ChemoCentryx, Inc.
Q1 2021 Earnings Call Transcript

Published: 29 Apr 2021

[Operator:]

Good day and thank you for standing by. Welcome to the ChemoCentryx First Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to Lee Roth of Burns McClellan. Please go ahead, sir.

[Lee Roth:]

Thank you, Lee. Good afternoon. And welcome to the ChemoCentryx first quarter 2021 financial results conference call. Earlier this afternoon, the company issued a press release providing an overview of its financial results for the first quarter ended March 31, 2021. This release along with a few slides that you may find helpful while you listen to this call, are available on the Investor Relations section of the company’s website at www.chemocentryx.com. Joining me on the call today is Dr. Thomas Schall, President and Chief Executive Officer of ChemoCentryx, who will review the company’s recent business and clinical progress. Following his comments, Susan Kanaya, Executive Vice President, Chief Financial and Administrative Officer of ChemoCentryx, will provide an overview of the company’s financial highlights for the quarter before turning the call back over to Tom for closing remarks. During today’s call, we will be making certain forward-looking statements as explained on slide two. These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve a number of risks and uncertainties that may cause our actual results to differ materially from those contained in such forward-looking statements. These risks are described in the company’s filings made with the Securities and Exchange Commission, including our annual report on Form 10-K filed on March 1, 2021. You are cautioned not to place any undue reliance on these forward-looking statements and ChemoCentryx disclaims any obligation to update such statements. In addition, this conference call contains time sensitive information accurate only as of the date of the live broadcast, April 29, 2021. ChemoCentryx undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this live conference call. With that, it’s now my pleasure to turn the call over to Tom. Tom?

[Dr. Thomas Schall:]

Thank you, Lee, and good afternoon to everyone listening. Thank you for joining us on our first quarter 2021 conference call. It’s been just 59 days since our Q4 and full year 2020 call. So in my remarks today, I’ll -- we’ll briefly review three main areas; first, avacopan, an ANCA-associated vasculitis as we move ever closer to potential launch; second, an update on our progress in making of avacopan, our pipeline and a drug; and third, our plans for CCX559, our oral immune checkpoint inhibitor. Moving on to slide three, I’ll start with highlights from our virtual R&D Day, which was held on April 14th. This was held as we look forward to the potential launch of our first medication soon after the PDUFA date of July 7th, which we believe deeply offers new hope to patients.

[Susan Kanaya:]

Thank you, Tom. Our first quarter 2021 financial results are included in our press release today and are summarized on slide 17. Revenue was $10.4 million for the first quarter of 2021, compared to $6 million for the same period in 2020. The increase in 2021 first quarter revenue was primarily due to the $10 million milestone payments from Vifor for the February 2021 acceptance of the Japan NDA for avacopan in the treatment of ANCA vasculitis. Research and development expenses were $23.4 million for the first quarter of 2021, compared to $19.3 million in the same period last year. This increase was primarily attributable to the manufacture of commercial drugs supply in anticipation of the launch of avacopan, a treatment of ANCA vasculitis and cost associated with the advancement of CCX559, our orally available small molecule checkpoint inhibitor. These increases were partially offset by lower Phase II related expenses due to the completion of patient enrollment of the avacopan AURORA clinical trials in patients with HS and the discontinuation of further clinical development of CCX140 in FSGS in 2020. General and administrative expenses were $16.3 million for the first quarter of 2021, compared to $8.8 million for the same period last year. This increase was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts and higher professional fees. These results produced a first quarter 2021 net loss of $29.7 million, compared to a net loss of $21.7 million in the same period in 2020. Total shares outstanding at March 31, 2021 were approximately 69.7 million shares. We closed the first quarter of 2021 with $424.2 million in cash, cash equivalents and investments and for 2021 we continue expect to utilize cash and investments in the range of $145 million to $155 million. Tom?

