Intra-Cellular Therapies inc (ITCI) Q3 2021 Earnings Call Transcript

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Intra-Cellular Therapies inc (ITCI -2.12%)
Q3 2021 Earnings Call
Nov 9, 2021, 8:30 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good morning, ladies and gentlemen. Welcome to our Intra-Cellular Therapies Third Quarter Financial Results Conference Call. As a reminder, today's conference call is recorded. I'd now like to turn the conference over to Dr. Juan Sanchez, Vice President, Corporate Communications and Investor Relations. Please go ahead.

Juan Sanchez -- Vice President of Corporate Communications and Investor Relations

Good morning and thank you all for joining us today. Our earnings press release provides our corporate update and details of the company's financial results for the third quarter, which ended September 30, 2021. This press release crossed the wire a short time ago and is available on our website at intracellulartherapies.com. Joining me on the call today are Dr. Sharon Mates, Chairman and Chief Executive Officer; Mark Neumann, Executive Vice President and Chief Commercial Officer; Dr. Suresh Durgam, Senior Vice President and Chief Medical Officer; and Larry Hineline, Senior Vice President and Chief Financial Officer.

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 use 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 and expectations regarding the commercialization of CAPLYTA, potential impact of the COVID-19 pandemic in our -- on our business 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 might 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.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Thanks, Juan. Good morning everyone and welcome to today's call. We're excited to share our third quarter progress, update you on our programs and describe our upcoming plans. In the third quarter, we continue to successfully execute our commercial plan for CAPLYTA, our FDA approved medicine for the treatment of schizophrenia in adults. CAPLYTAs prescription growth trajectory continued quarter-over-quarter. We have an upcoming milestone rapidly approaching with our FDA PDUFA date of December 17th for CAPLYTAs label expansion into bipolar depression in adults. We also continue to advance several other promising development programs.

Before I provide further details on our programs, let me first provide an overview of our financial and commercial performance. Total revenues for the third quarter grew to $22.2 million. CAPLYTA net product revenues were $21.6 million compared to $19 million in Q2 2021 and $7.4 million in the same quarter last year. Total prescriptions increased 15% quarter-over-quarter and approximately 200% versus Q3 of 2020. We achieved the sequential growth in spite of disruptions due to the latest surge of COVID-19 during Q3.

CAPLYTA has a compelling clinical profile having demonstrated efficacy coupled with favorable safety and tolerability with no dose titration required. In our clinical trials in schizophrenia, CAPLYTA results were similar to placebo for changes in weight, fasting glucose, total cholesterol, triglycerides and extrapyramidal symptoms, including akathisia. Market research and feedback from the field continues to indicate that patient and physician real life experiences with CAPLYTA are consistent with what was demonstrated in clinical trials. We're very excited about CAPLYTAs potential as an important treatment option for patients with bipolar depression. This label expansion would significantly extend the patient opportunity for CAPLYTA to more than 11 million Americans living with bipolar disorder.

There are only a few approved treatment options for bipolar depression, the most common and debilitating manifestation of this disorder. If approved CAPLYTA could help fill an existing need for effective treatments with a favorable safety and tolerability profile. The FDA is currently reviewing our sNDAs for the treatment of bipolar depression in adults. Our applications are supported by robust positive results from two Phase 3 studies that evaluated the effects of lumateperone in patients with either bipolar I or bipolar II disorder. In both studies, treatment with lumateperone substantially reduced depressive symptoms on both primary and key secondary endpoints.

Importantly, the favorable safety and tolerability profile in our bipolar depression program is consistent with that of our schizophrenia program. During the quarter, results from Study 404, our monotherapy study were published in the American Journal of psychiatry, a highly respected psychiatric journal. Upon approval, we expect to launch this important new option for patients with bipolar depression. Our sales force expansion is substantially complete and Mark will provide further details in a few moments.

Our longer-term vision is to establish lumateperone as the treatment of choice across a broad range of depressive disorders. Bipolar depression is the first indication in this strategy. This is followed by our Phase 3 studies in MDD, which our double-blind, placebo-controlled six-week study evaluating lumateperone 42 milligrams as adjunctive treatment to anti-depressants for patients who have an inadequate response to antidepressant therapy. In addition, we have an ongoing program evaluating lumateperone in patients who exhibit mixed features. Study 403 is a double-blind placebo-controlled six-week study evaluating lumateperone 42 milligrams as monotherapy for patients with MDD or bipolar depression, exhibiting mixed features.

