Q3 2020 Intra-Cellular Therapies Inc Earnings Call
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Ladies and gentlemen, todays conference is scheduled to begin shortly please continue to standby. Thank you for your patience.
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Good morning, ladies and gentlemen, and welcome to the intra cellular therapies third quarter ended September 30 of 2020 financial results conference call at.
At this time all participant lines are in listen only mode. After.
After the speaker's presentation, there will be a question and answer session.
To ask a question during the session you would need to press Star then one on your telephone as.
As a reminder, today's conference call is being recorded.
I'd now like to turn the conference over to your host.
Dr., Juan Sanchez, Vice President corporate Communications and Investor Relations.
Please go ahead.
Thank you operator.
Good morning, and thank you all for joining us for today's conference call.
Our earnings press release, providing a corporate update and details of the company financial results for the third quarter ended September Thirtyth 2000, or 20 closely monitored time ago Annies available on our website talking through a cellular therapies dotcom.
Joining me on the call today I'll go to Sharon mates, Chairman and Chief Executive Officer, Dr. Suresh dogma.
Chief Medical Officer Mark.
Mark Newman, Chief Commercial Officer, Lori Highland Chief Financial Officer, Michael Hostess 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 unintended utilization with the company's product development candidates, our clinical and Nonclinical plans, our plans to present or report.
External data.
Anticipated conduct and it's also from going on future clinical trials plans regarding regulatory filings future research and development, our plans and expectations regarding the commercialization of cup like there potentially any impact of the COVID-19 pandemic on our business I'm pulling people using soap existing cash and investment.
Sources.
These forward looking statements are based on current information assumptions and expectations that are subject to change on the balls on number of risks and uncertainties that may cause actual results to differ materially from those continuing to forward looking statements.
These I know there is kind of describe you know what you know what the other filings made with the Securities and Exchange Commission, including our quarterly and annual reports you.
You are cautioned not to place undue reliance on these forward looking statements and the company disclaims any obligation to pay such statements.
I will now turn the call over to Sean.
Thanks, Juan Good morning, everyone. We hope you have remain safe and healthy during this time of calls it.
Since we last spoke to you in August we've made substantial progress in executing our commercial objective.
And our clinical and preclinical development programs.
I am pleased to update you on this progress today.
Following my remarks, Mark Newman, our Chief commercial officer will provide an overview of our commercial activities registered on our Chief Medical Officer will discuss our clinical development programs and Larry Hi line, our CFO will provide details of our third quarter financials.
We continue to operate in an environment impacted by co. Good I am, particularly proud of our team's resilience focus and innovative spirit and supporting our growing number of kept lighter prescribers and patients during these unprecedented times.
We are proud of our almost four fold increase in total prescriptions in Q3 versus Q2.
We also continued to receive positive feedback from health care practitioners on their patients experience.
We are confident and expect continued prescription growth.
<unk> actively preparing for them the type of on label expansion, but the second indication in bipolar depression.
We have also continued to advance our clinical development programs and increased our strong financial position.
During the third quarter, we reported positive top line results I'm study for two evaluating when the tech <unk> as an adjunctive treatment to loot stabilizes in patients with bipolar depression.
With these positive results and the positive results of our monotherapy study. So he for all four we're preparing the submission to the FDA of our supplemental new drug application for the treatment of bipolar depression in patients with bipolar one or bipolar two disorder treated as monotherapy or EPS adjunctive therapy to lithium or.
Alpro awake.
We expect to complete the submission in the near term and would anticipate an F.D.A. target action date in the second half of 2021.
We believe limited well and has the potential to become a major product in bipolar depression there.
There are over 11 million adult Americans living with bipolar disorder with only a few approved therapies for bipolar depression.
There is an important need for safe and well tolerated alternative.
When the TEP alone has the potential to be the only approved treatment for a broad population, which includes patients with either bipolar one or bipolar two disorder, as a monotherapy or as adjunctive treatment to mood stabilizers.
