yes, you can stock.

Suresh: Please go ahead.

Suresh: Okay.

Suresh K. Durgam: In terms of the study itself, their recruitment is...

Suresh: In terms of the study itself.

Suresh: Sure.

Suresh: Recruitment is.

Suresh: Slower.

Suresh: And we are.

Sharon Mates: Wait a minute, wait, wait, wait. It's 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 things to look at. It's also different times than when SEROQUEL was first approved.

Speaker Change: Wait wait wait.

Suresh: The $2 14.

Suresh: The first part of the question was an update on monotherapy for M. D D.

Suresh: And that.

Suresh: Urquell kidney did try for a monotherapy and as.

Suresh: You correctly pointed out.

Suresh: Mike that the FDA was concerned about.

Suresh: Their metabolic consequences et cetera.

Suresh: I think that.

Suresh: We're evaluating all of this.

Suresh: And obviously as you know.

Suresh: There isn't.

Suresh: The safety concerns that one sees with Seroquel with <unk> Brown.

Sharon Mates: It's also different times than when Seroquil was first approved. On the PDE program, 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, etc. But we still are in 2025 in our timeline. So we've just left out saying first half, second half or anything which I don't think we said before either. Maybe we did, I can't remember. Um, so I think it is 2025.

It's also different times than when Seroquil was first approved.

Suresh: So we're looking at that there are a lot of there are a lot of things to look at it is also different time span when seroquel was first.

On the PDE program, 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, etc. But we still are in 2025 in our timeline. So we've just left out saying first half, second half or anything which I don't think we said before either. Maybe we did, I can't remember. So I think it is 2025.

Suresh: Approved.

Suresh: On the PDE program.

Suresh:

Suresh: Recruitment has gone slower than.

Suresh: Than we originally thought.

Suresh: That could be because of studies that are ongoing that could also be because.

Suresh: We try to ensure that we get in appropriate patients et cetera.

Suresh: But we still are in 2025 and our timelines. So we've just.

Speaker Change: Left out, saying first half second half or anything which I don't think we had said before either maybe with 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 inflammation, 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.

Speaker Change:

Sharon Mates: 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 inflammation, and that should help inform us both on taking forward 2,14 and Parkinson's disease and in taking forward other molecules within the PDE1 space into several different areas. With that, Suresh, did you want to add anything else? I'm sorry; I didn't mean to cut you off.

Speaker Change: So.

Speaker Change: I think it is 2025 and <unk>.

Suresh: Also you are correct that.

Suresh: Or actually I think the speaker before you was correct.

Suresh: Talking about Parkinson's is a crowded market, but we think that we're getting.

Suresh: We should be getting some very good data on the use of the PD one inhibitors.

Suresh: Neuro inflammation and that should help inform us both on taking forward.

Suresh: 2014 in Parkinson's disease and and.

Suresh: Going forward other molecules.

Suresh: Within the PD, one space into several different arenas.

Suresh: 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, the MDD program, that's true that; again, we'll be looking at the data, and then we'll figure out what to do next steps for the monotherapy.

Suresh: No in terms of the.

Suresh: The 501 study the MD program, that's true again.

Suresh: Looking at the data and then we will figure it out what could go next steps for the mono therapy.

Suresh: Yeah.

Michael Gennaro DiFiore: Very helpful; thanks so much.

Speaker Change: Very helpful. Thanks, so much.

Operator: Please, stand by for the next question. The next question comes from Jason Gerberry with Bank of America. Your line is open.

Speaker Change: Please standby for the next question.

Suresh: Yeah.

Suresh: The next question comes from Jason <unk> 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 periods to get to proof-of-concept and figure out dose. And just trying to get a rough sense of timeline here, ultimately.

Jason: Hey, guys. Good morning, and thank you for my taking my question.

Jason: ITI 12 84.

Jason: Not seeing this RCT dot 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 or theres going to be like 12 week treatment period to get to proof of concept and figure out dose and I'm just trying to get a rough sense of timeline here ultimately and then just as my follow up if I can squeeze it in I didn't hear an update on <unk>.