[Dr. Thomas Schall:]

Thank you, Susan. To summarize the first quarter of 2021 has positioned us strongly for the rest of the year, as you can see from slide 18. We are well prepared for the FDA Advisory Committee on May 6th and the potential commercial launch soon after the PDUFA date of July 7th. We aim to meet with the FDA to discuss the clinical benefit of avacopan for the treatment of C3G. We plan to initiate our next cycle of three clinical trials over the next few quarters. First in human studies in cancer patients for our small molecule checkpoint inhibitors CCX559, a Phase II/IIb adaptive study of avacopan in LN and the pivotal Phase III trial of avacopan in Hidradenitis Suppurativa early-stage three patients. By the time I report to you on our next quarterly results, we may have taken the final step to becoming a forward integrated novel therapeutics company with our first commercially available medication. Again, make no mistake, we will continue to be implacable in our pursuit of new science in the interests of the patients, the clinicians and the investors that we serve. I will now turn the call over the operator for your questions. Operator?

[Operator:]

Okay. Thank you. Your first question comes from Michelle Gilson from Canaccord. Your line is now open.

[Michelle Gilson:]

Hi, Tom. Hi, Susan. Thank you for taking my question. I guess, the first one, out of the sort of anticipated Adcom topics that you outlined at the R&D Day, is there one that you anticipate will be of greater focus than the others, I guess, from a higher level?

[Dr. Thomas Schall:]

Michelle, I think, that’s a very good question, of course. I think we’ve outlined the spectrum of items that we think will be important. There will probably be others as well. Other than that, I don’t think I’m going to speculate too much about the Adcom at this point, because we’re very close to it. And yet, it’s really up to the FDA about what kind of questions they’re going to put to the committee. So we’ll be ready for any and all questions that they might post.

[Michelle Gilson:]

Okay. And then, just as a follow-up, one of the areas that you -- that -- we’ve heard some feedback on is the trial design, and obviously, for ADVOCATE, the standard-of-care was different than it is today, when ADVOCATE was initiated, so including the steroid regimen, as well as maintenance therapy. Could you maybe walk us through how you think about avacopan fitting in with the current standard-of-care and how it compares to the current standard-of-care? And if this topic comes up in the Adcom, how you plan to support avacopan’s position within the current standard-of-care?

[Dr. Thomas Schall:]

Michelle, I think, there’s a lot of misconceptions about what is current, quote, standard-of-care there and there are some facts that have changed since we started the trial. But let me put it -- let me be very clear. We tried to make the ADVOCATE trial as close to real world practice as possible. I -- that includes steroid regimen and tapering both then best practice, and in fact, that’s now a best practice. We tried to make the background medication of either cyclophosphamide or rituximab as close to real word practice. And in fact, we were completely aligning ourselves with the label of all those medications at the time, including rituximab. So what we got was an excellent trial design and reflected then real word practice and still to a large extent now, the one thing that has changed is rituximab’s label was expanded towards the very end of the ADVOCATE trial by the way to allow for increased frequency of dosing. So before it was essentially one regimen at the start of the treatment phase, which is for an infusion phase by one week and now you can top up according to the label as frequently as every six months or so. Now, while that is becoming an emerging paradigm, especially for patients that have a history of ANCA-associated vasculitis with relapse, the latest figures I saw, by the way, for newly diagnosed disease, I don’t know if that’s yet been adopted as the majority paradigm. So I think while rituximab’s label has expanded fairly recently. I’m not sure I would call it exactly a changed standard-of-care. But it is a very fair point to say, well, look, rituximab is use ever more frequently. All the better. The features of the ADVOCATE trial actually allow us to leapfrog to what I think is the gold standard, which would be better for maintenance therapy once people are quiescent, how would you do that trial, you do a double blind, randomized placebo controlled trial. And as I referred to, in my remarks, de facto, you can get some of that information from weeks 26 to 52 in the ADVOCATE trial from the 65% of the people in that trial who had avacopan plus rituximab as a start, and then went on to have no further medication and as the trial were on, so they didn’t get tapped up with rituximab. What did we see, we saw about a 71% sustained remission in the avacopan group versus a 50 -- middle 50% remission in the prednisone group and this is the rituximab travel alone. And it’s not a tiny number of people, it’s 200 plus people. So it’s bigger than the whole rave trial. So what that tells us is that we have a very good way of maintaining remission after people get to quiescent state at that first 26 weeks and there isn’t a need to give unnecessarily more rituximab. And rituximab that is now at its consequences. So it’s at least an observation, is it a trial designed to answer that question? No, but it’s a feature of this trial that does shed light on that question. Could have avacopan can be used as a monotherapy in a maintenance search? And the answer is, well, these data suggested equipped. And that’s what Dr. Merkel and Dr. Jayne alluded to in their remarks at both International Congresses and Dr. Jayne at the R&D Day. So I think that’s how best I would answer the question. We did an excellent trial. We’ve reflect standard real world practices at the time and still, and the fact that we didn’t add additional rituximab actually gives a feature to our trial, which I think is very valuable. Finally, again, rituximab is a changing landscape. It’s not used routinely I think, even at this point for newly diagnosed people in the second six months. It’s mostly reserved for people in the history of relapse. So that’s -- I think that’s what I would put to the community at this point. It’s, again, a set of observations based on data.

