Hello, and welcome to the Iridium Pharmaceuticals Blute Kinase Update 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 Doctor. Glenn Schulman, Head of IR.
Please go ahead, sir.
Thank you, Kevin, and good morning, everyone. Pleased to welcome you to today's call to discuss the FDA approval of voclosporin now with the brand name, Loopkinus, the first oral medicine approved by the FDA for the treatment of active lupus nephritis. Joining me on the call this morning from the Aurinia team are Mr. Peter Greenleaf, our President and CEO Doctor. Neil Solomons, Chief Medical Officer Mr.
Max Kalau, our Chief Commercial Officer and Mr. Joe Miller, Chief Financial Officer. On the evening of Friday, January 22, we issued a press release announcing the approval of luteinus, which is accessible from our website at ww.areneapharma.com and has been filed on a Form eight ks with the SEC as well. 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 email at iruriniapharma dot com. Please note that during the course of today's 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 today's presentation, both of which are publicly available and our most recent filings with Canadian Securities Authorities and the U.
S. Securities and Exchange Commission. Also, please note that all the statements made today during the call are current as of today, 01/25/2021, 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. As I mentioned, we'll have a brief presentation with slides.
A reprint of the slides are available on the webcast event page from our website at ir.auriniapharma.com. With all that, it's my pleasure to now turn the call over to Peter Greenleaf, Aurinia's President and CEO. Peter?
Thanks, Glenn, I want to thank you all for joining us today. If you haven't heard, obviously, it's official, loop kindness is approved. And I'm happy to tell you today that you're going to hear a lot more about the fact that the product is also launched. So we were notified last Friday by Administration and subsequently announced that evening that voclosporin has been granted marketing approval under the brand name Loop Kinus. Loop Kinus was approved for use with background immunosuppressive therapy in the treatment of adults with active lupus nephritis.
Loop kinase is now the first oral medicine to be approved for this indication. Now that this milestone has been achieved, we move on to our next priorities, communicating to healthcare professionals that Loop kinase is ready to be prescribed and of course getting our product into the hands of the patient population in need. It was just a week ago that we provided an update during the JPMorgan Healthcare Conference detailing our commercial readiness. With this approval in hand, we have already launched Lupinus, turned on all of our websites, activated our Aurinia Alliance patient support program and initiated support for all of our customers, including healthcare professionals and patients. We are locked and loaded and in fact have already received loop kinase prescriptions.
Before going into the specifics of the label and our commercial activities, I'd first like to express my sincerest gratitude to the patients, doctors and healthcare professionals who partnered with us on the development program that led to this approval. In addition, we are very grateful to the lupus and lupus nephritis community and advocacy groups that have worked with us and have been incredibly helpful in educating stakeholders about the need for screening, diagnosis and rapid intervention to control this disease. I would also like to acknowledge and sincerely thank our clinical, regulatory, research and development and commercial manufacturing teams who've worked tirelessly to realize the FDA approval for loop kinase and of course our commercial team who have worked to ensure program launch on day one. Drug development doesn't happen overnight. And in the case of loop kindness, the road has been long.
But all of the work, the studies and trials completed over the years enabled us to differentiate voclosporin as a truly distinct new chemical entity. So to all of you, we say thank you. As I mentioned, loop kinase represents a major advantage in the treatment of LN. LN is a devastating complication of systemic lupus or SLE, whereby the body's immune system attacks the kidneys. Loop kinase brings a new option for people affected with lupus nephritis.
Of the two hundred to three hundred thousand patients in The U. S. Living with SLE, it's our estimate that up to forty percent are believed to have kidney involvement and LN. This represents approximately eighty thousand to one hundred thousand LN patients in The United States, of which a large number are experiencing active disease requiring intervention as soon as possible. The indication granted to loop kinase is for its use in combination with background immunosuppressive therapy in adult patients with active LN.
Patients begin treatment with loop kinase as detailed in the dosage and administration section of the package insert. The dose is modified based on eGFR response, which is monitored every two weeks during initiation of therapy and monthly thereafter as is part of their ongoing disease management. EGFR is an easily and routinely conducted lab test and represents a straightforward approach to ensure individualized dosing tailored to patient. As mentioned, our label includes EGFR an EGFR dosing protocol that aligns with our 36 method of use patent, and we see this as expanding the scope of our intellectual property protection for loop kinase. That patent has a term of December 2037, and we anticipate it being referenced in the orange book.
Consistent with our expectations, loop kinase carries a black box warning regarding an increase of malignancies and infection, which is also in the label of many other immunosuppressive drugs that both rheumatologists and nephrologists are accustomed to using every day. Thinking back to just over a year ago, immediately following the positive AURORA clinical trial results reported in December 2019, we went directly into build mode to prepare for this critical moment. Within months, we hired a senior leadership team in the commercial space led by Max Galao, our Chief Commercial Officer. And from there, spent the spring and summer months recruiting top notch and highly experienced commercial people. By September, we had onboarded our entire sales force and had them trained and engaged with customers in the field, providing disease state awareness programs throughout the fall.
