Juan Sanchez - VP, Corporate Communications and IR Sharon Mates - Chairman, CEO Kimberly Vanover - SVP Clinical Development Larry Hineline - VP, CFO Cedric O'Gorman - VP Medical Affairs.

Adnan Butt - RBC Capital Markets Ritu Baral - Cowen & Company Bill Tanner - Guggenheim Securities Leyi Wang - Leerink Partners Edward Nash - SunTrust.

Good morning, ladies and gentlemen, and welcome to Intra-Cellular Therapies' First Quarter 2016 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..

Thank you, operator. 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 quarter ended March 31, 2016, crossed the wire a short time ago. A press release is available on our Web Site at intracellulartherapies.com.

Joining me on the call today are Dr. Sharon Mates, Chairman and Chief Executive Officer; Dr. Kimberly Vanover, Senior Vice President of Clinical Development; Larry Hineline, Vice President and Chief Financial Officer; Dr. Cedric O'Gorman, Vice President of Medical Affairs; and Michael Halstead, Senior 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 product candidates, the anticipated conduct and the source of future clinical trials, plans regarding regulatory filings, future research and development 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 are cautioned not to place undue reliance on these forward-looking statements and the company disclaims any obligations to update such statements. I will now turn the call over to Sharon..

Thanks, Juan. Good morning, everyone, and thank you for joining us for today's conference call. Today we will be discussing our first quarter financial results, and we will also provide an update on the progress of our ongoing programs and our future drug discovery and development plans.

We continue to make strides in fulfilling our mission to develop and advance our innovative new medicines to treat patients suffering from neuropsychiatric and neurologic diseases.

In 2016 we have continued to expand our ITI-007 platform, including our late-stage programs in schizophrenia, bipolar depression and behavioral disturbances in patients with dementia, including Alzheimer's disease. We have also made progress with our other programs, including our ITI-007 long-acting injectable program.

We believe that based on its unique pharmacology and differentiated efficacy, safety, and tolerability profile demonstrated in our clinical studies, ITI-007 represents a potential advancement for the treatment of multiple neuropsychiatric and neurological disorders.

I will begin with a summary of the progress we have made with our ITI-007 platform, and then provide an overview of our drug development pipeline. Kim will then share more details on our schizophrenia clinical programs. Lastly, Larry will review our financial results and we will then open up the line for questions.

Our second ITI-007 phase III trial in patients with schizophrenia is progressing well and, as stated in our press release this morning, we expect to announce completion of patient enrollment this quarter.

Recently, at the Schizophrenia International Research Society meeting, or SIRS, we presented additional data from our positive phase III study of ITI-007 and from our positron emission tomography or PET study in patients with schizophrenia.

We believe that the positive results observed with ITI-007, combined with the high treatment completion rates, has the potential to translate to good medication adherence in the clinic and improved long-term outcomes. Kim will describe these presentations in greater detail. Our phase III bipolar depression program for ITI-007 is also progressing well.

This program consists of two phase III clinical trials and includes patients with both bipolar one and bipolar two disorder. One trial evaluates ITI-007 as a monotherapy, and the other trial evaluates ITI-007 as an adjunctive therapy with either Lithium or Valproate.

Bipolar disorder affects approximately 2.6% or 5.7 million adults in the U.S., according to the National Institute of Mental Health. Bipolar depression represents the most common clinical manifestation of bipolar disorder and is associated with a worse prognosis than bipolar mania.

There are few approved therapies for the treatment of bipolar depression. We believe ITI-007 has the potential to serve a broad patent population suffering from depressive episodes associated with bipolar one or bipolar two disorder, as both a monotherapy and as an adjunctive therapy.

With regard to our low-dose strategy, we expect to initiate our late-stage ITI-007 clinical program for behavioral disturbances in patients with dementia -- including Alzheimer's disease -- this quarter.

It has been estimated that over 44.4 million people worldwide were living with dementia in 2013, including over 5.2 million patients with Alzheimer's disease in the United States.

