Intra-Cellular Therapies - Q4 2019

Transcript

Speaker 0

Good morning, ladies and gentlemen, and welcome to the intracellular Therapies Fourth Quarter and Full Year Ended December 31, 2019 Financial Results Conference Call. As a reminder, today's conference call is being recorded. I'd now like to turn the conference over to your host, Doctor. Juan Sanchez, Vice President, Corporate Communications And Investor Relations. Please go ahead.

Speaker 1

Thank you. Good morning and thank you all for joining us for today 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 short time ago and is available on our website atintracellulartherapies.com. Joining me on the call today are Doctor. Cheryl Mates, Chairman and Chief Executive Officer Doctor.

Andrew Satland, Executive Vice President and Chief Medical Officer Mark Neumann, Executive Vice President, Chief Commercial Officer Larry Honeyland, Senior Vice President, Chief Financial Officer and Michael Halsted. 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, anticipated conduct and results of ongoing and future clinical trials, plans regarding regulatory filings, future research and development, our plans regarding commercialization commercialization of capital and possible uses of existing cash and investment resources. These forward looking statements are based 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.

This is another risk of describing 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.

Speaker 2

Thanks, Juan. Good morning, everyone and welcome to today's call. 2019 was a very supremia and adults. We are very excited about the launch of Keplyta later this month. Our launch plan is comprehensive and our preparations are fully on track.

We have a highly experienced and competitively sized commercial team in place and they are 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 Newman, 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 polar depression and our ITI-two fourteen Phase III 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 And A. As reflected in the Lida provides physicians and their patients an important new treatment option for this serious mental illness impacting approximately 1% of the global population translating into 2.4000000 adults in the United States.

Important unmet medical needs continue to exist. Patients with schizophrenia often discontinued treatment or seek treatment changes as a result of side effects such as weight gain metabolic disturbances and movement disorders. We are pleased that Kepelita 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 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 1 or bipolar 2 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 4 2, our global phase 3 study evaluating Lumateperone as an adjunctive treatment of press of episodes associated with either bipolar 1 or bipolar 2 disorder. We anticipate reporting top line results midyear. Further, we have commenced an additional phase 3 study, Study 4 3, 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 $224,000,000 in cash and investments, adding to our financial strength, we completed a $295,000,000 follow on public offering earlier this year, which resulted in net proceeds of approximately $277,000,000. We are well capitalized and to continue to advance our development programs. In 2019 we made strategic investments in our infrastructure to appropriately support our growing organization 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 Kaplida.

Mark?

Speaker 3

Thanks, Sharon, and good morning, everyone. Our commercial team has been very busy and we are very excited have the opportunity 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 Immediately after the approval of CAPLIDA 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 Catlight website and has delivered over 1,000,000 impressions to date. Kepleto will be available to pharmacies in mid March and our full launch promotional activities in which our multichannel marketing effort, including the deployment of a national sales force of approximately 240 neuroscience sales specialists, will focus on the approximately 23,000 healthcare providers who account for 80% of the branded anti psychotic schizophrenia prescriptions. Our entire sales leadership team and substantially all of our sales representatives are onboard and their training activities are in the final stages.

We are very pleased 15 years of selling experience in the bio pharmaceutical industry and greater than 90% of them have prior psychiatry experience. Let me now provide an update on since early in 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 addictible dynamic in the way new antipsychotics enter the market and formulary coverage is assigned. Consequently, we expect payers to manage Caplide Us 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 coverage determinations for CAPLIDA to be established from now through the second quarter. And based on recent precedence, we would expect similar timing dynamics for coverage determinations in the Medicaid channel. Commercial payers represent another important deal. We are in discussions with all the major payers and are starting to Overall, we expect market access formulary status for Caplida to be fully established across all payer channels within 9 to 12 months in accordance with expected review timelines 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 CAPLIDA consistent with how other antipsychotics were managed at launch.

Additionally, we have designed a comprehensive patient support program to facilitate access to CAPLIDA including appropriate prior authorization support and co pay savings assistance. In summary, we are very excited to and a strong Keplata 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?

