Aurinia Pharmaceuticals - Earnings Call - Q4 2020

Transcript

Speaker 0

Greetings, and welcome to the Aurinia Year End twenty twenty Financial Results Conference Call. At this time, all participants are in a listen only mode. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Glenn Schulman, Senior Vice President, Investor Relations. Please go ahead, sir.

Speaker 1

Thank you, Kevin, and good afternoon, everyone. Pleased to welcome you to today's call discussing Aurinia's fourth quarter and year end financial results. Joining me on the call this afternoon are Peter Greenleaf, president and CEO of Aurinia Neil Solomons, our chief medical officer Max Kalau, chief commercial officer and Joe Miller, our chief financial officer. This afternoon, just after 4PM, we issued a press release announcing our financial results and recent operational highlights, which is accessible from our website at www.auriniapharma.com and has been filed on a Form eight ks with the SEC as well. We also filed our financial statement and management's discussion and analysis in our annual report on Form 10 ks.

I'd like to remind everyone that today's call is being webcast live on Aurinia's 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 Aurinia. It may not be recorded, reproduced or transcribed without prior written consent obtained from Aurinia. For approval, please feel free to reach out to me, Glenn Schulman, via e mail at [email protected].

Speaker 0

Also during the course of

Speaker 1

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 a discussion of factors that could affect our future financial results and business, please refer to the disclosure in our press release and our annual report on Form 10 ks, 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 the statements made today during our call are current as of today, 02/24/2021, 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 this date. With all of that, let me now turn the call over to Peter Greenleaf, Aurinia's President and CEO. Peter?

Speaker 2

Oh, thanks, Glenn, and thank you all for joining our call today. Today's agenda is pretty straightforward, folks. This afternoon, we'll be recapping what was a very busy 2020 for the company, sharing an update on what's happening just twenty three business days post approval and launch of Luke Kinus as well as what's next as we continue to introduce this product to health care professionals and patients in The US 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 a product is obviously not 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 Leukanis well beyond launch and to expand the product into global markets around the world. On 12/15/2020, we announced a collaborative agreement with Lonza to build a dedicated manufacturing capacity within the company's existing small molecule API facility in Wiss, Switzerland.

The dedicated facility provides cost efficiency for the manufacturer of voclosporin while expanding existing capacity and providing supply security to meet future commercial demand. Just two days later, on December 17, we finalized and announced an ex US partnership with with Otsuka Pharmaceuticals, a company with a strong nephrology expertise to develop and market voclosporin in both Europe and Japan. These actions ensure that we can take voclosporin to even higher levels beyond The US and focus on it moving to a global product all the while increasing the overall value of the compound and its global potential. As part of the agreement, Aurinia received an upfront payment of 50,000,000 US dollars and has the potential to receive an additional 50,000,000 US dollars in regulatory and reimbursement milestones. And as you recall, in the back end of the deal, post market approvals, we share in double digit royalties and a cost plus manufacturing relationship with our partner.

Through this partnership, Aurinia is working closely with Otsuka to ensure successful outcomes with the EU and with Japanese regulatory authorities. In fact, Aurinia and Otsuka have already met with the EMA along with our rapitor and co rapitor in early January, and we remain on target to file execute an optimal strategy for inter interacting with and submitting a voclosporin application to the Pharmaceuticals and Medical Devices Agency or PMDA in Japan. All of this, of course, has been happening in the midst of The US launch. Max Kalau 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 wanna be with loop kinase 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 clinical and research and development teams remain hard at work finalizing the AURORA primary data 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 voclosporin to begin this year. Furthermore, the AURORA two blinded two additional year extension trial remains on track, and we anticipate achieving database lock by the 2021 and reporting our top line results in the 2022. Lastly, we continue to evaluate options to further leverage development of voclosporin in new areas that strengthen our base LN indication. We also do work to bolster our IP portfolio and strive to drive new innovation within our development pipeline through externalization and business development work. I'm deeply impressed with everyone at the on the Aurinia team and their ability to remain adaptable and fluid as as we operate through the pandemic in this unprecedented winter weather we've seen.

And we expect that things will only get better as the conditions improve and we begin to see a return to, quote, unquote, normalcy. I will now turn the call over to Max Galao, 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 Galao. Max?

Speaker 3

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 I might begin by saying that this is actually the thirteenth launch in my career. I guess that's a pretty good number. And, if nothing else, it just proves that I'm old, But I'm making a point because none of the other 12 were amidst an environment as unprecedented as what we all see with the COVID pandemic.

