Q3 2019 Earnings Call

Good morning, ladies and gentlemen, and welcome to the intra cellular therapies third quarter ended September Thirtyth 2019 financial results Conference call.

At this time all participant lines are in listen only mode. After the speakers presentation. There will be a question and answer session. That's the question. During the session you any to press Star then one on your telephone if you acquire any further assistance. Please press Star then zero as a reminder, today's conference call is being recorded.

Now I'd like to turn the conference call over to your host Dr. Sanchez, Vice President Corporate Communications and Investor Relations. Please go ahead Sir.

Thank you operator, good morning, and thank you all for joining us what today's conference call.

Earnings press release, providing a corporate update on details of the company, it's fine I sort of so.

For the third quarter and the September 32019 crossed the one or two or trying to go on its available to porno web site at the intra cellular therapies dotcom.

Joining me on the call today I spoke to shut them made chairman and Chief Executive Officer, Dr., Androscoggin Executive Vice President and Chief Medical Officer, Mark Newman Executive Vice President and Chief Commercial Officer, Dr., Kimberly been over senior Vice President early stage could it comes the vitamin control.

They should not have you seen lottery Highlands senior Vice President and Chief Financial Officer on Michael hosted Executive Vice President and General Counsel.

I saw reminder, during today's call will be making certain forward looking statements.

These statements May include statements regarding among other things the efficacy safety I need to end the utilization of the company's rather development candidates, our because I know because it got plans our parents Super Central report additional data the anticipated conduct under its both of them going on future clinical trials.

Since we started in regulatory filings.

One of them going and be a review process with you if alumina tempered on future research on lets on development our brands regarding come with the commercialization alumina to put it on possible uses of existing cash and investment resources.

These forward looking statements are based on current information assumptions and expectations.

Subject to change I mean, Buck a number of risk and said risks and uncertainties that might cause actual results to differ materially from those containing the forward looking statements.

These another at least can describe you know what music filings made with the Securities and Exchange Commission, including our quarterly our non Waterparks, you're cautioned not to place undue reliance on these forward looking statements on the company disclaims any obligation to update such statements.

I will now turn the call and others to Shannon.

Thanks, one good morning, everyone.

We are now within two months as a potential approval and then the TEP wrong for the treatment of schizophrenia with a PDUFA action date of December 27th of this year.

These are very exciting and transformative times for our company.

As such on today's call, we will be updating you on progress made across the company with particular emphasis on our limit pepper on programs and our preparations towards commercialization.

Mark Newman, our Chief commercial officer will elaborate on our commercial activities Andy's Allen, our Chief Medical Officer will provide an overview of our clinical development programs.

Lastly, Larry timeline, our Chief Financial Officer will review, our financial results and we will open up the line for QNX.

Our India is supported by two adequate and well controlled clinical trial and the safety database with over 1900 individual exposed to the drugs, including individuals with long term exposure.

We believe that argument pepper on schizophrenia program provides evidence in support of the efficacy and safety for the treatment of schizophrenia, and if approved may represent an important new treatment option for health care providers and their patients.

We continue to make substantial progress to support the launch at Bloom ATEP wrong in the first quarter of 2020.

We have been building, our commercial infrastructure and expanding our commercial organization, including the sales marketing and market access teams.

In addition, manufacturing and supply chain operations are in place and we are on track to support commercial supply.

Mark will elaborate during his remarks.

We've continued to make significant progress in our other than the pepper on clinical programs, including bipolar depression.

Bipolar disorder is a highly prevalent disease affecting approximately 6 million adults Americans. This serious psychiatric condition is characterized by episodes of mania in bipolar one patients or hypomania in bipolar two patients.

[noise] bipolar one and bipolar two patients experience episodes of depression, which tend to last longer and become more often than the manic or hypomanic episodes.

While there are several options for the treatment of mania. There are few options for the treatment of depressive episodes.

Recently approved drugs for the treatment of bipolar depression are only indicated for bipolar one patients a patient population that represents only about half of patients with bipolar disorder.

