Thank you for standing by, and welcome to the Intra-Cellular Therapies 3Q 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s call is being recorded.

I would now like to turn the call over to your host Dr. Juan Sanchez, Head of Investor Relations at ITCI. Please go ahead, sir..

Good morning, and thank you all for being here. Joining me on the call today are Dr. Sharon Mates, Chairman and Chief Executive Officer; Mark Neumann, Chief Commercial Officer; Dr. Suresh Durgam, Chief Medical Officer; and Larry Hineline, Chief Financial Officer. As a reminder, during today’s call, we will be making certain forward-looking statements.

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?.

Thanks, Juan. Good morning, everyone. I’m pleased to report on our continued progress and the strong third quarter results we delivered. The positive trajectory for CAPLYTA we have seen over the past few quarters continues bolstered by positive reports from both prescriber and patients.

In the third quarter, CAPLYTA total prescriptions increased by 71% compared to third quarter of 2022. Third quarter total revenues increased to $126.2 million. CAPLYTA net sales increased to $125.8 million, a 75% growth versus the same period in 2022. Demand for CAPLYTA has been strong, and we expect to sustain forward momentum.

As such, we are increasing our CAPLYTA net product sales guidance for the full year 2023 to $460 million to $470 million from our previous guidance of $445 million to $465 million. As CAPLYTA use continues to expand and patients and physicians continue to gain positive experience, we remain confident in CAPLYTA’s growth potential.

Looking ahead strong fundamentals fuel our confidence about CAPLYTA’s growth prospect, including its clinical profile, its broad label in schizophrenia and bipolar depression, as well as our proven commercial strategy. Both existing and new prescribers help to drive CAPLYTA’s growth.

Since CAPLYTA’s launch in bipolar depression, we’ve built a solid base of consistent prescribers, allowing us to help an increasing number of patients. Mark will share more details about our commercial performance.

In addition to maximizing the existing market opportunity for CAPLYTA, our strategy includes expanding CAPLYTA beyond its current indications. To this end, we continue to generate clinical data to further establish lumateperone as an important treatment choice across broad patient populations with mood disorders.

This is exemplified by our programs including our pivotal program for adjunctive treatment of MDD and our recently announced positive results from Study 403 in two important mood disorder patient populations those with MDD and mixed features, and those with bipolar depression on mixed features.

These results are one of many clear signs of CAPLYTA’s potential across broad patient populations with mood disorders. We have submitted our meeting request to the FDA to discuss the results from Study 403. We expect this meeting to occur later this year or in Q1 2024.

We have begun to share this important data at medical conferences including Psych Congress and the European College of Neuropsychopharmacology. We will continue to present our findings at other major medical meetings.

We will also be submitting a manuscript for publication soon, which will help to further educate prescribers about CAPLYTA and mixed features. Let’s now turn to lumateperone adjunctive MDD clinical program. We continue to make progress in our Phase 3 efficacy Studies 501, 502 and 505, as well as Study 503, our open-label safety study.

We are on track to report pipeline results from Study 501 and Study 502 in the first and second quarter of 2024, respectively. Subject to those results, we expect to file a supplemental new drug application with the FDA in the second half of 2024.

Turning to our lumateperone long acting injectable program, our goal is to develop long acting injectable formulations that are effective, safe, and well tolerated with treatment durations of one month or longer. We conducted a Phase 1 single ascending dose study with our initial LAI formulation.

This study evaluated the pharmacokinetic, safety and tolerability of lumateperone LAI in patients with stable symptoms of schizophrenia and lumateperone was safe and generally well tolerated. We have been evaluating several additional LAI formulations with treatment durations of one month and longer.

We have completed all non-clinical studies to support the initiation of Phase 1 study with four formulations. We expect to commence clinical conduct in this study in the first half of 2024. Given the encouraging tolerability data to date with oral lumateperone, we believe that an LAI option may provide a convenient treatment for appropriate patients.

I’ll now share updates across the remainder of our pipeline. Starting with ITI-1284. ITI-1284 is a deuterated form of lumateperone, a new chemical entity formulated as an oral disintegrating tablet for sublingual administration.

We completed the toxicology studies requested by the FDA and have initiated our phase programs evaluating ITI-1284 in generalized anxiety disorder or GAD in psychosis, in Alzheimer’s disease, and agitation in Alzheimer’s disease. We expect clinical conduct in these ITI-1284 Phase 2 studies to begin in the first half 2024.