Thanks, Mark, and good morning, everyone. With the approval of Caplida

Speaker 4

for the treatment of schizophrenia in adults, we are excited about the opportunity to help patients suffering from this serious, lifelong mental illness. The CAPITAL label clearly reflects the efficacy and safety profile observed in our clinical studies. The efficacy of CAPLITA 42 milligrams was demonstrated in 2 placebo controlled trials. Most common adverse reactions were somnolenceidation and dry mouth. In pooled data from short term studies, mean changes from baseline in weight gain, fasting glucose, triglycerides, and total cholesterol were 0.7% for Kepalida and 6.3% for placebo.

Our medical affairs team has been very active and energized by scientific change 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 Teplida 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 1 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, Doctor. Christophe Carell.

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 for lumateperone in this important indication and the possibility to help depressed individuals suffering from both bipolar 1 and bipolar 2 disorder. In Study 404, Lumateperone 42 milligrams met the primary endpoint with statistically significant greater improvement over Placebo on the Madras 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 two 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 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 or bipolar for severity of illness total score, as well as strong 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 Enrollment is on track in our ongoing adjunctive Phase III study, Study 40two, and we anticipate top line results mid year. 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 1 or bipolar 2 disorder. This study is being conducted globally and will include approximately 550 patients randomized 1 to 1 to 1 to receive Lumateperone 42 milligrams, 28 milligrams, or placebo once daily for 6 weeks, while being maintained on lithium or valproate as mood stabilizer.

3403 evaluates lumate lumateperone as monotherapy in patients with bipolar 1 and 2 disorder. It is also being conducted globally and will include approximately 350 patients, randomized 1 to 1 to receive lumateperone 42 milligrams or Placebo once daily for 6 weeks. The pre specified primary endpoint for both trials is changed from baseline at week 6 on the Madras Total Score versus Placebo. Subject to the results of Study 4 2 and our interactions with the FDA regarding our bipolar depression program, we expect 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 colorability trade offs.

We believe Lumateperone's pharmacological profile and existing safety and efficacy profile strongly support the development of the drug across major psychiatric illnesses 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 1 clinical study in 2020. We continue to advance our PDE-one program. Our ITI-two fourteen Phase III clinical trial in heart failure is nearing completion. This single ascending dose study aims to replicate the positive inotropic effects of ITI-two fourteen seen in a preclinical model of heart failure.

Clinical conduct for the 3rd and final cohort 90 milligrams is ongoing following 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 twenty twenty. Finally, we expect to initiate oral modulator of new opioid and serotonin receptors for the treatment of opioid and other substance use disorders, pain and mood disorder. A single ascending Larry?

Speaker 5

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 $89,100,000 compared to 132,200,000 2018. The $43,100,000 decrease is due primarily to lower clinical trial costs and to a lesser extent, manufacturing costs for CAPITAL Lumerteperone and is offset partially by higher non IPI-seven related projects and labor costs. General and administrative expenses for the year ended 2019 were $64,900,000 compared to $13,100,000 for 2018.

The increase of $34,800,000 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 $224,000,000 at December 31, 2019 compared to $347,500,000 at December 31, 2018. On January 10, 2020, we completed a $295,000,000 follow on public offering resulting in net proceeds to the company of approximately $277,000,000 from the sale of 10,000,000 shares of our common stock. This concludes our prepared remarks.

Speaker 0

Our first question comes from Charles Duncan with Cantor Fitzgerald. Your line is now open.

Speaker 6

Good morning. Sharon and team, thanks for taking our questions and congratulations on a great year last year. Quick question regarding Caplata in terms of commercialization. Then I had one follow-up for for the pipeline. In terms of Caplata 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, especially given the differentiated clinical profile of Caplida?

Speaker 2

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

Speaker 3

Yes, sure. Good morning, 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 1 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 Caplida, 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 needed by the marketplace. And that's exactly what we're seeing when we have those discussions with medical and pharmacy directors.

Speaker 6

That's helpful. And if I could just add one more on that one. In terms of supply chain, we never ask these questions generally, but in today's world, we need to. How does the supply chain? I guess, look, for Caplata in terms of 1st couple of beers or year of Ortho Supply?

Speaker 2

I'll start and I'll ask Mark if he wants 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 like that.

Speaker 3

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

Speaker 6

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 a significant overlap in terms of the clinical sites more with 404 than relative to 401 for that study. And then And then finally, anything new out of the 4 2 study that really drove you to design and, and, initiate this 403 study?

Speaker 4

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're 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 those data will be replicated. With regard to 4 2, that study is proceeding very well. We're nearing completion. We do expect to have by the middle of the year as we've said. We don't have anything new to report on that, and I think, that will wait for the results of that trial.

