Q4 2021 Intra-Cellular Therapies Inc Earnings Call
Good morning, ladies and gentlemen, and welcome to intra cellular therapies fourth quarter and year end financial results Conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question during this session.
I need to press star one on your telephone if you require any further assistance. Please press star zero.
As a reminder, today's conference call is being recorded.
I'd now like to turn the conference over to Doctor, One 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 fourth quarter and year ended December 31st two costs in 'twenty one.
This press release, because they wanted a short time ago and he said available on our website.
Joining me on the call today, I talked to Sharon mates, Chairman and Chief Executive Officer.
Mark Newman.
Thank you to the Vice President and Chief commercial Officer, and Laurie Highland.
<unk>, 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 intended use of the company's product development candidates, our clinical I don't clinical plans our plans to present or report addition of data.
The anticipated conduct and please tell us up ongoing or future clinical trials plans regarding regulatory filings for your total research and development, our plans and expectations regarding the commercialization of <unk> to the potential impact of the COVID-19 pandemic on our business and possible uses of existing cash hunting.
Investment resources.
These forward looking statements are based on current information assumptions and expectations that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those containing the forward looking statements.
These and other risks are described in our filings made with the Securities and Exchange Commission, including our quarterly and annual reports.
You had a question not to place undue reliance on these forward looking statements and the company disclaims any obligation to update such statements.
I will now turn the call over to Sharon.
Thanks, Juan good morning, everyone and welcome to today's call. We're excited to be here today to discuss our fourth quarter and full year results.
'twenty one was an extremely productive year for our company highlighted by the FDA approval and commercial launch in late December of kept lighter for bipolar depression.
We are very excited about this label expansion and the opportunity to help patients with bipolar disorder. In addition patients with schizophrenia.
Kept light it is the first and only treatment indicated with depressive episodes associated with bipolar one or bipolar two disorder in adults as monotherapy or as adjunctive therapy with lithium or valproate.
We believe this establishes strong differentiation in the market and provides an important advance for patients with bipolar one and bipolar two disorder underserved conditions that have had limited approved treatment options for bipolar depression until now.
Throughout 2021, we achieved consistent quarter over quarter prescription growth with kept lightest schizophrenia indication even in the face of a challenging pandemic environment.
This growth has accelerated in 2022 with the robust initial prescription uptake following the expansion of our label for bipolar disorder.
We have seen a significant inflection in both new and total prescriptions in the early weeks of the launch and we are encouraged by the highly positive feedback we've been receiving from prescribers and patients.
Our commercial team is executing a comprehensive launch plan and we are confident in Capsulitis continued growth.
We believe kept light it is well positioned to become a leading product for patients with bipolar depression.
Bipolar depression is the most common and debilitating clinical presentation of bipolar disorder.
These depressive episodes last longer or more difficult to treat recur more often and have a worse prognosis than monarch N hypomanic episodes.
There are only a few treatments approved for bipolar depression bipolar one depression tends to receive more attention because prior to kept lighter there was only one medicine approved for bipolar depression and only as a monotherapy.
Bipolar two was a complex clinical condition with depressive episodes that lasts longer and are more severe than bipolar one depressive episodes with patients having a higher risk of suicide.
Patient populations for bipolar one and bipolar two disorder are of similar size.
Safety and Tolerability trade offs can limit use of agents side effects, such as weight gain cardio metabolic disturbances and movement disorders are common reasons for patients to switch or discontinued treatment.
A favorable safety profile is important and there is demand for effective safe and well tolerated treatment options.
In clinical trials kept light has consistently shown a favorable profile on wake cardio metabolic parameters and extra pyramidal symptoms for EPS.
Specifically, EPS, including acre fees and changes in weight, where similar to placebo in our registration trials.
And our long term open label study patients with bipolar depression were stable with respect to wait with no waking from baseline at six months, while patients with schizophrenia lost an average of about seven pounds at one year.
Now turning to the progress we have made in our other clinical development programs.
Our goal is to establish kept light as a treatment of choice across a broad range of mood disorders.
That has already started with our approval for the treatment of bipolar depression.