The benefit of limited known as a broad treatment for bipolar depression is further enhanced by its efficacy and favorable safety and Tolerability profile.
So they could visa breathlessness extra pyramidal symptoms and changes in weight and metabolic parameters in our bipolar studies were similar to placebo consistent with the safety profile demonstrated in all other limit pepper on studies.
We have designed a broad clinical development program as we believe Limitx alone will become a major player in the treatment of depressive disorders, including bipolar depression major depressive disorder, or MDD and other depressive disorders.
You mean, the telephone has shown its any depressant effect still out our development programs. When the type one has generated positive outcomes in two large phase three bipolar depression studies. In addition, any depressant effect were seen in a subgroup of patients with co morbid depression in our short term schizophrenia study as well.
Within our long term study.
And our long term open label study in patients with schizophrenia, a strong anti depressant effect was observed in patients with comorbid depression, regardless of whether they were receiving any depresses or not.
This provides further support for our major depressive disorder development programs.
Today, Dr. Suresh Gergel, our Chief Medical Officer will outline our plans to advance the LTACH alone in MDD, including the changes we have made to study for AWS three and our plans for our phase three studies for limited <unk> as an adjunctive therapy in patients with MDD.
Following our positive results and the recently completed study for two we've amended study for us to me to expand the opportunity for limit TEP wrong.
In a post hoc analysis of study for all four in a subgroup of patients with bipolar depression with mix features when the TEP owns 42 milligram had a statistically significant improvement from baseline on the MADRS total score versus placebo.
Study for AWS three now evaluate patients with mixed features who have M.D.D. or bipolar depression about.
About a third of patients with MDD or bipolar depression exhibit mix features.
These patients respond poorly to antidepressants have greater symptoms that they already have a higher risk of suicide attempts and experienced severe illness with <unk> more co morbidities Suresh will further explain the unmet need in this metric in this patient population.
This has been a very busy quarter and we have several other clinical updates. We are excited to announce that following a recent successful type C meeting with the FDA, we will commence early clinical development of our long acting injectable subcutaneous.
The subcutaneous formulation of limit Pepperoni later this year.
Given the safety and efficacy profile of limits pepper on we believe this formulation can be an important option for patients.
Lastly, the clinical development of <unk> 333, our novel molecule for the treatment of substance abuse disorders is advancing.
Following a recent successful pre I.M.D. meeting with the FDA, we expect to initiate a phase one single ascending dose safety and Tolerability study evaluating ITI Threeq threeq rate in late 2020 or early 2021.
We've received a grant from the National Institute on drug abuse as part of the NIH, helping to and addiction long term initiative or heel to support the early clinical development of Ipi 333 for the treatment of opioid use disorder.
Further details will be provided as this program progresses.
Our company is in a strong position kept light. It is approved for the treatment of schizophrenia in adults and we have an experienced commercial organization supporting Cup lighter.
We expect this to submit an S.N.D.A. for Limitx alone for a second major indication bipolar depression, expanding the market opportunity for Illumina Pepperoni, and we have a broad development plan for limits pepperoni and major depressive disorder and other major neuro psychiatric conditions.
We are well capitalized and we ended the quarter with over $723 million in cash and investments I'll now turn the call over to Mark Mark.
Thank you Sharon and good morning, everyone.
I appreciate the opportunity to expand on Sharons remarks regarding our commercialization progress.
We continue to be very pleased with the strong commercial execution of our launch and the performance of capital Ida in the marketplace. Despite continued covert related disruptions to the health care system.
As cobot conditions remain fluid throughout the U.S., we continue to innovate adapt and execute our commercialization strategy deploying a hybrid model of in person and virtual sales force and medical education capabilities to support Castlight as ongoing launch efforts.
We've also enhanced our digital marketing initiatives effectively expanding our target audience reach and optimizing our engagements with physicians and consumers.
Got blood level of awareness trial and usage has grown significantly over the first six months of launch and this is reflected in our recent prescription performance.
