AUPH (2020 - Q3)

Greetings, and welcome to the Aurinia Pharmaceuticals Third Quarter 2020 results. [Operator Instructions] Please note that this conference is being recorded. I will now turn the conference over to our host, Dr. Glenn Schulman, Head of IR. Thank you. You may begin. Glenn Sc

Thanks, Diego, and good afternoon, everyone. Welcome to Aurinia's Third Quarter 2020 Results Conference Call. Joining me on the call today from the Aurinia team are Mr. Peter Greenleaf, President and CEO; Mr. Max Colao, Chief Commercial Officer; Mr. Joe Miller, Chief Financial Officer; and Dr. Neil Solomons, Chief Medical Officer here at Aurinia. This afternoon, we issued our press release and associated financial statement package detailing the third quarter 2020 financial results, both of which are available on our website at www.auriniapharma.com. And filed on a Form 6-K with the SEC as well. Before jumping into some brief remarks from the team, I'd like to remind everyone that today's call is being webcast live on Aurinia's Investor Relations website, and a replay of the call will be available approximately 2 hours after the completion of today's meeting. 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 ir@auriniapharma.com. During the course of this call, we may make forward-looking statements based upon 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 today's press release, our most recent filings with Canadian securities authorities and reports that we file on Form 6-K with the U.S. Securities and Exchange commission. Also, please note that all the statements made during today's call are current as of today, Tuesday, November 10, 2020, 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. So as I said this afternoon, we'll have some brief remarks from the team, after which we'll host a Q&A session. So with all that, let me turn the call over to Mr. Peter Greenleaf, Aurinia's President and CEO. Peter?

Well, thanks, Glenn. And I want to thank you all for taking the time to join us this afternoon on our third quarter update call. So since taking the reins here at Aurinia about 1.5 years ago, I couldn't be more impressed with how the Aurinia team has executed across all aspects of the company. While results aren't always what we set out to realize, I'm continually impressed by the professionalism, the dedication and the focus of our team across the globe. I know it was just a week ago, we had a call with you all to discuss our AUDREY results. And we are here today to provide a broader update on our third quarter financial results as well as a review of where things are heading as we move into 2021. To be clear, as we've said before, we are squarely focused on voclosporin and its upcoming PDUFA date as a potentially first approved treatment for lupus nephritis. As we reported today, we ended the third quarter with cash, cash equivalents and investments of approximately $421 million to support our activities and are fully funded to execute on our launch plans for voclosporin following its approval. 2020 has definitely been an interesting year for all of us. But despite the broader challenges, we have been fortunate to secure the resources necessary to achieve the goals as well as -- our goals as well as evolve the organization to meet the needs of our people, of people suffering for lupus nephritis. Strong resources, a solid strategy and great people to execute, combined with the potential of voclosporin is what we need to succeed. And today, all of those pieces are in place. Over the summer, we announced our NDA filing for voclosporin was accepted by the U.S. Food and Drug Administration, granted priority review and given a PDUFA action date of January 22, 2021. During the review period, we have had ongoing and collegial conversations with the agency. The review process appears to be on track. And as we've stated previously, we are not expecting to have an advisory committee meeting prior to the action date. At this point, we've completed the mid-cycle review with the agency and are awaiting confirmation on our late cycle review meeting. All work streams at this point are lined up and as expected heading into the PDUFA date in January. Looking beyond the U.S., we continue to advance our global regulatory and development strategy for voclosporin. In Europe, our interactions with the EMA continue and our expectation is to file an MAA for voclosporin during the second quarter of next year. This timeline is in sync with our previous guidance and dovetails with our ongoing ex U.S. partnering conversations. As we head into 2021, we also plan to advance our PMDA interactions and look forward to providing additional updates and details on our timelines for Japan early next year. In addition to the regulatory process, we continue to work to differentiate the profile of voclosporin relative to older generation CNIs and other therapies that are currently in development for lupus nephritis. Voclosporin has always been strongly positioned, given its characteristics as a new chemical [ entity ]. Of course, we look to continue to build upon that. The drug's robust efficacy, rapidity of activity, overall safety and tolerability profile observed in both the AURA-LV and the AURORA clinical trials combined with the differentiating aspects observed in vitro, including lack of impact on glucose and lipids and even the potential for antiviral activity being evaluated through an investigator-initiated trial for COVID-19 that was just recently communicated at a study in Leiden, the Netherlands. All of this supports our belief in this molecule and its differentiated applicability for patients. And of course, should the FDA give us the approval, we look forward to the rapidity -- for rapidly launching this drug in the U.S. and markets around the world. So with that intro, I'll turn the mic over to Neil for a brief update on our ongoing pipeline activities, after which Max Colao will provide some additional insight into our commercial readiness. From there, Joe will detail our third quarter results and then I'll come back on to close up for Q&A. With that, let me turn it over to Dr. Solomons. Neil?

