Aurinia Pharmaceuticals Inc. (AUPH) Earnings Call Transcript & Summary

Hello, and welcome to the Aurinia Pharmaceuticals LUPKYNIS update call. [Operator Instructions] As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Dr. 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 LUPKYNIS, 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; Dr. Neil Solomons, Chief Medical Officer; Mr. Max Colao, 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 LUPKYNIS, which is accessible from our website at www.auriniapharma.com and has been filed on a Form 8-K 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 2 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]. 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, January 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?

Well, thanks, Glenn, and I want to thank you all for joining us today. If you haven't heard, obviously, it's official, LUPKYNIS 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 the U.S. Food and Drug Administration, and subsequently announced that evening, that voclosporin has been granted marketing approval under the brand name LUPKYNIS. LUPKYNIS was approved for use with background immunosuppressive therapy in the treatment of adults with active lupus nephritis. LUPKYNIS 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 health care professionals that LUPKYNIS 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 health care conference detailing our commercial readiness. With this approval in hand, we have already launched LUPKYNIS, turned on all of our websites, activated our Aurinia Alliance patient support program and initiated support for all of our customers, including health care professionals and patients. We are locked and loaded and, in fact, have already received LUPKYNIS 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 health care 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 LUPKYNIS. And of course, our commercial team, who have worked to ensure program launch on day 1. Drug development doesn't happen overnight. And in the case of LUPKYNIS, 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, LUPKYNIS 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. LUPKYNIS brings a new option for people affected with lupus nephritis. Of the 200,000 to 300,000 patients in the U.S. living with SLE, it's our estimate that up to 40% are believed to have kidney involvement in LN. This represents approximately 80,000 to 100,000 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 LUPKYNIS is for its use in combination with background immunosuppressive therapy in adult patients with active LN. Patients begin treatment with LUPKYNIS, as detailed in the dosage and administration section of the package insert. The dose is modified based on eGFR response, which is monitored every 2 weeks during initiation of therapy, and monthly thereafter as it 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 the patient. As mentioned, our label includes an eGFR dosing protocol that aligns with our 036 method of use patent, and we see this as expanding the scope of our intellectual property protection for LUPKYNIS. That patent has a term up to December 2037, and we anticipate it being referenced in the Orange Book. Consistent with our expectations, LUPKYNIS 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 of 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 Colao, our Chief Commercial Officer. And from there, spent this spring and summer months recruiting top-notch and highly experienced commercial people. By September of last year, 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 10 years of rheumatology and 7 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 LUPKYNIS now approved by the FDA, along with our strong balance sheet with over $400 million at the end of 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 LUPKYNIS 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 2.5 milligrams a day or less of corticosteroids and response rates achieved across a diverse LN population. We are truly excited for what LUPKYNIS 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 Colao, our Chief Commercial Officer, who's someone you'll all get to know quite well over the next few months as he executes on our commercialization plan for LUPKYNIS. After that, we'll open it up to your questions. So with that, let me turn it over now to Dr. 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 200,000 to 300,000 patients in the U.S. Up to 40% have kidney involvement or lupus nephritis, which is one of the most serious manifestations of the disease, with approximately 90% 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 the 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 30% of LN patients experience this within 15 years. LN significantly increases the risk of premature death, especially related to cardiovascular events. From a health care system perspective, these patients have twice the hospitalization rate compared to other SLE patients, with longer stays and drastically higher health care needs and costs once kidney failure develops. Understanding the goals of treatment in LN 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 50% at 6 months and to a level of 0.5 to 0.7 at 12 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. Voclosporin 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 acquired in the presence of low-dose steroids. The odds ratio in favor of voclosporin was almost 3, indicating a strong treatment effect. Around twice as many voclosporin-treated patients achieved renal response as those receiving background therapy. Further differentiation of the LN treatment story is described here. Voclosporin-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 the 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 hypolipidemia are not on the label. The most common adverse events are related, to some extent, on the way the protocol was designed. Reductions in eGFR were anticipated and dose reduction is written into the protocol, reflected in the dosing and administration section. Adverse events were triggered when dose reductions were required, and the same for increases 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 the result of extraordinary amounts of work completed by our pioneering clinical development and regulatory teams at Aurinia. We continue to conduct the ongoing AURORA 2 blinded 2-year extension, with results anticipated by year-end 2021; evaluation of voclosporin in pediatric and adolescent patients diagnosed with LN as well as other post-marketing requirements and commitments in 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 LUPKYNIS 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 4 pillars to our commercialization strategy. The first is to establish LUPKYNIS-based treatment regimen as a first-line treatment and, as such, to become the new standard of care. We expect clinicians to embrace LUPKYNIS 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 LUPKYNIS plus standard of care were more than twice as likely to achieve complete renal response and experience the 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 3 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 LUPKYNIS. 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 4 of these pillars serve an overarching goal of driving LUPKYNIS 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 the 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 the 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 LUPKYNIS 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. LUPKYNIS 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 LUPKYNIS treatment regimen, steroids can be reduced to a low maintenance dose, significantly reducing their burden. So you can see that the value proposition that LUPKYNIS offers is quite compelling. And we've taken this into account in our pricing. Specifically, the price of LUPKYNIS is based on 1 unit of 60 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 LUPKYNIS to be approximately $65,000 per patient per year. This figure is not only based on patient-specific eGFR dosing for LUPKYNIS, but also accounts for factors, including mandatory rebates, channel discounts and anticipated patient adherence. Now to ensure that patients can gain access to LUPKYNIS, 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 pre-approval meetings with more than 50 payers, covering more than 100 million 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. LUPKYNIS 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 billion. 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 a 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&A session.