During the third quarter Cup light is new and total prescriptions grew by 229% and 279% respectively relative to Q2 during a time period when the overall anti psychotic market was essentially flat due to covert constraints.
This robust growth has continued into the fourth quarter.
We're also very encouraged by physician feedback that patient experience has been highly positive.
In our post launch market research surveys prescribers of capital Ida rate overall drug performance higher than other branded anti psychotics.
They highlight the efficacy and favorable metabolic weight and movement disorder profile.
Ease of reaching a therapeutic dose with no need for titration as well as the drugs novel mechanism of action.
It adds to our confidence that kept lyda is performing in the real world as we expected based on the clinical trial results.
Got that as market access position continues to be strong.
Payer access for cap lighter remains highly favorable and on track with our previously stated expectations. We've.
We believe that the strong access position in the largest payer channels Medicare part D and state Medicaid, having greater than 95% access in both channels is a contributing factor driving physician confidence when choosing to prescribed kept blida for their patients.
In addition to updating you on the launch of cap Lyda in schizophrenia I'd like to provide you with an early commercial perspective on the exciting potential opportunity for Loopnet pepperoni in bipolar depression.
We believe limit pepperoni has the characteristics to become a market leader in this multibillion dollar indication and we are laser focused on preparing to achieve this objective.
According to the National Institute of mental Health, there are about 11 million people living with bipolar disorder.
On an annual basis bipolar disorder affects about 6 million patients per year.
There remains a significant unmet medical need and bipolar depression with few approved treatment options for this underserved patient population.
The commercial success of recent branded entrants highlights this medical need and we expect the potential introduction of little bit pepperoni to continue to expand this market.
We also believe that limit TEP round has demonstrated a highly favorable profile as the only treatment for bipolar depression in patients with either boy bipolar, one or bipolar two disorder, and as an adjunctive treatment to mood stabilizers or as monotherapy.
We look forward to the potential for an expanded indication in bipolar depression that will complement our promotional efforts today in the schizophrenia market and.
We will continue to share our planting progress for the bipolar launch throughout the coming year.
In closing we are encouraged by our launch performance progress to date.
It's the market condition challenges presented by Cove. It we believe our large fundamentals are well established giving us increased confidence and optimism encap light as bright future.
We are pleased with our week over week prescription growth yes.
The accumulation of due to brand prescribers are increased reach supported by a comprehensive medical education programs.
Our real progress direct to consumer advertising campaign and kept lightest strong market access coverage.
We believe Castlight will continue on the path to become the leading choice for health care providers treating adults living with schizophrenia and are excited about the potential of lubitz, pepperoni and bipolar one and bipolar two depression.
I'd now like to hand, the call over to Suresh Suresh.
Thanks, Mark I Wouldnt boy, an overview of our regulatory and research and development plans.
Our team has been working diligently, but betting the submission for our supplementing and be a bit.
It's bank of bipolar depression in patients with bipolar, one or bipolar disorder, as monotherapy and adjunctive therapy.
I'm happy to share our plants to dial up that much if at all but the big make oh that moved together.
We had expanding that program to address millions of patients suffering some more desirable study. This study is a need for safe and effective treatment.
Let me start with our phase three program in major depressive disorder.
We have commenced our phase three clinical program evaluating limit to put on 40 milligrams and I didn't get the men do I get the sense for major depressive disorder.
Clinical conduct in two phase three studies will begin in India can do well.
Major depressive disorder affects the 10% to 15% of U.S. population every year, but.
But as far as it relates to the fullest from above their intervention, it's hard to say, but that many or 50% of patients who are candidates for either I didn't you.
Switching treatment strategies.
Let me continue with a plan to study limit they put out in patients with major depressive disorder, and bipolar depression with mix be just in steady for the company.
Patients with either unique will now also known as major depressive disorder, all bipolar disorder can exhibit manic symptoms, but below the pinnacle threshold for mania bipolar mania during that depressive episodes. These.