We are enthusiastic about the potential for limited front to advance the treatment of patients with bipolar depression due to its favorable safety and tolerability profile and the potential to treat patients suffering from bipolar one for bipolar too is to order.

Our bipolar Depression program consists of three studies to monotherapy studies and want Adjunctive study.

In the third quarter, we presented robust positive topline results from study for for our global clinical trial evaluating woman TEP wrong as monotherapy for the treatment of major depressive episodes in patients with bipolar one and two disorder.

Results from this study demonstrates the potential of limited brown as a new treatment option for the treatment of depressive episodes in patients suffering from bipolar one or bipolar disorder.

The robust results observed as measured by improvement over placebo in the month summary asked for depression rating scale or Madras total for the primary endpoint are supported by results an important measurements such as remote mission and response rate and the clinical global impression scale or <unk>.

These results are accompanied by the confirmation of the safety profile of limited bronze seen in previous studies.

We will be presenting data on this program at scientific conference later this year.

I'm also pleased to announce that study for owed to our global Adjunctive study for the treatment of bipolar depression in both bipolar one and two patients is progressing well and we anticipate reporting topline results mid next year.

Beyond the progress made in our lumen TEP wrong schizophrenia, and bipolar Depression program, we continue to advance our pipeline, including the development of limit TEP wrong, and our <unk> Oh seven platform in other indications, including depressive disorders, and our long acting injectable program for the.

Men of schizophrenia.

Our PD one program and our preclinical programs Andy will provide details on these programs.

We ended the quarter with $255.4 million in cash cash equivalents and investment Securities, which places us in a strong position to fund our commercial activities and continue to advance our development programs.

I'll now turn the call over to Mark.

Thanks, Sharon and good morning, everyone.

As Sharon mentioned, we're now within two months of the potential approval of lumen TEP rounds I'm pleased to have this opportunity to give you an update on the substantial progress we've been making in our commercial launch execution preparation.

Pending FDA approval of lumen tepper owned by our could do for date of December 27, we're planning for a commercial launch in the first quarter of 2020, and we remain on track in all areas to meet this timeline.

Let me begin with an update on our progress in building out the field based customer facing teams, including the Salesforce and market access schemes.

We've identified the top 15 to 20000 high prescribers of anti Psychotics, who treat schizophrenia, representing the majority of the market potential and we're confident that we upsized the salesforce to have a highly competitive promotional effort.

Our recruiting and hiring process is well advanced and we've been pleased with both the level of interest in joining our company as well as the quality of the talent that we are attractive.

At this point all of our area sales directors are onboard and hiring is ongoing for the regional business managers.

Of the sales leaders, we have hired thus far greater than 90% have previous psychiatry experience.

The sales leadership team is actively recruiting and interviewing the sales representatives, who we plan to onboard in Q1 in time for the launch pending approval of lumen temper.

And in addition to our hiring activities our operational infrastructure in support of the Salesforce is nearly complete.

We also now have our entire market access organization in place, including the leadership team and the national and regional account executives.

As with our sales leadership team all of these individuals join us with deep biopharmaceutical experience strong existing payer relationships and specific competencies in ensuring appropriate patient access to neuroscience medicine.

We have prioritized the top tier payers, who represent the vast majority of anti psychotic volume and claims processing for initial engagement in accordance with FDA guidance regarding pre approval communications.

Our account executives are introducing intra cellular therapies to medical and pharmacy directors as well as engaging in schizophrenia disease awareness and business to business planning discussions.

These important activities will continue throughout the fourth quarter.

We continue to make strong progress in the area of manufacturing and supply chain, where we are in an excellent position to support launch in the first quarter and to ensure that product supply is available for the Q1 launch timeframe.

And finally, you may recall that we had successfully launched a disease awareness campaign to the medical community in May in conjunction with the American Psychiatric Association meeting to highlight the significant unmet medical needs that remain in the treatment of schizophrenia.

This print and digital campaign remains ongoing and all of our metrics are tracking at or above our expectations.

