Q4 2019 Earnings Call
[music].
Ladies and gentlemen, thank you for standing by and welcome to the Vanda Pharmaceuticals fourth quarter 2019 earnings Conference call. At this time all participant lines are in listen only mode.
The speakers presentation, there will be a question and answer session to ask a question. During the session you will need to press Star then one on your telephone keypad.
Please be advised to today's conference is being recorded.
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I'd now like to have the conference over to your speaker today Mr., Kevin Moran Vice President Controller. Please go ahead Sir.
Good afternoon.
David This is they Jones, Chief Corporate Affairs officer, but thank you. So much lives for that set up I do appreciate it good afternoon, everyone and thank you for joining us to discuss Vanda pharmaceuticals fourth quarter and full year 2090 performance.
Fourth quarter and for your 2019 results were released this afternoon and are available on the Fccs Edgar system and on our website Vanda Pharmaceuticals Dot Com. In addition, we are providing live and archived version of this conference call on our website joining.
Joining me today for this call is Dr., Paul Maleh, Polymeropoulos, our president and CEO cover Moran, our controller and also incoming acting Chief financial Officer.
Tim Williams, our general counsel.
The other burst, Nick or Chief business Development Officer, and remember about R&D Committee and Jim Kelly on outgoing Executive Vice President Chief Financial Officer.
Following my introductory remarks, my house will give an update on ongoing activities and Kevin will review review, our financial results for the fourth quarter in for year 2019 I.
I will then comment on all plants were 2020 before opening the lines for your question.
Before I proceed I would like to remind everyone that various statements that were me on this call will be forward looking statements within the meaning of federal Securities law.
Forward looking statements are based on current expectations that involve risk changes in circumstances.
Functions and uncertainties. These risks are described in our risk factors and management discussion and analysis of financial conditions and results of operations section in our Air report on form 10-K for fiscal year ended December 31st 2018.
Yeah quarterly report on form 10-Q or for the quarterly ended in September Thirtyth 2019, which are available on the Fccs Edgar system and on our website additional factors maybe set forth in those sections of our earning our annual report on form 10-K.
Hey, fourth fiscal year ended December 31st 2019.
To be filed with the FCC into first quarter of 2020, we encourage all investors to read these reports and.
FCC falling.
The information we provide on this call is providing only as of today and we will undertake no obligation to update or revise publicly any forward leaning statements. We may also we may we may make on this call.
On account of new information future events, but otherwise except by required by law.
With that being said I would now like a turn call over to our CEO Dr. Mihael Polymeropoulos I was.
Thank you very much Ah ha good afternoon, everyone.
And thank you for joining us.
2019 was a transformative year for Vanda, we continue to drive strong growth and position the company for long term success.
As we move in 2020, we're confident in our ability to build on great strides in our efforts to innovate for the benefit of all of our stakeholders our patients our employees our shareholders and the broader communities that we serve.
Before I go into our update I want to take a moment to highlight some of our key accomplishments in the last year.
Looking first to our commercial projects I'm encouraged by the continued growth we see for HETLIOZ and Fanapt in particular, our ability to achieve double digit year over year project sales growth for HETLIOZ six years now into launch speaks volumes to the Darlington dedication nobody Expedia sales team.
As well is about you bought blind inside the patients with non 24 see in the treatment.
Fortunately.
We're pleased with the U.S. Supreme Court decision to deny the petition for your he took safety were already that was filed by westward pharmaceuticals subsidiary of coupon relating to our six and bargain for cannot.
This ensures the good protection of the 16 button will remain through November 2nd 2027.
Additionally, we've made excellent progress around the launch of our direct to consumer marketing campaign.
Fourth Fanapt, which is on pace to lock in the first half of 2020.
Turning to our boss building pipeline and our ongoing efforts to propel innovation pinko developing it is clearly an exciting time for vanda with several late stage indications and a number of critical milestones, but that expected over the next 12 to 24 months.
That said I would like to start with Tradipitant, our Euro Canyon, one receptor antagonist and provide an update on oral going programs.
We reported.
If you minutes ago results of the appeal and you study, okay stupid and indeed, it's going to produce any topic dermatitis.
If you only study did not meet its primary endpoint in reduction of produce across the overall study population. However.
The anti Pruritic effect of Tradipitant was robust in the mild a b study population.
