Q4 2019 Earnings Call
Ladies and gentlemen, today's conference is scheduled to begin shortly please continue to stand by thinking <unk>.
[music].
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I'd now like to trend in so what's your host Dr. wants Sanchez, Vice President corporate Communications and Investor Relations. Please go ahead.
Thank you.
Good morning, and thank you all for joining host for todays conference calls.
Well what earnings press release, providing a corporate update.
Details of the Companys financial results.
Fourth quarter full year ended December 31st 2019 crossed the one at short time ago. So vulnerable.
Right.
Seem to us cellular therapies dot com.
Joining me on the call today I'll talk to shut amazed.
<unk>, Chief Executive Officer, Dr. and your thoughts.
Secondly, Vice President Chief Medical Officer.
Mark Newman Executive Vice President and Chief Commercial Officer, Lonnie Lonnie Lane, Senior Vice President Chief Financial Officer, Michael posted.
So it could be worth, Brazil, and general counsel.
That's a reminder, during today's call we'd be making certain forward looking statements.
These statements May include statements regarding among other things the efficacy safety anything that you're going to assist you. Another company product development candidate our clinical no clinical plans, our plans to persist or report additional data.
You bet, a consulting to so I'm going on future clinical trials.
Regarding regulatory filings you to research and development our plans regarding comments really Fisher. The commercialization will come later possible uses of existing gosh on investment resources.
These forward looking statements are based on current information assumptions and expectations.
Got it subject to change Sonny Bono non Petrobras kind of incentive.
Cause actual results could differ materially from those concerns in the forward looking statements.
These and other risk are describing our periodic filings made with the securities and exchange Commission, including our quarterly or not wonder ports.
Cautioned not to place undue reliance with these forward looking statements.
Company disclaims any obligation to update such statements.
I will now turn the call over to Charlotte.
Thanks, Ron.
Good morning, everyone and welcome to today's call.
2019, with a very successful year for intra cellular therapies.
In December we received FDA approval for kept blida for the treatment of schizophrenia in adult.
We're very excited about the launch of kept lighter later this month.
Our launch plan is comprehensive and our preparations are fully on track.
Yeah, the highly experienced and competitively sized commercial team in place and they are ready to execute.
Our sales leadership team and substantially all of our sales Representatives are on board and we are in the final stages of their training.
Our market access team continues to be actively engaged in product discussions with payers.
Manufacturing and supply chain related activities are also in place.
Mark Newman, our Chief commercial officer will expand on our launch readiness shortly.
In addition to commercial preparations we continue to advance our pipeline.
We look forward to reporting results from our loop limit type wrong phase three trial in bipolar depression, and our IP I to 14 phase one two trial in heart failure mid year.
Andrew sat when our Chief Medical Officer will provide more detail on our clinical development programs.
Following Andy's comments, Larry Heinlein, our Chief Financial Officer will review our financial results.
We will then open the line for QNX.
As reflected in the label the clinical profile of Count flight is compelling we firmly believe kept lighter provides physicians and their patients and important new treatment option for this serious mental illness impacting approximately 1% of the global population translating into two point.
4 million adults in the United States.
Important unmet medical needs continue to exist patients with schizophrenia, often discontinued treatment or seek treatment changes as a result of side effects, such as weight gain metabolic disturbances and movement disorders.
We are pleased that kept light I will be available to patients very soon.
Schizophrenia is just to start a bar broadloom type run development program, we believe that when the cap Ron's efficacy and safety profile demonstrated in schizophrenia has the potential to translate to other therapeutic indications, including various depressive disorders.
Last July we reported robust safety and efficacy results from study for all for a phase three trial of limits have grown in patients with a depressive episode associated with either bipolar one for bipolar to disorder.
These robust results have reinforced our resolve to bring this important medicines to patients suffering from bipolar depression, and we have a broad clinical program for this indication.
Patient enrollment is ongoing and on track and study for up to our global Phase three study evaluating the TEP wrong as an adjunctive treatment of depressive episodes associated with either bipolar one or bipolar disorder.
