Q3 2021 Intra-Cellular Therapies Inc Earnings Call
Good morning, ladies and gentlemen, and welcome to Hcl.
<unk> third quarter financial results Conference call as a reminder, today's conference call is being recorded.
I'd like to turn the conference over to Dr. Juan Sanchez, Vice President Corporate Communications and Investor Relations. Please go ahead.
Good morning, and thank you all for joining us today.
Our earnings press release provides a corporate update.
And details of the company's financial results for the third quarter, which ended September 32021.
This press release close they wanted a short technical and is available on our website at intra cellular therapies dot com.
Joining me on the call today, I will talk to Sharon mates, Chairman and Chief Executive Officer, Mark Newman Executive Vice President and Chief Commercial Officer.
Doctor Suez Telecom Senior Vice President and Chief Medical Officer, and Laurie Hyland, Senior Vice President and Chief Financial Officer.
As a reminder, during today's call we will be making certain forward looking statements. These statements may include statements regarding among other things.
Safety and intend to use the company's product development candidates, our clinical and non clinical plans our plans to present or report additional data.
Anticipated conduct and results of ongoing and future clinical trials plans regarding regulatory filings future research and development.
Our plan and expectations regarding the commercialization of <unk> potential impact of the COVID-19 pandemic on our business and possible uses of existing cash and investment resources.
These forward looking statements are based on current information assumptions and expectations and as such.
It could change on a number of risks and uncertainties that might cause actual results to differ materially from those contained in the forward looking statements.
These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports.
Your question not to place undue reliance on these forward looking statements and the company disclaims any obligations to pay such statements.
I will now turn the call over to Sharon.
Thanks Juan.
Good morning, everyone and welcome to today's call.
We are excited to share our third quarter progress update you on our programs and describe our upcoming plans.
In the third quarter, we continued to successfully execute our commercial plan for <unk> are FDA approved medicine for the treatment of schizophrenia in adults.
Lightest prescription growth trajectory continued quarter over quarter.
We have an upcoming milestones rapidly approaching with our FDA.
Date of December 17th for cap lightest label expansion into bipolar depression in adults.
We also continued to advance several other promising development programs before I provide further details R&R programs. Let me first provide an overview of our financial and commercial performance.
Total revenues for the third quarter grew to $22 $2 million kept light of net product revenues were 21 6 million compared to $19 million in Q2, 2021, and $7 4 million in the same quarter last year.
Total prescriptions increased 15% quarter over quarter, and approximately 200% versus Q3 of 2020.
We achieved the sequential growth in spite of disruption due to the latest surge of COVID-19 during Q3.
<unk> has a compelling clinical profile, having demonstrated efficacy coupled with favorable safety and tolerability with no dose titration required in our clinical trials in schizophrenia kept lighter results were similar to placebo the changes in weight fasting glucose total cholesterol triglycerides and extra.
<unk> symptoms, including acreage feature.
Market research and feedback from the field continues to indicate that patients and physicians real life experiences with TERP lighter are consistent with what was demonstrated in clinical trials.
We're very excited about <unk> potential as an important treatment option for patients with bipolar depression.
This label expansion, which significantly extend the patient opportunity for cap lighter to more than 11 million Americans living with bipolar disorder.
There are only a few approved treatment options for bipolar depression, the most common and debilitating manifestations of this disorder.
Proved kept light it could help fill an existing need for effective treatment with a favorable safety and tolerability profile.
The FDA is currently reviewing our NDA.
The treatment of bipolar depression in adults.
Our applications are supported by robust positive results from two phase III study that evaluated the effect of <unk> in patients with either bipolar one or bipolar two disorder.
In both studies treatment with limited brown substantially reduced depressive symptoms on both primary and key secondary endpoints.
Importantly, the favorable safety and Tolerability profile in our bipolar depression program is consistent with that of our schizophrenia program.
During the quarter results from study 404, our monotherapy study were published in the American Journal of Psychiatry, a highly respected psychiatric journal.
Upon approval, we expect to launch this important new option for patients with bipolar depression or sales force expansion is substantially complete and Mark will provide further details in a few moments.