Over 50% of patients with dementia also suffer from behavioral symptoms, including agitation, heightened aggression, depression, sleep disorders, sun-downing and psychosis, behavioral disturbances which result in significant patient and caregiver distress and lead to early institutionalization.

We believe the unique pharmacology of ITI-007, which employs potent 5-HT2A antagonism, along with efficient modulation of other neural transmitter systems, including dopamine, may translate into a safe and effective treatment for these patients. We continue to advance our innovate phosphodiesterase or PDE platform.

We believe that the lead compound in our PDE-1 portfolio, ITI-214, is the first selective PDE type one inhibitor to be tested in humans. To date, ITI-214 has been studied in four phase I clinical trials and has been found to be safe and generally well tolerated in both healthy volunteers and patients with schizophrenia.

We will provide an update on the next steps for this program later this year. Moving to our financials, we ended the quarter with $456.1 million in cash, placing us in a very strong financial position to advance our research and development programs. Shortly, Larry will provide further details on our financials.

I would now like to turn the call over to Kim..

Thanks, Sharon. I am pleased to provide an update on our ITI-007 clinical program and highlight our recent presentation at SIRS. During the last quarter, we have continued to advance our ongoing trials, planning for future clinical programs and disseminating our ITI-007 data at medical conferences.

Enrollment is progressing well in our ongoing clinical programs, including our second ITI-007 phase III study in schizophrenia and our phase III bipolar depression program.

Furthermore, we are advancing our program for the treatment of behavioral disturbances in patients with dementia, and are on track to initiate our clinical study in this patient population later this quarter. Focusing on our schizophrenia program, clinical conduct in our second phase III trial in patients with schizophrenia, or 302 trial, is ongoing.

This trial is evaluating the efficacy and safety of ITI-007 60 milligrams and 20 milligrams compared to placebo over six weeks of once daily oral treatment with Risperidone as an active control. While the dose of Risperidone needs to be titrated for tolerability issues, no dose titration is required for ITI-007.

The primary end point is change from baseline versus placebo at six weeks on the positive and negative syndrome scale -- or PANSS -- total score. As Sharon mentioned, we expect patient enrollment to be completed this quarter, and we will provide an update on our clinical activities at that time.

We just returned from having a strong presence at the SIRS conference where we had an oral presentation and two poster presentations featuring additional efficacy and safety data from the -301 study, our recently completed phase III clinical trial in patients with schizophrenia.

An additional poster presentation featured data from the ITI-007 PET study in patients with schizophrenia. We are very enthusiastic about the positive response to our data by the scientific and medical community at the meeting.

The data presented at SIRS highlighted the positive results from our first phase III clinical trial in schizophrenia, including the high completion rates seen in patients receiving ITI-007, compared to placebo.

The results demonstrated a statistically significant improvement versus placebo in schizophrenia symptoms and a favorable safety and tolerability profile.

In this trial, once daily ITI-007 60 milligrams met the primary end point, demonstrating a statistically significant improvement versus placebo in schizophrenia symptoms at day 28, as measured by the PANSS total score.

Moreover, ITI-007 60 milligrams showed significant efficacy as early as week one on both the PANSS total score and PANSS positive symptoms sub-scale score, which was maintained at every time point throughout the entire study. These results indicated early and sustained reduction in symptoms of psychosis by ITI-007.

ITI-007 60 milligrams also met the key secondary end point of statistically significant improvement on the clinical global impression scale for severity of illness, or CGIS, indicating a clinically meaningful reduction in symptom severity.

A key differentiating feature of ITI-007 is an improvement in psychosocial function as measured in this trial by statistically significant improvement for 60 milligrams compared to placebo on both the PANSS-derived pro-social factor and the personal and social performance scale, or PSP.

The 40-milligram dose of ITI-007 showed statistically significant improvement in CGIS, the PANSS positive symptom sub-scale, and the PANSS derived pro-social factor, indicating that both doses were pharmacologically active and provided clinical benefit.

Importantly, the data presented at SIRS highlighted a high treatment completion rate observed with ITI-007, with 87% and 82% of patients on 60 milligrams and 40 milligrams completing treatment respectively, versus 75% of patients on placebo.