Our print effort has reached 95% of the psychiatry audience.

Combined print and digital has delivered over 800000 touch points and our website as the journey Dot Com has also been well received by the medical community.

We plan to continue this unbranded campaign up to the time of potential approval.

When we will then begin to focus on branded promotion of lumen temper.

Thank you and I would now like to hand, the call over to Andy to discuss our clinical development program updates Andy.

Thanks Mark.

We continue to advance our clinical programs for Lumet, TEP around and other investigational new drugs in our pipeline.

Our team has presented data on our limits have run programs at medical conferences, and we've been very pleased by the positive reception limits have grown as received during these meetings and the interactions weve had with important stakeholders in psychiatry.

Recently, we made presentations at the European College, Neuropsychopharmacology annual meeting and at that 32nd annual Congress highlighting limit temperance clinical results.

Looking at favorable safety and Tolerability profile established in the schizophrenia program.

We're very excited about the robust results observed in study for all four our global phase three monotherapy study and bipolar depression.

In this study Lumacaftor on 42 milligrams met the primary endpoint.

Statistically significant greater improvement over placebo on Madras at week six.

The mean improvement from baseline for limit TEP around 42 milligrams was 16.7 points.

Versus 12.1 points for placebo for.

For a 4.6 point difference between the two groups.

Robust effect size of 0.56.

And it typically significant P value of less than 0.0001.

Benefit was seen in both bipolar one patients and bipolar to patients.

Subgroup analyses for each diagnosis, demonstrating typically significant improvements versus placebo on the Madras total score.

This trial was conducted in six countries, including the United States and Europe .

It was a statistically significant separation versus placebo on the primary endpoint in both the U.S. population subgroup, representing approximately 30% of enrolled patients and in the ex us population subgroup.

When we kept on also met the key secondary endpoint of statistically significant improvement.

The clinical global impression scale for bipolar for severity of illness total score within effect size of 0.46 and on the clinical global impression scale component that specifically assesses depression.

Within effect size of 0.5.

We're very encouraged by these robust results, which in our opinion uniquely position lumen tougher on it as a potential advance in the treatment of patients suffering from both bipolar one and bipolar disorder.

In a separate study study for a one conducted entirely in the less lumen kept her own not suffering from placebo high placebo response was observed in the trial.

Large placebo effects are increasingly common in clinical trials in depression, and other psychiatric disorders, especially in the United States, making success in these trials more challenging.

In both trials limits have to run demonstrated a favorable safety profile in was generally well tolerated as seen in previous studies in schizophrenia.

The rest of Asia restlessness, an extra pyramidal symptoms combined.

Were less than 1% and similar to placebo in both studies.

Our bipolar depression program continues to advance and as Sharon mentioned, we anticipate reporting topline results from study for old two in mid 2020.

Before I go to is our study evaluating lumacaftor own as adjunctive therapy for the treatment of depressive episodes in patients with bipolar one or bipolar disorder.

Study is being conducted globally and will include approximately 550 patients randomized one to one to one.

Receive limits have grown 42 milligrams 28 milligrams or placebo once daily for six weeks.

As in our other bipolar depression studies.

Pre specified primary endpoint for the trial is change from baseline at week six on the Madras total score versus placebo.

Our rationale to pursue the development of limits have grown for the treatment of depressive disorders, including MDD continues to strengthen and is based on limit heparins unique pharmacology and on improvements in depressive symptoms seen in patients with co morbid depression in our schizophrenia program as well as the positive results.

From study for all four in bipolar depression.

We believe lumen tougher on has the potential to exhibit potent and rapid anti depressant effect.

And we have an ongoing program in major depressive disorder.

In order to explore the effective different modes of drug administration and the potential for rapid onset antidepressant activity.

Our program includes the assessment of novel formulation to limit pepperoni.

We're continuing to explore the pharmacokinetics of these formulations.

We anticipate initiating a phase two clinical study in major depressive disorder in 2020.

We're also pleased with the progress being made in our PD one program as we continue to explore the potential of this novel mechanism of action.