Bipolar disorder affects approximately 11 million adults in the United States and our plan is to expand our label to include major depressive disorder or M D D, which affect another approximately 21 million adults.
Only half of patients with M. D D respond to initial therapy and only one third achieve remission.
Patient enrollment is ongoing in our M. D. D. Registration studies. These are double blind placebo controlled six week studies evaluating <unk> 42 milligrams as adjunctive treatment to Penny depression.
In addition to our Adjunctive Mbd program and study 403, we are evaluating <unk> as monotherapy in patients with M. D D or bipolar depression exhibiting mixed features.
Roughly one third of patients with M D D and bipolar disorder, who experienced depressive episodes have mixed features.
Additionally, we are developing long acting injectable formulations of <unk>.
We have completed initial clinical conduct in our phase one single ascending dose study to evaluate the pharmacokinetics safety and Tolerability of our long acting injectable formulation in patients with schizophrenia.
We are encouraged by the safety and Tolerability results, we have seen in the study to date. We are now exploring alternate sites of injection with this formulation as well as progressing other formulations. This will assist us in evaluating dosing strategies and formulations for our efficacy study.
The goal of our program is to develop formulations that are effective safe and well tolerated with treatment duration of one month and longer.
In addition to limit TERP wrong, we've continued to advance other programs in our pipeline.
In our ITI 12, 84, ODT S. L program, we have completed single and multiple ascending dose studies in healthy young and elderly subjects, demonstrating rapid absorption and excellent drug exposure, allowing doses to be selected for our next studies in.
In these studies 12, 84 was shown to be safe and generally well tolerated at all doses tested.
Additional phase one studies are either ongoing or planned, including food effect and brain imaging studies.
We expect to commence clinical conduct in our ITI 12, 84, all timers disease agitation program in 2022.
We also have additional studies planned in 2022 in dementia related psychosis and certain depressive disorders in the elderly.
Additionally, we are making progress in our phosphodiesterase type one inhibitor or PD one program.
We are evaluating our lead PD, one compounds blend must potent in a phase II clinical program for Parkinson's disease, we expect to begin patient enrollment in the first half of this year.
We continue to explore additional potential applications of our PD one inhibitors.
Last year, we presented preclinical data describing the antitumor effects of PD, one inhibitors when administered in conjunction with checkpoint inhibitor immunotherapy.
We continue to be excited by the prospect of treating cancer with limited treatment options by combining our PD one inhibitors with other immunotherapies.
We look forward to presenting additional preclinical data later this year.
Finally, we continue to make progress on our ITI Triple three drug candidate for the treatment of opioid use disorder and pain. We recently completed a phase one single ascending dose study evaluating the safety Tolerability and pharmacokinetics of ITI Triple threat.
In this study I T I used to be three three was generally safe and well tolerated and achieved plasma exposures at or above those required for efficacy as determined in preclinical models. We look forward to providing further details as this program progresses.
I'll end my remarks, with a brief summary of our Q4 2021 and full year financial performance.
Last year, we continued to deliver consistent quarter over quarter kept light of prescription growth in a market environment still constrained by the coronavirus pandemic.
This growth is a testament to the commitment agility and resilience of our commercial organization.
Total revenues were $25 $7 million for the fourth quarter 2021, representing a 106% increase over the same period in 2020 and $83 $8 million for the full year 2021, representing a 267% year over year increase Larry.
He will provide additional details on our financial performance in his remarks.
We're in a strong financial position. We ended Q4 2021 with approximately $412 3 million in cash cash equivalents and investment securities.
In January 2022, we received approximately 433 million.
And net proceeds from our public offering of common stock.
Additionally, we have no debt.
In summary, I'm very proud of our team our accomplishments and our commitment to patients.
I look forward to continued productivity and growth and sharing updates on our progress with you in the year ahead.
I'll now turn the call over to Mark who will provide further granularity on our bipolar launch and our commercial performance Mark.
Thanks, Sharon and good morning, everyone.
I'm very pleased to have the opportunity to highlight our commercial accomplishments during 2021 and provide an update on the strong start to the launch of our new bipolar depression indication.
