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Edited Transcript of ITCI earnings conference call or presentation 2-Mar-20 1:30pm GMT

Q4 2019 Intra-Cellular Therapies Inc Earnings Call

NEW YORK Mar 12, 2020 (Thomson StreetEvents) -- Edited Transcript of Intra-Cellular Therapies Inc earnings conference call or presentation Monday, March 2, 2020 at 1:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Andrew Satlin

Intra-Cellular Therapies, Inc. - Executive VP & Chief Medical Officer

* Juan Fernando Sanchez

Intra-Cellular Therapies, Inc. - VP of Corporate Communications & IR

* Lawrence J. Hineline

Intra-Cellular Therapies, Inc. - Senior VP of Finance, CFO, Treasurer and Assistant Secretary

* Mark Neumann

Intra-Cellular Therapies, Inc. - EVP & Chief Commercial Officer

* Sharon Mates

Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President

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Conference Call Participants

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* Charles Cliff Duncan

Cantor Fitzgerald & Co., Research Division - Senior Analyst

* Jason Nicholas Butler

JMP Securities LLC, Research Division - MD and Senior Research Analyst

* Jessica Macomber Fye

JP Morgan Chase & Co, Research Division - Analyst

* Lin Tsai

Jefferies LLC, Research Division - Equity Analyst

* Marc Harold Goodman

SVB Leerink LLC, Research Division - MD of Neuroscience & Senior Research Analyst

* Robert Cummins Hazlett

BTIG, LLC, Research Division - MD & Biotechnology Equity Research Analyst

* Sumant Satchidanand Kulkarni

Canaccord Genuity Corp., Research Division - Analyst

* Umer Raffat

Evercore ISI Institutional Equities, Research Division - Senior MD & Senior Analyst of Equity Research

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Presentation

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Operator [1]

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Good morning, ladies and gentlemen, and welcome to the Intra-Cellular Therapies' Fourth Quarter and Full Year Ended December 31, 2019, Financial Results Conference call. (Operator Instructions)

As a reminder, today's conference call is being recorded. I'd now like to turn the conference over to your host, Dr. Juan Sanchez, Vice President, Corporate Communications and Investor Relations. Please go ahead.

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Juan Fernando Sanchez, Intra-Cellular Therapies, Inc. - VP of Corporate Communications & IR [2]

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Thank you. Good morning, and thank you all for joining us for today's conference call. Our earnings press release providing a corporate update and details of the company's financial results for the fourth quarter and full year ended December 31, 2019, crossed the wire a short time ago and is available on our website at intracellulartherapies.com.

Joining me on the call today are Dr. Sharon Mates, Chairman and Chief Executive Officer; Dr. Andrew Satlin, Executive Vice President and Chief Medical Officer; Mark Neumann, Executive Vice President and Chief Commercial Officer; Larry Hineline, Senior Vice President and Chief Financial Officer; and Michael Halstead, Executive Vice President and General Counsel.

As a reminder, during today's call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy, safety and intended utilization of the company's product development candidates, our clinical and nonclinical plans, our plans to present or report additional data, anticipated conduct and results of ongoing and future clinical trials, plans regarding regulatory filings, future research and development, our plans regarding commercialization -- the commercialization of CAPLYTA and possible uses of existing cash and investment resources.

These forward-looking statements are based on current information, assumptions and expectations that 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're cautioned not to place undue reliance on these forward-looking statements, and the company disclaims any obligation to update such statements.

I will now turn the call over to Sharon.

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [3]

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Thanks, Juan. Good morning, everyone, and welcome to today's call.

2019 was a very successful year for Intra-cellular therapies. In December, we received FDA approval for CAPLYTA for the treatment of schizophrenia in adults. We are very excited about the launch of CAPLYTA later this month. Our launch plan is comprehensive and our preparations are fully on track. We have a highly experienced and competitively sized commercials team in place, and they are ready to execute.

Our sales leadership team and substantially all of our sales representatives are on board, and we are in the final stages of their training. Our market access team continues to be actively engaged in product discussions with payers. Manufacturing and supply chain-related activities are also in place. Mark Neumann, our Chief Commercial Officer, will expand on our launch readiness shortly.

In addition to commercial preparations, we continue to advance our pipeline. We look forward to reporting results from our lumateperone Phase III trial in bipolar depression and our ITI-214 Phase I/II trial in heart failure midyear. Andrew Satlin, our Chief Medical Officer, will provide more detail on our clinical development programs. Following Andy's comments, Larry Hineline, our Chief Financial Officer, will review our financial results. We will then open the line for Q&A.