My old a D represents over 60% of the total he told me dermatitis population into United States.
The appealing study continued to demonstrate that tradipitant is safe and well tolerated.
Although we are disappointed that appealing you did not meet its primary endpoint the profile of efficacy demonstrated in this study potentially address is a highly unmet need of treating intractable crude because for a large portion of 80 patients.
Due to their potent immuno suppressive effect garen systemic therapies for a D are typically only years in moderate to severe <unk>.
The C plus all of the Bbten, coupled with a significant Amy me did onset obese reduction by the first full day of treatment may provide a much needed therapy for the majority of 80 patients that experience mild 80 lesions severity, but still suffer from Sig.
Nipigon and severe cruises.
It'd be on your was your randomized placebo controlled phase three study with 341 patient seem they intend to treat books relation.
With severe pre cruise with a range of disease todays presentation from mild 23% of them to model, 64% in severe 15% of patients as determined by the investigator's global assessment scale or I G.A.
Patients were randomized one to one to receive either tradipitant or placebo 40 people might be a debate weeks.
Pieces would assess the baseline enforce randomization with a number of symptomatic and disease, who basically skills performed at regular intervals.
The appealing decided exactly be hypotheses that tradipitant those that 85 milligrams twice a day opus improvement on the disease symptoms and signs of a D over the evaluation period.
I do we paid a deeper and placebo patients demonstrated significant in meaningful improvement in printers as measured by the worst each numeric rating scale W.I.N.S., but while the tradipitant bargain of improvement was greater than that of placebo the difference between too.
Groups was not statistically significant.
A significant interaction was observed between baseline DCC Basie, hi, Jay one through four and treatment and that was to give you kinda with a P value of 0.000 for.
This is yes.
The study participants with different baseline disease severity expedias different treatment outcomes.
We're not counting for that baseline disease severity and treat many interaction a significantly larger improvement in Dublin is we're seeing with a deeper done out the pre specified endpoint of we came into full trial population and I do wish to give kind of where the P value <unk> 0.0 to one seven.
Similar effects were seeing through out the treatment period, I told push randomization visits comprising weeks 2468, and these data are summarized in table one of the press release that you can see on our website.
Given the observed significant interaction between baseline disease baby and treatment.
A subgroup analysis showed that patients with mild disease, who got 80, 23% of the population.
With I.D.A. scores are wanting to.
Experienced the largest improvement over placebo.
Specifically in the mile A.B. group.
Deeper down significantly improved W.I.N.S. over placebo at every visit and these again can be viewed.
In table one of the personally is and the associated figure one.
The categorical W.A.N.R.S. responded in an analysis, where patients are responding by four points or more so that's certainly need 2.5%. Okay. You couldn't pay says headed clinically meaningful response as compare to 33.3% of placebo patients and that difference.
What's significant is being again in table, one with a P value <unk> 0.000, so highly significant.
These results suggest a large insignificant on paper it took effect of Tradipitant in mile Day D.
And were confirmed with patient daily diary entries.
For a mild they'd be patients had time course, a response also showed that the anti pruritic effect. We're seen immediately after the first full day of Tradipitant dosing, suggesting a large and immediate therapeutic effect similar improvement it was observed for nighttime sleep often describe.
Opted in patients with severe cruises.
Results from the appeal. When you study is shown in figure two of the person is and the scientific literature suggests that.
Mild and severe he'd be types appear to be distinct.
And the types.
With different sets of causative factors and of course.
The American Academy of Dermatology, he talked about ideas guidelines list predators is an essential feature on the topic dermatitis.
The significant pruritus associated with a mild type of baby and the worsening of lesions through scratching allow me to slip disruption continue to represent a significant unmet medical need.
The results of the appealing you studies suggest the tradipitant can produce a large in rapid.
Okay, Great took effect in mile D. Currently.
American Academy of Dermatology treatment guidelines indicate Enrico Mad Immunomodulatory medications only after topical regimens and for the therapy I've found not to do I do could be controlled it does it.
Well tolerated systemic anti pruritic agent with rapid onset of action like Tradipitant, good adds significant value to patients.
And take a primary place indicates amid all agree okay atopic dermatitis patients.
The results of the appealing to study.
We'll need to be confirmed in a full upside.