Thanks, Peter, and good afternoon, everyone. Just a brief update from the clinical and regulatory world. My team has been working steadfast on their goal of continuing to differentiate voclosporin from other therapies and working to enhance the overall awareness of the broad data set generated with voclosporin for lupus nephritis. Over the past weekend, voclosporin was detailed in 2 poster presentations during the 2020 American oncology of rheumatology annual meeting. The first presentation detailed the previously announced drug-drug interaction study, which showed that voclosporin had no impact on mycophenolic acid or MPA, the active moiety of [ MMA ]. Further, the pooled safety and efficacy data from the AURA-LV and AURORA trials in LN, it was reported that voclosporin achieved significantly faster improvements in proteinuria. This is particularly important for people with lupus nephritis who are racing against time to achieve long-term kidney health. As we say at Aurinia, time is [indiscernible] . On the regulatory front, and as Peter mentioned, we have recently completed the mid-cycle review of the voclosporin NDA with the FDA and continue our interruptions you we head towards the late cycle review with the agency. All that said, the timelines are on track for our January 22, 2021, PDUFA date. Looking beyond the U.S., we have commenced interactions with the EMA with reviewed scientific discussions with the rapporter and co-rapporter due to occur early next year. With these activities, we are on track to file the MAA in quarter 2 of 2021. Lastly, I just wanted to take another moment to comment on the AUDREY dry eye program, which we reported results on last week. Once again, our sincerest thanks to all the patients and investigators who participated in the clinical research. Although the results are disappointing, the team continues to work on fully dissecting and understanding results. But as we announced last week, the VOS program remains suspended and Aurinia does not plan to conduct any additional clinical studies. With that brief overview, I'd like to pass it along to Max for an overview of voclosporin's commercial readiness. Max?

Thanks, Neil, and good afternoon, everyone. I appreciate this opportunity to provide some additional detail on the progress we've made over the last quarter to prepare ourselves to realize the full potential this opportunity presents for patients, health care professionals and the company. So first, let me highlight why we see this opportunity as so significant. Lupus nephritis is one of the most serious and life-threatening complications of SLE. There are currently no FDA-approved treatments for LN. And the current standard of care typically results in suboptimal long-term health outcomes. For example, 70% to 80% of people on the current standard of care treatment, these patients are typically women and in particularly, women of color of childbearing age. They failed to achieve a complete response to therapy in 1 year. Furthermore, these patients still show signs of active kidney disease that can lead to kidney failure. However, in our pivotal Aurora and AURA studies, voclosporin has shown great promise, as a potential treatment for lupus nephritis. Patients treated with voclosporin, in combination with the standard of care achieved statistically superior and fast arena response rates when compared to the standard of care alone. These results were consistent across patient subgroups, including different races and ethnic backgrounds. As a company developing a pioneering therapy with such potential, we see ourselves as not only having a unique opportunity for people effective in lupus nephritis, but also an obligation to these patients as well. To that point, let me provide some insight on our preparedness for a launch. I have no desire to come across as immodest, but I do feel it is fair to say we have now assembled a world-class, rare disease commercial team at Aurinia. This exceptional and dedicated group have their focus on highlighting the importance of early diagnosis and on improving long-term health outcomes in LN. As a result of this focus, we have already undertaken initiatives with payers and clinicians. And importantly, these activities have been undertaken in collaboration with some of the most widely published and recognized lupus key opinion leaders. Already, we have reached payers covering 100 million lives. We've been highly encouraged to see that at each of our national and regional education programs, as many as 100 physicians have been in attendance virtually. As a result of these initiatives, we expect to reach the overwhelming majority of payers and more than 1,000 MDs treating lupus and LN by the end of the year. We are leveraging technology to the fullest so that our progress isn't delayed or undermined by the current pandemic. In fact, in all areas that are critical to successful commercialization, education, promotion, access, patient services. The entire commercial team is aligned for a launch that aims for voclosporin to be quickly and widely adopted by the LN community. We are now ready to quickly launch and get voclosporin into the hands of patients if and when its approval is granted by the agency. That's quite a testament to the experience, talent and commitment of my commercial team colleagues, particularly during this stressful times. So I would like to conclude my portion of the call with a deeply sincere thank you to all of them for their inspiring commitment, to making a tremendous contribution to the health of patients with LN. After approval and with the final label in hand, I look forward to providing you all with more specifics on the launch of voclosporin. I'll now pass it over to Joe for a recap of our financial results. Joe?