These patients so that's fine, but what do you do it under the process how great sometimes community have higher this question say their dumps and expedia severely less but more comorbidities.
The diagnostic and statistical manual mental dissolve us RMBS, some five I kind of just as to the identity and incorporates and mixed feed just specify a better kind of place these patients.
The number of patients with either unique Paula our bipolar depression doesn't think similarly with mixed speech it is significant.
That all approximately 17 million patients experiencing a major depressive episodes each year in the U.S. with.
With them over a third of these episodes being accompanied by mixed features.
Importantly, make speeches associated with MDB represent an important this factor for the dollar amount of bipolar one and my follow up is all about highlighting the importance of fighting fighting the presence of the space if I have to monitor patients treatment.
Bipolar disorder is also highly prevalent check that the condition affecting approximately 11 million Americans I bought a third of patients with bipolar depression on estimated to have mixed features.
There are no drugs approved funny that MDB was mixed we just all bipolar depression with mixed features limit.
Limits, but no one has shown its anti depressant effect in two phase three bipolar depression studies as well as in patients would go morbid depression in our schools opinion program.
Importantly in steady fertile for our global Phase three study in bipolar depression.
Post talk analysis show, a little bit, but almost I talked to you in a subset of patients with mix, we just with a P value of 0.003.
We were independent thinking these days about future medical meetings.
We have I'm good steady photo study the study limit patients.
Patients bipolar depression.
And Andy David May be just.
This global study evaluate.
Probably two milligrams as monotherapy, what's the split Siebel and the primary endpoint is changed from baseline on my best starting school at week six.
Jason had to discuss progress regarding our new stage programs. We look forward to continued to update you on our future data.
I will now then follow up the lobby lobby.
Thanks, Suresh I will be reviewing our financial results for the quarter ending September Thirtyth 2020.
We recorded net product sales of capitalized for the third quarter of 2020 of approximately $7.4 million no.
No net product sales were reported in the same period of 2019.
Research and development expenses for the third quarter of 2020 were $10.3 million compared to $21.3 million for the third quarter of 2019.
The $11 million decrease is due primarily to a decrease of approximately $6.2 million alumina pepperoni clinical and nonclinical costs, a decrease of approximately $2.9 million in research manufacturing cost and overhead a decrease of $2.6 million for other projects.
And is offset by an increase of $2.7 million for stock based compensation.
Selling general and administrative expenses were $52.5 million for the third quarter of 2020 compared to $15 million for the same period and 29.
Selling expenses were $38.3 million for the three month period ended September Thirtyth 2020, as compared to pre commercialization expenses of $6.4 million in the same period in 2019.
This increase in selling related expenses is primarily due to an increase in sales related labor expenses.
$15.4 million and commercialization and marketing expenses of $15.2 million.
General and administrative expenses were $14 million in the three month period ended September Thirtyth 2020, asking.
As compared to $8.6 million for the same period in 2019 [noise].
The increase is primarily due to increased information technology costs of $2.4 million professional fees of $1.4 million and stock compensation expense of $1.4 million.
Cash cash equivalents restricted cash and investment securities totaled $723.3 million at September Thirtyth 2020, compared to $224 million at December 30, Onest 2019.
In September 2020, we completed a public offering resulting in net proceeds to the company of approximately $358 million from the sale of 12.7 million shares of our common stock.
This concludes our prepared remarks, operator could you. Please open the line for questions.
Thank you.
As a reminder to ask a question you would need to press Star then one on your telephone to withdraw your question. Please press the pound key.
Our first question comes on the line of Jessica Fye with JP Morgan. Your line is now open.
Hi, there good morning, thanks, so much for taking my question.
Maybe first were there any changes to the amount of inventory in the channel at the end of the third quarter relative to the end of the second quarter.
Hi, Jeff. This is your I'm going to ask Larry to take that.
When when you mean changes in inventory you mean quantities.