As reflected in the label, the clinical profile of CAPLYTA is compelling. We firmly believe CAPLYTA provides physicians and their patients an important new treatment option for this serious mental illness impacting approximately 1% of the global population, translating into 2.4 million adults in the United States. Important unmet medical needs continue to exist. Patients with schizophrenia often discontinues treatment or seek treatment changes as a result of side effects, such as weight gain, metabolic disturbances and movement disorders. We are pleased that CAPLYTA will be available to patients very soon.

Schizophrenia is just the start of our broad lumateperone development program. We believe that lumateperone's efficacy and safety profile demonstrated in schizophrenia has the potential to translate to other therapeutic indications, including various depressive disorders.

Last July, we reported robust safety and efficacy results from Study 404, a Phase III trial of lumateperone in patients with a depressive episode associated with either Bipolar I or Bipolar II disorder. These robust results have reinforced our resolve to bring this important medicine to patients suffering from bipolar depression, and we have a broad clinical program for this indication.

Patient enrollment is ongoing and on track in Study 402, our global Phase III study evaluating lumateperone as an adjunctive treatment of depressive episodes associated with either Bipolar I or Bipolar II disorder. We anticipate reporting top line results midyear. Further, we have commenced an additional Phase III study, Study 403, a global monotherapy study that mirrors the design and conduct of Study 404. We plan to initiate a Phase II clinical proof-of-efficacy trial in major depressive disorder later this year.

Shortly, Andy will elaborate on these programs and provide an update on our other pipeline assets as well. We ended the year with $224 million in cash and investments. Adding to our financial strength, we completed a $295 million follow-on public offering earlier this year, which resulted in net proceeds of approximately $277 million. We are well capitalized to fund our commercial activities and to continue to advance our development programs.

In 2019, we made strategic investments in our infrastructure to appropriately support our growing organization, including in our research and development, clinical and commercial capabilities. We are stronger than ever, and I'm very proud of our accomplishments.

I will now turn the call over to Mark, whose team has been very busy preparing for the launch of CAPLYTA. Mark?

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Mark Neumann, Intra-Cellular Therapies, Inc. - EVP & Chief Commercial Officer [4]

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Thanks, Sharon, and good morning, everyone. Our commercial team has been very busy, and we are very excited to have the opportunity to bring CAPLYTA to market later this month and provide an important new treatment option to help improve the lives of individuals suffering from schizophrenia. I'm pleased to have this opportunity to give you an update on our launch execution preparations and to describe the market access conditions we anticipate in the early months of commercialization.

Immediately after the approval of CAPLYTA, in late December, we executed a robust now approved digital and print awareness campaign, which has reached over 90% of the psychiatry audience, driven nearly 40,000 unique visitors to our CAPLYTA website and has delivered over 1 million impression to date. CAPLYTA will be available to pharmacies in mid-March, and our full launch promotional activities will commence in late March. We have a comprehensive plan in place in which our multi-channel marketing efforts, including the deployment of a national sales force of approximately 240 neuroscience sales specialists, will focus on the approximately 23,000 health care providers who account for 80% of the branded antipsychotic schizophrenia prescriptions.

Our entire sales leadership team and substantially all of our sales representatives are on board and their training activities are in the final stages. We are very pleased with the caliber of talent of the sales representatives we have attracted. They have an average of almost 15 years of selling experience in the biopharmaceutical industry, and greater than 90% of them have prior psychiatry experience.

Let me now provide an update on our market access activities. Our entire market access organization has been in place since early in the fourth quarter of last year, including the leadership team and our national and regional account executives. This group of professionals has deep neuroscience experience, established relationships with payers and strong competencies in achieving patient access for medicines in the mental health area. Antipsychotics are well-established drug class, and there has been a predictable dynamic in the way new antipsychotics enter the market and formulary coverage is assigned. Consequently, we expect payers to manage CAPLYTA similarly to the other previously launched branded antipsychotics.

As you know, the payer landscape is complex and includes several types of payers, including Medicare Part D and Medicaid. Under Medicare Part D, antipsychotics are considered a protected class, and as such, newly approved products are reviewed for coverage rapidly within 90 days.

Our market access team has been meeting with these payers, and we expect coverage determinations for CAPLYTA to be established from now through the second quarter. And based on recent precedents, we would expect similar timing dynamics for coverage determinations in the Medicaid channel.

Commercial payers represent another important theme. We are in discussions with all the major payers and are starting to see uptake in coverage determinations in this channel. This will progress over time.

Overall, we expect market access formulary status for CAPLYTA to be fully established across all payer channels within 9 to 12 months in accordance with the expected review time lines and decisions. It is important to note that while all these payers are conducting their formal reviews, we expect there will be a pathway to access for CAPLYTA, consistent with how other antipsychotics were managed at launch.

Additionally, we have designed a comprehensive patient support program to facilitate access to CAPLYTA, including appropriate prior authorization support and co-pay savings assistance.