There's a lot 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 are a world apart from launching a therapy for a larger patient population. Those dynamics haven't changed even amidst COVID.

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, they're 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 to 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 four planks, establish loop kindness as the standard of care, ensure LN patients receive optimal outcomes, ensure there are no delays in the diagnosis of LN, and critically, ensure that patients can gain access to loop kindness. Achieving all four of these strategic objectives is critical to the success of Leukineus. What we've achieved in a short amount of time showcases our ability to execute strongly towards these goals. Leukinus was approved late on Friday, January 22.

Aurinia Alliance was online right early on Monday following the approval and receiving prescriptions within fifteen minutes. Seventy two hours later, Leukinus was in the channel. Our field team was fully trained and deployed within hours of approval. Interestingly, so far, 70% of our sales calls have not been virtual. 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 confirms very robust interest on the part of physicians. It also speaks to the incredible dedication and tenacity of our team. Talk about not letting rain, snow, sleet get in the way. We all know what the weather's been like, and this team is powered on to make and keep appointments with great energy and commitment. Reports from our field indicate that the physician response to kindness has been very positive.

As I've discussed before, ours is not a team of novices. They're very experienced. They know 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 lupus. That degree of specificity and thought is obviously encouraging.

We've completed over 3,000 calls on health care professionals so far, reaching more than twenty percent of our prescriber base. These include not only individual practitioners, but clinical staff at lupus clinics, which are starting to get set up for a loop kindness prescribing. We've also completed interactions with payers, covering a 190,000,000 lives. And when we complete our upcoming scheduled meetings, we will have met with payers representing 75% of the nation's insured lives. Yes.

That's seventy five percent of insured lives in just four weeks since launch. That really does speak to 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 that I think say it all. The first says, thank you.

Thank you. Thank you. My sister died many years ago as a result of complications from lupus nephritis. This means that other families may not have to go through that wrenching experience. Another post begins, thanks to the almighty.

Finally, he has answered many people's prayers. Thank you, Aurinia Pharma. Happily, this is very typical of the comments that we're seeing and hearing through Aurinia Alliance and other venues. 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 of the financials. Joe?

Speaker 4

Thank you, Max, and good afternoon, everyone. As of 12/31/2020, Arena had cash, cash equivalents and investments of $423,000,000 compared to $3.00 $6,000,000 at December 3139. Net cash used in operating activities was $69,900,000 for the year ended 12/31/2020, compared to $63,600,000 for the year ended December 3139. The company believed that it had 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 planned R and D programs into at least 2023. For the year ended 12/31/2020, Arena recorded a consolidated net loss of $102,700,000 or $0.87 per common share.

Revenues were $50,100,000 and $300,000 for the years ending 12/31/2020 and 2019, respectively. The increase of $49,800,000 in 2020 was due to the upfront license payment received from Otsuka of $50,000,000 recorded as licensing revenue in the 2020. Research and development expenses decreased to $50,300,000 for the year ended 12/31/2020, compared to $52,900,000 for the year ended December 3139. The primary driver of the decrease of $2,500,000 in R and D spend in 2020 was a 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 Arena prepared for FDA approval. Corporate administration and business development expenses increased to $96,000,000 for the year ended 12/31/2020, compared to $22,300,000 for the year ended December 3139.

The primary driver for the increase of $73,600,000 was the build out of commercial infrastructure in advance of approval, which included an increase in salaries and employee benefits, shared based compensation expense and professional fees incurred during the year. For the three months ended 12/31/2020, Arena recorded a consolidated net loss of $8,100,000 or $05 per common share. Revenues were $50,000,000 and $300,000 for the three months ended 12/31/2020 and 2019, respectively. The increase of $50,000,000 in 2020 was due to the aforementioned upfront license payment received from Otsuka of $50,000,000 R and D expenses decreased to $13,200,000 for the three months ended 12/31/2020, compared to $13,300,000 for the three months ended December 3139. The primary drivers for the slight decrease in R and D spend in 2020 was a decrease in drug manufacturing and supply costs, lower CRO expenses and other third party clinical trial expenses, partially offset by an increase in regulatory related costs as Aurinia prepared for FDA approval.

Corporate, administration and business development expenses increased to $38,800,000 for the three months ended 12/31/2020, compared to $7,300,000 for the three months ended December 3139. The primary driver for the increase of $31,500,000 in 2020 was the build out of the commercial infrastructure in advance of our approval, which included an increase in salaries and 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?