Speaker 6

Okay. Very good. Thanks for the added info.

Speaker 0

Our next question comes from Mark Goodman

Speaker 7

supply chain that you were talking about. All 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 can give us a sense of what the fourth quarter reflected and what we should expect kind of as the year progresses for spending? Thanks.

Speaker 2

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?

Speaker 5

Yes. Mark, if you look at the results of the fourth quarter of 2019, we had research and development expense about $19,000,000 in general and administrative expenses of $22,800,000. And we expect that the research and development expenses will increase modestly in the first quarter and stabilize their forward going forward rather. And then our SG and A expenses will increase in the first quarter as we put our, commercial staff in place. And then they'll stabilized throughout the rest of the quarters

Speaker 7

So the SG and A step up obviously, I mean, the sales reps were not in the 4th quarter, right? So we have that for a step up and then just regular spending.

Speaker 5

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

Speaker 7

Right. And so first quarter is a big number. And then you're saying second, third and 4th in the SG and A line or in the range of first quarter?

Speaker 3

Yes.

Speaker 7

Okay. Got it. Thank you.

Speaker 0

Thank you. Our next question comes from Umer Raffat with Evercore. Your line is now open.

Speaker 8

Hi, thanks so much for taking my question. 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, what exchange you've had with FDA already, what their feedback was? Do they want you to have the junk readout in hand before you file? Just wanted to understand what feedback FDA share you on the existing bipolar results?

Speaker 2

Right. Hi, and 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 4 2 study, if that's successful, then we would anticipate filing by yearend. So that's the data as we have it right now.

Speaker 8

Thank you.

Speaker 0

Thank you. Our next question comes from Jessica Fye with JPMorgan. Your line is now open.

Speaker 9

Hey guys, good morning. Thanks for taking my question. I was hoping you could talk about the genesis for the decision to start 403 before, the results of the next trial readout?

Speaker 2

So I'll start that and I'll ask Andy if you have anything to add. Thanks. And hi, 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 mid year. 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 anything?

Speaker 4

Yeah, 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 opportunity to submit data to the FDA and get this drug approved in that indication as well. So this is

Speaker 10

just part of the

Speaker 4

strategy we think as Sharon said, it's prudent. And I think that many companies would follow in this indication.

Speaker 9

Okay, great. And just following up to that, I think you've talked about bipolar too as a potential point of differentiation. What are some of the reasons or factors why there have been few approvals for bipolar 2 thus far?

Speaker 4

So, I think, it's a, a choice whether you're going to study bipolar bipolar too. 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 it's only approved in bipolar 1 and bipolar 2 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 the drug available to as broader range of patients with the disorders who could benefit, as possible.

Speaker 9

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

Speaker 4

So we're starting our initial, study with that shortly. And Yes, 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 safety and efficacy in the schizophrenia population. So we're not anticipating anything unusual in the way that this will move forward.

Speaker 2

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. Got it. Thank you.

Speaker 0

Thank you. Our next question comes from Brian Abrahams with RBC Capital Markets. Your line is now open.

Speaker 11

Hi, this is Leo on for Brian. Thanks for taking my question. We've heard some anecdotal reports from KOLs about the importance of potential effect on other aspects of the disease that are not fully captured by the current data set such as beginning return to a job and improve socialization. So what are some of these longer term outcomes that you're thinking about for Caplasia 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?

Speaker 2

Yes, we do. And I'll ask Andy just to elaborate a little further, but I have to say you sound exactly Brian. That's really very funny. So I'm sorry. I didn't mean to get us off track here, Andy, did you want to?

Speaker 4

Yes. No, thanks for asking actually. 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 lumateperone 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, including longer term studies. And we are definitely thinking about pursuing 1 or more of those additional indications within the schizophrenia area.

So, yeah, we think 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 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. Thank you.

Speaker 0

Thank you. Our next question comes from Sumant Kulkarni Canaccord. Your line is now open.

Speaker 4

Good morning. Thanks for taking

Speaker 10

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

Speaker 5

Yes, we're going to recognize revenue on shipment and with estimated, adjustments were pulled through.

Speaker 10

And then a couple of questions on the pipeline. So on the long acting formulation, you've complete preclinical development, given that there was some focus on preclinical data prior to the approval of oral

Speaker 4

is.