We are very encouraged by the robust initial uptake and accelerated prescription trends for cap lighter following FDA approval of our label expansion.
We are also encouraged by the positive physician receptivity to cap light is bipolar approval in a broad patient population and then its favorable weight metabolic and EPS profile.
More on the bipolar launch in just a moment.
Throughout 2021, we drove consistent quarter over quarter kept light of prescription growth demonstrating strong execution in the COVID-19 environment.
Total prescriptions for the fourth quarter increased 15% sequentially over the third quarter and increased 98% year over year versus the fourth quarter of 2020.
This growth performance significantly outpaced the branded and overall anti psychotic markets for both periods.
Capital item maintain broad market access coverage throughout 2021 in the Medicare part D and Medicaid channels with greater than 98% of lives covered and we expanded coverage in the commercial channel from approximately 55% to over 80% by year end.
In Q4, we increased our sales force to 320 neuroscience sales specialists to cover an expanded customer base of approximately 43000, prescribers, including psychiatrists nurse practitioners and primary care physicians, who treat bipolar depression.
Our sales force continues to effectively execute our hybrid commercialization model combining primarily in person presentation with supplemental virtual engagements.
Now, let me provide some additional detail on our bipolar launch.
We initiated the commercial launch of capital Ida for bipolar Depression immediately following FDA approval in late December and have subsequently seen a significant inflection in both new and total prescriptions.
Comparing the first seven weeks of this quarter following the launch to the same period in the prior quarter kept lighter has grown new prescriptions by 48% and total prescriptions by 35%.
We have also seen a significant increase in capsulitis sample requests are leading indicator signaling future prescription growth.
Physicians typically dispense product samples to patients to evaluate effectiveness and tolerability of a new medication.
It is important to note that these samples are not captured as prescriptions and the data services.
Early physician feedback on <unk> latest clinical profile in bipolar depression and their patient's initial experience with the product has been highly positive.
Physicians cite the approved indications in both bipolar one and bipolar two in adults as monotherapy and adjunctive therapy, with lithium or valproate as unique and addressing an unmet need.
They point to the proven efficacy in both bipolar one and bipolar two as well as the favorable safety and Tolerability profile with weight metabolic changes EPS and akathisia, all similar to placebo as powerful reasons to prescribe.
And they appreciate the convenience of kept latest titration free once daily dosing that can be taken with or without food.
Looking forward, we see a major opportunity for brand growth by increasing market penetration for cap lighter and by expanding the market.
Kept light as new indications, including both bipolar one and bipolar two combined with proven safety and Tolerability and convenient dosing provide an important treatment option for newly diagnosed patients or those seeking a treatment change due to either suboptimal efficacy or tolerability issue.
Use with their existing antipsychotic.
This will drive market penetration for capital Ita.
Additionally, we expect the bipolar market to continue to expand.
Many patients with bipolar disorder are initially misdiagnosed with unit polar depression, resulting in a delay inappropriate treatment.
Over time with education, we see the number of patients being properly diagnosed and receiving effective therapies increasing.
This is especially true for bipolar II patients where capital Ida is one of only two drugs approved.
In summary, we are very encouraged with the initial stages of Capsulitis launch in bipolar depression, and our current launch trajectory.
We are privileged to be able to help patients with bipolar depression, and we are confident that kept lightest prescription growth will continue to accelerate.
I'll now turn the call over to Larry.
Thank you Mark I will now provide a summary of our financial results for the fourth quarter and for the year ending December 31 2021.
Total revenues in the fourth quarter grew to $25 $7 million compared to $12 $5 million in the fourth quarter of 2020.
We recorded net product revenue of capital Ita of $25 $5 million in the fourth quarter of 2021 compared to $21 $6 million in the third quarter of 2021, and $12 4 million for the same period in 2020, representing an 18% growth versus Q3, 2021, and a year over year quarterly income.
<unk> of 106%.
Research and development expenses for the fourth quarter of 2021 were $29 5 million compared to $14 $3 million from the fourth quarter of 2020.
Selling general and administrative expenses were $79 $7 million for the fourth quarter of 2021 compared to $58 $3 million for the same period in 2020.