[Michelle Gilson:]

Thank you so much for taking my question.

[Dr. Thomas Schall:]

Thank you.

[Michelle Gilson:]

Good luck this week.

[Dr. Thomas Schall:]

Thank you.

[Operator:]

Your next question comes from Steve Seedhouse from Raymond James. Your line is now open.

[Timur Ivannikov:]

Hi. This is Timur Ivannikov on for Steve Seedhouse. Thank you for taking our question. In terms of the post-week 52 relapse rates you indicated, not sure whether it’s fair to analyze those rates from 4% over eight weeks to 26% per year. But with that rate be comparable to what you would expect outside of the trial setting? And can you also remind us whether you’ve shared this data with the FDA? Thank you.

[Dr. Thomas Schall:]

I don’t think it’s very -- it’s analyzed the data, because it’s such a short period and is still fairly small. So I don’t want to over interpret that data. So that’s an important point. And by the way, I would say that, when we talk about numbers and comparisons, we’re all trying to compare number from study A to study B, and we’re looking at the numeral, but the definitions can be different and that really is of critical importance. So I would have to say, be cautious about what we talked about with relapse from study-to-study. How is it defined? So, certainly, in our study, what was interesting is there was a moderate decline in the rate of sustained remission once the people stopped taking avacopan and it started to be similar to what we see in the prednisone group. And so that was an interesting observation. It’s, again, an eight-week period, still a fairly small number of people. But it was an interesting observation. I probably wouldn’t have made that much of it, if we hadn’t also seen again, a modest decline in EGFR, after a steady increase week-by-week from very early on in the trial continuing to increase out to week 52. So again, the suggestion is that, there might be need or benefit by keeping people on avacopan, and I think, it’s really, I’ll limit my interpretation to that at this point. And again, without going into what would be in our briefing book, per se, but at least that’s a document that we own. I think it’s fair to say that those data are the FDA or aware of those data.

[Timur Ivannikov:]

Okay. Thank you very much.

[Dr. Thomas Schall:]

Thank you.

[Operator:]

Thank you. Your next question comes from Dae Gon Ha from Stifel. Your line is now open.

[Dae Gon Ha:]

Yeah. Good afternoon and thanks for taking our questions. I’m very much looking forward to the Adcom next week. But, Tom, I just wanted to go back to some of the additional data that you presented at the R&D Day. Specifically just wondering, you highlighted the rituximab cohort data and looking at sort of the de facto monotherapy data as you just mentioned as a prior question. But just wondering if you had done any additional subgroup analyses, for example, patients that do not have the renal involvement and I’m just wondering, coming from a more rheumatology focus. What about those patients that did not necessarily have the renal involvement, what to do there? And I guess the follow-up question to that is, in terms of flares, given that the trial was not inferior, but superior in the last 26 weeks, it wasn’t 100%. So I would presume there to be some flares that have been in the interim. Any color you can provide in terms of what types of flares or severity that you saw during that period? Thanks.

