Q2 2023 Arcutis Biotherapeutics Inc Earnings Call
Yeah.
Good day and thank you for standing by welcome to the argued as Biotherapeutics second quarter 2023 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 the session you will need to press star one on your telephone.
You will then hear an automated message advising that your hand is raised to withdraw your question. Please press star one again.
Please be advised that today's conference call is being recorded.
I'd now like to hand, the conference over to your speaker today, Eric making tire head of Investor Relations. Please go ahead.
Thank you Corey good afternoon, everyone and thank you for joining <unk> second quarter earnings call.
As for today are available on the investors section of our website on the call today, we have Frank <unk>, President and CEO .
<unk>, our interim Chief commercial Officer, Patrick Burnett, Chief Medical Officer, and Scott Burrows, Chief Financial Officer.
I would remind everyone that we will be making forward looking statements. During this call. These statements are subject to certain risks and uncertainties and actual results may differ materially. We encourage you to review the information disclosed in our latest SEC filings.
With that I'll hand, the call over to Frank.
Thanks, Erica and I'm going to make some brief introductory comments and then I'll turn it over to the experts here.
I'm on slide five of the slide deck.
I'm really proud that our team is effectively executing on our strategy to build the leading innovation driven dermatology company.
<unk> launch is strengthening on all fronts laying solid foundation for sustained long term growth physician and patient feedback remains exceedingly positive and the launch is building momentum.
We're really encouraged by our script growth as clinicians gain positive real world experience with <unk> and in Q2, we saw around 40% growth in <unk> versus Q1, and we've seen even further growth. So far in Q3 and remember we're just scratching the surface here on the broader topical steroid opportunity, which is still roughly 20 times the <unk>.
<unk> of the current non store market.
One key element to unlocking the broth in the long term conversion from topical steroids is our success in obtaining broad high quality access and we're thrilled to have announced the Cvs coverage decision in early July .
Less than 12 months from launch we've now secured coverage at all three of the large national Pbms as well as other large downstream health plans, which is unusually fast for any launch and we think as validation of our pricing and access strategy.
Currently more than $130 million commercially insured patients have access to <unk> and over 90% of those patients have access without any prior authorization, which meets our goals for high quality access.
I'm also pleased to report that gross to net has improved in the second quarter. As we had previously indicated and so far in Q3, we are seeing additional improvement in part due to the expanded coverage as well as our focused execution with the percentage of scripts being covered reaching all time highs and we expect further gross to net improvement in Q3 and additional improve.
In Q4.
Beyond those reviews launch we're also executing to build for the future in June we launched or even Canada, and thus far we've had an excellent reception from physicians and patients as well as rapid progress in building the same high quality access that we've achieved in the U S.
Early days, but the script growth has been healthy and we've already secured coverage for us right with the top three private payers representing more than half of the Canadian private market.
We also strengthened our overall patent estate with a recent recent issuance of a new patent covering methods of treatment of February dermatitis with were slim last for them and Thats a U S patent by the way.
We already enjoyed very strong IP protection on top of our swim last phone increase through 2037, and this new patent extends protection for the phone and separate dermatitis through 2041, which we're obviously delighted with.
So turning now to slide six we've shown this slide previously, but I think it is a reminder of the true opportunity for topical <unk> and also what makes it a very unique molecule with potentially four products in one as we execute multiple launches in the quarters ahead.
With the read today, we're competing in a market of about 2 million patients topically treated for their psoriasis in U S dermatology offices than.
Then we have potential upcoming launches every two to three quarters with <unk> at the beginning of 'twenty for <unk> in the second half of 'twenty, four and then scalp and body psoriasis in 2025.
We also have a very large opportunity outside of the dermatology office, particularly with the expected approvals in atopic dermatitis and separate dermatitis, both which are frequently treated in a primary care setting.
As we've indicated before we do not intend to build our own primary care sales force, but we'll look for a partnership to help US access this market in a cost effective way.
So when you factor in all of those opportunities were pursuing both inside dermatology and out that's a 13 million patient addressable market and more than a six fold increase over the current <unk> market, we're competing in.
Now I want to turn the call over to <unk>, our interim Chief commercial officer to provide more details on this re launch but before I do I want to comment on how impressed ive been with her performance as our interim CEO over the past few months.