Despite a global pandemic, this team was assembled all virtually and represents a highly motivated, successful and experienced field force with an average of more than ten years of rheumatology and seven years of nephrology experience combined in the field. Our troops completed their launch training in a meeting last week and they are fully trained and deployed in the field as we speak. With loop kinase now approved by the FDA, along with our strong balance sheet with over $400,000,000 at the 2020 and a great team singularly focused on making a difference for this patient population, my expectations are high and know we have incredible aspirations for the future of this company. In short, we know how to execute. We've done it before, and we're going to do just that.
So, loop kinase profile and label reflect nearly everything we hoped and realized, demonstrating a superior renal response rates and the ability to reduce proteinuria twice as fast as the current standard of care. In parallel, to reducing steroid burden with the majority of LN patients having received two point five milligrams a day or less of corticosteroids and response rates achieved across a diverse LN population, we are truly excited for what Loop Kinus can deliver for patients. With that, I'm going to pass the call over to Neil for a brief review of LN, the clinical program that supported the approval, as well as why rapid intervention to control LN is so important. After Neil, you'll hear from Max Kalau, our Chief Commercial Officer, who is someone you all get to know quite well over the next few months as he executes on our commercialization plan for loop kinase. After that, we'll open it up to your questions.
So with that, let me turn it over now to Doctor. Neil Solomons. Neil?
Thanks, Peter, and good day, everyone. So systemic lupus erythematosus or SLE, as Peter said, is an autoimmune disease that can affect the entire body. Based on the literature and everything we know, conservative estimates suggest a prevalence of two hundred to three hundred thousand patients in The U. S. Up to forty percent have kidney involvement or lupus nephritis, which is one of the most serious manifestations of the disease with approximately ninety percent of sufferers women most of childbearing age.
It tends to be more aggressive in black, Hispanic and Latino patients. LN is a devastating disease and it's important to remember that it can cause irreversible damage to kidney and the clinicians want to control the disease rapidly. In essence, time is nephrons. There is a significant clinical and economic burden associated with lupus nephritis over and above that of just SLE. An LN flare or active disease may lead to permanent loss of kidney function.
This in turn increases the risk of kidney failure to the extent that up to thirty percent of LN patients experienced this within fifteen years. LN significantly increases the risk of premature death, especially related to cardiovascular events. From a healthcare system perspective, these patients have twice the hospitalization rate compared to other FLE patients with longer stays and drastically higher healthcare needs and costs once kidney failure develops. Understanding the goals of treatment in LLAN is important and is set out in very recent guidelines published in Europe. They give clear and aggressive targets to rapidly reduce the level of proteinuria by fifty percent at six months and to a level of 0.5 to 0.7 at twelve months.
Importantly, there is a need to reduce steroid exposure in doing so. I'm going to briefly remind you of the study design and why we believe that the results are so important. Voxelsporin was compared to placebo on the background of MMF and low dose corticosteroids. The criteria of renal response outcome are detailed on
the
slide. Of importance, after a year of therapy, the target UPCR of 0.5 was required in the presence of low dose steroids. The odds ratio in favor of voclosporin was almost three indicating a strong treatment effect around twice as many voclosporin treated patients achieve renal response as those receiving background therapy. Further differentiation of the LN treatment story is described here. Voxelsporin treated patients had a 50% response and a complete renal response much more quickly than those receiving background therapy.
A comparison of the median time to 50% reduction and achievement of UPCR of 0.5 is seen here with voclosporin treated patients reaching their respective goals in fewer days. Time is nephrons and achieving control of the disease is paramount. When reviewing the safety information, it's important to understand that it is consistent with Aurinia's expectation of receiving a calcineurin inhibitor class label. However, there are some differences that need pointing out. There is no black box for nephrotoxicity and diabetes and hyperlipidemia are not on the label.
Most common of those events related to some extent on the way the protocol was designed, reductions in the EGFR were anticipated and dose reductions written into the protocol reflected in the dosing and administration section. Adverse events were triggered when dose reductions were required and the same for increase in blood pressure, which were controlled primarily by adjustment of background medications. Voclosporin has a predictable and manageable safety profile, which permits personalized dosing without the need for therapeutic drug monitoring. Finally, I'd like to thank the patients and investigators that supported our development program around the globe. Approval is a result of extraordinary amounts of work completed by our pioneering clinical development and regulatory teams at Aurinia.