Speaker 2

Thanks, Joe. Thank you, Max, and thank you all for joining us and giving us your time today. With the launches of Leukinus underway, we wanna hear you we want you to hear from us, bottom line, that we're on track with our internal projections for The US 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 MAA filing by the first half of the year. 2021 will also be a busy year with continued clinical development, medical presentations surrounding voclosporin. We 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?

Speaker 0

Thank you. We'll now be conducting a question and answer session. Session. Our first question today is coming from Alethia Young from Cantor Fitzgerald. Your line is now live.

Speaker 5

Hi. This is Emily on for Alethia. 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 to their physicians to get treatment, treatment, or do you anticipate maybe a bit of a challenge getting patient motivation?

Thank you.

Speaker 2

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 troops. Max, what are we seeing?

Speaker 3

Yeah. Thanks thanks for the question. Yeah. I would say that it's variable across The United States. We are definitely hearing of patients that are delaying their visits, but we're also hearing of physicians that are actively engaging their patients either through telemedicine or getting them in live for visits.

So we're seeing it's variable across The US, but it doesn't take away from, again, you know, the effort and our confidence in seeing that the patient opportunity is there.

Speaker 5

Okay. Thank you.

Speaker 0

Thank you. Our next question today is coming from Ken Cacciatore from Cowen and Company. Your line is now live.

Speaker 6

Hey, guys. Just have a couple of questions. I was wondering now that you've had a little bit more managed care engagement, is there any reason to to sharpen the the kind of the net pricing that you gave us before of 65,000? Just wanted to know if there's any additional nuance there. And and also in the early going, just just wondering if patients qualify for a medical exemption or how that's gonna be handled.

Second question I have is just around the the whole process with Aurinia Alliance. Are are you I I know this is gonna sound silly, but with some early prescriptions written, how smoothly is the system getting patients to, sorry, getting product to patients and patients to actually be able to take the the medication? Just any early, you know, glitches or successes that you're seeing and and some nuance there. And then also wondering if you could help us a little bit on spending guidance for the year, some thoughts on that. Thanks so much.

Speaker 2

I'll, thanks, Ken. And and I'll take the the bookends on this one. I think as it pertains to, you know, the the net price assumptions, it's at at the end of the day, I think it's too early to tell. Policies are are currently getting put in place, and I think our assumption is still where we want to keep it. So we'll keep you tuned as things progress.

Max, you want to take the following too, the medical exemption question and

Speaker 7

the other?

Speaker 3

Yeah. And and I can tell you that in all of our payer interactions, the payers have they've appreciated that the clinical and economic burden of LN. They've also appreciated that voclosporin offers more than the standard of care. And they've also appreciated that we're talking about a really small number of patients relative to their covered lives. So we've been encouraged with our interactions.

And I can tell you that we have, prescriptions that are now reimbursed across every payer segment. So we have prescriptions reimbursed on the commercial side, on Medicaid, on Medicare, and also by the federal government. I can also tell you that the payers, you know, this is looks to me like, any other rare disease launch where, you know, going from prescription to kind of, working through the adjudication approvals and finalizing that prescription takes some time. And definitely, we're seeing that as well, very consistent with what you would expect in a rare disease launch.

Speaker 2

Joe, you want to take the one on expense guidance?

Speaker 4

Yes. Yeah. Thanks, Peter. So as we've previously spoke, the Q4 run rates will are fully burdened with kind of the build out of our commercial infrastructure. So if you're kind of looking forward, it's probably best to look back at Q4.

That will give you a reasonable estimate about where we'll 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 future quarters to come.

Speaker 6

Great. Thanks so much.

Speaker 0

Thank you. Our next question today is coming from Maury Raycroft from Jefferies. Your line is now live.

Speaker 8

Hi, everyone. Thanks for taking my question. So first question, I'm not sure how much more you're going be able to say on this, but just wondering if you can comment generally on the types of patients you're getting on loop kinase, whether the patients are primarily switches from off label generics or treatment naive? And if you're getting more uptake in community or academic centers, any additional perspective on those?

Speaker 2

Max, jump right in.

Speaker 3

Sure. 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 when as we get into our next call. And tell me, the second part of your question was the Academic versus community.

So Yeah. So we we're definitely having more access on the community side. You know, as you as you can, you know, as as you can expect, academic centers, in in heavy COVID areas, are 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.

Speaker 8

Got it. Thank you. And second question was just on if you can talk more about the potential to get QDIGO guidelines updated. Is this a priority, and is it contingent on the phase three data getting published?

Speaker 2

Neil, because I know those are in progress. Neil doctor Neil Salmons is on the call. So, Neil, you wanna give an update on, on guidelines, maybe even the manuscript as well?

