Q4 2020 Aurinia Pharmaceuticals Inc Earnings Call
Yeah.
Greetings and welcome to the Iridium at yearend 2020 financial results Conference call. At this time, all participants are in a listen only mode.
I didn't want you require operator assistance. Please press star zero under the telephone keypad. As a reminder, this conference is being recorded its now my pleasure to turn the call over to Glenn Schulman Senior Vice President Investor Relations. Please go ahead Sir.
Thank you Kevin and good afternoon, everyone I'm pleased to welcome you to todays call discussing of rainy its fourth quarter and year end financial results.
Joining me on the call. This afternoon are Peter Greenleaf, President and CEO of perennial Neil Solomons, Our Chief Medical Officer, Mexico, low Chief Commercial Officer, and Joe Miller, Our Chief Financial Officer.
This afternoon, just after four P. M. We issued a press release announcing our financial results and recent operational highlights which are accessible from our website at www dot of rainy of pharma Dot Com and has been filed on a form 8-K with the SEC as well. We also filed our financial statements of management's discussion.
On analysis in our annual report on form 10-K.
I'd like to remind everyone that today's call is being webcast live on our rainy of Investor Relations website, and a replay will be available approximately two hours after the completion of today's call.
Please also note that the content of today's call is the property of Iranian it may not be recorded reproduced or transcribed without prior written consent obtained from Iranian for.
For approval, please feel free to reach out to me Glenn Schulman via email at IR at of rainy of pharma dotcom.
Also during the course of this call we may make forward looking statements based on our current expectations. These forward looking statements are subject to a number of significant risks and uncertainties and our actual results may differ materially for.
For a discussion of factors that could affect our future financial results and business. Please refer to the disclosure on our press release and our annual report on form 10-K, which is publicly available.
Along with our most recent filings with the U S Securities and Exchange Commission and Canadian Securities authorities.
Also please note that all of the statements made today during our call are current as of today February 24th 2021 and are based upon information currently available to us.
Except as required by law, we assume no obligation to update any such statements as of the state.
With all of that let me now turn the call over to Peter Greenleaf, President and CEO Peter.
Oh, Thanks, Glenn and thank you all for joining our call today today's agenda is pretty straightforward folks. This afternoon will be recapping what was a very busy fourth quarter of 2020 for the company sharing an update on what's happening just 23 business days post approval on launch of loop kind of us as well as what's the next as we.
To introduce this product to health care professionals and patients in the U S market.
Of course, we will also provide an update on where we're at financially as we close out the year.
We all know launching of product is obviously not as simple as flipping a switch or pushing a button.
The fourth quarter was quite busy with label negotiations launch readiness prep, our internal launch meeting and preparing to ship the product to the U S market.
We were also hard at work finalizing important long term agreements to shore up our ability to deliver and market loop kindness, well beyond the launch and to expand the product into global markets around the world.
On December 15th 2020, we announced the collaborative agreement with longer to build the dedicated manufacturing capacity within the company's existing small molecule API facility in Switzerland.
The dedicated facility provides cost and production efficiency for the manufacturer of Voc low scoring well.
All expanding existing capacity and providing supply security to meet future commercial demand.
Just two days later on December 17th, we finalized and announced an ex U S partnership with the without suk of Pharmaceuticals, the company with the strong nephrology expertise to develop and market baucus born in both Europe and Japan.
These actions ensure that we can take barco sworn to even higher levels beyond the U S and focus on it moving to a global product of all the while increasing the overall value of the compound and its global potential.
As part of the agreement a rainy of received an upfront payment of 50 million U S dollars and has the potential to receive an additional 50 million U S dollars and regulatory and reimbursement milestones.
And as you recall on the back end of the deal post market approvals, we share and double digit royalties and of course, plus manufacturing relationship with our partner.
Through this partnership of rainy is working closely with otsuka to ensure successful outcomes with the EU and the Japanese regulatory authorities in fact, Iranian ought to get already met with the EMA along with our rapid tour and co rapid turn early January and we remain on target to file the.
<unk> for an MAA in the first half of 2021.
We are also working with datsyuk of to execute on optimal strategy for and are interacting with and submitting of Voc lists for an application to the pharmaceuticals and medical devices agency or P. M D. A in Japan.
All of this of course has been happening in the midst of the U S launch.
Mexico Al will provide more specifics on the commercial team's progress to date.
But it's safe to say, we're right on track with where we want to be with loop kind of us out of the gate.
