Q4 2020 Intra-Cellular Therapies Inc Earnings Call
And then.
Good morning, ladies and gentlemen, and welcome to the intra cellular therapies fourth quarter and year end 2000, and 'twenty financial results Conference call. At this time all participants are in a listen only mode. After the speaker presentation. There will be a question and answer session to ask a question. During the session you will need the press star one.
On your telephone as a reminder, today's conference call is being recorded I would now like to turn the conference over to your host.
Doctor Juan Sanchez, Vice President Corporate Communications and Investor Relations. Please go ahead.
Good morning, and thank you all for joining us for today's conference call.
Our earnings press release provides the corporate update and details of the company's financial results for the fourth quarter and year ended December 31 2020.
The press release crossed the wire and a short time ago and is available on our website at intra cellular therapies dotcom.
Joining me on the call today and talk to Sharon mates, Chairman and Chief Executive Officer, Mark Newman Executive Vice President and Chief Commercial officer, Dr Rich darker and.
Senior Vice President and Chief Medical Officer, and Larry Hineline, 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 of the efficacy safety and intend to use of the company. The protocol development candidates, our clinical and non clinical plans our plans to present or report additional data the anticipated conduct.
And the sales of ongoing and future clinical trials plans regarding regulatory filings future research and development, our plans and expectations regarding the commercialization of kept like their book.
Pension impact of the COVID-19 pandemic, one of our business and possible uses of existing cash and investment of resources.
These forward looking statements that are based on current information and assumptions and expectations that are subject to change and evolve and number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements.
These and other risk of describing and where periodic filings made with the securities and Exchange Commission, including our quarterly and annual reports.
Caution not to play in the first place undue reliance on the forward looking statements and the company disclaims any obligations to update such statements.
I'll now turn the call over to Sharon.
Thanks, Ron and welcome everyone to today's call.
2020 was a transformational year for intracellular therapies and I am proud of our team's successful execution of our commercial objective and development programs, particularly given the challenging environment. The COVID-19 has caused.
We successfully launched our first FDA approved product kept lighter for the treatment of schizophrenia in adults.
Just as the pandemic began to cause major disruptions and patient care.
Throughout the year, we also made substantial progress on our bipolar depression program and we advanced other clinical development programs.
This year and addition to our ongoing commercial efforts for kept later, we are pursuing advances and three major areas first.
We look forward to expanding our kept of Ida label with indications and bipolar depression. We recently submitted the supplemental new drug applications for kept lighter and anticipate and F. D. A target action date and the second half of this year.
Second we will continue our late stage development programs for whom the TERP earn and depressive disorders.
Third we will continue to advance the clinical development of our long acting injectable formulation of looked at when the type of Brown I T. I Triple three and R. P. D E. One inhibitors as well as ITI 12, 80 for our newly introduced the program.
Before I give an overview of our commercial efforts I want to take a step back and put our progress and the context of our company's mission.
I T C. I has set out to create better medicines to provide benefit for people who are living with some of the most difficult diseases to treat.
We developed bloom of tap along with strong belief and its potential to help patients living with highly prevalent neuro psychiatric conditions like schizophrenia, bipolar disorder and major depressive disorder.
Our first focus with schizophrenia, which affects about $2 4 million adults and the United States.
Anti psychotics have side effects of contribute to patients and cycling through of medicines or discontinuing use.
<unk> has demonstrated efficacy and a favorable safety and tolerability profile to help address significant unmet needs and schizophrenia.
Another condition and need of additional treatment options is bipolar disorder with more than 11 million of American adult affected by this disorder.
Bipolar depression is the most common and most difficult to treat manifestation of this disorder, but only a few of proof therapies exist for these depressive episodes and only one is approved for bipolar to patients and the only as a monotherapy.
In addition, there is the large unmet need for patients with major depressive disorder, each year more than 17 million adults are affected with this condition and America.
And over 50% of these patients fail to respond adequately to first line therapies and require additional treatment.
There are few and I psychotics approved for adjunctive treatment of depression, and there are safety and Tolerability trade offs with these drugs for patients.