We anticipate reporting topline results mid year.
Further we have commenced an additional phase three study study for all three a global monotherapy study that mirrors the design and conduct of study for all four.
We plan to initiate a phase two clinical proof of efficacy trial and major depressive disorder. Later this year.
Shortly Andy will elaborate on these programs and provide an update on our other pipeline assets as well.
We ended the year with $224 million and cash and investments.
Adding to our financial strength, we completed a 295 million dollar follow on public offering earlier this year, which resulted in net proceeds of approximately $277 million, we are well capitalized to fund our commercial activities and to continue to advance our development program.
In 2019, we made strategic investments in our infrastructure to appropriately support our growing organization, including in our research and development clinical and commercial capabilities.
We are stronger than ever and I'm very proud of our accomplishment.
I will now turn the call over to Mark whose team has been very busy preparing for the launch of kept blight Mark.
Thanks, Sharon and good morning, everyone of our commercial team has been very busy and we're very excited to have the opportunity to bring cap laid out to market. Later this month and provide an important new treatment option to help improve the lives of individuals suffering from schizophrenia.
I'm pleased to have this opportunity to give you an update on our launch execution preparation and to describe the market access conditions, we anticipate in the early months of commercialization.
Immediately after the approval of capital <unk> in late December we executed a robust now approved digital and print awareness campaign, which has reached over 90% of the psychiatry audience.
Driven nearly 40000 unique visitors to our cap lighter weight a web site.
And has delivered over 1 million impressions today.
Got blida will be available to pharmacies in mid March and our full launch promotional activities will commence in late March.
We have a comprehensive plan in place in which our multichannel marketing efforts, including the deployment of a national sales force of approximately 240 neuroscience sales specialists.
We'll focus on the approximately 23000 health care providers, who account for 80% of the branded anti psychotic schizophrenia prescriptions.
Our entire sales leadership team and substantially all of our sales representatives are on board and their training activities are in the final stages.
We're very pleased with the caliber talent of the sales representatives we have attracted.
They have an average of almost 15 years of selling experience in the biopharmaceutical industry and greater than 90% of them have prior psychiatry experience.
Let me now provide an update on our market access activities.
Our entire market access organization has been in place since early in the fourth quarter of last year, including the leadership team and our national and regional account executives.
This group of professionals has deep neuroscience experience.
Tablets relationships with payers and strong competencies in achieving patient access for medicines in the mental health area.
Anti Psychotics are well established drug class and there's been a predictable dynamic in the way new anti psychotics enter the market and formulary coverage is a sign.
Consequently, we expect payers to manage cap leidos similarly to the other previously launched branded anti Psychotics.
As you know the payer landscape is complex and includes several types of payers, including Medicare part D and Medicaid.
Under Medicare part D. Anti Psychotics are considered a protected class and as such newly approved products are reviewed for coverage rapidly within 90 days.
Our market access team has been meeting with these payers and we expect coverage determinations for cap laid out to be established from now through the second quarter.
And based on recent precedents, we would expect similar timing dynamics for coverage determinations in the Medicaid channel.
Commercial payers represent another important [noise].
We're in discussions with all the major payers and are starting to see uptake in coverage determinations in this channel.
This will progress overtime.
Overall, we expect market access formulary status for capital Ida to be fully established across all payer channels within nine to 12 months.
In accordance with expected to review timelines and decisions.
It is important to note that while all these payers are conducting their formal reviews. We expect there will be a pathway to access for cap lighter consistent with how other anti psychotics were managed at launch.
Additionally, we have designed a comprehensive patient support program to facilitate access to capital Ida, including appropriate prior authorization support and co pay savings assistance.
In summary, we are very excited to bring this important new medicines to patients.
We have a highly experienced commercial team and a strong cap litle launch plan and we look forward to providing future updates as we execute against this plan.
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.