For the full year 2021, total revenues were $83 8 million compared to $22 8 million in total revenues for 2020.
Net product revenues of capital item were $81 $7 million for the full year 2021, compared to $22 $5 million for 2020.
Cost of product sales was approximately $8 million for the year ended December 31, 2021, compared to $1 $9 million for 2020.
Research and development expenses for the year ended December 31, 2021 were $88 8 million compared to $65 $8 million for 2020.
This increase is due to higher alumina tap around clinical and non clinical trial cost and an increase in share based compensation cost.
Selling general and administrative expenses were $272 $6 million for the year ended December 31, 2021, compared to $186 $4 million for 2020.
This increase is primarily due to an increase in marketing labor and share based compensation cost.
Net loss for the year ended December 31, 2021 was $284 $1 million or $3 50 per share compared to a net loss of $227 million or $3 23 per share for 2020.
Cash cash equivalents and investment securities totaled $412 $3 million at December 31, 2021, compared to 657 $4 million at December 31 2020.
In January 2022, we completed a public offering of our common stock in which we sold approximately $10 95 million shares of common stock for aggregate gross proceeds of $460 million and net proceeds of approximately $433 $7 million.
This concludes our prepared remarks, operator, please open the line for questions.
As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key.
So you please limit yourself to one question. Please standby, while we compile the Q&A roster.
Our first question comes from the line of Jessica Fye from J P. Morgan. Your line is now open.
Hey, there good morning, Thanks for taking my questions.
Couple on kept lighter can you talk about your DTC strategy here I guess, what is the strategy. How do you measure success and how do you kind of measure the return on those efforts and then another commercial question. How Leverages Bowl is your current sales infrastructure, when we think about future expansion.
And into Adjunctive M D D with.
Would this require a sales force expansion to target, even more prescribers and if so what's a good framework to use to think about that.
Great.
Good morning, Jeff Scott and thanks for the questions.
<unk> Mark.
To take these questions. Please.
Yeah, sure Sharon and thanks, Jessica Yeah.
We believed from the start that the patient and consumer is an important part of our strategy overall for cap lighter.
Starting with schizophrenia, and we certainly believe continuing on into bipolar.
That reaching out.
Driving awareness with potential patients having them ask their physician if cap light isn't appropriate treatment for them.
Is an important part of the marketing mix and we expect to continue to do that.
Certainly.
As we execute on that plan.
We track prescriptions, we track awareness levels, we track receptivity to message all of those things will tell us just how successful our consumer efforts are being.
Regarding the sales force infrastructure I think it's still a little early to talk about the sales force any potential sales force expansion in the M. D D.
Certainly there is overlap with the psychiatry community.
Nurse practitioners and with primary care.
But I think at this stage is probably a little too early to be commenting on any kind of specific numbers or or magnitude of a potential expansion.
Okay. Thank you.
Okay.
Thank you. Our next question comes from the line of Brian Abrahams from RBC capital markets. Your line is now open.
Hey, guys. Good morning, Congrats on the launch progress and thanks for taking my question.
I guess it sounds like you've made a lot of headway on in terms of patient access.
For commercial payers I'm curious when you think we can get to a point, where it's a comparable access to public payer.
Are you still anticipating comparable gross to nets, there and then any differences we should be thinking about with respect to the time or effort required to convert scripts for commercial patients versus public pay patients and how that might evolve and then just real quick I was wondering if you could comment on the degree to which timing and conduct of the ongoing mixed feature an M. D D studies.
Be impacted by having our Ukraine, and Russia site. Thanks.
Okay.
Good morning, Brian This is Sharon.
Thanks for your questions I tried to write them.
As quickly as you were speaking, but we may need for you to Ah repeat some of them.
Ill ask Mark to start with payer access then Larry to talk about our gross to nets.
And then I will talk about.
The impact of ongoing conflict on our clinical studies.
Mark.
Mark would you like to start please.
Yeah sure thanks for the questions Brian and.
Yeah, and just to take a step back on the payer access is as you're aware.