And some there is a significant need for effective safe and well tolerated treatments for these major neuro psychiatric conditions we.
We believe room of tap loans will be an important addition to available options for these patients.
Now, let me give you some highlights of the past year.
We are pleased with kept light of quarter over quarter prescription growth and Q4 prescriptions grew 77 per cent compared to the prior quarter.
Net product revenues of kept lineup for the fourth quarter were $12 4 million compared to $7 $4 million and the third quarter for.
For the full year kept light of generated $22 5 million and revenue.
Larry Heinlein, our Chief Financial Officer will provide further details on our financial performance later in our remarks.
We began the year 2020 by hiring our national sales team to launch kept lighter and we strengthened our infrastructure to successfully commercialize our first product.
Kept light of was launched in late March 'twenty and 'twenty, coinciding with the start of major COVID-19 disruptions.
Our team quickly adapted our commercialization model to include in person and virtual sales force interactions and medical education.
The accompanied those efforts with digital marketing initiatives and direct to consumer promotion.
In spite of the COVID-19 challenges, we have had a strong commercial launch of kept lighter and Mark Neumann, our chief commercial officer will provide further details during his remarks.
In addition to launch and kept lighter we are proud of our other accomplishments as well and September of 2020, we reported positive results from study four O. Two our phase III study that evaluated limit around as an adjunctive therapy to mood stabilizers and bipolar depression.
Moving the type of around 42 milligrams met the primary endpoint of improvement in depression.
This follows the positive results from study four O four evaluating and on the Tech zone as a monotherapy.
These two studies serve as the basis of our S. N D E filings for bipolar depression.
Both studies demonstrated robust efficacy and a favorable tolerability and safety profile consistent with the findings and all of our previous studies.
Looking ahead to 2021, we are positioned to expand our kept light of label.
And if approved kept lighter would be the first therapy indicated for the treatment of depressive episodes associated with bipolar one or bipolar two disorder, both as monotherapy and as adjunctive therapy, with lithium or valproate and adults.
We will continue to make progress and our depressive disorders program. This year. Our large late stage study four O. Three is ongoing and is evaluating the antidepressant effect of Luna taproom and patients who exhibit mixed features with bipolar depression or mixed features with major depressive disorder.
We expect results from the study and the second half of 'twenty and 'twenty two.
And 2020, we began our adjunctive M D D program and anticipate enrolling patients in two phase III studies evaluating on the type of run as an adjunctive treatment and major depressive disorder or later this year.
In addition, we are advancing our long acting injectable formulation of bloom of type of.
Our single ascending dose phase one study is in progress and we anticipate initial results and the second half of 2021.
Finally, we are continuing to advance our other pipeline programs.
I'd like to start with $12 84, which is the most recent addition to our pipeline.
12, 84 as of do the rated form of Bloom of Taproom delivered sublingual <unk> as an orally disintegrating tablet.
Abbreviated as ODT S L.
ITI 12, 84 O D. T. S. L may offer pharmacologic benefits and ease of use for patients, particularly and elderly population.
Our recently completed phase one program found that ITI 12, 84 was rapidly absorbed into the systemic circulation with metabolically stable and resulted in high systemic exposure.
We plan to initiate studies evaluating ITI 12, 84 for the treatment of behavioral disturbances and patients with dementia.
The treatment of dementia related psychosis and for the treatment of certain depressive disorders and the elderly we expect to initiate these studies late this year and next year.
Next I'll discuss our phosphodiesterase type one inhibitor program. Our PD one inhibitor program is focused on diseases, and which the P. D. E. One enzyme is over expressed.
And for the new abnormal immune cell function contributes to disease pathology.
This provides opportunities to pursue innovative treatments for multiple diseases, including Parkinson's heart failure and other disease States.
We have already reported positive results from phase one two studies.
Evaluate lenders Poten, formerly known as ITI, 214, and patients with Parkinson's disease and in patients with chronic.
Chronic systolic heart failure, we plan to advance lenders potent and to a phase II clinical study in Parkinson's disease later this year.
