Good day, ladies and gentlemen, and welcome to the Intra-Cellular Therapies Inc. First Quarter 2019 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call may be recorded. It is now my pleasure to hand the conference over to Mr. Juan Sanchez, Vice President of Investor Relations..

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 for the company’s financial results for the first quarter ended March 31, 2019, crossed the wire 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; Dr.

Kimberly Vanover, Senior Vice President of Early Stage Clinical Development and Translational Medicine; 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 non-clinical plans, our plans to present or report additional data, the anticipated conduct and results of ongoing and future clinical trials, plans regarding regulatory filings, future research and development, our plans regarding the commercialization of lumateperone 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..

Thanks, Juan. Good morning, everyone, and thank you for joining us. Today, I will provide an overview of our progress with our Lumateperone Clinical Program.

Mark Neumann, our Chief Commercial Officer, will discuss our commercial preparations and Andrew Satlin, our Chief Medical Officer, will provide an overview of our progress in our other clinical research program. Then, Larry Hineline will review our financial results and we will open the line for Q&A.

Our NDA for Lumateperone for the treatment of schizophrenia is under review by the FDA and the PDUFA target action date is September 27, 2019.

We believe that our Schizophrenia Clinical Development Program for Lumateperone provides evidence and support of the efficacy and safety for the treatment of schizophrenia and potentially represents an important advance for patients and the psychiatric community. We continue to advance our clinical programs for Lumateperone.

At a recent meeting of the Schizophrenia International Research Society or SIRS, we presented additional results from our Lumateperone Long-term Safety Study or Study 303 in patients with stable symptoms of schizophrenia. This study switched patients from the standard of care anti-psychotics to Lumateperone for a treatment duration of up to one year.

In this study, Lumateperone was generally well tolerated and was associated with statistically significant improvements from baseline on key cardio-metabolic and motor measures that are often impacted adversely by other antipsychotic medications.

Patients treated with Lumateperone remained stable with respect to their symptoms of schizophrenia upon switching from the standard of care.

Importantly, a mean body weight reduction of 3.16 kilograms was observed at one year of treatment with statistically significant reductions from the standard of care baseline in total cholesterol, LDL cholesterol, and prolactin while other cardio-metabolic parameters remained stable.

There were no signs of treatment-emergent extrapyramidal side effects, akathisia, or dyskinesia.

These results are consistent with prior findings in our short-term studies and we are encouraged by the unique safety and tolerability profile of Lumateperone and its potential to improve the treatment of individuals with neuropsychiatric and neurologic disorders.

At SIRS we presented results on the improvements in symptoms of depression seen in our long-term safety study with Lumateperone in patients with stabilized schizophrenia experiencing moderate to severe comorbid depression. Depression has been reported during all stages of schizophrenia.

Prevalence rates for depression in schizophrenia may vary but have been reported to be as high as 60%. Symptoms of depression contribute substantially to functional and social impairment as well as increase the risk of suicide.

In our study, the anti-depressant effects of Lumateperone were assessed using the Calgary Depression Scale for Schizophrenia or CDSS a validated scale to assess depression in patients with schizophrenia.

In these patients with moderate to severe depression defined by a CDSS score of at least six at baseline, Lumateperone treatment was associated with marked improvement in symptoms of depression. Specifically, mean CDSS scores decreased by approximately 60% from 7.4 at baseline to 3.1 at day 300.

In addition, 60% of patients experienced a clinically meaningful reduction in depressive symptoms of at least 50%.

Importantly, Lumateperone improved symptoms of depression not only as a monotherapy in patients who were not on an anti-depressant but also adjunctively in patients who were taking anti-depressants and still exhibiting symptoms of depression.

These data extend results we previously reported on improvements in depressive symptoms seen in patients with acute symptoms of schizophrenia and comorbid depression.

These results reinforce the positive feedback we’ve received from the medical community and from patients and continue to support our commitment to the development of Lumateperone for the treatment of a range of mood disorders.

Our Bipolar Depression Program is ongoing, and we expect top-line results from our two monotherapy studies, Study 401 and Study 404, later this quarter. In addition, our program in major depressive disorder, MDD, is ongoing.

In order to explore the effect of different modes of drug administration and the potential for rapid onset anti-depressant activity, our program includes the assessment of novel formulations of Lumateperone. Pharmacokinetic studies evaluating these formulations are continuing.

We ended the quarter with $312 million in cash, cash equivalents, and investment securities which places us in a strong position to advance our development programs and commercial activities.

Before I turn the call over to Mark who will provide a brief update on our pre-commercialization efforts, I would like to highlight that we will have presentations describing our Lumateperone Schizophrenia Program at the upcoming American Psychiatric Association annual meeting in San Francisco which runs from May 18th to May 22nd.