With the approvals kept light up for the treatment of schizophrenia in adult we're excited about the opportunity to help patients suffering from this serious lifelong mental illness.
The cap lighter label clearly reflects the efficacy and safety profile observed in our clinical studies.
Efficacy of cap light up 42 milligrams was demonstrated in two placebo controlled trials.
Most common adverse reactions were some middle installation and dry mouth.
In pooled data from short term studies mean changes from baseline in weight gain fasting glucose triglycerides and total cholesterol.
Similar between kept light and placebo.
The incidence of extra pyramidal symptoms was 6.7% for cap light and 6.3% for placebo.
Our medical Affairs team has been very active an energized by scientific exchange with the medical community, including Congress participation an individual discussions with key opinion leaders and medical and pharmacy directors last year, we presented data ONTAP light at several medical conferences highlighting its safety.
Realty profile.
And we will have a strong presence at medical conferences this year, including the upcoming American Psychiatric Association annual meeting.
We're pleased with the publication in Jamess psychiatrists, describing the results of one of our pivotal studies study 301.
Article titled Efficacy and safety of limit TEP around for treatment of schizophrenia randomized clinical trial with lead author Dr. Christophe Corral.
In addition to schizophrenia, our initial indication we continue to advance the development of limit tepper on for other indications, including bipolar depression, and other depressive disorders, including major depressive disorder.
Last July we reported positive efficacy for Lumos Pepperoni and study for all four our global Phase three monotherapy study in bipolar depression.
Based on these strong results in the favorable safety profile observed in this study and across all of our lumen type run programs. We're very excited about the opportunity for little bit TEP around in this important indication.
And the possibility to help depressed individual suffering from both bipolar one and bipolar disorder.
In study floral for limit Tepper on 42 milligrams met the primary endpoint with statistically significant greater improvement over placebo on the Madras total score at week six.
The mean improvement from baseline for limit Tepper on 42 milligrams was 16.7 points versus 12.1 points for placebo.
For a 4.6 point difference between the two groups a robust effect size of 0.56.
And a statistically significant P value less than 0.0001.
We're very encouraged by the internal consistency of the results as reflected by the benefits Dean in both bipolar one and bipolar two patients.
A statistically significant separation versus placebo on the primary endpoint in both the U. S and X U.S. population subgroups.
Statistically significant improvement on the key secondary endpoint the clinical global impression you know for bipolar for severity of illness total score.
As well as stronger so in responder and remission analyses.
The results from this trial were presented in December at the annual meeting of the CNP and we're very pleased by the positive reception received from the medical community.
Polar depression continues to be an area of unmet medical need we believe that limit tepper on can be a valuable addition for this condition, which has only a few approved treatments, including only one for patients with bipolar one or bipolar disorder.
Enrollment is on track and our ongoing injunctive phase three study study for road to and we anticipate topline results mid year.
Building on the program momentum. We also initiated study for a three a global monotherapy study I'll take you through the study design.
Do you borrow to evaluate limit tepper own as an adjunctive therapy for the treatment of depressive episodes in patients with bipolar one or bipolar disorder.
This study is being conducted globally and will include approximately 550 patients randomized one to one to one to receive lumen TEP Rone 42 milligrams 28 milligrams or placebo once daily for six weeks.
While being maintained on lithium or valproate late as mood stabilizers.
Study for a three evaluates limit TEP around as monotherapy in patients with bipolar one and two disorder. It's also being conducted globally and we will include approximately 350 patients randomized one to one to receive limit tepper on 42 milligrams or placebo once daily for six weeks.
The pre specified primary endpoint for both trials is change from baseline at week six.
On the Madras total score versus placebo.
Subject to the results of study for wrote two and our interactions with the FDA regarding our bipolar depression program, we expect to submit to the F.D.A. in late 2020 supplemental new drug application for regulatory approval for limited around for the treatment bipolar depression.
