Q2 2020 Intra-Cellular Therapies Inc Earnings Call
Ladies and gentlemen, please standby your conference calls scheduled started momentarily once again, thank you for your patience and please standby.
[music].
Good morning, ladies and gentlemen, and welcome to the intra cellular therapies second quarter ended June Thirtyth 2020 financial results Conference call.
At this time, all participants' lines are in listen only mode.
After the speakers presentation, there the question and answer session.
You asked a question during the session you need to press star one on your telephone.
As a reminder, today's conference call is being recorded.
I'd now like to turn the conference I would your host Dr., Juan Sanchez, Vice President Corporate Communications and Investor Relations. Please go ahead.
Thank you operator.
Good morning, I'm thinking again for joining host for todays conference call.
Oh, what any sprint to leave providing a corporate update on details for the Companys financial results for the second quarter ended June 30, It took out sort of 20 crossed the wire true technical onep available on our website intra cellular therapies dotcom.
Joining me on the call too they are Dr., Sharon mates shouldn't <unk>, Chairman and Chief Executive Officer.
And your Sauflon Executive Vice President and Chief Medical Officer, Mark Newman Executive Vice President and Chief Commercial Officer.
Hi line Senior Vice President and Chief Financial Officer, Michael hosted Executive Vice President and General Counsel.
I would either during today's call we'd be making certain forward looking statements. These statements may include statements, we talked in among all the things. If you can see safety. How do you think that utilization of the company's product candidates, our clinical I don't clinical plans our plans to percent.
Both additional data the MPC pinnacle bulk can be sustainable going how future could make a child blunt regarding regulatory filings future research and development our block on expectations. We're talking to someone said. He says you know cup lighter potentially backup copies 19 pandemic on our business.
People, usually it's up existing platform investment resources.
These forward looking statements I do some calling to permission assumptions and expectations.
Dick the change on E book I'm, not the risks uncertainties and they are close I try to supposed to be pretty materially from does contain forward looking statement.
These another rig count describing our public filings made with the Securities and Exchange Commission, including our quarterly had wonderful.
Ill caution not to pay some do when I answered. These forward looking statements on the company disclaims any obligation to update such things.
I will now turn the call over to Shadow.
Thanks, one good morning, everyone. We hope you have remained safe and healthy this summer.
We have completed our first quarter of commercial activities and I'm encouraged by kept later this week over week prescription growth and increasing prescriber base, while adapting to the unprecedented challenges presented by Cobot 19.
During these challenging times the team it into cellular therapies has been executing our commercial launch of kept later to provide schizophrenia patients a new well tolerated treatment option.
In concert with our commercial execution of kept later, we're also advancing our development programs.
During this call I will provide updates on our ongoing kept play to launch and other corporate initiatives. Following my remarks, Mark Newman, our Chief commercial officer will provide additional details on our commercial activities, Andrew Sautman, Our Chief Medical Officer will provide an update of our clinical development programs.
Larry Heinlein, our CFO will provide details of our second quarter financials.
Let me begin with our commercial progress we launched kept light on March thirtyth in the midst of strict cobot 19 walk down which resulted in nature disruptions in patient care.
We are pleased with the Swift response of our commercial and medical teams to navigate and adapt to this environment.
We have launched a series of program said enable engagement with health care providers, but the goal of offering comprehensive education on cap later.
We have accomplished this in both virtual environment and most recently with in person deployment of our field sales team. We are pleased with our very strong market access position.
Our two largest payer channels Medicare part D and state Medicaid, we have achieved formulary coverage of greater than 95% of covered lives and commercial coverage continues to grow.
I'm happy to report, we're seeing great progress we are encouraged by.
For a week prescription growth, which continued into July in both new and be filled prescriptions as well as the increase in our prescriber base.
We continue to increase the awareness level of cap light among prescribers.
Most importantly, we are encouraged by physician feedback that patient experience is very positive and inline with our expectations and psychiatrists, how the strong intention to prescribe castlight.