As seen in our presentations in the form of Kaplan-Meier curves, patients randomized to ITI-007 60 milligrams demonstrated a statistically significant longer or better time to treatment discontinuation due to the any reason compared to placebo and a statistically significant longer or better time to treatment discontinuation due to lack of efficacy.

The number of patients who discontinued treatment in this trial due to an adverse event was low and the time to treatment discontinuation due to an adverse event was not statistically significantly different from placebo for either dose of ITI-007.

In the trial ITI-007 given orally once daily in the morning without dose titration was well tolerated and demonstrated a safety profile that did not differ from placebo.

The only treatment-emergent adverse events considered at least possibly related to ITI-007 occurring in at least five percent of patients and at least twice the rate of placebo were somnolence, sedation and fatigue, all predominantly mild.

ITI-007 showed a motoric profile similar to placebo, according to adverse event reports or when objectively measured by the Simpson Angus Scale, the Barnes Akathisia Rating Scale and the Abnormal Involuntary Movement Scale.

These findings are important, as many existing treatments for schizophrenia are associated with high rates of EPS, akathisia, Parkinsonism, tremor and restlessness. ITI-007 also showed a metabolic profile similar to placebo as measured by metabolic parameters including cholesterol, triglycerides, glucose and insulin.

In the treatment of schizophrenia, prescribers are often faced with the clinical dilemma of making a choice between treatments [who] are associated with significant cardio, metabolic, and/or motoric side effects, which can result in patients discontinuing their medication.

We believe that the placebo-like safety and tolerability profile for ITI-007 in this regard underlies the high completion rate seen in our studies and may predict better medication adherence in clinic practice.

ITI-007 60 milligrams reduced psychosis in patients with schizophrenia at relatively low levels of striatal d2 receptor occupancy, lower than the occupancy range required by most drugs currently approved for the treatment of schizophrenia.

Unlike existing schizophrenia treatments, ITI-007's dopamine receptor phosphoprotein modulation or DPPM acts as a pre-synaptic partial agonist and post-synaptic antagonist at D2 receptors.

This mechanism, along with potent interactions at 5-TH2A receptors, serotonin transporters and D1 receptors with indirect glutamatergic modulation likely contributes to the efficacy of ITI-007 with improved psychosocial function and favorable tolerability. We will continue to present our data at a number of upcoming scientific and medical meetings.

As a reminder, according to the National Institute of Mental Health, over one percent of the world's population suffers from schizophrenia, and more than 2.5 million Americans suffer from the illness in any given year. There remains a substantial unmet medical need for the treatment of schizophrenia.

Existing treatments, while helpful for the positive symptoms of schizophrenia, do not provide broad symptom control over other symptom domains, and are limited by significant tolerability issues, including motoric and metabolic side effects.

We believe ITI-007 represents a novel approach to the treatment of schizophrenia and has the potential to address these unmet medical needs. We are pleased with our progress on our programs for bipolar depression and behavioral disturbances in patients with dementia, which Sharon has already summarized.

We look forward to providing a further update on those programs on our next call. I will now turn the call over to Larry, who will review the financial results for the first quarter..

Thanks, Kim. I will be reviewing our financial results for the first quarter ending March 31, 2016, and provide an overview of our expectations for the use of our cash in investments. The net loss for the first quarter of 2016 was $27.8 million, compared with a net loss of $22.3 million for the first quarter of 2015.

Basic and diluted net loss was $0.64 per share for the first quarter of 2016, compared to a basic and diluted net loss of $0.72 per share for the same period in 2015. Research and development expenses for the first quarter of 2016 were $23.4 million, compared to $18.6 million for the first quarter of 2015.

The increase is primarily due to costs associated with the second phase III clinical development program for ITI-007 in schizophrenia and to a lesser extent the phase III trials of ITI-007 to treat patients with bipolar depression.

General and administrative expenses for the first quarter of 2016 were $5.1 million, compared to $3.8 million for the prior year period. The increase is primarily the result of higher stock-based compensation expense and to a lesser extent increased salaries and professional fees.