In summary, we are very excited to bring this important new medicine to patients. We have a highly experienced commercial team and a strong CAPLYTA launch plan, and we look forward to providing future updates as we execute against this plan.

Thank you, and I would now like to hand the call over to Andy to discuss our clinical development programs. Andy?

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Andrew Satlin, Intra-Cellular Therapies, Inc. - Executive VP & Chief Medical Officer [5]

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Thanks, Mark, and good morning, everyone. With the approval of CAPLYTA for the treatment of schizophrenia in adults, we are excited about the opportunity to help patients suffering from the serious, lifelong mental illness. The CAPLYTA label clearly reflects the efficacy and safety profile observed in our clinical studies. The efficacy of CAPLYTA 42 milligrams was demonstrated in 2 placebo controlled trials. The most common adverse reactions were somnolence and sedation and dry mouth.

In pooled data from short term studies, mean changes from baseline in weight gain, fasting glucose, triglycerides and total cholesterol were similar between CAPLYTA and placebo. The incidence of extrapyramidal symptoms was 6.7% for CAPLYTA and 6.3% for placebo.

Our medical affairs team has been very active and energized by scientific exchange with the medical community, including congress participation and individual discussions with key opinion leaders and medical and pharmacy directors.

Last year, we presented data on CAPLYTA at several medical conferences, highlighting its safety and tolerability profile, and we will have a strong presence at medical conferences this year, including the upcoming American Psychiatric Association annual meeting. We're pleased with the publication in JAMA Psychiatry describing the results of one of our pivotal studies, Study 301. The article is titled "Efficacy and Safety of Lumateperone for Treatment of Schizophrenia, A Randomized Clinical Trial," with lead author, Dr. Christoph Correll.

In addition to schizophrenia, our initial indication, we continue to advance the development of lumateperone for other indications, including bipolar depression and other depressive disorders, including major depressive disorder.

Last July, we reported positive efficacy for lumateperone in Study 404, our global Phase III monotherapy study in bipolar depression. Based on these strong results and the favorable safety profile observed in this study and across all of our lumateperone programs, we are very excited about the opportunity for lumateperone in this important indication and the possibility to help depressed individuals suffering from both Bipolar I and Bipolar II disorder.

In Study 404, lumateperone 42 milligrams met the primary endpoint with a statistically significant greater improvement over placebo on the MADRS total score at week 6. The mean improvement from baseline for lumateperone 42 milligrams was 16.7 points versus 12.1 points for placebo for a 4.6 point difference between the 2 groups, a robust effect size of 0.56 and a statistically significant p-value of less than 0.0001. We are very encouraged by the internal consistency of the results as reflected by the benefits seen in both Bipolar I and Bipolar II patients, a statistically significant separation versus placebo on the primary endpoint in both the U.S. and ex-U. S. population subgroups, the statistically significant improvement on the key secondary endpoint, the clinical global impression scale for bipolar for severity illness total score as well as strong results in responder and remission analyses. The results from this trial were presented in December at the annual meeting of the ACNP, and we are very pleased by the positive reception received from the medical community.

Bipolar depression continues to be an area of unmet medical need. We believe that lumateperone can be a valuable addition for this condition, which has only a few approved treatments, including only one for patients with Bipolar I or Bipolar II disorder. Enrollment is on track in our ongoing adjunctive Phase III, Study 402, and we anticipate top line results midyear.

Building on the program momentum, we also initiated Study 403, a global monotherapy study. I'll take you through the study designs.

Study 402 evaluates lumateperone as adjunctive therapy for the treatment of depressive episodes in patients with Bipolar I or Bipolar II disorder. The study is being conducted globally and will include approximately 550 patients randomized 1:1:1 to receive lumateperone 42 milligrams, 28 milligrams or placebo once daily for 6 weeks. While being maintained on lithium or valproate as mood stabilizers.

Study 403 evaluates lumateperone as monotherapy in patients with Bipolar I and II disorder. It is also being conducted globally and will include approximately 350 patients randomized 1:1 to receive lumateperone 42 milligrams or placebo once daily for 6 weeks. The prespecified primary endpoint for both trials is changed from baseline at week 6 on the MADRS total score versus placebo.

Subject to the results of Study 402 and our interactions with the FDA regarding our bipolar depression program, we expect to submit to the FDA in late 2020, a supplemental new drug application for regulatory approval for lumateperone for the treatment of bipolar depression. The use of antipsychotics in major psychiatric indications is limited due to existing safety and tolerability trade-offs. We believe lumateperone's pharmacological profile and existing safety and efficacy profile strongly supports the development of the drug across major psychiatric illnesses, including bipolar depression and other mood disorders. We continue to advance our ongoing program in major depressive disorder and anticipate initiating a Phase II clinical study this year.