Thanks, Max. On the financial front, Aurinia ended the third quarter of 2020 with cash, cash equivalents and investments of $421 million compared to $306 million at December 31, 2019. Net cash used in operating activities was $30.3 million for the third quarter ended September 30, 2020, compared to $11.8 million for the third quarter ended September 30, 2019. As we detailed in today's press release, we reported a consolidated net loss of $34.1 million or $0.28 per common share for the third quarter ended September 30, 2020, as compared to a consolidated net loss of $19 million or $0.21 per common share for the third quarter ended September 30, 2019. The loss for the third quarter ended September 30, 2020, reflected a noncash decrease of $2.6 million in the estimated fair value of derivative warrant liabilities compared to a noncash decrease of $4.5 million and the estimated fair value of derivative warrant liabilities for the same period in 2019. The derivative warrant liabilities will ultimately be eliminated on the exercise or forfeiture of the warrants and will not result in any cash outlay by the company. The outstanding warrants expire on December 28, 2021. The loss before the change in estimated fair value of derivative warrant liabilities and income taxes was $36.7 million for the third quarter ended September 30, 2020, compared to $23.5 million for the same period in 2019. R&D expenses decreased to $4.8 million for the third quarter of September 30, 2020, compared to $17.8 million for the same period in 2019. The decrease is due to a decrease in activities related to clinical trials and exploratory development work, the capitalization of previously expensed inventory and the capitalization of internal development costs. In accordance with IFRS, capitalization of inventory and internal development costs is appropriate when approval of the NDA is reasonably assured. Management believes that approval by the FDA of voclosporin as a treatment for LN was reasonably assured following the acceptance of the NDA by the FDA in the third quarter of this year. Noncash stock compensation expense charged to R&D increased to $814,000 for the third quarter ended September 30, 2020, compared to $596,000 for the same period in 2019. The increase in stock option compensation expense for the 3 months ended September 30, 2020, reflected higher stock option grants resulting from the hiring of new employees and an increase in the fair value of the stock options granted due to an increase in our share price. Corporate administration and business development expenses increased to $31.1 million for the third quarter of 2020 compared to $6.1 million for the same period in 2019. The increase reflects the investment incurred to build out our commercial and administrative organizations to support the launch of voclosporin as a treatment for LN, subject to FDA regulatory approval being granted. Since the release of the positive results of our AURORA trial in December of 2019, we have moved quickly to develop our commercial and administrative capabilities across the organization, including the expansion of our commercial team. Noncash stock compensation expense charged to corporate administration and business development increased to $3.8 million for the third quarter ended September 30, 2020, compared to $1.4 million for the same period in 2019. The increase in stock option compensation expense for the 3 months ended September 30, 2020, reflected higher option grants resulting from the hiring of approximately [ 135 ] new employees and an increase in the fair value of the stock options granted due to an increase in our share price. With that review, I'll pass it back to Peter for some closing remarks. Peter?

Thanks, Joe. And with a strong balance sheet and cash and cash equivalents and investments of approximately $421 million at the end of September, we're amply funded to support the launch of voclosporin. As I said before, strong resources, a strong strategy and great people to execute, combined with the potential of voclosporin is exactly what we need to succeed, and I believe that all those pieces are in place. So with that, operator, can you please open up to a Q&A session. Thank you, everyone.

[Operator Instructions] Our first question comes from Ken Cacciatore with Cowen & Company.

Yes, I was just wondering if you could comment on the review and interaction in a little more detail around manufacturing, if there's been an inspection on the site? And then wondering on the commercialization. Just could you point to any examples of what you would say are really quality orphan or specialty launches, kind of any of the good learnings you can take from that, share from us what they've done right and what you're trying to emulate?

And I'll take the first one and then to give Max a little preparation time. I'll let him take the commercialization one second. And I can hopefully build upon that. But on the manufacturing front, Ken, we can't really say the FDA doesn't necessarily notice us -- notify us when they're doing the inspections. But obviously, we note that there are inspections ongoing, and we know there as of our most recent interaction with our reviewer that everything seems to be on target. I can tell you that our preparedness for those inspections, whether they be Aurinia-specific facilities or our partners around the world are right on target with where we want them to be. As we've said previously, we partner with Lonza on our API manufacturing, one of the world's largest API manufacturers. And then with Catalent here in the United States on our encapsulation and then through to packaging, again, one of the largest in the country and of the world for that matter. So we feel really confident in the fact that these facilities get reviewed very often and for different drugs reviewed many, many times a year. So everything seems to be on target, and our preparedness is there. Max, on the commercialization front, anything you would point to in terms of a drug and/or an analog to, say, what success looks like here?