Another program and our pipeline is our I T I triple three platform with ITI Triple three our lead compound in development for the treatment of opioid use disorder.
We initiated a phase one single ascending dose study evaluating the safety Tolerability and pharmacokinetics of ITI Triple three and healthy volunteers.
And we anticipate results from the study in the second half of this year.
We look forward to providing more details on these programs and our pipeline during and R&D day, which we anticipate conducting and Q3.
Finally, we ended the year with approximately $659 million and cash cash equivalents and investments Larry will provide additional details in his remarks.
In summary, I'm very proud of all our accomplishments in the past year and I look forward to continued growth and expansion and the year ahead of.
I'll now turn the call over to Mark Newman for details on our commercial efforts Mark.
Thank you Sharon and good morning, everyone.
Looking back on the year ITC I delivered strong commercial execution, enabling the successful launch of capital even in the midst of the COVID-19 pandemic.
And late March we pivoted from and in person commercial launch two and all virtual Wan and very short order.
Our team demonstrated agility and creativity and ingenuity to adapt to the new commercial environment. The COVID-19 created.
The Sharon mentioned, we deployed a hybrid model of in person and virtual programs for sales interactions and medical education.
We also increased our digital marketing initiatives and direct to consumer promotion.
These efforts were clearly successful based on the performance of capital Ida and the market.
Couple of it is market access position continues to be strong with coverage standing at more than 95% of covered lives and both Medicare part D and state Medicaid.
These are the major payer channels and schizophrenia, representing approximately 70% to 85% of all prescriptions for schizophrenia.
Our lighter link patient support program continues to be highly competitive and effective and assisting prescribing physicians and the eligible patients to gain access to <unk>.
We've seen consistent robust prescription growth since launch and this performance extended through the end of 'twenty and 'twenty.
Specifically during the fourth quarter kept lightest total prescriptions increased 77%.
Relative to Q3.
Keep in mind. This was during the time when the overall antipsychotic market was essentially flat because of Covid constraints.
And while Covid continues to impact patient care and we're confident that kept the lightest prescription numbers will continue to grow.
We're also very encouraged to see that both patients and doctors continue to report highly positive experiences with capital item.
And market research surveys kept light of prescribers rated higher for overall drug performance compared to other branded anti psychotics that had been on the market for a much longer period of time.
And they highlight the efficacy and favorable metabolic and weight and movement disorder profile.
And the ease of reaching a therapeutic dose with no need for titration.
Another indicator that kept lighter is being well received by patients is the rate at which they are refilling their prescriptions.
We're pleased with the refill rate for cap lighter showing that many patients who have started kept lighter tend to stay on it longer than we see for other products at the same time and their launch.
We are extremely pleased to see our product performing so well and the marketplace and we will continue to adapt our commercial efforts to the fluid COVID-19 environment in 'twenty and 'twenty, one to bring kept light to even more adults with schizophrenia.
As you heard from share and earlier, we are also looking forward with great anticipation to our potential label expansion and bipolar depression later this year and are well into our commercial planning for this exciting opportunity.
Today, there are only a few approved treatment options for this underserved patient population.
We expect the introduction of <unk> to be a welcome addition to this market because it has demonstrated robust improvement and depressive symptoms and a favorable safety and tolerability profile and has the potential to be approved for the broadest range of patients.
We plan to make the appropriate additions to our sales force and advance of the bipolar depression, the due for the target action date.
And we will be prepared on day, one to seize this opportunity.
We are proud of the strong commercial execution of the team and our successful launch of capital Ita.
We continue to be very pleased by the kept light of growth trajectory and our team will be ready to expand our commercial efforts to help even more adults with schizophrenia and patients with bipolar depression going forward.
I will now turn the call over to our Chief Financial Officer, Larry Heinlein.
Thank you Mark I will review, our financial results for the fourth quarter and for the year ending December 31 2020.
And the fourth quarter, and we recorded net product revenue of cap later of $12 $4 million.
Compared to a $7 $4 million and the third quarter no net product revenues were reported and the same period of 2019.