Patients with mixed features, who make up roughly one-third of those with bipolar depression and MDD, have greater symptom severity, higher risk of suicide attempts and higher comorbidities.. They also respond poorly to anti-depressants. We expect to complete our ongoing 403 study in the second half of 2022. We recently held our first Research and Development Day where we had the opportunity to hear from a group of prominent experts in psychiatry, who shared their perspectives on the therapeutic needs in major psychiatric conditions, including schizophrenia and mood disorders, with an emphasis on bipolar depression.

They provided insights into lumateperone's potential to address these needs, which was consistent with feedback we have received. We are confident that lumateperone addresses an unmet medical need and if approved lumateperone will have broad utility across a range of depressive disorders, with bipolar depression being the first approval within this category. During the event, we provided an overview of molecules in our robust pipeline, including the lumateperone long-acting injectable formulations and ITI-1284 ODT-SL programs.

We have initiated our program for the development of ITI-1284 for the treatment of agitation in patients with probable Alzheimer's. Clinical conduct in this program is expected to begin early next year. Studies in dementia related psychosis and certain depressive disorders in the elderly are planned for the first half of next year. We also presented important aspects of the mechanistic underpinnings, our existing data and our clinical development plans for our PDE1 inhibitors and ITI-333 platforms.

We discussed the features that make PDE1 enzyme unique among the large family of phosphodiesterases. We also discussed the PDE1's unique tissue distribution and the selective pathway regulation that allows for broad therapeutic opportunity for our portfolio of PDE1 inhibitors. We presented preclinical and early stage clinical results in Parkinson's disease supporting the recent advancement of lenrispodun into Phase 2 clinical development. Our external expert explained the therapeutic needs for treating motor symptoms and non-motor symptoms, including cognition in this patient population.

Our goal for this program is to study lenrispodun's potential to improve motor and non-motor symptoms, including cognition by enhancing or restoring neuronal function in effective brain regions. We also highlighted ITI-333, a promising drug candidate, to address important unmet therapeutic needs in opioid use disorder and pain. ITI-333 is a novel compound that act as a partial agonist at new opioid receptors and as an antagonist at the serotonin 5-HT2A receptors. At new opioid receptors, it act as a partial agonist, signaling through G-protein-coupled pathways, but acts as an antagonist at the beta arrestin pathway.

Our external expert explain the current opioid use crisis in the U.S. and outline the unmet therapeutic needs. Results from an ongoing Phase 1 single ascending dose study are anticipated in the fourth quarter of 2021. We ended the third quarter in a strong financial position with $478.7 million in cash, cash equivalents and restricted cash. We're very proud of our performance and our team's efforts over the last quarter. As we continue to grow and expand, we remain committed to fulfilling our mission to develop innovative treatments to improve the lives of individuals with neuropsychiatric and neurologic disorders.

Mark will now share details of our ongoing commercial activities, including our plans for bipolar depression. Following his remarks, Larry will provide additional details on our financial performance. Mark?

Mark Neumann -- Executive Vice President, Chief Commercial Officer

Thank you, Sharon. It's a pleasure to be here with all of you today to provide an update on the commercial performance of CAPLYTA in schizophrenia and to share our launch readiness progress for the exciting potential opportunity in bipolar depression. As Sharon noted CAPLYTA performed well in the third quarter, increasing total prescriptions by 15% sequentially over the second quarter. This growth was achieved in spite of the latest delta surge in the pandemic, which impacted the care of patients with schizophrenia and suppressed the overall antipsychotic market during the quarter.

While restrictions continue to exist, COVID case numbers are decreasing across the country and vaccination rates are gradually improving. As a result, more psychiatry offices are reopening for patient appointments and our sales team is gaining greater in-person access to healthcare providers in some practices. These encouraging market developments coincide with the expected approval timing of CAPLYTA in bipolar depression, putting us in a stronger position for the upcoming months.

I'm pleased to report that our bipolar launch preparations are all on track and we expect the launch will be successful for several reasons. There remains a very significant unmet medical need in bipolar depression and additional treatment options are required for this debilitating disorder. CAPLYTA has demonstrated strong efficacy and favorable safety and tolerability results in our clinical trials and has the potential to be approved in the broadest range of adult patients with bipolar depression, including those with bipolar I and II and as monotherapy or as adjunctive therapy to lithium or valproate.