I have no doubt about <unk> ability to fill in as an interim CTO when we appointed her to that role and she has done incredibly well filling in while we search for a permanent chief commercial officer. She is providing strong leadership and our commercial team has not missed a beat as you can see in our recent sales performance and with that I used to go ahead.
Thanks, Frank moving to commercial performance on slide eight we are proud of the growing momentum across all aspects of our launch everything starts with very strong product profile at the core which continues to pay dividends, but patients physicians and payers, we are seeing steady prescription growth at <unk>.
Clinicians gain experience and determining the rail world how does the REIT can perform for a variety of their patient.
And as we've said in the past do you think that somebody wants drug companies need to constantly evaluate tactics and adjust as needed and our team is doing just that our results in Q2 reflect our ongoing adjustments and improvements and we will look for ways to further optimize our performance going forward.
On this slide we're showing the TV demand data now approaching one year into launch we see healthy consistent growth trends, but nearly 40% <unk> growth quarter over quarter in Q T. Plus first further growth in the third quarter to date, surpassing all time highs in both Prs and <unk>.
<unk> post the fourth of July holiday.
Okay.
And patient feedback on <unk> performance in the real World remained exceptional, especially its rapid efficacy with the once daily treatment that can be used anywhere in the body the ability to use it in intertriginous insensitive areas as well as very positive feedback on its effectiveness in treating the most difficult plaques in areas like <unk>.
EMEA.
And of course.
Clinicians and patients who really appreciate the favorable tolerability profile of <unk> as well.
Moving to slide nine since launch we've made great strides and Unblocking broad high quality access for <unk> that will drive further patient demand and growth to net improvement.
As Frank mentioned is that <unk> is now covered on the top three largest commercial pbms on their national formulary, which gave us hcp's peace of mind about how easy it is for their commercially insured patients to obtain serene.
With over 130 million commercial lives now covered we have secured access for 80% of commercial lives in the U S.
With this broad coverage Hcp's don't have to think about where they are we may or may not be reimbursed.
Importantly, about 80% of commercial lives over 90% are covered without a prior authorization, which reduces the hassle factor that typically limits prescribers from putting pen to paper. We believe this distinction along with our product profile is critical to facilitating the long term conversion from topical.
Stir right.
We also expect that the high quality coverage enjoyed by <unk> will also help with our expected launches and fabric dermatitis and atopic dermatitis in 2024.
On slide 10, this slide details our broad high quality commercial coverage for <unk> on the national Formularies at the three largest pbms.
Payers are responding favorably to <unk> clinical profile with the most recent example, being Cvs not requiring a step for patients with psoriasis and sensitive areas.
Certainly a nod to our differentiated label and aligned with what is best for these patients in practice.
Our pricing and access strategy is resonating with payers as evidenced by a growing number of instances, where we have an advantage and utilization management criteria preferential tier status and certainly are trying to coverage compares favorably to other recently launched branded topical agents.
We're also making progress with coverage outside of the commercially insured population.
Just recently updated its clinical guidelines, where we see another example of pairs valuing the clinical profile of <unk> like Cvs. There is no step requirement for patients with platinum sensitive areas.
And to the VA also imposed a requirement to step therapy to step three of the <unk> to get to the other new branded non steroidal as we've said all along this difference this differentiated high quality coverage ultimately make sense or even less burdensome for health care providers to right, which is critical to converting the topical.
Stir right market over the long term.
Additionally, we're also starting to see benefits of our improved coverage and focus field execution on our gross to nets.
Our field reimbursement team is now fully on board, we have further fine tuned our co pay offerings and our sales team is making positive strides in pulling through covered prescription prescriptions. We have the right plan and tactics in place and are executing against that in Q2, we saw improvement in the percentage.
Prescriptions covered and that improvement has accelerated in Q3.
In fact in July we've seen our best month, yet in terms of covered prescription, giving us confidence in our plan and team's execution.
We are seeing improvement in the percentage of covered prescriptions across all major pbms, most notably since the Cvs coverage decision in early July we have seen a more than doubling in the percentage of prescriptions are reimbursed by Cvs.
We expect our improved coverage coupled with field force execution to produce improved gross to net in Q3 with further improvement in Q4, which reinforces our conviction that we can achieve our target steady state gross to net over time.
Yes.