Of course post approval the company doesn't just stop and wait for the sales and marketing team to do their magic the.
Our clinical and our research and development teams remain hard at work finalizing the Aurora primary day to manuscript publication, which we estimate during the first half of the year.
Also continuous data display opportunities at upcoming major medical meetings.
And working on to meet post marketing obligations as well as in addition, preparing for pediatric and adolescent studies with Farquhar boring to begin this year.
Furthermore, the Aurora too blinded to additional year extension trial remains on track and we anticipate achieving database lock by the end of 'twenty 'twenty, one and reporting out topline results in the first quarter of 2022.
Lastly, we continue to evaluate options to further leverage development of Voc Osborne in new areas that strengthen our base L N indication.
We also do work to bolster our IP portfolio and strive to drive new innovation within our development pipeline through external as Asian and business development work.
I'm deeply impressed with everyone that they were on the or any of the team and their ability to remain adaptable and fluid as we operate through the pandemic in this unprecedented wet winter weather we've seen.
And we expect that things will only get better as the conditions have improved and we began to see a return to quote unquote normalcy.
I will now turn the call over to Max Colao, Our Chief commercial officer, who will provide you some more detail about the commercial team's activities after that our CFO, Joe Miller will provide an update on the fourth quarter and year end financial results. So with that let me turn the call over to Max Colao acts.
Thank you Peter and good afternoon, everyone.
So I'm happy to share with you what we've achieved over the past month since our approval and launch and it might begin by saying this is actually the 13th launch in my career.
I guess, that's a pretty good number and if nothing else. It just proves that AMOLED, but I'm, making a point because none of the other 12, where amidst an environment as unprecedented as what we all see with the Covid pandemic.
There's a lot of we've had to do in ways that have never been done before and as you'll hear in a minute. The commercial team has stepped up to this challenge in a very admirable way.
Of those 13. This is the fourth time I've launched the transformative therapy for a rare disease.
As many of you know the market dynamics that drive such our world of apart from launching of therapy for a larger patient population.
Those dynamics haven't changed even amidst COVID-19.
So while I can certainly appreciate everyone's interest in hearing comments related to prescription counts.
I'm sure you can appreciate that such numbers at this early stage and amidst this environment can't provide a good indicator of market response.
Even so I will say that we've been genuinely pleased with the level of initial prescription volume.
The numbers are tracking to our expectation in fact, if anything there are a little ahead of what we were anticipating.
We feel about the very initial very early initial trend and we will certainly be in a position the share more details around this obviously important metric on our next call.
In the meantime today it is entirely reasonable to highlight even at this early stage our progress in executing our strategy.
Just to refresh our strategy has for planks established with kind of as the standard of care and sure L. N patients receive optimal outcomes ensure there are no delays in the diagnosis of L N and critically ensure that patients can gain access to the kindness.
Achieving all four of these strategic objectives is critical to the success of look guidance.
What we've achieved in a short amount of time.
Showcases our ability to execute strongly towards these goals.
Look I mean this was approved late on Friday January 22nd.
The alliance was on mine right early on Monday, following the approval and receiving prescriptions within 15 minutes.
72 hours later look kind of this was in the channel.
Our field team was fully trained and deployed within hours of approval.
Christina Lee.
So far 70% of our sales calls have not been virtual set.
70% have been live and in person fully compliant local guidelines.
We think that in the context of Covid restrictions.
This high ratio of in person calls.
Firms very robust interest on the part of physicians.
It also speaks to the incredible dedication and tenacity of our team.
Talk about not letting range snow sleet get them away.
We all know what the weather has been like and this team is powered on to make them keep appointments with great energy and commitment.
Reports from our field indicate that the physician response to the kindness has been very positive.
As I've discussed before ours is not a team of novices.
They're very experienced the.
No. The stakes are high for us as a company and for them as individuals to hold back on sharing genuine feedback from the field.
In fact, our team has seen many physicians actually identify patients in real time during the sales call who are likely candidates for loop.
That degree of specificity and thought is obviously encouraging.
We've completed over 3000 calls on health care professional so far reaching more than 20% of our prescriber base.
These include not only individual practitioners.
Lineal staff of lupus clinics, which are starting to get set up for a loop kind of prescribing.
We've also completed interactions with payers covering 190 million lives and when we complete our upcoming scheduled meetings, we will have met with payers representing 75 per cent of the nation's insured lives.
Yes, that's <unk> 75 per cent of insured lives in just four weeks since launch.