Ns cardiovascular and other condition.

We intend to pursue the development of our PD one inhibitors for the treatment of several CNS and non CNS indications with a focus on diseases, where excessive PD. One activity has been demonstrated and increased inflammation is an important contributor to disease passive Genesis.

We have completed a translational clinical study of Ipi to 14 in healthy volunteers using functional and MRI neuro imaging.

This study was designed to provide data supporting proof of mechanism for PD, one integration to indirectly modulate dopaminergic systems in the brain during complex that April tests.

Results will inform the development of ITI 214 in a variety of central nervous system disorders, We anticipate topline results from this study later this year.

All right to 14 program in heart failure continues to progress Ipi to 14 has potential.

Increased cardiac contractility, an output without increasing vascular resistance.

To 14 increases heart contractility through a pathway involving adenosine eight to be receptor signaling.

Introducing a new mechanism of action for the treatment of heart failure that is different from beta energy agonism NPD three inhibition.

Unlike paid at generic agonists and PD three inhibitors.

To 14 does not increase the inflow of calcium in cardio myocytes, and therefore provides the potential for a safer alternatives to existing therapies.

Our ongoing phase one two single ascending dose study aims to replicate the positive inotropic effects of ITI 214 seen an animal.

Clinical conduct with a third and final cohort 90 milligrams is ongoing following successful completion of the 10 milligram and 30 milligram dose cohort where no safety concerns were identified we anticipate reporting topline results from this study in the first half of 2020.

Finally, we expect to initiate our clinical program for ITI Threethree three in the first half of 2020.

Hi, 333 is our novel oral modulator of serotonin dopamine and Mu opioid receptor is for the treatment of opioid and other substance used to sweaters pain and mood disorders.

I will now turn the call over to Larry will review the financial results.

Right.

Thank you Andy.

I will be reviewing our financial results for the quarter ending September Thirtyth 2019, and provide an overview of our expectations for the use of our cash in investments.

The net loss for the third quarter of 2019 was $34.9 million compared with a net loss of $41.5 million for the third quarter of 2018.

Basic and diluted net loss was 63 cents per share for the third quarter of 2019 compared to a basic and diluted net loss of 76 cents per share for the same period in 2018.

Research and development expenses for the third quarter ended September Thirtyth, 2019 were $21.3 million compared to $35.4 million for the third quarter of 2018.

This does this decrease of 14.1 million is due primarily to a decrease of approximately $10.7 million of cost associated with the completion of certain limits pepper and clinical trials.

The decrease of approximately 1.4 million of cost will limit tepper own nonclinical efforts and a decrease of approximately 1.8 million of manufacturing costs.

General and administrative expenses for the third quarter of 2019 were $15 million compared to $8 million for the third quarter of 2018.

The increase of $7 million is primarily the result of an increase in pre commercialization costs of approximately 3.8 million approximately 1.9 million of higher labor costs, and an increase in stock compensation and rent expense.

Cash cash equivalents and investment securities totaled $255.4 million at September Thirtyth 2019, compared to $347.5 million at December 30, Onest 2018.

We expect these existing funds will be used primarily for pre commercialization activities.

Initial commercialization activities, including developing a national Salesforce and related infrastructure expansion in connection with the commercialization of limit TEP room, if approved for the treatment of schizophrenia.

The development of limit Tepperman, our late stage clinical programs the development of our other product candidates, including ITI 214, the continuation of manufacturing activities and general operations. This concludes our prepared remarks, operator could you. Please open the line for questions.

Thank you as a reminder to ask a question you need to press Star then one on your telephone.

Withdraw your question press the pound key.

Please standby, while we compile the Q Sir.

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

Good morning, Thanks for taking our question congrats on the.

Progress in the quarter, Sharon and team I'm going to be an exciting time, hopefully coming up here soon.

Im sure that you won't be able give us a lot of granularity or information, but I'm wondering if you've had recent discussions with the agency, perhaps even entering into labeling or more importantly, I'm I'm kind of wondering if you've shared observations are actual data with the FDA.