When we had the schizophrenia indication only it was very important for us to have very broad access in Medicare part D and Medicaid we achieved that early on in the launch and we've maintained that broad access in those two channels over the course of the launch at over 98% of patients as we began to prepare.
For the bipolar depression opportunity, we recognize that there would be a shift in patient mix more towards the commercial channel as with schizophrenia, only about 15%, 15% to 20% of patients.
Come through the commercial channel, but with bipolar it.
It is closer to 50 50 commercial and public markets. So are.
We increased our commercial.
Coverage from about 55% are in the middle of the year up to over 80% by year end and we do expect that to continue to grow.
And expand in the in the coming weeks in the coming months. So.
Maybe I can turn it over to Larry to comment on on gross to nets.
Yes sure.
As you would expect.
With the bipolar launch off to a very good start in our in our commercial channel <unk>.
Increasing.
You would have.
The potential impact on the amount of co pay assistance provided to patients.
As a result, I think you would look for our gross to net.
To be at the higher end of the range that we had previously disclosed to you which is the mid twenty's to the low thirties.
Well so now we're looking at the higher range of the gross to net in the low thirty's.
Okay.
I think then I'll take the.
Last of your question I think and that is.
An impact.
Of the ongoing conflict on our clinical studies. So again, let's just take another step back and look at our clinical program.
And again in particular, those that may have exposure from the ongoing conflict.
Let's start with our mixed features or study for <unk> three.
As you know this is a global study and include sites that have been enrolling in the Ukraine and Russia.
We have implemented mitigation strategies in response to recent events and given these strategies. We continue to expect that we will complete clinical conduct later this year.
As we've said previously depending on when the clinical conduct is completed we anticipate reporting top line data either late this year or early next year.
Now, let's look at our M D D program.
Which has also been designed as a global program with sites in the U S and numerous countries in Europe .
As you know regulatory approvals take longer at international site and in the U S.
We have recently received approval to begin clinical conduct.
In several European countries.
And also in the Ukraine, and we expect approval shortly in Russia.
We have no ever not commenced patient enrollment.
In the Ukraine or Russia.
And in these studies, we have also implemented mitigation strategies as well.
We continue to expect our filing for FDA approval timelines to remain intact.
Our filings in 2024.
That's really like with.
I would like to make an additional comment and it's in response to some comments made by some of the analysts and some of their questions.
These clinical studies and clinical sites.
Clinical.
<unk>.
Sometimes people have tended to just take your number of clinical sites and divide them up by the number of patients you're enrolling and saying, Okay. Therefore were getting X number of patients from a particular country.
That isn't the way one should be thinking about this.
Each site does not enroll the same number of patients so I wouldn't put equal weight on each site.
So I'd ask you to keep that in mind as well.
Okay.
That's really helpful. Sharon. Thanks, so much maybe just to quickly clarify the mid twenty's to low thirties gross to net was that for first quarter or for this full year 2022 expectation.
No Sharon said that we and we.
I propose that the low thirty's is where we'll be headed in 2022.
That's really helpful. Thanks again.
Sure.
Thank you. Our next question comes from the line of Andrew Tsai from Jefferies. Your line is now open.
Okay. Thanks. Good morning, everyone. So first question is more about the outlook for 2022, and you know as we're wrapping up Q1.
Can you maybe talk about how you feel going into Q2 as well as second half. In addition to sampling are there other kind of leading indicators that you are paying attention to and if they are indeed, pointing to continued acceleration and then secondly is.
You're increasing your target prescriber base to include PCP. This seems like a very interesting dynamic to me so how.
How much do you think that setting can drive growth for our cap ladder and I also wonder if the other branded anti psychotics or.
Once branded drugs are being promoted in that setting.
Yeah, just curious whether the PCP marketplace could be a big opportunity for our capitalized okay. Thank you.
Mark do you want to take that.
Mark you are on mute.
I knew I was going to do that at least once today.
So Andrew Thanks, and let me go back to the first part of your question.
About leading indicators.
That cigna.
Signal continued accelerating growth with with kept lighter certainly sampling is one of those things that we believe signals that.