Our first study will be an adjunctive study to SSRIs and SNRIs approved for GAD. This is a condition with around 10 million diagnosed adults in the U.S. with half of these patients not responding adequately to initial therapy.

There are currently no approved antipsychotics for GAD, and only a minority of these patients are being treated off-label with antipsychotics. We see a major opportunity for an effective, safe and well tolerated treatment for these patients. Our phosphodiesterase inhibitor clinical programs continue to advance.

We are enrolling patients with Parkinson’s disease in our lenrispodun Phase 2 clinical trial, which will evaluate improvements in motor symptoms, changes in cognition and inflammatory biomarkers. We expect to complete enrollment for this study in late 2024 with top line results anticipated in the first half of 2025.

ITI-1020 is our highly selective PDE1 inhibitor being developed for oncology indications. Our Phase 1 single ascending dose study is ongoing, evaluating the pharmacokinetics, safety and tolerability of different doses in healthy volunteers.

Next, our novel product candidate, ITI-333 is being developed to the treatment of opioid use disorder and pain, a multiple ascending dose study and a PET study looking at receptor occupancy are both currently ongoing. We anticipate completing our MAD study in 2024 in the doses tested to date, ITI-333 is safe and generally well tolerated.

Last quarter, we introduced ITI-1500, our new program focused on the development of novel non-hallucinogenic psychedelics. This program is focused on treating mood, anxiety and other neuropsychiatric disorders, notably without the liabilities of known psychedelics, such as hallucinogenic potentials and risk for cardiac valvular pathologies.

Our lead product candidate in this program, ITI-1549, continues to advance through IND-enabling studies and is expected to enter human testing in late 2024 or early 2025. We plan to present data on this preclinical program at a scientific conference later this year. In summary, we are excited about the progress being made across our company.

We are confident about CAPLYTA’s commercial growth prospect and its potential to expand across different mood disorders. We are proud to continue building our company with our very novel pipeline.

All of our efforts underscore our continuous commitment to transforming the lives of patients with complex neurologic and neuropsychiatric diseases through effective, safe and tolerable treatments.

We are in a strong financial position, ending the third quarter with approximately $495 million in cash, cash equivalents and investment securities, and no debt. We look forward continuing to share our progress with you. I’ll now turn the call over to Mark.

Mark?.

Thanks, Sharon. Good morning, everyone. It’s really great to be with you today. CAPLYTA continues to establish itself as a major therapeutic option in the treatment of bipolar depression and schizophrenia.

In the third quarter, our commercial team drove strong growth, increasing total prescription 71% compared to the same quarter last year and 7% sequentially compared to Q2 of this year.

We are pleased with CAPLYTA’s prescription growth this quarter considering the impact of the typical summer seasonality that saw the overall oral antipsychotic market register zero growth for the quarter. Looking more broadly, in the first nine months of 2023, CAPLYTA total prescriptions grew 100% compared to the same nine months in 2022.

A growing number of physicians and patients continue to try CAPLYTA and experience positive results. During the quarter, we continued to increase both the breadth of our prescriber base and their depth of prescribing. As of the end of the third quarter, there were over 32,000 cumulative prescribers of CAPLYTA since launch.

Importantly, we are also increasing their depth of prescribing every quarter, as prescribers see the benefits that CAPLYTA provides for their patients. As Sharon mentioned, this strong permanence in Q3 has led us to increase both the top end and bottom end of our full year CAPLYTA revenue guidance range to $460 million to $470 million.

And this strong performance also adds to our confidence that we will see continued long-term growth. On the market access front, we continue to benefit from broad coverage across all three payer channels. Our market access for CAPLYTA covers approximately 90% of commercially-insured lives and greater than 98% of the Medicare Part D and Medicaid lives.

We also recently improved the quality of our coverage.

Toward the end of the third quarter, two of the largest Medicare Part D plans changed their utilization criteria for CAPLYTA from a prior authorization and two step edit to unrestricted status, boosting CAPLYTA to 50% unrestricted coverage overall in the Medicare Part D channel similar to established products in this category.

Our salesforce and broader commercial team continues to execute extremely well, maintaining high productivity with our 43,000 HCP targets and complementing that effort with well attended peer to peer medical education programs, comprehensive digital promotion and on the consumer side our lead in the light direct-to-consumer national advertising campaign continues to raise awareness of CAPLYTA among prescribers and to prompt more patients to ask their physicians about CAPLYTA.

Our brand messaging of proven efficacy and FDA approved indications across schizophrenia and both bipolar I and bipolar II depression, favorable safety and tolerability profile and a single once daily dose continues to resonate well in the marketplace.