Sure. Sure. Thanks for the question. Yes, we've been actively looking at analogs in the specialty space, analogs that have launched in COVID-19. We've looked at analog competitors. And we've also not just looking at -- learning for what's worked, but also looking for underperforming. And so products that we looked at specifically on specialty, ONPATTRO, Ocaliva, [ Civista ]; underperforming, [ Reald ], NUPLAZID, COVID-19, Neurotech, PADCEV; LN competitors, [ Enlibre ], [ Fencerra ], NUCALA. So those are the kind of all the analogs we looked at. I would say some of the key learnings have been early and targeted investments. Prioritized access and patient support. The -- from the underperforming, the -- we saw the ineffective prelaunch payer engagement, we saw little commercial investment pre-approval. Some of the COVID-19s, we learned that the company is rapidly pivoted to digital and accelerated DTC that they pivoted to virtual engagement. And yes, so I would say that we've taken all these learnings and incorporated into our launch plan. And yes, so that's what we've done.

Thanks, Ken. And thanks, Max. The only thing I would add is, obviously, the one thing we know is -- we have to have metrics and measurement as we go into the launch, obviously, and we have to have a solid launch strategy and the right people. But we know we have to beat expectations. And if one thing, the market is good about marking a successful launch is the drugs that beat expectation. And recent -- if you look at TEPEZZA over at the Horizon -- I think they've just done an exceptional job of launching that product. So we're trying to look at those who really not only done the right thing for the drug and patients and getting it in the hands of docs and patients, but also what market expectations are going to be. And we're making sure that we metric and measure ourselves against all of the above.

Our next question comes from Alethia Young with Cantor Fitzgerald.

Congrats on the progress. A couple just one, most of them are kind of high level, though. But one is just -- I know you guys are probably in the field doing checks. But can you just talk about how like patients in lupus nephritis community have been responding to the COVID-19. Are they going to doc less frequently, et cetera, et cetera. I guess the reason I ask is just because it feels like you may be launching when we're still dealing with COVID. So I just wanted to try to see if you had a graph on like what those patterns look like currently. And then the next question is -- I get this question a lot from people. And I know you won't give up everything here, but people ask, well, hey, there's all these other bigger companies like EU pharmas that may be having assets in the space. How can a company like yours compete? Is it by contracting or payers? Or is it just kind of just a much better strategy? If you could give some high-level color to give people some comfort, I think that would be helpful as well.

Why don't I -- thanks, Alethia, and let me maybe start with the second one first, and then I'll ask Neil and Max to come with what we may be gleaning from some field market research? What we're hearing from physicians about patient visits, et cetera? Obviously, we have [ field ] troops on the ground now. A medical affairs team that's out there talking to physicians every day. So we -- hopefully, can give you some directional color there. Obviously, we have a near-term competitor that's a large pharmaceutical company. And no company of our size is going to be able to throw the same amount of dollar resources that -- at a problem and/or an opportunity than a large company with very deep pockets. But I can tell you that most of us come from and have been trained by and have launched successful drugs in the environments of both small and large companies. And the characteristics of successful launches aren't just deep pockets. I mean, it's good strategy. It's people who know what they're doing. It's having a field team that is motivated and passionate about what they want to do and what they want to drive. And a solid strategy along both of those. And last, and obviously, the most important is having the right drug and having a drug that has an efficacy profile and one that impacts patients in a way that provides those very talented and experienced people with the tools that they need in order to go in and do what they know how to do from the learnings that they've built over years. And we've echoed a lot the experience of our people and the talent that we brought into the company. And I think that's probably because we passionately believe that people are the quotient that's going to make the difference here alongside of our strategy in this great drug. So we think we can compete and we know we've got the market research to support early premarket, what we think we can do with this drug and the profile of this drug. So we feel very confident about our prospects here. I'd say the second one is we have significant resources. And while I know it's not always the most popular thing in the world to be raising money and ensuring that you have the right level of investment capital going into a launch. I think where many companies end up falling short is coming in with a low expectation as to whether the company will ever have to launch the drug. And they under invest. And not that underinvestment is always a decision made to extend runway. Sometimes, it's just a decision made of having a lack of capital, of which we do not have now. So we can make those right investment decisions. So we feel very confident about our commercial prospects here. We only have one near-term potentially approved competitor directly in LN. In the future, that could change. But we've got a couple of years where we can really make a strong dent. The second question about how patients are responding, visits, et cetera. Why don't I first start with maybe what Neil might be seeing through our ops team that's out there in the field on the medical side and then see if maybe Max has anything to add to that. Dr. Neil?