Research and development expenses and the fourth quarter of 2020 were $14 3 million <unk>.
Compared to $19 1 million for the same period and 2019.
This decrease is due primarily to a decrease and manufacturing expense and a decrease of Luna tempur on clinical and non clinical expenses.
Selling general and administrative expenses totaled $58 3 million for the fourth quarter. This is compared to $22 8 million for the same period and the prior year.
This increase was primarily due to an increase in sales related labor expenses and commercialization expenses.
Net loss and the fourth quarter was $60 $7 million compared to a net loss of $40 6 million for the same period of 2019.
For the year total revenues were $22 $8 million and capitalize the net revenues were $22 5 million no net product revenues were reported in 2019.
Research and development expenses for the year ended 2020 were $65 8 million compared to $89 1 million for 2019.
Selling general and administrative expenses for the year ended 2020 were $186 $4 million compared to $64 $9 million from 2019.
Selling expenses for 2020 were $132 $5 million as compared to pre commercialization expenses of $32 5.002 million 19.
General and administrative expenses for the year were $53 9 million as.
And to $32 $4 million from 2019.
Net loss for the year ended 2020 was $227 million or loss of $3 and 23 per share compared to a net loss of $147 $7 million or $2 68 per share for 2019.
Cash cash equivalents restricted cash and investment securities totaled $658 $8 million at December 31, 2020.
This concludes our prepared remarks, operator could you. Please open the line for questions.
Thank you, ladies and gentlemen, as a reminder to ask a question you will meet the press star one on your telephone we ask that you. Please limit yourself to one question and one follow up question to withdraw your question press the pound key please standby, while we compile the Q&A roster.
Our first question comes from Ross <unk> with Evercore. Please go ahead.
Hi, this is both of them.
Thanks for taking all the questions.
Two if I may the first is could you give us some color on the data package for the bipolar depression, and that's N D E and but.
Clearly we are in Q.
Curious to know whether there's any update of drug drug interaction study of the UGG inhibitor, such as of upright and co administered with a little bit of Tetra.
And maybe a follow up question for Mark.
The commercial and could you give us some updated thoughts on the duration of treatment.
And you mentioned the continued prescription rates and your prepared remarks, which is comparable for the to the.
And should we then think about the duration of treatment is also similar to these antipsychotics.
Thanks, both of the question I'll start this is Sharon and and I low.
Alex the rush of people like to add anything so you've asked us for some color on our day to package. So yes, we have.
And submitted.
And our S M D as for the treatment of bipolar depression, and yes, there is updated information.
On the U T T interaction and and our studies, we have not seen interaction and we think this is great news and so we have submitted all of our data and.
Of course, this will be part of our label discussions Suresh would you like to add anything on that.
No no nothing nothing further to add that in fact that we did submit the information to the FDA.
Yes.
And then I think the second part so I hope that answers. The first part of your question and then the second part of the question is.
As you directed towards marks of Mark would you like to take that please.
Yeah sure. Thanks, Sharon and good morning, Bob. Thanks for your question about duration of therapy, and and yes. This has been a very encouraging part of the launch thus far with with capital Ida.
And what I would say it is it is still too early to do sort of your classical compliance and persistency curves.
We'll need several more months to be able to do that however, while we are tracking very closely as an interim metric is the T Rx to and our X ratio and when we do that for cap lighter and we compare that to other recently launched oral anti psychotics at the same time in their launch we find that kept light is actually.
The outpacing.
Those anti Psychotics in terms of the refill rate and in terms of the T Rx to and our X ratio.
And we find that very encouraging and.
Consistent with the hypothesis that we had a.
Debt, the safety and Tolerability profile for capital Ida.
And would be received well by patients and allow them to stay on their therapies. So it's something we'll continue to watch and as we get more information around compliance and persistency curves, we'll share that information with you as well.
Thank you very much.
Thank you. Our next question will come from Charles Duncan with Cantor Fitzgerald. Please go ahead.
And thank you good morning, Sharon and team congrats on a great quarter and and the pipeline expansion I head of.
A question on commercial and then one on the pipeline quickly on commercial regarding.