We look forward to our participation and contribution to this important global medical meeting. Following Mark’s comments, Andy, who just presented our ITI-214 Study on Parkinson’s disease at the American Academy of Neurology annual meeting, will report on our progress with ITI-214 in Parkinson’s disease and other indications.

Mark?.

Thanks, Sharon, and good morning, everyone. Over the past several months, we’ve continued to intensify our efforts in preparing critical areas of our organization to support the potential commercialization of Lumateperone.

I’m pleased with the advancements we are making in building our commercial capabilities in the areas of sales, marketing, and managed care and in our manufacturing and supply chain readiness.

We also continue to make considerable progress in the implementation of enterprisewide systems and processes to support our future commercial operations and our growing organization. As Sharon just mentioned, we will have presentations at the upcoming APA meeting in San Francisco describing our Lumateperone program in schizophrenia.

I am also pleased to announce that concurrent with the APA meeting, we will be launching a new disease awareness campaign to highlight for physicians and other healthcare practitioners the significant unmet medical needs that remain in the treatment of schizophrenia.

Schizophrenia, which afflicts over two million patients in the United States, continues to place a substantial burden in suffering, disability, and cost on patients and caregivers.

We’ve conducted extensive market research including speaking directly with individuals suffering from schizophrenia and their caregivers to better under their journey with this disease.

Based on these insights, we have developed a campaign that features actual patients and highlights their experiences and the challenges they face at different stages in their journey.

The campaign will be launched later this month at APA and will run over the next several months supported by a significant print and digital effort to reach those healthcare providers who treat schizophrenia.

We are excited to introduce this disease awareness campaign and look forward to providing you with updates on its progress as well as with our overall pre-commercialization efforts in the upcoming months. I would like to now hand the call back to Andy to discuss our other clinical development program updates.

Andy?.

Thanks, Mark. Let me start with the poster I just presented at the 2019 American Academy of Neurology annual meeting on results from our phase 1/2 clinical trial of ITI-214 our selective phosphodiesterase 1 inhibitor in patients with mild to moderate Parkinson’s disease maintained on dopamine replacement therapy.

The primary objective of the study was to evaluate the safety and tolerability of ascending doses of ITI-214 administered for one week. Favorable safety and tolerability were demonstrated over the full range of tested doses from 1 milligram to 90 milligrams.

Efficacy in improving motor symptoms of Parkinson’s disease and motor complications associated with dopamine replacement therapy was explored using multiple scales, providing input from both patients and site raters. We observed improvements in motor symptoms on top of these patient’s standard treatment and reductions in dyskinesia at some doses.

Several patients experienced profound improvements in motor impairment while taking ITI-214 only to have these improvements disappear when tested again one month after cessation of ITI-214 treatment. We are currently planning to advance this program with a phase 2 proof of concept clinical trial of ITI-214 for the treatment of Parkinson’s disease.

Our ITI-214 program in heart failure continues to progress. We are conducting an escalating, single dose study of ITI-214 evaluating the hemodynamic effects and safety in patients with systolic heart failure.

Clinical conduct for the second cohort 30 milligrams is now ongoing, following completion of the first cohort with 10 milligrams where no safety concerns were identified.

We are pleased with the progress being made in our PDE1 program as we continue to explore the potential of this novel mechanism of action in neurological, cardiovascular and other conditions. I will now turn the call over to Larry, who will review the financial result.

Larry?.

Thank you, Andy. I will be reviewing our financial results for the quarter ending March 31, 2019, and provide an overview of our expectations for the use of our cash and investments. The net loss for the first quarter of 2019 was $34.8 million compared with the net loss of $35.5 million for the first quarter of 2018.

basic and diluted net loss of $0.63 per share for the same period in 2019. Compared to a basic and diluted net loss of $0.65 per share for the same period in 2018. Research and development expenses for the first quarter ended March 31, 2019, were $25 million compared to $30.7 million for the first quarter of 2018.

This decrease of $5.7 million is due primarily to a decrease of approximately $4.8 million of the cost associated with the Lumateperone Development Programs, a decrease of approximately $1.7 million of non-ITI 007 projects, and overhead expenses, which is offset in part by an increase in labor and stock compensation expense.

General and administrative expenses for the first quarter of 2019 were $11.7 million compared to $6.4 million for the first quarter of 2018. The increase of $5.3 million is primarily the results of an increase in pre-commercialization costs and to a lesser extent labor costs, stock compensation expense, and rent expense.