Today is currently conducting a p. on you too and we plan to reassess the design of decided as good as we continue to analyze the results of the P. on you and becoming a next steps.
Before I would like to catch up on our other pipeline projects before I.
Turning over the.
Coal to Kevin.
On Gastroparesis, our study ultra deep standing that indication that's a phase two study continues to enroll in randomize patients.
Who suffered from both idiopathic and diabetic gastroparesis.
To remind you following the completion of the phase two study in our motion sickness program. We typically well last here. We have now began to recruit for the large phase three study for patients with motion sickness, we expect to complete this program in motion sickness and filed a new drug application with the FDA.
Hopefully by end of yet.
And then you here we are Oh, we also continue to.
Aggressively dry for without an exciting indications.
Well you have to use vanda has submitted.
In application for me if I gave you.
Syndrome, along with the liquid formulation to be accepted by the FDA or 40 view in 2020.
For the treatment of jet lag disorder, we continue our engagement with the FDA to resolve the issues that precludes approval and we remain confident that our supplemental India for jet lag disorder demonstrates the significant and clinically meaningful effects of HETLIOZ in the core features.
Ted talked disorder that are required to demonstrate substantial evidence.
For approval in that indication.
And observations study of delayed sleep phases, or the D.S.P.D. is ongoing and we expect to initiate a phase the interventional study.
In D.S.P.D. in 2020.
Briefly touch upon Fanapt, our atypical antipsychotic in schizophrenia, Hey phase three study in bipolar disorder has been initiated.
As well as the pharmacokinetic study of long acting injectable formulation on Fanapt isn't going.
I'll stop here with our with these updates and turn the call over to Kevin and welcome Kevin. Thank you boss.
So I'll begin by summarizing our exceptional for your 2019 financial results before turning to discuss the fourth quarter plan team.
Total revenues for the for your 29 team were 227.2 million, 18% increase compared to 193.1 million for 2018.
Heaviest product sales of 143 million were the primary contributor and driver of our 2019 revenues, it's all 23% growth compared to 2018.
Now products sales of 84.2 million reflects 9% growth compared to 2018.
For the full year 2019 been reported net income of 115.6 million compared to net income of 25.2 million for 2018.
The income tax benefit of 86.5 million, reflecting the financial results for the full year 2019 includes the favorable impact of the release of vendors deferred tax asset valuation allowance, which occurred in the third quarter of 2019.
This onetime tax benefit is noncash item. Therefore does not have an immediate impact on vandas cash balance.
I mean, its cash cash equivalents marketable securities referred to as cash as of December 30, Onest 2019, or 312.1 million, representing an increase of 54.8 million to cash during 2019.
Turning now to our quarterly results total revenues for the fourth quarter of 2019 were 60.9 billion, a 15% increase compared to 53 million in the fourth quarter of 2018.
HETLIOZ net product sales were 38.6 million in the fourth quarter 2019, a 19% increase compared to 32.4 million in the fourth quarter of 2018.
We have those patients on therapy number grew in the fourth quarter as compared to the third quarter of 2019. During 2019, we saw a downward and favorable Medicaid payer mix trend. The resulted in higher net revenue per unit.
As of December 30, Onest 2019, the specialty pharmacy channel held less than two weeks of inventory as calculated based on trailing demand specialty pharmacies inventory on hand at the end of the fourth quarter of 2019 with higher when compared to the third quarter of 2019 the value of this inventory change was approximately 300000.
Fanapt net product sales of 22.3 million in the fourth quarter of 2019 reflect an 8% increase compared to 20.6 million in the fourth quarter 2018.
As of December 31st 2019, wholesalers have increased inventory on hand, when compared to the third quarter of 2019 the value of this inventory changes approximately 100000.
Not prescriptions as reported by equivalent exponent decreased by approximately 3% in the fourth quarter compared to the fourth quarter of 2018.
In the fourth quarter of 2019 been reported net income of 4.2 million compared to net income of 10.1 million for the fourth quarter of 2018.
Operating expenses in the fourth quarter of 2019 were 56.7 million compared to operating expenses of 43.9 million in the fourth quarter of 2018.
12.8 million increase was a combination of higher non 24 awareness corporate and legal costs.
[noise] Vanda expects to achieve the following financial objectives in 2020.