That really does speak too intense and skillful execution.
Finally, but very importantly, the early patient awareness and response to our launch has been incredibly gratifying.
In fact I'll.
Close by sharing with you two posts from social media than I think say at all.
The first says.
Thank you. Thank you. Thank you.
My sister died many years ago as a result of complications from lupus nephritis the.
This means that other families may not have to go through that wrenching experience.
On another post begins.
Thanks for the Almighty finally, he has answered many people's prayers. Thank you Irene of pharma.
Happily. This is very typical of the comments that we're seeing and hearing so Irina alliance kind of a message.
Yes.
These responses not only continue to inspire us but they also confirm the confidence we have that our vigorous accelerated execution of our strategy is creating a highly fertile environment for an extremely successful launch.
Thank you and I look forward to further updates.
I'll now turn it over to Joe for a review the financials Joe.
Thank you Max and good afternoon, everyone as of December 31, 2020 arena of had cash cash equivalents and investments of $423 million compared to $306 million at December 31, 2019.
Net cash used in operating activities was $69 9 million for the year ended December 31, 2020, compared to $63 6 million for the year ended December 31 2019.
The company believes that it has sufficient financial resources to fund its current operating plans, which include funding commercial launch activities manufacturing and packaging of commercial drug supply and conducting our plan of R&D programs into at least 2023.
For the year ended December 31, 2020 Arena recorded a consolidated net loss of $102 7 million or <unk> 87 per common share.
Revenues were $50 1 million and 300000 for the years ending December 31, 2020, and 2019, respectively.
The increase of $49 8 million in 2020 was due to the upfront license payment received from US who got a $50 million recorded as licensing revenue on the fourth quarter of 2020.
Research and development expenses decreased to $50 3 million for the year ended December 31, 2020, compared to $52 9 million for the year end of December 31 2019 the.
The primary driver of the decrease of $2 5 million in R&D spend in 2020 was the decrease in drug manufacturing and supply costs lower contract research organization CRO expenses and other third party clinical trial expenses, partially offset by an increase in regulatory related costs as the rainy unprepared for FDA approval.
Corporate administration and business development expenses increased to $96 million for the year on December 31, 2020, compared to $22 3 million for the year ended December 31 2019.
The primary driver for the increase of $73 6 million was the build out of commercial infrastructure in advance of approval, which included an increase in salaries and employee benefits share based compensation expense and professional fees incurred during the year for.
For the three months ended December 31, 2020 Arena recorded a consolidated net loss of $8 1 million or five cents per common share Rev.
Revenues were $50 million and 300000 for the three months ended December 31, 2020, and 2019, respectively. The increase of $50 million in 2020 was due to the aforementioned upfront license payment received from otsuka of $50 million.
R&D expenses decreased to $13 2 million for the three months ended December 31, 2020, compared to $13 3 million for the three months ended December 31 2019.
The primary drivers for the slight decrease in R&D spend in 2020 was the decrease in drug manufacturing and supply costs lower <unk> expenses and other third party clinical trial expenses, partially offset by an increase in regulatory related costs as Irene of prepared for FDA approval.
Corporate administration and business development expenses increase of $38 8 million for the three months ended December 31, 2020, compared to $7 3 million for the three months ended December 31, 2019. The primary driver for the increase of $31 5 million in 2020 was the build out of the commercial infrastructure in advance of our approval, which included an increase in salaries.
Employee benefits share based compensation expense and professional fees incurred throughout the quarter.
With that I would like to hand, the call back over to Peter for some closing remarks Peter.
Hey, Thanks, Joe Thank you Max and thank you all for joining us, giving us your time today.
With the launches of of loop kind of underway. We want to hear you. We want you to hear from US bottom line debt. We're on track with our internal projections for the U S launch.
Furthermore, with our ex U S partnership with Otsuka, we look forward to working with them to expand into additional territories, including Europe with the upcoming in the MAA filing by the first half of the year.
2021 will also be a busy year with continued clinical development medical presentation surrounding varco, scoring.
We can also continue to work to enhance value by exploring opportunities to expand our pipeline and we look forward to providing additional updates in the months and quarters to come.
As I stated earlier, we continue to work to enhance value by exploring new opportunities to expand our pipeline.
As the launch in the U S progresses, we look forward to providing additional updates in the months and quarters to come.
So with that I'd like to open it up to any of your questions operator.
Thank you well now be conducting a question answer session, if you'd like to be placing of the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is on the question queue. You May press star two if he'd like true most of your question from the queue.