[Operator Instructions] Our first question today is coming from Ken Cacciatore from Cowen and Company.

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 would be helpful to give a little bit of history behind that patent and the prosecution history of it and why it's so critical.

So why don't I start off? You blipped out on me a little bit there so hopefully, you can hear me, Ken. 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, we 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 30, 60 and 90 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 036 patent. Let me add that, one, we were issued this patent in '19. 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. Now 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 of patients on this dosing protocol is only going to support and enable that 036 patent. So we feel very, very good about the fact that it appeared where it has. And to be honest, all along, Ken, we've said that 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. Just -- I guess I would just finish off with the Aurinia Alliance program. Often the plumbing of getting a prescription written in for 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'm going to let Max Colao jump in on this one. But one of the things that I thought Max brought day 1 in his initial buildup of the strategy for the company was the fact that he has the luxury in his career of crossing 2 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 and 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 there?

Yes. No, it's all good. And thanks for the question, Ken. And yes, Aurinia Alliance is a patient support program. We have bulked 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 Aurinia Alliance.

Our next question today is coming from Alethia Young from Cantor Fitzgerald.

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, in particular, maybe how the market breaks out from a payer standpoint? I would guess that there's 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 23 mg dose, like roughly like 3 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, it's a -- that's the big focus here.

Yes. Okay. Let me start off. First off, the price of LUPKYNIS is based on 1 unit of 60 capsules that we refer to as this wallet, as Max referred to in his part of the presentation. The WAC of LUPKYNIS, 1 of these wallets of 60 units is $39.50. That's based on the WAC. So based upon the -- 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. What we didn't want to do is get into boxing ourselves on estimates before we really had the ability to see what 30 and 60 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 analogues 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 of 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 average is 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 study, somewhere between 25% to 30% 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 and 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 line 70% 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 25% to 30%. In terms of patient mix, it's a 50-50 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 have 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. So it's surprising to me that -- I know it's not new to you, but it's -- we spend a lot of time educating on these method of use patents, their 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, Glenn has a pretty good example of that actually recently. So I appreciate you reminding us of that. Thanks.

Our next question today is coming from Maury Raycroft from Jefferies.

I'll add my congrats on the approval. You mentioned the blinded extension data by year-end '21. 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. 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. Time lines are quite long, reflecting the scarcity of patients in this 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 said, vis-à-vis 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, I just -- yes, not a specific question around the extension data.

Yes. So that's also -- we've committed to send the reports to the FDA early next year with the outcome of the AURORA 2 extension study. And there are other requirements around a lactation study that we have to perform and other things as well.