CAPLYTA has an extremely compelling product profile and we are well positioned for consistent growth in coming years. I look forward to continuing to update you on the successful launch of CAPLYTA. Now I’ll pass the call over to Larry to walk through our financial performance.

Larry?.

Thank you, Mark. I will provide highlights of our third quarter financial results. Total revenues were $126.2 million for the third quarter of 2023, compared to $71.9 million for the same period in 2022. Demand for CAPLYTA remains strong.

Net product sales of CAPLYTA were $125.8 million in the third quarter of 2023, compared to $71.9 million for the same period in 2022, representing a year-over-year increase of 75%. In the third quarter, CAPLYTA net sales increased 14% sequentially over the second quarter of 2023.

Our gross to net percentage during the quarter remained in the low 30s as previously guided. We expect our gross-to-net percentage to increase modestly, but remain in the low 30s for the fourth quarter of 2023.

During the quarter, days on hand of CAPLYTA, at the wholesale level remained stable, maintaining channel inventory at adequate levels to meet growing demand. CAPLYTA’s strong uptake continues. And as previously mentioned in this call, we are raising our CAPLYTA full year 2023 net product sales guidance range to $460 million to $470 million.

Selling, general and administrative expenses were $105.2 million for the third quarter of 2023, compared to $88.4 million for the same period in 2022. Research and development expenses for the third quarter of 2023 were $41.6 million compared to $33.3 million for the same period in 2022.

For 2023, we are lowering our estimated full year SG&A expense range to $405 million to $420 million, and we’re lowering our estimated full year R&D expense range to $185 million to $200 million. Our financial position remains strong. Cash, cash equivalents investment securities, and restricted cash totaled $494.8 million at September 30, 2023.

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

Thank you. [Operator Instructions] Our first question comes from the line of Jessica Fye of J.P. Morgan. Your line is open. Jessica, your line is open..

Good morning. Hey, good morning. This is Tanmay on for Jessica Fye. Thanks for taking a question. I have just one question. Assuming success in adjunctive MDD, can you talk about how much leverage there is with your existing commercial infrastructure versus how much additional investment you might want to put behind that launch? Thanks..

Hi, thanks for the question. This is Sharon calling.

Maybe Mark, would you like to take that?.

Yes, sure. Thanks for your question. We view the opportunity in MDD with successful trials of approval to be a really significant future event for us, and we would look to resource that launch accordingly.

Just to give you a little bit of background, our current target audience for schizophrenia and bipolar is about 43,000 prescribers, predominantly psychiatrists and nurse practitioners. And one segment of primary care physicians who treat bipolar depression are comfortable treating that and prescribe similarly to how psychiatrists prescribe.

But the vast majority of primary care physicians are not included in that. As we think about and plan for an approval in MDD, that prescriber target audience would increase significantly from the 43,000.

We believe we have very strong existing leverage of the existing infrastructure, because virtually all of the 43,000 physicians who are high prescribers for schizophrenia and bipolar will also be high prescribers for MDD.

So we’ll have a great deal of brand awareness with those prescribers, and we’ll be able to leverage our existing infrastructure there. But there is another segment of primary care physicians who do not see a lot of schizophrenia or bipolar patients, but they do see a lot of MDD patients.

And for those physicians, that’s where we would look to increase our salesforce size so that we can ensure that we have adequate coverage of those physicians and get the MDD launch off to a successful start.

We’ve not quantified that at this point in time, externally, as we get a little bit closer to the time of a potential MDD approval, that’s when we would come back and provide more details on that..

Thank you..

Just to be clear, the primary care physicians that we do call on now, they are high prescribers for bipolar depression. Primary care providers, however, don’t typically prescribe for schizophrenia. That’s prescribed by the psychiatrist primarily..

Thank you. [Operator Instructions] Our next question comes from the line of Andrew Tsai of Jefferies. Your line is open..

Hey, good morning, guys. Congrats on another great quarter and the consistent growth trajectory of CAPLYTA. So it’s really great to see a strong execution on your side. So for us, we wanted to kind of ask on another interesting development that happened earlier this quarter. One of your, I think, orange book patents were extended.

So can you talk about this a little bit more? Why did you choose to extend that patent specifically? Why not that loses exclusively for a later date? What is the significance of this patent particular? And then maybe talk about the overall strength of your IP portfolio? Do you think you can solidify your IP even further with more patents expect to be issued in the future date? Thank you..

Great. So hi, Andrew, and thanks for the congratulations. Yes, we’re very excited.