For participants using speaker equipment of may be necessary to pick up your handset before pressing star one one moment, please probably pull for questions.
First question today is coming from our VP of young from kids of Prestero of your line is now live.
Hi, This is I'm really I'm truly it there and thanks for taking my question I was wondering how you think about the lupus nephritis patient population in terms of getting treatment. During the pandemic do you feel like these patients are continuously going for their physicians to get treatment or do you anticipate maybe a bit of the challenge getting patient motivation.
Yes.
Yeah since we have on the ground experience with that now I won't project I'll ask Max what he's hearing from our field true smacks, what are we saying.
Yeah. Thanks. Thanks for the question, Yeah, I would say that its variable across the United States, we are definitely hearing.
Of the patients that are delaying their visits.
Also hearing of physicians that are actively engaging their patients either through telemedicine or getting them in line for for visit so we're seeing it's variable across the U S. But it doesn't take away from again.
FERC on our confidence in seeing that the patient opportunity is there.
Okay. Thank you.
Thank you. Our next question today is coming from Ken Cacciatore from Cowen and company. Your line is that a lot.
Oh, Hey, guys just have a couple of questions. I was wondering now that you've had a little bit more managed care of engagement is there any reason to sharpen.
The the kind of the net pricing that you gave us before of 65000, just wanted to know if theres any additional new once they're in and also in the early goings of just wondering if patients qualify for a medical exemption or how that's going to be handled.
The second question I have is just around the the whole process with Iridium Alliance I know this is kind of sounds silly, but with some early prescriptions written how smoothly as the system getting patients to sorry, getting product to patients and patients to actually be able to take the the medications just any early.
Really the glitches of successes that you're seeing in somebody wants there and then also wondering if you could help us a little bit on spending guidance for the year of some thoughts on that thanks. So much.
All of it thanks, Ken and I will take the bookends on this one I think as it pertains to you know the.
The net price assumptions, it's at the end of the day I think it's too early to tell on policies or are currently getting put in place and I think our assumption is still where we're where we want to keep it. So we'll keep you tuned as as things progress.
Mac do you want to take a take the following to the medical exemption captured on the other.
Yeah, and I can tell you that in all of our payer interactions the payers have they've appreciated that the.
The clinical and economic burden of L. N. They've also appreciated that vocalist foreign offers more than the standard of care and they are also appreciated that we're talking about a really small number of patients relative to their covered lives. So so we've been encouraged with our interactions and I can tell you.
That we have.
Prescriptions that are now reimbursed across every every payer segments. So we have prescriptions reimbursed on the commercial side on Medicaid Medicare and also our federal government.
I'll just tell you that that the payers. This is look like any other rare disease launch, we're going from prescription to kind of working through the adjudication approvals and finalizing that prescription it takes some time.
And definitely we are seeing that as well very consistent with what.
What you would expect an urgency for lunch.
And Joe you want to take the one on the unexpected guidance.
Yeah, Yeah. Thanks, Peter So as we've previously spoke the.
The Q4 run rates will are fully burdened with kind of the build out of our commercial infrastructure. So if you are kind of looking forward. It's.
It's probably best to look back on Q4 that'll give you a reasonable estimate of about where it will trend going forward, we haven't specifically guided to the numbers, yet but that would be a good target point to kind of look what's going to happen in the.
The future quarters to come.
Great. Thanks, so much.
Yeah.
Our next question today is coming from Maury Raycroft from Jefferies. Your line is now live.
Hi, everyone.
Thanks for taking my question so.
First question I am not sure on much more going to be able to say on this but just wondering if you can comment generally on the types of patients you're getting on with kind of is whether the patients are primarily switches from off label generics or treatment naive if youre getting more uptake in the community of academic centers and the additional perspective on on those.
Max jump right in.
Sure. So so yes maury thanks for the question.
It is too early for us to have any deep insights on the types of patients that we're seeing prescriptions for we'll definitely have more win as we get into our next call.
And Tony the <unk>.
Part of your question was the.
Academic versus community.
We are definitely having more access on the community side.
As you as you can.
As you can expect academic centers, especially in <unk>.
Heavy COVID-19 areas are pretty locked down so, but we're making inroads, we're making inroads across both but we definitely have better access on the community side.
Got it. Thank you and second question was just on.
If you can talk more about the potential to get could I go guidelines updated of is this a priority and is it contingent on the phase III data getting published.
