Q1 2021 Aurinia Pharmaceuticals Inc Earnings Call
[music].
Location. It is now my pleasure to turn the floor over to your host Glenn Schulman sort of the flow as yours.
Thanks, Matthew and good afternoon, everyone. Good afternoon, everyone and I'm pleased to welcome you to today's called discussing already and yes first quarter financial results joint.
Joining me on the call this afternoon or Peter Green leaf, our President and C. E O Max <unk>, Chief commercial officer, and you'll Solomon's Chief Medical Officer, and Joe Miller R T Financial Officer and.
This afternoon after the clothes, we issued a press release announcing our financial results and recent operational highlights which is accessible from our website at www Dot from radio farm, a dot com and it's been filed on a form 8-K with the S. P C as well and we also filed our financial statement and Manhattan management's discussion and analysis.
<unk> and a quarterly report on form 10-Q.
I'd also like to remind everyone that today's call is being webcast live on already it's I our website and a replay will be available approximately two hours after the completion of today's call.
Please note that the content space call is the property and Virginia and May not be recorded reproduced or transcribed without prior written consent obtained from Marina for.
For approval, please feel free to reach out to me Glenn showman via email at I R and arena pharma Dot com.
Also note that during the course of today's call. We may make forward looking statements based on our current expectations.
And he is forward looking statements are subject to a number of significant risks and uncertainties and our actual results may differ materially.
For a discussion of factors that could affect our future financial results and business. Please refer to the disclosure and our press release and on a quarterly report on form 10-Q, which is publicly available along with our most recent filings with the Securities and Exchange Commission and Canadian Security authorities.
And also please note that all of the statements made during today's call. Our current as of today and a 620 21 and are based on information currently available to us <unk>.
Except as required by law, we assume no obligation to update any such statements as of the state and.
With all of that let me now turn the call over to Peter Greenleaf, <unk>, President and CEO Peter failures.
Oh, Thanks go ahead, and and I Wanna, Thank everyone for joining us today I'm gonna spend a couple of minutes upfront walking everyone through our activities for the first quarter, including the launch a loop kindness will also review, what's coming up and the back half of the year a brief update on her ongoing clinical and R&D activities as well as a review of our financial position.
<unk>.
Show Introspect and little kindness launch as you all know by now we were granted F. D. A approval around the end of January and once we had the approval and hand, we got to work getting the therapy to patients and.
<unk> is here today, and he'll provide with with more specifics and a few minutes, but and short we're executing the plan and have a great deal of confidence and the team and and the trend that we're currently seeing during the first quarter and and two second quarter and we ended the first quarter with two months and hard data, which included too hot.
157 patient star forms and a solid all be it early conversion rate.
And these trends continue and have grown into the early part of Q2 things.
Things are off to a good start and just like any novel drug launch the back half of the year is going to be that much more important.
As mentioned by one of our sales side analysts notes most launches only realize is so small percentage give or take less than five per cent or so a first year sales and their initial launch quarter.
We had just 60 days so when you look at this metric we believe that we are right on trend and currently pointing and the right direction.
It's also and practice impressive to see these types of results and and environment highly impacted by COVID-19, and now with vaccines being broadly available and the U S and with current vaccination rates escalating around the country, we expect things to open up more broadly.
Ah returned and do something close to free COVID-19 levels would be a big event, especially for patients clinicians as well as our reps who are out there and the field doing their jobs every day.
On our and we continue to ramp up all of our activities are commercial team is out in the field and continues to educate clinicians we launched our consumer AD campaign for Luke kindness, which leverages traditional and digital strategies. We also continue to engage with the Payor community and I've seen more policies coming on line.
And and formulary inclusion per loop kindness, obviously, increasing our access with additional commercial and government providers.
A few of the things I'd like to mention as we look forward to the rest of 2021 <unk>.
First we're looking forward to the upcoming publication of the Aurora Phase III clinical study and a peer reviewed journal.
This manuscript has been accepted and it should be published and the very near future.
And we will also have bakos four and data presented at the upcoming you Lora and they are a congresses and June are.
Our day to display and new cuts a day to continue at every major medical event during 2021.
And the clinical and regulatory fronts, we along with our European and Japanese partner out Sukkah are making the final preparations and remain on track to file D. M. A a for backless born and the E M. A by the end of the current quarter.