Jason: <unk> features I think you guys were waiting for the minutes, which tend to come like I think 30 days after the meeting so just.

Suresh: Curious if theres a mixed features update thanks.

Sharon Mates: 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. 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 is that we will be posting these studies, as 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.

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.

Speaker Change: I'll start with the second part.

Suresh: Ask Suresh.

Speaker Change: The rush to chime in on.

Suresh: The first part so could we did update you on the next features and said that we would come back to you after.

Speaker Change: Our readout at 502.

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, as 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: And as we continue to put together our strategy.

Suresh: For next features an M D D.

Speaker Change: Stay tuned.

Suresh: Hopefully in the near future, we'll have some updates for you.

Suresh: On the next phase.

Suresh: And.

Suresh: Well I'll give you the short answer on $12 84, as we will be posting.

Suresh: These studies please.

Suresh: Ed.

Suresh: Before the end of this quarter and.

Suresh: I'll.

Speaker Change: Leave it to <unk> to talk to you about the design and powering these studies.

Suresh Durgam: Yes, regarding the 1284 studies, we have 3 programs right now, that is 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 registration study. It's as an adjunct to treatment, and that is sample size would be somewhere in the range of about 600 patients. It's going to be 3 arms, placebo versus 2 doses. Again, the details, once we start the trial soon, in the next few--we'll be posting that online for the [Inaudible].gov. Similarly, for 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 study. And they are intended to start this in the second quarter.

Speaker Change: Yes.

Speaker Change: Regarding the tolerated four studies, we have three programs right now.

Speaker Change: That is the <unk> program.

Speaker Change: Psychosis and Alzheimers disease.

Speaker Change: And education in Alzheimers disease. The first study we will be starting as the Geordie program that is.

Speaker Change: Fully powered study.

Speaker Change: So did you say it held steady.

Speaker Change: Just as an adjunct treatment and.

Suresh K. Durgam: 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 weeks, we'll be posting that online at clintrials.gov. Similarly, for agitation and psychosis in Alzheimer's, those are Phase II studies but are powered as registrational studies. Those details will also be posted as soon as we start the study, and it is intended to start this in the second quarter.

Speaker Change: Sample size would be somewhere in the range of about 600 patients it's going to be three arms placebo.

Speaker Change: Bus two doses again the details once we started the trial.

Speaker Change: So in the next few.

Speaker Change: We will be posting that online <unk> dot gov.

Speaker Change: Similarly for the.

Suresh Durgam: Similarly, for 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 study. And they are intended to start this in the second quarter.

Speaker Change: <unk> and psychosis and Alzheimers.

Speaker Change: Our phase II studies, but Howard as you.

Speaker Change: Just say some studies those details also will be a poster at <unk>. So we started the studies.

Speaker Change: Intended for stock.

Speaker Change: This.

Speaker Change: The second quarter.

Speaker Change: Got it thank you.

Operator: Please, stand by for the next question. The next question comes from Sumant Kulkarni with Canaccord. Your line is open. Thanks for taking my questions. Sorry about that.

Operator: Please, stand by for the next question. The next question comes from Sumant Kulkarni with Canaccord. Your line is open.

Speaker Change: Please standby for the next question.

Speaker Change: The next question comes from Sumit Kulkarni with Canaccord. Your line is open.

Thanks for taking my questions. Sorry about the two-parter. So on the last MDD data-focused call, I know you 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 this 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.

Sumant Kulkarni: Thanks for taking my questions. Sorry about the two-parter. So on the last MDD data-focused call, I know you 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?

Sumant Satchidanand Kulkarni: So on the last MDD data-focused call, I know you 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 for the various sub-indications of depression? And on Lumetapron for autism spectrum disorder, I'm asking because there is a high unmet need. 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 on the market right now in terms of logistics around dosing?

Sumant Satchidanand Kulkarni: Thanks for taking my question. Sorry about the two-parter.