And discussed.

For the bipolar program and discussed the challenges with us patients here in the states not only in bipolar but schizophrenia.

Well, that's a lot of questions.

Which I was not writing down so I hope and others on our team work and we'll try and answer all of them. Thank you for your comments child, and we too we do think it's a very exciting time for us.

I will ask Andy to address the question on the first question dealt with our FDA interactions and.

And there was a part b to that as well, which may be you remember thank you.

So thanks Charles.

With regard to discussions with the FDA so.

This is an active review we continue to have come back and forth with the FDA regarding information that Weve provided.

We have had us.

Ongoing questions. We've responded to the questions in a timely fashion and within FDA deadline.

We believe all the information that we continue to provide to them substantiates.

The data that we have provided previously so we're confident that we're moving in the right direction with all of that.

With regard to bipolar no we have not yet had a chance to discuss those data with FDA thats something thats plan, but during the.

Busy time with the FDA review for schizophrenia that has not happened yet.

And okay that makes sense, but really.

Really my question is along the lines of do you take is that your sense set the agency gets gets it with regard to the challenges of placebo effect.

Going up in schizophrenia, as well you've shown in by Paul.

Yeah, I think they are well aware of this and a variety of indications theyve actually published in this area.

So the.

Issue with placebo response rates across I guess indications, particularly in depression, perhaps particularly in the United States are things that are.

They are well aware of and we as well and yes. You had asked also about what did any of these discussions concern labeling, yes, and there have been discussions around labeling issues as well.

Okay. One quick question them from Mark and then I'll hop back in the queue and that is regarding.

Well, it's it's availed question on pricing, but it really is meant to help us think about.

The pharmacoeconomic value that you see in movements have grown and the feedback that you've gotten an early discussions with reimbursement authorities I guess, what I'm wondering is on do you do you feel.

At the reimbursement authorities I understand the different potential differentiation of so much pepperoni and its ability to or patients ability to take it overtime and therefore see efficacy what do you how do you think about pharmacoeconomic value.

Yeah. Thanks, Charles for the for the question and we've had I would say extensive discussions.

Over the past year or so in a market research setting and in advisory boards, both with pharmacy directors and medical directors.

From from payers and a couple of themes have emerged from those discussions.

That are actually very consistent with how the physicians that we've spoken to in market research.

Have have come to us and two themes in particular that are encouraging to us number one the recognition that in spite of there being several anti psychotics on the market both generic and branded there's a recognition that because of the dynamic in the marketplace of patient cycling through multi.

Couple anti Psychotics there continues to be a very significant unmet need for an effective anti psychotic with a favorable safety and tolerability profile and so that's well recognized by the payers. In addition to the physicians.

And then when where we would share the clinical data from our program that Andy has talked about.

With medical and pharmacy directors, they see the same differentiation of limit tepper own.

That the physicians do on the psychiatrists do and that is.

At effect of anti psychotic and one that has a favorable safety and Tolerability profile. In addition to a unique mechanism of action.

And so in our discussions with payers they recognize that.

There is a very strong value proposition that lumet pepperoni, if approved will bring to the marketplace and it'll be our job to make sure that we bring forward the right Pharmacoeconomic data to help turn some of the theoretical benefits of adherence due to a favorable.

Safety and Tolerability profile into.

Tangible benefits that pharmacy, and medical directors will be able to see so that's a big part of what our medical affairs team is doing as we speak.

Certainly once we get approval if approved.

Then real world data with lumen TEP around will also play a critical role in helping to establish those benefits as well. So I hope that answered your question, but I wanted to provide at least a little more full of an answer about the kind of feedback that we've been getting from payers. In addition to the physician.

Thank you.

Our next question comes from the line of Jessica Fye with JP Morgan.

Your line is now open.

Great. Good morning, Thanks for taking my questions I guess first just following up on that question on pair feedback should we expect the typical step edits that some physicians have indicated they face with Latuda for example.

Yes, Thanks, Jessica for the question. This is this is mark again.