Kept blida isn't oral medication taken once a day that does not require type location. So a patient can start and stay on the therapeutic dose.
Kept lighter has a compelling clinical profile, having demonstrated efficacy coupled with a favorable safety profile.
Changes in weight asked in glucose total cholesterol triglycerides and extra pyramidal symptoms, including I could see show were similar to see placebo in our registration trials.
The progress we've made to date is a testament to kept light as compelling profile as well as our commercial teams resilience and adaptability.
We look forward to building on our momentum.
I'm also excited to announce that we are augmenting our prescriber facing efforts with a comprehensive consumer campaign called real progress, which is launching this week and includes a national direct to consumer television AD and accompanying social media campaign as well as a partnership with the leading tell us.
<unk> platform.
Mark Wilshere further details on these initiatives a little later in his remarks.
As we look towards label expansion on the cap wrong is in late stage clinical development for the treatment of bipolar depression.
We look forward to reporting topline results from study for up to our phase three study evaluating limit TEP, Ron as adjunctive therapy, and bipolar depression by mid September.
Depressive disorders represent an important part of our Luna type on label expansion strategy and we plan to commence it later stage clinical trial in M.D.D. late this year.
We also plan to enter clinical trials with our long acting injectable formulation of limits Pepper on later this year.
We also expect to initiate early stage clinical studies for I.T.I. Triple three our novel oral modulator of new opioid and serotonin receptors and where the treatment of opioid and other substance used to sort of pain and mood disorders. This year.
We recently announced positive top line results from our phase one two clinical trial of ITI 214, RMBS I suppose I asked race, one or PD, one inhibitor in patients with chronic systemic heart failure, Andy will elaborate on this study in his remarks.
In addition to the positive results in heart failure, we've continued to investigate our portfolio of PD one inhibitors in a variety of therapeutic areas.
Our particularly excited about the anti inflammatory effects of inhibiting PD, one and its potential utility in infections cancers and other disease States, we will be discussing this in more detail later this year.
We ended the second quarter of 2020 with $409 million in cash and investments we are in a position of financial strength and look forward to continuing our mission to develop and commercialize novel drugs to improve the lives of patients with neural psychiatric disorders.
Before turning the call over to Mark to provide details on our commercial plans and progress I want to take a moment to thankfully intra cellular therapies team across the organization, including our scientists and clinical teams for creating and advancing our pipeline and to the commercial team and supporting functions.
Focusing on the cap lighter launch we have a great team and I'm, particularly proud of how they have quickly adapted and are succeeding in knees unprecedented times.
I'll now turn the call over to Mark Mark.
Thanks, Sharon and good morning, everyone I'm pleased to provide additional details of our first full quarter of launch activities and the initial commercialization of cap lighter.
Sharon mentioned are kept lighter promotional activities started in late March justice to cope with 19 pandemic Lockdowns were beginning to disrupt the delivery of patient care in the mental health community and challenging our industry's efforts to access and educate health care providers.
As a commercial organization, we quickly identify these challenges and met them head on.
Our team was agile and creative adapting to these market conditions by pivoting to a completely virtual launch for all of our Salesforce and peer to peer medical education activities.
I'm extremely proud of our team's ability to execute our business plan under those circumstances.
Despite this challenging environment, we've seen sustained week over week growth in both new and refill prescriptions.
We're especially pleased with the rate at which patients are refilling their cap light up prescriptions.
Refill rate of capital Ida has grown steadily throughout the second quarter and into July and is ahead of competitive benchmarks at this stage of launch.
We're also encouraged by the addition of significant numbers of new prescribers, each week to our growing base of existing kept lighter writers.
We've been able to reach our prescribing audience through an effective mix of personal and non personal promotion, including both remote and more recently lives in person interactions by our sales team.
Peer to peer medical education Journal advertising virtual medical conferences, and products theater presentations and or digital marketing efforts.