We have completed preclinical development of a long-acting injectable formulation of lumateperone and plan to initiate a Phase I clinical study in 2020. We continue to advance our PDE1 program. Our ITI-214 Phase I/II clinical trial in heart failure is nearing completion. This single ascending dose study aims to replicate the positive inotropic effects of ITI-214, seen in a preclinical model of heart failure. Clinical conduct for the third and final cohort, 90 milligrams is ongoing following the successful completion of the 10-milligram and 30-milligram dose cohorts where no safety concerns were identified. We anticipate reporting top line results from this study in the first half of 2020.

Finally, we expect to initiate our clinical program for ITI-333, our novel oral modulator of new opioid and serotonin receptors, for the treatment of opioid and other substance used disorders, pain and mood disorder. A single ascending dose study in healthy subjects is planned to initiate later this year.

I will now turn the call over to Larry, who will review the financial results. Larry?

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Lawrence J. Hineline, Intra-Cellular Therapies, Inc. - Senior VP of Finance, CFO, Treasurer and Assistant Secretary [6]

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Thanks, Andy. I will be reviewing our financial results for the year ending December 31, 2019. Research and development expenses for the year ended 2019 were $89.1 million compared to $132.2 million for 2018. The $43.1 million decrease is due primarily to lower clinical trial costs and to a lesser extent, manufacturing costs for CAPLYTA, lumateperone and is offset partially by higher non-ITI-007 related projects and labor costs.

General and administrative expenses for the year ended 2019 were $64.9 million compared to $30.1 million for 2018. The increase of $34.8 million is primarily due to increases in pre-commercialization costs, labor costs, stock compensation expense and facilities-related costs.

Cash, cash equivalents and investment securities totaled $224 million at December 31, 2019, compared to $347.5 million at December 31, 2018.

On January 10, 2020, we completed a $295 million follow-on public offering resulting in net proceeds of -- to the company of approximately $277 million from the sale of 10 million shares of our common stock.

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

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from Charles Duncan with Cantor Fitzgerald.

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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division - Senior Analyst [2]

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Sharon and team, congratulations on a great year, last year. Quick question regarding CAPLYTA in terms of commercialization, then I had one follow-up for the pipeline.

In terms of CAPLYTA and thinking about pricing and pharmacoeconomic value, what kind of feedback have you gotten in terms of -- from the market access outreach from payers and prescribers on the value proposition and unmet need in schizophrenia is, especially given the differentiated clinical profile of CAPLYTA?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [3]

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Charles, thanks for the question. Mark, would you like to take it?

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Mark Neumann, Intra-Cellular Therapies, Inc. - EVP & Chief Commercial Officer [4]

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Yes, sure. Charles, so as we've described before, we had conducted quite a bit of market research prior to the approval. And now that our account executives have been out meeting with payers, both with medical directors as well as pharmacy directors with payers, there are a couple of themes that we've been very encouraged by that we've heard across the different channels and across the different payers. Number one is that they recognize that there continues to be a very significant unmet medical need in the treatment of schizophrenia for an effective antipsychotic that has a favorable safety and tolerability profile. And secondly, importantly, when they're provided with a clinical overview of the profile of CAPLYTA, what they see is a differentiated profile with an antipsychotic that is effective and has a very favorable safety and tolerability profile.

And as you know, the value proposition and the pharmacoeconomics all begin with having a profile of a product that is needed by the marketplace. And that's exactly what we're seeing when we have those discussions with medical and pharmacy directors.

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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division - Senior Analyst [5]

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That's helpful. And if I could just add one more on that one. In terms of supply chain -- we never asked these questions generally, but in today's world, we need to. How does the supply chain, I guess, worked for CAPLYTA in terms of first couple of years or a year worth of supply?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [6]

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I'll start, and I'll ask Mark, if you want to then add anything. Our supply chain is very robust, and I don't think that we have any issues on our supply chain going forward. And we have a very robust supply in the United States that we are ready to roll out and can keep rolling out for CAPLYTA.

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Mark Neumann, Intra-Cellular Therapies, Inc. - EVP & Chief Commercial Officer [7]

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Yes. And I would just add, Charles, in the near term, all of our supply chain-related activities with the wholesalers, retailers, et cetera, are very much on track, and we're ready to go and launch in the mid- to late-March time frame.

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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division - Senior Analyst [8]

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Okay, very good. And one quick question for Andy. Relative to the new study number 403 in bipolar depression. I guess, I'm wondering if you could provide some additional insights on the kind of design features that you'll be implementing to limit placebo effects?

And is there -- do you anticipate significant overlap in terms of the clinical sites more with 404 then relative to 401 for that study?