[Dr. Thomas Schall:]

Flares were defined, I think fairly carefully in the New England Journal paper. So I probably would refer you to that, rather than speak on the call. But to be clear, you could have not had a flare certainly over a certain set of criteria that would constitute a major flare. You could not have had a flare between weeks 26 and 52, and be considered in sustained remission at week 52. So the fact that some 66% of the patient population in the avacopan group, or nearly 67%, as I recall, I’m just thinking, quoting off the top of my head versus 55% in the prednisone group, were still in remission is considerable, and as you said, statistically superior and the comparison. Mind also, this is all based on intention to treat numbers. So that the, we know that 10% of the people did drop out of the trial or had basically. So they were not available for that now, they already -- that takes us down from 100 to 90 available as a top number to get the ITT analysis. And in fact, if you look at the numbers, an additional 10%, while still in the study, that had stop taking study medication, basically in both groups. So, again, if you really had for whatever reason wanted to say, well, if you looked at the number of people still on both study drugs over that period of time, again, the top number would be about 80. So it’s kind of an interesting way of thinking about it. But we have a considerable sustained remission rate, clearly better than the prednisone group. Without getting into subgroup analysis too much, I will say this that, we look at all the subgroups and especially when we look at the some of the factors that you’re talking about. But essentially subgroups do consistently as well numerically or better than the prednisone group. They do that by not having to take the prednisone load -- the daily oral prednisone load along away. And typically, they also have improvements in the clinically relevant secondary endpoints when they’re on avacopan, EGFR, relapse rates lower, et cetera. So we hope to be able to publish a lot more of this data as we get through the next phase of our development program. But I would be hard pressed to point to any subgroup at this point, that doesn’t do at least as well, typically better than prednisone-based therapy and even if the numbers were exactly the same, which is atypical by the way, for any subgroup. But even if they were exactly the same. Remember, they got there without taking the prednisone load. So they get the benefit of reduced prednisone induced toxicities. And as I mentioned, the other clinically relevant secondaries also fall in line with that. So the signals consistently show avacopan and benefit across most of these parameters.

[Dae Gon Ha:]

Okay. Awesome. Thanks very much. Looking forward to next week.

[Dr. Thomas Schall:]

Thank you.

[Operator:]

Thank you. Your next question comes from Ted Tenthoff from Piper Sandler. Your line is now open.

[Ted Tenthoff:]

Thank you very much. And I’ll start by saying break a leg or gridlock or whatever you believe in for next week. But I think the data are so compelling here. I’m scratching my head to see what the FDA could really kind of find fault with. And I guess the one question I keep coming back to is, does the FDA recognize and again not asking you to put words in their mouth, but do they recognize how bad of an actor the steroids are? And do you think there needs to be further education there or do they pretty much understand and accept that?

[Dr. Thomas Schall:]

Well, Ted, it is a really good question. I know in my own case, I mean, I’ve been studying this disorder for a long time. But the first couple of years, it was studying it from afar. And I could read the charts and the side effects and I could conceptualize somewhat and abstract what this might mean. And it painted a pretty bad picture for me and sort of my intellect. It wasn’t until I started talking and seeing individuals who were on the steroid regimens, that I truly got just helpful in how these steroids are?

[Ted Tenthoff:]

Yeah. Okay.

[Dr. Thomas Schall:]

Steroids, they’re just poison. I made the statement publicly and I people tell me, I’m provocative when I make it, but I think it’s backed up by science. Steroids, maim, and kill, full stop. And until you see that, until you live with it, you just don’t you can’t grasp it. So…

[Ted Tenthoff:]

Yeah.