We continue to conduct the ongoing AURORA two blinded two year extension with results anticipated by year end 2021. Evaluation of voclosporin in pediatric and adolescent patients diagnosed with L1 as well as other post marketing requirements and commitments from the FDA as part of our approval. And with that summary, I'd like to pass the baton over to Max for a review of the Loop Kindness commercial and launch readiness. Max?
Thanks, Neil, and good morning, everybody. So as Peter indicated, I'm going to provide you an overview of our strategy, and I want to share with you some specifics that support Peter's confidence when it comes to our launch readiness. As Peter said, we are locked and loaded and not just ready to go, we're going. Our strategy is grounded in the premise that Neil just highlighted. And to reiterate, it's that early treatment intervention and renal response are strongly linked to better long term outcomes and preventing irreversible kidney damage.
With that in mind, there are four pillars to our commercialization strategy. The first is to establish kinase based treatment regimen as a first line treatment and as such to become the new standard of care. We expect clinicians to embrace loop kinase as first line because we've heard firsthand just how frustrated they are with existing therapies and the low complete renal response rates that they achieve today. Patients on loop kinase plus standard of care were more than twice as likely to achieve complete renal response and experienced a decline in uPCR twice as fast as patients on standard of care alone. The second pillar focuses on ensuring optimal outcomes, and this is going to be achieved in three ways.
The first is through early treatment intervention. We know this is necessary because we've seen in our profiling and research that there can be significant delays to treating active LN. The second key to optimal outcomes is by targeting low proteinuria levels. Here again, we've also seen variability in the types of outcomes that HCPs target for treatment. And the third approach to optimal outcomes is facilitating and enhancing a patient's involvement in their own care.
We know this is a significant opportunity because we've heard from patients that they lack knowledge and support relative to their treatment journey. So the earlier we can facilitate treatment of active LN and with patients actively engaged in their care, the more likely we will see optimal outcomes. The third pillar is to ensure no delays in LN diagnosis. And we know this is an issue too because LN is a rare disease. As in all rare diseases, there can be significant delays to a diagnosis.
In the case of LN, such delays may result in irreversible kidney damage, so the stakes are high. And as such, this is a strategic priority. The fourth pillar is all about ensuring patient access to loop kindness. Our goal will be to realize unrestricted access by educating payers of our compelling clinical and economic value proposition and by providing reimbursement support directly to patients. All four of these pillars serve an overarching goal of driving Leukinus adoption.
And to achieve this goal, we've deployed a very robust infrastructure, enabling us to access all of the key stakeholders. Capturing the attention and interest of these stakeholders in today's environment is not a simple task, and that's where the exceptional nature of the team that we've assembled will make a big difference. As Peter highlighted, our sales force comes with deep nephrology and rheumatology experience. In addition to the sales force, our team includes some of the most experienced professional advocacy relations personnel, field based access and reimbursement personnel that I've ever had the opportunity to work with. I can tell you from experience, this is truly a commercial team that ranks among the finest in our industry.
But I think it's also valuable for you to know it's not just a deep experience across our entire customer facing team that's so impressive. Having been personally involved in the recruitment and preparation of many of these talented individuals, I've seen firsthand degree of their passion and commitment to the patients that they intend to serve. It is truly inspiring. And I wouldn't underestimate the importance of such passion as a driver to our ultimate success. As we work with these stakeholders, we're confident that they will quickly recognize LUPINIS is a product with high clinical and economic value.
That confidence stems from the reality that until today, patients have had to settle for a standard of care with suboptimal and costly health outcomes. Leukinus changes that paradigm. It improves on efficacy and achieves faster results compared to the standard of care. These results are consistent across patient groups regardless of age, gender and ethnicity, which had not been the case previously. And in addition, through a Leukinus treatment regimen, steroids can be reduced to a low maintenance dose, significantly reducing their burden.
So you can see that the value proposition of Leukainus offers is quite compelling. And we've taken this into account in our pricing. Specifically, the price of Leukainus is based on one unit of sixty capsules. We refer to this unit as a wallet. And the wholesale acquisition cost is $3,950 per wallet.
While we expect the wallet dosing for each patient to be variable according to eGFR, we expect that the average net revenue to be realized for Leukinus to be approximately $65,000 per patient per year. This figure is not only based on patient specific eGFR dosing for Luke Kinus, but also accounts for factors including mandatory rebates, channel discounts and anticipated patient adherence. Now to ensure that patients can gain access to Luke Kinus, we have launched a patient support program called Aurinia Alliance, which will provide personalized reimbursement support and individualized case management. That's certainly an important part of our launch. And make no mistake about it, we are in launch mode already.