Yes. Thanks, Peter. I mean, so our experience on the clinical side is limited to the follow-up visits from our AURORA 2 study. But obviously, we have a number of U.S. sites and a number of patients in the U.S. And certainly, what we found is aside from probably a couple of months back in March or April, where some of the visits were being delayed, these lupus nephritis patients have all been threatening disease. And we find they're getting their test, they're getting their urinalysis, they're getting their blood tests. And they're often seen in different parts of the hospital. So certainly, the experience in the clinical trial setting has been relatively normal. There's been no problems of access of our clinical trial monitors to the sites. Also on the medical affairs side as well, although more challenging, they're a very resourceful bunch, and they've managed to really maintain and build up a very, very high level of contact with the lupus prescribers. But I think it's probably best if I hand over to Max to add a bit of color to what I've said. Max?

Yes. And thanks for the question. And yes, we've been following this closely, both in terms of just kind of the general market trends and also through our field intelligence. And there has been -- there clearly has been a decline in specialty patient visits. But prior to this resurgence of COVID, though, the patient visits were about 97% of baseline about a month ago. So the visits were coming back, even though about 20% of them were virtual. The -- and that is consistent with what we've been hearing for -- from nephrologists and rheumatologists in terms of their lupus and LN patients. But the follow-up is happening, some of it is happening virtually and maybe a little less than what it's been in the past. We remain confident and encouraged by what we're seeing in terms of the patient visits and that the opportunity is successful.

Our next question comes from Joseph Schwartz with SVB Leerink.

So I was just thinking back to the fairly rapid pace of AURORA trial enrollment despite fairly constrained patient enrollment criteria? Or at least you were certainly more careful after [indiscernible]. It seems you were very selective. So if we were to think about -- or I was wondering if you could give us some insight into the team that executed that trial with fairly selective enrollment. How you think about the label, how it will compare to the enrollment criteria in terms of whether it's broader, I would think, broader. And then obviously, the current environment is challenging. And then lastly, you're going to have a team of sales and MSL people that are executing launch. Can you help us think about the different levers there? And how we should think about in terms of order of magnitude, the pace of launch relative to the pace of AURORA trial enrollment?

Yes. Let me -- why don't I start and then ask Neil to build upon maybe what I'll say. I would say -- I think it's one thing to talk about the difficulty of enrolling clinical trials in both a competitive environment, an environment where you're trying to find patients globally and compare that to necessarily what the market opportunity might be. Our trials, and when we look at both the Phase II and the Phase III that we did, give us access to a very large percentage of those patients with active lupus nephritis upwards of -- we believe upwards of north of 80% of those patients. We'll have to see where the label comes out, obviously, but our trial criteria gives us that open access point. So we don't see the difficulty of trials being a direct correlation to potentially how the asset then reacts and/or what you see in terms of prescription uptake. And we can track that through ICD 9 codes and what patients are out there, what we know from the patients who are actively suffering from the disease. So I think the 2 are separate and distinct. But let me not answer that question fully. Let me also ask Neil to build on that with me.

Yes. So I mean, thanks, Joe, for the question. You said one thing that's not quite true or at least perhaps, I'd just like to build on. You were talking about the restrictions that we put on compared to maybe the first chart. A lot of those restrictions were kind of qualitative rather than hard fast rules in the protocol. The protocols are actually very similar. It was more -- we learned a lot about the drug between the 2 studies and we learned about the kind of patients and comorbidities that may result in perhaps a more difficult outcome in certain countries. If you look at the actual entry inclusion/exclusion criteria, they were very, very similar. And of course, they parlay into the label as we move forward. And of course, when the drugs actually launched, we will have learned even more about the drug. So I would just say that in some ways, I would [ count that ] and say, actually, we had a very, very broad bunch of entry criteria, which encompass most of the patients that require treatment with lupus nephritis in the doctor's clinic, albeit in a kind of prescribed way in the protocol.

Maybe on the second part of your question, Joe, I can ask Max Colao to join me here and give his thoughts on an early uptake, what are the key drivers of that for us? And I'll see if I can add anything to that. Max?