In the channel.
Yeah.
The amount of inventory held by wholesalers any different at the end of Threeq you relative to two.
Yeah, Let me just remind you that this.
This is a business that it's unlike many years ago, where there was a lot of stocking there isn't stocking going on in this class we have movement of product that happens very rapidly up within 24 hours, usually so it's not a.
And inventory late <unk>.
Product.
At this point in time, the wholesalers actually are able to move product extremely efficiently.
And I'll add to what Sharon, saying as we're increasing sales were increasing inventory and that goes along with what are the sort of just in time.
Inventory system that we're seeing so as sales increase the the inventory in the channel obviously will increase.
Okay makes sense. So it looks like Gerson EPS were fairly modest in the third quarter and I'm wondering is this average net selling price you're seeing a good run rate to think about going forward or are there other swing factors that could cause it to differ in subsequent quarters.
In particular, I'm, just trying to think how to 2021 and if we shouldn't see any variability in quarterly growth China looking ahead.
As you know we've never really comment on gross to net and gross to net is that as you know dependent upon several several factors some of which is product mix and the like so and you're seeing it from compare I'm, assuming comparing scripts to our revenue and so as as.
As we're maturing and into in our sales ER and our you know.
Product mix, you'll see changes, but were not an outlier with regards to other companies that are in our same same stuff position, but in our evolution. So I really can't comment too much on the on on the changes of gross to net as you see them, but I can say that there werent there not an out.
Lyron and they're reasonable.
Okay. Just thing that has some companies to be a little bit more of an impact.
And part D. In the first part of the calendar year relative to later in the year. So yes, we'll just keep an eye on that yeah, yeah switching to study.
We're a three just want to make sure I understand the changes here. So these patients can have either M.D.D. or bipolar depression. They all need to happen next speakers now is that correct [noise].
[noise] [noise] I'll ask threats to answer that.
Yes, Hi, this is a good morning.
Before opening he has been amended to include patients both with major depressive disorder.
And bipolar depression.
And the patients will exclusively have mixed with weakness in this new amendment.
Okay, and then when you say a third of patients have much features.
Ah between Mbd in bipolar depression is that proportion the same in each respective group, it's a third and M D and a third and I for depression.
Yes in terms of the.
And your trade show.
Days meeting or.
HM.
[laughter] readying.
Readying ranges.
In the third would a reasonable estimate on when it comes to estimate both for major depressive disorder and for bipolar depression, and you will see a mix we just similar to third in both populations.
Thank you. Our next question comes from the line of Charles Duncan with Cantor Fitzgerald. Your line is now open.
Hi, This is Peter the rough was on for Charles Congratulations on the quarter.
Thank you.
Yeah, I was just wondering spec.
Expected are there any specific analog Becky sort of help us think through the ramp rate and ultimately the time it takes to develop the.
The traction you're anticipating.
Okay.
Got it.
I don't know Mark do you want to take that or would you like me to.
Yeah, I know I can I can make a couple of comments Sharon and you can add to it if you'd like a you know analog.
Our challenging both in this category and because of the Kogut related conditions that we've been operating under since the beginning of the launch I would say when we look at the various recent Brent and I'd say reason over the past five to seven years.
Branded anti Psychotics part of the challenge in an analog is many of the products launched with multiple indications, whereas we're launching with just the schizophrenia indication. So we look we try to triangulate and look at a variety of the different branded anti psychotic uptake and then do some adjustments.
Based on some of the coated related disruptions or that we've mentioned and overall I would say that when we look at that we are very pleased with both the commercial execution that we've been able to deliver during this time as well as the uptake trajectory and to consider.
Let's see of the growth that we've seen a week over week in prescriptions are and as we mentioned in the quarter over quarter growth.
So we're pleased with where we are and you know we'll have to see as time goes on with Cove. It. We believe we can operate very effectively in this environment and adapt as we need to and then as the Cobi period passes and we get back to the new normal.