We have a multifaceted commercial plan in place and are ready to hit the ground running to maximize this exciting opportunity. We believe this plan will significantly accelerate the use of CAPLYTA. We have conducted extensive market research that shows physicians, payers and patients; all have a favorable impression of the clinical profile of CAPLYTA in bipolar depression. They cited efficacy in both bipolar I and bipolar II and as both monotherapy and adjunctive therapy across a broad patient population, as well as its favorable safety and tolerability profile. They are especially impressed by its low risk of weight gain, metabolic changes and movement disorders.

To ensure broad awareness of CAPLYTAs potential bipolar indication and clinical profile, we are increasing our target audience to the 43,000 prescribers, who account for approximately 85% of all oral branded antipsychotic prescriptions written for schizophrenia and bipolar disorder. This will include psychiatrists, nurse practitioners and primary care physicians who treat significant numbers of patients with bipolar depression. We have expanded our sales force from 240 representatives to a total of 320. This will ensure a highly competitive share of voice with the expanded prescriber target base. We are pleased with the talent that has been attracted to our Company and have hired experienced sales representatives with proven track records prior to and during the pandemic. We are confident in their ability to drive strong results.

Our sales efforts will be complemented by a comprehensive multi-channel promotional campaign to optimize adoption of CAPLYTA including peer-to-peer medical education, digital media promotions and DTC advertising to increase awareness of CAPLYTA among healthcare providers and patients. On the market access front, CAPLYTA continues to maintain broad coverage in the Medicare Part D and Medicaid channels with greater than 95% of lives covered. These are the two primary channels through which the majority of schizophrenia prescriptions flow.

In our preparations for the bipolar depression label expansion, our team operating under the FDA pre-PDUFA guidance has completed comprehensive bipolar disease awareness and clinical trial data presentations, with the formulary decision makers at strategic payer accounts, including the largest commercial insurers and PBMs. With the potential approval of CAPLYTA for bipolar depression, we would over time, expect to see an increasingly larger percent of our prescriptions coming through the commercial channel due to the nature of the bipolar patient population.

Recently, we have improved our coverage in this channel to approximately 70% of lives and expect that to continue to increase in the coming months. Additionally, we see competitive reimbursement approval rates for CAPLYTA consistent with other branded antipsychotics and our LytaLink patient support program has been very effective in supporting the prescription process and in minimizing out-of-pocket expenses for our commercially insured patients. In summary, we are extremely excited about the potential label expansion of CAPLYTA for bipolar depression and we are confident that we have a highly effective and competitive commercial plan in place to achieve a strong uptake in prescriptions.

I'll now turn the call over to Larry to share our financial results. Larry?

Lawrence J. Hineline -- Senior Vice President of Finance and Chief Financial Officer

Thank you, Mark. I will now provide a summary of our financial results for the third quarter ended September 30, 2021. Total revenues in Q3 grew to $22.2 million compared to $7.4 million of total revenues in the third quarter of 2020, CAPLYTAs third quarter net product revenues reached $21.6 million compared to $19 million in the second quarter of 2021 and $7.4 million in the same period last year. Cost of product sales were $2 million in the third quarter of 2021, compared to $0.6 million in the third quarter of 2020.

Research and development expenses for the third quarter of 2021 were $27 million compared to $10.3 million for the third quarter of 2020. This increase is due to higher lumateperone clinical trials costs and an increase in other development programs. Selling, general and administrative expenses were $70.5 million for the third quarter of 2021 compared to $52.5 million for the same period in 2020. This increase is primarily due to increased marketing and commercialization costs.

Net loss for the third quarter of 2021 was $76.9 million compared to a net loss of $55.2 million for the third quarter of 2020. Cash, cash equivalents, restricted cash and investment securities totaled $478.7 million at the close of the third quarter of 2021 compared to $658.8 million at December 31, 2020. This concludes our prepared remarks.

Operator, could you please open the line for questions.

Questions and Answers:

Operator

Thank you. [Operator Instructions] Our first question comes from the line of Brian Abrahams from RBC Capital Markets. You may begin.

Brian Abrahams -- RBC Capital Markets -- Analyst

Hi, good morning and thank you for taking my questions. Congrats on the continued progress. My first question is on the overall, I guess, commercial landscape and I'm sort of curious with COVID having spiked and now waning, the sort of dynamics that you're seeing on the ground in terms of physician-patient engagement, how that may be shifting as we get toward the end of the year? Any changes in telemedicine? And how you expect those trends might shape both fourth quarter sales and schizophrenia as well as the bipolar launches, as you think about that into the early part of next year?