Speaker 9

Yeah. That's right. I mean, I think it's a good point. I mean, guidelines are clearly helpful, you know, and we've been in contact with, the the people who are writing the guideline for for a few years now. But you're right that it's, but it refers to published data only, and that's why, the, sort of rapid publication of our primary management, which is, as Peter said in the introduction, is coming fairly soon.

He's gonna he's gonna be instrumental, and they can they will kinda wait wait for peer reviewed, literature, in order to update the guidelines.

Speaker 8

Got it. Okay. Thank you for taking my questions.

Speaker 2

Thanks, Maury.

Speaker 0

Thank you. Our next question today is coming from Justin Kim from Oppenheimer. Your line is now live.

Speaker 5

Hi. Good afternoon. Thanks for taking the question. Just wondering when you

Speaker 7

think about the commercial launches progress, just how the team feels about the current commercial team and the footprint the team is able to address during the current environment. I know sort of Max gave some color about how there's, you know, heavy sort of in person touch points. I'm just wondering how

Speaker 6

you feel about the size of

Speaker 7

the team and whether it it could grow going forward.

Speaker 2

Yeah. I mean, I I think what 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 in interactions. I can tell you from from, you know, other boards of commercial companies that I sit on, these types of access numbers that we're getting live are are higher, quite a bit higher than what what we're seeing at at other specialty companies that I work with. And, so we're encouraged by that. I guess the last thing I would say, and then, Max, if you've got any additional comments.

Listen. We've got resources that if if we found there was opportunity to shift a 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 forethought that we put into making sure we had 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 we're deployed right. Max, anything you're learning in the first, couple weeks we're out there?

Speaker 3

Yeah. No. I I think it's it's right on. I think we've got the right level of deployment. It's so early at this point.

It's it's really, very difficult to to assess otherwise.

Speaker 5

Got it. Got it. Great. Thanks.

Speaker 7

Maybe just another one on a sort of macro level. Are you seeing any differences in you know, based on how you expected conversations between rooms and nephrologists to go? Just wondering, you know, is is the commercial launch to target rooms, you know, ending up different from through your communications with nephrologists?

Speaker 2

Yeah, Max. I think you can jump right in on that one. I think the short answer is no, but he can give more detail.

Speaker 3

Yeah. That's it. The short answer is no. We're we're targeting both specialties. We're targeting about 12,000 physician across both specialties, and prescribing that we're seeing is across both specialties as well.

Speaker 7

Okay. Got it. And maybe just a a final, sort of clarification question, on sort of the OpEx side. I I I know sort of the the r and d numbers were a little bit sort of, variable quarter to quarter. Just wondering, is R and D fourth quarter numbers also sort of the

Speaker 10

right way to think about the go forward spend? Joe Miller?

Speaker 4

Yeah. Thanks for the question. Yeah. So as we kind of noted throughout the call today, there are continuation studies ongoing. So I would say directionally, there'll be a shift in R and D related expenses towards other activities.

But generally speaking, directionally, they'll probably be fairly consistent with what you saw in Q4 going forward. There might be some timing related differences as a result of when and if and when we start the trials. But overall, I think directionally, you'd be fairly correct.

Speaker 5

It. Great. Thanks for taking the question.

Speaker 2

Thanks, Justin.

Speaker 0

Thank you. Our next question today is coming from David Martin from Bloom Burton. Your line is now live.

Speaker 11

Yes. Thank you for taking the, questions. I I know it's early, but are you seeing that physicians are treating one set of patients with Benlysta and another set with voclosporin, or are physicians making a decision? I'll I'll treat all my patients with one drug or the other. And if patients are already on Benlysta for SLE, are there any cases where they're adding voclosporin to Benlysta?

Speaker 2

Yeah. So I I think my answer to both of those would be, you know, it's it's early probably for us to be, to be seeing, you know, the trends, and we're not actually out there aggregating, you know, data on on where Benlysta 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 if Neil has any comment as well. But but my my answer would be I think we have much of that data at this stage of the game. Max, are you hearing anything?

Speaker 6

Yeah.

Speaker 3

Look, I just it's yeah, we don't it's too early for us to have real insights, to your questions or good questions. You know, we we haven't even run market research pulse surveys yet, you know, given that we're twenty three days into launch. We have many scheduled, but we haven't run any yet. Right? So so we'll we'll have more insights as we go along, but it's a good question.

But, you know, we're not there yet in terms of that those deep insights.

Speaker 11

Okay. I did have another question. Oh, sorry?

Speaker 2

Yeah. Neil, anything from you?