Our longer term vision is to establish limit <unk> alone as a treatment of choice across a broad range of depressive disorders bipolar depression is the first indication in the strategy. This is followed by our phase III studies in MDT, which are double blind placebo controlled six week study evaluating <unk> around 40.
Two milligrams as adjunctive treatment to antidepressants for patients who have an inadequate response to anti depressant therapy.
In addition, we have an ongoing program evaluating <unk> in patients who exhibit next features study.
Study for <unk> three is a double blind placebo controlled six week study evaluating <unk> 42 milligrams as monotherapy for patients with MTT or bipolar depression exhibiting next features.
Patients with mixed features who make up roughly one third of those with bipolar depression and N V. D have greater symptom severity higher risk of suicide attempts and higher comorbidity.
They also respond poorly to antidepressants, we expect to complete our ongoing for <unk> III study in the second half of 2022.
We recently held our first research and development day, where we had the opportunity to hear from a group of prominent experts in psychiatry, who shared their perspectives on the therapeutic need and major psychiatric conditions, including schizophrenia and mood disorders with an emphasis on bipolar depression.
They provided insights into <unk> potential to address these needs, which was consistent with feedback we have received.
We are confident that <unk> addresses an unmet medical need and if approved <unk> will have.
Rod utility across a range of depressive disorders with bipolar depression being our first approval within this category.
During the event, we provided an overview of molecules and our robust pipeline, including the women on long acting injectable formulations, and ITI 12, 84, ODT S L programs.
We have initiated our program for the development of ITI $12 84 for the treatment of agitation in patients with probable Alzheimer's clinical conduct in this program is expected to begin early next year.
Studies in dementia related psychosis, and certain depressive disorders in the elderly are planned for the first half of next year.
We also presented important aspect of the mechanistic underpinning our existing data and our clinical development plans for our PD, one inhibitors and ITI triple three platforms.
We discussed the features that make PDE one ends on unique among the large family of thoughtful day yesterday.
We also discussed the PD one's unique tissue distribution and the selective pathway regulation that allows for a broad therapeutic opportunity for our portfolio of PD one inhibitors.
We presented preclinical and early stage clinical results in Parkinson's disease supporting the recent advancement of languished potent into phase two clinical development.
Our external expert explained therapeutic needs for treating motor symptoms and non motor symptoms, including cognition in this patient population.
Our goal for this program is to study land respondents potential to improve motor and non motor symptoms, including cognition by enhancing or restoring neuronal function and affected brain regions.
We also highlighted ITI 333, a promising drug candidate to address important unmet therapeutic needs and opioid use disorder in pain.
ITI Triple three is a novel compounds that act as a partial agonist at new opioid receptors and as an antagonist at the serotonin five Ht receptors.
At new opioid receptors and act as a partial agonist signaling through G protein coupled pathways, but acts as an antagonist at the beta Orexin pathway.
Our external expert explained the current opioid use crisis in the U S and outlined the unmet therapeutic needs.
From an ongoing phase one single sending dose study.
Anticipating in the fourth quarter of 2021.
We ended the third quarter in a strong financial position with $478 $7 million in cash cash equivalents and restricted cash.
Very proud of our performance and our team's efforts over the last quarter.
As we continue to grow and expand we remain committed to fulfilling our mission to develop innovative treatments to improve the lives of individuals with neuropsychiatric and neurologic disorders.
Mark will now share details of our ongoing commercial activities, including our plans for bipolar depression. Following his remarks, Larry will provide additional details on our financial performance Mark.
Thank you Sharon it is a pleasure to be here with all of you today to provide an update on the commercial performance of <unk> in schizophrenia and to share our launch readiness progress for the exciting potential opportunity in bipolar depression.
As Sharon noted kept lighter performed well in the third quarter, increasing total prescriptions by 15% sequentially over the second quarter.
This growth was achieved in spite of the latest delta surge in the pandemic, which impacted the care of patients with schizophrenia and suppress the overall antipsychotic market during the quarter.
While restrictions continue to exist.
<unk> case numbers are decreasing across the country and vaccination rates are gradually improving.
As a result, more psychiatry offices are reopening for patient appointments and our sales team is gaining greater in person access to health care providers in some practices.