Sumant Satchidanand Kulkarni: Alright, Thanks for taking my question sorry about the two partners. So on the last NPD data focused call. I know you did question me to hold off on this question on does this update so I'll ask it now are 12 84 are you planning to specifically develop that product in the various sub indications of depression and on limit that run for autism spectrum disorder, I'm asking the unmet need is high how does the company.

And on LUMATEPERONE for autism spectrum disorder, I'm asking because this 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.

Sumant Satchidanand Kulkarni: Thinking about dosing for pediatric patients is that a weight based dosing paradigm.

Speaker Change: Simple as the product gets out there in the market right now in terms of.

Speaker Change: Sticks around dosing thanks.

Speaker Change:

Sharon Mates: Suresh, do you want to take the second part, and then I'll need you to repeat the first part?

Speaker Change: Suresh you wanted to take the second part and then I'll.

Suresh: I need you to repeat the first part.

Suresh Durgam: Regarding the second part about 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 come 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 adults, for example, from 13 to 17, it will be similar to 42 milligrams. So the lower age groups we have to figure out by the PK studies.

Suresh: Yes.

Suresh: Regarding the second part about the.

Speaker Change: Autism.

Suresh: And for <unk>, we are going to be starting those studies.

Speaker Change: Irritability in autism.

Speaker Change: And regarding the dosing we are.

Speaker Change: Looking at we have the finished fast finished the PK studies.

Speaker Change: For the lower age group.

Speaker Change: Two if I could quite attend.

Speaker Change: Daniel So based on the PK exposure level that comes from that study will be.

Speaker Change: Deciding on.

Speaker Change: The dosing for those patients.

Speaker Change: Patients in the upper age group that will be similar to what it is.

Speaker Change: As an add on for example from 13 to 17 it can be it will be it will be similar to product. The milligrams. So the lower it's going to have to figure it out by the PK studies.

Sharon Mates: Got it. And the first part was in 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 depression context? Yeah, well,

Got it. And the first part was in 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 depression context?

Speaker Change: Got it and on the first part was on <unk> before we know youre developing for Alzheimer's disease psychosis and agitation in 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.

Speaker Change: Yeah.

Sharon Mates: 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. Thank you.

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.

Speaker Change: We are contemplating other.

Speaker Change: Other indications within 12 months to 84, but let US get these studies started first and then we'll come back to you with the other studies that will be.

Speaker Change: That will be doing.

Speaker Change: Thank you.

One moment for the next question. The next question comes from Jeffrey Hung with Morgan Stanley. Your line is open. Hi, this is Michael Riad on behalf of

Operator: One moment for the next question. The next question comes from Jeffrey Hung with Morgan Stanley. Your line is open.

Operator: One moment for the next question. The next question comes from Jeffrey Hung with Morgan Stanley. Your line is open. Hi, this is Michael Riad on behalf of

Speaker Change: One moment for the next question.

Speaker Change: Okay.

Speaker Change: The next question comes from Jeffrey Hung with Morgan Stanley. Your line is open.

Michael: Hi, This is Michael.

Michael: On for Jeff hung Thank you for taking our question.

Michael: Thinking more generally about the results from the study 501 versus four three.

Michael: How important is it to get DSM five classifiers into the label versus arent broad label like adjunct MDT I guess I'm just trying to ask what happens more regularly and scan their clinical practice and to what extent do classifiers influence treatment decision. Thanks, so much.

Michael Ryan: Hi, this is Michael Ryan 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 extend do you classifiers influence treatment decisions? Thanks so much.

Michael: Yeah.

Michael H. Riad: So I think our broad label is obviously what we always aim for, and what we're doing is exploring value of having anything specific in any label that we have. And again, 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? No.

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 specific in any label that we have. And again, 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?

Speaker Change: So I think our broad label.

Speaker Change: <unk> is obviously, what we always aim for and what we're doing is exploring.

Speaker Change: Value.

Speaker Change: Having anything.

Speaker Change: Specific in any label that we have.

Speaker Change: And again as we as we get the fiber to readout.

Speaker Change: We'll come back to you with further updates on exactly what it is.