Speaker 2

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

Speaker 10

Yes, sure. So I meant in terms of the before the approval of the oral kapitalita, there was intense focus on the preclinical data set generated by Keplyta 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 were predictable responses there. That was the question.

Speaker 2

The predictable responses that we haven't seen any of these metabolites and that is correct. We have looked for them and we don't see them.

Speaker 10

Got it. And on MDD, when should we expect this MDD, when should we expect to see the phase 2 data?

Speaker 2

Phase 2 data where we are anticipating starting the studies this year.

Speaker 4

Right. Got it. Thank you.

Speaker 0

Thank you. Our next question comes from Brett Haslett with BTIG. Your line is now open.

Speaker 12

Thanks. Yes, just two quick ones and then maybe a broader picture 1. In terms of the quick ones, maybe you said it, but the timing of the readout of 403

Speaker 2

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

Speaker 12

Okay. Thank you. 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.

Domicile from this point? Or is it domiciled Internationally? And if so, where is it coming from?

Speaker 2

So As we've said, we have 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 a 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.

Speaker 12

Terrific. Thank you. And then With regard to, looking a little bit further out with regard to Keplyta, it's clearly differentiated in terms of the adverse event profile that it brings to the table. As you think, Mark and Sharon 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? Thanks.

Speaker 2

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?

Speaker 3

I would just emphasize that and just reiterate what said before that, we feel confident that the profile of CAPLIDA 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 Kapalita going forward into the future as well.

Speaker 12

Thanks. We look forward to the launch.

Speaker 2

Thank you.

Speaker 0

Thank you. Our next question comes from Jason Butler with JMP Securities. Your line is now open.

Speaker 13

Hi. Thanks for taking the question. 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, or 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? Thanks.

Speaker 2

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

Speaker 4

Yes. I think the preclinical data was really, the initial basis for moving in this direction and that Lumateperone has very interesting pharmacology that in some respects is similar to that seen with ketamine in terms of downstream effect 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.

Speaker 2

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

Speaker 4

Okay, great. Thanks for taking the question. Thank

Speaker 0

you. Our next question comes from Andrew Tsai with Jefferies. Your line is now open.

Speaker 14

Thanks and good morning. As we think about the launch, upcoming launch, should investors expect some kind of inventory build in Q1 or Q2 in Also is there a sense that there could be some kind of bolus in the 1st few weeks of launch? And I have a follow-up.

Speaker 2

Mark, do you want to take that?

Speaker 3

Yes. So, hi, Andrew, it's Mark. So, as I've mentioned in my prepared remarks, 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.

Speaker 8

Great. And then

Speaker 14

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 a sales rep would need to make before a doctor starts prescribing to Playa? Thanks.

Speaker 3

Yes, sure. Andres, it's a good question. And I think each physician is different. Each physician has 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 healthcare 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 Caplida 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 23000 healthcare providers.

Speaker 8

Thank you.

Speaker 0

Thank you. Our next question comes from Matt Kaplan with Ladenburg Thalmann. Your line is now open.

Speaker 8

Hi, this is Raymond in for Matt. Congrats on the progress. Thanks for taking my questions. Just regarding quickly on the pipeline, maybe

Speaker 2

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

Speaker 8

Sorry. Can you hear me now? Yes. Oh, sorry. Yes, this is Raymond in for Matt.

Thanks for congrats on the progress. 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 focusing on the novel formulation? As a monotherapy perhaps?

Speaker 2

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

Speaker 4

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

Speaker 8

Okay. Yes. I guess maybe also for perhaps Lumateperone, do you consider any other indications beyond bipolar MD currently thinking? Forward?

Speaker 2

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

Speaker 8

Okay, cool. Thanks. And just one final question for ITI-two fourteen, do you intend to partner the asset in the non CNS indications or or in the CNS indications as well? Just for construction clarification.

Speaker 2

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

Speaker 8

Okay, cool. Thanks for the color. That's all I have for now. Thanks. Sorry for that.

Yeah.

Speaker 2

Okay, operator.

Speaker 0

I'm not showing any further questions at this time. I would now like to turn the call back over to Doctor. For any further remarks.

Speaker 2

Just want to thank everyone for today's participation on the call. And we're very excited about bringing, CAPALIDA to market and providing a new option for patients And I'd like to thank our whole team at intercellular 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.

Speaker 0

Ladies and gentlemen, this concludes today's conference