The majority of the second quarter or Salesforce was operating in a 100% virtual environment engaging our prescribing audience with remote product presentation and sampling capability.
In mid June we began to deploy our salesforce into the field in a phased approach consistent with local conditions.
By the end of June we had our entire salesforce deployed conducting a combination of live in person interactions supplemented by continuing virtual engagements.
Our sales call activity has increased significantly as more parts of the country open up.
Physician offices begin accepting in person appointments with sales representatives.
We expect this trend to continue throughout the remainder of the year.
Additionally, the interesting cap light up by health care providers has been extremely high driving stronger than anticipated attendance to our virtual peer to peer medical education programs.
In the second quarter alone we had over 3000 attendees at our in depth medical education programs on kept light up which has been exceptionally well received and continue to build awareness of kept blida amongst the medical community.
We recently fielded an extensive market research study and found that our combined promotional activities have resulted in increasing awareness and high intent to prescribe levels for castlight.
Next our targeted prescribers.
And among those providers, who are already prescribing kept blida. They raised its performance highly citing its demonstrated efficacy favorable safety and tolerability profile and convenient once daily penetration free dosing.
These are all very positive signs and contribute to our optimism that we will continue to see an acceleration in cap light a prescription volume in the coming weeks and months.
We also continue to make strong progress in all market access payer channels, where the timing of coverage determinations and quality of coverage is playing out exactly as we thought it would.
Got Blida has now achieved broad formulary coverage for greater than 95% covered lives in both Medicare part D and state Medicaid our two largest channels.
We're particularly pleased with our advances made in the state Medicaid channel, which has recently opened up the cap light up where the ability of prescriptions to be processed has been fully activated across the nation.
Looting and high population states, such as California, New York, Texas and Florida.
We continue to see coverage determination improvements in the commercial payer channel with final coverage to be established by year's end.
Additionally, our light to link patient access and affordable affordability program is fully operational and supporting eligible patients.
Let me now provides some additional details about the exciting new consumer campaign real progress that Sharon announced earlier in the call.
The aim of this campaign to educate patients and their caregivers about cap light up and to open a dialogue about optimizing care and treatment options.
During these challenging times mental health care has never been more important.
People with chronic mental health issues are risk of not receiving the care they need.
Patients with schizophrenia are particularly vulnerable because of the social and health care challenges they often face.
The current cobot 19 environment has amplified that vulnerability.
The campaign features a national television AD, which depicts the hope of real progress that some adults with schizophrenia may see with cap lighter.
And extends to a digital marketing campaign on social media platforms, which includes home pages and video ads on Facebook and Instagram.
Additionally to further encourage physician patient dialogue about schizophrenia care, we have partnered with a leading tell us psychiatry platform.
From the cap lighter website patients will be able to access an independent virtual platform in order to connect with a mental health care provider.
Well, we're still early in the launch we're making substantial progress in educating our prescribing audience about the benefits of cap light up at our delighted by physician feedback that patient experience is very positive and inline with our expectations.
We are encouraged by the week over week gross encapsulated prescriptions and we're confident that are increasing prescriber access.
Comprehensive medical education program strong market access position and our exciting new DTC campaign.
Result in a further acceleration of prescription performance.
We continue to believe cap lighter will become a leading choice for health care providers treating adult patients with schizophrenia.
We look forward to continuing to report on our commercial progress.
Thank you and I would now like to hand, the call over to Andy to discuss our clinical development programs Andy.
Thanks, Mark and good morning, everyone.
We're very pleased with the reception kept lighter has had a medical practitioners and the feedback we've been receiving about the positive experiences reported by patients being treated with cap later.
It's a pre India is a highly prevalent lifelong psychiatric condition and the majority of patients discontinued treatment or seek treatment changes as a result of side effects such as we gain metabolic disturbances and movement disorders. We're proud to cap later now provides physicians and their patients in import.
New treatment option for the serious disorder.