We would look for continued acceleration in prescription so.
Sure and I don't know if you want a dad anything to that.
I have nothing to add.
Thank you very helpful.
My question with the Edson.
The filing in the near future for PDP.
Oh, what should we think about how the current commercialization can be leveraged and what needs to be put in place as we go.
Yes, the new indication if anything.
So mark you want to take that one too.
Yeah sure I think the the the biggest area would be in the area of our sales force as we think about the opportunity in bipolar depression.
The good news for US is that our current target audience of 23000 physicians that represent.
80% of the branded anti psychotic opportunity in schizophrenia virtually all of those 23000 also treat patients with bipolar depression. So we will be able to leverage our existing footprint our existing sales force. However, as you've heard some of the prevalence numbers the prevalence of bike.
Our depression is significantly higher than schizophrenia. So the patient numbers are very high much.
Much higher than schizophrenia, and therefore, the physician target audience will be larger as well. So there is a nother subset of physicians, who treat bipolar depression patients in significant numbers, who don't currently treat schizophrenia patients and so that would be a the <unk> the disease.
And subset that we would look to expand our sales force. We're in the middle of doing that work right. Now we don't have specific numbers for you, but we would expect to expand.
Our sales force in order to ensure that we have sufficient coverage to get to the opportunity that we see in bipolar depression I would say that's probably the biggest area.
Of expansion for the organization now as we do that we also have to bear in mind some of the changes to that.
That Cove. It has brought on in some of the permanent changes that we think will take place in terms of virtual engagement of physicians and their preference for virtual engagement and we're factoring all of that into.
Our final decisions about the magnitude of the expansion of the Salesforce that we would have.
Thank you. Our next question comes on the line of Steven My Sumant Kulkarni with Canaccord. Your line is now open.
Good morning, Thanks for taking my question.
We know you've spoken about you went from mutations of limit that their own potentially for M.D., but do any of the planned trials involved you formulation and does the monotherapy trials, specifically evaluate the potential for human capital as a rapid acting product for mbd.
Suresh would you like to take back or you want me to.
Yes, I care.
The MDT programs being studied with <unk>, how much capital Adjunctive treatment program is going to be studied with limited capital and.
We will update you on the ammunitions.
Okay.
Ladies.
Got it and then on the commercial side a question for Mark Im sorry, if I missed this but you know that you're into the launch for a few months do you have any better sense of how many patients.
Wed on how many drugs before cycling through two new mechanism. It happened on for schizophrenia got beta.
Yeah. Thanks, John as you know this is a category and therapeutic area that it has as its hallmark.
Significant cycling through various anti psychotics by patients because of some of the limitations of the existing anti psychotics, whether it's on the efficacy side or on the safety and Tolerability side and what we're seeing in terms of the patients that we are sourcing for Castlight is really across the board we are seeing.
Initial starts new patient starts for Castlight as well as those patients that have been on multiple anti psychotics. So I would say you know the vast majority.
Patients living with schizophrenia have been on multiple anti Psychotics 234, anti Psychotics and this is really where the most significant opportunity for a switch to comply to exist. So I'm not sure if that answers your question some on specifically, but I guess.
I would say is we are seeing patients being sourced across the board whether they'd been I'm wondering I psychotic two anti psychotics three anti psychotics as well as some patients at their insurance allows for initial therapy following diagnosis as well.
Got it thank you.
Thank you.
Our next question comes from the line of Umer Raffat with Evercore. Your line is now open.
Hi, This is Paul thanks for taking our questions I have two if we may 1st on the patent patent.
Patent status, how should we think about the kind Atlanta exclusivity given the Orange book patent on that thought pattern on the salt Crystal form has a 2029 expiry.
And how important should we think about the method of use patents and 90 injectable formulation and ER lifecycle management.
Second question, if we may it's on the study for Threeq with the Amendment. We are curious given the primary endpoint is still met our as change at week six it's a depression rating scale, how how should we think about the efficacy measure for the manic symptoms.