The extensive preparation in the past months has been fully activated. We've identified more than 12,000 physician targets. We've completed profiling for top lupus prescribers, and we've also completed education programs reaching more than 1,000 physicians. Furthermore, we've completed preapproval meetings with more than 50 payers, covering more than 100,000,000 lives, And we've done all this amidst one of the most extraordinary environments many of us have ever lived through. With our milestone approval on Friday, our commercial efforts are well underway.
MucKinus is available for prescription. We started to receive prescriptions this morning. The Aurinia Alliance program is live and online. Product is being shipped. Branded HCP and patient campaigns are rolling out.
And of course, personal and digital sales efforts have begun. Given everything that you've heard us discuss over the course of this call, I can speak on behalf of the entire leadership team when I say that our expectations are to achieve peak year sales of over $1,000,000,000 And as exciting as that is, we are just as excited, and in fact, even more so, to enhance patient outcomes in LN and to set our new standard of care. With that goal in our sights, you can count on the fact that we are ready, that we are willing and most of all, that we are more than able to make this a reality. So stay tuned for future calls when we look to share exciting news about our progress in this incredibly important and worthwhile endeavor. Thank you for your time today so far.
And now let's open it up to questions. So with that, operator, please open up for a Q and A session.
Thank you. And I'll be conducting a question and answer session. Our Our first question today is coming from Ken Cacciatore from Cowen and Company. Your line is now live.
Congratulations to the whole team and obviously wonderful for patients today. Just have a couple of questions. The first folks is around some launch metrics that maybe you'll provide us as we go along. Are you going to be giving us kind of some patient numbers? Any expectations around penetration rate?
And then maybe thoughts around the consensus figures, if you're not going to be giving us some sales guidance? And then just second question is around the label language around the dosing and the patent. Maybe it'd be helpful to give a little bit
of
history behind that patent and the prosecution history of it and why it's so critical. Thanks so much.
So why don't I start off? You've looked out on me a little bit there. So hopefully, can hear me, Ken, and good morning. First off, I think we've been purposeful in what we've tried to roll out in terms of the what we think the average net pricing will be per year. Launch metrics, obviously, have a pretty extensive list of key performance indicators we're going to be tracking.
But since this is a new indication, since we know there's crossover on how at least the DRG coding that we've seen out there is between LN and lupus nephritis. And of course, the fact that it's a new launch and we've got to ensure that everything gets up on the right ramp. We're going to hold back from metrics like specifically penetration, and what we think patients could be out there. Because while we have good epi numbers, these crossovers in diagnosis codes make it tough to really identify how many active LN patients are out there today. So we're going to learn a lot over the next thirty, sixty and ninety days.
And our promise to all our shareholders is that we'll add more in terms of the quantification of how we see the business as we learn more. Your other question about how we feel about consensus generally right now, I can tell you, while we haven't guided to a revenue number, we're not afraid of where consensus is at this stage of the game. And then your last question, Ken, was specific to the 36 patent. Let me add that, one, we were issued this patent in 2019. We have always been very bullish, not only because we're management, but because we've done our own technical diligence around this patent and the importance it brings to the longevity of the asset.
But we believe now that it is clearly outlined as an important factor to the dosage and administration of this product and we can move it out of the clinical trial setting and into the real world practice setting, will only further reinforce the importance and the enforceability of the patent. I'm not an IP attorney, but I can tell you having it in the dosage and administration section of the package insert as the preferred dosing of the product. And in addition, going out there with this as part of our primary messaging, so we can get the majority patients on this dosing protocol is only going to support and enable that 36 patent. So we feel very good about the fact that it appeared where it has. And to be honest, all along, Ken, we've said we really didn't see it another way since our Phase II and our Phase III trials had this in the clinical trial protocol.
Next question, Ken?
Yes. Guess I would just finish off with the Aurinia Alliance program. Often the plumbing of getting a prescription written into the patient, there's a lot of complications in between. And you did a great job of laying it out. Maybe just a little bit more context.
Sounds like you've really bulked up the staff to be able to engage in the patients on a one on one basis, both it seems clinically and also from a managed care perspective. But any more commentary around that? And that's my last question and congratulations again.
Thanks, Ken. And I want to let Max Kalau jump in on this one. But one of the things that I thought Max, brought day one, in his initial, buildup of the strategy for the company was the fact that he has the luxury in his career of crossing two major areas, one of which we were competitors in the past. But he spent a lot of his time on the rheumatology side of the business, building a biologics franchise around one of the largest brands out there in Enbrel and then shifted his career to spend more than a decade over at Alexion, learning and building really the rare disease model. And as it pertains to customer support and customer care and ensuring that patients get on, stay on and are supported through the process of getting on to a new medication, bringing this rare disease model approach to a highly specialized product, I think, is critical and is a key differentiator.
So sorry, Max, I probably stole some wind, but what would you add Yes.