Regarding the further development to limit tougher on we have a comprehensive late stage clinical program and bipolar depression.
Last year, we presented robustly positive safety and efficacy results from study for all four.
Phase three trial would limit tepper own in patients with the depressive episode associated with either bipolar one or bipolar disorder.
As Sharon mentioned, we anticipate topline results by mid September from study for up to.
This global study enrolled 529 patients.
Depressive episodes associated with either bipolar one or bipolar disorder, who were randomized one to one to one to receive lumen TEP around 42 milligrams 28 milligrams or placebo once daily for six weeks.
While being maintained on lithium or valproate weight as mood stabilizers primary endpoint is change from baseline on the mattress total score at week six.
In addition in the first quarter of this year, we commenced U.S. patient enrollment in study or three feet three global study.
Are you waiting limit tougher on 42 milligrams as monotherapy in the treatment of depression in patients with bipolar one what bipolar to disorder.
For which we anticipate reporting topline results in the second half of 2021.
[noise] bipolar, one and bipolar disorder or serious highly prevalent psychiatric conditions affecting approximately 6 million adult Americans. These disorders are characterized by recurrent episodes of mania for hypomania interspersed with episodes of major depression.
Well it wanted bipolar to each represent about half of the overall population of patients with bipolar disorder.
Bipolar depression is the most common clinical presentation.
Is that because those tend to last longer or more difficult to treat rijkaard more often and are associated with the worst prognosis than the manic hypomanic episodes.
There are few approved treatments for major depressive episodes in bipolar disorder.
Only one of those approved for bipolar to disorder. These treatments are associated with Tolerability issues. We are enthusiastic about the potential of limit TEP around as a new treatment option for major depressive episodes in patients with bipolar one or bipolar disorder.
Turning now to our P E. One platform during the quarter, we reported positive topline results from a phase one two trial of Ipi to 14.
Patients with chronic says dollar heart failure. This study evaluated the human economic profile and safety.
Single ascending doses of ITI 214.
Turning available heart failure drugs.
And improve the contractual strain of the heart muscle are associated with safety risks, most notably arrhythmia as a result their clinical use is primarily limited to severe circumstances. For example, decompensation and are generally administered for short periods of time.
In our study.
I'd like to 14 improved cardiac output, both by increasing hard French fries guilty and decreasing vascular resistance that is.
I to 14 functions have been I know dilator.
The improvement in cardiac output was not associated with the development of arrhythmias. Consequently, I see I to 14 has the potential to be a safe treatment.
Possible benefit in a broad range of clinical situations, including acute and chronic treatment of patients with heart failure and reduced ejection fraction due to diverse etiologies.
The reason I got to 14 improves cardiac output without promoting severe arrhythmias lies in its novel mechanism of action.
He won inhibition increases cyclic AMC in the Cardiome eyesight via adenosine eight to be receptor signaling without increases intra cellular calcium levels.
Both respects the mechanism differs from that of currently use Pee Dee re inhibitors, such as milburn out.
As a result E. One inhibition with I'd like to 14 strengthens heart contractility without triggering arrhythmia.
Preclinical experiments with our PD one inhibitors have also pound anti inflammatory effect in various models.
These data provide opportunities to pursue innovative treatments beyond heart failure, including multiple CNS and non CNS indications, we look forward to continuing to expand the potential of this novel mechanism for the benefit of patients.
I'll now turn the call over to Larry will review the financial results.
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Thanks, Sandy I won't be reviewing our financial results for the quarter ending June Thirtyth 2020.
We recorded net product sales of capital item for the second quarter of 2020 of approximately $1.9 million no net product sales were reported in the same period of 2019.
Research and development expenses for the second quarter of 2020 or $25.2 million compared to $23.7 million for the second quarter of 2019.
The 1.5 million dollar increase is primarily due to an increase of approximately $9.2 million of limit pepperoni clinical cost and is offset by a decrease of approximately $5.3 million manufacturing costs and a decrease of approximately 3 million for $3 million for nonclinical related efforts.