Speaker Change: That our strategy.

Speaker Change: Is now and will be Mark did you want to add anything to that.

Mark: No I think that's good.

Speaker Change: Okay.

Mark Neumann: No. I think that's good.

Speaker Change: Okay.

Mark Neumann: Okay. The next question comes from Graig Suvannavejh with Mizzouho. Your line is open.

Sharon Mates: Okay.

Speaker Change: One moment for the next question.

Operator: The next question comes from Graig Suvannavejh with Mizuho. Your line is open.

Speaker Change: The next question comes from Greg Susan average with Mizuho. Your line is open.

Speaker Change: Good morning, everyone. This is charles wearing off or Greg. Thanks for taking my question. Given study 501 indicated a very strong with stable adjusted effects size of $4 nine does the company expect to see similar efficacy and study Pablo too.

Operator: Good morning, everyone. This is Charles Wang on for Greg. In Study 501 indicated a very strong placebo adjusted effect size of 4.9. Does the company expect to see similar efficacy in Study 502? Yeah, that was a point change, but 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. I know if you look at press events for other studies, 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, or are you OK? No, that's correct. Yeah, I would agree with that.

Charles Wang: Good morning, everyone. This is Charles Wang on for Greg. In Study 501 indicated a very strong placebo adjusted effect size of 4.9. Does the company expect to see similar efficacy in Study 502?

Greg Susan: Yes that was a point change that wasn't the effect size.

Greg Susan: The effect size was very strong as well.

Speaker Change: And I think what you're looking for the studies are powered.

Speaker Change: To show actually this study was powered to show.

Yes, 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 was powered to show a 2-point change because in adjunctive study, typically you are at the lower end of the 2 to 4-point change in the matter that you're seeing. So I think we're very close to the data--we hope very much that we have a strong read out as we saw in 501, but no 2 studies are alike. And you can-- as you know, if you look at precedents in other studies, no 2 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-- are you-- No, that's correct. Yeah, I would agree with that.

Sharon Mates: Yes, 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 was powered to show a 2-point change because in adjunctive study, typically you are at the lower end of the 2 to 4-point change in the matter that you're seeing. So I think we're very close to the data--we hope very much that we have a strong read out as we saw in 501, but no 2 studies are alike. And you can-- as you know, if you look at precedents in other studies, no 2 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-- are you--

Speaker Change: A two point change because an adjunctive studies typically you are at the lower end of the 2% to $4 change on the mattress that youre seeing.

Speaker Change: So I think we're very close to the data.

Speaker Change: We we hope very much that we have as strong a readout.

Speaker Change: As we saw in 501.

Speaker Change: But no two studies are alike.

Speaker Change: And you can as you know if you look at precedent at other studies there.

Speaker Change: No two studies are exactly the same even within the program. So we look forward to seeing the data and we'll update you as soon as we get it.

Speaker Change: So asking that you wanted to.

Speaker Change: No no Thats correct, yes, I would agree with that.

Suresh Durgam: No, that's correct. Yes, I would agree with that.

Multiple: One moment for the next question. The next question comes from Troy Langford with TD Cowen. Congrats on all the progress this quarter, and thank you 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?

Multiple: One moment for the next question. The next question comes from Troy Langford with TD Cowen.

Speaker Change: One moment for the next question.

Troy Langford: Congrats on all the progress this quarter, and thank you 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?

Speaker Change: The next question comes from Troy Langberg with TV Cowen Your line is open.

Troy Langberg: Hey, congrats on all the progress this quarter and thanks for taking our questions.

Troy Langberg: Just on the capital either 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.

Troy Langberg: How long do you think it will take for us to see the impact of the new TV Capillatus sales trajectory.

Mark Neumann: Yes, sure. I could take that. Yes. I think 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 6 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.

Speaker Change: Yeah sure I can take that yes.

Speaker Change: We are we've been very pleased with the.

Mark Neumann: Yeah, I think 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 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.

Speaker Change: The impact that the additional 50 representatives that we brought on.

Speaker Change: A little over a year ago.