No, it's all good. And thanks for the question, Ken. Yes, Auridialliance is a patient support program. We have built up resources, dedicated support personalized for each patient and health care provider. And we have an exclusive pharmacy network that's going to ensure consistency of care for all patients.
And we have some very, very high standards of the type of support that we want to provide patients and health care providers. And we've set up this network. We didn't go with an open network because we don't believe that open networks can really provide the standards to where we want to be with a Rinnie alliance.
Okay. Thanks, Ken. Next question.
Our next question today is coming from Alethia Young from Cantor Fitzgerald. Your line is now live.
Morning, Hey,
what's up? Congrats. This is awesome for patients. I guess maybe a couple for me. One, can you kind of just help us kind of unpack a little bit of what underpins the net price, I guess, particular, maybe how the market breaks out from a payer standpoint?
I would guess, is there some Medicaid? And then also just are you kind of assuming a higher baseline than this like 25% to 30% kind of eGFR reductions you saw in the clinical trial? And then the second one is just kind of, I guess, clarifying my math. When you went through the wallet, is the wallet as high as the like at the average twenty three mg dose, like roughly like three wallets a month? Or just kind of I wanted to just kind of unpack that math and think about the growth?
And then my last question is just, do you have any examples of dosing IP that's kind of similar to yours where the patent has been defended? Obviously, that's the big focus here. Thanks.
Yes. Okay. Let me start off. First off, the price of Leukinus is based on one unit of sixty capsules that we refer to as this wallet, as Max referred to in his part of the presentation. The WACC of Lukainus, one of these wallets of 60 units is $39.5 or that's based on the WACC.
So based upon these what you already sort of leaned into, how we're trying to come up with or at least guide to what we think an average net price could look like are several factors that we're going to have to see play out. And what we didn't want to do is get into boxing ourselves in on estimates before we really had the ability to see what thirty and sixty days of this looks like. But things you have to factor. Obviously, discount rates out there are going to be low. I would use specific I would use analogs and other specialty areas and sort of closed networks, products like ours.
We're going to have to pay some discount to wholesalers for doing their job and helping support the distribution and payers, but it's minimal. And then in addition to that, there's a percent of doses a patient will get per year. Obviously, we're launching here on January 22. And there are only so many doses a patient is going to be able to get per year based on the first year of launch. So that averages in there as well.
Then in addition, you asked specifically about the payer mix and eGFR dosing. And if you look at our studies, in our studies, somewhere between twenty five percent to thirty percent of patients saw a dose reduction based upon eGFR, what their eGFR response rates look like. It's our estimation because it's in our dosage administration section of our package insert and because it's going to be part of our primary messaging that a higher percentage will get it. So if you just straight lined seventy percent of patients not with an eGFR dosing, you get to a higher net. And what I would say is while we're not guiding to exactly what that percentage would be, I would say it's going to be higher than twenty five percent to thirty percent.
In terms of patient mix, it's a fifty-fifty split sort of public pay to more commercial pay. Obviously, because of the fact that this is a disease that hits different classes of people. And that mix is going to be more, let's call it, 50% Medicaid, Medicare with a higher percentage on Medicaid. And then, of course, the rest being on the commercial pay side. Last thing, I'll have Glenn shoot you over our list of examples.
But there been several examples that have and probably some of the bigger stronger ones come from Jazz and Novartis over the last several years of method of use patents on multibillion dollar products that have been adequately defended in the courts. It's surprising to me that and I know it's not new to you, but it seems we've spent a lot of time educating on these method of use patents or enforceability and their importance. But we'll happily get a list of those over to you post the call.
Yes. And Peter, maybe I would add just one more thing. That we looked at our the totality of our clinical trials to understand the average wallets utilized across the patient base as well as the length of treatment. And all of that is taken into account in the $65,000 net revenue number that we communicated.
Okay, great. I guess, Glenia is a pretty good example of that actually recently. So I appreciate you reminding us of that. Thanks.
Thanks, Alethia.
Thank you. Our next question today is coming from Maury Rayquel from Jefferies. Your line is now live.
Hi, good morning everyone and I'll add my congrats on the approval. You mentioned the blinded extension data by year end 2021. And so I'm wondering what's the status of the pediatric and adolescent studies? And now that you're approved, can you provide more specifics on what FDA is asking for in your post marketing requirements and commitments?
With that, I will ask Neil, remember to take yourself off mute, but Neil to give both the PMR and where we're at with the other studies. Neil?
Yes. So thanks for the question. So the pediatrics is actually part of the post marketing requirement as is common with most drugs that are approved. Timelines are quite long reflecting the scarcity of patients in the specialty. And also we have agreement to conduct single protocols with Europe as well.