Sure. Thanks, Peter. Thanks for the question. Yes. So as I mentioned, we're encouraged that the patient opportunity is accessible. At the same time, we're still -- we're heading into a time where COVID infections are increasing. And as COVID increases access to the actual physicians becomes more challenging geographically. So I would say that, that's going to be a determinant to our early uptake was just the extent of access to physicians. But again, the -- we're -- we continue to be very encouraged in terms of what we hear from physicians and what we've heard in market research, what we've heard about our value proposition. And so I would -- I suppose my guidance would be similar to other therapies that are launching during COVID times.

And the last thing I would add to that, I think the biggest driver, Joe, for us is going to be, one, the label and when we get it. And then we got to have motivated people that want to go out and drive this, and we think we've got that. I mean, the sales force is still the #1 conduit and to physicians and aiding them to understand the approval of a drug, the dosing administration of the drug, the data on a drug. And we've got a highly motivated and passionate group of people who are going to go out and drive that. If we had underfunded there that would be a major concern of mine. Access is still going to be an issue to Max's point, but at the end of the day, we have other tactics to try to support that, whether they be online tactics. And we've said in previous calls that we purposely went out and hired a sales force, a team that's highly tenured and not only highly tenured, but highly tenured in rare disease and with significant experience in the areas of nephrology and rheumatology so that if they need access most of these people, if not all of these people, know the people they're calling on. There won't be people introducing themselves for the first time. Sorry, you had a follow-on question there, too, Joe, so let me let you ask that?

It's really helpful context. So I was just wondering who are the most likely patients to need the drug or be early adopters at the outset? Is it patients in a flare? And if so, like how often does that happen? How are you helping centers visualize, which patients to want to provide the drug for first?

Yes. I think I'll start and then ask Max to catch anything I miss. But we're going to set a very aspirational target in what we ask for, dependent, of course, upon approval and what the label allows us in the sort of degrees of freedom we have that the label provides us to ask for those patients. But we studied this drug in addition to the standard of care, and we ran it directly against the standard of care. So -- and up to 80% of patients with active lupus nephritis have ability, at least from the studies that we've done to get access to this drug. So we're going to go in and challenge a standard of care. We're also going to try to support good diagnosis, good patient education to drive more patients and to create higher awareness and increase the total diagnosis pool of patients that might be getting an inadequate response to their current meds. So I think we have a pretty wide open field in what we can ask for, and we have tactics to support trying to gain even broader access to that, all dependent, of course, upon the label that we see and the hopeful approval we see come our PDUFA date in January. Max, anything I'm missing on there?

No, I think you hit the nail on the head. We see ourselves as position to reset the standard of care with voclosporin. And as Peter said, we compared ourselves to the standard of care in our pivotal 3 trial. And those are the types of patients that we will go after right from the outset.

Our next question comes from Maury Raycroft with Jefferies.

Congrats on the update. So you conducted the drug-drug interaction analysis with MMF. And then the analysis showing how drug monitoring is not needed, when on voclosporin. So just wondering if you think these data will go into the label? And can you contextualize these data competitively? And maybe talk about how important the findings are to payers, doctors and patients?

Neil should comment on the DDI study and the particulars around that. The one thing I can say is, competitively, this sets us up quite well. Listen, if anybody wanted to compare us and why we might be in a different mechanism might -- not mechanism but a different compound here. This is one of the main drivers of that difference. The fact that you can flat dose this product is incredibly important in terms of its competitive profile. And we've done market research with physicians, and that obviously is one key area they see and one they find highly favorable. Neil, on the study itself and what our thoughts are around the label, you want to give your directional answer to that?

Yes. I mean, so the drug-drug interaction trial, in terms of getting the label, I think what we won't have is we won't have a comment saying that there's interaction with MPA. Now of course, cyclosporine does have an interaction with MPA, it reduces the AUC quite significantly the exposure and hence, the efficacy of MMF. And we're not going to have that. This was done in lupus patients. It was a formal drug-drug interaction study precisely to disprove the thesis that voclosporin with similar to cyclosporine. It's not, and it behaves differently other than that. In terms of the therapeutic drug monitoring or lack of requirement for that, again, that supports our dosing. Our dosing is that we start with the flat dosing and we adjust according to GFR. And of course, there's intellectual property around that as well. In terms of commercial differentiation, that's pretty unique. There's not many drugs that do that. And of course, the other drugs in the class require trough levels therapeutic drug monitoring to even try to get to the right target, which has not actually been determined. So that's further kind of competitive advantage from voclosporin.

Got it. And I'm guessing doctors definitely appreciate these points. Can you talk about the payer perspective on some of these points?