And then finally, anything new out of the 402 study that really drove you to design and initiate this 403 study?

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Andrew Satlin, Intra-Cellular Therapies, Inc. - Executive VP & Chief Medical Officer [9]

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Yes, thanks, Charles. So the new Study 403, which is a monotherapy study, single dose of lumateperone versus placebo done globally is very similar in design to Study 404, which was our successful trial in -- with the same monotherapy indication. We are using some of the same sites. We're doing this globally in some of the same countries. And generally, the preparation that we're doing for this is in line with what we've done for 404, where we're actively training the sites about placebo response.

Again, we were using investigators who've been successful in the past, and all the other criteria for the study are the same as those in 404. So we're very hopeful that this -- those data will be replicated.

With regard to 402 that study is proceeding very well. We're nearing completion, we do expect to have results by the middle of the year, as we've said. We don't have anything new to report on that, and I think that we'll wait for the results of that trial.

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Operator [10]

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Our next question comes from Marc Goodman with SVB Leerink.

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Marc Harold Goodman, SVB Leerink LLC, Research Division - MD of Neuroscience & Senior Research Analyst [11]

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Yes. So just to confirm on the supply chain that you were talking about. All the -- the product is all in the United States already. That's why you were saying that there were no issues, right? Just to confirm that.

And then second of all, what type of spending guidance, can you give us for this year? And maybe you could give us a sense of what the fourth quarter reflected? And what we should expect kind of as the year progresses for spending?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [12]

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So I'll take the first part on the supply chain, and then I'll ask Larry to address the guidance.

So yes, you heard right. We have a very, very robust supply here in the United States. So we are not dependent on requiring anything coming ex-U. S. in the foreseeable future.

Larry, do you want to then?

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Lawrence J. Hineline, Intra-Cellular Therapies, Inc. - Senior VP of Finance, CFO, Treasurer and Assistant Secretary [13]

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Yes. Yes. Marc, if you look at the results of the fourth quarter of 2019, we had research and development expenses of about $19 million and general and administrative expenses of $22.8 million. And we expect that the research and development expenses will increase modestly in the first quarter and stabilize there -- or going forward, rather, and then our SG&A expenses will increase in the first quarter as we put our commercial staff in place, and then they'll stabilize throughout the rest of the quarters.

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Marc Harold Goodman, SVB Leerink LLC, Research Division - MD of Neuroscience & Senior Research Analyst [14]

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So the SG&A step up, obviously, I mean, the sales reps were not in the fourth quarter, right? So we have that for a step-up and then just regular spending?

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Lawrence J. Hineline, Intra-Cellular Therapies, Inc. - Senior VP of Finance, CFO, Treasurer and Assistant Secretary [15]

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Yes. And in the first quarter, we'll have a market increase -- markedly increasing expenses in the SG&A line.

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Marc Harold Goodman, SVB Leerink LLC, Research Division - MD of Neuroscience & Senior Research Analyst [16]

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Right. And so first quarter is a big number. And then you are saying, second, third and fourth in the SG&A line are in the range for the first quarter.

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Lawrence J. Hineline, Intra-Cellular Therapies, Inc. - Senior VP of Finance, CFO, Treasurer and Assistant Secretary [17]

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It's the same line.

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Operator [18]

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Your next question comes from Umer Raffat with Evercore.

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Umer Raffat, Evercore ISI Institutional Equities, Research Division - Senior MD & Senior Analyst of Equity Research [19]

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Sharon, I saw the press release mentioned you guys will possibly file later in the year on bipolar. My question is, can you walk us through what exchange you've had with FDA already? What their feedback was? Do they want you to have the adjunct readout in hand before you file? Just wanted to understand what feedback FDA has shared with you on the existing bipolar results?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [20]

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Right. Thanks, Umer. So we have not met with the FDA yet. We have told you that we will be meeting with them and that we have 3 shots on goal here. We have the very successful 404 study. We have the ongoing 402 study and we have the recently commenced a 403 study. So we will be discussing with the FDA, all of the different permutations here of what will be required for our filing.

What we've said is if scenario A of the successful 404 study or a scenario B, that study plus the 402 study, if that's successful, then we would anticipate filing by year-end.

So that's the data as we have it right now.

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Operator [21]

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Our next question comes from Jessica Fye with JPMorgan.

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Jessica Macomber Fye, JP Morgan Chase & Co, Research Division - Analyst [22]

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I was hoping you could talk about the genesis for the decision to start 403 before the results of the next trial readout?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [23]

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So I'll start that, and I'll ask Andy, if you have anything to add. Thanks, Jessica. So we wanted to start 403. It's simply to have more shots on goal. We have no information about 402 as an adjunctive study. And that, as Andy mentioned to you, we'll read out midyear. We think it's prudent to have many shots on goal. And this is not unusual to have several studies ongoing in the depressive disorders. It's also not unusual in the depressive disorders that -- or in any psychiatric disorder that not all studies are going to be positive. Hence, we thought it prudent to -- we do think that based on the very robust data from the 404 study that we have a molecule that will benefit patients with depressive disorders in bipolar disease. So we thought it prudent to have as many shots on goal as we can. Andy, did you want to add any?