Speaker Change: Typically it takes up to six months for.

Speaker Change: Representatives to see an optimized performance in their territory. So I think there they are 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.

Mark Neumann: And in terms of the DTC impact, we've been continuously running our DTC with the Lead in the Light 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 Lead in the Light 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.

Speaker Change: And in terms of the DTC impact we've been continuously running our DTC with a lead into light campaign.

Speaker Change: I mentioned in the prepared remarks, we are very pleased to have just very recently launched a new campaign that builds on the led and the light campaign.

Speaker Change: And we would expect to see the impact of that over the course of the year.

Speaker Change: As well we've been pleased with the response.

Speaker Change: That we've seen in all of the metrics that we track for our DTC programs.

Speaker Change: And we're very pleased to be able to refresh that.

Speaker Change: Creative campaign, so keep an eye out for that in the coming weeks and months.

Speaker Change: Great. Thanks for the color.

Speaker Change: One moment for the next question.

Operator: One moment for the next question. The next question comes from Ash Verma with UBS. Your line is open. Good morning.

Operator: One moment for the next question. The next question comes from Ash Verma with UBS. Your line is open.

Speaker Change: The next question comes from Ashwin <unk> with UBS. Your line is open.

Ashwin: Hi, good morning, Thanks for taking our question. So just quickly on the on the pipeline.

Ashwin: 1500, the psychedelic.

Ashwin: I just wanted to understand like what's the base molecule you're pursuing here what is the target study. It is hitting just mechanistically. If you can talk about like what is the value proposition.

Ashwani Verma: Good morning. Thanks for taking my question. 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.

Ashwin: 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 have been discovered and worked on internally, going based off of our many years of knowledge in serotonin biology and, in particular, 5-HT2 Biology. So that's what these molecules have been molded around.

Speaker Change: Yeah. Thanks.

Speaker Change: The first part of your question got a little muscle for them they need to ask you to repeat it but I think you were asking about the.

Speaker Change: The mechanism.

Speaker Change: Of the 1500 series and where it comes from.

Speaker Change: It is.

Speaker Change: The entire program has been developed in house.

Speaker Change: It has been.

Speaker Change: Discovered.

Speaker Change: The scaffold.

Speaker Change: Have been discovered and worked on internally.

Speaker Change:

Speaker Change: Based off of our.

Speaker Change: Many years of knowledge in serotonin biology, and in particular and.

Speaker Change: Five H T two biology.

Speaker Change: No.

Speaker Change: That's what these molecules have been.

Ashwani Verma: 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-HTQA agonists in general. So we're very pleased with that.

So that's what these molecules have been molded around,

Speaker Change: Molded around.

Speaker Change: And.

Speaker Change: We are very excited because they are agonist, but they do not have the mechanic activity.

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-HT2A agonists in general. So we're very pleased with that.

Speaker Change: In animals.

Speaker Change: And.

Speaker Change: Also they do not have the.

Speaker Change: Cardiovascular side effects that you see with five Ht agonist in general So we're very pleased with that.

Sharon Mates: [Operator Instructions] The next question comes from Ami Fadia with Needham. Your line is now open. Hi, good morning.

Operator: [Operator Instructions] The next question comes from Ami Fadia with Needham. Your line is now open.

Speaker Change: As a reminder, please limit to one question.

Speaker Change: Please standby for the next question.

Speaker Change: The next question comes from Ami <unk> 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 4-week study? Thank you. Suresh?

Operator: 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 inflammation. 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? Thank you.

Ami: Hi, good morning, Thanks for taking my question.

Ami: I had a quick follow up on ITI two one for you.

Ami: You mentioned, you're going to collect some biomarker data on information could.

Ami: Could you elaborate a little bit more about how that could translate into differentiation versus.

Ami: Existing treatment options within Parkinson's.

Ami: And also in the past.

Ami: You've talked about potentially looking at impact on movement in cognition.

Speaker Change: Could you sort of.

Speaker Change: Remind us.

Speaker Change: There are ways in which you would be measuring that.