[Dr. Thomas Schall:]

.. I can’t speak to the FDA. I’m sure there are many fine professionals who have had clinical experience, maybe even seen this disease. But I can say that most of us even those knowledgeable in this disorder, it just don’t get it until you see it firsthand. So…

[Ted Tenthoff:]

Yeah.

[Dr. Thomas Schall:]

… I’ll just leave the question there.

[Ted Tenthoff:]

Yeah.

[Dr. Thomas Schall:]

For education, I think, necessary education all across the Board.

[Ted Tenthoff:]

And I have to agree, I mean, I don’t think I appreciated this until I started attending your event. So I do think you’re working for the patients here. That’s very clear. And every time we hear more testimony from patients, it’s so clear the need. So we’re seeing in the best of luck next week and we’ll certainly be paying close attention.

[Dr. Thomas Schall:]

Thank you, Ted.

[Operator:]

Thank you. And your next question comes from Ed White from H.C. Wainwright. Your line is now open.

[Ed White:]

Hi, Tom and Susan. Thanks for taking my questions. Just a couple of maybe one for Susan first, can you give us an update on where you are with the sales force? Are they in place now including the related clause? And prepare to launch prior to July 7th, if in fact, the approval comes before the PDUFA date?

[Susan Kanaya:]

Sure. And thanks for the question. Actually, we have the benefit of having Tosh Butt on the line with us today, our Chief Operating Officer. So I think I’ll allow Tosh to answer that question. Tosh?

[Tosh Butt:]

Susan, thank you very much for punting the question over happy to take it. Yes. So regarding the field force, what I can share is that, we have been in the process of building up our field force that comprises both medical science liaisons, as well as sales professionals. The medical science liaisons are enroll and they’ve been interacting with key opinion leaders, having appropriate disease education conversations about ANCA-associated vasculitis. We have hired our sales managers and they are in the process of hiring as sales professionals. What I can share with you is that those sales professionals will be on board with adequate time to train them on the disease state, to train them on avacopan, and to train them on the customers in their relative geography. That work is about to take place very shortly. And in terms of your question around should the approval come a few days in advance of the 07/07 PDUFA date, we expect to be ready to move very, very quickly if it does come early.

[Ed White:]

Great. Thanks Tosh. And Tom, maybe a question for you regarding the lupus nephritis study. Maybe you can give us a little bit more detail on what that study will look like? Any thoughts that you can give us on the size of the study, protocols, et cetera? Thanks.

[Dr. Thomas Schall:]

Ye. Thank you. We would love to begin an advocate type trial of lupus nephritis. Immediately we found it’s a little bit more complicated that. Ultimately that’s what we aspire to. It’ll take a step or two to get to that level of trial, which we would aspire to be the registration step of a study for avacopan and lupus nephritis. It turns out that the way medicine is practiced in lupus nephritis though is a little bit different. They’re very used to just add-on therapies and looking for incremental benefit. I’m not saying incremental in small way, certainly, significant benefit. And that’s how medicine has been practiced. So even with all of the latest therapies, and there’s been some really nice advances recently, as you know, still probably and these are added on to glucocorticoids, for example, there’s still a lot of daily prednisone into this world routinely. And we’re still only getting true benefit for about 44% to 0% of the patient population even with all the latest care. And that’s on top of, not insignificant amounts of daily bread. So I think we’re going to have to go through a step as we had to some time ago as well, but we can do it in a very efficient and accelerated way to first showing that, yes, we can safely step-down GC in the presence of avacopan to virtually nothing on a daily basis and then expand the trial quite rapidly and vigorously to get to a larger end and something that looks a bit like ADVOCATE and go forward and using that as a registration step. So beyond that, I’m going to not comment too much further on the details, because it’s an active process right now. And but I think we’re getting to a very powerful plan here that will be very effective for the lupus world.

[Ed White:]

Okay. Thanks, Tom, and good luck next week.

[Dr. Thomas Schall:]

Thank you, Ed.

[Operator:]

Your next question comes from the line of Joe Schwartz from SVB Leerink. Your line is now open.