On slide 11, I remind you all of the three pillars to commercial success that we set out for sustain <unk> growth first driving HCP awareness and expanding the prescriber base.
We have now seen over 7500 unique writers since launch.
We remain focused on increasing our reach and frequency with the highest prescribing healthcare providers.
At the same time, there is still a lot of headroom for further expansion of providers and we are actively targeting those hcp's, who have yet to begin prescribing the newer non steroidal.
Second patient engagement and experience.
Refills are growing very nicely in Q2 in Q1, we averaged approximately 20% it increased in Q2 to 27% and for the month of July our refills were approximately 33%.
Sustained growth here is important to achieve the long term potential of the Reed and also is an encouraging indicator of patient adherence to the right.
We previously we previously said that we would look at enhancing our DTC efforts as access comes on board more broadly.
With our recent progress on coverage, we feel the time is right to fuel the next leg of the <unk> launch into 2024 and beyond.
And as a result, we will be going live with a focused connected TV campaign later this quarter, which will activate patients to ask me to ask their dermatologists for is erased.
In closing, we look forward to delivering on the long term promise of the reef and with that I will hand, it over to Patrick.
Thank you Alicia for my end I, just wanted to provide a quick update on our near term clinical and regulatory milestones milestones and these are on slide 13. These all remain on track building significant sustained long term growth potential as Frank mentioned earlier, so starting off with atopic derm, we have been taking mid peed readout on track for later this.
Quarter and as a reminder, this study is in the two to five year olds. A population. We also look forward to submitting the NDA in late Q3 early Q4 for atopic dermatitis for ages, six and above based on the <unk>, one and two positive readouts.
Turning to February of dermatitis, we have our producer set for December 16th and HCP excitement is already incredibly high and right now we're doing a lot of disease state awareness with the medical team in the field.
Briefly on psoriasis, we look forward to the potential approval for a label expansion for injury or down to the age of two in the fourth quarter and this builds on our existing label for adolescents and adults in psoriasis.
One additional update on the early pipeline recall that we started a phase <unk> study with our unique topical JAK for alopecia Areata initially in healthy volunteers and now we've progressed through enrollment of our first alopecia area out of subjects in that study, we'll have more to share on this study as it nears enrollment completion with that I'll turn it over to Scott.
Thanks, Patrick turning to.
Page 15 of the slide deck total revenues were $5 $2 million in the second quarter net product revenues were $4 8 million driven by nearly 40% quarter over quarter demand growth as well as improved gross to net recall, we communicated in our last earnings call that we expected most of our second quarter growth would be driven by demand, but we were pleased to see gross to net improvement.
Meaningfully contributing to revenue growth as well in Q2.
Based on the expanded insurance coverage that our usual highlighted as well as our efforts to ensure prescriptions are appropriately process thats covered prescriptions. We expect further gross to net improvement in Q3 and continued improvement in Q4.
In the second quarter, we also recognized $400000 in other revenues, which was the value of an equity stake received from our previous collaboration partner.
Turning to the rest of the P&L.
Research and development expenses were $25 million in the second quarter. The decrease year over year is primarily due to lower clinical development costs as we wind down our topical referral bonus programs.
In addition to lower reform last development costs, the comparison versus the.
First quarter also benefited from the $3 million separation hepatitis FDA filing fee in the first quarter. Some one time favorable clinical study true ups and our broader efforts to reduce spend in our early stage R&D programs.
For Q3, we would expect R&D to tick back up closer to $30 million as we do not expect the same one time favorability from study true ups.
A further step down in R&D expenses in 2024.
SG&A expenses were $46 million for the quarter, reflecting our continued investment in is a re launch and the upcoming launches in February of dermatitis in atopic dermatitis.
As I just mentioned, we will begin our focused connected TV efforts later this quarter and into Q4, driving some additional SG&A expense growth.
Net loss per share was $1 16 for the quarter compared to $1 31 in the same quarter last year.
Turning to our final slide on page 16, we provide some key balance sheet and cash flow items, we remain well capitalized with cash of $270 million as of June 30.
Our burn decreased in the second quarter, driven by lower R&D costs, and the timing of certain payments.
Similar to my operating expense comments, we would expect cash burn to tick back up slightly in the third quarter as we invest in the psoriasis and upcoming scepter launches overtime wed expect a general downward trend in quarterly cash burn as revenues continue to grow and as we benefit from sales across multiple indications. We also remain confident in our near term ability to.