Speaker Change: Four week study.

Speaker Change: Josh.

Speaker Change: Yes.

Sharon Mates: Suresh?

Suresh Durgam: In terms of the 214 Parkinson's study, that is a proof-of-concept study, as indicated, we are looking at the Movement Scales, Cognition, and Inflammatory Biomarkers. Your question is specifically regarding cognition. We are measuring what is called the symbol-digit modalities test. This measures the processing speed with a simple substitution task that is sensitive to detect 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.

Speaker Change: In terms of the.

Speaker Change: The $2 four Parkinson's study that is a proof of concept study.

Speaker Change: As indicated we are looking at the moment.

Speaker Change: Scales.

Speaker Change: Cognition and implementing Biomarkers.

Speaker Change: Your question specifically regarding the cognition, we are measuring what is gone.

Speaker Change: Symbol to get Martin modalities.

Speaker Change: This measure the processing speed.

Speaker Change: But the simple substitution.

Speaker Change: First that essentially to detect cognitive dysfunction.

Speaker Change: And.

Speaker Change: The scale is similar to the BSF <unk> Washington.

Speaker Change: What about Parkinson's patients this is a better washington of that.

Speaker Change: For Parkinson's patients.

Suresh K. Durgam: 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 of these biomarkers and in terms of the utility of that, that will help us in our other indications where we are pursuing in inflammation. That will help us figure out what other things we can do with that.

Speaker Change: In terms of the biomarker testing.

Speaker Change: Biomarkers for inflammation.

Speaker Change: IL six IL 18 Ccs.

Speaker Change: Hi.

Speaker Change: Being tested on other Biomarkers are tested.

Speaker Change: <unk>.

Speaker Change: The.

Speaker Change: The effect on these biomarkers.

Speaker Change: And in terms of the utility of that and that will help for us in our other indications we are pursuing.

Speaker Change: In inflammation that will help us figure out what other things we can do that.

Operator: One moment for the next question. Our next question comes from Corinne Johnson with Goldman Sachs. Your line is open.

Speaker Change: One moment for the next question.

Your line is open.

Corinne Johnson: Good morning, everyone. I want to circle back to your answer to Jessica's question earlier around financial interest and 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 when 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 products.

Speaker Change: Our next question comes from Corinne Johnson with Goldman Sachs. Your line is open.

Corinne Johnson: Good morning, everyone.

Corinne Johnson: I wanted to circle back to your answer to Jessica question earlier around potential interest in asset acquisition and I guess as you.

Corinne Johnson: Think about and evaluate the assets that are out there what sort of parameters you have in mind as you evaluate these opportunities and how do you think about that development our business development in the context of not just the commercial priorities, but also your other pipeline.

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.

Speaker Change: Yeah.

Speaker Change: Right.

Speaker Change: Start and I'll ask Mark if he wants to.

Speaker Change: Ed anything so hi, Craig Thanks for the question so obviously.

Mark: 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.

Speaker Change: So that has.

Mark: That as they're out there.

Mark: They can be speaking about both <unk> and <unk>.

Mark: And another product.

Sharon Mates: Going down the wrong step one step, if we are not successful there, which we do look at, 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 looked at late-stage development assets. And we've been moving earlier and earlier. 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.

Going down the wrong step one step, if we are not successful there, which we do look at, 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 looked at late-stage development assets. And we've been moving earlier and earlier.

Mark: Okay.

Mark: Going down the wrong one step if.

Mark: If we are not successful there, which we do look and to date, we haven't brought in anything there we go to Adjacencies.

Mark: So.

Mark: 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.

Mark: And then.

Mark: We also look at.

Mark: 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 on the 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 only early stage programs. So you're always weighting these things. And 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.

Mark: And.

Mark: You're absolutely right in.

Mark: Implying or suggesting or asking a question of how do you then prioritize bringing in an early stage product.