These encouraging market developments coincide with the expected approval timing of cap lighter in bipolar depression.
US in a stronger position for the upcoming months.
I am pleased to report that our bipolar launch preparations are all on track and we expect the launch will be successful for several reasons.
There remains a very significant unmet medical need in bipolar depression and additional treatment options are required for this debilitating disorder.
<unk> has demonstrated strong efficacy and favorable safety and Tolerability results in our clinical trials.
And has the potential to be approved in the broadest range of adult patients with bipolar depression, including those with bipolar one and two.
And as monotherapy or as the adjunctive therapy to lithium or valproate.
We have a multifaceted commercial plan in place and are ready to hit the ground running to maximize this exciting opportunity.
We believe this plan will significantly accelerate the use of capital right now.
We have conducted extensive market research that shows physicians payers and patients all have a favorable impression of the clinical profile of cap lighter in bipolar depression.
Excited its efficacy in both bipolar one and bipolar two.
And as both monotherapy and adjunctive therapy across a broad patient population as well as its favorable safety and Tolerability profile.
They are especially impressed by its low risk of weight gain metabolic changes and movement disorders.
To ensure broad awareness of capital items potential bipolar indication and clinical profile, we are increasing our target audience to the 43000 prescribers who account for approximately 85%.
All oral branded antipsychotic prescriptions written for schizophrenia and bipolar disorder.
We'll include psychiatrists nurse practitioners and primary care physicians, who treat significant numbers of patients with bipolar depression.
We have expanded our sales force from 240 representatives to a total of 320.
This will ensure a highly competitive share of voice with the expanded prescriber target base.
We are pleased with the talent that has been attracted to our company and have hired experienced sales representatives with proven track records prior to and during the pandemic.
We are confident in their ability to drive strong results.
Our sales efforts will be complemented by a comprehensive multi channel promotional campaign to optimize adoption of capital Ita <unk>.
Including peer to peer medical education digital media promotions, and DTC advertising to increase awareness of <unk>, among healthcare providers and patients.
On the market access front capital Ida continues to maintain broad coverage and the Medicare part D and Medicaid channels with greater than 95% of lives covered.
These are the two primary channels through which the majority of schizophrenia prescriptions flow.
And our preparations for the bipolar depression label expansion our team operating under the FDA pre Purdue for guidance.
As completed comprehensive bipolar disease awareness and clinical trial data presentations with the formulary decision makers at strategic payer accounts, including the largest commercial insurers and pbms.
With the potential approval of cap lighter for bipolar depression, we would over time expect to see an increasingly larger percent of our prescriptions coming through the commercial channel due to the nature of the bipolar patient population.
Recently, we have improved our coverage in this channel to approximately 70% of lives and expect that to continue to increase in the coming months.
Additionally, we see competitive reimbursement approval rates for capital Ida consistent with other branded anti Psychotics in our lighter link patient support program has been very effective in supporting the prescription process and in minimizing out of pocket expenses for our commercially insured patients.
In summary, we are extremely excited about the potential label expansion of capitalized for bipolar depression, and we are confident that we are a highly effective and competitive commercial plan in place to achieve a strong uptake in prescription.
I'll now turn the call over to Larry to share our financial results Mary.
Thank you Mark I will now provide a summary of our financial results for the third quarter ended September 32021.
Total revenues in Q3 grew to $22 $2 million.
Third to $7 4 million of total revenues in the third quarter of 2020.
<unk> third quarter net product revenues reached $21 6 million compared to $19 million in the second quarter of 2021 and $7 $4 million in the same period last year.
Cost of product sales were $2 million in the third quarter of 2021 compared to <unk> $6 million in the third quarter of 2020.
Research and development expenses for the third quarter of 2021 were $27 million compared to $10 3 million for the third quarter of 2020.
The increase is due to higher alumina tepper own clinical trials costs and an increase in other development programs.
Selling general and administrative expenses were $70 5 million from the third quarter of 2021 compared to $52 5 million for the same period in 2020.
This increase was primarily due to increased marketing and commercialization costs.
Net loss for the third quarter of 2021 was $76 9 million.