What I would say is that the anti psychotic category has been around for several years, it's a category that payers are familiar with.

It's a category that they want to ensure access to the appropriate medications to treat serious diseases like schizophrenia.

And so I think you'll have a mix there are payors, who will provide.

Unrestricted access.

We would expect to lumen TEP run as they do for other agents and there will be other payers who will employ.

Techniques like step edits, where they will require one or two generic products to be used prior to the branded product, but what I would say about that in particular is if you look at the the patients who are out there today.

Suffering from schizophrenia.

The majority of them the vast majority of them have already been on multiple anti psychotics. So they've already met the requirements of many of the step edits that the payers will be putting in place and so when a physician goes to write a product like lumet pepperoni.

And can demonstrate that the patient has already been on one or two other anti psychotics.

Then typically that that prescription would get approved and get filled so.

Something that we're aware of.

And something that.

We think is a manageable.

Piece of the payer dynamics.

Got it Okay makes sense you also mentioned the that you sized the Salesforce can you tell us what that projected size will be.

Yeah. Thanks, Jessica up until this point, we've not communicated the exact number of or the size of of the salesforce for competitive reasons and we're continuing.

To keep that a little close to divest that what I would say when I said on the call is we we have a very good understanding of the audience of physicians, who writes the majority of.

And I psychotic prescriptions for schizophrenia patients.

We though which physicians or the high prescribers and we have size the salesforce to enable us to be highly competitive in those offices.

With our Lumet Tempero and.

Promotion. So at this point I think that's all I'm going to say on that but if that at least gives you a sense of.

The 15 to 20000 physicians, who write the majority of prescriptions for schizophrenia of anti Psychotics. Those are the physician offices, where we'll be concentrating in and in those offices will have a highly competitive effort.

For our Salesforce.

Thank you. Our next question comes from the line of Andrew Hi, Jefferies. Your line is now open.

Thanks, Good morning.

So apologies if this has been asked before and prior conference calls, but I.

I believe the F.D.A. canceled you're asking about one week prior to the actual day and it's my understanding that companies themselves tend to receive preliminary briefing docs. Many two weeks before hand at least this timeline was confirmed by another company in this morning. So.

Just wondering if you have received a draft and if so what topics Danielle. Thanks.

Yes, hi, thanks. Thanks, This is Sharon and.

You write this has been addressed.

Many times before and really.

The FDA had decided to cancel our AD com and really we don't have much.

Much more to say about that other than we're moving forward.

Hi, I kind of missed some of your timeline in there and I'm not sure it was actually quite right but.

It doesn't matter because we.

We are here today.

We.

We to this date do not have another AD com schedule.

We are moving on looking towards our approval.

Sounds good.

And also.

Since early September has there been any anecdotal evidence out there that you've found internally that would support the notion of an approval, perhaps looking at the recent history PDUFA extensions and outcomes.

As an example.

Thanks.

I'm, sorry, I'm I'm not sure I understand the question you understand that I'm not sure I got to except that I would say that we're focused on our own submission and wanting to ftn request for a around RMB a and.

Thats our concern at this point and when we think Thats progressing.

In a satisfactory manner.

Okay and my last question is just that for the bipolar program. It sounds like you still need to talk to that FDA to establish a path forward.

So one could we expect a meeting.

And should investors expect the base case in Iowa to be a filing after.

The final phase three study readout in mid 2020.

So yeah. Those those are the types of questions, we would be addressing with FDA.

Don't have a timeline yet for it so it is something that we intend to do in the near future.

Thank you. Our next question comes from the line of Marc Goodman was SVB Leerink. Your line is now open.

Yes, good morning.

First on this bipolar depression and Joe to study can you just give us a sense of where enrollment is right now.

And second question has to do it spending just total spending this year.

Seems to be coming in much less than what you thought it was going to be I guess, you know six months ago can you just give us a sense of how you're thinking about spending now for the rest of the year.