So we do, we have a very broad patent portfolio, and our portfolio is composed of both the Orange Book listed patents, which go through 2039, as well as what’s called an entire set of defensive patents, which is outside of the scope of what’s in your Orange Book, but also have very important filings in them addressing CAPLYTA.

So you might have to repeat some of the questions, I think the main question was over the extension and what did we extend and why did we extend that? And we selected to extend 839. And we did that, which now expires in the mid to late 2033. And then, of course, we expect to receive another six months extension for pediatric use.

And so that would be into 2034. We chose 839, because it’s very, very broad. And 839 covers the treatment of all CAPLYTA indications at all of our doses. And it uses any form of lumateperone, anything containing lumateperone, any composition, including all the crystals, all the salts. So it would be extremely difficult to circumvent this patent.

And so I think we believe this is a very strong patent, and we’re very pleased to have extended that patent. You asked – we do have other patents that – upon approval of other indications or their issuance, if covering present indications, would be listed in the Orange Book as well.

So I think that may cover all your questions, if not it would be all whatever it was. Okay, great, thanks so much..

Thank you very much..

Thank you. [Operator Instructions] Our next question comes from the line of Brian Abrahams of RBC Capital Markets. Your line is open..

Hi, hello, this is Leo on for Brian. Thanks for taking our question. I just wanted to follow-up on the mixed features regulatory discussions that you’re going to have. I guess, I’m curious what your strategy is going into FDA meetings.

Are you going to approach them specifically on mixed features? How are you going to layer on the data you’ve gathered and analyzed in anxious depression? And then curious if you’re potentially going to discuss if mixed features can also be supportive of an MDD filing, just given the significant overlap between the major depressive population and the mixed features population? Thanks..

Hi, [indiscernible] this is Sharon and I’ll start and then I’ll ask Suresh to chime in. So first, I think, yes, we have a very broad label in bipolar disorder, and we believe mixed features is encompassed within that label. As you know, we don’t yet have a label for depression.

And so really, front and center are the questions that we have about mixed features in MDD, in major depressive episodes in MDD. So I think that while we have to wait for us to have our discussions with the FDA to be very granular, I would tell you that’s really where I would be looking forward to having majority of the discussions.

Anxious distress, we do think is extremely important. We think it’s very prevalent in both bipolar patients as well as in MDD patients. We did get that data a little bit later and we are still looking at our strategy there and we will let you know as that strategy evolves.

I don’t know, Suresh, did you have anything you want to add?.

Not at this time, no. Thank you..

Thank you. [Operator Instructions] Our next question comes from the line of Charles Duncan of Cantor Fitzgerald. Your line is open..

Yes. Hi, Sharon and team. Thanks for taking our questions and let me add my congratulations on a really nice quarter and appreciate the guidance increase. I had a commercial question and then one R&D question. Mark for the commercial question, when you consider the guidance and contemplate next year.

I guess, I’m wondering what would be the key thing that you would be looking for? Would it be new patients or increasing persistence, perhaps even within the bipolar community? And then I’ll ask my pipeline question..

Yes. Thanks, Charles. And the answer is both. And certainly, we’ve been pleased with the pace at which we’ve been adding new patients in bipolar depression for CAPLYTA.

And in fact, earlier this week, when we got our NBRx data, new to brand prescription data, we hit a new all time high, which is the best reflection of how many new patients are being added to your brand. We expected to see that following some of the typical summer seasonality that we see.

And so that’s a really good sign to us that the fourth quarter is off to a good start, and we would see that continuing into next year as well.

And of course, we – the new patients come with existing prescribers, but they also come with new prescribers that we’ve also been doing, I think, a really good job of adding new first time prescribers to our prescriber base. And as I mentioned in the prepared remarks, we now have over 32,000 unique prescribers of CAPLYTA.

In each quarter, we’re adding significant numbers of new prescribers to that base. So we would see all of that momentum continuing through the fourth quarter and into 2024 as well..

Okay. And then relative to the pipeline, I guess, I’m wondering about deuterated lumateperone, quite intriguing target product profile there. Is it included in the IP that was recently extended? I guess, it’s for the 839 patent. Sharon, and if not, are there, call it, non-obvious observations on its PK/PD that may be patentable that you can imagine..

Yes. The ITI-1284 is an NME. It’s a new molecular entity with its own patent portfolio. So it has a totally unique patent portfolio with a unique patent coverage. So you should look at that as a totally separate molecule..

Okay. Helpful. Thanks for taking….

I’ll leave that. Yes..