[Joe Schwartz:]

Thanks very much. I was wondering if you could elaborate on your commercial preparedness, in terms of your interactions with treating physicians and maybe even groups of patients and advocacy folks themselves. For example, I heard you mentioned your recent ANCA initiative. Is there any way that you can quantify the reception you’ve seen so far in terms of registrations for more information and maybe how many AV patients are treated at the centers that have accepted your outreach?

[Dr. Thomas Schall:]

Well, Tosh perhaps you’d like to speak to that topic.

[Tosh Butt:]

Yes. I can talk about that. Yes. So the question is about the reception to our product so far and about education. So what I can share with you is that, we have been interacting, well, let me step back if I. So when you look at this marketplace, the top 400 physicians who treat ANCA-associated vasculitis comprising of rheumatologist and nephrologist. They write about 30% of the prescriptions. So initially at launch, that cohort of customers will be a big, big source of attention for us, because they see they treat the bulk of the patients and they can have the biggest positive impact on these patients on their lives and the subsequent healthcare ecosystem costs. So we’ve been interacting with those physicians on a very appropriate basis, engaging in disease awareness with them. Many of them have seen the ADVOCATE publication in the New England Journal of Medicine that was published in February. They’ve also seen the wholly independent and accompanying two-page editorial, also in that same addition. And you’ve seen the download figures that Tom talked about over 35,000 downloads, making it one of the most popular New England Journal articles of recent history. So there’s a tremendous amount of interest. You also saw the slide that Tom shared with some recent market research that we’ve done very recently. In fact, that research is currently ongoing and that research speaks to the awareness and familiarity. These physicians primarily rheumatologist and nephrologists have around avacopan its 65% of physicians have heard of avacopan now and 89% have a positive impression of their product profile. And we expect this awareness of avacopan and the positive impression to elevate after the Adcom as we get closer to FDA approval.

[Joe Schwartz:]

Okay. And…

[Tosh Butt:]

And Ed…

[Joe Schwartz:]

Go ahead.

[Tosh Butt:]

And your question around patience as well, so look, we have been conducting patient advisory boards, really to understand the disease a lot better so we can really get under the skin to understand what are these patients feeling? What are they hoping for from a new treatment? So -- and Tom’s alluded to many of those factors. We’ve also been engaging appropriately again, with patient advocacy groups, because they have a really close relationship with these patients. They understand where these patients go for treatment. They understand what these patients are going through and they most importantly understand what these patients want from future treatment and any organization that is hoping to introduce a new medicine and/or product service for these patients. So we’ve been working, working very, very closely with those patient advocacy groups as well. Hopefully that answered their question.

[Joe Schwartz:]

Yeah. Super helpful. Thank you. So I guess my follow-on question would be, have you come across any intriguing analogues for avacopan that might be instructive for how the AV launch could go based on the ability to replay steroids which has happened in other areas of medicine, as well as offer other important clinical benefits, any dialogues that we should keep in mind as we’re modeling a launch?

[Tosh Butt:]

Well, look, I wouldn’t want to speculate on the launch uptake at this stage. All uncomfortable sharing is that look, if you look at the actual patient population that Tom alluded to. We believe there are 20,000 potential patients. And initially, well, the focus will be on those 8,000 patients who mimic what we see in the advocate study, which is anchored associated patients, either with life threatening or organ threatening disease. We believe those patients are potentially ideal for medication like avacopan and that will be the focus certainly in the short-term, should we get FDA approval. But we do believe there’s potential for avacopan use in the other 12,000 patients who have what we call grumbling disease, whereby yes, their condition is not life threatening. They don’t have an immediate organ threatening disease, but they’ve grumbling disease, they’re still on chlorinate glucocorticoid steroid, and quite frankly, they’re not well. So that’s what I’d say there.

[Joe Schwartz:]

Great. Thanks for taking my question.

[Tosh Butt:]

Yeah. In terms of uptake.

[Joe Schwartz:]

Go ahead, Tosh.