And then as we think about next year, obviously, the number of reps will kick in in the first quarter. So that's incremental for next year and I understand you're not going to disclose that number but that's incremental spend that there's going to be obviously, some supporting spending.

Around advertising promotion can you just give us a sense of that type of number.

And how you're thinking about R&D, what's the incremental changes you're going to be going into next year.

Bigger and smaller than this year. Thanks.

Sure So Dan Knotts lot of questions I'll ask Andy to answer the bipolar and then wiring and I will take the.

Larry and I will take the financial sure yes. So.

With regard to the bipolar jump to study steady flow to enrollment is going very well and has picked up as weve enlarge the number of countries that are involved in this trial and as a result, as we said today we.

We are able to state that we anticipate having.

That's filed by the Middle of 2020, So I think it's.

Along very nicely with that.

Yes, Hi, Mark this is Larry are.

Our spend for the fourth quarter, we're we're estimating it could go as high as 45 million.

We've been under that.

Quarterly for the first three quarters.

You are right going forward, we'll see an incremental spend.

As we do the things that you had mentioned and.

You can.

You can guide.

The guidance based on that.

Yes, well give you we haven't given you any guidance to the spend and 2020 at others on.

We've gone through Q4 at the moment right and it will be going up in from yes, and were certainly and you're absolutely right that we have.

Spent less than we originally projected and this was.

Don purposely we've.

Unable to tighten things up really go back and look at each of us each area of hours and so we think we've been very.

Prudent on our cash spend.

Thanks.

Good.

Go ahead sorry.

Problem. Thank you. Our next question comes from the line of Brian Abrahams.

With RBC capital markets. Your line is now open.

Hey, Tim. This is all went on for Brian . Thanks for taking my questions. Just couple of quick ones from me first one anymore color you could give us on manufacturing supply chain activity you sort of what are the gating factors there and.

Have you already built up some some commercial supply at this stage or is that still ongoing and then on the sales side. You know you noticed you I noted you're hiring some regional business business managers, now and and can you talk a little bit about what still needs to be done.

On that front and the end of this year and into first quarter. Thanks.

Yes, sure sure Churro and thanks. This is this is mark yes from a.

Manufacturing and supply chain perspective, we feel very good about where we are.

We do have a commercial supply ready to go and.

As I said in my prepared remarks, and Sharon did as well.

We feel very confident in the ability to provide commercial supply in line with.

Our planned Q1 launch so we feel very good there the supply chain pieces are all coming together in.

In terms of negotiations with with wholesalers.

Et cetera, So we feel we'll be ready to go once we get approved and we get out into the marketplace, So thats manufacturing and supply chain.

From a salesforce perspective, yeah, I guess, just a little bit more background on that as I've said in the past we I've had my head of sales on board since the very beginning of the year. The first order of business was getting the area sales directors onboard they are all.

Hired and onboard.

At this stage and they've been busy doing the recruiting and hiring of the regional business managers, which are the first line managers, who will be managing the sales representatives, though as I mentioned, our hiring of the regional business managers is ongoing.

We have many onboard already in that effort continues and at the same time in parallel.

With those that are on board the recruiting the identification and the interviewing of the sales representatives has already begun as well and that will continue throughout the fourth quarter and into the first quarter next year.

We've said before that we won't onboard the sales representatives until after approval in the first quarter, but our plan is to have them in place in time for the first quarter launch. So hopefully that provides a little bit more detail in terms of what you were looking for there.

Thank you. Our next question comes from the line of Sumant Kulkarni with Canaccord Genuity.

It is now open.

Good morning, Thanks for taking my questions I have a few here.

First on the more recent discussions you've had with the FDA on defending human capital and Andy could you help characterize build in the context of whether the agencies relative emphasis has been on preclinical or clinical data or something aesynt that'd be like labeling.

Yes, I think.

Thanks.

For your question.

The discussions of covered all of those areas and they continue to we've had discussions throughout the process with regard to those different areas I think with regard to the costs as we mentioned being submitted some new data while back.

Theres been sort of discussion around that some follow up but really labeling discussions as well. So we're moving along I think in a way that we'd expect.