In addition, we also remain on track with our plans for approaching the P. M D a and Japan this year.
With respect to our post marketing commitments to the F. D. A we plan to initiate our first pediatric adolescent study with thoughtless. Born later this year as well as finance finalizing our plans for required lactation study.
In addition, and the Aurora too blinded to your continuation study is on target to a Jesus database locked by the end of 2021, and we look forward to reporting to you all our top line results during the first quarter of 2022.
And behind the scenes are R&D group is actively working on continued product differentiation for Bakos Forum mortar reported in the future, but as you've seen and we continue to publish R&D work evaluating novel attribute tobacco's foreign related to its lack of impact on elements, such as glucose and lipids more to come in and.
Future on this and.
And then lastly on the financial front and we ended the first quarter with just over $360 million, which will support well us and our efforts well and to 2023.
So we have a strong balance sheet to support our ongoing activities.
I want and now turn the call over to Mexico out our Chief commercial officer will provide you with some more detail about our first quarter launch activities and after that Joe Miller are CFO will give you more details about how our first quarter financial results laid out so.
So with that let me turn the call over to Max Max.
Thank you Peter and good afternoon, everyone and.
Let me begin with the three takeaways, but I love actually from my remarks, and then I'll provide some supporting D.
From the key points.
First as Peter highlighted I'm pleased to report that our progress and results and the first quarter are in line with our expectations are.
A rare disease commercial model is working second the dynamics of launching and the COVID-19 environment are proving to be even more of a challenge than we initially expected.
And let me tell you that's really saying something because we went into this environment with our eyes wide open even so the headwinds have been stronger than forecast and so more about this and admitted as well.
The third takeaway is more promising and that is an event both rare and significant that occurred after the quarter closed.
It has the potential to generate additional momentum by providing clear payer guidance and establishing look kind of coverage policies.
That's cost per excitement not only for us, but also for patients and their caregivers and I will provide details and just a minute.
But first how about some greater detail around the first quarter.
The matrix I'm gonna share reflect 48 business days of activity post approval.
Over this time, we've tenaciously worked to drive with kind of adoption and to support Hcp's and patience to.
To gain access to treatment.
To give you a sense of a back of the magnitude behind the suffer more than 2000 and Hcp's have attended our education programs.
These have been a very effective form for top kols to share their insight on the current state of the art and treating lupus nephritis, and I'll move kindness and particular.
In the field, we've engaged over 6008 to.
To educate identify patients.
This represents 50 per cent of our target universe.
That number is even more impressive when viewed in the context of the current COVID-19 environment, where HCP access remains a formidable challenge.
And when you consider that over 60 per cent of these interactions have been face to face versus remote you can see why I say the team's efforts have been truly tenacious.
As a result of these efforts we received 257 patient start forms into her in your lines and Q1.
In terms of conversion rates, 40% of these patients started treatment by the end of March.
It's important to remember that this difference is not do either bad start forms or lack of access.
Rather it reflects the time it takes for a script to be fully vetted by of care.
And then reimburse.
Dot timing can be anywhere from 22 as many as 50 days.
So the real point here is that are in your alliance has clearly benefactive and supporting patients and providers game product access.
<unk>, we see further evidence of this as patient and start forms and patients on treatment continue to increase here and the second quarter.
Qualitatively the feedback from both patients and providers on a linear line support has been exceptional.
I'll share with you too brief quotes of the many comments that we received the.
The first one is quote the support has been exceedingly helpful.
As much as I love hearing that this next testimonial is the one I like even better and reference to renew alliance. This particular individual describes it as the best I've ever encountered.
Our team has been just as tenacious repairs as we have with healthcare providers and patients.
As a result of our proactive payer education efforts, we have today confirm coverage for more than 120 million lives.
40% of the total.
And even though it's still early 11 payers have published move kind of specific coverage policies.
As a man.
All of the policies provide coverage to our and patients. According to the labeled indication and are consistent with how Luke kindness with study and it's clinical trials.
We expect the majority of players.
To establish look kind of policies Max six months.
So to some of the first quarter these metrics around the kind of prescribing and access.
Actually ended up and mind with what we anticipated and.
And as such we remain confident and the credibility of our goal of establishing with kindness has the standard of care for outline and the viability of our commercial model to achieve that goal.