Compared to a net loss of $55 2 million for the third quarter of 2020.
Cash cash equivalents restricted cash and investment securities totaled $478 $7 million at the close of the third quarter of 2021 compared to $658 8 million at December 31 2020.
This concludes our prepared remarks, operator could you. Please open the line for questions.
Thank you.
It's time to ask a question. Please press Star then one on your Touchtone phone.
If you'd like to remove yourself from the queue. Please.
Please press the pound key once again Thats star one for questions. Our first question will come from the line of Brian Abrahams.
Alright from RBC capital markets you may begin.
Hi, good morning, and thank you for taking my questions. Congrats on the continued progress.
My first question is.
On the overall I guess commercial landscape I'm sort of curious with Covid, having spiked and now waning.
The dynamics that Youre seeing on the ground in terms of.
Physician patient engagement, how that may be shifting as we get towards the end of the year any changes in telemedicine.
And how you expect those trends might shape, both fourth quarter sales in schizophrenia as well as the bipolar launch as we think about that into the early part next year.
Hi, Brian Thanks for the question and I'll ask.
Mark would you like to.
Just address that.
First I would go into the landscape for schizophrenia patients in particular, and then go on from there. Please.
Yes sure. Thanks for the question Brian.
Yes, we were pleased with the performance of cap line during the third quarter.
Where COVID-19 and the Delta battery in.
Was present during the quarter now as we came out of the third quarter and into the fourth quarter as you know.
The cases overall have been decreasing.
And vaccination rates have been increasing and so what we're seeing as a result of that are more psychiatry offices are reopening.
For in person patient visits.
Our sales force is gaining in some practices greater access for in person detailing.
And we would expect to see that continue into the fourth quarter and into the next year. So we expect to continue to see the quarter over quarter growth of capital Ida.
And in particular I think.
As Sharon mentioned the patients with schizophrenia, when the Covid cases are high they are probably more impacted than.
Some other patient population.
But even in the schizophrenia area, we're beginning to see more patient flow coming back into the offices and a greater access for our sales force. So we're encouraged by those market development, both for our fourth quarter with schizophrenia and also as we prepare to launch for the potential approval.
The bipolar depression indication the timing is coinciding with that launch as well. So we think that puts us in a stronger position going forward as we close out the year and as we head into 2022.
Got it. Thanks, Thank you Mark and then maybe one more if I could.
As we look towards the Purdue for.
If we do close in December.
Can you maybe just characterize I guess.
Give us any sense as to whether those.
Main on track and your level of confidence and should we be thinking about these as sort of two different decision points that may come out at different times and may be different for the different indications or should we assume that this will be I guess grouped together as one.
So I'll take that this is Sharon and.
We do expect.
Yes.
Everything to come out together.
And we are on track.
Great well I think thanks, Ken.
Shortened suite.
Okay.
Good to hear thank you.
Our next question comes from the line of Andrew Tsai from Jefferies. You may begin.
Okay, great. Thanks, Good morning, Thanks for taking my questions.
I didn't want to build off of Brian's question, just a little bit just to see if.
If you can provide a little bit more color because we are essentially one month into your produce essentially so when I look at the guidelines. It sounds like companies generally enter final label labeling discussions with the FDA. So I don't know to the extent that you can share I mean, any additional color Mike.
Be helpful and is it also fair to assume within this F&D package, we're not the FDA is not even looking at CMC or anything of that sort because.
<unk> builds on the fundamental initial NDA filing rate.
Wanted to ask those questions. Thanks.
Hi, Andrew.
Thanks for your question and yes.
Youre right.
Does.
And S. NDA builds on your NDA, but they do look at everything in your package they look at everything.
They should.
As it pertains to the indication that you're filing for.
So.
As you mentioned or could do per day is.
Coming off its December 17th and we're working toward that diligently.
And.
As I.
Brian Everything's on track and we're looking forward to our can do per day.
Fantastic.
One more follow up.
Arms of.
The launch obviously, we'll be tracking sales in 2020, two and beyond so maybe as we think about the launch dynamics and I. Appreciate all the color that you provided why this could be a.
A strong launch.