Neil, just in addition, Maury, 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 in -- it shows 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 II data. And so the question is, do you have a plan to break out the Phase II and Phase III 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 that, you're right, this is pooled data, and that's the normal way we do NDAs and there is a -- increases in the size of the safety database here. In terms of the differences, what we did when we combined the data is, we wrote another analysis plan to sort of make sure the data was consistent across the studies. In terms of breaking them back out again, as Peter said, medical affairs have got plans for a number of publications coming out over the next year or so. But as I mentioned in my call -- in my piece before, the eGFR decreases were kind of basically driven by protocol-related dosing requirements and would have been similar across studies.

Got it. Congrats again.

Our next question today is coming from Ed Arce from H.C. Wainwright.

Great. 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 mentioned you had already reached out to payers that represent over 100 million 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 the 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 0 copay cards or anything like that, especially given the competitive environment that you're in right now?

Yes, I'm going to tee this right over to Max Colao. Obviously, a lot of this will be public. But 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, without a price at that point in time, but 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 ICER report, you saw voclosporin, even though it was an assumed analyst price, was deemed highly, highly cost -- or highly cost effective. So now we're in the phase we're just getting started with payers. Obviously, there's -- 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's just -- that's getting going. And then as far as…

Sorry, Max. Go ahead.

Yes, as far as Aurinia Alliance, yes, we have a robust patient support program that's wrapped around it. We do have copay cards, 0-pay copay 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.

Our next question today is coming from Joseph Schwartz from SVB Leerink.

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 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 LUPKYNIS?

Yes, Joe, so as I said previously, the universe of rheums and nephrologists is quite large. It's about, in our estimation, somewhere north of 5,000 rheums and somewhere around 7,500 nephrologists. Taking into account the obvious 80-20 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, et cetera, 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 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 spend 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 you get 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, right 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, 2/3 of physicians indicated that they would have a 1-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. The -- we expect that the nonresponders would be less than a year.

Obviously, on this, Joe, and the 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 30, 60, 90 days' worth of on-the-ground data and feel 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 questions?

Our next question is coming from Doug Miehm from RBC Capital Markets.

Okay. Congratulations as well. First question just has to do with the Phase III clinical trials and the patient composition such that you had the 25% to 30% 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/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 30%. But could you provide a bit more detail there?

So why don't I have Neil, if your -- 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 80% and 90% 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. The study was -- the outcomes of the study, we studied a very broad range of patients, duration of disease, severity of disease, race, different regions. And we didn't see a huge amount of difference in outcomes between any of those groups actually, which is sort of somewhat reassuring, of course, from the perspective of the drug, but also I think from the applicability to the market. I know that, that sort of information useful from that. So I mean, Max, do you want to comment on the commercial implication?

Sure. 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 PI is the length of treatment. And so we looked at that along with the length of treatment to try and understand, again, the consumption of dose over the patient population. We've looked at that, and 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 subset. So we did subset to the U.S. patients. And we looked at the average dose and length of treatment there, too, right? So -- and the fact of the matter is when you look at the U.S. 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, et cetera, et cetera, 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 don't want to focus on that at this stage. And 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 1 year of data before we're able to provide that.

Our next question today is coming from Justin Kim from Oppenheimer.

Let me add my congratulations on the approval. Just a question, maybe as a follow-up. For AURORA 2, do you anticipate those who complete the study to transition to commercial supply, knowing that there was a sort of 1-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 a perspective of -- yes, go ahead.

Peter, just -- let me just clarify 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 will 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, primarily, this is a 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 2 that when we get into that study, patients and its majority of patients who went into AURORA will have had 3 years of therapy. And when you look at the relapsing-remitting nature of this condition, I think that's going to be incredibly important data for us.

Got it. And just maybe one -- maybe a more high-level question. 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 the way that they need to. But go back to underlining the fact that Max Colao 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 this space and sold products, if you've talked to rheumatologists, for example, in the Philadelphia metropolitan area for 10 years and your manager has been in that marketplace for 10 years and your regional sales folks have been in that marketplace for 10 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.

Thank you. We've reached 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 LUPKYNIS 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.