Net product sales from both HETLIOZ and Fanapt of between 240 in 260 million.
Yes, net product sales in between 155 and 165 million.
Fanapt net product sales up between 85, and 95 million year end 2020 cash of greater than 320 million.
Of note or HETLIOZ net product sales guidance is based on our currently approved indication for non 24, we expect first quarter 2020, HETLIOZ revenue to be impacted by the seasonal Medicare manufacturer contribution and the annual payer disruption linked to new plan years plan changes and Reauthorizations, which we witnessed in prior years.
We expect expect both R&D and that's Genie operating expenses to rise in 2020 as compared to 2019 spending levels. The primary contributions to the 2020 growth and spend include commercial DTC programs on Fanapt in HETLIOZ and an increase in R&D activities related to our late stage clinical programs for Tradipitant Fanapt and HETLIOZ that said, we expect to continue our trend of adding to our year end.
2020 cash balance while advancing our portfolio of investments in support of patients I'll now turn the call back to easier Jones to discuss finished 2020 plants.
Thank you, Kevin and welcome to good.
And 2020 for HETLIOZ, we will continue to advance the commercial commercialization of Hep HETLIOZ for non 24 in the U.S. and also in Germany and for the exclude our commercial plans and he and I knew you markets for for now we will continue to expand commercial support for for now for schizophrenia in the U.S.
As it relates to R&D will we continue our clinical and commercial activities in support of Tradipitant.
We will also advanced the lifecycle management HETLIOZ, both in R&D and also commercial activity, including SMS. What it was mentioned earlier, we will also advanced for now lifecycle as well as continued R&D and <unk> commercial activity.
For early stage both.
The QW.
051, VTR dash to nine seven and also see if Youre, we will continue to move those along the chemical pals and programs that had been announced.
Additionally, we will also habit. We were also other business objectives related to our IP and portfolio.
Are there still IP and portfolio support them all of our products. We will also is as heavily as well in terms of hiring in terms of human capital to ensure the advancement of our scientific innovation and also to develop core competencies towards our long term growth as our company with that being said I will now turn the call over back to my House Mohan.
Hi, Thank you very much on a day and Kevin at this time, we'd be happy to answer any questions you may have.
As a reminder, ladies and gentlemen to ask a question you will need to press Star then one on your telephone keypad to withdraw your question press the pound.
Please standby, we compile the Q and a roster.
Our first question comes from line of Chris Howerton with Jefferies. Your line is now open.
Great. Thanks, so much for for taking the questions and congrats on the degree commercial year last year. So for I guess, you know top of mind given that the atopic dermatitis results were released today.
You know and that it appears to have a beneficial effect in the mild patients.
You know what would be the realistic outcome here you know do you think that you could change the second phase three trial to focus more on the mild patients and that would be the regulatory path forward or you know what are some other options that we can think of in terms of consideration of moving forward that program.
Yeah that is certainly.
So first of all the summary of the results.
But the hypothesis is that Tradipitant is a oh, okay predicated across the spectrum, obviously very acute obey D has not been confirmed.
However for people with a mild hi.
Well they D. A it appears that Tradipitant has a strong on day pre take effect and does so early in the clinically meaningful way.
The way, we think about these results piece is that.
There are two significant to ignore.
Meaning that.
Well the headline of course is unfortunately and disappointing. So the appealing you study did not confirmed that blocking the actions of substance P. Through NK. One receptor is will be up significantly beauty can fact to all 80 patients.
Nonetheless.
The effect is large is appears from this study.
The results of the study would need to be confirmed.
To be certain that both the result is it producible and second that the magnitude.
He is reproduce stuff as well.
If so.
We certainly understand from discussions with experts in the field.
That does could.
Feed and a significant unmet medical need in an area that the topic dermatitis field is not concentrate in today you treatments are concentrating to treat primarily the nissan's seen into moderate and severe patients, but certainly there is no other effort for a.
Systemic safe and they predict treatment for patients with mild visits so what does that mean for vendors program.
The only two study is in early phases.
Which means it can be efficiently.
Reassessed and adapted to.
To be sifted through which the population that we think the drug like he has the largest effect and that is about population another consideration.
That are experts are urging us to look at is whether the drag would have an effect in the population of 12 to 18 year old ITT population that primarily has the mild type of a D associated with severe printers and four wins.