Can you talk about maybe other launches happening in parallel why that should not impede with your own launch expansion and then maybe.
I don't know I mean, as we head into 2023, one a branded drug is expected to go generic.
Fundamentally can you kind of discuss why that should not impact top line.
Launch thank you.
So mark would you like to take that and I can add at the end.
Sure.
Let me start with the second part second part of your question Andrew.
Yeah.
What we've seen historically in the antipsychotic class is when a branded product goes generic obviously theres an impact on that brand, but generally theres not a significant impact on the remaining other branded products.
You're well aware and drove the dynamic that exists.
In this category, where you have the frequent cycling through multiple different anti psychotics.
And if they.
The condition that physicians are used to payers are used to.
And we really don't see that there'll be a significant impact of another branded product going generic on the rest of the branded market.
In terms of the other other launches we're focused on our launch we're extremely excited.
About the opportunity.
Our sales force expansion is essentially complete all of the representatives will be trained and ready to go for launch we'll be launching immediately upon approval.
Feel like we've got the right size of the sales force to cover the vast majority of the opportunity both in bipolar as well as in schizophrenia.
We feel like we have a comprehensive commercial plan in place.
From a medical education perspective from a digital media perspective, an advertising perspective, so we feel like we have all of the elements in place and we're just ready and waiting on the approval.
To press go and we're excited to get out there and begin to educate the physician base.
On the terrific profile, we think we have of capitalized in bipolar depression.
Great. Thank you for all the color I look forward to more positive updates.
So anyway.
Our next question will come from the line.
<unk>.
Evercore you may begin.
Hi, guys Hi, guys. Thanks for taking my question maybe.
Maybe let me focus on the depression study today, if I may.
Perhaps three questions in particular, one what do you expect the baseline matter rest of look like in that trial and I know the inclusion criterias matter with above 24 should we be thinking around 28 or perhaps higher.
<unk>.
I noticed in both the phase III isn't this adjunct MDT.
Trial sites are in U S only and I'd be curious what the thought process was on sort of not doing ex U S.
And then finally I was.
Particularly interested in noting that.
There is a exclusion criteria, whereby if a patient has a 25% matter S decrease between screening and baseline.
They are excluded from the trial.
And I was trying to understand.
How long is that interval between screening and baseline, which allows you to sort of manage this placebo response, if I may and have other depression studies on that thank you so much.
Okay.
Thanks, Hi, Lauren Thanks for your questions.
I think.
<unk> would you like to.
Answer and I can chime in as well.
Sure.
Thanks for the question.
For the first.
Question in terms of.
Matt does baseline scores, we'd have to see usually.
With.
<unk> current report on about you expect the higher baseline sports and.
And we saw it also adjunctive treatment trials. So you typically see.
In that range anywhere.
But we have to wait and see what that will be going to be.
Okay.
Reasonable to expect.
Maybe you Wanna. Thank you how are you.
In terms of.
Regarding U S sites.
As you know that.
Once we enroll patients.
Charter market with U S sites.
The ex U S typically agenda lipsticks.
A few more months to add cost.
That's from the individual countries. So we won't see that around the globe.
Sites also coming on board soon.
But both the studies.
And.
The third question.
Basically the interval between screening and baseline because yes and exclude patients that they have a matter has dropped by 25%.
And I'm trying to understand this.
This is effectively a sort of a lead in that you guys have and I know a couple of trials have done. It. So I was trying to understand how long is that interval between screening and baseline that allows you to exclude perhaps hypo responders on placebo.
So the screening between screening and baseline. So there is a screening period of up to <unk>.
14 days.
It's a two week screening period.
So again you are right.
Several studies have included several different strains that are included different strategies to commvault for placebo. This is one of the strategies.
And to answer this is not uncommon.
And.
Most if not all studies imply either this or other.
Ways of trying to.
Reduce the.
Our response of patients coming in.
Also.
On that.
Global trial sites this too is.
Standard practice that your U S site start up and running first and then.
You are substantially the rest of your sites will come on board pretty pretty quickly pretty soon afterwards, so nothing here is unusual.
And Sharon would you describe the study as a partial responder or a non responder study.
Suresh.
Yes.