Cash, cash equivalence, and investment securities totaled $312.8 million at March 31, 2019, compared to $347.5 million at December 31, 2018.

We expect these funds will be used primarily for pre-commercialization activities and related infrastructure expansion, and, if our Lumateperone NDA is approved for schizophrenia, initial commercialization activities.

It will also be used for the development of Lumateperone in our late-stage clinical programs, the development of our other product candidates including ITI-214, the continuation of manufacturing activities in connection with the development of Lumateperone and general operations. This concludes our prepared remarks.

Operator, will you please open the line for questions?.

[Operator Instruction] Our first question will come from the line of Jessica Fye with JP Morgan. Your line is now open..

Hey, guys. Good morning. Thanks for taking my question.

Have you had mid-cycle feedback from the FDA at this point? Have you heard whether there will be an advisory committee Lumateperone ahead of the September PDUFA date?.

Hi. Thanks, Jessica. Thanks for the questions too. As you know, we have said at the beginning of this process that we are really not commenting on all of our day to day activities. With the FDA, we have continuously had conversations with them and questions, which are called requests for information, and we continue to.

This is the normal course of business in getting through this NDA process. We have said from day one that we believe we are first in class new molecular to date and as such we expect to have an Ad Comm and we are preparing for an Ad Comm. We’ll update you more as time goes on..

Okay. Great. As we think about the Bipolar phase 3 reading out this quarter, can you remind us when enrollment completed for the second Bipolar Depression trial? I’m just trying to think about when we could expect to see that topline results data within the quarter..

So, I don’t remember the exact date. This is Sharon, again. I don’t remember the exact date. The readout will be later this quarter..

Okay. Maybe just a last one on Bipolar Depression.

For that ongoing phase three adjunctive study, is there any update you can provide on the enrollment progress for that one?.

We’ll be able to provide an update on the enrollment and the approximate timeline for completion within the next few months..

Great. Thank you..

Sure..

Thank you. Our next question will come from the line of Brian Abrahams, RBC Capital Markets. Your line is now open..

Hey, guys. This is Owen on for Brian. Thanks for taking the question. You talked a little bit about commercialization preparation.

I wonder if we could get some more detail there whether it be on if you’re targeting specialty psych centers or more primary care and thoughts on the size sales force you might need, and then whether or not you’re planning to launch immediately following potential approval at the end of September. Thanks..

Mark, will you answer that, please?.

Yes. Good morning, Owen, and thanks for your question. Let me give you some overview comments on our preparations. As I said in the prepared remarks, we over the past several months have been intensifying our efforts to be ready for launch early after approval. As we think about those preparations, there are really three areas.

We think about shaping the market, shaping the product, and shaping the company. As I said in my prepared remarks, from a market perspective we are preparing to launch the Disease Awareness Campaign concurrent with APA. That’s a really progressive step for us moving forward. From the company perspective, we really think about it in three areas.

We think about hiring talented and experienced senior leadership. We have communicated before that we have the entire commercial leadership team on board at this stage. We think about the infrastructure that is going to be required to support our transition from a clinical stage organization to a fully integrated commercial organization.

Those preparations are proceeding well. And we talk about the commercial capabilities across sales and marketing and managed care. We’re very pleased with how that is going as well. From a targeting perspective, yes, we plan to target those physicians who treat schizophrenia patients.

As you can imagine, the majority of those are psychiatrists but there are other allied health professionals that also treat schizophrenia and we will be targeting those as well..

Great. Thanks. That’s really helpful..

Thank you. Our next question will come from the line of Ritu Baral with Cowen. Your line is now open..

Hi. This is Subbu Nambi on for Ritu Baral. Thank you for taking my question. I have two questions. First one, I was wondering if the depression data from the schizophrenia study could have a lead on bipolar depression..

I’ll ask Kim to take that one on, please..

Hi. Thanks for the question. So, we do believe that the improvements in depression that we’ve seen in patients with schizophrenia and comorbid depression will translate favorably to other mood disorders, including bipolar depression and major depressive disorder.

We also believe the safety profile that we’ve seen that’s been favorable in our schizophrenia program will translate favorably to mood disorders as well..

I see.

My follow up question is are you getting a sense of the payer landscape? How have the conversations been so far?.

I’m sorry. I don’t think we could understand your question.

Could you say it again?.

Are you getting a sense of the payer landscape? How have the conversations been so far with the payers?.

Thanks. I’ll ask Mark to answer that..

Sure. Thanks for the question. Yes.

Across all of our customer areas with physicians and payers and patients, we’re doing extensive market research and also have had the opportunity, particularly with payers, medical directors, and pharmacy directors, in an advisory board setting to understand the current dynamics of the market, to share with them the profile of Lumateperone.