[Tosh Butt:]

Yeah. In terms of uptake. I would add that look and reiterate the point that Tom made is that, this is a new drug and it’s going to take us six months to 12 months. If you look at various payers, various hospital systems across the U.S. and their processes and their timelines for new drug reviews, it can be anywhere from six months to 12 months before these medicines are added to their electronic formularies. And once it’s added to an electronic formulary, the prior authorizations, medical necessity appeals, they tend to go through -- that process is a lot smoother and shorter. So for the first year, we expect there to be a little bit of challenge as we work through paper-based systems, where physicians have to do individual patient appeals to get the drug approved later based on medical necessity. But that’s normal for a new drug, particularly in rare disease or the specialty space.

[Joe Schwartz:]

It makes sense. Thanks for the color.

[Dr. Thomas Schall:]

Thank you.

[Operator:]

And your next question comes from the line of Anupam Rama from JPMorgan. Your line is now open.

[Anupam Rama:]

Hey, guys. Thanks so much for taking the question. I was looking at the FDA Advisory Committee page for May 6th earlier today, and it was noted that some of the presentations will be pre-recorded and those pre-recordings would actually be available May 4th. Do you have a sense of which portions are being pre-recorded? Is any of ChemoCentryx’s portions being pre-recorded, just to get a sense of what we -- what the totality of what we might see on sort of May 4th? Thanks so much.

[Dr. Thomas Schall:]

Thank you, Anupam. Good to hear from you. Yes, the world of COVID is still with us and it’s just created a world of how these Advisory Committee meetings are done. So that’s correct. But I think there will be pre-recorded sessions from us the sponsor. I think they get posted on May 4th. That’s my understanding. It’s a so-called -- that’s the so-called long or 60-minute presentation. 60-minute plus or minus, by the way. I think FDA also has a presentation and I believe that might get publicly posted. I’m a little bit confused myself, to be honest with you, but that’s my current understanding. And then the committee hears those pre-recorded publications as well. On the day of the meeting, there’s an additional short presentation, I believe, both by us so that the committee can ask us additional questions, the sponsor and by the FDA. And so that’s additional. There may be some overlap between those two or there may be some new information. I can’t really speak to content. But yes, it’s a little bit different COVID then of course, agency. I’m sorry. Maybe we’ll ask questions, both to us and I think we’ll have another question period with the agency. And then in the afternoon, the open public forum occurs as well. So it’s a much different format in this era as we try to be virtual. There are constraints because it’s all slides and recording, it’s not in-person and there’s not video allowed and all that other stuff. So it’s not perfect, but it’s still can be a very effective forum. So, yes, I anticipate based on my current knowledge that presentation from us will be posted publicly on May 4th. But that will be a slight, somewhat different presentation that will actually occur on May 6th. So that will be an additional one.

[Anupam Rama:]

Got it. Thanks so much for taking my question.

[Dr. Thomas Schall:]

Certainly. Thank you.

[Operator:]

And your next question comes from Yanan Zhu from Wells Fargo Securities. Your line is now open.

[Yanan Zhu:]

Hi. Thanks for taking my questions. Tom, you elaborated really well the rituximab used in the ADVOCATE study. I’m wondering if you could also elaborate on the steroids use as well. Could you talk about the speed of tapering in the control arm, and whether that could be considered standard-of-care by physicians? And also equally importantly, the fact that the steroids were tapered down to zero over 21 weeks…

[Dr. Thomas Schall:]

Yes.

[Yanan Zhu:]

… instead of lower dose, kind of a maintenance dose, whether that can be considered standard-of-care by physicians? Thanks.