Sharon Mates: And I have to tell you, every time we evaluate something that's in the 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, Unknown Attendee, Umer Raffat, Ami Fadia, Leonid Timashev, Jason Gerberry, Leonid Timashev, Jason Gerberry, Leonid Timashev, Jason Gerberry, Leonid Timashev, Jason Gerberry, Leonid Timashev, Jason Gerberry, Leoni

Mark: Our own pipeline.

Mark: And I have to tell you every time, we evaluate something that early stage.

Mark: 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.

Mark:

Mark: Wood.

Mark: Probably displace one of our own early stage programs, you always weighing these things and we.

Mark: We do we do look across the spectrum now.

Mark: From the marketed products that I gave you the order that we look at these all the way down to early stage programs.

Mark: Yeah.

Mark: Thanks.

Speaker Change: Paul I appreciate it.

Operator: One moment for the next question. The next question comes from David Amsellem with Piper Sandler. Your line is open.

Speaker Change: One moment for the next question.

Speaker Change: The next question comes from David <unk> 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 setting and, and Axon's ovality in late stage development. But I'm just wondering out loud, you've got a couple of randomized withdrawal studies that Axon is running on or has run on ovality, but then you also have more regular randomized studies. I'm just trying to get a sense from you or how you think 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.

David: Hey, Thanks, So I wanted to drill down a little more deeply on.

David: The <unk> program.

David: Particularly interested in your thoughts on the path forward in <unk>.

David: All timers agitation.

Speaker Change: With one product.

Speaker Change:

Speaker Change: Already approved for this further setting in exxon's ability at late stage development, but I'm just wondering out loud.

Speaker Change: <unk> got a couple of randomized withdrawal studies.

David: The axon is running on or has grown on a validated but then you also have more regular way randomized studies and I'm just trying to get a sense from you on how youre thinking about what are you going to need to do.

David A. Amsellem: I'm just trying to get a sense from you or how you think about what you're going to need to do to move AD agitation forward, given that it's not exactly a well-worn regulatory pathway. Thank you.

David: To move the 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 scales are allowed. We also know the FDA has been refining their requirements, et cetera. So I think that the study that we're doing, which Suresh told you about, it is a Phase II study powered as a Phase III study. 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, what scales you use in these studies, how you use them.

Speaker Change: Sure. Thanks for the question I'll start and then I'll ask Suresh if he wants to add anything.

Sharon Mates: You're correct. It's not a well-worn regulatory pathway, but the path is becoming clearer and clearer. With the approval of RIC-SALT in Alzheimer's agitation, we know what scales are allowed. We also know the FDA has been refining their requirements, et cetera. So I think that the study that we're doing, which Suresh told you about, is a Phase 2 study augmented as a Phase 3 study. We look forward to that data and then, and by the way, The randomized withdrawal study has been, we've gone back and forth with the FDA; 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.

Suresh: You are correct, it's not a well worn regulatory pathway, but the pathway is becoming clearer and clearer.

Suresh: With the approval of salty and.

David: All timers agitation, we know.

David: Okay.

Speaker Change: We also.

Speaker Change: The FDA has been refining the air requirements et cetera, So I think that the study that we're doing that Suresh.

Speaker Change: Told you about it is a phase III study powered as a phase III study.

Speaker Change: So.

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, 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 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? Just, again, to reiterate that...

Speaker Change: We look forward to.

David: That data and then and by the way the study has been.

David: We've gone back and forth with the FDA. We they are completely apprised and has had input into how you do these studies and what what you do and what scales you used in the study.

Sharon Mates: So, I think that, and the randomized withdrawal is something that is oftentimes used, and again, that 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? Just, again, to reiterate that...

David:

David: So I think that and the randomized withdrawal is something that is is oftentimes used.

David: And again that is with would be with discussion with the FDA.

David: As we go forward should we choose to want to use that paradigm.

Suresh Durgam: Just, again, to reiterate that the path, as you said, while it is not fully there, but at least with the breadth proposal, there is a path forward from that angle. We have to see if other designs would be okay with FDA at this point.

David: Stretch did you want to add anything.