Partially on Thats one of those studies.
Perfect. Thank you so much.
Yes.
Yeah.
Our next question will come from the line Mark Goodman from SVP Leerink you may begin.
Two questions.
First of all it's market are we having any off label usage at all for this product.
Bipolar depression, specifically.
Second of all I'm curious what the team has thought of the <unk> <unk> data and if there are any learnings there.
That will help you.
And then third just what was the gross to nets in the third quarter and how should we think about those changing into next year. Thank you.
Okay.
Yeah.
Hi, Mark this is Sharon thanks for your questions.
So as you know, we don't speak to off label use.
Suffice it to say, though that.
<unk> are allowed to prescribe.
Once your product is approved and I think if you look at.
Yes.
Ikea.
Anthony.
You can see whether or not there's been any off label use.
Hi.
As to.
The gross to net so I'll ask Larry to respond.
Yes, Hi, this is Larry yes, our gross to nets have been pretty consistent over the last several quarters.
And we don't expect much change in that we did.
Clothes that were in the mid <unk> to the low <unk> range and we expect to stay in that range even after.
Bipolar approval if it comes.
When it comes.
At.
Yeah.
I'm not sure I heard you Larry.
I'm sorry, what's that.
Did you hear me did you hear me on my response.
Yeah, Yeah yeah.
That's fine.
Alright, good luck.
The learnings from the very low data.
Right, So I think the.
Just so everybody's on the same page Gray bar.
<unk> has had ongoing studies and adjunctive treatment with major depressive disorder.
They have done.
Many studies five studies and they just reported out on two studies.
One being.
Negative and one having one dose being positive now they didn't tell us a whole lot about the studies they told us.
P values they didn't tell us anything else that we really don't know much they say they are.
Filing on this again, we don't comment on other studies I think the take home messages.
That CNS is that.
These are very complex.
The FDA is very accustomed to seeing.
Some studies works.
These have.
Complicating factors that makes them not work again, we don't know what happened in these studies I'm sure that.
That.
Abbvie will present all of their data.
At some point and then we will know more and then we can we can say more suffice it to say these are very large markets. These are.
Underserved market still.
And.
The more.
Opportunities patients have for new treatments.
The better for the patients so.
Thank that.
We're encouraged and we move forward.
Okay.
And our next question will come from the line Jessica Fye from Jpmorgan you may begin.
Hey, guys. Good morning, Thanks for taking my questions.
Once you launched in bipolar depression will you or will we have any way of discerning, which scripts are being written for schizophrenia, and which are being written for bipolar depression I am curious, how youre going to gauge our performance and execution in each of those indications.
Mark.
Okay cool.
Yes, sure Jessica there are data sources that allow us to understand.
For which indications prescriptions are being written they're not perfect data sources.
And you have to take them directionally, but it is something that we will be watching and certainly will be.
Following and tracking.
Typical metrics that you would in any launch in terms of new.
New patient starts and new prescribers looking at total prescription looking at our market access coverage rejection rates reversal rates et cetera.
But yes, there are data sources that allow you to.
Take a look at that and we'll be following us.
Okay, and then again on the bipolar depression launch can you help us think about the timeframe within which.
I expect to have coverage in that indication.
Yes.
So Jessica.
Layers don't manage the different indications differently they manage it at the at the brand level, we expect.
For bipolar depression to be added to the formulary coverage.
Just as the schizophrenia patient population is so we will continue to have very broad coverage in Medicare and Medicaid with over 95% of the covered lives.
And as we mentioned our coverage in commercial.
Growing steadily we're up to about 70% coverage and we expect that to continue to improve and increase over the coming weeks and months.
Okay, and just a last one how are you thinking about the growth in the schizophrenia indication going forward.
Yes, so we've we've been despite the COVID-19.
The pandemic.
The challenges that that presents for the schizophrenia patient population, we've been pleased with the continuous quarter over quarter growth in schizophrenia that we've seen with capital either and we expect that to continue in addition to.
Launching the bipolar.
Depression indication, where we expect to see a further acceleration in the overall prescribing of capital either given the opportunity that we have.
The marketplace with the large <unk>.
The market opportunity there is 11 million patients compared to $2 4 million.