[Dr. Thomas Schall:]

Yanan, very, very important questions. When we started the design of the trial, some years ago in fact, we impaneled body of experts, both academic and practicing clinicians and we asked them. Look, we read the literature, we’ve done our interviews, we can’t come up with what the steroid taper really looks like in this field and rheumatologist tell us that they taper steroids, within six months and yet, the patients are still on 5 minutes or 10 minutes a day. Nephrologist will say they taper steroids within six months and they’re essentially down to zero by four weeks. What is standard? So the fact is, we took a range of what the standard was. We appeal to all the clinical trials at the time, including PEXIVAS which was ongoing at the time. And what we got as a consensus from the expert panel was an emerging Modern Standard of steroid taper, at least in aspired standard, which is, let’s get people off of daily scheduled glucocorticoids within six months. And so that will, that’s what we put into our trial is sort of a model, standard-of-care best practice. In the real world, there’s probably a lot more persistent glucocorticoid use, which is fine all to the good. It just speaks again to the need for a substitute alternative to glucocorticoid, with a highly targeted therapy, by the way. So I believe that if you talk to any individual status of the physician, just like a statistic, they might say, well, that’s not how I would taper or I would actually keep mine five big for another six months or something like that. This does represent modern best practice trying to minimize both daily steroids load, have a fairly rapid taper and get them off of daily glucocorticoids certainly by six months. And so that I think we reflect that in our trial design with steroids. And I think we’re right again within the range of total glucocorticoid load over the six months and even the 52-week period where we have essentially a seven-fold median higher glucocorticoid exposure in the prednisone group over the entire period of the trial, nine-fold median higher of oral glucocorticoid during the period of the trial and so there’s a massive reduction in total glucocorticoid. And again, our goal was to eliminate as much as possible the need for daily scheduled oral prednisone. So I think we can say we’re standard care. Although, any given physician, she or he will have their own opinion on that in their practice and you’re quite correct. Rheumatologists tend to keep people on daily prednisone. Once they get down to 5 mgs, they kind of dismissed that. I wonder why that is though, because the data really shows that there’s probably no safe daily steroid dose right down to 2.5 mgs. I think a very recent paper meta-analysis published across six autoimmune diseases including vasculitis, undefined kind of vasculitis really showed that even if 2.5 mgs of oral prep per day, there is a three-fold increase in severe cardiovascular disease you’re on here. And as you get up towards higher doses 25 mgs per day, 30 mgs per day, there’s a six-fold increase in cardiovascular disease. That’s what the parameter was measured in that paper. So, again, it’s really -- we’ve gotten used to steroids and their effects, but it doesn’t mean that they’re not really dangerous even at low doses. So sorry about the long-winded answer, but we did try to standardize best modern practice with glucocorticoid administration, particularly the daily oral prednisone and I think we were successful in that.

[Yanan Zhu:]

Great. Thank you for that detailed answer. And then just a quick follow-up just to anticipate what happens next week. I know you prepared your briefing document without knowledge of the FDAs briefing document. So when the briefing documents are both made available next week. Do you think we could find answers to FDAs questions in your document or we’d better wait for the actual committee meeting to find out? Thanks.

[Dr. Thomas Schall:]

I think, again without speaking to the FDAs Briefing Book. I fundamentally believe that the answer to our questions about how outside experts will think about this data. We need to wait for the Ad Committee meeting. We’ll know at the end of the day on May 6th, what outside experts think about the data package. I wouldn’t -- I think that’s what this is all about, both we and the FDA are trying to get an idea of what to informed outside people think not necessarily vasculitis experts by the way, but informed rheumatologists and nephrologist whether they think of this data unbalanced. And so, my advice is wait for May 6th and we’ll see what the answer is.

[Yanan Zhu:]

Got it. Got it. Thank you and best of luck next week.

[Dr. Thomas Schall:]

Thank you very much.

[Operator:]

Thank you. There are no further questions at this time. I’d like to hand the call over to Dr. Schall for any closing remarks.

[Dr. Thomas Schall:]

Well, thank you very much for everyone for their attendance today. I really appreciate your time and energies. We look forward to talking to you again in the near future. And again, thanks for your time and you may now disconnect. Good day.

[Operator:]

Ladies and gentlemen, this concludes today’s conference call. You may now disconnect. Thank you for your….

[Susan Kanaya:]

Good bye. Operator … participation.