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Hi, Brian. Thanks for the question. And I'll ask, Mark, would you like to just address that? First, I would go into the landscape for schizophrenia patients in particular and then I go on from there, please.

Mark Neumann -- Executive Vice President, Chief Commercial Officer

Yes, sure. Thanks for the question. Brian, and yes, we were pleased with the performance of CAPLYTA during the third quarter where COVID and the delta variant was present during the quarter. Now, as we came out of the third quarter and into the fourth quarter, as you know, the cases overall have been decreasing and vaccination rates have been increasing. And so what we're seeing as a result of that are more psychiatry offices are reopening for in-person patient visits.

Our sales force is gaining in some practices greater access for in-person detailing and we would expect to see that continue into the fourth quarter and in the next year. So we expect to continue to see the quarter-over-quarter growth of CAPLYTA and in particular, I think as Sharon mentioned, the patients with schizophrenia, when the COVID cases are high, they're probably more impacted than some other patient population, but even in the schizophrenia area, we're beginning to see more patient flow coming back into the offices and a greater access for our sales force.

So, we're encouraged by those market developments, both for our fourth quarter with schizophrenia and also as we prepare to launch for the potential approval of the bipolar depression indication, the timing is coinciding with that launch as well. So, we think that puts us in a stronger position going forward as we close out the year and as we head into 2022.

Brian Abrahams -- RBC Capital Markets -- Analyst

Got it. Thank you, Mark. And then maybe one more if I could. As we look toward the PDUFA, the PDUFA is in December, can you maybe just characterize, I guess, if you can give us any sense as to whether those remain on track and your level of confidence? And should we be thinking about these as sort of two different decision points that may come out at different times and may be different for the different indications or should we assume that this will be, I guess, group together as one? Thanks.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

So I'll take that. This is Sharon. And we do expect everything to come out together and we are on track.

Brian Abrahams -- RBC Capital Markets -- Analyst

Great. Thanks again.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

I think that's short and sweet. Okay.

Brian Abrahams -- RBC Capital Markets -- Analyst

Good to hear. Thank you.

Operator

Our next question from the line of Andrew Tsai from Jefferies. You may begin.

Andrew Tsai -- Jefferies -- Analyst

Okay, great, thanks. Good morning, thanks for taking my questions. I did want to build off of Brian's question, just a little bit just to see if you can provide a little bit more color because we are essentially one month into your PDUFA, essentially. So when I look at the guidelines, it sounds like the company generally enter finally labeling discussions with the FDA. So, I don't know to the extent that you can share, I mean, any additional color might be helpful? And is it also fair to assume within this sNDA package, we're not -- the FDA is not even looking at CMC or anything of that sort because this sNDA builds on the fundamental initial NDA filing, right? I just wanted to ask those questions. Thanks.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Hi, Andrew. Thanks for your question. And, yes, you're right. This does -- an sNDA builds on your NDA, but they do look at everything in your package. They look at everything as they should as it pertains to the indication that you're filing for. So, as you mentioned, our PDUFA date is coming up, its December 17th and we're working toward that diligently. And as I said to Brian, everything is on track and we're looking forward to our PDUFA date.

Andrew Tsai -- Jefferies -- Analyst

Fantastic. And one more follow-up is in terms of the launch, obviously, we'll be tracking sales in 2022 and beyond. So maybe as we think about the launch dynamics and I appreciate all the color that you provided why this could be a strong launch. Can you talk about maybe other launches happening in parallel, why that should not impede with your own launch expansion. And then maybe, I don't know, I mean, as we head into 2023 when a branded drug is expected to go generic. Fundamentally, can you kind of discuss why that should not impact CAPLYTAs launch? Thank you.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

So, Mark, would you like to take that and I can add at the end.

Mark Neumann -- Executive Vice President, Chief Commercial Officer

Sure, Sharon. [Speech Overlap] Let me start with the second part of your question, Andrew, first. What we've seen historically in the antipsychotic class is when a branded product goes generic. Obviously, there's an impact on that brand, but generally, there's not a significant impact on the remaining other branded products. You're well aware, Andrew of the dynamic that exists in this category, where you have the frequent cycling through multiple different antipsychotics and if they -- it's a condition that physicians are used to, payers are used to and we really don't see that there'll be a significant impact of another branded product going generic on the rest of the branded market.