So that's much more convenient for us. And we'll be kicking those studies off fairly soon, but they're quite leisurely when it comes to recruiting, like I say, because of the difficulty in finding patients. With respect to the blinded extension, we are anticipating results towards the very end of this year. And I can't remember, was there a question around that particularly or just about timing?
No. Just got yes, not a specific question around the extension data.
Yeah. So so that's also, you know, we've committed to send the reports to the FDA early next year with the outcome of the the AURORA two extension study. And there are other requirements around lactation study that we have to perform and other things as well.
Yeah. Neil, just in in addition, Maury, because because it's the right lead in and this call was so focused on The U. S. Launch, I'll make sure to add that things continue to move forward with the EMA. We've had several dialogues in Europe with them, And Otsuka is right there at the table with us for a projected filing in the first half of this year.
So not just in The U. S, but things continue to move forward in our global filings as well. Do you have another question, Maury?
Yes. Yes. I had one other question. Just, in the label, it shows the EGFR decrease in the safety table in your label. And so the data is pooled, and it makes it look like there's a difference between, the treatment versus placebo.
But if I remember correctly, this difference and others in the table are driven primarily by the Phase two data. And so the question is, do you have a plan to break out the Phase two and Phase three safety data and reconcile the differences for when you're marketing?
Neil should address as it pertains to the label specifically, but I can tell you our medical affairs people can drill into that with physicians through medical request letters. But Neil, you want to take the differences and any commentary that you might have there?
Yes. So
I mean, you're right,
this pooled data and that's the normal way do NDAs, there was a question that increases the size of the safety database here. In terms of the differences, what we did when we combine the data, it's we wrote another analysis plan to sort of make sure the data is consistent across the studies. In terms of breaking them back out again, Peter
said, you
know, medical affairs have got plans for a number of publications coming out over the next year or so. But, know, as I mentioned in my call and in my piece before, the GFR decreases were kind of basically driven by the protocol related dosing requirements and would have been similar across studies.
Got it. Congrats again and thanks for taking my questions.
Thanks, Warren.
Thank you. Our next question today is coming from Ed Arce from H. C. Wainwright. Your line is now live.
Great. Thanks everyone and congratulations on the approval. That's quite an achievement after a number of years. A couple of questions for me. First on access, I know that on the third quarter call you had you had already reached out to payers that represent over 100,000,000 lives.
Is there any sort of extra detail you could provide today as to where things stand in terms of access or where they might over the next few weeks in terms of what you're lining up? And then secondly, in terms of Aurinia Alliance, the patient support program, any further details as to specifics on tactics, what you're looking to do for the launch? For example, is there any intention to use sort of initial zero co pay cards or anything like that, especially given the competitive environment that you're in right now? Thanks.
Yes. I'm going to tee this right over to Max Kalau, with obviously a lot of this will be public. Max, you want to talk about access, access programs and
the
fact that we've been well ahead of the curve on this one?
Sure, sure. Yes. So as you highlighted, yes, we've met with a large number of payers communicating our value proposition. Clearly, a price at that point in time, we've communicated our clinical data. And I'll tell you from those initial communications, the clinical value was exceptionally well appreciated.
I think also you may have seen ICER came out with their report last Friday. And I think it's quite notable there too, where lupus is typically a difficult area to sort out economic value. Yet at the same time, in that ISO report, you saw voclosporin, even though it was an assumed analyst price, was deemed highly, highly cost or highly cost effective. So, you know, now we're in the phase. We're just getting started with payers.
Obviously, there's you know, right out of the gates, there's kind of blocking and tackling of setting up NDC codes, getting all the administrative stuff set up with payers that's starting right now. And also and we'll start to meet with payers with the price and value proposition and help them understand just how compelling that is. So that that's just that's getting going. Then as
far as Oh,
sorry, Max. Go ahead.
Yeah. As far as Aurinia Alliance, yeah, we have a very we have a robust patient support program that's wrapped around it. We do have co pay cards, zero pay co pay cards. We have additional support that's wrapped around our program. It's we've designed it to be very comprehensive for the patient.
I'll stop there.
Ed, any more questions?
No, that's it. Great. Thank you so much.
Thanks, Ed.
Our next question today is coming from Joseph Schwartz from SVB Leerink. Your line is now live.
Thanks. Good morning and congratulations as well. I was hoping you could talk some more about the physician audience you're targeting. It sounds like you've been able to get in front of over 1,000 physicians already. Do Do you have a sense of how many patients are at these treatment sites, that you've been able to get in front of?
And how often do these patients tend to flare or otherwise encounter a logical opportunity to add a new treatment option like LUKIND?