In fact, we believe our metrics would even be more favorable were it not for the limiting effects of the ongoing COVID-19 environment and.
And this is a mere conjecture, it's a belief that's grounded and data <unk>.
As reported by the World Lupus Federation Lupus patient care has been disrupted significantly by the COVID-19 pandemic.
And they're a recent survey Ah lupus patients W. O F reported that 50 50 per cent of the participants has decreased access to care.
Patients reported significant hurdles and seeing their physicians and and access to medical testing.
Our own data corroborate the impact of COVID-19 on our launch trajectory.
Consider this terror.
[noise] territories, and Florida, and Texas are outperforming territories, and Massachusetts, New Jersey, and Michigan buy multiples that range from five to 15 times.
And this variability is not a reflection of inconsistent town and the field.
As I mentioned on previous calls we've recruited a season committed and expert sales team for all geographies.
Is the completion of the institute of clinical and economic review, our ISR and <unk>.
<unk> completed cost effectiveness assessment, and it's published guidance for payer policy.
<unk> is a completely independent organization that.
That conduction reviews analyses to determine the extent of a channel.
Clinical value of drug offers over and above therapeutic alternatives and the current standard of care.
Also it evaluates whether or not the drug is priced in alignment with its clinical value.
And provides.
Payer policy guidance.
In other words it provides payers guidance on how to make a therapy available and what type of restrictions are appropriate to consider.
And their analysis of Leucadia's ISR leverage the knowledge and perspective of multiple stakeholders.
For instance, there was insight from world, leading Kols in this therapeutic area, including Dr. Brad Roven, Dr. Megan Mckay.
Also the solicited input from caffeine, Ernst and president of the Lupus and I'll lead Allied diseases Association.
And Linda <unk>, President and CEO of the Black Womens Health initiative.
And Sir actually saw and input from payers themselves, such as Humira Humana and Primera Blue Cross.
With all this multifaceted expertise and context.
Permit me to share some relevant verbatim from their report.
Well.
The <unk> is an important new treatment option.
That's good but it gets better.
Look <unk> is priced in alignment with estimates of its benefits for patients.
That's good too, but it gets better yet.
This should guide payers to defined coverage criteria that do not narrow coverage from the FDA label and that there is no other treatment that could be considered a first step treatment prior to eligibility.
Okay.
I have one more to share with you and it's the one I like the best and it's the reason and so enamored with it is that it comes from Icf's, President, Steve Pearson, who.
Understandably prides himself on a skepticism of drug company pricing.
But with regard to the <unk> He said quote.
It's a celebration to have needed treatments like this how often do we see brand new drugs, they're first indication to be to be priced within shouting distance of a fair cost effectiveness range almost never.
It's just that rare we're fortunate to be able to welcome that event and quote and thank you Dr. Pearson.
His point about how rare it is understates the case.
Four out of the 102 therapeutic assessments that ICF has completed over the years only 12 therapies.
12 therapies were judged.
Judge to be cost effective.
So again you can appreciate why we look at this as a true milestone events.
So to sum up as I promised at the outset, let me summarize.
We had a positive first quarter, we're on track no small accomplishment in this challenging COVID-19 environment.
And while I'm, the last person and the world to say that these challenges are fully behind us I do believe it's fair to forecast some reduction and these headwinds and the coming months.
They are definitely visible signs of this I mean, the uptake and rush hour traffic has to be encouraging I suppose.
But seriously to whatever degree that takes place there are multiple factors that justify our expectation for increased momentum.
And not the least of these is the feedback from providers and patients that they are you PCR numbers have been cut in half and even though the patients have been receiving with kindness for a short time.
That type of encouragement continues to energize, our incredibly dedicated are and your team who have gone above and beyond since launch.
Done a great job and communicating the loop kind of value proposition supporting providers and patients and the most challenging of environments.
It's exciting to see their efforts beginning to come to full fruition.
I'd now like to turn the call over to Joe for a review of the financials and Joe.
Thank you Max and good afternoon, everyone as of March 31, 2021 Arena had cash cash equivalents and investments of $361 million compared to $423 million at December 31, 2020.
The decrease is primarily related to the commercial infrastructure spend to support the launch of book guidance, coupled with an upfront investment made in connection with the previously discussed model plant manufacturing facility and onetime milestone payments triggered by the approval and first commercial sales with kindness, both of which were paid out in the quarter.