The use of antipsychotics and major psychiatric indications is limited due to existing safety and Tolerability trade offs, we believe limit TEP runs pharmacological profile and existing safety and efficacy profile strongly support the development of the drug across major psychiatric illnesses, including bipolar depression and others.
Disorders.
We continue to advance our ongoing program in major depressive disorder, and anticipate initiating a phase two clinical study this year.
We have completed preclinical development of a long acting injectable formulation of limit TEP, Ron and plan to initiate a phase one clinical study in 2020.
We continue to advance our PD one program.
Our ITI 214 phase one two clinical trial in heart failure is nearing completion.
This single ascending dose study aims to replicate the positive inotropic affects of ITI 214 seen in a preclinical model of heart failure.
Clinical conduct for the third and final cohort 90 milligrams is ongoing following successful completion of the 10 milligram and 30 milligram dose cohorts, 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 <unk> 333, our novel oral modulator of new opioid and start Tony receptors for.
For the treatment of opioid and other substance abuse disorders pain and mood disorder.
A single ascending dose study in healthy subjects is planned to initiate later this year.
I will now turn the call over to Larry who will review the financial results Larry.
Thanks, Andy.
I will be reviewing our financial results for the year ending December 31st 2000 might be.
Research and development expenses.
For the year ended 2019, reighty $9.1 million compared to $132.2 million for 2018.
The $43.1 million decrease is due primarily to lower clinical trial costs and to a lesser extent manufacturing cost for cap lighter warmer temperatures and it's offset partially by higher non ipi those seven related projects and labor costs.
General and administrative expenses for the year ended 2019 $64.9 million compared to $30.1 million for 2018.
The increase of 34.8 million is primarily due to increases in pre commercialization costs.
Labour cost stock compensation expense and facilities related costs.
Cash cash equivalents and investment Securities totaled 224 million at December 31, 2019 compared to $347.5 million.
Number 31 2018.
On January 10th 2020, we completed a 295 million dollar follow on public offering resulting in net proceeds of the to the company of approximately $277 million from the sale of 10 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 wanted to press star one on your telephone to withdraw your question pest. Upon key please standby of all the commodity Kennedy roster.
Our first question comes from Charles Duncan with Cantor Fitzgerald. Your line is open.
Good morning, Sharon and team thanks for taking our questions and congratulations on a great year.
Last year.
Click a quick question regarding cap play that in terms of commercialization then I had one follow up for.
For the pipeline.
In terms of kept plate and thinking about pricing and pharmacoeconomic value what kind of feedback have you gotten in terms of.
From the market access outreach from payers and prescribers.
On the value proposition and unmet need in schizophrenia, as especially given a differentiated clinical profile of kept player.
Hi, Charles Thanks for the question Mark would you like to take it yeah sure a good morning Charles.
So as we've described before we had conducted a quite a bit of market research prior to the approval and.
Now that our account executives have been out meeting with payers, both with medical directors as well as pharmacy directors with payers.
There are a couple of themes that we've been im very encouraged by that we've heard across the different channels and across the different payers number one is that they recognize that there continues to be a very significant unmet medical need in the treatment of schizophrenia for a an effective and I'd say.
Kotick that has a favorable safety and Tolerability profile and secondly importantly.
When they are provided with a clinical overview of the profile of kept blida, what they see as a differentiated profile.
With that an anti psychotic that is effective and has a very favorable safety and tolerability profile and as you know the value proposition.
And the Pharmacoeconomics all begin with.
Having a profile of a product.
That is needed by the marketplace and that's exactly what we're seeing when we have those discussions with medical and pharmacy directors.
That's helpful and if I could just add one more on that one in terms of supply chain. We never ask these questions generally but in today's world, we need to how does the supply chain.
I guess looked for kept played out in terms of first couple of years or your worth the supply.
[music].
I'll start and I'll ask Mark if you want them add anything our supply chain is very robust and I don't think that we have any issues on our supply chain.
Going forward and we have a very robust supply in the United States that we are ready to roll out and can keep rolling out for Castlight, Yeah, and I would just that Charles in the near term all of our supply chain related activities with the wholesalers retailers.