In terms of the other launches, we're focused on our launch, we're extremely excited about the opportunity. Our sales force expansion is essentially complete, all of the representatives will be trained and ready to go for launch. We'll be launching immediately upon approval. We feel like we've got the right size of the sales force to cover the vast majority of the opportunity both in bipolar as well as in schizophrenia and feel like we have a comprehensive commercial plan in place from a medical education perspective, from a digital media perspective and advertising perspective. So we feel like we have all of the elements in place and we're just ready and waiting on the approval to press go and we're excited to get out there and begin to educate the physician base on the terrific profile we think we have a CAPLYTA in bipolar depression.

Andrew Tsai -- Jefferies -- Analyst

Great, thank you for all the color. I look forward to more positive updates.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

So do we.

Operator

Our next question comes from the line Umer Raffat from Evercore. You may begin.

Umer Raffat -- Evercore ISI -- Analyst

Hi guys, thanks for taking my question. Maybe let me focus on the depression study today, if I may. And perhaps, three questions, in particular. One, what do you expect the baseline MADRS to look like in that trial and I know the inclusion criteria is MADRS 24, should we be thinking around 28 or perhaps higher? Second, I noticed in both the Phase IIIs in this adjunct MDD, the trial sites are in U.S. only and I'd be curious what the thought process was on sort of not doing ex-U.S.?

And then finally, I was particularly interested in noting that there is a exclusion criteria, whereby, if a patient has a 25% MADRS decrease between screening and baseline, they are excluded from the trial and I was trying to understand how long is that interval between screening and baseline, which allows you to sort of manage this placebo response if I may? And have other depression studies done that? Thank you so much.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Thanks. Hi, Umer and thanks for your questions. I think, Suresh, would you like to answer and I can chime in as well.

Suresh Durgam -- Senior Vice President, Chief Medical Officer

Sure. Thanks for the question. For the first question in terms of the MADRS baseline scores, we have to see usually with entry criteria of 24 and above, you expect a higher baseline scores and these are also adjunctive treatment trials. So, you typically see in that range anywhere, but we have to wait and see what that will be, 28 to 30 is reasonable to expect or maybe even slightly higher.

In terms of your question regarding U.S. sites, as you know that once we enroll patients, we have started off with the U.S. sites the ex-U.S. typically generally takes a few more months to add because they have to get approvals from the individual countries. So, you will see later on the global sites also coming onboard soon for both the studies. And the third question?

Umer Raffat -- Evercore ISI -- Analyst

Basically, the interval between screening and baseline because you know how you can exclude patients that have a MADRS drop by 25% and I'm trying to understand -- this is effectively a sort of a lead in that you guys have and I know a couple of trials have done it. So, I was trying to understand how long is that interval between screening and baseline that allows you to exclude perhaps hypo-responders on placebo?

Suresh Durgam -- Senior Vice President, Chief Medical Officer

So the screening between screening and baseline. So, there is a screening period of up to 14 days, it's a two weeks of screening period. So, again, you're right that several studies have included -- several different studies have included different strategies to control for placebo. This is one of the strategies.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Right. And to answer, this is not uncommon and most if not all studies imply either this or other ways of trying to reduce the placebo response of patients coming in. Also on the global trial sites, this too is standard practice that your U.S. site start up and running first and then your -- substantially, the rest of your sites will come onboard pretty quickly, pretty soon afterwards. So, nothing here is unusual.

Umer Raffat -- Evercore ISI -- Analyst

Got it. And Sharon, would you describe the study as a partial responder or a non-responder study.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Suresh?

Suresh Durgam -- Senior Vice President, Chief Medical Officer

Yes. These are partial responder studies.

Umer Raffat -- Evercore ISI -- Analyst

Yes, perfect. Thank you so much.

Operator

Our next question comes from the line of Marc Goodman from SVB Leerink. You may begin.

Marc Goodman -- SVB Leerink -- Analyst

Two questions, first of all market as market -- are we having any off-label usage at all for this product, bipolar depression specifically. Second of all, curious with the team's thought of the VRAYLAR MDD data and if there are any learnings there that will help you? And then third, just what was the gross to nets in the third quarter? And how should we think about those changing into next year? Thank you.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Yes. Hi, Marc. This is Sharon. Thanks for your questions. So, as you know, we don't speak to off-label use, suffice it to say though that physicians are allowed to prescribe once your product is approved and I think if you look at IQVIA and Seasonique, you can see whether or not there's been any off-label use. As to the gross to nets, I'll ask Larry to respond.