Net cash used in operating activities was $53 5 million for the quarter ended March 31, 2021, compared to $22 6 million for the quarter ended March 31, and 2020 the.
The increase was primarily due to the commercial infrastructure spend to support the launch of <unk> as a reminder, and the prior year. The company was still and the development phase with guidance and as a result, we did not incur any material related selling expenses the.
The company believes we have sufficient capital and financial resources to fund our current plans, which include funding commercial activities manufacturing and packaging of commercial drug supply conducting our plan R&D programs, including our FDA related post approval commitments and operating activities into at least 2023.
For the quarter ended March 31, and 2021 Arena recorded a consolidated net loss and $54 million or <unk> 40 per common share as compared to a net loss of $25 9 million or 23 per common share for branded March 31 and 2020.
Revenues were $1 million and $30000 for the quarter ended March 31, 2021, and 2020, respectively. The increase was a result of commercial sales of loop kindness, which began in January of 2021.
Cost of sales were 48000 and $0 for the quarters ended March 31, and 2021 and 2020, respectively. The increase was related to commercial sales and kindness.
Gross margin for the quarter was approximately 95%.
Research and development expenses were $9 8 million and $13 8 million for the quarter ended March 31, and 2021 and March 31, 2020, respectively. The decrease in expense is primarily due to lower contract research organization expenses and other third party clinical trial expenses following the approval.
Including a reduction and NDA preparation costs cash.
<unk> of supply cost following approval as well as the termination of the dry eye trial and Q4 of 2020.
R&D share based compensation expense for the quarter was approximately $1 1 million.
Selling general and administrative expenses were $39 3 million and $11 1 million for the quarters ended March 31, and 2021 and March 31 2020, respectively.
The increase is primarily due to the expansion of our commercial infrastructure administrative functions and patient assistant programs and support of kindness launch selling general and administrative share based compensation expense for the quarter was approximately $6 $6 million.
With that I'd like to hand, the call back over to Peter for some closing remarks Peter.
Hey, Thanks, Joe and Max and I want to thank you all for taking the time with us today and close its early days, but we're feeling good about the lupron and its launch and we want you to hear directly from us that we're executing the plan and right on track with our internal projections as we reviewed theres going to be a lot of activity going on and the back half of the year.
Year, and especially as things open up here and the states, we're excited about seeing greater progression.
We look forward to providing even more updates additional updates and the quarters to come in the months to come.
But for now we'd like to open it up to any questions that you might have so let me let me now turn it over to the operator for opening up lines for questions.
Certainly ladies and gentlemen, the floor is now open for questions. If you have any questions or comments. Please press star one on your phone at this time, we do ask that while posing your question. Please pickup your handset if you're listening on speakerphone and to provide optimum sound quality.
And once again, if you have any questions or comments. Please press star one on your phone.
Total and poll for questions.
Your first question is coming from Alicia young.
Your line is live.
Hey, guys. Thanks for taking my call.
Question and congrats on the new part numbers and it looks pretty bad.
A couple of things one I guess I know, it's early but can you kind of give us your perspective on what you're seeing and the real world around titration, and I know southern and <unk>.
And after that.
Our non Alibaba and the titration regimen and so I just wanted to kind of how to think about that and then just another question on <unk> can you give us and that kind of on some of the Medicaid formularies and different things like that if that is indeed, a clickable and just thinking about getting broadening out access and.
And then the last one and stuff.
And you know what you're hearing or what your how your sales force of counter detailing or educating against them.
Good day have I'm, sorry, I've been left that actually if.
If it happens to come up and the conversation.
Why don't I start out with the first and maybe the third question there and ask.
Max to build on the third and maybe give us commentary on the government pay side of the equation.
The simple answer Bill atheist, titration and this is for those.
And that don't know this is the Egfr dosing protocol that we have in place I guess, our experience has been net debt.
And with a few number of weeks out there and limited access to direct information from office to office as that it's that it's on track. So our net calc and turnover in terms of what we think our net value per patient per year has seem to be playing out and the and the early weeks of the launch.
So on track with what our assumptions would be my answer there at Lithia and then on.
<unk> been listed thing are first you can feel very comfortable that our team understands our data and understand theirs and.