Further strengthen the balance sheet with non dilutive capital through our ex U S licensing efforts.
Concludes our financial update I will now turn the call back to Frank.
Thanks Scott.
Just in closing first of all I would like to thank all the members of the <unk> team as you can imagine folks are working incredibly hard to deliver these results and I am constantly impressed by the dedication of our team.
Also want to thank every one of you for taking the time out of your day to calling on our quarterly earnings call.
That we will wrap up and open things up to questions and answers.
Thank you we will now conduct a question and answer session. As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please stand by while we compile the Q&A roster.
Okay.
Yes.
Our first question comes from Tyler Van Buren of TD Cowen Your line is open.
Hey, guys. Good afternoon, it's great to see the improvement in coverage that occurred over the last quarter and you mentioned the percent of covered prescriptions are at an all time high.
So the first question is.
What percent of what was the percent of covered prescriptions during Q2 and July separately relative to Q1.
Then.
For a second question.
Just kind of related but just for additional detail on the quarter can you talk about the cadence of improvement of gross to net during Q2, I presume may and June were better than April as the second GBM came online on may 1st.
As we think about the trajectory heading into Q3 was the gross to net during June significantly improved relative to me.
Tyler Thanks for your questions.
Maybe I'll take the first one and then I'll ask you should it go into little more detail on your second question in terms of percentage covered prescriptions.
Level of detail that we probably are comfortable really getting into.
I will say that we are seeing a steady trend upwards.
Every every quarter in the percentage coverage and that includes as I mentioned earlier since the end of Q2, we've seen further improvement.
Do you want to maybe talk about.
What we saw within the quarter in terms of the cadence of improvement.
Sure. So first off what I would note is that as it relates to if there was a couple of different components. One what is the deductible resets. We did start to see an improvement there as patients actually got through their deductible secondly, as it relates to PBF number two coming on board once that implementation went in place we saw improvement.
And then further they're having further thereafter and then we started to see some improvements, but the pull through related to the reimbursement field team.
Okay.
Corey we can go to the next next question.
For our next question go ahead sorry.
Okay.
Corey go ahead. Our next question comes from Vikram.
Morgan Stanley .
Hi, good afternoon, thanks for taking our questions. We had two both on the or even psoriasis first could you just provide a bit of color on how the mix of patients being prescribed so might be changing over time since the launch in terms of line of use prior treatment status.
Things like that and then secondly.
Back to gross to net but taking a step back what's your current thinking on what a steady state gross to net could look like and what do you think your timeline is for getting there.
Yes, so maybe I'll take the second one and then I'll ask <unk> to talk about mix of patients.
I will say, our granularity and that data is.
Isn't perfect but.
I think we've continued to say that.
<unk>.
We remain confident in our ability to get to a steady state gross to net and somewhere in the 40% 60% range.
And we still believe that today, particularly with the improvement that we're seeing in Q2 and in Q3.
I think it's probably going to take us a little bit longer to get there than what we had initially anticipated, but certainly we think that's well within our reach.
The exact timing I think it's really difficult to predict we are in and I think a somewhat unusual circumstance that.
We're launching multiple products.
In the same window of time before we get to steady state.
The expected scepter launch in early 2004 and then.
In mid 'twenty, four and then scalp and early 'twenty for sometime in 'twenty five.
Every time you launch a new product that has impact on your gross to net trends I think it's difficult at this point for us to say exactly when we will get to a steady state.
<unk> said before it certainly won't be in 'twenty, three but I.
I also don't think its going to be 2028, but at this point I think it's too early to call and we'll we'll update you guys as we get more clarity going forward on that.
Can you maybe talk about the mix of patients that we're seeing.
Absolutely so in particular as it relates to the patient so first off it's similar to what we've discussed in the past.
It's the patients that have tried a steroid and or other topical and then also it's been a mix of patients that have tried a single steroid for the most part.
Thank you.
Alright.
I'd just add just as a reminder, in any given year.
95% of psoriasis patients are continuing patients theres not a huge amount of new patients coming into the system every year and so most patients have been on something previously for the plaque psoriasis.
Sure understood.
Thank you thank.
One moment for our next question.