Et cetera are very much on track and we're ready to go.
And launch in the late in the mid to late March timeframe.
Okay very good one quick question for Andy relative to the new.
Studied number for Oaktree and bipolar.
Depression, I guess I'm wondering if you could provide some additional insights on the kind of design features that you'll be.
Implementing to limit placebo.
Ill effects and is there do you anticipate significant overlapped in terms of the clinical sites more was for all four then relative to for a one for that study and then.
And finally anything new additive for over two study that really drove you to design and and initiate this faros free style.
[music].
Yes, Thanks, Charles So the new study for all three which is a monotherapy study single dose of Lumacaftor on versus placebo.
Done globally is very similar in design to study for all four which was our successful trials in with the same monotherapy indication.
We are using some of the same sites.
We are doing this globally and some of the same countries.
And and generally the preparation that we're doing for this.
Is inline with what we've done for four or four where we're actively training the sites about placebo response, a again and we're using investigators who have been successful in the past.
And all the other criteria for the study are the same as those in Florida for so we're very hopeful that this as.
Those data will be replicated.
With regard to for a two that's studies is proceeding very well we're nearing completion, we do expect to have results by the middle of the year as we've said we.
We don't have anything new to report on that and I think.
That will wait for the results that trial.
Okay very good thanks for the added and so.
Thank you. Our next question comes from Marc Goodman with SVP Liang. Your line is now open.
Yes, so just to confirm on the supply chain that you were talking about all that but the product is all in the United States already that's why you were saying that there were no issues right just to confirm that and then second of all.
What type of a spending.
Guidance can you give us for this year and maybe you could give us a sense of what the fourth quarter reflected in what we should expect.
Kind of us as the year progresses for spending thanks.
So I'll take the first part on the supply chain and then I'll ask Larry to [noise] address the.
The guidance. So yes, you heard right we have a very very robust supply here in the United States. So we are not dependent on on a requiring anything ex U.S.
In in the foreseeable future.
Larry do you want to them.
Yeah.
Mark if you look at the the result for the fourth quarter 2019, we had research and development expenses about 19 million general administrative expenses were 22.8 million.
And we expect that ER.
The research and development expenses will increase modestly in the first quarter and stabilize their.
Going forward, rather and then are actually in a expenses will increase in the first quarter as we.
But our commercial staff in place and then though stabilize throughout the rest of the quarters.
So so the S.J. step up obviously I mean, the sales reps were not in the fourth quarter right. So we have that first step up and then just regular spending.
And the first quarter, we'll have a market increased markedly increasing expenses and the SP and they've gone.
Right and so first quarter is a big number and then you're saying second third and fourth of the yesterday lighter or.
In the range at first quarter.
Okay got it thank you.
Thank you.
Our next question comes from all my rough Hot with Evercore. Your line is now open hi, Thanks, So much for taking my question Sharon I saw the press release mentioned you guys will possibly file a leader in the air and bipolar. My question is can you walk us through what.
What exchange you've had with FDA already what their feedback was do they want you to have the a junk readout in hand before you file I'm just wondering I understand what feedback empty a shared with you on the existing bipolar result.
Right [laughter] hi, Thanks, Mark.
So we have not met with the FDA yet we have told you that we we will be meeting with them and that we have three shots on goal here.
We have a very successful.
For all four study.
We have the ongoing for two study and we have so recently commenced a four three study so we will be discussing with the FDA all the different.
Permutation skier of what will be required for our filing what we've said is if scenario a successful.
For all four study or a scenario b that study plus the four out to study if that's successful then.
We would anticipate a filing.
By by year end.
So got it that's that's the data as we have it right now.
Thank you.
Thank you Sir our next question comes from Jessica Fye with JP Morgan Your line is open.
Hey, guys. Good morning, Thanks for taking my question.
I was hoping you could talk about the Genesis for the decision to start for a three before.
The results for the next trial read out.