Lawrence J. Hineline -- Senior Vice President of Finance and Chief Financial Officer

Yes, hi, its Larry. Our gross to nets have been pretty consistent over the last several quarters and we don't expect much change in that. We did disclose that we are in the mid '20s to the low '30s range and we expect to stay in that range even after bipolar approval if it comes or when it comes. [Speech Overlap]

Sharon Mates -- Founder, Chairman and Chief Executive Officer

I'm not sure he heard you, Larry.

Marc Goodman -- SVB Leerink -- Analyst

Sorry, what's that.

Lawrence J. Hineline -- Senior Vice President of Finance and Chief Financial Officer

Did you hear me on my response.

Marc Goodman -- SVB Leerink -- Analyst

Yes.

Lawrence J. Hineline -- Senior Vice President of Finance and Chief Financial Officer

Okay, that's fine.

Marc Goodman -- SVB Leerink -- Analyst

Yes. And then the last question, [Speech Overlap] learnings from the VRAYLAR data?

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Right. So, I think we -- just so everybody's on the same page, VRAYLAR has had ongoing studies and adjunctive treatment with major depressive disorder. They have done many studies, five studies and they just reported out on two studies, one being negative and one having one dose being positive. Now, they didn't tell us a whole lot about the studies. They told us p values, they didn't tell us anything else. So, we really don't know much. They say they are filing on this. Again, we don't comment on other studies. I think to take home messages that CNS studies are very complex, that the FDA is very accustomed to seeing some studies, work -- some studies have complicating factors that makes them not work. Again, we don't know what happened in these studies. I'm sure that as we will present all of their data at some point and then we'll know more and then we can say more. Suffice it to say, these are very large markets. These are underserved market still and the more opportunities patients have for new treatments, the better for the patients. So I think that we're encouraged and we move forward.

Operator

And our next question comes from the line Jessica Fye from J.P. Morgan. You may begin.

Jessica Fye -- J.P. Morgan -- Analyst

Hey guys, good morning. Thanks for taking my questions. Once you're launched in bipolar depression, will you or will we have any way of discerning which scripts are being written for schizophrenia and which are being written for bipolar depression? I'm curious how you're going to gauge your performance and execution in each of those indications?

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Mark, you want to take that?

Mark Neumann -- Executive Vice President, Chief Commercial Officer

Yes, sure, Jessica. There are data sources that allow us to understand for which indications prescriptions are being written. They're not perfect data sources and you have to take them directionally, but it is something that we'll be watching and certainly we'll be following and tracking typical metrics that you would in any launch in terms of new patient starts and new prescribers looking at total prescription, looking at our market access coverage, rejection rates, reversal rates etc. But yes, there are data sources that allow you to take a look at that and will be following us.

Jessica Fye -- J.P. Morgan -- Analyst

Okay. And then again on the bipolar depression launch. Can you help us think about the timeframe within which you expect to have coverage in that indication?

Mark Neumann -- Executive Vice President, Chief Commercial Officer

Yes, so, Jessica, the payers don't manage the different indications differently. They manage it at the brand level. So, we expect for bipolar depression to be added to the formulary than the coverage, just as the schizophrenia patient population is. So we will continue to have very broad coverage in Medicare and Medicaid with over 95% of the covered lives and as we mentioned, our coverage and commercial is growing steadily. We're up to about 70% coverage and we expect that to continue to improve and increase over the coming weeks and months.

Jessica Fye -- J.P. Morgan -- Analyst

Okay and just the last one. How are you thinking about the growth in the schizophrenia indication going forward?

Mark Neumann -- Executive Vice President, Chief Commercial Officer

Yes. So we've been -- despite the COVID pandemic, with the challenges that that presents for the schizophrenia patient population, we've been pleased with the continuous quarter-over-quarter growth in schizophrenia that we've seen with CAPLYTA and we expect that to continue in addition to launching the bipolar depression indication where we expect to see a further acceleration in the overall prescribing of CAPLYTA given the opportunity that we have in the marketplace. It's a large market opportunity.

There's 11 million patients compared to 2.4 million with schizophrenia. There are fewer treatment options available to treat these patients and we feel very confident in the profile of CAPLYTA that emerged from the bipolar depression trials with the robust efficacy, the favorable safety and tolerability that we essentially replicated, the safety and tolerability profile that we saw in schizophrenia in the bipolar depression population as well. And as I mentioned, we feel we have a very strong commercial plan comprehensive in place ready to go and we expect to see an acceleration in prescriptions due to that.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Yes. And given the favorable safety and tolerability profile, we would expect that in a non-COVID environment, you will see even more of an uptake in the schizophrenic population.

Jessica Fye -- J.P. Morgan -- Analyst

Got it. Thank you.