Yes.
Our next question comes from Seamus Fernandez of Guggenheim Securities. Your line is open.
Great. Thanks for the question so.
Just two.
Quick question can you guys help us understand that.
There are accounts that you are.
Currently and in marketing to at this point in time, just trying to get a better sense of that some of the survey work that we've done has shown actually pretty strong penetration among physicians and users.
Tom.
With good growth expectations for that.
There are internal.
Use but it seems like the kind of growth that that would deliver.
There isn't a lot of additional growth in the practices that you're promoting to that.
Really as kind of practice growth and greater experience that's going to drive.
Script growth for <unk>, and then separate and incremental to that can you just help us understand.
Whether you whether you believe your fully resource.
With the current sales force and kind of the marketing efforts to launch the foam once the sub derm indication as long as <unk> is approved.
Sure.
When you say accounts Youre talking about physician accounts right correct, yes, exactly yes, so I think I mentioned on the call that right now about 7000.
Physicians have prescribed <unk>.
<unk> and Thats out of.
About.
13000 targets, so there's still quite a bit of headroom in terms of bringing new doctors on prescribing <unk>.
And then I think the other fact that and I made reference to this if you think about the size of the topical steroid market today being in 20 times the size of the non sirona market even in those markets.
Those offices that have started to adopt.
There is still a great deal of upside in terms of deepening the prescribing base as well. So we think about growth as being both of those both in expansion of the base as well as the deepening of the prescribing base and I think as I mentioned I think in my introductory comments, we really think that we're just scratching the surface.
<unk> as.
I think the momentum around the move away from steroids built in the dermatology community.
And then with regard to your second question around Resourcing for Scepter launch, maybe again I'll ask Guy you should comment on that as our CTO.
Absolutely Frank so as it relates to the Resourcing. The team is well resorts from a sales force as well as a marketing perspective right now we're hyper focused on doing the disease state awareness education to providers and ensuring that and it's more focused on not just provider, but more importantly or to patients.
So definitely feel very confident in the resources that we currently have right now to help us to accelerate our approval excuse me got approvals.
Alright launch for us that breakdown the tightest.
Great. Thanks for the questions.
Thank you one moment for our next question.
Our next question comes from.
Mizuho Your line is open.
Hey, guys. Thanks for taking my question.
Just a quick one could you sort of.
So I think too early but can you kind of speak to the persistence rate.
Mike I think you mentioned.
Number.
Is it three 3% refills or something but.
Are you seeing this.
A lot more patient.
Are patients also going off.
Hum.
Continuing to use the therapy or not and I guess the second question financially I think Scott you mentioned.
2024 entity, a downtick could you just sort of help us quantify that in terms of R&D spend thank you.
Yes, okay, yes, so in terms of persistence persistence rate I'm, sorry, I think it's still.
Very early days to gauge exactly what that is as I mentioned that.
Refills in July have grown now to 33% of total of total volume.
And so we certainly have seen a steadily increasing number of refills from patients.
There are some patients who are refilling quite frequently I think Kent previously mentioned that we have seen patients refill as many as five times, but I think thats really.
At the at the Skinny and of the tail and Bell shaped curve. We continue to think that it's probably something like three tubes, a year and so the bulk of patients maybe just coming up on their first prescription refill right now, but that's something that we'll continue to monitor in terms of discontinuation due to a lack of.
You know our pediatric Adie study and our long term extension study ongoing that spend it will reduce again in 2024 and until were approved and step germ. Some of our ongoing for example, like manufacturing efforts continue to hit the R&D lines. So once that's approved that will all that will come out of the R&D line. So that's those are kind of it.
[noise] drivers that we would expect going into 2024.
Okay. Thank you.
Thank you one moment for the next caller.
Our next question comes from the Latin of Chris You Bitani at Goldman Sachs. Your line is open.
Hey, Tim This is Stephen on for Chris. Thanks for taking my question two from Us.
Can you help us characterize the physicians have not yet prescribes or eve and how you think about gaining mind share among that group of physicians too.
To the extent that they're either they don't see the value in the product versus they haven't been adequately detailed to this point.
And then our second question is.
Can you just talk about why you think now is the right time to do television marketing ads I think you had talked previously about until you felt you had a sufficient level a pair coverage. So that would make sense to me I just want to hurt yourself. Sir. Thank you, yes, I sure can you made me take those too.