Schizophrenia, there are fewer treatment options available to treat these patients and we feel very confident in the profile of cap light of that emerge from the bipolar depression trials with the robust efficacy.
Favorable safety and Tolerability that we essentially replicated the safety and Tolerability profile that we saw in schizophrenia in the bipolar depression.
Population as well.
And as I mentioned, we feel we have a very strong commercial plan comprehensive in place ready to go.
And we expect to see an acceleration in prescriptions due to that.
And given the favorable.
Given the favorable safety and Tolerability profile, we would expect that in a non COVID-19 environment.
You will you will see.
Even more of an uptake in the schizophrenic population.
Got it thank you.
Okay.
In the interest of time, please limit yourself to one question. Our next question will come from the line of Ashwin <unk> from Bank of America, you may begin.
Hi, Thanks for taking our question I wanted to ask Mark how do you think you have commercial investments compared to your peers in the antipsychotic space.
I'd say that DIY decent size sales force that drives us to you will be at <unk> Sumitomo say that not to these targeted three party. That's now they're down to 260 kind of in the same ballpark and just curious.
I wanted to see if you could compare your DTC investment and our strategy.
Any kind of metric on number of spots that you're running versus the competitor does.
Yes. Thanks. Thanks for the question our goal is to have a highly competitive share of voice.
In the bipolar depression space and so we sized our salesforce.
To reach the prescribers that generate 85% of the oral branded antipsychotic prescriptions that are written for the combination of bipolar and schizophrenia. So we feel like recovering the vast majority of the opportunity there and in addition to that with our peer to peer medical education.
Our digital media promotions and our DTC advertising our goal is to ensure that the.
The benefits of capital Ida and the messaging that we have around cap later on.
I heard in the marketplace and we feel like the plan that we have in place will do exactly that.
And just to remind you in a pre COVID-19 environment, one operated a little bit differently and as we told you.
Pre COVID-19, we were expecting that with a bipolar indication we would just about double our sales force now with Covid I think we've all learned how to do things a little bit differently. So while we do still.
Need to increase our presence because of the increase in the number of docs in offices et cetera.
As you see it's not a doubling of the sales force and we think we've sized it appropriately from what we've learned is hybrid.
Both virtual and in person.
Meetings.
Thank you. Our next question comes from the line of Chang Lu from Needham you may begin.
Hey, this is a chance for Ami.
So we just wanted to ask you can.
Can you talk about your expectations for the pace of the launching bipolar depression post approval.
What may be the positives challenges, having two of the launch.
We may have a second question.
Can you tell us whether the pre approval site inspection has been completed for bipolar depression.
And a 483 observations.
Right.
Okay.
Mark I'll ask you to take the first part and I'll address the second part.
So you want to take the first part please.
Yes sure.
Let me take a shot at it if I understand the question correctly.
This misses the Mark Please let me know and I'm happy to provide further color, but we do plan to launch in bipolar depression immediately upon approval our salesforce expansion is essentially complete.
All of our representatives, including the new Representatives will be trained and <unk>.
Ready to go.
Right. After the launch all of our marketing material the patient support services that we have in place the infrastructure commercially that we built for the schizophrenia launch and the leverage for the bipolar launch will.
We will be ready to go.
As you know our <unk> date is December 17th.
Last two weeks of the year our holiday weeks.
But we will be out there will be out there with our sales force will be out there with our non personal promotion.
Many of the offices during that time or closed or theyre not seeing representative so.
So we wouldn't expect a huge spike in prescriptions those first couple of weeks.
After the launch, but we will be out there.
And ready to go from from day, one so I hope that I hope that provides some color.
The question that you're asking.
Turn it back to Sharon for the second part of the question.
Yes.
As we said earlier, we're not going through the Nitty gritty.
Of our <unk>.
S NDA application suffice it to say, though that should answer your question that we are completely on track.
Al has been going well and we're looking forward to.
Our <unk> date.
Thank you.
Next question will come from the line of <unk> <unk> from Canaccord.
Yes.
Good morning, Thanks for taking my question.
Conceptual one so youre adjunctive MDT trial has begun enrollment and it's one of the first waves of trials in this indication that might be able to benefit from our learning.