It's not the primary that comes up and conversation I think and I'd ask Max colao to build on and that's from what he's hearing at the at the field level.
The primary is getting physicians to one identify what patient might be appropriate for this therapy, and then ensuring that there.
They are committed to <unk>.
Differentiating the product versus other therapies that might be available or challenging them on why they may.
You may not have the sense of urgency to lower proteinuria and these patients. So there is a big education factor and trying to change the way physicians have historically treated so I think that's coming up more often than hey, what I'm, making a treatment decision do I use been lister or do I use loop cognex.
So let me turn it to to Max and see if he can dig a little more into maybe that question and and the public payer side of the equation Matt.
Yeah. Thanks, Thanks, Peter and thanks for Lithia, Yes.
Peter spun on really what our focus is really creating that urgency in terms of bringing the patient in and and starting a treatment.
We're definitely seeing that Theres, just a large number of patients with high high levels of proteinuria that are non controlled and so it's really it's really working through creating that urgency and explaining the value proposition of leukemias and.
So Medicaid so it's a great question so.
As of April one and we've now confirmed that 90% of Medicaid lives have coverage. So we now are months out and the mandated Medicaid coverage is in place and so we've confirmed and 90% of lives now having coverage.
Oh Wow 90 per cent. That's also congrats again.
Thanks for Lithia and any more questions.
Now I'll hop back in queue.
Okay. Thank you operator next question.
Certainly your next question is coming from Ken and Kathy <unk>. Your line is live.
Hey, Thanks, guys. Good evening I know you reviewed a lot of different metrics. So I'm just going to ask a couple here to help us out just wondering as we get to the current moment is the pace accelerating of enrollment forms and.
Conversion of those enrollment forms so could you take us up to real time are you seeing a constant and steady building.
We're working through a little bit of a bolus, so just love to hear.
How you frame that out and then also now that you have engaged the number of clinicians that you suggest just just wondering as you're getting almost a real time survey of the patient landscape can you talk about your views of actual patient size I know, it's a debate amongst us investors and how many L and patients are out there and access.
<unk>.
I would think with your interactions youre able to kind of get a really good sense of that so you can talk about any learnings and just kind of early interaction and then also Peter I hate to ask the question, but there's been commentary previous from you. All about is the street consensus number achievable can.
Can you just kind of frame your commentary around what youre seeing consensus and how we should be thinking about that thanks. So much.
Okay. Thanks, Ken.
Sure well first let me just go into all the numbers that we gave for the quarter were sort of locked into the quarter. So I wanted to try to stay very consistent to that what I can tell you about both patient start forms and the time from a patient start forms turning into a patient on drug.
And have both steadily increased and our decreased meaning our PARP patients start forms per day per week continue to increase on pace as Mac said with what our expectations are into Q2 and with that a subsequent decrease we're seeing as policy start to come online.
Your line is.
Our or any alliance work with physicians and patient starts to come more online a decrease and the time. It takes from a patient to go from a patient and initial start form too.
And to actual drug and so so we feel good about the numbers as although we didn't quote exactly what the numbers are through this time period and a quarter, we feel good at the trends that we're seeing.
So I'll kind of I'll kind of leave it at that one thing you did mention is did we see a bolus of patients and the first quarter through patient start forms.
Call that we have and ongoing two year extension and our Aurora.
And.
Our original phase III Aurora trial, so we didn't have a group of.
30, or 40 patients that came out of that trial and went onto commercial drugs and so there was no bolus there and since we didn't have approval and our reps were newly trained we were not.
Out there identifying specifically patients for therapy to keep our our reps and the right zone from a compliance standpoint. So what you see generated has been the grass roots effort and the first.
Just just about just under actually two months of the first quarter of launch.
You asked a question about patient size I think our answer is going to be consistent here.
And I think we still believe there's somewhere between 80 to 100000 patients with active lupus nephritis and the U S and of that we think we have and ability to play and about 80% of those patients now what I will put a strong caveat on is we had seen.
And this COVID-19 environment access restrictions at certain centers, which is obvious many of the major medical institutions, especially tertiary care centers are pretty locked down right. So lupus clinics and many of those centers are not happening or theyre happening virtual and as a day to Mac share pace.
And visits and general and follow up diagnostic patients for patients with her visits for patients with lupus are down almost 50% and according to a very sizable patient survey done by the World Lupus Foundation.