When we look at in addition to looking at total prescriptions and new prescriptions. We also look at new to brand prescriptions, which is a strong indicator of true new patient acquisition and when we look at the N B Rx levels for capital Ida.
In the first seven or eight weeks of the launch there has been a very significant inflection in those and the levels that we're at now.
About triple what they were right before the.
The approval in bipolar depression, so that's a signal to us that we're gaining new patient acquisition.
And that's a very strong signal for continued future growth. In addition, we look at things like general awareness levels awareness of the indication.
And all of those key performance indicators are signaling to us that the growth is going to continue and it is going to accelerate regarding the P. C piece, yes, we when we expanded our sales force and we expanded our target prescriber base. In addition to psychiatrists and nurse practitioners, we added a group.
Of primary care physicians, who are high prescribers of branded anti Psychotics and treat bipolar depression, and we do believe that this will contribute to the.
The ongoing growth and acceleration in growth for capital items over the course of 2022, So I hope I hope that's helpful.
That's very helpful. Thank you guys.
Thank you. Our next question comes from the lineup of <unk> from Evercore ISI. Your line is now open.
Hey, guys. This is might be jewelry in for Omar. Thanks, So much for taking my question and congrats on the quarter just two for me with AUM of concept, citing I guess the key question remains as to whether it kept a lot of sales will continue to be treat expectations. This year.
That said any any updated thoughts on <unk>.
You guys, giving potential guidance for this year or if any or either fourth quarter on a quarterly basis.
And my second question is if there is any update to the additional bipolar depression patents that you guys are seeking I think last time, we spoke to about one and a half years into the application process. So I wanted to see if there's any any updates on that front. Thank you.
Hi, Mike.
Maybe we'll take this in reverse order so that I can remember the questions. When you said update to bipolar patents I think he meant updates to the.
The boats the Orange book listed patents as well as to <unk>.
Right.
Correct, yes, okay, alright, so on the extension.
Typically it's about a three year process.
And where.
So we're getting there, but the simple answer is we haven't had.
Any updates on that yet and you will be sure to know when we do because we.
We will obviously lift that so then so that's a quick one then the next one is maybe mark would you like to.
Talk a little bit about what you've seen with <unk> and what Youre seeing now and then I can.
Talk about.
Guidance, very simply and saying, we're not providing guidance this year.
Mark why don't you go ahead.
Yeah sure I guess I would just simply say that we are seeing continued improvements in the environment out there as omicron begins to subside.
And things begin to return back to normal.
For us what that means is greater access for our sales representatives to physicians I think the the decline in cases, the lifting of restrictions and quite honestly the excitement about the new indication in bipolar depression is opening a lot more doors for our sale.
Representatives.
Perhaps in the past and so we see that as an encouraging sign and we certainly hope that this.
This progress will continue as we as we go throughout the year.
Great. Thank you.
Thank you. Our next question comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is now open.
Yeah, Good morning, Sharon and team congrats on the recent approval and launch as well as pipeline progress.
Yes, thanks for taking the questions I had a question about camp light with regard to the initial launch Mark provided some color, but I'm wondering if he might expand on the initial feedback from prescribers relative to the patient experience is it mostly about EF.
You could see or is it about tolerability that he's hearing good feedback and is it across the board in Bliss B PD, one and two and then back to your your statement on guidance. You mentioned you wouldn't be giving that this year, but could you imagine giving that next year and what are the pushes and pulls.
On that.
Okay.
I'll ask Mark Mark you start and then I'll.
Come up with the <unk> on the last part on guidance.
Yeah. So Charles the the short answer is we're hearing very positive feedback on all I say all three of the areas you mentioned efficacy.
And Tolerability I would also add to that the convenience of Capsulitis single 42 milligram dose where the physician can start the patient at the effective dose without having to titrate.
And that and the medicine can be taken with or without food. So.
We do get a lot of really good feedback from physicians on the clinical profile.
When they see and learn and are educated on our clinical trials the efficacy that they see in both bipolar one and bipolar too.
And in particular bipolar two they recognize that this is an underserved condition it's in area.
Where there's only one other product indicated improving in that area.