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Andrew Satlin, Intra-Cellular Therapies, Inc. - Executive VP & Chief Medical Officer [24]

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Yes. No, not really. I mean, I think you made the important point, which is that we believe, based on the results of 404 that the lumateperone does work in bipolar depression. So we're moving forward with everything we think we need to do in order to have as quick a opportunity to submit data to the FDA and get this drug approved in that indication as well. So that it's just part of the strategy that we think, as Sharon said, is prudent. And I think that many companies would follow in this indication.

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Jessica Macomber Fye, JP Morgan Chase & Co, Research Division - Analyst [25]

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Okay, great. And just following up to that, I think you've talked about Bipolar II as a potential point of differentiation. What are some of the reasons or factors why there have been few approvals for Bipolar II thus far?

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Andrew Satlin, Intra-Cellular Therapies, Inc. - Executive VP & Chief Medical Officer [26]

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So I think it's a choice whether you're going to study Bipolar I and Bipolar II. We made the decision to do that because we wanted to cover as broad a population within bipolar depression as possible to make our drug, which is such a safe drug, available to the full spectrum of patients with that indication.

As an added point, there's a greater medical need there because, as you say, it's not approved for -- is only approved in Bipolar I and Bipolar II for one other drug, which is Seroquel. And we think our safety profile matches up very well with any other drug out there. So -- but I can't really comment on other reasons why other companies may have made other choices. We think it's important to make this drug available to as broad a range of patients with disorders who could benefit as possible.

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Jessica Macomber Fye, JP Morgan Chase & Co, Research Division - Analyst [27]

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Okay, great. And maybe just the last one. You talked about a long-acting injectable formulation for lumateperone. Could you just help us think at a high level, just how we should think about that development path and time lines for that product?

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Andrew Satlin, Intra-Cellular Therapies, Inc. - Executive VP & Chief Medical Officer [28]

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So we're starting our initial study with that shortly, and it's a fairly standard development in terms of establishing how the drug is distributed and metabolized in the body, followed up with studies to assess its safety and efficacy in the schizophrenia population. So we're not anticipating anything unusual in the way that this will move forward.

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [29]

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And we'll give you further guidance on that once we do this first study with a PK study so that we can have a better idea, how quickly we can progress with that.

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Operator [30]

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Our next question comes from Brian Abrahams with RBC Capital Markets.

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Unidentified Analyst, [31]

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This is [Leo] on for Brian. We've heard some anecdotal reports from KOL about the importance of potential effects on other aspects of the disease that are not fully captured by the current data set, such as beginning to return to a job and improved socialization. So what are some of these longer-term outcomes that you're thinking about for CAPLYTA that could influence uptake?

And do you have any plans to formally evaluate these for potential label expansion or to enhance the value proposition for payers?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [32]

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Yes, we do, and I'll ask Andy just to elaborate a little further, but I have to say you sound exactly like Brian, that's really very funny, so. Sorry, I didn't mean to get us off track or Andy, if you want to...

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Andrew Satlin, Intra-Cellular Therapies, Inc. - Executive VP & Chief Medical Officer [33]

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Yes. No, thanks for asking, actually, because this is one of the areas that we find most exciting with this drug. As you know, we've said for quite a while now as we've reported the results of our studies with lumateperone in schizophrenia that there are signals for benefit in other areas, including in depression and in negative symptoms. And those are things that do require additional study, and including longer-term studies, and we are definitely thinking about pursuing one or more of those additional indications within the schizophrenia area.

So yes, we think that schizophrenia has a broad spectrum of activity within the schizophrenia syndrome. And we do want to provide additional data to clinicians to help them to make the best use of this drug with patients who have either negative symptoms, depressive symptoms, possibly other symptoms associated with schizophrenia as well. So we'll be able to provide additional information about that later.

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Operator [34]

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Our next question comes from Sumant Kulkarni with Canaccord.

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Sumant Satchidanand Kulkarni, Canaccord Genuity Corp., Research Division - Analyst [35]

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First, I'm happy to be asking this question on revenue recognition. Do you expect to recognize shipping or pull-through for CAPLYTA?

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Mark Neumann, Intra-Cellular Therapies, Inc. - EVP & Chief Commercial Officer [36]

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Yes, we're going to recognize revenue on shipment and with estimated adjustments for pull-through.