Operator

In the interest of time, please limit yourself to one question. Our next question will come from the line Ashwani Verma from Bank of America. You may begin.

Ashwani Verma -- Bank of America Securities -- Analyst

Hi, thanks for taking our question. I wanted to ask Mark, how do you think your commercial investment is compared to your peers in the antipsychotic space? I see that you have a decent sized sales force, that drive us to peers. So, you'll be at 320. Sumitomo say that Latuda, they started with 340 that's now they're down to 260, kind of in the same ballpark and just curious -- wanted to see like if you could compare your DTC investment or strategy or any kind of metric on number of spots that you're running versus the competitors?

Mark Neumann -- Executive Vice President, Chief Commercial Officer

Yes, thanks for the question. Our goal is to have a highly competitive share of voice in the bipolar depression space and so we sized our sales force to reach the prescribers that generate 85% of the oral branded antipsychotic prescriptions that are written for the combination of bipolar and schizophrenia. So, we feel like we're covering the vast majority of the opportunity there. And in addition to that, with our peer-to-peer medical education, our digital media promotions and our DTC advertising, our goal is to ensure that the benefits of CAPLYTA and the messaging that we have around CAPLYTA are heard in the marketplace and we feel like the plan that we have in place will do exactly that.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

And just to remind you, in a pre-COVID environment, one operated a little bit differently and as we told you, pre-COVID, we were expecting that with a bipolar indication, we would just about double our sales force. Now with COVID, I think, we've all learned how to do things a little bit differently. So, while we do still need to increase our presence because of the increase in the number of docs and offices, etc., as you see, it's not a doubling of the sales force and we think we've sized it appropriately from what we've learned of these hybrid, both virtual and in-person meetings.

Operator

Thank you. Our next question will come from the line of Chang Liu from Needham. You may begin.

Chang Liu -- Needham -- Analyst

Hey, this is Chang for Amy. So, we just wanted to ask, can you talk about your expectations for the pace of the launch in bipolar depression post approval? What may be the positives and challenges heading to the launch. If we may have a second questions, tell us whether the pre-approval site inspection has been completed for bipolar depression and if there were any 483 observations at the site.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Mark, I'll ask you to take the first part and I'll address the second part. So you want to take the first part, please.

Mark Neumann -- Executive Vice President, Chief Commercial Officer

Yes, sure and let me take a shot at it if I understand the question correctly, if this misses the mark, please let me know and I'm happy to provide further color. But we do plan to launch in bipolar depression immediately upon approval. Our sales force expansion is essentially complete. All of our representatives, including the new representatives will be trained and ready to go right after the launch. All of our marketing materials, the patient support services that we have in place, the infrastructure commercially that we built for the schizophrenia launch and the leverage for the bipolar launch will be ready to go.

As you know, our PDUFA date is December 17th, the last two weeks of the year are holiday weeks, but we'll be out there with our sales force, we'll be out there with our non-personal promotion. Many of the offices during that time are closed or they're not seeing representatives. So, we wouldn't expect a huge spike in prescriptions those first couple of weeks after the launch. But we will be out there and ready to go from day one. So I hope that provide some color for the question that you're asking. Now, I'll turn it back to Sharon for the second part of your question.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Yes. And as we said earlier, we're not going through the nitty-gritty of our sNDA application. Suffice it to say, though, this should answer your question that we are completely on track and all has been going well and we're looking forward to our PDUFA date.

Operator

Thank you. Our next question will come from the line of Sumant Kulkarni from Canaccord. You may begin.

Sumant S. Kulkarni -- Canaccord Genuity -- Analyst

Good morning, thanks for taking my question. This is a conceptual one. So you're adjunctive MDD trial has begun enrollment. It's one of the first phase of trials in this indication that might be able to benefit from our learning during this pandemic. So just as we've learned in the sales force size that you may not need as many than you had in the past. Are there any specific differences of variables you may have needed to adjust to optimize your Phase 3 design solely based on the pandemic?

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Suresh, do you want to take that or would you like for me to?

Suresh Durgam -- Senior Vice President, Chief Medical Officer

Yes, I couldn't understand the question you're asking.

Sumant S. Kulkarni -- Canaccord Genuity -- Analyst

I was asking if there was anything that you've learned from the COVID-19 pandemic that might help you to optimize Phase III trial design in the adjunctive for MDD, any variables that you might have otherwise done differently if this pandemic were not around?