The traction youre getting with prescribers looks good but I'm wondering yes for this year. Your goal is to focus on and new prescribers or deepening the use of prescription of Luna tapped her own are kept later with the N of prescribers space and then I'll come back and ask.
The pipeline question.
Mark do you want to take that.
Yeah sure Thanks, Charles and what I would say is we have been pleased overall when we look at both the the breadth and the depth of prescribing that supports the growth trajectory that we've seen on cap light of thus far in launch the the answer to your question is we will continue to look to both.
And the breadth of prescribers.
But also those have who have already tried cap light of we will be seeking to increase their depth of prescribing as well and one of the things that is very encouraging to us is the the really favorable feedback that we get on the experience that both patients and physicians have been having with cash.
Light of early on and the launch.
As you know early on and the launch you want them to have a very positive experience with the medicine and when they do then they're more likely to increase their depth of prescribing and that's something that will build upon that success that we had in 'twenty and 'twenty.
As we go throughout 2021 as well.
That makes sense. Thanks for the added color and Mark on the pipeline just quickly. It's a two part question and I apologize for that one is bipolar I just I'm trying to work out the timing and it seems like the recent press release was very likely driven by the acceptance of <unk>.
So could I assume the timelines if M. S. N D. A takes the only roughly six to 10 months and that could produce.
<unk> date could be and the third quarter and then is.
As a follow up to that in terms of the pipeline expansion and the DRP. The 12 months 84 program looks very interesting to me and I'm just kind of wondering if you could provide little more color on the target product profile for of Dude rated or in the ODT.
Form of lunar cat prone and and what what is it that you'd really like to achieve for that particular patient population and the elderly patient population. Thank you.
Okay. So you asked the.
Bunch of questions I'll start with the bipolar timing.
And I can then.
Either start either go on to the of 12.
12, 84 question or maybe both of the rush and I will take that one because I'm not sure I wrote down the entire question, but.
And on the bipolar timing on our press release, what we what we announced was that we submitted.
And recently.
And so I think that and we have guided you.
The two expect.
Standard review, which is a 10 month review.
So you can work out the numbers and see where that takes you okay and that's helped us so that's on the bipolar timing.
And on our ODT.
It is 12 84.
As you know is a new molecular entity and we believe it is well suited to study and the elderly population based on its pharmacologic characteristics.
And our recently completed phase one program, we did find that a 12 day before it was rapidly absorbed into the systemic circulation with metabolically stable and resulted in high systemic exposure.
And these studies, we didn't report no and no serious adverse events and either group and and the elderly cohort are the.
The reported adverse events were infrequent, but the most common the adverse events being transient dry mouth and Russ did you want to add to that at all about 12 84.
Yeah in terms of the safety profile of Youre correct that is.
And then there was safe and well tolerated there was no adverse or serious adverse events.
And in fact of the elderly population had infrequent.
The common adverse events of what mainly tranches of dry mouth and.
And we had also.
The orally disintegrating and allows for use and elderly population.
We're seeing indications and the lollipop.
And we are mainly looking at.
Behavioral disturbances and patients with dementia.
Linda and dementia related psychosis.
And treatment of slipped on the pursuit of as artists and the elderly.
Okay.
Okay. That's helpful and look forward to seeing that.
Get underway in terms of clinical studies, thanks for taking my questions.
Thank you. Our next question will come from Brian Abrahams with RBC capital markets. Please go ahead.
Hi, Hello. This is Leo on for Brian Thanks for taking my question.
I guess I was just curious about thinking ahead to the commercial performance and 2021.
How are you thinking about the adopt and.
Adjusting your hybrid strategy.
And for a potential shift and the pandemic towards the greater reopening too.
And to drive a greater sales inflection in Athleta, and then sort of as a follow up to that and as you look ahead to the bipolar launch and you've been interacting with the prescribers.
The sort of the.
Physician interest on the ground for the bipolar launch and do these physicians care.
Equally for the same factors as and schizophrenia like the low AE profile, there might be interested more in other aspects such as the ease of dosing of the efficacy.