My second one is on the bipolar depression data, it's a follow up but do I guess to a follow up especially looking at what point do you expect to meet with the FDA to discuss the phase three results you have so far and when that meeting negated by the availability of data from the global Adjunctive trial, and how would that onset change if at all if you made up alone is approved for schizophrenia, because that would mean potential.

SMB, which made a quite a single successful trials.

Yes, so all the good comments and good questions no as I mentioned before we don't have a definite timeline for meeting with FDA at this point, although we're moving toward that.

And all data that we have available will be discussed and.

But you're right that it will depend on.

On outcomes in other areas going forward as well.

Yes.

Thank you. Our next question comes from the line of Bert Hazlett with BTI G. Your line is now open.

Thank you I have to just getting back to the market research.

Other aspects as you've done any market research with regard to its profile that materially resonate with physicians either on the side or on the efficacy side, but relative lack of weight gain or movement disorders. If you could shed any light on what might be particularly resonating that would be great and then a second one just on two one for.

As you consider the breadth of the indications there assuming you are successful and you see positive signals with Doe to one for is it your attention to.

Pursue both CNS and Didnt on CNS roots internally. Thank you.

Yes. So first this is mark I'll take the first part of that and then turn it over to Andy or share in Fourq for the second part and yes, you're right. We as I said before we've done an extensive amount of market research on the profile.

Of Lumet Pepperoni and certainly.

The the themes that have come through.

From that research is that lumet pepperoni and the clinical data that supports it represents a an effective anti psychotic that has a favorable safety and tolerability profile and as I think you're aware the dynamics of the marketplace and the existing anti psychotics.

Each of them are effective than had been approved for schizophrenia.

But each of them also has some liability or multiple liabilities when it comes to safety and tolerability and that tends to be in two or three major areas either in the metabolic profile.

The increase in lip is increasing glucose.

Weight gain prolactin abnormalities et cetera, or on the movement disorder side of things, where you have ACA fees.

Other dyskinesias et cetera.

And many of these.

I'd effects are are truly in tolerable to patients and that's why you get this.

Dynamic of the frequent cycling through multiple anti psychotics.

For schizophrenia patients now when they when physicians in market research see the clinical data supporting Lumet, pepperoni, and they see the favorable metabolic and weight.

Results and they see the lack of movement disorders.

These are aspects of the profile that they find to be very differentiating.

From other existing anti Psychotics so.

I think thats, what I'll say about that and I'll turn it over to Andy for for the second part of the question.

Yes, sure, but so thanks for asking about a 10 to 14, which were also very excited about and as you are right. You said, you're absolutely correct. We're looking at a number of different indications both in the CNS and non CNS area and we're considering other indications it could.

Build on what we know about the pharmacology of this compound in the PD, one and efficient in general right now everything that we're doing is.

And the different.

Indications is in at this stage of proof of principle proof of mechanism proof of concept and obviously as data come in.

We'll need to do exactly what you suggest which is to look overall at the portfolio of indications to make some strategic decisions to think about whether and how to pursue those.

And also to potentially have discussions.

Wins outside companies or others to help us and.

And moving forward with those so it's a little preliminary at this stage, but we are looking for forward very much to.

Getting a chance to fully explore with this compound can do.

Thank you.

Next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Your line is now open.

Hi.

It is Raymond in for Matt one of the analysts have asked my questions, but I'll just have one question on the pipeline.

Can you, perhaps give some color on where you are in completing the formulation for that and DT indication reps.

So no go have got work is ongoing there as well as we mentioned with.

Friday PK studies.

So that's that's ongoing work.

That was that we are pursuing.

Okay, Alright, I guess.

That's it for now thanks.

Okay.

Thank you. This concludes today's question and answer session I like to turn the call back over to Sharon mates for closing remarks.

Thank you operator, and thank you everyone for joining our call and thank you to those who ask questions. They were.

Very in depth and.

Hey useful question. So we appreciate that thanks, everybody and we look forward to updating you.

Thank you.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.