It's kind of hard to tell what we're learning in terms of real world on the ground data because of the COVID-19 environment, but we still stay very confident and those higher there was higher level numbers as we learn more and things open up more and we'll make sure to relay some of that information too.
The markets and then lastly are your last question was centered around where consensus is and I will just reiterate that we feel comfortable and the zone of where consensus is.
And as.
As we are hard charging with our business that has not changed and the first quarter.
And a follow on question Scott.
No. Thanks, Peter I appreciate it and thanks to the whole team.
Thank you operator.
Another question and the Q.
Certainly your next question is coming from Joseph Schwartz Your line is live.
Great. Thanks for all of the helpful insights about the launch it's good to hear.
The encouraging leading indicators I was wondering if you could just expand a little bit by passing on some of the most common adoption patterns you're seeing.
So far.
For example is it mostly physicians that you've met with and person or virtually at.
Also the case and.
Who have submitted start forms and for which patients will be reaching for <unk>.
Is it larger practices are academic practices versus smaller practices and community practices at this point given what I heard you say about the greater appreciation for the importance of proteinuria at some places hoop and the early adopters and.
How do you expect the adoption patterns to evolve at the ground level.
Yeah, Thanks, Joe and let me, let me turn net rate too to Max Colao, and he can give you a little bit more color.
You know from the first 60 days or so of what we're seeing in terms of dock and physician trends Max share.
Sure Thanks trends.
So yes, so the prescribers.
It's 50% of them, it's really kind of split down the middle between Rheumatologists and Nephrologists.
50% on each side.
<unk> of our prescribing at this point is in the community.
Now there is most of the patients are and the community.
Issue there is that.
The physicians and the community we will only have a handful of patients right. So you have to reach many physicians.
And the community to drive adoption.
And the lupus centers, we've talked about this before there are about 60 <unk> centers in United States. They are most theyre all within academic centers. They are definitely the areas, where we have the most difficult time, gaining access some of the lupus centers are actually still virtual some of them plan to be virtual so till year end.
But we've gotten adoption in 50% of the loop the centers and we have some leading loop at centers that are starting to lead to start to lead the way, including Hopkins UCSF Suni.
SUNY downstate. So so we're pleased to see that we are.
Making progress even though it's.
It's more challenging because of the access issues.
Yeah, right and I can appreciate that and I'll make one more point, which is in terms of patients so the patient and staff.
Net are going on treatment.
Across all.
Class 345.
Primarily.
Okay, that's where I was going next actually and.
Are you finding that physicians R. R.
Is there really no.
Instead of common patterns I mean, how are the physicians choosing these patients as the next patients that were set.
And set to come in.
Anyway, they reaching out and any cases to their worst cases.
Are the is it patients that are.
The most refractory and advanced.
Yes, I would say that it reflects from.
The I would say that it reflects what we see to be the largest patient opportunity.
At launch, which are basically the patients that that may likely have been treated but are treated and they are not achieving their proteinuria targets.
Yeah.
And Joe the one thing I would add that was already said and I think it's an important point, we're seeing some regional differences right like where access is much higher and we're seeing a higher productivity and.
We think that trend is going to evolve.
As as things open up and some other geographies more that's the only thing I would add.
Very very helpful. Thanks again.
Thanks, Joe Operator, do we have another question.
Certainly your next question is coming from Maury Raycroft. Your line is live.
Everyone. Congrats on the progress and thanks for taking my questions.
First one is just checking.
Checking and to see if it's possible to see some Aurora two data and you learn.
And so just wanted to clarify on that.
Hum.
Or what else should we be expecting it and you are meeting.
Yeah, and then neil's on the phone.
Neil I don't know, if we've submitted or any of our.
And I don't have to ask you about the deadlines are for you Laurie, but you want to give any commentary on.
And what might be seen this year around Aurora to Aurora to Aurora two year extension.
Yes, I mean, obviously.
The Aurora two continues and combine these fashion, but there are interim cuts that have been made for them.
The regulatory submissions. So there was a <unk> FDA submission 90 day shift growth.
The EMEA and Europe, which is going and at the end of June and there is.
A presentation.
<unk>.
Some of that or two.
And in aggregate data.
And Tim in June and we don't have to the exact date.