Sure.
Hi, Lee of Great questions I'll ask Mark would you like to address that please.
Yeah, Shirley Thanks for your questions and yeah, the what I would say about our commercialization model as we feel very good.
At this stage.
About the hybrid model that we have in place and again the hybrid model means that our both our sales representatives as well as our speakers who do our promotional talks about cap light up.
Person engagements, but we do believe.
That there will be a permanent change in the commercialization model, where we will supplement those in person engagements.
With active digital engagement, both by the representatives as well as through our other digital marketing initiatives. So we think we're poised and we're well placed.
And to make that transition back to a post COVID-19 world, If you would and be very.
And in doing that.
The the second part of your question around bipolar from a commercial perspective prior to and approval of our sales force speakers et cetera.
And do not engage on bipolar depression at all as it would be off label. So I can't really comment on any feedback that we're getting.
In the field on bipolar depression, I can say and the market research that we do <unk>.
Physicians recognize that some of the dynamics that exist in the schizophrenia marketplace, where you have limitations of the current anti psychotics because of side effects and the cycling of those patients through other anti Psychotics also exists and bipolar depression, and we believe that the favorable <unk>.
If the and Tolerability profile.
I'll take that and I T. I Triple three is a very different molecule from the the trawl first of all it is a.
New opioid partial agonist with very low intrinsic activity it does not have.
And a substance use associated with it at all it is also of five H T. Two a uhm antagonist. So it is a totally different mechanism of action from Vitol.
So no comparison there and.
And in terms of the L. A I, yes, there are some characteristics we have several formulations of our L. A I and that's because it wasn't and this was not an easy molecule to formulate for and the L. A I. It took a lot of development, but we do believe.
And that we have as I said, we have several formulations. However, we do think that the formulation network testing is and optimal formulation and it is administered subcutaneously and so we think that is an advantage patience have expressed and.
A choice for a subcutaneous over and I am injection.
If you asked another part of the question I can't remember it and maybe does that answer your question. Our first the first formulation is babette were testing is S. A one month formulation and and we will go from there to other durations.
Got it okay. Thank you.
Thank you and our next question comes from Jessica Fine with J P. Morgan. Please go ahead.
Good morning, This is Dan and wait for just to verify thanks for taking care of question two questions for me, one Oh, well, we understand that you have and provided guidance four of 2021 revenue how comfortable are you with the consensus numbers and two regarding 12 84, and how does the P T profile compare.
There with that off limits of of Brown. Besides rapidly developing are there any other property and that makes it a medical to treat the indications that you are currently interested and dementia and and others.
Right. So thank you Daniel Uhm earlier. This year, we did say that we were comfortable with consensus numbers, which or 110 million about 110 million and we remain comfortable with.
Those numbers.
So that's your first question, we we anticipate a strong build over the course of the year and particularly and the second half of the year when as Mark stated, we anticipate COVID-19 disruptions to be improving markedly so.
And we are comfortable and we are comfortable with our numbers.
Moving to 12 84, I think that we said that we do believe that there that that the <unk>. The both the molecule and the formulation of 12 84 has advantages to it for used and especially in.
Killer and elderly patients because it's rapidly absorbed into the systemic circulation, it's metabolically very stable and it results and high systemic exposure.
Thank you.
Thank you and our next question will come from Sumani, Carl Kearney was Canaccord. Please go ahead.
Good morning, Thanks for taking my questions and my first one is actually is very specific one of one day before uhm could you frame how do the may have looked like the the electric do regular limit the up room and the fifth one day and if you've generated sofa. The most specifically going forward, which of the Ludo ZIP is used and the fire try and and all the patients uhm.
And and the second part of that this is it fair to assume that you'll be using it for I would probably be two parts of me for this new <unk>.
Hi, <unk>, that's a lot of questions, so and dosing relative to phase one we did a single ice ending dose study. So we did test and.
Uhm, two doses and a single I, sending the study and then and of multiple a sending the study as well where it was dosed once a day for seven days.
I think.