Yeah, thanks..

Our next question comes from the line of Umer Raffat of Evercore. Your line is open..

Hi, guys. Thanks so much for taking my question and congrats on a great quarter. Two for me. Number one, clarify the reasons for your lowered OpEx spend expectations this year. And secondly, CAPLYTA TRx trends have been positive since Labor Day, showing positive week on week growth in three the last five weeks.

And was just wondering if this was driven by any special promo activities and could we expect these trends to continue, given the favorable change of coverage in two of those Part D plans that you mentioned before? Thank you..

Great, thanks. I’ll ask Larry, do you want to take the first question and then Mark will take the next question. Okay, thanks..

Yes. Right. The decrease in R&D is primarily driven by the time – I’m sorry. Okay. Yes. Operating expenditures we’ll start with R&D first is driven by the timing….

This quarter of OpEx, which he asked about, please..

No, I asked about the reason behind the lowered operating expenses, expense with guidance, what’s driving right. Thank you..

Yes. Okay. Well, the reduction in the operating expenditures are in two areas – two primary areas, research and development, okay, which is driven the lower expectations are driven by the timing enrollment of clinical trials in our early stage programs. All right.

And as far as DNA is concerned, we’ve been pretty disciplined with our OpEx spends there and while still achieving the strong results that we’re seeing on top line revenues. So I think those are the explanations that especially SG&A, we run a tight ship here and it’s across the board sort of reduction. Hopefully, that answers your question..

Thank you. Yeah..

Hi, Umer, it’s Mark. I can take the second part of your question, and yes, we have been pleased, but not surprised at the reacceleration of our growth in total prescriptions. Each year, you see the summer seasonality in Q3, which suppresses some of the growth. As I mentioned in my prepared remarks, there was zero growth in the overall market.

We were able to drive 7% growth and continue to penetrate the market. And now, as we got past Labor Day, we’re seeing new all time highs in TRx, we’re seeing them in NBRx. And we believe that’s reflective of the overall market recovering in the fourth quarter, as it tends to do each year. But also, I think you mentioned some of the activities.

Certainly, our salesforce execution has been very strong. You’re aware that at the beginning of the year, towards the middle end of the first quarter, we added 50 new sales representatives. It typically takes about six months for them to get fully up to speed and fully optimized. And those 50 are now really just hitting their stride.

So we expect an even greater contribution from them this quarter. And as we go into 2024, our ongoing DTC efforts continue to be very effective, bringing new patients into CAPLYTA.

And then lastly, the two payer wins that I mentioned in my remarks, we do expect that to drive additional volume, but like other things, it does take a little while for that to be fully realized. We expect some of that benefit in the fourth quarter, but we’d really expect the full benefit of that in 2024.

So I guess, to summarize, we are pleased in the reacceleration in the growth. We expect that to continue this quarter and then really expect to carry that momentum over into 2024. So I hope that answers your question..

Yes, it does. Thanks so much..

Thank you. Our next question comes from the line of Jeffrey Hung of Morgan Stanley. Your line is open..

Hi. This is Michael Riad on for Jeff Hung. Thank you for taking our questions, and congrats on all the progress. We have two. First, on the long acting injectable, the company is looking at four more formulations to begin single ascending dosing first half next year.

How do the four formulations differ from the one you already took through FAD? And what criteria will you be evaluating beyond treatment duration to compare? Thanks. And I have a follow-up..

Yes, this is Sharon, and I’ll take that one. So the different formulations, look at exactly that there are different vehicles, and we’re also looking at different sites of injection.

So I think that – and what we’re looking at is a sustained PK profile of either one month or greater, in particular two months, as well as a clean safety and tolerability profile..

Thank you. That’s very helpful. And then on the second one, so you’re seeing antidepressant effects of lumateperone across a broad spectrum of mood disorders, schizophrenia, bipolar depression, MDD, mixed features, and now anxious distress. But a shared outcome for a lot of these patients is that they are either refractory or only partially respond.

So in that context, what do you think is giving luma’s ability to broadly deliver antidepressant effects, specifically when traditional SSRIs? So thanks so much..

Yes, thanks for the question. I think that it’s a confluence of many different factors, and in particular, it’s the mechanism of action that we believe this drug is acting by. So, unlike other antipsychotics, this drug does have SSRI activity, but it’s not solely the SSRI activity that is at work here.

In fact, we have shown through our Intra-Cellular signaling pathways work, which is what we really formed the company on is to not only look at cell surface receptors, but to look downstream of the receptor.