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Sumant Satchidanand Kulkarni, Canaccord Genuity Corp., Research Division - Analyst [37]

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And then a couple of questions on the pipeline. So on the long-acting formulation, you've completed preclinical development, given that there was some focus on preclinical data prior to the approval of oral CAPLYTA. Is it fair to assume that formulation differences led to predictable preclinical responses?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [38]

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I'm not sure I understand the question. Can you try to say it again?

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Sumant Satchidanand Kulkarni, Canaccord Genuity Corp., Research Division - Analyst [39]

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Yes, sure. So I meant, in terms of the -- before the approval of the oral CAPLYTA, there was intense focus on the preclinical data set generated by CAPLYTA in the oral setting, when that translates to a long-acting formulation, for example, in some species. How have the preclinical data been? I assume that there are predictable response there? That was the question.

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [40]

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The predictable response is that we haven't seen any of these metabolites and that is correct. We have looked for them, and we don't see them. Does that answer?

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Sumant Satchidanand Kulkarni, Canaccord Genuity Corp., Research Division - Analyst [41]

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Got it. Yes, it does. On MDD, when should we, when should we expect to see the Phase II data?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [42]

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Phase II data, we are anticipating starting the studies this year.

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Operator [43]

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Our next question comes from Bert Hazlett with BTIG.

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Robert Cummins Hazlett, BTIG, LLC, Research Division - MD & Biotechnology Equity Research Analyst [44]

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Just two quick ones, and then maybe a broader picture one. In terms of the quick ones, maybe you said it, but the timing of the readout of 403?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [45]

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Bert, so we expect that study to be finished mid next year.

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Robert Cummins Hazlett, BTIG, LLC, Research Division - MD & Biotechnology Equity Research Analyst [46]

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Okay. Then secondly, the supply chain, back to that for a second. You said clearly that you have a lot of supply in the United States. Is the incremental production U.S. domiciled from this point? Or is it domiciled internationally? And if so, where is it coming from?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [47]

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So as we've said, we have disclosed one of our -- this is all API we're talking about, and we have disclosed that our API comes from Switzerland. We do have a secondary and the tertiary supplier, if necessary. So -- and this has been ongoing for several years. So I think we are in a really good spot as far as our supply chain goes.

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Robert Cummins Hazlett, BTIG, LLC, Research Division - MD & Biotechnology Equity Research Analyst [48]

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Terrific. And then with regard to -- looking a little bit further out with regard to CAPLYTA, it's clearly differentiated in terms of the adverse event profile that it brings to the table. As you think market share and/or others, as you think about the competitive landscape evolving in schizophrenia there's some novel mechanisms with regard to the muscarinic receptor system. And could you just give us your view a little bit longer-term about how you see the competitive landscape unfolding in schizophrenia?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [49]

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Thanks. So I'll start, and I'll ask Mark to chime in. I think, first of all, as you know, there really is a huge unmet need in schizophrenia. And I think there is room for several players. I think that some of the early programs are moving along. And again, we are in favor of anything that brings better options or more options for patients. So I think that we don't see anything as an either/or. I think we see this as an evolving landscape, and hopefully, better drugs coming to market that can replace some of the older drugs that we've seen, which themselves are effective, but do have side effects associated with them.

Did you want to add anything?

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Mark Neumann, Intra-Cellular Therapies, Inc. - EVP & Chief Commercial Officer [50]

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I would just emphasize that and just reiterate what I said before, that we feel confident that the profile of CAPLYTA that has come out of the clinical development program is very consistent with the type of profile needed to help address some of the significant unmet needs that Sharon spoke about in schizophrenia. So we feel very good about the profile of CAPLYTA going forward into the future as well.

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Operator [51]

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Our next question comes from Jason Butler with JMP Securities.

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Jason Nicholas Butler, JMP Securities LLC, Research Division - MD and Senior Research Analyst [52]

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Just one on MDD. You commented that you're looking at new formulations to potentially increase or focus on rapid onset of action. I guess, just pulling from the experience in bipolar depression, you saw rapid within a week onset there. So can you just maybe talk about the goals here and any preclinical data that you have that is driving your focus on the new formulations?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [53]

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Sure. Jason. Do you want to talk about our preclinical data and...

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Andrew Satlin, Intra-Cellular Therapies, Inc. - Executive VP & Chief Medical Officer [54]

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Yes. I think the preclinical data was really the initial basis for moving in this direction in that lumateperone has very interesting pharmacology that, in some respects, is similar to that seen with ketamine in terms of its downstream effects on phosphorylation of proteins in the mTOR system, again, suggesting that the drug might have a rapid-acting effect on depressive symptoms. So with that in mind, we've been looking at different formulations to see whether we might be able to take advantage of that opportunity. And it will be one of the things that we're looking at in the clinical proof-of-efficacy trial that we'll start this year.