Selling general and administrative expenses were $41.4 million for the second quarter of 2020 compared to $15.4 million for the same period in 2019.
The increase of $26 million is due to an increase of $20.6 billion for selling related cost and an increase of $5.4 million for general and administrative cost.
The increase in selling related cost is due primarily to hiring I salesforce and increasing our marketing efforts.
The increase in general and administrative cost is due primarily to an increase in labor related expenses and professional fees.
Cash cash equivalents restricted cash and investment securities totaled $409.2 million at June Thirtyth 2020, compared to $450.4 million at December 30, Onest 2019.
On January 2020, the company completed a $295 million public offering resulting in net proceeds to the company of approximately $277 million from the sale of 10 million shares of its common stock.
This concludes our prepared remarks, operator could you. Please open the line for questions.
As a reminder, well that's the question you need to press Star one on your telephone to withdraw your question. Please press the monkey.
Please standby, while the compiled the culinary roster.
First question comes from the line of Bryan Adams Abrams with RBC capital markets. Your line is open.
Hi, This is a leo on for Brian Thanks for taking my question.
So with the bipolar data on the horizon can you give us some sense of the regulatory strategy you're envisioning. If the study is supportive but not that Sig would you consider filing and can you lay out how you might expect a supportive study to look that might not be stat. Segun do you see any differences or I guess what.
Your expected label be given that you're going to be filing an adjunctive and a monotherapy.
Thanks.
Thanks, Leo I have to say you sound just like Brian.
Oh this is Sean and I'll start and then I'll ask Andy if he would like to add anything.
So as you said, we are expecting a data shortly on study for up to.
If the data is positive then of course, a well be filing.
If the data is not positive, but as you said a shows the trend then of course will go and well talk with the FDA.
As you know we also have a if the data is totally negative there's nothing no signal. There then as you know we have Uh huh.
A third another study ongoing study four or three which will read out the second half of next year. So we have multiple.
Stage strategy here, but we're looking forward to the data that will be coming very soon study for a too.
Andy did you want to add anything.
Just that I think the question also was about monotherapy versus adjunctive. So for a few is positive we will of course, the submitting applications for approval vote as a monotherapy enters the jumped to therapy.
And the Sharon said, if we need to have additional discussions with FDA that will be part of the discussion as well.
Thank you so much.
And our next question comes on the line as Marc Goodman with SBB glue Leerink. Your line is open.
Hi, Congrats on a quarter or is this rudy on the Coppermark Oh, so two questions. Firstly regarding kept light a commercial so just want to make sure how's the physician feedback so far on advocacy work so other like generic antipsychotic.
And secondly, its were.
The study for a full too.
Oh I'm, just wondering any thoughts on the potential impact.
From the Koby 19, condemning like especially for to placebo response.
So thanks for the question, maybe Mark can take the first apart on physicians.
Comments on on kept light up and Andy on the.
Potential intact.
On Oh, Yeah, cobot I'm on placebo.
Yeah sure sure Sharon Hi, Rudy This is mark thanks for the question and yeah to answer that in two ways. One as I mentioned in my prepared remarks, we're delighted by the feedback that we are getting from physicians about the experienced they're having a with patience, while long cap lie to and that.
Really cuts across all aspects of the product, including the efficacy of cap light that they're seeing as well as the favorable safety and Tolerability profile and I think also importantly, the convenient.
Once daily titration free dosing, where they can start the patient at the effective dose and maintain them on that same dose.
So through our salesforce in their interactions with the physicians, we've been getting very positive feedback.
On the profile of cap light up.
And as I said and that includes efficacy as well as safety and Tolerability. We also recently fielded I'm a very extensive market research study to get feedback.
On the initial reaction to the product profile in the marketplace and that was a very much confirming what we were hearing from physicians directly through our salesforce.