Yeah, absolutely can I think as it relates to the prescriber gotta have yet.
There was prescribed <unk> and have yet to write the Reed and I think we do have is at first is recognize that there are just ingrained habit with providers that are using topical steroids. Our team is consistently going in and helping them to understand what the value proposition is reed and reminding them at the important.
Because as we have a reminder is that out there. When you are talking to prescribers with those that have utilized <unk>, absolutely love and are bought and on the clinical profile now secondly, as it relates to your question TTC you are correct that and the fact that we've been evaluating this this tactic for quite some time, but we won.
Had to wait for us to read coverage to be in place and we are now at that critical mass, where we feel great to go ahead and flip the switch and turn it on.
Perfect. Thank you very much.
Thank you one moment for our next question.
Our next question comes from Louise Chin of cancer. Your line is now open.
Hi, Thank you for taking my question. So I wanted to ask you on sceptre on what gives you confidence that you can build a greenfield opportunity here.
Secondly, can you elaborate any of the payer work you did for some reason psoriasis for your a topic Dear I'm opportunity.
And then lastly, how do you think about a primary care partner, what would be an ideal company for Ya and any thoughts on timing of when we might need something with it would it be this year more likely next year and beyond thank you.
Sure. So I'll address the G. C. P. PS and then I'll ask I used to talk a little bit about our thoughts around around Sept Durham, and then sorry, excuse me I think around February I'm Gonna make sure of Patrick's amount of sleep and I'm Gonna ask you to talk about that as a clinician [laughter] and then we'll ask I used to to talk about the coverage. These just with.
Regarding PCP partnership I think from a timing standpoint, you know we've been saying consistently we feel like that is something that we really want to have in place around the atopic dermatitis launch, which you know is probably the second half of next year.
There could be a benefit to doing it earlier against <unk> is often treated in the primary care setting as well, but but we didn't feel like we had to rush to get the partnership ready for for <unk>. It will contribute you know I think as we get momentum going.
So yeah, I I would look to something second half of next year, probably is the most likely time frame and then in terms of the ideal partner you in an ideal world. It's it's a a accompany with a very capable and large primary care salesforce, calling on both primary care physicians internists and G p's as well as pediatricians, who are seeing a lot of.
Of atopic dermatitis patients and if there is a little bit of allergist in the mix that would be great too, but I think that that's less critical just because of the sheer size relative size of the three opportunities.
For us the most important thing is having someone who's very good execution.
Someone who works well with with our team and then Patrick can you maybe talk a little bit about that.
Senator of opportunity how much building, we really need to do versus just stepping into an existing market.
Yeah, absolutely yeah, I I think one of the key things about February actor or a Titus patience is that they're already in dermatologists office and and we we heard that very early when we started talking to them and it's and it's been borne out by you to repeat it AD boards and just more and more conversation. They they have just as many said <unk> patients in there.
Officers, they do psoriasis and and that's just people come in and keep in mind that there hasn't been a new drug for February dermatitis for decades, and so now we're gonna be bringing a nonsteroidal treatment that is really the first opportunity for them as a C. P has to be able to offer something new to there.
Patience you have her there for the entirety of most of their practice, they've been using topical steroids and antifungals and some <unk> combination and when a patient gets referred to them with February dermatitis. They offer that has been treated with these already and now they don't really have any a they do to offer them. So you know I think that's one of the reasons I mentioned that we.
Have just very high H C. P excitement over this launch is because it really fits with patients that they're already see and now it's gonna give them something new to be able to to treat them and I think that's you know that's one of the things that makes big a physician rewarding and so I think it fits really nicely with the the current practice.
And then I should do you want to talk a little bit about coverage and how how psoriasis in September my interact.
Yes, absolutely so what we've done to date as we built the groundwork with certain key pair agreements with psoriasis, that's actually going to help us to build a foundation for our access but <unk> I know in the past that we have alluded to having uhm agreements already in place and so that is what is going to be able to provide us with the act.
There'll be foundation that we need in order to secure the access for separate dermatitis.
Thank you.
Thank you one moment for the next call.
Ah next call comes from Sean Kim of Jones trading your line is open.
Alright. Thank you for taking my questions I guess or just one final question on the prescriber base.