We show that through Intra-Cellular signaling, through the D1 receptor, we believe that we are a partial agonist, and we’ve shown how we proceed down the mTOR pathway and that we affect the glutamate system.

So we think that that is very exciting and very helpful in treating depression as well as we have with very rapidly saturate the 5-HT2A receptor, which we know boosts the activity of other receptor biology.

So, in fact, we are boosting the activity that we see in both D1 pathway as well as in the SSRI, which, again, the unique opportunity here is the 5-HT2A antagonism that we have, and then the serot reuptake inhibition, which allows for more serotonin to be in the cleft.

So it’s a very unique profile of the molecule that we believe leads to the antidepressant effects. And not to forget about the D2 two receptor activity, which acts, we believe as a partial agonist presynaptically and postsynaptically as an antagonist.

So that’s important for bipolar, it’s important for schizophrenia, it’s important for several other psychiatric indications as well..

Thank you. That’s really helpful. I appreciate the response. Thanks..

Thank you. [Operator Instructions] Our next question comes from the line of Marc Goodman of Leerink. Your line is open..

Yes. Good morning, Larry, the IQVIA daily capture rate seems to open down. I was just curious if you’ve noticed that and if there was a reason for that. Anything you can help us with there? Because the prescriptions just seem to be not driving what we would think to be driving the sales in the quarter.

But you told us the gross-to-nets didn’t change much. Obviously inventory didn’t change much. So it’s got to be this IQVIA data that we’re looking at. So I’m just curious if you had any comment on that. And then, secondly, you mentioned the ITI-1500.

You talk about data we’re going to see and what meeting you’re talking about that’s going to happen before the end of the year. Thanks..

Sure. So maybe to start you off, maybe I’ll ask Mark to address to start out on what we’re seeing about the capture rates and then ask Larry to chime in if he has anything to add to that. And then if I remember by that time you may need to remind me, I’m come back to the 1500 series.

Mark?.

Yes, Sure, Sharon. And yes, thanks, Marc for the question. Yes. What I would say, Marc is the – as with previous quarters, the primary driver of our revenue growth in the third quarter was driven by strong underlying demand and the growth that we’re seeing in prescriptions.

As Larry mentioned in his prepared remarks, gross-to-net remained in the low-30s and it was comparable quarter-over-quarter.

And regarding inventory, the days on hand of CAPLYTA at the wholesale level remained stable during the cover and that maintained the channel inventory at adequate levels to meet the growing demand that we see in the marketplace.

So I think when you put all three of those factors together that helps to explain what we’re seeing in terms of the overall revenue growth that we see for CAPLYTA in the quarter. Sharon, I’ll turn it over to you for the second part of the question..

So on the 1500 series, as you know these are non-hallucinogenic psychedelics that we’ve been developing. This is all in-house developed where they’re new molecular entities, they’re not modifications of the present psychedelics. The – I think there is only one medical meeting left this year. I’m not sure they’re not happy for people to announce things.

But it is AT&T at the end of the year that we’ll be presenting there. So – and we will of course make the information available to you after that..

Thank you. [Operator Instructions] Our next question comes from the line of Ami Fadia of Needham & Company. Your line is open..

Hi, good morning. Thanks for taking my question, and congratulations on the strong quarter. I had a question about just where the demand for CAPLYTA is coming from and if you could throw some light into it. You talked about the total prescriber base now reaching about 32,000 physicians of the 43,000 that you’re targeting.

Can you talk about sort of the potential of expanding into the remaining 9,000 or so and also more importantly, the depth of prescribing and maybe any commentary you can provide around what is the current average number of prescriptions per physician and where is the potential for it to go to..

Yes. Sure, Ami, so thanks for your question. Yes, was – so there’s a lot of different ways to characterize where the demand is coming from. And what we’re pleased about with the launch of CAPLYTA is that the product is not being niched in any particular area and by that I mean we’re seeing new patient starts as well as switches and add-ons.

We’re seeing switches come from branded products and generic products. We’re seeing use of CAPLYTA across all lines of therapy. As you know in this category there’s a lot of switching of agents. So many of these patients have already been on one or two or three antipsychotics and CAPLYTA is getting used in each one of those situations.

And in fact, what we hear from physicians is as long as the patient’s insurance will allow first line use, they would prefer to use it that way because of the favorable safety and tolerability. Another way to characterize it is clearly the strong growth that we’ve seen for the last 18 months is being driven by bipolar depression.