So I'll start that and I'll ask Andy if you have anything to add thanks, Hi, Jessica.
So we wanted to start for all three it simply on to have more shots on goal, we have no information about four or too.
As as an adjunctive study and that as Andy mentioned to you will read out.
Mid year.
We think it's prudent.
Many shots on goal.
And it this is not unusual.
To have several studies ongoing in the depressive disorders. It's also not unusual in the depressive disorders that we're in any psychiatric disorders that not all studies are going to be positive. Hence we thought it prudent to Ah, we do think that based on that very robust.
Data from the four or four study that we.
Have have a molecule that will benefit patients with depressive disorders and bipolar disease. So we thought it prudent to have as many shots on goal.
As we can.
Andy to do you want to add any.
Yes, no I'm not really I mean, I think you've made the important point, which is that we believe based on the results of four reports that the limit tepper own does work in bipolar depression.
So we're moving forward with everything we think we need to do in order to have is quicker.
Opportunity to.
Submit data to the FDA and get this drug approved in that indication as well. So thats just part of strategy that we think is as parents as prudent and I think that many companies with would follow in this indication.
Okay, Great and just following up to that I think you've talked about bipolar too as a potential point of differentiation, where some of the reasons or factors why there have been few approvals for bipolar to thus far.
So I think a you know it say a choice whether you're going to study bipolar one end bipolar too we made the decision to do that because we wanted to cover.
Broad a population within bipolar depression as possible to make our drug which is.
You know such a safe drug available to the full spectrum of patients with that indication.
As an added point.
There's a greater medical need there because as you say, it's not approved.
For its only approved in bipolar one and bipolar two for one other drugs, which is seroquel.
And we think our safety profile matches up very well with any other drugs out there so.
But I can't really comment on other reasons why other companies may have made other choices. We think it's important to make this drug available to us broad range of patients with disorders, who could benefit.
Possible.
Okay, Great and maybe just the last one you talked about a long acting injectable formulation for lumen type run.
I think at a high level shall we should think about that development path and timelines for that product.
So we're starting our initial a study would that shortly and <unk>.
It's a it's a fairly.
Standard development in terms of establishing how the drug is distributed and metabolized in the body followed up with studies to assess its safety and efficacy.
In the schizophrenia population so.
We're not anticipating anything unusual in the way this will move forward.
And we'll give you further guidance on that once we do this or study with the PK study right that we can.
Have a better idea.
How quickly we can progress with.
Got it thank you.
Thank you.
Next question comes from Brian Abrahams with RBC capital markets. Your line is open.
Hi, This is a little on for Brian. Thanks for taking my question.
We've heard some anecdotal reports from K wells about the importance of potential effects on other aspects of the disease that are not fully captured by the current data set such is beginning to return to a job and improve socialization. So what are some of these longer term outcomes that you're thinking about for kept fly to that could influence uptake and do you have any plans to formally.
Evaluate these for potential label expansion or to enhance the value proposition for payers.
Yes, yes, we do and I'll ask Andy just to elaborate a little further but I have to say you sound exactly like Brian.
The money [laughter] I'm, sorry, I didn't mean to get us off track or Andy if you want it.
Yes, no. Thanks for asking actually because this is one of the areas that we find most exciting with the strike as you know we've said.
For quite a while now as we reported the results of our studies would limit temperament schizophrenia that there are signals for benefit in other areas, including a depression.
And in negative symptoms and those are things that do require additional study and including longer term studies and we are definitely thinking about pursuing one or more of those additional indications within the schizophrenia area. So yeah, we think that schizophrenia has abroad.
That term of activity within the.
The schizophrenia.
Syndrome.
And we do want to provide additional data to clinicians.
To help them to make the best use of this drug with patients who have either negative symptoms depressive symptoms, possibly other.
Uh huh.
Symptoms associated with schizophrenia as well so we will be able to provide additional information about that later.
Thank you.
Thank you. Our next question comes from Sumant Kulkarni with Canaccord. Your line is open.