We’ve been pleased with the reaction to the profile. Our belief is in this marketplace there remains a significant unmet medical need for an anti-psychotic that is effective but has a safe and tolerable profile. We think that’s the clinical profile that’s emerging with Lumateperone.

We believe we’ve got a very strong clinical value proposition and we’ve been engaging in an advisory setting with payers along those lines..

Got it. Thank you. Thank you, guys, for taking my questions..

Thank you. Our next questions will come from the line of Marc Goodman with SCP Leerink. Your line is now open..

Yes. Good morning. A couple of questions.

First, with respect to the numbers, can you just give us a sense of spending and how you’re thinking about spending as the year progresses in R&D and G&A as much as you’re willing to talk about that? Second of all, can you talk about what data you will be having in San Francisco in a few weeks? Third, with respect to the bipolar depression, there was already a question asked but let me just ask it in a different way.

Can you clarify the amount of time there was between the last patient that was enrolled in Study 401 versus Study 404, so we just have a sense of timing of these things? Thanks..

Okay. Thanks, Marc. I think we have a bunch of questions there. I’ll ask Larry to talk about the numbers first and then we’ll go from there..

Hi. This is Larry. We spent approximately $35 million in the first quarter and we expect that to increase as we go through the rest of the year and ramp up our pre-commercialization and our commercialization efforts as needed..

On the second question, the data in San Francisco, we’ll be presenting our Lumateperone program including our efficacy and safety package, so the entire profile of the product. And the last question about the last patients enrolled, we don’t have those numbers off the top of our head.

The two studies will be locked, and data will be available simultaneously on the two studies later this quarter..

Okay. Thanks..

[Operator Instruction] Our next question will come from the line of Robert Hazlett with BTIG. Your line is now open..

Thank you for taking the question.

Could you give a little bit more color on the MDD indication, any specifics of the formulation that you’re developing? And then I guess, is the main characteristic that you’re hoping to achieve in MDD, the rapid onset? And if that’s not the case, if you could describe any other characteristics that you hope to elucidate with Lumateperone in that study, that would be helpful.

Thank you..

Thanks for the question. I’m not really sure I understand everything about the question. So I mean on what we can say are these are different formulations of lumateperone. I think since – maybe Kim has some more understanding of your question. And yes, if you’re asking if it’s an injectable, it’s not. It’s not a long acting injectable product.

And I don’t know for further color, if Kim would like to add anything to that..

Sure. So just as a reminder, we’re very excited about the potential of lumateperone to treat depressive disorders. In particular, the pharmacology of lumateperone supports a rapid acting onset of effect with the indirect glutamate enhancement of neurotransmission through both NMDA and AMPA current downstream from the D1 receptor activation.

And given the profile pharmacologically of lumateperone, we’re trying to optimize a novel formulation to be able to deliver a rapid onset of effect with combining the pharmacology and the root of administration.

So we have PK studies that are ongoing evaluating these, and we’re excited about the opportunity, and we’ll be updating you as we move forward..

That’s very helpful. Thank you..

Thank you. And our next question will come from the line of Matt Kaplan with Ladenburg Thalmann. Your line is now open..

Hi. Good morning. I just wanted to dig in a little bit more into your commercialization preparation.

Specifically, could you give us an idea of the size of the sales organization that you plan to have in place as you go into September around the PDUFA date and launch the product and after the launch, after approval? And then also, give us a little bit more detail in terms of with the advisory committee meetings in terms of payers, with that output, what you’re thinking about in terms of pricing.

Start with those two and I have some more on commercialization..

Mark?.

Yes. Sure. Thanks for your question. I’ll start with the sales force. What I would say about our sales force preparations is that we have a very good understanding of the size of the sales force that we’ll need to support the launch of Lumateperone. We know which healthcare practitioners that we plan to target.

We know the size of our competitor’s sales forces. I guess the main message here is that we’re going to size the sales force to be highly competitive in the offices of our target prescribers. As we proceed through the year and we get closer to the potential launch, we’ll share more details about the configuration.

But at this point, we prefer not to share that. The target prescribers that our sales force will be calling on will be those high prescribers who treat schizophrenia patients, as you can imagine.

In terms of the interactions that we’ve had with payers and how that’s informing our strategy from pricing and contracting perspective, again, the interaction that we’ve had has been in a market research setting sharing with, as I said, medical directors and pharmacy directors the clinical profile that’s emerging with Lumateperone.

Getting their understanding of how they managed this category, what they see as the unmet need. So, with that, we have conducted a very comprehensive pricing strategy assessment and that indicates to us that we have a very strong value proposition with Lumateperone.