Cash in investments totaled $456.1 million at the end of the first quarter of 2016, compared to $475.2 million at year-end, 2015.

We expect that existing cash in investments will be dedicated primarily to the ITI-007 development program, including to fund clinical trials of ITI-007 in schizophrenia, bipolar depression, behavioral disturbances in dementia, depressive disorders and related clinical and non-clinical activities; to fund pre-commercial activities for ITI-007 for the treatment of schizophrenia and, if ITI-007 receives regulatory approval, initial commercialization efforts; to fund pre-clinical and clinical development of the Company's ITI-007 long-acting ingestible program; and to fund non-clinical activities, including the continuation of manufacturing activities in connection with the development of ITI-007.

Funds will also be used for other clinical and pre-clinical programs, including the company's phosphodiesterase, PDE, development activities.

With that, operator, could you please open the line for questions?.

[Operator Instructions] Ladies and gentlemen, if you have a question for the speakers at this time, you may dial star then the number one on your key pad. That's star, then one. If your question has been answered or if you wish to remove yourself from the queue, you may press the pound key.

Our first question comes from the line of Adnan Butt from RBC Capital Markets. Your line is open..

Hi, good morning. Thanks for the question. I heard a comment on Risperidone needing to be titrated for tolerability. Was that just a general observation or is that something related to the ongoing phase III? Just wanted to clarify that.

And then, secondly, on the bipolar depression phase III studies, is there a reason why timelines appear to be generally longer for these bipolar depression studies versus schizophrenia? Thanks..

I'll take the first one on the Risperidone. So Risperidone always needs to be titrated. So you titrate up a dose, for Risperidone as well as for many other antipsychotics. And that's one of the advantages of ITI-007 is that at 60 milligrams on day one you give the dose of 60 milligrams; there's no titration needed.

If you don't titrate a drug like Risperidone, you get more movement disturbances. The second question on bipolar disorder and why it takes longer -- why the recruitment rates are long, what we've done, what we have assumed is a slower recruitment rate than we've seen for schizophrenia, based on previous studies.

This because these patients are depressed and in schizophrenia, when they are acutely exacerbating, or in bipolar disorder when they have a manic episode, they oftentimes present to the emergency room. In bipolar depression, they present to the emergency room less frequently, so more often they are withdrawing and staying at home.

One needs to allow more time for recruitment of these patients..

And Sharon, one follow-up on the dementia study.

It's defined as a -- I guess the question is is it something that's potentially registration-enabling, or is that left for later discussions with the FDA for the behavioral disturbance study?.

Every study we do is used with registration in mind. I think that when we put the study on -- with studies on ClinicalTrials.gov we'll give you further guidance as to where in that spectrum we think we are..

Okay. Thank you..

Thanks, Adnan..

Thank you. Our next question comes from the line of Ritu Baral from Cowen & Company. Your line is open..

Good morning everyone. Thanks for taking my question. A couple on 302.

Sharon, could you characterize trial conduct at this point as far as what you're seeing, especially drop-outs versus expectations?.

Sure. Hi, Ritu. I think I'm going to ask Kim to address trial conduct..

Yes, absolutely, Ritu. Thanks for the question. The 302 study is progressing well and I think that we have no surprises and we are on track to be able to complete enrollment later this quarter; we'll provide a further update at that time..

And I think that the -- I don't think there are any surprises on the drop-out rate, at least that I'm aware of..

That's right. There are no surprises..

I think that it's similar to both the phase II and the first phase rate..

Excellent. Thanks. And then can you help us frame expectations for your 20-milligram arm? It's sort of been the focus of a lot of discussion.

Do you expect that to be a biologically or a clinically active arm? Are there certain scales where it could be active and others where you think it doesn't have much of a chance? Can you help us out with that?.

Yes, I think that's a really good question. We have a lot of pre-clinical and clinical data that demonstrate that doses lower than 60 milligrams are pharmacologically active and provide clinical benefit.

We believe that in -302 study, 20 milligrams will not only help inform our schizophrenia program, but will also allow us to look at which symptom domain may be improving with the 20 milligram dose. That can then help inform additional therapeutic indications that we may want to pursue.