That's a big deal to them so when they see the proven efficacy in both bipolar one and bipolar two this is something they see is unique for the product and certainly addresses an unmet need that they have.
For those physicians that we're familiar with cap light through their experience with the schizophrenia indication when they see in our clinical data that the safety and tolerability, particularly around weight and akathisia, which are the two tolerability issues that concern bipolar patients the most and when they see.
<unk>.
Our profile in each of those is similar to placebo and they recognize that that's a.
Essentially replicated with what we saw in schizophrenia that gives them a great deal of confidence as well in another reason to prescribe <unk>. So I think all of these things together.
We're hearing very positive physician feedback and they also relay a lot of terrific patient stories to us of successes that their patients are having so we we we find all of that.
Highly encouraging.
So Sharon I will turn it back to you for.
The rest of the question.
Great. Thanks.
Good morning Charles.
I think we're taking it one year at a time and we said this year I cannot provide any guidance at some point in the future we will but I think for right now we're taking it one year at a time.
Okay makes sense.
Cause.
And just one question, but I wanted to ask relative to the Tolerability.
Mark are you seeing persistence in schizophrenia that perhaps.
Is consistent with her or beyond what you would have expected given the improved tolerability profile. Thanks.
Yeah. Thanks, Charles we we we are we had a hypothesis even prior to the launch when we saw the safety and Tolerability profile from our clinical trials in schizophrenia.
And while it's still a little too early to do the classical persistency curves, we need a bit more data to do that we have been tracking.
Proxies for that ever since the launch.
Mostly looking at refill rates and T Rx, Dan Rx ratio and when you do that for cap light up.
And you compare that to other branded anti psychotics at the same time in their launch we find that kept play that is outpacing those other branded anti psychotics.
Which is not a surprise to us but to US is a strong signal that patients are persisting longer.
<unk> and when you also look back now at its very early with cap light, obviously in bipolar depression, but when you look back historically at other products and you look at the persistency in bipolar disorder.
It tends to be longer than in schizophrenia. So we would expect to see the same with cap later as well.
Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question press. The pound key we ask that you. Please limit yourself to one question.
Our next question comes from the line of Marc Goodman from SVP Leerink. Your line is now open.
Hey, Thanks for taking my questions. This is rudy on a like Vermont.
Regarding tech led us accelerated growth trajectories in first quarter.
Can you provide more color on the impact of U S sales force expansion that was completed in Q.
Yeah.
Another question, how should we think about antipsychotic market dynamics, especially in the upcoming generic entry of Latuda and the potential label expansion of at least a millionaire.
D D.
So thanks question Rudy I think it was a little bit difficult to.
To understand what you're saying you're coming through a little bit muffled, but mark were you able to get the questions.
Yeah, I think so in an already if if I don't hit on it exactly.
Just follow up with a follow up question, but in terms of our sales force productivity and the level of detailing out in the marketplace.
We expanded our sales force.
Just before the approve.
Approval of bipolar last year from approximately 240 representatives up to 320 Representatives and what we're seeing in the early weeks of the bipolar launch is a significantly higher level of detailing due in part to having additional sales representatives are as part of our.
Our overall sales force structure, but also as I mentioned before we are seeing improvements in the environment from a COVID-19 perspective.
And in addition, the excitement of a new indication in bipolar depression is something that physicians are very interested in hearing about so all of those things are leading to a high level of detailing in the marketplace and at a level that we believe is gives us a a very strong.
Share of voice.
To communicate the capitalize a message.
In terms of potential impact of a latuda patent expiry.
We don't believe that that will have a significant impact on cap later.
Or the other branded products in the marketplace typically when you look back historically in this category certainly the that brand is impacted by a generic entry. So latuda, we'll will obviously be very impacted by that but the other brands tend not to be impacted and that's because.
This is a category that theres, an awful lot of churn theres, an awful lot of discontinuation and switching of medicines and quite honestly. Many of these patients have already been on on Latuda by the time. It goes generic so we we don't foresee a significant impact on cap lighter of that event in the marketplace.
Yeah.
Thank you. Our next question comes from the line of Jason <unk> Barry from Bank of America. Your line is now open.