Hi, there no approved.
Hey, systemic treatments, we will know that mild treatment is treated with a.
Good skin hygiene them audience, and also local claims, including continuing inhibitors and crucible.
So in that population.
A systemic safend pay pretty thick to thin can play a significant role so high.
Vanda plan is to continue to utilize the if you on the a wealth of data.
Quickly reassess Oh, how we can best utilize the ongoing if you only need to study which can be.
Streamlined and by that I mean that.
We did dissolved sinking biking is we see fewer patients will be needed.
To evaluate whether or not the results in nippy Arnie is confirmed.
And I can be certain that we also answer the regulatory question what does it mean, if you succeeded to confirm this result.
I would say it depends a typically the regulatory agencies would require a two confirmatory studies.
But of course it depends on the.
Magnitude of results seen upon confirmation so I will leave it there and I'm sure we'll have more to say about that can the coming quarters.
Okay.
Okay that makes sense, absolutely, okay, and then for.
It was at least in my mind can speak usually not mention but there was obviously you know interaction with the FDA with respect to.
The long term toxicology requirement for a nine month dog study and clearly there was a court decision recently with respect to that so has there been any additional interactions between band and the FDA on this program and what updates can you provide to us with respect to strategy.
Yeah. So.
To recap and summarize for all our audience.
Vanda has a disputed.
The necessity of an additional nine month dog study as a pre clinical additional toxicology study on top of all the toxicology studies that have been done without any significant safety signals that could inform a human studies.
Of course, the FDA disagreed with that Oh dispute went to to the court a court decision recently agreed with the FDA that well they have not provided.
Oh evidence that this study should be required and how is it predictive for human safety record. Nonetheless agreed with the FDA that they have the authority to decide whether to requires such study or not.
We continue discussions with the FDA.
We evaluate and number of options.
That.
Include a regulatory path.
But also even additional boss said I'm not gonna specifically addressed today. So the Oh, our view is that we have a number of options in front of us and we remain optimistic or that we will identify is suitable solution.
Okay, and you know I I certainly respect that you know you're not prepared to discuss those strategies strategic options right now, but when can we expect a more color information on that strategy. Just I guess is progression discussions progress with the FDA or is there something internally that needs to happen to bank kinda.
To be able to put that forward.
Well, we say a you know we give you have data where do we have the update.
Okay [laughter].
Certainly you know there a lot of.
Thanks in process.
Hey, specifically with the.
The FDA that we hope we can make some sense.
Okay and then maybe just one last question for me also regulatory you know maybe you could just describe again with a packages for as to Madison and what has been your interactions with the FDA with respect to that package.
So the the bank is is we discussed before the core a part of that package.
Is the.
Phase.
Three single Phase three study or does it was a study that will discuss crossover design. The results of this study have been discussed with the FDA a in a P.M.D.A. meeting.
And we agreed what we will submit a we have.
Submitted.
And were waiting for this package to be filed and it has two components one is the.
They see a clinical data, but also a a separate as Cindy a on the liquid formulation.
Mind, you that study was conducted in both adults and children.
And it included a both the current capsule formulation and the proposed liquid formulation.
Okay, Okay, great well. Thank you so much my honest for taking the questions and I'll hop back in the Q.
Thanks, Chris.
Our next question comes from a line of Jason Butler with JMP Securities. Your line is now open.
Hi, its Roy in for Jason Thanks for taking my questions I had a few on.
Tony I guess can you tell us what that baseline worse. It scores were for the mild versus the moderate and severe patient for each tree trimming groups.
And then I guess is it possible that any concomitant medications or other treatments confounded the results in a moderate to severe patients.
I will answer the last one we do not believe.
That any concomitant medications have confounded.
So we truly believe that you see very tied a is actually true and not confounded finding a within that population.
I would refer you for the first one.
To the figure to.
In the press release and that would be in a box be a you will see some baseline parameters are broken by 81, two and ideally for and your question question worst its entered as a is that I baseline.
All patients who are required to have and Ah average Oh.
Worsted score of seven in Oh, great in zero to 10 scale and you can see here that the average was 7.2 is the I do want to group and 8.3 in the 3.4.
Okay, Great and then as far as 2020 guidance for HETLIOZ. It's kinda. It suggests slowing growth can you.