Speaker 9

No. I was I was gonna add that, although people talk theoretically, hypothetically about the combination of Benelux and voxaparin, I think, it's too early. We don't have an awful lot, about that combination, but, we may do it in the future months.

Speaker 11

Okay. Thanks. Peter, you mentioned post marketing obligations. What are those? What what are you required to do?

Speaker 2

Yeah. So, I mean, there are what we're required to do, and there's what, you know, the FDA has had further questions about that that we can, you know, sort of formulate a response to and decide whether we're gonna do more work on or not. So, Neil, do you wanna maybe just go into some of that detail?

Speaker 9

Yeah. In terms of the requirements, which are, which are things that we actually have to do, there's there's presenting the AURORA two, final study report next, next year, is number one, which, of course, we're doing anyway. There's a lactation study and also the pediatric, adolescent and then pediatric plan as well. We've also got a drug drug interaction trial, which is something the FDA would like to see as well, so we're looking at doing that.

Speaker 2

Okay. Thank you. Thanks, David. Thank you.

Speaker 0

Our next question today is coming from Ed Arce from H. C. Wainwright. Your line is now live.

Speaker 10

Great. Thanks for taking my questions. So firstly, realize, again, this is very early days as you've mentioned before, twenty three days past approval and launch. But, and the Rx counts can't really provide any good indication just yet. But wondering, you know, given, the variability in in the early days, do you have a sense for when that variability may may may, sort of level out and therefore start to provide some indication of of value on what the demand looks like, how far out, you know, before the Rx counts actually start to signal some sort of a trend.

And along with that, are there, any other, important metrics that, that you're following in launch that that that could help provide, further insight?

Speaker 2

Yeah. I I I think, you know, Max mentioned many of the high level metrics that we're we're looking at right now, whether that be, you know, the amount of calls we're actually making on targets, what our access looks like in those targets, you know, the payer work that we're doing, you know, policies that we're following, etcetera. But but I'll, in a in a second, turn over to Max and see if he wants to add any more color. I think our promise to everyone is gonna be that over time, as we're more than twenty three business days into this, is to give more color not just on, what actual prescription trends look like and policy and coverage trends look like, but to also give give leading indicators that we think are important to look at. We've given the ones today that that we think are important this early in the game.

So and on the, you know, the prescription trend front, I think just wanna make sure everybody heard heard what we said. I I think while we're not giving exact numbers, you should feel comfortable that that the trends we're seeing are on target with what our internal expectations have been with from from day one. And our access numbers in terms of, you know, seeing physicians live, albeit it's tougher in the academic centers, is above target with where we expect it to be. 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, would be indicative of of, really, you know, where we are so early.

So anyway, Max, what would you add?

Speaker 3

I think you covered it perfectly. I think the only other thing that we're going to be watching very closely is payers as they develop blue kinase specific coverage policies. You know, right now, we only we have one payer that's developed a blue kinase specific coverage policy, Blue Cross Blue Shield of North Carolina, and I'm sure, you know, many others will follow in the next months.

Speaker 10

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 have an aggregated coverage, of a 190,000,000 lives, I I think you said. And with, the next couple meetings coming up in a few days, total insured lives would represent 75% or about a 140,000,000 of that.

Is that is that correct?

Speaker 3

That the numbers will add to the to the 190. We have I think it's another 36,000,000 lives lined up in terms of these upcoming meetings.

Speaker 10

Okay. Great. And then, lastly, with the data coming up in the first quarter of next year for AURORA two, just, if you could remind us, what, yeah, key data points you're looking for there, what you're expecting, and and what you're measuring.

Speaker 2

Thanks, Ed. Neil, you wanna jump in? Just give the Yeah. Detail.

Speaker 9

Yeah. So so I think it should be, should remind people that this is primarily a safety study. That was our commitment. And that's gonna be the primary, output from this from this trial. But clearly, are other things we're gonna look at as well, such as, relapse rates in both arms, and obviously, the stability of renal function, over the, the three year period together with things like compliance, whether people continue to stay on drug, or not.

But, yeah, I mean, I think it's gonna be gonna produce a huge amount of very valuable data for us and the prescribers.

Speaker 10

Fantastic. Thanks so much.

Speaker 0

Thanks, Dave. Thank you. We've 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.

Speaker 2

Well, thank you, operator, and I want to thank you all for joining us on the call this afternoon. As you can see, 2021 will continue to be an exciting year for the company, and I'm looking forward to providing we're looking forward to providing additional updates as our progress continues over the next coming months. Thank you all for your continued support, and have a great evening.

Speaker 0

Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.