Those physicians that have tried capitalize a rate the product performance very highly again across all parameters, including efficacy safety and Tolerability and dosing. So I hope that answers your question and I'll I'll turn it over to Andy for the second part.
Yeah, So with regard to the impact of coking 19 on study for it to a first keep in mind that the study was largely.
Well it was well under way and largely almost a in the U.S. completely gone in Europe or towards the latter stages of the study once coking 19 became or was it started to have an impact it's hard to speculate about the effect on a placebo response I don't think that that's something that were concerned about it.
We believe the studies adequately powered a we don't see any reason or Didnt happen. You don't have any reason at this point to be any more concerned about the results in that respect from coping 19.
We there was no impact of called at 19 on enrollment because of the time and when that started.
So you know we don't think that there's an impact on placebo response or and what we're going to see in terms of the results.
Got it yeah, that's very helpful.
[noise] and our next question comes from the line Oh, Chen with Evercore. Your line is open.
Hi, Thanks for taking my questions.
First I have a question on the jumped four to study it seems that these data analysis will be taking a roughly two to three months or could you remind us what are the timeline for the three a one because of free new trial, which it seems to have a shoulder data analysis.
And for two and if there any pushing and pushing his pools.
That we should keep in mind.
I can start that or Andy I'm, Ken as well I don't frankly, I don't remember how long three one took a three a one actually was a smaller study, though so I think that there is nothing unusual here.
Yeah.
Other than remember after patients come in and they're treated they they have six week treatment and then a two week follow up.
I think that.
I I have not compare this to three one so I don't know, but I don't think there is on do and do a long time here. So I think where a were just fine.
And he did you want to add anything yeah, yeah, yeah. So no there hasn't been I mean, the data analysis isn't taking any longer with this trial, then or will not take any longer but this trial done with any of our other large trials there has been a little bit of extra time to.
Complete.
<unk>.
Involved in cleaning the data just because.
There was there were some.
Limitations on being able to monitor the sites due to the Cobiz 19 situation, but that's kind of small impact and doesn't have any right.
Thank you very much.
Once again, ladies and gentlemen, you have a question please press star and the number one.
Our next question comes on line of Charles Duncan with Cantor. Your line is open.
[laughter] good morning, Thanks for taking the questions [laughter], Congrats Sharon and and scheme on on the progress in the quarter.
Canada commercial question then a pipeline question regarding the commercial question I was wondering if you could give us some person perspectives on the percentage of prescriber target engagement. If you will that you've seen in the quarter and and whether or not you have.
Have a process in place to manage any kind of spikes or second wave if it's cold that could come back.
Mark.
Yes, Thanks, Sharon and good morning, Charles Good to hear from you Yeah. So as I mentioned in my prepared remarks during the second quarter for the majority of the quarter, we had our salesforce operating in a in a virtual environment. That's the country was really shut down.
And we were operating consistent with both federal and local guidance in terms of non essential workers.
In June we began to phase our salesforce.
Back out into the environment. When we felt it was safe to do so both for our employees as well as for the the community the medical community.
That they serve and so by the end of June a we had iron our entire salesforce out there operating.
And in person.
Doing in person employment, but you know not all offices are open at this point and so they are operating both in in person.
Approach when they can but they're supplementing that continuing to do virtual engagements either through a you know tell a platform or by phone.
And they are getting better and better and more more effective as as they do that so as you mentioned Charles no. One knows what the course of the virus is going to do and whether there's going to be additional pullbacks or shutdowns, it's something that we monitor very closely.
And as local and federal guidelines get issued.
We react accordingly, and make appropriate decisions as to whether it's safe.
For our salesforce to be out there or whether they pull back and they they continued to do their virtual and.
Engagement either way, we feel like we can effectively.
Reach our prescribing audience through that mix of in person and virtual as well as through our non personal efforts with our digital marketing campaign as well.
And then just if I may have follow up on on the commercial side I suppose it's too early to have any persistence feedback. If you will you did mention the early clinical experience, but have you had any feedback regarding.