Thanks, a lot.
Great.
Hi, Bob This is Sharon I'll take the first part about patents and I'll ask Suresh to address the second part about the Madras and how you're going to measure.
What you're going to use for the mania portion.
So first let me just start with an overall statement about we believe we have a very strong patent portfolio that we expect will protect <unk> brought into the mid 2000 thirtys.
We have multiple Orange book listed patents with expirations ranging from 2028 through how to 2039.
In addition, as you know we have the option to select one of the earlier expiring patents for extension to the mid Twentys Thirtys.
We also expect to list additional patents in the Orange book following approval of Lumacaftor wrong for bipolar that will run well into the 2013.
So I would not focus on the one patent that you did focus on I don't think that's the right place to be a patent sales include coverage of any pharmaceutical composition containing the active England ingredient limited.
I call the use of Lumacaftor on to treat schizophrenia and bipolar following its approval a little tougher on in various dosage forms, including a 42 milligram dose.
But when the taper on crystals and so we believe that our position is extremely strong and that generics cannot avoid using our the approved drug substance the approved indication or the approved dose. So we believe these patents are not readily circum that oh.
So I think that that's really the answer to your question.
And then Suresh would you like to comment on.
If you remember now.
The question on Ah Okay Yeah.
Yes regarding the photocopy, we have amended the study both populations major depressive disorder, and bipolar disorder and mix we just.
And the primary efficacy endpoint will be.
Destocking score because the primary diagnosis is depression with mixed features and for the mix. We just want them hypomanic symptoms and the manic symptoms that we see we are also mentioning quite a modest young mania editing skin in the study so that can give us the information regarding domestic symptoms.
Thank you.
Our next question comes from the line of Mark that men with SVB Leerink. Your line is now open.
Hi, This is Ron on the line for Mark Thanks.
Thanks for taking the question I have two first on the four or three study could you remind us about your expected topline readout timing given the amendment.
And second question is flipping to schizophrenia I was curious if you could give us any color if possible on any persistence rates or discontinuation rates, you're observing from twoq to threeq you. Thanks.
So I'll take the first part and I'll start with saying that I'd like to remind you that this study is not part of our S.M.D.A.
Of course safety data is always reported where you are but it is it will not be.
Well I Sunday, it's not dependent upon study for me.
Oh, that's burst.
Then you asked about the readout time because of these types of coal that were giving ourselves a lot of.
A lot of time here and what we're going to say is bought in 2022.
I guess for your next question is about persistence and.
I think it's a little early to talk about that but Mark do you want to add anything about that.
Yeah, No that's right you're in it is too early to get a sort of the longitudinal persistence and compliance.
Rates that you're asking about but what I would say is what we are tracking very closely is the refill rate of prescriptions and we've been very pleased.
To see Oh, hi, refill rate consistent with our expectations given the profile of cap light over the favorable safety and Tolerability profile on the efficacy profile that has.
And as we track those and look at historical benchmarks. We are tracking ahead of historical benchmarks in this area. So we're actually very pleased with the refill rates that we're seeing.
Thank you.
The interest of time, we ask that you please limit yourself to one question.
Our next question comes on the line of Brian Abrahams with RBC capital markets. Your line is now open.
Hi, Leo on for Brian. Thanks for taking my question I guess I had a kind of a multi part question on MDD. So just to clarify that before of three gone to being monotherapy or MDD and it's just going to be able to support an SMB for M.D.D. and then looking ahead.
The other two MDD trial that you're gonna be running can you give any initial thoughts on what you think are going to be primary and secondary endpoints patient enrollment numbers and then I guess, just lastly on the thing point I mean, MDD bipolar often there's the misdiagnosis there. So I'm just wondering if you had an opportunity to look back across the bipolar.
The trials and perhaps any initial instead of efficacy in MDD. Thanks.
Yes, I'm sorry.