Hey, guys. Thanks for taking my questions.
Just following up on the last question just wanted to confirm my understanding.
Ending is in some of the more generic anti psychotic markets. There's typically a two step edit.
Rule, but in Bpd Theres only one generic step at it. So is it your kind of assumption that latuda going generic would not shift the balance to a two generic step edit type of dynamic and then just.
The Bpd launched curious early days, but do you have a sense what line of therapy, what prior treatments. The typical profile of a patient getting kept lighter for D. P. D or is it just too early to say.
Yeah, that's it.
Thanks, Jason Yeah, but when you look at the utilization criteria that exist across the various payers across various channels for anti psychotics are at.
It really varies depending on the payer you you have unrestricted access.
Available through certain payers, you have those payers who employ.
Step edits typically it's either one or two generic steps usually not more than that.
And then you have those that manage the category two through a prior authorization and possibly a step edit associated.
With that so it really varies across the board what I would say certainly unrestricted status is is the best.
Electronic step at it whether it's a single step or two steps, we don't see as a significant barrier in in the marketplace. This is not something that the physician or the physician staff has to do anything for they they write the prescription the patient shows up at the pharmacy and this is all done behind the scenes electronically.
So it really isn't a barrier to usage in the in the marketplace.
In terms of the the second question you said late lines of therapy again still early on in the launch, but what we are seeing similar to what we saw in in schizophrenia. In this regard is utilization across all lines of therapy, we're seeing a newly diagnosed patients being placed on cap lidar.
As well as a.
Second line third line et cetera.
And we're also when we look at the.
Products, the anti Psychotics that theyre being switched from.
They are being switched from a wide variety of anti psychotics as well so it's not like there's just one or two specific.
Products that physicians are looking to switch from two kept light it really is coming across the board, which to US again is is a very encouraging sign.
Thank you. Our next question comes from the line of Amit <unk> from need him. Your line is now open.
Thanks, Good morning.
And I have one question and one follow up.
With regard to the sampling can you give us some color with regards to the volume of samples that you may have contributed so far.
And if you know you can give us some sense of how that might be a leading indicator.
For new prescriptions total prescriptions.
And then secondly, just with regard to a prior question around <unk>.
Guidance.
You've given us some color with regard to your comfort level with consensus numbers for the year.
I'm seeing consensus stands at roughly $214 million for the year could you give us a.
Any comment on how comfortable you are with regards to being able to achieve that thank you.
Okay, Mark I'll ask you to start with.
Defining the sampling parameters.
As you see them and then I'll come back on that.
Yeah sure I think as most of you are aware physicians utilize samples in order to try a new medicine for the patient. So typically they will give them a week or two of samples.
To test early on the effectiveness and that patient to see if theres any tolerability issues.
And if all goes well then those samples than typically are followed by a prescription sometimes a physician will give them the samples that a prescription at the same time they take the samples and then they sell it when they're done sometime.
Sometimes the physician will.
Want to hear back from the patient and then write a prescription but we believe it's a it's a future indicator.
Of prescription growth because it signals a willingness and a commitment to try the medicine.
In our new patient, which ultimately results in a prescription.
And in terms of the magnitude or what I would say is we have seen a significant increase.
Both in physician requests for samples unsolicited requests for samples as well as the sampling that our salesforce provides disposition as they make their sales calls.
So Sharon I'll turn it back to you for the second part of the question.
Yes so.
No. We said, we're not giving you guidance. This year. So we're not giving you any guidance on.
On.
Numbers consensus et cetera for this year.
Okay.
Thanks.
Yeah, I think I think.
If there is not another question week, we can wrap this up or if there was one more question. We can have that one asked.
At this time I'm showing no further questions I would like to turn the call back over to Dr. Sharon mates for closing remarks.
Great. Thank you so much.
We thank everyone for participating this morning.
We're very excited about.
Our launch and.
The continuing expansion of cap lighter.
<unk>.
And we're very very excited about the possibility and probability of helping patients so with that operator.
You can disconnect.
This concludes today's conference call. Thank you for participating you may now disconnect.
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Okay.