Patients continuing to be interested in taking on kept player.
Yeah as I mentioned, Charles we are actually very encouraged by the refill rates that we're seeing and the ratio between new prescriptions and total prescriptions, which is a a sort of a leading indicator to us.
That patients are refilling.
They're medicines and that would be consistent with our belief that cap light a is a well tolerated and I psychotic that's effective.
And then agent that they would look to be refilling. So as you mentioned, it's still it's still early we don't have long term sort of longitudinal tracking but the early indicators in the metrics that we're looking at a we find very encouraging in terms of patients wanting to refill their medicines.
Super and then if I could ask either sharing or Andy regarding.
Floro two versus four three.
You know some of US maybe trying to gauge probability success in and perhaps if I could just ask you maybe from a mechanistic rationale perspective, if he thought about floro too and the activity of Lumet tempur own as an adjunct therapy versus four.
Three in a monotherapy you know I know you've got that for a for success I'm just kind of wondering what your thoughts are in terms of good drugs ability to demonstrate therapeutic king.
So I'll ask Andy to start and then I may chime in.
Yeah. So.
We believe the drug is going to work in the adjunctive setting.
Very similar fashion to the way we've seen at work in the monotherapy situation and study floral for.
And you know we've carefully analyzed the results from oral for.
And the results from us.
A number of things from those analyses.
[noise] design and so far the conduct of study for wrote two and the way they designed and powered study for three we remain very confident that we're on track with those that we have every reason to believe that I'm not the drug should be it with the drug working that we should be able to see a successful results.
In both of those trials. So we're adequately powered the where the studies are being done the types of patients that are coming and all are consistent with what we've been expecting for that.
Thanks for taking my questions.
And our next question is on the line or Sumant Kulkarni with Canaccord. Your line is open.
Mike Thanks for taking my questions. There's a very specific photo two related question in a scenario, where the trial works in either bipolar depression, and bipolar disorder type, one or two but not boat or would that mean that you are.
Oh open to filing for an outerwear label, initially and then waiting and watching as to what might happen with the monotherapy trial to report next year.
Yeah, I'll start and then I'll ask Andy to gets further details no I think remember we have four or four which.
It was effective in both bipolar one bipolar too so I think that.
We would be filing for both bipolar wine and bipolar to upon success of study for up to.
Do you think you want to add.
No. That's that's absolutely correct as long as for wrote two is positive overall will be filing and we'll be filing for it jumps does end monotherapy and that will include both patients with bipolar one about where to.
There's no expectation that individual subgroups in any study need to be positive in order for the overall trial to serve as positive pivotal trial. So.
That's how we would be proceeding absolutely.
And then on the commercial side, we know what might be too early and given the side effect profile. If this product the potential for compliance being higher here is pretty high I would think but on the other hand have you seen anyone not continuing with scoped play doh once they've been on a prescription.
Yeah, Hi, some on its its mark <unk> as I've mentioned before the it's a little early on in the launch to do you'd be doing the longitudinal tracking of of patient data and so what we're looking at is the the ratio between the new Rx is in the Trx is and what we're seeing.
As I mentioned is encouraging, especially compared to competitive benchmarks at the same stage of launch, which which leads us to.
Believe that patients are adhering to the medicine I can't speak to whether individual patients are.
Doing that or not but overall in the aggregate we've been very encouraged by what we've seen.
Thank you.
Thank you and that does end the allotted time that we have for questions I'll now turn the call back over to Sharon mates for closing remarks.
Thank you operator, and thank you everyone for joining the call today.
We look forward to updating you on our clinical progress and our commercial progress and our read out soon in our bipolar studies and our other studies that are on going as well so with that operator, we I.
I should say, we wish everybody a hope everyone remained safe and healthy and look forward to talking too soon and with that operator, you can disconnect the call. Thanks very much.
Ladies and gentlemen, this does conclude the program you may now disconnect. Thank you could this be participating.
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