Neil because I know those are in progress Neil Dr. Neil Solomons us on the call. So what Neil you want to give an update on the on guidelines, maybe even the manuscript.
Yeah, that's right I mean, I think is a good point I mean, our guidelines of could be helpful.
And we've been in contact with the.
The pizza of writing that goes on.
For few years now, but you're right the dates.
The refers to published data around the and that's why.
The sort of rapid publication of on time.
The.
As Peter said in the introduction is coming from these soon.
We're going to be instrumental in that kind of they will kind of wait wait for peer reviewed in the future.
Sure.
Guidelines.
Got it okay. Thank you for taking my questions.
Good morning.
Thank you for our next question today is coming from Justin Kim from Oppenheimer. Your line of there's a lot.
Hi, good afternoon, thanks for taking the question.
Just wondering when you think about the commercial launches progress.
Just how the team feels about the current commercial team and the footprint of the team is able to address during the current environment I know sort of Max gave some color about how there's heavy sort of in person touch points of just wondering how you feel about the size of the team and whether it could grow going forward.
Yeah, I mean, I think what we've said previously is we feel very comfortable with how we're deployed against the.
The opportunity that's out there today and Max can give more color as to how they're seeing that and interactions I can tell you from from other boards of commercial companies that I sit on these types of access numbers that we're getting live or are higher.
A bit higher than what we're seeing it at other specialty companies that I work with and so.
So we're encouraged by that I guess, the last thing I would say and then some.
Max if you've got any additional comments listen we've got resources that if if we found there was opportunity to shift of resource to a certain area, where we saw we could fuel an opportunity or we saw the possibility of needing to expand we could do that I think the the forethought.
Debt, we put in to making sure we have enough cash on the balance sheet to do this launch gives us the ability to make adjustments we have to make but I think the short answer is we feel were deployed right Max anything you're learning in the first couple of weeks for out there yes.
Yes, no I think its right on I think we've got the right level of deployment of its so early at this point it's really.
Very difficult to access otherwise.
Got it got it.
Maybe just another one on the sort of macro level are you seeing any differences and you know based on how you expected conversations between rooms and the Nephrologist to go just wondering.
On the commercial launch the target rooms.
Ending up the different from sort of your communications with Nephrologists.
The Max I think you can jump right in on that one I think the short answer is no, but he can give more detail.
Yes, that's the short answer is no. We're targeting both specialties were targeting of about 12000 physician across both specialties and the prescribing that we're seeing is across both specialties as well.
Okay got it.
And maybe just a final sort of.
Clarification question on.
On sort of the Opex side.
Those are the the R&D numbers were a little bit sort of low variable quarter to quarter. Just wondering is R&D fourth quarter numbers also sort of the right way to think about the go forward spend.
Joe Miller.
Yeah. Thanks for the question, yes. So.
As we kind of noted throughout the the call today. There are continuation study is ongoing so I would say directionally.
There'll be a shift in.
And R&D related expenses towards other activities, but generally speaking <unk>.
Directionally there'll probably be fairly consistent with what you saw on Q4 going forward on there might be some some timing related differences as a result of it.
And if when and when we start the trials, but overall I think directionally be fairly correct.
Got it great. Thanks for taking the question.
Thanks, Justin.
Thank you for the next question today is coming from David Martin from Bloomberg. Your line is now live.
Yes, thank you for taking the questions.
I know, what's the early but are you seeing the physicians are treating one set of patients with enlist and another shot with farquhar for them or our physicians, making a decision all treat all of my patients with one drug or the other and if patients are already on been less stuff for S. L E R.
Are there any cases, where they're adding box of sport and took that muster.
Yeah. So I think my answer to both of those would be a it's early probably for us to be to be seeing you know the trends and we're not actually out there of aggregating.
No data on on where bin list of fits into the treatment paradigm.
So let me let me see if Max has been hearing any of this and it might actually be good to see Neil has any comment as well but.
The answer would be I don't do I don't think we have much of that data at this stage of the game Max you're hearing of anything.
Look I.
Just.
Yes, we don't it's too early for us to have real insights to your questions are good questions.
We havent even brand market research pulse surveys yet.
Given that were 23 days into launch we have many schedule, but we havent run any yet right. So so we'll have more insights as we go along but it's the good questions but no.
We're not there yet in terms of debt does deep insights.
Okay and I did have another question Oh, sorry.
Yeah, Neil anything for you.
No as I was kind of odd that some of them.