Go ahead, [laughter] Suresh I was gonna just shorten it for the sake of time, Let's go ahead, and then off the line.
[laughter].
In terms of the first question for the photo, but it isn't monotherapy a wood treating patients with major depressive disorder bipolar depression.
Makes features so that is a monotherapy trial.
In terms of the adjunctive treatment as we said the clinical conduct when beginning can be done.
And we really are a bit sharply once or twice a stop ed or.
On.
Think does stop go that'd be dance off are the primary endpoint and other details in terms of the sample size I'm not going to be bolstered.
Then Doug.
Thank you.
Our next question comes from the line of Jason Butler with JMP Securities. Your line is now open.
Hi, its Roy in for Jason. Thanks for taking the question just a quick one can you give us an update on the plans and timing for ITI two one for thanks.
Yeah, Hi, this is Sean thanks for the question.
So we we had a lot going on this quarter and we really had.
I wanted to make sure that we spent all the time on.
Lumacaftor on and those and those product we did talk about the long acting injectable and we also did talk about couple of three the PD one programs of which there are a few both.
Both preclinical and that will go.
In two clinical study more clinical studies for instance in Parkinsons disease, We will update you on that on our next call.
Thank you.
Our next question comes on the line of Andrew just signed with Jefferies. Your line is now open.
Thanks. Good morning, I guess my question is as I said in US investors do more work in the bipolar depression market.
Can you maybe just kind of explain how physicians are currently treating bipolar one into depression, you know at all.
I guess patients in the U.S. treated by anti Psychotics lithium and I'll pray or is there going to be some white space out there for Atlanta, and I guess, a secondary question to that is just within bipolar depression are.
Patient cycling through available therapy, similar to the dynamic we see in schizophrenia market. Thanks.
Okay, I'll start and I'll ask and thrash wants to sell anything in on and off of sort of go backwards, there's definitely white space as you call it because.
There are many patients with bipolar disorder, who are not being treated right now.
As Mark mentioned, there are 11 million.
Arrogance with bipolar disorder.
Patients do cycle through these dogs.
As.
As well as what we see with schizophrenia of of course, there are fewer of these drugs they do.
So they have fewer options to cycle through.
[music].
I missed some of your other questions I know you had a couple more.
Andrew are you there.
Right.
Hello.
Yeah, well I'm, sorry, we couldn't hear you.
Okay I personally just want to understand if within the bipolar two space Oh, sorry, I'll call is being used.
For all bipolar two patients and patients have exhausted that.
Anti psychotic and there are no treatment options.
So circle is being used either either.
Other drugs are being used as well.
And.
The extent to which they're used is a little bit on the numbers are not.
Exactly.
Mark do you want to fill and do you want to add to that.
Yeah, I'm I'm, sorry, Andrew could you just restate your question on that.
Yeah, I mean, there seems to be a lot of in theory bipolar two depression patients in the U.S. and so given that sort of close the only drug approved technically in the label for bipolar too I mean, it have all patients essentially gone on several call bye.
Bipolar two page.
Thanks.
Yeah, No I I I wouldn't think that all patients have gone on to Seroquel, what I would say for us from a commercial perspective.
Having a the indication for which we would expect upon approval.
Gives us the opportunity as a commercial organization to actively promote in that patient population and I also think that it gives physicians added confidence.
That the FDA has approved for efficacy and safety specifically in that patient population and we believe that will be a very strong compelling message for castlight ER again, if and when we are approved in bipolar depression.
Makes sense okay. Thank you.
Thank you. This concludes today's question and answer session I would now like to turn the call over to Dr., Sharon mates for closing remarks.
Great. Thank you operator, and thank you all for participating on today's call.
We're very excited as we move forward.
Hi, Nick.
Next indication that filing for the treatment of bipolar depression, and within our long acting injectable as well as our programs.
Like Triple three and 214 programs. So we look forward to updating you.
In the near future and I think operator, you can now disconnect. Thank you.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
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