Our estimation is somewhere north of 5,000 rooms and somewhere around 7,500 nephrologists. Taking into account the obvious eightytwenty rule, so 80% of the overall potential in the market coming from 20% of those players is pretty much true here. The fact that you have group practices, etcetera, we're well deployed against what we think 80% of the opportunity is going to be. In terms of the patient consolidation, I think I would roll right back to what I said. I think if the opportunity is patients that exist in probably 20% of those top players and we're deployed against them, we feel very comfortable that those programs we've targeted against are targeted against top prescribers.
So I would take that away. And then in terms of how we feel in terms of the early reach to patients and what our ramp will look like, obviously, we're not giving any specific guidance to that. But for some qualitative feedback, let me turn it to Max since he just spent a week, well, we all did, spent a week with our sales and marketing team on a launch meeting last week leading up to this. So our people are in the field, and he got a lot of that feedback live from our people. Max?
Yes. And to your numbers, yes, we've educated more than 1,000 physicians. But in terms of our profiling efforts, we've gone way beyond 1,000 physicians. And as Peter highlighted, our profiling efforts are that we do understand some initial set of patients, but it's quite preliminary, right? So we're just getting out of the gates now.
And we'll keep you posted as we progress through our efforts.
Okay. And then how should we think about the duration of therapy both for patients who achieve remission versus those who do not?
Sure. Let me take that one on. So obviously, now, the our estimate of duration of therapy is by looking at our clinical trials and also through our market research. And in our market research, two thirds of physicians indicated that they would have a one year course of treatment. And so that's our starting assumption at this point.
And is that for both sets of patients, those that remit or don't?
No. We expect that the nonresponders would be less than a year.
Okay. Yes. No, obviously, on this, Joe, no reason. We're not providing the specifics around what our internal it's a lot of guesstimate work, as everyone can appreciate. And it's educated guesstimate work because we're out there doing market research.
But once we've got thirty, sixty, ninety days' worth of on the ground data and field, we'll be able to come back and say what this really looks like. But know that these numbers come from a pretty well educated base of research that we've been doing over the last couple of years. Thanks for the question, Joe. Operator, do we have any other Yes.
The next question is coming from Doug Neum from RBC Capital Markets. Your line is now live.
Okay. Thank you and congratulations as well. First question just has to do with the Phase III clinical trials and the patient composition such that you had the twenty five percent to thirty percent dosing reduction. When you look at that patient composition relative to the types of patients that you're going to be treating on a commercial basis, can you compare and contrast maybe based on race? And I know that this is one of the reasons why you're going to be above that 25 to thirty, but could you provide a bit more detail there?
So why don't I have, Neil, if you're the base of the question as it pertains to our research work. And then maybe, Max, if you can give any color about what we may have gleaned from our market research work. I think I would just say upfront to both of that. And if I there's nothing more to add from either, just say so. The beauty of how Neil constructed the trials and our team internally constructed these trials, and I think it shoots directly at the amount of experience that this team had specifically in LN and specifically with immunosuppressants is that as it pertained to active LN, we probably covered somewhere between eighty percent and ninety percent of those patients suffering from active LN.
And as part of that, our message would not differentiate particularly based on the profile of the patient. So in other words, you can go online, you can see our patient websites, and you can see that we're trying to have the drug appeal to the patient population in its entirety. And I think that goes back to our data. And I think it's an important element of our consumer marketing approach. So with that, Neil and Max, what can you add to the question?
So I mean thanks, Peter. You basically got it that the study was the outcomes of the study. We started a very broad range of patients, duration of disease, severity of disease, race, you know, different regions. We didn't see huge amount of difference in outcomes between any any of those groups actually, which is, you know, sort of somewhat reassuring, of course, from the space of the drug. But also, I think from the applicability to market, I know that, you know, that that that sort of information is useful useful for Max.
So, I mean, Max, did you want to comment Sure. On the commercial
Thanks, Neil. And my sense is you're trying to get a handle to understand the impact of eGFR dosing. And you'll see in the package insert that there's an average daily dose, right? So the average daily dose that's disclosed in the package insert, that's from the AURORA trial. We clearly looked at that.
What's not disclosed in the PIs, the length of treatment. And so we looked at that along with the length treatment to try and understand, again, the consumption of dose over the patient population. We've looked at that. Then we've also looked at the integrated data set. So AURORA plus AURA, we looked at that as well, average dose, length of treatment.
And then we also looked at the the subset. So we did subset to The US patients, and we looked at the average dose and length of treatment there too. Right? So so and and the the fact of the matter is when you look at The US patients compared to the integrated data set, it's very, very similar results. And again, all of that is factored into what we communicated to you in terms of our expectations around consumption and our expectation around what the average net revenue will be.
Okay. And then just as a follow-up question. With respect to the wallet pricing, in the event, let's say, including various discounting, etcetera, etcetera, if there were no dose reduction for a specific patient, what would be the annual pricing?