Morning, Thanks for taking my questions first Im happy to be asking this question on revenue recognition you expect to recognize ship and are both through Fourq up later.
Yeah, we're going to recognize revenue launched shipment and with estimated adjustments were pool group.
And then a couple of questions on the pipeline. So on the long acting formulation, you've completed preclinical development given that there was some focus on preclinical data prior to the approval of autos supply to is it fair to assume that formulation defenses led to predictable preclinical responses.
I'm not sure I understand the question can you can you try it again, yes sure. So a I meant in in terms of the up before the approval of the autos complain that there was intense focus on the preclinical data set and they did buy displayed on the auto setting.
When that translates to a long acting formulation for example in some species.
However, the preclinical data being I assume that the predictable to sponsor that that was the question.
As the predictable responses that we haven't seen any of these metabolites and that is correct. We have looked for them and we don't see them.
Got it and then empty.
Yes. It does thanks on everybody when should we expect to see the phase two data.
Phase two data with where we are anticipating starting the studies this year right.
Got it thank you.
Thank you Sir our next question comes from Bert Hazlett with BTG. Your line is now open.
Thanks, Yes, just two quick ones and then maybe a broader picture one in terms of the quick ones, maybe you said it but the timing of the read out for three.
Okay.
Hi, Bert So we expect that study.
To.
The finished mid next year.
Okay. Thank you then secondly, the supply chain back to that per second you said clearly that you have a lot of supply in the United States is the incremental production U.S. domiciled from this point or is that domiciled internationally and if so what is coming from.
So.
As we've said we have.
We have disclosed one of our did this is all apiay, we're talking about and we have disclosed that are a pie comes from Switzerland.
We do have a secondary and tertiary supplier if necessary.
So and this has been ongoing for several years.
So I think we are in a really good.
But as far as our supply chain goes.
Terrific. Thank you and then with regard to looking a little bit further out with regard to kept Florida. It's clearly differentiated in terms of the adverse event profile that it brings to the table.
As as you think market share and or others. As you think about the competitive landscape evolving in schizophrenia Theres. Some novel mechanisms with regard to the must correct a receptor system and.
Could you just give us your view a little bit longer term about how you see the competitive landscape unfolding in schizophrenia. Thanks.
So [noise].
I'll start and I'll ask Mark to chime in I think first of all as you know it really is a huge unmet need in schizophrenia and I think there is room for several players I think that.
Some of the early programs are moving along and and again, we we we are in favor of anything that brings better options or more options for patients. So I think that we don't see anything as an either or I think we see this as an evolving landscape.
And hopefully better drugs coming to market that can replace some of the older drugs that we've seen a which themselves are effective but do have side effects associated with them.
Did you want to add.
I would just emphasize that and just reiterate what I said before that.
We feel confident that the profile of cap light that has come out of the clinical development program.
Is very consistent with the type of profile needed to help address some of the significant unmet needs that Sharon spoke about in schizophrenia. So we feel very good about the profile of cap light to going forward into the into the future as well.
Thanks, we look forward to the launch.
Thank you.
Thank you. Our next question comes from Jason Butler with JMP Securities. Your line is open.
Hi, Thanks for taking the question just one on M.D.D. you commented that you're looking at no new formulations to potentially.
The increase or focus on rapid onset of action I guess, just pulling from the experience and Biopolar Depression, you saw a rapid within a week onset. There. So can you just maybe talk about the the goals here and and and any preclinical data you have that is driving your focus on the.
The new formulations. Thanks.
Sure Hi, Jason do you want to talk about our preclinical data and.
I think the preclinical data was really the initial basis for our moving in this direction and that limit tougher on has very interesting pharmacology that in some respects.
Similar to that seem with ketamine in terms of its downstream effect on phosphorylation of proteins in the m. towards system again, suggesting that the drug might have a rapid acting effect on depressive symptoms. So.