Sharon, do you have more?.

No, I think that's right. I think it is a very good question on the symptom domain, that exploring these lower doses will allow us to look at different subscales within the PANSS and different questions within the PANSS as well as the overall PANSS score --.

Got it --.

-- so, looking forward to this..

My last question is just relating the SIRS data to what may come from -302 at six weeks. Obviously your SIRS data on movement disorders was incredibly positive. How long does it take for akathisia and movement disorders to emerge with current schizophrenia therapies? Sort of the timing and points of emergence of those side effects.

I think I'm just trying to figure out if, once we see six weeks data, if we are completely out of the woods as far as monitoring for potential movement disorder side effects [inaudible]..

So you kept fading in and out. So let me just try and repeat the question and make sure we got it right. So your question is how long does it take for the akathisia, for you to see this, because you're wondering if we're, "out of the woods" --.

Yes..

-- if we don't see the akathisia. So I'm going start, and then I'm going to ask Kim to chime in. So, Akathisia you see immediately or in very short term. There are many movement disturbances and a lot of them you see immediately. There's the Parkinsonism, there's akathisia -- please chime in --.

-- Parkinsonism, tremor, restlessness, extrapyramidal syndrome..

Right. So all of those you see -- that was Cedric -- all of those you see immediately or almost immediately. There are movement disturbances; there's tardive dyskinesia, which takes a long time to see. The literature suggests that compounds that have little or no motoric disturbances do not have the tardive dyskinesias. We have not seen any..

I would just add, Sharon -- hi, Ritu -- you just need to look at some of the U.S. prescribing information, or the labels of currently approved antipsychotics, to appreciate the emergence of these akathisia motor disturbances -- EPS, restlessness, tremor, Parkinson's, that do emerge in the short-term studies of many of these antipsychotics.

It gives you a feeling for that..

Thank you. Our next question comes from the line of Bill Tanner from Guggenheim Securities. Your line is open..

Thanks for taking the question.

Sharon, I was going to ask you some questions on the behavioral disturbances program and it sounds like -- I mean your comment was that things are going to get posted on ClinicalTrials.gov, but I'm wondering if you could speak to maybe a little bit of it as it relates to the inclusion criteria for patients that you're enrolling in the trial.

I guess, more importantly, wondering -- or do we just need to wait for the posting -- if you could talk to the end points that you're going to look at? I guess specifically wondering if the instruments that would be used to measure these things already exist or if anything going to have to be developed specifically for this program? Thanks..

Hi, Bill. This is Kim. We're really excited about this program; we continue to make progress on our overall low-dose strategy. As we've said, we're on track to start the clinical trial later this quarter. We believe that ITI-007 will be of benefit across a wide range of behavioral disturbances associated with dementia.

We've been looking at a variety of validated measures that already exist that we can use in our trial and certainly in advance of starting the trial, we will be posting more detail on ClinicalTrials.gov with regards to the specific end point. So to answer your last point, we are not developing new scales; we are using existing scales..

Got it. I think it was mentioned at least once on the call about the LAI.

Can you just give us a sense of when roughly that might be commercialized, relative to when -007 is in the oral formulation?.

I won't give you guidance on when it will be commercialized, but I would give you guidance on when we think we can enter the clinic..

Okay..

I think that we're looking towards the end of 2017 to enter the clinic there. We do think that the number of clinical trials -- the clinical trial development course, should be a lot shorter than it has been for the first indication, obviously, for the oral indication, but I think when we go into the clinic, we would give you more guidance..

Thank you. Our next question comes from the line of Leyi Wang from Leerink Partners. Your line is open..

Hi, good morning. This is Leyi on behalf of Seamus Fernandez. Thanks a lot for the question. I think most of my questions have already been answered, so just a couple quick ones regarding expenses.

From a modeling perspective, how should we think about the full year expenses as you guys are wrapping up the schizophrenia trial, but also will be beginning to enroll patients for the bipolar depression and behavior disturbances trial? Also, assuming the second phase III trial is successful, presumably your team will be planning for regulatory and commercial activities, and how should those factor into the full year expenses going forward? Thank you..