Yes. As we've said on this one, Doug, it's very dependent on how many doses a patient gets per year when they get put on the drug. And we're not about to try to estimate what the max price could be. I mean, as you know from other companies you cover and other drugs that are out there in the marketplace today, the reality isn't that max price is ever what's seen in the market space today. So we're we don't want to focus on that at this stage.
The fact that we're launching on January 22 tells you that we won't see that fully realized patient much in our book. But after a couple of months of the drug being out there, we'll be able to tell you more accurately what the actual average dose we're seeing is. And we'll need at least one year of data before we're able to provide that.
Great. Thank you. Thanks, Doug.
Thank you. Our next question today is coming from Justin Kim from Oppenheimer. Your line is now live. Hi, good morning.
Thanks for taking the questions and let me add my congratulations on the approval. Just a question, maybe as a follow-up for AURORA two, do you anticipate those who complete the study to transition to commercial supply knowing that there was a sort of one year dosing regimen? And just wondering, any thoughts there on how those data will inform longer term treatment?
I think the second part of your question is highly speculative, but I'll see if Neil wants to go out on a limb there. The first part of your question is, we would hope that the majority of patients will stay on drug and continue on drug for longer periods of time outside of the trial, and we will have a transition plan to ensure that they move from clinical study drug to commercial drug as seamlessly as possible. Neil, on I guess from yes, a perspective of a go ahead.
Just one thing though. At this point in time, we don't have any patients that we're transferring from clinical trials to commercial supply, right? They've all continued on therapy. All the patients that we'll be initiating will be de novo patients.
Thanks, Max. Good clarification. Neil, anything on at least just giving guidance on what we are studying and maybe even a little bit of a level set of what we're not studying in that extension?
Yes. So I mean,
I think, you know, primarily this is safety study, but we're also going to be picking up very, very valuable information. And I think it's important to note in AURORA two that when we get into that study, patients and it's majority of patients who went into AURORA will have had three years of therapy. And, you know, when when you look at the relapsing remitting nature of this condition, think that's gonna be incredibly important data for us.
Got it. Thank you. And this may be one one, maybe, a more high level question. You know, I appreciate that the state of the pandemic sort of evolves on a day to day, but can you talk a little bit about how you might anticipate the launch to shift over the course of 2021? And just any thoughts on sort of how the hybrid digital physical launch holistically could change and whether you see that sort of being an improvement for the pace of the commercial launch in the event that the pandemic alleviates or whether it's sort of independent of that?
Yes. I think it's a great question and one that probably every research analyst on this call has broader perspective than we do because they talk to a lot of companies with active drugs in the market and or companies like ourselves that are launching drugs. But what I can tell you is that our marketing mix reflects what the current environment is, and we will be agile in terms of how we evolve that mix based upon how and when the global pandemic situation opens up. I will reinforce outside of just the fact that our marketing mix is appropriately tailored towards more multimedia online sort of approaches to ensure that our sales force is supported in a way that they need to. But go back to underlining the fact that Max Galao and his team were very purposeful in the target type of marketer and commercial person that we wanted in the organization.
And the global pandemic played into that. Yes, we wanted the best in the business to help us launch this drug. And I think the fact that Max and I have been out there doing this for a little while and have been doing it in this space was helpful. We specifically wanted rheumatology and nephrology deep experience. And the way I see this tactically playing out and for those who've been in the space and sold products, If you've talked to rheumatologists, for example, in the Philadelphia Metropolitan Area for ten years and your manager has been in that marketplace for ten years and your regional sales folks have been in that marketplace for ten years, access to physicians is better.
It's you know your customer. You've been working with them for years and you can get access regardless of if it's in the office itself. And we say this a lot, and I just want to make sure that people understand how important that was to us and how we think we really did put the right team together to go out and do this. And I think it should make a difference in how we see the sales curve. But realistically, we are still in more of a lockdown mode.
I've heard estimates of access being anywhere from 25% to 30% live in office with great variability around the country. The fact that our people know their end customer base, I think, will be a strategic advantage to us. We're not starting from scratch.
Got it. Thanks very much.
Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to Mr. Greenleaf for any further or closing comments.
Thank you, operator, and thank you to all our investors. I did go back and note in my thank you to everyone, I didn't put an extreme thank you out to our shareholders who have been dedicated shareholders and supported our growth and given us the resources to be able to bring the company where it is and with a strong balance sheet going into a launch. We are well poised to take on this opportunity. I want to thank you all for joining us on the call today. We hope you share our incredible excitement about the approval and launch of Lupus Kindness and what it means for people living with lupus nephritis.
2021 will continue to be an exciting year, and I'm looking forward to providing additional updates along with the team on our progress over the coming months. Thank you for your continued support and have a great day.
Thank you. That does conclude today's teleconference. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.