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Why don't know I and then -- while Suresh is thinking. I think that, as you know, during the pandemic FDA put out a guidance document on what -- how one should conduct their clinical studies if necessary. And so we have put in, this is for monitoring and their visits during COVID and we did put that into place for our bipolar studies that were still ongoing. And we have put that in place here for the MDD studies, just as for the bipolar study that was ongoing during COVID, we really did not need to employ those methods. We -- if COVID doesn't spike again, we probably won't need to employ those methods again, but they are in place, they are ready to go, they can be used if necessary. So that was a learn as you go during COVID. So -- and I think right now the trial is being conducted as you've seen on clinicaltrials.gov.

Sumant S. Kulkarni -- Canaccord Genuity -- Analyst

Got it. Thanks, Sharon.

Operator

And our last question will come from the line of Charles Duncan from Cantor Fitzgerald. You may begin.

Charles C. Duncan -- Cantor Fitzgerald -- Analyst

Hi, Sharon and team. Thanks for fitting, assembler juggling calls this morning. So I apologize if our question has been asked. So, regarding the in-market experience in schizophrenia with regard to CAPLYTA, can you green any anecdotal evidence of persistence and reduced healthcare resource utilization in schizophrenics that you may be able to apply to your efforts in bipolar? And then I had a follow-up if I could on the pipeline.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

So, hi, Charles, and yes, we understand, it's an extremely busy morning today. Maybe Mark, do you want to address the question and I'm not sure that we'll actually have the time to get into the pipeline, but let's see how long the answer to this question -- the first question takes. So Mark, do you want to go ahead?

Mark Neumann -- Executive Vice President, Chief Commercial Officer

Yes, sure. Yes, Charles, all signs point to CAPLYTA having a very strong persistency profile in schizophrenia. The caveat is it's too early to do the classical persistency curves where you follow cohorts of patients over time, we probably need another six to nine more months until we have that. But what we do look at very closely each month, our retail rates and the TRx to NRx ratio. And when we do that with CAPLYTA and we compare that to historical benchmarks, we find the CAPLYTA is outperforming the other antipsychotics at the same time during their launches. So, we do believe we're seeing a strong persistency profile for CAPLYTA in schizophrenia and we know from historical data that persistency tends to be a bit better in bipolar patients than it is in schizophrenia. So, we think that's a very encouraging sign for the persistency profile for CAPLYTA in bipolar depression once we get approved there.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

In addition, I think that our refill rates really not only speak to the tolerability of CAPLYTA, but also to be efficacy. Patients are not having breakthrough cases of schizophrenia of acute exacerbations and so we think that our refill rates do speak to both the safety and tolerability as well as the efficacy of CAPLYTA.

Charles C. Duncan -- Cantor Fitzgerald -- Analyst

It's a great segue in terms of that differentiated profile both efficacy and tolerability, how do you think about ex-U.S. opportunities, if at all? Thanks.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

So I think that what we have said is we right now are very focused on the bipolar indication and that we will be turning to looking at ex-U.S. opportunities following the bipolar indication. So, we'll come back to you on that hopefully very soon.

Operator

Thank you. And I'm not showing any questions in the queue. I turn the call over to the speakers for any closing remarks.

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Yes. Thank you. So thank you all for joining today. As I said, I know this morning became, as the morning run on, an extremely busy morning. So thank you for participating. And it's really a very exciting time for us at Intra-Cellular Therapies and we look forward to updating you to providing innovative medicines to patients going forward and we look forward to speaking with you soon. So with that, operator, you can disconnect. Thanks.

Operator

[Operator Closing Remarks]

Duration: 52 minutes

Call participants:

Juan Sanchez -- Vice President of Corporate Communications and Investor Relations

Sharon Mates -- Founder, Chairman and Chief Executive Officer

Mark Neumann -- Executive Vice President, Chief Commercial Officer

Lawrence J. Hineline -- Senior Vice President of Finance and Chief Financial Officer

Suresh Durgam -- Senior Vice President, Chief Medical Officer

Brian Abrahams -- RBC Capital Markets -- Analyst

Andrew Tsai -- Jefferies -- Analyst

Umer Raffat -- Evercore ISI -- Analyst

Marc Goodman -- SVB Leerink -- Analyst

Jessica Fye -- J.P. Morgan -- Analyst

Ashwani Verma -- Bank of America Securities -- Analyst

Chang Liu -- Needham -- Analyst

Sumant S. Kulkarni -- Canaccord Genuity -- Analyst

Charles C. Duncan -- Cantor Fitzgerald -- Analyst

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