As far as the regulatory pathway. This is the new molecular and today, we will have discussions with the appropriate regulatory authority on on that regulatory pathway as we move forward.
And and we'll let you know as soon as as soon as we know.
Got it and then just from the the mood of the do the N E vs. Two or three trials relative to the low dose of no makeup room that was used and the end of the patience and the prior Trump.
Can you wait til, we put it on clinical trials Dot Gov. Please what our dosing strategy is going to be I think of do that soon and I I would rather I'm always uncomfortable of saying, what we're going to do until we do it.
Oh, and you know that from US, we're very conservative and wait we will publish it on clinical trials Dot Gov. As we go forward and to phase two studies on these different indications, which and.
<unk> may be the same or may differ and the indication.
And the dose may differ depending on the indication and we'll let you know.
Got it thanks for the check every day [laughter].
Thank you. Our next question will come from burnt Haizlip with B T. I G. Please go ahead.
Thank you. Thank you for taking the question congrats on the progress I just thought of a another question on 12 84 Uhm to actually first of all you talk about it the stabilizing lumen chaperone does it alter the specifically all through the formulation persistence of behavior of any of the metabolites.
Have room, and then certainly could you remind us of the I P and would you expect for limits of room, how long do you expect exclusivity alright.
Let me.
Can you date the first part of your question again, I missed the yeah mm mm mm, except the one of the number of the tabloids as you're well aware I'm just wondering whether the do the rated version of alters the formulation persistence or any of the behavior of any of the metabolites of Luma and then again, the I T and how long you expecting exclusivity from and.
And with that room.
For the room of tougher on her for the 12 84, well I can tell you about so there are no new metabolites and and 12 84, and we qualify all metabolites and again as we go forward and.
We can describe the metabolite profile for Ya, we do have robust patent profile for both of them of type run the and 12 84. So I think that if you're asking 12 of 84 is into the 2040.
<unk> and <unk> is a very solid and to the mid to late 2030.
Okay. Thank you for that look forward to the characterization of of the the tab like thank you.
Thank you and our next question will come from Greg Suzanne Avi with Goldman Sachs. Please go ahead.
Hi, good morning, and congrats on the corner. Thanks for taking my questions I've got to please one uhm I know it's early days, what I'm curious about your M. D D program and and no you're expected to initiate studies five O. One and 502 I was wondering if you could just.
Help us think about what the.
Clinical phase three trial program overall is gonna look like in terms of expected timelines and.
If we were to start thinking about perhaps adding revenue of just trying to get a sense of what the time might look like here and how does the four O. Three study if it all fit and supporting that registration of program.
And then my second question is maybe more on on the financials and and looking at 2021 was wondering if you could provide uhm of view on what the quarterly progression of Opex spend will look like with respect to R. N D and S. Jana. Thanks.
Yeah.
So are of junk did studies five O one and 502 or studies looking at major depressive disorder as the chunk of two standard of care and so you said there are two studies clinical conduct will begin.
And this year and I think you should expect two years for enrollment and read out of the studies that is what is typical for for these kinds of of studies. They are conducted globally, including the U S.
And we will post uhm on clinical trials Dot Gov as we start each of the study.
And then I think you asked before you get to the Uhm financial and I think the easy one on the financials is we we are not giving quarterly guidance on our projections and maybe it's Larry has anything to add he can add to that but.
Yeah.
And that gets the <unk>.
Yeah, we're not gonna give coordinate alright, and can I get quarterly guidance, but I think it's safe to say that.
From the R&D perspective, we will see the expenses increased over the last year's expenses, 2020th expenses and I would see them increase and you know quarter to quarter. So no no particular guidance, but certainly see and incline as we go through 2021.
Insurance just.
Ask if if you could come and and help the four O three studies fits and the context of what you're trying to do too expand the opportunities for.
And what's up room.
Right. So it is an expansion and I'm glad you came back to that it is and expansion of the opportunity for a room of tepper on it. It is not it is not part of the adjunctive studies and M. D day. The study four O three is.
Looking at both bipolar and major depressive disorder and.