With that in mind, we've been looking at different formulations to see whether we might be able to take advantage of that opportunity and you know it'll be one of the things that we're looking at in the clinical proof that 60 trial that will start this year and you're right in the bipolar depression, we did see we did see Uh huh.
That we were effect of that week, one which was the first time that we test.
Okay, great. Thanks for taking my question.
Thank you Sir our next question comes from Andrew side with Jefferies. Your line is now open.
Thanks, Good morning, as we think about the launch upcoming launch.
Investors expect some kind of inventory build in Q1 or two two and I'm also is there a sense that there could be some kind of bolus in the first few weeks and watch and I will follow.
Mark Let me take yes, hi, Andrew it's Mark So as I had mentioned in my prepared remarks.
The product will be available to pharmacies by mid this month.
And we will be commencing our full promotional activities, including the deployment of.
The salesforce late in the month. So I think you can expect that there will be some inventory build.
In the month of March and then prescriptions really will begin to.
Flow in the in the second quarter and build overtime consistent with.
How anti Psychotics have been taken up in the marketplace.
Great and then.
As a follow up so with your 240 sales reps just curious how quickly can those reps touch all of your 24000 high prescribers Docs I'm curious just how many.
Our actions are calls do you think the sales rep would need to make before a doctor starts prescribing flat.
Thanks.
Yeah sure Andrew it's it's a it's a good question then I think each each position is different each physician has a different adoption practices.
You we have size the salesforce.
In a way to ensure that we're getting the right kind of reach and frequency.
On the 23000 health care providers that as we mentioned generate approximately 80% of the branded anti psychotic prescriptions for.
Schizophrenia so.
They will be out there with sort of I guess, you would call it industry standard calls per day.
We've we've been able to meet with many of these representatives, they're very excited.
About the opportunity to launch capital Ida and will be as I mentioned in my prepared remarks. They are a they've been doing all of their background training over the past couple of weeks.
By the end of the month, there will be fully trained and ready to call on those 23000 health care providers.
Thank you.
Thank you.
Our next question comes from Matt Kaplan with Ladenburg Thalmann. Your line is open.
Hi, This is rain in for Matt Congrats on the progress. Thanks for taking my question just regarding quickly on the pipeline maybe I'm sorry, we can't hear you can you maybe speak little I don't know sorry can you hear me now.
Yes, Oh, sorry, yet disagreement in for Matt. Thanks, Congrats on the progress I'm just regarding the pipeline I was wondering maybe on the MDD indication steep potentially moving ahead with the would temporarily or as a monotherapy or combination therapy or instead, focusing on the novel formulation as a bottom there.
Yeah, I think well well update you.
In the near future as to the design of our studies and.
And and the formulations et cetera, So I think it's a little bit premature, but hopefully near term, we'll be able to do that Andy you want.
No just we're considering a number of options right. Okay. Yeah, I guess, maybe also for perhaps limit temporal sitting other indications on bipolar and currently thinking.
Yes, it if I heard you right. It's very hard to hear you I think you're asking are we looking at other indications for Ireland tap Brown.
And the ends and the answer is yes, we're looking at several of the depressive disorders.
Okay cool, Thanks, and just one final question for <unk> to one for do you intend to partner the asset in the non CNS indications or on the CNS indications as well.
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Clarification.
So our present thinking is we do have a a number of indications that we are pursuing or the not the classified assets one inhibitors and and we do anticipate that on certain of those indications we would look to partner because we.
We would not be doing all of those indications on around.
Okay cool thanks for thanks for the color that's all I have for now thanks.
Yeah.
Okay outbreak.
I'm not showing any further questions at this time I'd now like to turn the call back over to Dr. Sharon mates for any further remarks.
Just.
Thank everyone for today's participation on the call and we're very excited about bringing a cap lighter to market and providing a new option for patients and I'd like to thank our whole team at intercellular for all the work we've done and for all the patients who have participated and all of our clinical.
Studies to date.
And with that operator, you can disconnect the call. Thanks.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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