So just as we've learned in the sales force size that you may not need as many as you had in the past at any specific differences. So video moves you may have needed to adjust to Dr. <unk>, Dr Phase III designs solely based on the pandemic.
Okay.
Suresh do you want to take that or would you like to.
Me too.
I understand the question you're asking.
I was asking if.
If there was anything that you've learned from the COVID-19 pandemic that might help you to optimize phase III trial design and the adjunctive four mbd any valuables that you might have otherwise.
Otherwise differently. This pandemic we're knocked around.
Yeah.
Why don't know yet.
Suresh is thinking.
I think that as you know during the pandemic.
The FDA put out a guidance document.
On what how one should conduct their clinical studies if necessary.
So we have put in this is for monitoring visits during COVID-19.
And we did put that into place for our bipolar studies.
We are still ongoing and.
We have put that in place here or are they LGD studies.
As for the bipolar study that was ongoing during COVID-19.
We really did not need to employ those methods.
We.
If COVID-19 doesn't spike again.
We probably won't need to employ those methods again, but they are in place. They are ready to go they can be used.
Necessary.
So that was a learn as you go during <unk>.
Covid.
Yes.
So.
And I think right now.
The trial is being conducted.
Okay.
Theme on clinical trials Dot Gov.
Yes.
Got it thanks, Joe.
And our last question will come from the line of Charles Duncan from Cantor Fitzgerald, you may begin.
Hi, Sharon and team thanks for fitting our Sam we're juggling calls this morning, So I apologize if my questions been asked.
So regarding the end market experience in schizophrenia with regard to cap line Ken.
Ken can you.
Glean any anecdotal evidence of persistence and reduce healthcare resource utilization in schizophrenics that you may be able to apply to <unk>.
Your efforts in bipolar and then.
A follow up if I could on the pipeline.
Yeah.
Yeah.
So hi, Charles and yes, we understand it's an extremely busy morning today.
Maybe mark do you want to address the question and I'm not sure that will actually have the time to get into.
On the pipeline, but.
Let's see.
How long the answer to this question. The first question take so Mark do you want to go ahead.
Yes, sure, yes, Charles all signs point to capitalize having a very strong persistency profile.
Schizophrenia.
The caveat, it's too early to do that.
Classical persistency curves, where you follow cohorts of patients over time, we probably need another six to nine more months until we have that but what we do look at very closely each month, our refill rates and the <unk> ratio and when we do that with capital light and we compare that to <unk>.
<unk> benchmarks, we find that kept light it is outperforming the other anti psychotics at the same time during their launches. So we do believe we're seeing a strong persistency profile for <unk> in schizophrenia, and we know from historical data that persistency tends to be a.
Better in bipolar patients than it is in schizophrenia. So we think thats.
A very encouraging sign for the persistency profile for capital light in.
In bipolar depression, once we get there.
In addition, I think that our refill rate.
Really.
Not only speak to the Tolerability of kept light, but also to the efficacy.
Patients are or are not have not having breakthrough cases of schizophrenia.
Acute exacerbations and so we think that.
Our refill rates to speak to both the safety and Tolerability as well as the efficacy.
Of capital either.
Okay great.
Great segue in terms of that differentiated.
Profile both efficacy.
And Tolerability, how do you think about ex U S opportunities.
At all.
Thanks.
So I think that what we have said is we.
We right now are very focused on the bipolar indication.
And that we will be turning.
Two looking at ex U S opportunities following.
Bipolar indication.
We'll come back to you on that hopefully very soon.
Thank you and I'm not showing any questions in the queue.
Ill turn the call over to the speakers for any closing remarks.
Yeah. Thank you so.
Thank you all for joining today as I said I know this morning.
Became has the morning went on an extremely busy morning.
So thank you for participating and it's really a very exciting time for us.
Pat intracellular therapies and <unk>.
We look forward to updating you to providing.
Innovative medicines to patients going forward and we look forward to speaking with you soon so with that operator, you can disconnect. Thanks.
Thank you and this will conclude today's conference call. Thank you for participating you may now disconnect everyone have a great day.
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