I'll start and then, if I don't answer something, Larry can chime in. He's all the way at the other end of the table here, so you might not be able to hear him so well. We've given you guidance - oh -- we've given you guidance last quarter that we expected to use between $130 million and $160 million for the year.

In fact, you see what we've spent this quarter, so I would subtract that from our spend..

-- it's about $20 million dollars in spend in the first quarter. We've looked at projections and we still will be within the $130 million to $160 million range for the whole year. So now we're at $110 million to $140 million the rest of the way.

Then of course from an expense perspective, there are some non-cash expenditures that'll probably be around $10 million. From a modeling perspective, with that information I think you can for your full year projections be pretty close to where we'll end up.

Obviously, yes, obviously, given that we've only spent $20 million and had loss of $27 or so million, we'll be ramping up, especially as the bipolar trials move on, so --.

And the dementia..

And the dementia trials as well, yes. You'll see a ramp-up..

Could you hear him?.

Yes. Thank you very much..

Thank you. Our next question comes from the line of Edward Nash from SunTrust. Your line is open..

Great. Good morning, guys. Thanks so much for taking the call.

I wanted to ask, so what elements of the schizophrenia study -- especially the second phase III, since the read-out's going to be coming very soon -- could we look at that could potentially give us some read-through into how you could perform in the bipolar outcome phase IIIs?.

I think that, even already in the previous trials that we've shown so far with the published data from our phase II study and from our first phase III and continuing to look at this in the -302 trial, that we really have a lot of elements that we believe will translate well to bipolar depression.

In the patients with schizophrenia who also have co-morbid depression, you see improvements not only their psychopathology related to schizophrenia, but also in their symptoms of depression.

Together with the pharmacological mechanism of ITI-007 and the preclinical data that we had to show antidepressant effects, altogether we believe that we're in a strong position that these data will translate well into bipolar depression, and seeing the beneficial safety profile, it will translate as well..

Cedric, did you want to add anything to that?.

Yes. That's exactly right. I'm just going to add that because we haven't seen on the safety side, Kim, any akathisia or activation, this is very important in the bipolar arena because we know that akathisia and activation in these patients can add to their impulsivity and is also a risk factor for suicide.

Another important safety component for ITI-007..

Great. Thank you. Especially with these bipolar patients who are more sensitive and suicidality rate is high. Akathisia tends to increase the suicidality rate..

Okay, that's helpful. Thanks.

And then just one other question, which is, with regard to the bipolar depression, since the phase III is ongoing with the next indication after schizophrenia, then if successful, how do you see the market kind of splitting up between the two for 007 as far as on a percentage basis? Do you see the need for the bipolar depression? What are your thoughts there?.

So I think after we have the results of the second phase III study, we might give you more guidance there. For right now I would say that we think that ITI-007 has many attributes that will allow it to have a strong presence in the market.

We talked about the safety profile and the ability to improve social function as well as other domains in schizophrenia. From a sheer numbers point of view, the number of cases, the number of patients with bipolar disturbances and bipolar depression is, is much larger than that with schizophrenia.

So, so we think that there is a large market opportunity both for schizophrenia and certainly for bipolar disorder as well..

Thank you. That's all the questioners that we have in the queue at this time, so I would like to turn the call back over to management for closing remarks..

Thank you, operator, and thank you all for joining the call. In summary, 2016 continues to be an exciting year as we advance our programs and move closer to announcing top line results from our second phase III schizophrenia trial.

Based on the unique pharmacology of ITI-007 and the positive clinical data we generated to date, we feel confident that ITI-007 will benefit patients who suffer from a broad range of neuropsychiatric and neurologic disorders. These patients remain underserved by existing medications.

We are committed to bringing innovative treatments that address a broad range of symptoms without the safety and tolerability issues associated with current therapies. We look forward to speaking to you again soon to report on the progress of our program. Operator, you may now disconnect the call..

Ladies and gentlemen, thank you again for your participation in today's conference call. This now concludes the program and you may all disconnect the telephone lines at this time. Everyone, have a great day..