So Tom and <unk> not been released yet, but you will see some of that.
See towards the back half of the U S and and the ACR and it's our intention to submit you've more day to that.
Got it okay, that's helpful and.
There are two extension data.
Just wondering if you tested that and your market research surveys with Kols and if that had any impact on their future use of loop kinase or if there's any any additional color you can provide on and the mark.
Research and and some of the results and you saw there.
Yeah.
Ill start and and.
Obviously, the Guy who is the closest to it Max class should should build on whatever I might miss here, but.
Listen I mean, Mack said it right like the intend to utilize the drug by both rooms, and Nephrologist is greater than 50 per cent right. So I think it's encouraging and that's that's irregardless of the Aurora two extension study.
And I wonder on Max if we've done any research specifically asking about that but I think it's intuitive.
Assume net debt with that data, it's only going to strengthen our position.
Primarily a safety study, but showing that the drug continues to be safe out to that time period is only going to strengthen.
Docs conviction around the product and the amount of time they can use the product do we have anything specific Max.
Non specific tour or too.
But what we do have specific two in the market researches that.
The efficacy messages are resonating.
And there is both strong recall and and high impact.
From the efficacy messages.
Definitely we see that the physicians are looking for more safety data and we believe that that Aurora II will be.
Important and helping to kind of illustrate especially what the long term treatment the consequences of long term treatment. So yes, we're looking forward to that.
Got it okay. Thanks for taking my question.
Thank you thanks more interest operator, and then another question.
Absolutely. Your next question is coming from Justin Kim Your line is live.
Hi, good afternoon, and thanks for taking the question.
Just one from me is the team able to characterize what a goal depth of engagement might be for targeted prescriber, maybe to say it another way, how many sort of interactions on average.
Maybe ideal before.
And had enough comfort and writing a script et cetera.
And how that sort of engagement has been impacted by the pandemic or improved over the recent months.
Yeah, I think we actually have some of that data and <unk> and.
And Max I don't know if you want to go maybe into a little of that detail.
Yes, sure and so and I alluded to this.
And the areas.
Really and the South where access is more open and actually we can get frequency with physicians and so that's where we're seeing the highest levels of prescribing and your question is spot on.
It takes multiple engagements for with the physician to get comfortable to identify the patient to get into a linear alliance.
On average across the nation we've had.
And I think it's about two and a half.
And <unk> across all of the prescriber base, but and the areas, where we see the <unk>.
Highest prescribing that that average goes into like 710 and above.
<unk>.
Got it and and maybe just another one is a follow up how long does the team expect to reach that sort of double doubling of the physicians engaged and is there sort of a time estimate in terms of how long that might take.
Oh, yes.
And I think we have our internal projections of.
Revenue reps getting out there and talking to docs, but you know the.
Alive engagements is going to evolve so I'm not sure I am not sure we have a.
We definitely don't hold that up as a metric to our sales force you're not going to want you to see X number of physicians X number of times, Max and we do have a more.
Antifouling will answer to that.
That's spot on because of the regional differences around access we haven't set specific targets.
But again, what we're seeing is that frequency increases as we as things open up.
Understood. Thanks, so much and congrats on a partner.
Thanks, Justin.
Operator, do we have another caller.
Yes. Your next question is coming from Ed Arc. Your line is live.
Hi, everyone. Thanks for taking my questions and congrats on the early partners to launch.
First the first question's just on.
The first obvious to your as you just get into the launch which is.
Patient access and reimbursement you mentioned at this point, you've already got 120 million lives.
<unk>.
And 11 per.
Layers of actually published.
And with kind of specific coverage plans.
I was wondering first if you.
Free to disclose any of those 11 payers.
And then with.
With those policies.
Are there any specific sort of restrictions along the coverage pathway that are of interest.
Especially given the broad label and the very favorable.
And I sort of recommendation just curious if there were any sort of.
Odd restrictions placed by any of those and.
And then lastly.
You mentioned.
The number of start forms and the conversions.
Again, it's early days I'm, just wondering if there have been any payer declination so far.
And again.
Max All Oh, TD U on net on.
And the payer and and other questions that I just ran through half a day color, but you are the closest.
And actually maybe on mute.
Yes, thanks for that so so thanks for the question and so yes 11 payers. They include let's see.
And our Sigma Hi, Mark anthem, a number of the blue crosses.