Describe what the main driver drivers of that is.
Hi, well.
It is it is through that if you calculate backwards and backout price, which you've done already.
That although we guide in the upper Dan on the double digit growth like we had to double digit growth is here. It's certainly those numbers are smaller.
It is the first quarter are there many things. So no. We are six years into the launch and as you know.
It is very very unlikely that projects I'm in a rare orphan disorder, we'll continue to grow like we've seen HETLIOZ. However.
Well, we still forecast growth in the non 24 business up the our initiatives that we have ongoing and hopefully we'll expand a in the coming quarters.
We believe that they cannot to that growth.
Specifically I would like to speak towards one of them.
As we have discussed in the past a non 24 disorder can be comorbid <unk> not only with us psychiatric disorders that we've spoken.
How about in the last couple of years, but also in patients with traumatic brain injury and traumatic brain injury, our hockey large number of patients.
We've got caught mild to severe concussions.
That does have the remaining sleep wake disorder, many times of the non 24 intact.
That association with Dbi is well known and described in the diagnostic institution Statistical manual five of <unk> psychiatric disorders.
What we're doing towards that is were exploring with neurologists.
There understanding interest and awareness.
Around the presence of non 24 in TV I patients.
This is a very early project, but you should expect says that our sales force and marketing will make a oh significant effort.
To identify and treat these patients. So that's one example of initiative and of course, we are hot baking into seats. They forget you syndrome <unk> indication approved.
So that will allow us to out market directly.
To the Prime Minister in patients with SMS, and we said in the past.
We appreciate our longstanding multi year relationship with a new organization presumes, a the key advocacy organization for several hundred and populous a into here.
Okay, great. Thanks for taking my questions.
Thanks right.
Our next question comes from Derek I feel like with Stifel. Your line is now open.
Hey, great. Thanks, guys. This is a bit on for Derek Thanks for taking my call I'm. Just wondering if you can share with data expected for this fanapt T.K. a study.
The I.
Pharmacokinetic studies going up but I can give the p. view.
Got the early data suggest that profile.
That will be compatible with a long acting injectable.
So while were continuing to learn and finalizing pharmacokinetic study were actually in the early stages of designing a.
Fanapt schizophrenia efficacy study with a long acting injectable.
Okay.
Thanks, and then one more for us.
Just in light of the Oh DTC spend campaign for for up to now.
How should we think about opex for for this year and then possibly in 2021 as well thanks.
As a you know just we've not given a specific number for opex were guiding.
For a <unk> cash balance at the end of the here to exceed a 320.
Now as we have said actually the Oh past quarter, we expect that the opex sequentially will be increased.
Due to and intensified direct to consumer campaign, including the <unk> campaign.
But also the number of Fox studies that were pursuing a in R&D.
Okay. Thanks to the information.
Sure.
Our next question comes from Joel Beatty with Citi. Your line is now open.
Hi, guys. This is Sean Egan, calling in for Joel a few from our team you know probably never results probably the only.
What did it seems current hypothesis <unk> could be effective in the mild patients versus the more severe and I know you mentioned that the mild setting the fisher typically treated with immune suppressive threats of agents could that be impacting or maybe just your high level of use or not.
Yeah, Hi that is a actually a question that of course, there's not a.
Complete answer however.
The prevailing literature today I suggested a topic dermatitis.
<unk> is a complex disorder and heterogeneous.
In that there are different types with different consolidate and different of course, so that mile day D is not any atopic dermatitis with mild symptoms, but rather a distinct <unk> what is called <unk> entities.
In fact, we have some references in our Presley's conduct.
Both decency mile de de and severely D. They experienced severe pruritus. So while they are characterized clinically by different type of leases mile di di is milder lesions. This severe a D is more severe decisions with a higher extend the.
Symptom of pruritus. Nonetheless is severe in both of that or can be severe in both of them now.
To the speaking towards the end the tight.
What we begin to understand and in fact.
We are conducting a very large analysis in the entire population of over 800 patients that we screen into the A.D. Luke in Boston had Com Oh Biomarkers.
But also.
The genetics of this individuals having now completed the whole genome sequencing analysis in every pace in this study what were identified.
Some of it is presented in figure to a India associated press release.