Yes. I think to some degree, payers are going to take the base data, and then you're going to take lead from the thought leader physicians and medical directors that within the plans. And all the research that we've done up to this point is pointing quite positive to that. I mean the data speaks for itself. And then when other scenarios of step-throughs and other things are put in front of them, we feel very good about what our profile looks like going into a potential launch. Payers, obviously, look first at the data. And then look to get advice from their physicians that advise them, both directly and indirectly. And everything we've done so far, Maury, in terms of our market research with both payers, physicians and patients has pointed to a good payer profile in terms of what the data actually shows. Now we got to go through those strokes once we have an FDA approval, and we price the drug. And we have those actual conversations, but feel very, very comfortable that Max and his team are out there having those preliminary conversations in terms of education through our medical science liaisons on the data itself. So I think we're right on target with where we need to be. And I can tell you, things look quite favorable. I would tell you, I've launched other drugs in the past that didn't have as much of an open window. So we feel really good about it.

Our next question comes from Justin Kim with Oppenheimer & Company.

Just curious, have you had any conversations with KOLs on whether you expect LN population being earlier or later candidates for potential COVID-19 vaccine. And whether you foresee any special considerations on vaccines implemented over the course of voclosporin treatment?

That's a -- thanks, Justin. That's a great question. I actually do not have an answer to it because we have not -- I have not pulsed any docs on this. So I would turn to Neil, who may be hearing more of this through follow-on work with our sites. But I don't have an answer to you on that one as I wouldn't probably for any other drugs, including drugs that I or my children might be on. I don't know that any guidance has been put out there nationally or globally and specific to the LN population, I can't comment. Neil, do you know? Have you heard anything?

Not specifically. In very general terms, it was a conversation we had earlier that these obviously are higher risk patients because of their condition and because their immunological kind of disordered immune system, so to speak. So I would imagine they would be higher up the ladder. But other than that, I don't know anything. I don't know whether Max would you have any experience to these discussions?

Yes, Neil. No, would not have any perspective on those discussions at this point.

Okay. Got it. Just curious. And then [ Dr. Roven ] provided a really interesting [ CAGR ] at ASN on how he see the treatment landscape changing in LN. With regards to potentially reaching patients sort of beyond the eGFR status included in AURORA, can you just discuss how you see that potentially broadening over time? And what types of clinical evidence or physician experience may support that expansion?

I'm going to weigh heavy on you on this one since I -- not that I haven't -- one, I haven't seen the presentation. And number two, you might have more of a directional answer, idea where [ Dr. Roven ] was going with that.

Yes. I mean, so it's such a really good question. We kind of set a cutoff of eGFR, which we kept over 2 studies at 45. And to honestly, most of the patients with the worst eGFR that -- those that are really not doing very well, and may actually not be suitable for C&I therapy anyway. Regardless, we were in -- or getting into label discussions with the agency and we don't know how they're going to pan out on what the recommendation is going to be on the label. But certainly, it's a consideration because there are some patients in our study. As you can imagine, the eGFRs fluctuate widely, whose eGFRs at least in [ price a steroid pulse ] are actually reasonably low and did pretty well. So I think eGFR, as a function of disease severity, may not be ultimately for a few years down the line absolute contraindications to this class of drugs. Whether that comes from physician experience or any Phase IV clinical trials that we decide to do. We're not sure yet. This is something that we have to take onboard when we see how the label goes and how the drug's received in the community.

Okay. Got it. Just maybe a final housekeeping sort of question. Noticing that the G&A trap has sort of been recognized on the P&L. Can you maybe discuss on a personnel level and sort of as an organization, how much growth we can expect sort of into 4Q? And maybe whether that caps out going into 2021 or whether there would be a little bit more growth there as well?

Yes. Obviously, we haven't given any revenue and/or expense guidance. So let me try to directionally give you an answer. Maybe you can try to model it out from there. But listen, we've hired the majority of the people that we need to. And obviously, people are the majority of our costs as we end into the last quarter and into this quarter. So as you see those numbers, I think a steady state around modeling sort of the people-based numbers there is probably not a bad idea. Obviously, marketing costs and elements of sales costs are going to go up over time. Obviously, our costs, at least as it pertains to voclosporin investment and the pipeline are going to go down over time because of the recent announcement around dry eye. We hope to find a way to fulfill that soon with a diversified pipeline. But as for now, that's the way I would model it. But I think if you were to look at this quarter and into next quarter, it will give you a good idea of what our expense base is. And then if you work around sales and marketing costs around averages and successful launches, you'll probably get there, Justin. But as I said, we haven't really given guidance on it, especially quarterly guidance. So -- but thank you for the question.