Obviously, as we go through the next couple of months and we prepare for launch, we will continue to monitor the clinical landscape, the policy landscape, any competitive actions. That will all go into informing our final pricing and contracting strategies.

Again, that’s something that we’re not sharing the details of at this point, but as we get closer to launch, we’ll share more of that with you..

I guess, a follow up on that.

Do you expect patients will have to step through other medications before they get to Lumateperone? What does your research show there? Maybe another way of asking the question in terms of the size of the sales force in terms of thinking about your cost of the launch and how we should think about that later this year going into next year..

So, let me address the first question on the payers. I think what you have to think about is the characteristic dynamic in the schizophrenia marketplace today is the idea that it’s a chronic disease.

These patients are frequently cycling through multiple medications because many of them, either due to inadequate efficacy or intolerable side effects, discontinue at a fairly high rate. The statistic that we’ve seen in a clinical study is that 75% of patients starting an antipsychotic will discontinue within 18 months.

So, you have this dynamic where patients are frequently switching their medications. They are cycling through multiple medications. It’s not unusual for a patient with schizophrenia to be on their third, or fourth, or fifth anti-psychotic. What that means is that there is an ongoing need for additional treatment options.

And so most payers generally cover a broad range of antipsychotics because of this switching dynamic. What they tend to do to manage the utilization is through either a tiered structure which has a differential copay, or they put in place step edits and prior authorization.

So, many payers will require a step through one or two generic products before providing access to the branded agent. But again, the dynamic in this marketplace is such that because patients are cycling through different lines of therapy, there is always a need for newer antipsychotics.

I think that is demonstrated by some of the success that some of the branded products, newer banded products, in the market. I hope that answers your question there.

Would you mind just repeating the second part of your question?.

Yes. That’s very helpful. The second part of the question is if you can give us a sense in terms of how we should think about the cost of the launch going into later this year and next year given your lack of clarity, at this point, in terms of sharing the size of the sales organization..

Yes, again, at this stage, for competitive reasons, we’re not sharing the size of the sales force that we intend. I think the main message that I would communicate is that we do have a good understanding of what that needs to be in order to be successful with the launch.

As we get closer to the potential approval, we’ll share more of the details of that with you..

Great. Thanks a lot..

Thank you. Our next question will come from the line of Sumant Kulkarni with Canaccord. Your line is now open..

Good morning. Thanks for taking my questions. Both of them are on 214. First, on the data that was presented at ANN and the poster, could you talk a little bit about the dose dependence? If you look at the blocks in the poster, there seems to be a dose dependence up to the 30 mg point and then the 90 mg is somehow different.

Could you help us conceptualize why that difference might be? Is it because of the baseline or something else?.

Andy?.

Yes. Sure. Thanks for stopping by the poster. It was nice chatting with you, and I guess we didn’t get to all the questions. I’m happy to discuss that a little bit further. Yes, as you can see, the cohorts were relatively small. There were eight patients in each cohort, six on drug and two on placebo.

We didn’t require a certain amount of baseline severity for inclusion in the trial. Patients had to have mild to moderate Parkinson’s disease but without any specific requirements or either a certain amount of motor impairment or a certain amount of motor complications including dyskinesia.

So, that probably accounts for a lot of the variability that we saw across the doses. I think, particularly since the baseline amount of motor impairment and the dyskinesia in the 90 mg group was less, that may account for why we saw less of an effect there.

The important thing is that you could see that there were trends toward greater effect both in terms of treatment of dyskinesia when we got to the higher doses. That is suggestive of the effectiveness of the drug itself and gives us a lot of confidence going forward in terms of designing a more rigorous proof of concept phase two trial..

Got it.

The follow up on 214 is are there any preliminary thoughts you can share on how dosing might be in the heart failure indication?.

Yeah.

Andy?.

Not really at this point. As we mentioned, we’re in the second cohort studying 30 milligrams. We will be evaluating the data as we get it and determining how many cohorts we’ll have in this trial and what dose we’ll go up to. Until we’ve been able to do that, we wouldn’t be able to say..

Got it. Thanks..

Thank you. I’m showing no further questions in the queue at this time. It is my pleasure to hand the conference over to Ms. Sharon Mates, Chief Executive Officer, for any closing comments or remarks..

Great. Thank you and thank you, everyone, for joining the call. Stay tuned. We’ll have many updates as we go forward. It’s a very exciting time for us at Intra-Cellular Therapies. With that, Operator, you can disconnect the call. Thank you..

Ladies and gentlemen, thank you for your participation in today’s conference. This does conclude our program and we may all disconnect. Everybody have a wonderful day..