Suresh K. Durgam: Just again, to reiterate that the path, as you said, while it is not fully there, but at least with the breadth proposal, there is a path forward from that angle. We have to see if other designs would be okay with FDA at this point.

Stretch: Just again to reiterate the path as you said why that is not fully there, but at least with the Brexit.

Stretch: Well there is a path forward from that angle. We have received other designs would be would be okay with FDA at this point.

Speaker Change: Very helpful. Thank you.

Speaker Change #104: And our last question.

Joel: Will come from Joel.

Operator: And our last question will come from Joel Beatty with Baird. Your line is now open.

Joel: BD with Baird. Your line is now open.

Joel: Thanks for taking my question for <unk> sales, how much growth is coming from new first time prescribers versus greater depth from existing prescribers.

Joel Lawrence Beatty: Thanks for taking my question. For CAPLYTA sales, how much growth is coming from new first-time prescribers versus greater depth from existing prescribers? Mark, do you want to take that? Yeah, Sharon, I can take it.

Joel Beatty: Thanks for taking my question. For CAPLYTA sales, how much growth is coming from new first-time prescribers versus greater depth from existing prescribers? Mark,

Joel Beatty: Thanks for taking my question. For CAPLYTA sales, how much growth is coming from new first-time prescribers versus greater depth from existing prescribers?

Joel: Yeah.

Joel Beatty: Mark, do you want to take that? Yeah, Sharon, I can take it.

Sharon Mates: Mark, do you want to take that?

do you want to take that? Yeah, Sharon, I can take it.

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, and that continues to grow at a strong rate each quarter. We're adding 3,000 to 4,000 new first-time prescribers every quarter, and we really haven't seen that slow down over the quarters. 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: Mark do you want to take that.

Mark Neumann: Yes, Sharon, I can take that. So we're seeing a nice balanced contribution both from increasing new prescribers as well as from depth of prescribing. Over time, as I mentioned in my prepared remarks, we now have over 39,000 unique prescribers of Kapalita, and that continues to grow at a strong rate each quarter. We're adding 3,000 to 4,000 new first-time prescribers every quarter, and we really haven't seen that slow down over the quarters. 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 an effort toward both getting new prescribers of Kapalita as well as increasing the depth of prescribing for each of those prescribers.

Mark: Yes, Sharon I can take that so we're seeing a nice balanced contribution both of.

Mark: Increasing new prescribers as well as depth of prescribing.

Speaker Change #100: Over time.

Mark: As I mentioned in my prepared remarks, we now have over 39000.

Mark: <unk> prescribers of cap line that continues to grow at a strong rate each quarter, we're adding 300 to 4000, new first time prescribers every quarter and.

Speaker Change #100: And we really haven't seen.

Speaker Change #100: That slowed down over the quarters. So we look at our desks then our breath metrics.

Speaker Change #100: For the launch and we're very encouraged by what we're seeing there so we.

Speaker Change #100: We continue to put effort toward both.

Speaker Change #100: Getting new prescribers of capital Ida as well as increasing the depth of prescribing for.

Speaker Change #100: For each of those prescribers.

Speaker Change #102: Thank you.

Operator: At this time, I would now like to turn the call back over to Sharon for closing remarks.

Speaker Change #102: 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 in 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.

Speaker Change #100: Yes.

Sharon Mates: Well thanks, everyone.

Sharon Mates: Participating on today's call and thanks for all of your questions.

Sharon Mates: As well.

Sharon Mates: We look forward to updating you.

Sharon Mates: Our M D D.

Speaker Change #100: <unk> studies as well as on our other studies, we think it's a very exciting time.

Speaker Change #100:

Speaker Change #100: For <unk>, 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. Thank you.

Operator: This concludes today's conference call. Thank you for your participation. You may now disconnect.

Speaker Change #103: Very much bye bye.

Speaker Change #105: This concludes today's conference call. Thank you for your participation you may now disconnect.

Speaker Change #103: Yeah.

Speaker Change #103: Okay.

Speaker Change #103: [music].

Speaker Change #103: Okay.

Speaker Change #103: [music].

Speaker Change #103: Okay.

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