Health now.
So so that's the.
Those are the ones that have published look kind of specific coverage policies and like I said all of them are aligned to the labeled indication and all of them.
Me and are consistent with how it's how good.
And studied and I would say out of all those lies in the in the covered by the 11.
Policies, 90% of them don't have any.
Stepped through requirements and then the ones that do the primary sector requirement is through MMF and steroids. So those are those are the coverage policies.
Of course, we've had.
Payer denials and that's common just because even though if there isn't a covered if there isn't a look kind of specific policy. Then it's unclear what the criteria is and so you don't you do and this is typical and any rare disease launch you do go through a denial and appeal process on a set of.
A set of prescriptions.
And Thats just par for the course, but that's from what we've seen in terms of denials appeals and working through the process. There is nothing really that stands out that would be.
Different than what we've seen and other rare disease launches.
Great. Thanks, Mike I appreciate it.
Yeah.
Operator, do we have another question.
Thank you. Your next question is coming from David Martin Your line is live.
Yes, thanks for taking my questions.
First one relates to the last question that you were asked.
So the 11 payers that you need and what percentage of the 100 million lives do they represent.
Yes.
And so on that one.
It's hard to.
Exactly quantify that.
I would say it's.
Kind of very very rough estimate would be 20%.
And if the dose if amongst those 80 million and otherwise there isn't.
A specific coverage plan in place how how are the request for reimbursement handled and what what is the reimbursement and those situations.
Yes. So every payer has a non formulary.
The request process and its simply its typically just generic prior authorization type of form where the physician articulated the rationale of why they want to use.
The named therapy, and so that's the that's the process if there isn't a coverage policy in place.
Okay.
Another question are any patients or many patients coming onto Luc kindness as they start MMF and steroids or most of them coming on only after they fail dose.
Yeah. So so we don't have.
Visibility to exactly all of the treatments.
And the patients are on and when they started treatments. We don't have the visibility through Iranian line, but I can just tell you anecdotally that we are hearing of Av.
Newly diagnosed patients coming on <unk>, even though the bulk of the patients that are on the kind of us are ones that have been on other treatments and just are not getting to their personnel vehicle.
Okay and last question.
Has there been any pushback like you mentioned that some doctors are waiting for the long term safety data.
Are any not prescribing it until they get that data because it comes from urine inhibitors do have.
And the older ones have a history of solid long term nephrotoxicity and.
Is there any pushback because there are cheaper callison urine inhibitors on the market.
Well I mean, let me start there first off I just want to make sure we put the right context out there and it gets calcium and inhibitor data.
In terms of net for toxicity has been seen and primarily the transplant population and higher doses, that's not to say it doesn't the problem doesn't accrue to us and it's not to say that we don't get the question because we do.
And we do hear from some some physicians out there not a hesitancy to wait to utilize the product, but I think one of the areas. We got to focus on and really put intention and intensity of our education efforts around impact not just our not just our data but also.
So around disease state awareness and what the impact of not aggressively trading is on these patients we do hear that.
Well, yes.
No the drug and I know the data and you know I'll consider it for patients that that I consider for first generation and C&I like this is a better C&I, obviously those physicians don't even really understand how we've studied the drug and I think thats just a matter of education, but Max you can build on and I wouldnt say that that.
And as a and that is representative of the full community. We I'm just being completely clear that we do hear that question I don't know that we hear a lot that I am not going to utilize the product until I see two year data have we Max.
And.
And I would characterize just very consistent when you launch.
A new therapy.
And that's been studied and clinical trials. So you have a subset of physicians that will that are.
Our cautious and they want to see more data more safety data right and I think thats just very consistent with.
And what we're seeing is very consistent with what we've seen and other launches.
Okay.
Okay, great. Thank you.
Thanks, David.
Operator, and anyone else left and the Q.
There are no further questions in the queue at this time.
Okay.
Well listen I want to thank everybody for joining us after business hours on the East coast.
And as I said in my closing comments I wanted to.
Thank you and promise everyone that as we continue to make significant progress here and we'll look forward to laying that out over the quarter and quarters and months to come. Thank you for your time Tonight and take care.
Thank you ladies and gentlemen, this does conclude todays event you may disconnect. Your lines at this time and have a wonderful day. Thank you for your participation.
And.