We continue to grow the schizophrenia business. It’s an important business to us. It’s obviously important for patients, and we continue to grow that business. But the real explosive growth that you’ve seen is coming from bipolar depression.

And then a third way even to characterize it is, as you suggest in – and we have been very pleased that both of those metrics continue to increase with the pace not falling off at all as we go quarter-over-quarter. So we’re now into our seventh quarter of the bipolar depression launch.

We continue to add significant new numbers of first time prescribers of CAPLYTA, as you mentioned, now over 32,000. And that’s just a matter of working up the adoption curve. All physicians fall somewhere on the adoption curve for new medicines.

Some start it very early, some wait quite a bit longer to try a new medicine for the first time, and many of them fall within the middle. And it’s really just the day-to-day effort in our promotional activities, communicating the message about the benefits of CAPLYTA and continuing to get new prescribers.

And in addition to that, each of those prescribers then finding additional appropriate patients for CAPLYTA and increasing the depth. And what I would say about the depth is each quarter, quarter-over-quarter, that depth continues to increase at a similar pace.

So overall, we’re very pleased with all of the metrics that we follow in terms of what it says about not only the current growth of CAPLYTA, but what we see as continued robust growth into the future as well..

Great. Thank you. And if I may ask just another follow-up on mixed features. You talked about mixed features patients exhibiting anxious distress.

What percent of the population is that, and would one of your avenues of discussion the FDA be to perhaps focus on that subset of the population, or would you still be looking for a label in mixed features patients?.

Hi Ami, maybe I’ll ask Suresh to take that question..

Yes. So in terms of anxious distress, there is a lot of overlap between anxious distress and mixed features. Patients with major depressive disorder or bipolar depression have mixed features and also anxious distress. A larger percentage of patients have anxious distress and mixed features, and there is also an overlap between these two.

Our focus right now at the FDA will be talking about mixed features. However, we are also looking at the anxious distress. Once we finish talking about mixed features, we will be evaluating the next steps for anxious distress..

Got it. Thank you..

Thank you..

Thank you. [Operator Instructions] Our next question comes from the line of Ashwani Verma of UBS. Your line is open..

Hi. This is [indiscernible] on for Ash. Thanks for taking our questions. For our question, it’s for CAPLYTA. What level of contracting do you currently have and in the long run, how much more can contracting play a part? Thank you..

Mark, you want to take that?.

Yes, sure. Yes, I can take that, Sharon. So in terms of the breadth of our coverage and number of covered lives, our Medicare and Medicaid has very broad coverage at over 98% of covered lives. In the commercial channel, we have approximately 90% covered lives.

And so across all three channels, we’re pleased with the coverage that we have, which means that the vast majority of patients have access to CAPLYTA.

There’s also the – what we call the quality of coverage, which is whether when these patients are covered, whether they’re covered in an unrestricted way, whether there’s a step edit or in some cases a prior authorization. And so as we look forward, we will always look at opportunities to take a look at the price and volume trade-off.

If we see an opportunity with a particular payer, where perhaps we want to move from a prior authorization situation to an unrestricted status and we believe that the rebate level is appropriate, then that’s a decision that we’ll take.

So for example, at the end of the third quarter, as I mentioned in my prepared remarks, there were two large Part D payers that we were able to move CAPLYTA from a prior authorization and two step edits to unrestricted status.

And we believe that that will bring in significantly increased volume with those payers and contribute to revenues as we head through the fourth quarter and into next year.

So while we are very pleased overall with where we stand with our market access situation, we’ll continue to look at individual opportunities at the margins to continue to improve that.

So I hope that answers your question, maybe a little bit more background than you were asking for in your question, but I thought it was important just to provide some of the details for you there..

Thank you. Our next question comes from the line of Graig Suvannavejh of Mizuho Securities. Your line is open..

Good morning. Thanks. It’s Graig Suvannavejh at Mizuho. Congrats on all the progress in the quarter. My question is regarding the mixed features opportunity, I think you had mentioned that you were hoping to get on the FDA calendar this quarter or perhaps early next quarter.

I was just curious as to the time with which, since you have the data in hand, which I believe, if I recall correctly was late March and just kind of the sequence and the timing as to I guess the time it’s taking to be able to get in front of the FDA and whether that’s related to additional analyses that you wanted to do in prep for that meeting.

It’s just a little longer than perhaps I would have expected.

And then maybe the corollary question is regarding as to again the strategy there, are you – just to clarify, are you looking for a formal indication in mixed features to put on the label, or is it really more about getting the data from Study 403 incorporated perhaps and reflected in the label versus a formal indication? Thanks..