In panel see you wouldn't see the description that it appears that patients with ita wanting to have the lower yes, you know people count.
As compared to patients than I'd, a three and four and what is a very significant is that using a field com appears to be a marker of a disease not a marker of a disease states showed that patients who have high as you know feel account.
Upon improving their blood is going to feel count does not become lower so that is one very interesting a into tight.
The second one a in comes from genetics.
It appears that patients with I just wanted to do not have an accumulation of hot fill our game mutations <unk> protein, whose jane has been shown to be mutated.
Frequently in patients with the topic dermatitis cataloguing constituting a protein in the skin bear so what you see a you know said and it is beginning to be demonstrated in the literature as well that patients with wanting to do not have an accumulate.
Jason of inherited causes of his.
Skin barrier mutations.
So it comes down now to the question why would a NK one antagonist work better in idea wanting to done three and for the hypothesis kids as follows that substance P.
Maybe a prominent mediator of its.
In patients with the topic dermatitis in his team that does not have the inflammatory response and immune over action that you see in Ita, three and four NIGC and foreign severe lesions, we all know now that internally.
For interleukin 13, and the presence of other cytokine.
Someone and entire a response with secondary agents that Im increase it's so besides substance fee you will have histamine, she's retiring NCR and a number of site propane to rethink cytokine. So most probably the substance P contribution.
Gets flooded by other pre today indicated in the three and four and that is why well of course, we do see.
Response. The response is not a prominent it's not significantly better than what you see with placebo.
Got it. Thank you all if I really appreciate the color on that <unk>, maybe another question on HETLIOZ, just kind of shifting gears, a little bit and the delayed sleep wake feet phase disorder, and have you done much work no kind of understanding awareness for the indication and maybe to help us understand how high the unmet need is and how these patients are typically.
Treated currently.
Yeah. So DSP D. A is actually a condition that may affect a you know in different studies from a half to a several what percentage of the population and as we know it's more prominent are between adolescents in nonetheless.
Since in gunk adults.
What is very interesting people can self diagnosed very quickly calling themselves snide dolls or difficulty getting up in the morning and being a consistent.
Often people have trouble getting up to go to school or go up to work, but they have no trouble sleeping eight or nine hours when they left to initiate sleep.
On their on schedule and typically that is in the early morning hours.
Two three o'clock in.
In the morning, so much about prevalence in self diagnosis.
When things get worse and this be de <unk> impacts the occupation doesn't social functioning of these patients the seek treatment.
Unfortunately, there's very little to treat them with.
Because sleep the agent May help you fall asleep, but they will not to do anything to the circadian cycle and in fact a worsening.
The work we're doing now is also inspired by the work of five Michael Young at Rockefeller.
Who is in a belt prize winner a couple of years ago I haven't discovered a prominent mutation.
In humans with D C D.
Station.
Just a mutation in the cry one team and we're actually following up with that with an observational study in Turkey, where these families I came from in a collaboration with investigators in I'm correct.
And we're learning a lot about the expression of the S.P.D. there and also were doing a similar study.
With the SPD patients in the U.S. Our goal is to conduct an interventional study both in patients with cry on mutation and without try one mutation and begin to characterize the effect of a depending that population.
Perfect.
And then my last question is just with Jim leaving wouldn't be any kind of changes in the corporate strategy at the end there going forward.
Everything will be even better.
Oh, I and nothing immediate but I would like to take the opportunity and a really thank Jim for.
10 years, so far I told his tireless work building a significant parts of the company.
Often commercially and being a encouraging a developing RVR compounds and of course, putting up better communication with all of you guys and doing an excellent job.
Thank you Jim.
Hi, Jim.
All right, well and I'll take them I'm at a thanks models for bringing me onboard 10 years ago and being a part of everything that we filled and accomplished a you know my house and this entire team well certainly Miss all my colleagues passion, president and have enjoyed interacting with with yourselves.
Analysts and the investment community.
And look forward to watching great progress here Andrew in years to come.
Thanks, Jim.
Great.
I'm showing no further questions in queue at this time I'd like to turn the call back to Dr. Polymeropoulos for closing remarks.
Yeah, Hi, Thank you very much all for joining us plenty to be discussed Tony Peay on in upcoming scientific meetings and certainly we look forward updating you on all our programs next time. Thank you.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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