Peter Greenleaf: Yeah, I think the short answer is the difference between AUR 200 and 300 in our pipeline was we own AUR 200. Yes, we have follow-on commitments to those that we purchased it from, very minimal, but we do have commitments. So, we will either seek to develop the drug through someone else or to efficiently move the drug forward on our own if, in fact conversations with others don’t produce the type of value that we would see for the asset and the type of speed we would want for the asset. So, in other words, we don’t want to just, you know, shelve it and not get the value of, you know, this APRIL, BAFF inhibitor, which obviously more and more data emerges every day on the APRIL, BAFF space as it pertains to IgAN in particular, but we think more broadly there’s going to be a place for APRIL, BAFF inhibitors in the B cell pathway and much more, you know, immunology disorders moving forward.
So we want to keep this thing moving forward, whether it’s in our own hands or someone else’s.
Stacy Ku: Okay. Thank you so much.
Peter Greenleaf: Thanks, Stacy.
Operator: Thank you. [Operator Instructions] Our next question is coming from Joseph Schwartz from Leerink Partners.
Joseph Schwartz: Hi. Thank you. And congrats on a strong quarter. I wanted to ask first about your initiatives around screening and diagnosis. Where is the community now on that front? How much screening is being done? And how much have you been able to move that needle? And how is progress there contributing to new patient starts relative to the other initiatives you have ongoing?
Peter Greenleaf: Thanks for the question, Joe. I think we have one series of sort of physician-reported AAU that’s been done. And at least at the rheumatologist level, what we can tell you is that we’re seeing some improvement in treatment. We’re seeing some improvement in awareness of need to diagnose lupus patients and do urine screens. We haven’t seen that, Joe, pull through yet to actual claims data. And there’s no direct — it’s not one to one, and it’s kind of — even our interpretation of claims data is kind of you have to take some liberties around what’s submitted through the claim to try to get under that. What I can tell you is these numbers have been like grossly low historically, at least as reported by a large patient record audit that was done by Optum a few years back, looking at lupus patients, a couple of hundred thousand lupus patients over several years.
And you’re looking at numbers like less than 50% of these patients even get a urine screen. This is lupus patients. Guidelines say they should get it every time they come in the office and when they do have a positive proteinuria or a proteinuria level that the guidelines would indicate. Indeed, our is a lupus nephritis diagnosis, only 30% of them even get treated. And you say, well, geez, why? I think one is just general awareness and I think hematologists will treat proteinuria and lupus nephritis differently. I think they see lupus nephritis as several grams of proteinuria and — or protein to urine and they see low proteinuria as not indeed be nephritis. Now that’s a little bit of a liberty from some of the research work we’ve done, but the awareness we need to build is that even low levels are indicative of poor outcomes for the patient moving forward, and you’re never going to find it unless you’re doing a urine screens.
So I think we’re making impact there, more to come as we continue the campaign forward.
Joseph Schwartz: Yeah, it seems like a great area for our white space. I was wondering also regarding the updated label, I think that happened a fair amount ahead of expectations, given we were expecting an update in the second half. So, can you talk about why that turned around so fast? How does the updated label fit within your expectations? And is there any potential to limit the REMS in the future with any additional label updates going forward?
Peter Greenleaf: Well, we don’t have a REMS in the technical sense. So maybe I’ll answer the question and maybe as you’re thinking about it, Joe, come back to me with what you mean by the REMS. As we previously communicated, we let the agency know that we were going to do the extension study and that we were also going to do a biopsy substudy as part of the pivotal. The agency said great, we’d love to see that data, but it wasn’t packaged as your classic supplemental NDA, right? So when we fed this data to the US. FDA, obviously, we were glad they would take it, but understood that it wasn’t — it could potentially fall outside of the technical as the technical supplemental new drug application process. The agency luckily treated it much like a supplemental.
And they performed within the 9 months to 12 months category of what a normal supplemental is. And we were more conservative probably in our estimate because this technically was, in our view, a supplemental NDA package. So it came earlier than maybe the way we guided externally, which is a positive. And I think in terms of our expectations, this hit pretty much on everything we had expected. We wanted the language removed from the indication statement now that there’s more than one year data and we wanted the data incorporated on. I will say that the biopsy substudy data was not incorporated but we don’t think that’s limiting on. We think that data can still be made available through publication and through medical drug and information request forms.
Joseph Schwartz: That makes sense. That answers my question. And then what about on your recently announced buyback? Have you made any progress on buying any shares back yet?
Peter Greenleaf: Short answer is yes, well within the quarter but we actually up until the I believe this is up until the end of April. We purchased about $18.4 million worth of stock with an average cost of $5.37, which equates to about $3.4 million of total shares. Just for future because I’m sure that’s kind of a follow-on question. We would look to fund any future purchases through discretionary purchase, repurchases through cash flows and not through what’s the cash on hand. And it’s at the Board’s discretion. So we’ll report out more buys as we go here but 18.4 through the end April.
Joseph Schwartz: Helpful. Thank you
Peter Greenleaf: Thanks, Joe.
Operator: Thank you. Next question is coming from Ed Arce, H.C. Wainwright. Your line is now live.
