Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) Q1 2024 Earnings Call Transcript

Ed Arce: Hi, good morning. Thanks for taking my questions. Just a couple here. I wanted to follow up again really on the bigger picture here in particular with the updated label. I gather you got me. The main aspects of that you’ve got into this new label in particular. I wanted to have you speak a little bit further Peter, if you could on your view of that, the impact of that label, particularly longer-term persistence and doctors eventually treating this as a long-term treatment along with the “Know the Signs“ campaign, which particularly targets the rheumatologists, which have been the lower prescribing group of the two. Just brought a trough on the longer-term perspective and impacts of those?

Peter Greenleaf: Well, I’m sure wasn’t missed on anybody but over the last couple of quarters we’ve actually seen improvement in terms of our persistency and at least from my history of doing this for a little while on multiple drugs. Persistency is a really hard thing to move within the biologics category when we launched anti-TNF. Remember those numbers staying fairly consistent for a very long time, no matter how much money we throw at it. And I think here we were sort of right below 50%. We inched up to 50% at one year and now we’re at 56%. So on a macro level I think having this data out there that shows that at least C&I can be used on this. This next-generation C&I can be used for longer periods of time is incredibly helpful.

I think alongside of that, the guidelines are now very vocal about aggressive diagnosis, earlier treatment. And they’ve always been fairly consistent about levels and meeting treatment but now they’re very clear and you actually have companies and investment going into educating and making sure that that people start to actually put these guidelines into place. So for the longer-term the bigger picture question, we need to see more aggressive diagnosis in the rheumatologist office, we need to see target levels of proteinuria treated by rheumatologists, when there are signs and this is not just a ready is goal. This is the goal of the treatment guidelines and then dose treatment guidelines estimate the patient should be on an estimated three to five years.

So all of those things had significant level of improvement that can happen. And I think that’s what’s going to move this whole category to a much larger opportunity for the industry. And I also think it’s going to take the burden of disease for the patients. We’re trying to care for here and take it down dramatically. So that’s kind of the big picture view at least as we see it at.

Ed Arce: Great. That’s helpful. A couple of more if I may. Just one question on AUR200. You mentioned that remains a very interesting target, the April BAFF inhibitor. Just wondering if you have any particular development time lines, or anything you can share in terms of news flow near-term with that? And then last question I wanted to ask about the comment about that the newer higher expectations for LUPKYNIS pricing 70 to 75 versus the 65 previously off of what is it that you think has persisted and changed your view from prior expectation? Thanks again.

Peter Greenleaf: Yeah, I’ll take the first one and then Joe kind of gives his two cents on 70 to 75 on average net. Listen, I guess just to give the most update our information that we have on an AUR200, the IND was approved by the US FDA. So we are ready to start on the SAD/AD studies. And we’ll as I said on the call, our goal is to keep this thing moving forward. So when we actually do have a path whether it’s internally or externally forward, we understand that getting clear about how long those SAD/MAD studies will take when you’re going to have your first in-human clinical studies and when you should expect to see Phase 2 data, Phase 3 data, et cetera. And what indications it assumes. So on I would earmark that one for a future call, but know that the IND has been approved by the US FDA and we are moving into animal tox and in the SAD/MAD studies his year either through linear or through an external party? So the pricing question, let me let me kick that to Joe.

Joe Miller: Yeah. The follow-up on your pricing question, I think it’s kind of two factors. One is obviously Peter already touched on it, which was the persistency itself. That has evolved considerably over time. I think if you look back Q1 of 2023, it was about 51% by 12 months, it’s now moved to 56% at 12 months. So that’s probably your largest driver for the evolution of the net revenue per patient estimate. Also coupled into that is some small price increases over time that have high inched up that number on average.

Operator: Thank you. You next question is coming from David Martin from Bloom Burton. Your line is now live.

David Martin: Yes, good morning. Thanks for taking my questions. First off, also going back to the updated LUPKYNIS label. Is there any part of that that could give rise to new patent claims do you think, or is everything related to the change already in your existing patents?

Peter Greenleaf: Well, as we’ve mentioned previously David, we have patents on file with the US DA that have not been — or the US Patent and Trade Office and have not publicly been disclosed and won’t be until we actually get some action whether it’s an acceptance of the patents or not on. I can tell you that regardless of the US label change and the US label can be helpful to those patents in terms of Orange Book listing, we started looking at that back when we unearth the data from the extension study in general. And I would just leave you with note that it follows that line of possibility in terms of those patents that are on file with the US FDA. So the short answer is, yes, but we haven’t had a readout from the USPTO yet.

David Martin: Got it. On the second question with restarts becoming more important and trending up? Do you have a read on what percent of patients have the proteinuria rebound after coming off LUPKYNIS, and how long does it typically take for that rebound to occur?

Peter Greenleaf: The short answer is and I would look to Greg if he’s got a clinical answer to this on. I think the data is emerging on this in terms of what we know internally in terms of seeing the percent of the patients come back. I’m not sure that we have a quantitative read as to how long that takes and what those proteinuria levels are. What we do know is unfortunately the disease and this isn’t LUPKYNIS issue, this is an MMF issue, this is a LUPKYNIS issue. It’s any drug that comes after us until we get more alignment to treatment guidelines that it’s treated episodically and that when patients and some of this might be due to the fact that historical drugs had a lot of toxicity alongside of them that they used to treat the disease.