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [55]

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And you're right, in the bipolar depression, we did see that we were effective at week 1, which was the first time that we tested.

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Operator [56]

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Our next question comes from Andrew Tsai with Jefferies.

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Lin Tsai, Jefferies LLC, Research Division - Equity Analyst [57]

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As we think about the launch -- upcoming launch, should investors expect some kind of inventory build in Q1 or Q2? And also, is there a sense that there could be some kind of bolus in the first few weeks of launch? And I have a follow-up.

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [58]

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Mark, do you want to take that?

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Mark Neumann, Intra-Cellular Therapies, Inc. - EVP & Chief Commercial Officer [59]

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Yes. Andrew, it's Mark. So as I had mentioned in my prepared remarks, the product will be available to pharmacies by mid this month, and we will be commencing our full promotional activities, including the deployment of the sales force late in the month. So I think you can expect that there will be some inventory build in the month of March, and then prescriptions really will begin to flow in the second quarter and build over time, consistent with how antipsychotics have been taken up in the marketplace.

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Lin Tsai, Jefferies LLC, Research Division - Equity Analyst [60]

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Great. And then as a follow-up, so with your 240 sales reps. Just curious how quickly can those reps touch all of your 24,000 high prescriber docs? I'm curious just how many interactions or calls, do you think that a sales rep would need to make before a doctor starts prescribing CAPLYTA?

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Mark Neumann, Intra-Cellular Therapies, Inc. - EVP & Chief Commercial Officer [61]

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Yes, sure, Andrew. It's a good question, and I think each position is different, each physician has a different adoption practices. We have sized the sales force in a way to ensure that we're getting the right kind of reach and frequency on the 23,000 health care providers that, as we mentioned, generate approximately 80% of the branded antipsychotic prescriptions for schizophrenia. So they will be out there with sort of, I guess, you would call it, industry-standard calls per day. We've been able to meet with many of these representatives. They're very excited about the opportunity to launch CAPLYTA and will be -- as I mentioned in my prepared remarks, they are -- they've been doing all of their background training over the past couple of weeks. And by the end of the month, they will be fully trained and ready to call on those 23,000 health care providers.

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Operator [62]

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Our next question comes from Matt Kaplan with Ladenburg Thalman.

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Unidentified Analyst, [63]

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This is [Raymond] in for Matt. Congrats on the progress. Just regarding quickly on the pipeline, and maybe...

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [64]

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I'm sorry, we can't hear you. Can you maybe speak a little louder?

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Unidentified Analyst, [65]

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Sorry. Can you hear me now?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [66]

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Yes.

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Unidentified Analyst, [67]

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Sorry. Yes, this is [Raymond] in for Matt. Just regarding the pipeline, I was wondering, maybe on the MDD indication, do you see potentially moving ahead with lumateperone? Or as a monotherapy? Or combination therapy? Or instead of focusing on the novel formulation as a monotherapy, perhaps?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [68]

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Yes. I think we'll update you in the near future as to the design of our studies and the formulations, et cetera. So I think it's a little bit premature, but hopefully, near term, we'll be able to do that. Andy, if you want to add anything?

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Andrew Satlin, Intra-Cellular Therapies, Inc. - Executive VP & Chief Medical Officer [69]

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Yes. No, just that we're considering a number of options.

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [70]

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Right.

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Unidentified Analyst, [71]

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Okay. Yes, I guess, maybe also for perhaps lumateperone. Do you considering other indications beyond bipolar MDD currently thinking forward?

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [72]

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Yes. If I've heard you right, it's very hard to hear you. I think you're asking, are we looking at other indications for lumateperone. And the answer is yes, we're looking at several of the depressive disorders.

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Unidentified Analyst, [73]

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Okay, cool. And just one final question for ITI-214. Do you intend to partner the asset in the non-CNS indications or in the CNS indications as well? Just for some clarification.

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [74]

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So our present thinking is we do have a number of indications that we are pursuing for the class, the phosphodiesterase 1 inhibitors, and we do anticipate that on certain of those indications, we would look to partner because we would not be doing all of those indications on our own.

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Operator [75]

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I'm not showing any further questions at this time. I would now like to turn the call back over to Dr. Sharon Mates for any further remarks.

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Sharon Mates, Intra-Cellular Therapies, Inc. - Co-Founder, Chairman, CEO & President [76]

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Just -- I want to thank everyone for today's participation on the call, and we're very excited about bringing CAPLYTA to market and providing a new option for patients. And I'd like to thank our whole team at Intra-Cellular for all the work we've done, and for all the patients who have participated in all of our clinical studies to date. And with that, operator, you can disconnect the call. Thanks.

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Operator [77]

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Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.