So after 13000 dermatology, just that you mentioned or they're going to call.
And you are considered high prescribers and all of that 7500.
Prescribers that you mentioned how many are also considered hi prescribed person is you're seeing any improvements in terms of the number of prescriptions for prescriber.
One question on pipeline he says for <unk>.
I'm just wondering what the timing of <unk> My P. M is there any after Cassandra points for that program. Thank you.
Sure. So you know with regard to the prescriber base you know I think it is a relative term you know there are there are probably around 20000 clinicians working in dermatology that's M. DS at D O as as well as the nurse practitioners a physician's assistant so the 13000 that we're targeting already are the higher prescribing.
Clinicians and then within that there obviously are gradations as well you know there's a relatively small group of the very highest the physician prescribers or clinician prescribed as you know the so-called your desk. All eight definitely does all 10 doctors that's a relatively small number and then you know you've got.
<unk> middling doctors and then the <unk>.
Lower end of the high prescribing volume right. If you can think about it and you know I I think.
As a nation that you know there's no correlation between liveliness to use the newer nonsteroidal as an volume you have some very large volume doctors, who aren't using the new non steroid was you have some very low volume doctors are relatively levonne doctors, who are [laughter] and Unfortunately, you have high volume doctors, who are writing a lot of the New Orleans store I was includes rude as well.
<unk>, but.
You know is it really it it it comes back to just looking at their total volume across the entirety of of the the prescribing basket read the relevant prescription basket and I used to I don't know if you have any additional comments that you wanted to add about about the characterization of the prescriber base.
Nothing else, Frank I think you've covered it.
Patrick can you maybe talk a little bit about the the phase one study.
Yeah, absolutely. So yeah. This is a phase one be trial. So it's not really designed to give us a clear read on efficacy. We're really looking at PK profile safety Tolerability data as well as certain biomarkers that we would use to potentially inform our efficacy expect expectations within the next trial a phase two trial.
You know we've completed the healthy volunteer portion and you know, we're enrolling alopecia areata patients right now as I as I mentioned with regard to the timing of that study I think as we get further into the enrollment and we have a clear idea of exactly what that timeline will be will come back to you with a little bit more information on that but.
As of as of right now given where we are in the study were just not ready to get the same thing more about it.
Okay. Thank you.
Thank you one moment for our last question.
Next question comes from <unk> <unk> <unk> of need him. Your line is open.
Hi, This is Rohan <unk>. Thanks for taking our questions can you just talk about where you currently stand in terms of managed care coverage and where do you expect to be down the line.
And then what are your expectations for the upcoming entitlement <unk> should we expect different results can previous phase three trials. Thanks.
Sure Uhm Asia can you may be addressed the managed care question, the Patrick to talk about it with me.
Sure Uhm, so first off as it relates to our our managed care coverage as it relates to commercial uhm that noted earlier remark uhm.
And we <unk>, we have 80% of commercial coverage for our patient for plaques psoriasis, Rosemary excuse me and then uhm, the 80% 90% of those patients do not have to.
No prior authorization Uhm. Additionally, I will say is outside of the commercials at the commercial patient population. We did receive notice from the <unk> that we did receive access forgery, even send the clinical guidelines have been updated where there is no step required for patients with three that have sensitive that have plaques and.
Sensitive areas.
Yeah, and I can pick up on integument P. So just as a reminder, that is a study and the two to five year olds with atopic dermatitis and it's with the 0.05 per cent, what's the 0.05 and the 0.15 per cent. We're both studies in the phase two and the efficacy looked similar.
<unk> between those two doses in that trial in our expectation for the readout haven't taken the pieces that you would see a very similar safety and efficacy profile, what Michelle taking that wanted to with ages six and above you in general atopic dermatitis tend to have a similar efficacy across the different <unk>.
<unk> when looking at earlier clinical development program.
Thank you.
Thank you at this time I would now like to turn the conference back to Frank What's not B C U.
Okay, well first of all Sir Thanks, once again to everyone for for calling in and thank you for as usual a group of really good questions. I think we're we're blessed with a wonderful group of analysts that are covering company and we look forward to talking to everyone again in about 90 days for the next quarterly call. Thanks a lot.
Thank you. This concludes today's conference call. Thank you for your participation you may know disconnected thigh.
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