Hi, Graig. So let me try and take that and then I’ll ask if Suresh wants to add anything else. We did say in our prepared remarks that we do have – that we have requested a meeting. So we do have a meeting request in to the FDA and we do expect to meet with them the end of this year, early next year. So that is done.

We also said that we do believe that our label right now for bipolar is extremely broad and does include a broad patient population. And as you know, we don’t have a label today in MDD patients.

So I think that the real focus of this discussion is going to go there and that we are presently looking further into the data that we have in anxious distress. And we will have more to say about that as we – as our position there evolves and as the data directs us to describe the data. So I think that answers your question.

And I think in terms of what the next steps are, I think that now we’ve submitted the request, we’ll have the meeting, and we’ll update you once we have that meeting. Okay..

Thank you. [Operator Instructions] Our next question comes from the line of Jason Gerberry of Bank of America. Your line is open..

Hey, guys, thanks for taking my questions. Just on the earlier comments about MDD and sort of the target prescriber footprint, if you will, I was taken by the comment about a significant increase, and I guess I would have thought that with atypicals getting used maybe in a later line patient, that this would have been the domain of the psychiatrist.

And so maybe, mindful you’re not going to specifically tell us how much that increases the prescriber footprint by, but you did say significant. So I just wanted to confirm that that would be a pretty meaningful step change in terms of the number of prescribers that you have to reach if MDD was added to the label. Thanks..

Yes. Thanks, Jason. It’s always difficult to get the right characterization of that because as I’ve said, we’re not at a point where we’re providing the specific numbers of what that expansion might look like. But let me try to clarify again.

The 43,000 prescribers that we currently have are predominantly psychiatrists and nurse practitioners who treat the predominant number of schizophrenia and bipolar depression patients. There is a segment of primary care physicians that we currently call on those primary care physicians are comfortable treating bipolar depression.

They don’t treat much schizophrenia. So we never really targeted them for schizophrenia, but they are comfortable treating bipolar depression, and their prescribing habits look very similar to the psychiatrist in bipolar depression.

That’s not the majority of primary care physicians, but there is a segment that is like that, and we currently target those primary care physicians. As we contemplate an approval in MDD and we look at the prescribing habits of other segments of primary care physicians, that’s where that segment expands.

And so any expansion in our target audience would be to go after primary care physicians.

And then the question just becomes how deep do you go into primary care? And that’ll determine the number of prescribers that you add to the target list, and that will determine how much of a sales force expansion we would have in order to cover those primary care physicians.

And as we get closer to the MDD potential approval and launch, we’ll come back to you with more details about that..

Thank you. [Operator Instructions] Our next question comes from the line of Corinne Jenkins of Goldman Sachs. Your line is open..

Yes. Good morning, everyone. Maybe one on the 1284 program.

Just when should we anticipate kind of clinical data from those? And then are you thinking you’d pursue all of those programs if they showed activity, or are there kind of criteria you’re using to evaluate go/no-go decisions or any constraints on kind of the number that you could pursue into Phase 3? Thanks..

Hi Corinne, thanks for the question. So first on 1284, we will be going into I mean we started the programs and we expect clinical conduct to begin next year.

As to whether we would pursue all three indications, I think that will be dependent on what the data shows from these studies, right? I mean, if we have great data from all three, yes, we’ll pursue all three. If we – if it looks like there’s a better opportunity in two out of the three, we would do that.

So I think it’s a little early to say how many of these will be pursuing full blown Phase 3 programs on, but we’re very encouraged by what we’ve seen to date and very enthusiastic about these programs. And we’ve now outlined for you the GAD what that program is going to look like in terms of the first study, who will be enrolled..

We are out of time for questions for today. I’d like to turn the call back over to Sharon Mates for any closing marks..

So thank you, everybody for participating today. As you can see, I think we had a very strong quarter, and we’re very pleased with the progress we’ve been making on all fronts both on CAPLYTA and on our pipeline.

I think that we have demonstrated and we talked a little bit about the uniqueness of the way that we develop our drugs, that we not – we look not only at the cell surf, but look downstream of the receptor as well, and how that has been driving our development programs actually from the start of the company.

And so we’re very enthusiastic about our pipeline and about our research as well as on continuing to advance CAPLYTA. So with that, I think operator, we – just to say we look forward to updating you as we go forward. And with that, operator, you can disconnect the call. Thanks..

Thank you. Ladies and gentlemen, this does conclude today’s conference call. Thank you for participating. You may now disconnect. Have a great day..