And patience with mixed teachers. So before we go further into that maybe I'll asks the rash can you. Please define for the audience. What mixed features are both and major depressive disorder and bipolar disorder, and then I'll come back and talk about what we think the opportunity is again.
Okay, yes. Thank you.
We have a mixed reach us is the condition, they say, especially if I had the within the V of some sorry for the boat.
The the deficit disorder and also of bye bye.
And my father bizarre, though.
<unk> M D D. With mixed features have severe and if you have your list you can see the a different list.
They also have high and it.
Suicide Ideation My day.
Sort of suicide thoughts of the headaches of ridiculous.
Okay.
And also that is Hyatt came out of of the days and be sort of a difficult to take the patient.
And if these patients.
One of them and feedback.
The shows with M D D.
Have a technician will be diagnosed with bipolar bizarre the look at all.
Now coming to the my patience with fixed we just in the bipolar Fisher.
And I also.
Having the same feature mainly of.
Having some symptoms of.
Of the shut the symptoms of many of of Hypomaniac and how it.
And the Fisher.
And although the third of the patients and both the Appalachians, both and M B D and the and but.
Have mixed features.
There's this vicious difficulty of street and right now and this time, there's no specific medication and.
And.
This is.
And we had the following the form of three which was amended to include these patients.
And the.
This is the Philly follow up study and so they just a sort of study and.
And it's been kind of kind of.
The.
And so the status of them.
The speaker there'll be on the next steps of regarding this.
So just to follow up on that we think this is a large unmet medical need about a third of patients and.
M D D and about a third of patience and bipolar the disorder exhibit. These features so and these patients as the rush said are more difficult to trees have more comorbidities uhm and have and increased rates of suicide and suicidal ideation. So we think that the.
These are important patient populations within each of these domains and.
And there are no approved drugs to treat these patients so they keep cycling through all available alternatives until you know that are and it's all of course off label until hopefully you stumble on something that is helping the patient.
So we think that with a third of beach patient populations that this is a huge unmet medical need and that we will look at the results of of study four O three and go to the F. D. A with these results and discuss the path forward for the.
<unk>.
So we're very excited about that as adding this to our label for a room of Tech Brown.
I think operator, and we might have time for one more question. If there was the last question.
Yes, we do have a follow up question from Omar of of Fat with Evercore. Please go ahead hi.
Hi, Thanks, so much for taking my question I have a couple of if I may insurance, one theoretically given everything we know about the Emily metabolite formation and how it blended itself more to the formation and and and non human models and and been and human.
Is there any sort of mechanistic reason to expect why of the duration would change that just given everything we've known from from the past and then secondly, and you're thinking about M. D. D studies going forward and indication of expansions would there be of consideration for possibly promoting.
The 12 84 for those indications and not kept later, thank you very much.
Yeah. So first of all you can't improve on.
Nothing so as you know [laughter] and human beings as you said the.
Those and lines are scene and species and are not humans and so you can't improve if you on on a lack of seeing something so 12 84 is is.
Does not have Annalynne formation, neither did loom of tepper and human so that is not of question.
And.
And the question about other indications for 12 84, we are very pleased uncomfortable with room of <unk> and the press and indications that we are studying and we are very excited about the studies that we've mentioned too.
You with 12 84, Uhm, we will.
You know as we go forward, we'll we'll keep you apprised of any other indications that we decided to go into with 12 84, but for the moment, what we're launching with and the path. We're going down right. Now is the state of pathway that we told you about the <unk> and it passed away that we talk.
You about the 12th 84, so stay tuned.
Thank you.
And by the way, just and Everquest on and I Hope I answered both question and the beginning about the U T. T. S. Yes, we're very comfortable we've had we'd conducted all of our studies we've submitted all the information to the F. D. A so that kind of dovetails with your questions.
Okay, then I I want to I think we're over our time I wanted to thank everybody for participating on the call and thank you for all of your questions <unk> very good questions and we look forward to keeping you a price at the very very busy.
Here for intracellular and we look forward to updating you and.
As we go forward with all of our programs.
Thanks, very much and the operator, you can now disconnect.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
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