Although people talk theoretically educate about the culmination of been the stream of looks for in a scene.
Too early we don't have loans.
About the commission, but some major in future months.
Okay. Thanks, Peter you mentioned post marketing obligations.
What are those.
What what are you required to do.
Yeah. So I mean, there are what we're required to do and there's what the FDA has had it further questions about the that we can sort of formulate a response to and decided whether we're going to do more work on or not so Neil do you want to maybe just go into some of that detail.
Yeah in terms of the requirements.
The things that we actually have to do is.
Presenting on the Aurora two funding stood of your pulp mix next year.
As number one of course for doing anyway, there's a lot of <unk>.
<unk> study.
And also the pediatric.
And the MPD actually funds loans.
We've also kind of a drug drug interaction trial, which.
It's something you have to.
Seasonal assortment of doing that.
Okay. Thank you.
Thanks, Dan.
Thank you as a reminder, that star one to be placed in the question queue.
Our next question today is coming from Ed Arce from H C. Wainwright. Your line is that of life.
Great. Thanks for taking my questions.
So for.
Firstly I realize again this is very early days as you've mentioned before of 23 days past the approval on launch but.
The Rx accounts can't really provide any good indication just yet but wondering.
Given.
The variability of and in the early days do you have a sense for when the that variability may make me sort of level out and therefore start to provide some indication of.
Of value for them, what the demand looks like how far out.
Before the Rx accounts actually start to.
Signal some sort of a trend.
And along with that are there any other.
The important metrics that are.
You're following on the launch that that could help provide.
Further insight.
Yeah, I think the Max mentioned many of the high level metrics that we're looking at right now whether that be you know the amount of calls were actually making on targets, what our access looks like in those targets.
The payer work that we're doing policies that were following et cetera, but all in in the second turn it over the Max and see if he wants to add any more color I think our promised everyone is gonna be that over time as we're more than 23 business days into this is to give more color not just on.
What actual prescription trends look like in policy and coverage trends look like but to also give give leading indicators of we think are important to look at we've given the ones. Today that we think are important this early in the game.
So and on the you know the prescription trend for them I think.
Just want to make sure everybody heard heard what we said I think while we're not giving exact numbers you should feel comfortable that the trends. We're seeing are on target with what our internal expectations had been with the from from day, one and our access numbers in terms of seeing physicians alive, albeit it's tougher in the academic centers is above target with.
Where we expect the debate so we feel good about things. We just think it's too early to throw numbers out there because those numbers I don't think we'd be indicative of of.
Really where we are so early so anyway, Max what would you add.
I think you I think you've come on.
On perfectly I think I think the only other net we're going to be watching very closely is.
They develop on kind of specific.
The policies right now we only have one payer that's developed the loop kind of specific coverage policy Bluecross Blueshield of North Carolina.
And I'm sure many others will follow in the next months.
Okay great.
And then just.
As a follow up to confirm I heard this correctly Max.
The.
Total number of payers that you're targeting.
The aggregate coverage.
190 million lives I think you said in.
With the next couple of meetings coming up in a few days.
The total insured lives would represent 75% or about 140 million of of that does that.
Of that correct.
But the numbers will add to the to the 190, we haven't I think it's another 36 million lives lined up in terms of these upcoming meetings.
Okay.
Great and then lastly.
With the data coming up in the first quarter of next year for Aurora two.
If you could remind us what.
Key data points, you're looking for there or what you're expecting and what you're measuring.
Yeah.
Thanks, Ed Neil you want to jump in and just give the.
Detail.
Yes.
I think it should be should remind the.
People. This is primarily a safety study that was on a commitment in the us.
Can we the primary.
From this from the strong but clearly the other the teams within the kind of as well.
Such as relapse rates in both zones.
Don't you see the stability of.
Renal function.
For the three year period, because of it seems like kind of compliance for the people continue to stay on drug.
Hi, Jim.
It's going to be kind of produce a huge amount of very valuable data for us and the prescribers.
Fantastic. Thanks, so much.
Thanks Jay.
We have reached the end of our question and answer session I'd like to turn the floor back over to Peter for any further or closing comments.
Well, thank you operator, and I want to thank you all for joining us on the call. This afternoon as you can see 'twenty 'twenty, one will continue to be the exciting year for the company and I'm looking forward to providing we're all looking forward to providing additional updates as our progress.
10 years over the next coming months.
Thank you all for your continued support and have a great evening.
Thanks for that does conclude today's teleconference and webcast you may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.