[Operator Instructions] Our next question comes from Ed Arce with H.C. Wainwright.

Congrats on the continued progress. And I have 3, one regulatory and 2 commercial. So first one is you had mentioned in your prepared remarks that you're preparing for a light -- excuse me, a late-cycle review with the agency coming up. Can you tell us when that is? And what specific aspects do you expect to be discussed at that meeting?

Yes. I would say the late cycle review Ed is on normal course. When we said we're waiting, if you just sort of map out when these things are expected to hit we're right on track with what the review cycle should be. So I wouldn't read into whether that's ahead of schedule or behind. It's right on the money as to when these things should come through. Neil, you want to try to take a swing? It can be so varied as to the areas that are covered in any one of those late-cycle reviews. But Neil, you want to -- have you been closer to the day-to-day conversations, maybe take a swing at that?

Yes, sure. I mean it's a statutory meeting, Ed. So obviously, we knew we were going to have it, and we knew the approximate data as well. What it does is it ties up. It gives the agency a further kind of opportunity to sort of tie up their review to address any questions or obviously, what they -- they need from us so that they can complete their review as part of the open dialogue that we have, but it's kind of more formalized. We get actually written guidance about what we're required to provide them. And it's done usually in a timely manner. But it really is, I guess, the last odds and ends just statutory review before the label negotiations really start intensifying.

Okay. Great. Fair enough. So turning to commercial. As you noted in your release, you're working on being fully prepared for the potential launch by year-end. Given that the PDUFA date is only 3 weeks after that. Just wondering what specifically does that entail between now and year-end? What is left really to do? Or is it just kind of wrapping things up that if I would imagine most everything is already well underway? Just wondering specifically what is still left to do and get in place by the end of the year?

It's a good question without going into the absolute specifics. If I were on the call on the other side, listening and the company said, we'll be ready to launch this thing on the PDUFA date. My natural question would be, well, what if you have an early approval, will you be ready? And while we're in no way projecting that we will have an early approval, we want to increase the confidence of our investors and the docs and patients out there could be recipients of this drug, if and when approved, that we'll have the ability to start not just marketing this drug and selling it with ground troops and our tactics ready to roll once we have a label. But more importantly that we'll be able to start shipping product. Too often, I think companies are caught with an approval date that is far removed from their actual "launch" date or when they start shipping. And while I will agree with your statement that what else would we have to do. Well, probably not a whole heck of a lot to be prepared because we're preparing almost a month ahead of what our potential action date is with the FDA. So the communication is meant to be an internal battle cry to be prepared if we end up on our PDUFA date, know that we will be even that much more prepared. And it's a ticking and tying of tactics, people and resource deployment, packaging, getting labels onto that packaging and being ready to ship. It's all those elements and to increase the confidence that we should be well ahead of our PDUFA date to be prepared to do that.

Okay. Great. Then the final question for me is related to some commentary earlier in the Q&A about some of the key factors in competitive environment, especially when you've got a very large global pharma relative to small biotechs and of course, one of the things that was mentioned, really at the end of the day is the right drug, the best drug, perhaps, especially when it comes to the actual data itself. So wondering in your discussions, what do you find are the key points of differentiation that appear to especially resonate with payers and clinicians, especially relative to Benlysta and GazyVa?

We -- I wouldn't say we put together a Chinese menu of restaurant menu of different options for physicians to choose from in terms of what attributes do you like versus approved and unapproved drugs. We do ask questions to some degree, to try to get an idea of what attributes of our drug, they see as being the most important, starting with first what attributes they see as being the most important in the disease state in terms of controlling patients and keeping patients out of bad outcomes. And then we try to, obviously, go back and then apply how many of those apply to our drug. And I can tell you there's a solid list there. Max, since you're closer to the day-to-day research and how we've been doing this. Anything you want to add as it pertains to competitive profile, et cetera?

Yes. So I would say that the -- with payers, specifically the efficacy of voclosporin resonates very strongly, also the time to response. And I would say kind of a key metric that the payers focus in on is the number needed to treat, to get an additional response, which is about 5 with voclosporin and that resonates strongly with payers.

Thank you. There are no further questions at this time. I'll turn it back to management for closing remarks. Thank you.

Thank you, operator. And on behalf of the company and our Board of Directors, I want to thank you all for joining us on the call today. We really and truly do hope you share our excitement about what's on the horizon this year for Aurinia. We want to thank you all for your continued support, and we would like you to please have a great and safe evening. Thank you.

Thank you. That concludes today's call. All parties may disconnect. Have a great evening.