Unidentified Analyst: Yes, thanks.
Operator: Your next question comes from the line of Yigal Nochomovitz with Citigroup. Yigal Nochomovitz, your line is now open.
Yigal Nochomovitz: Yes, hi, thanks. Congrats on the progress. I may have missed it, but did you comment on the 511 start forms, what fraction of those 511 are on commercial drug at this point? Thanks.
Eric Dube: Yigal, we’ve not provided those details in terms of number of patients at this point in the launch. We’ll continue to provide those rates of PSFs as well as revenue and access as we see those as the core components of launch performance in the first part of the launch. I think what we certainly are seeing is a continued progress in terms of the number of patients that are treated as we move forward as outlined by Peter. Peter Is there anything more that you’d like to add?
Peter Heerma: No, I think we’ve covered everything.
Yigal Nochomovitz: Thank you.
Operator: Thank you. Your next question comes from the line of Mohit Bansal with Wells Fargo. Mohit Bansal, your line is open.
Unidentified Analyst: Thank you very much. This is Reid on for Mohit Bansal. My first question here is just on the KDIGO guidelines, could we see an improvement for the guidelines ahead of that September 5th PDUFA date? Thank you.
Eric Dube: Jula, I’ll turn that one over to you.
Jula Inrig: We anticipate the KDIGO guidelines to be out soon. That is what we’re hearing. And with regards to how that could help with f FILSPARI, I would say that it’s twofold. We anticipate that the KDIGO guidelines will suggest that patients who remain at risk for progression despite RAS inhibitors would be considered to switch to FILSPARI. So just further reinforcing the foundational role that FILSPARI should play, because we know most patients have been on a RAS inhibitor, many predating their diagnosis, and FILSPARI is superior to RAS inhibitors at lowering proteinuria, as we demonstrated in a phase three head-to-head trial. The other aspect that goes beyond that is that we anticipate that KDIGO guidelines will lower the proteinuria treatment target. That means that even more patients will need better treatment, which FILSPARI clearly offers.
Operator: Thank you. Your next question comes from the line of Vamil Davin with Guggenheim Partners. Vamil Davin, your line is open.
Vamil Davin: Great. Thanks for taking my question. So I just had one I was going to ask, but maybe to follow up on the prior comment you made around the compliance and persistence. And I think you said you’re having a high rate of compliance and persistence. I’m just wondering if you can quantify that a little bit more for us in terms of what percentage of patients are still on therapy three months or six months after starting. But then my main question was really just around the types of patients that are getting treated now, if you can provide a little more visibility on that in terms of what percentage are going through SGLT2s before they might start something like FILSPARI, what percentage maybe have used Tarpeyo or are using this before Tarpeyo.
And also, I think previously you talked a little bit about the use in the community setting versus academic physicians. If you can provide any sort of update there in terms of just where these prescriptions are coming from and what sorts of patients are being prescribed. Thanks.
Eric Dube: Vamil, thanks for the questions. Peter, we’ll have you cover these.
Peter Heerma: Yes, there were a lot of questions, I believe, in the question. So let me try to decide on them. To start with the last one, I think one of the questions was like, are patients coming from community or academia? Well, as a dynamic IgAN therapy, you need to cover a broad range of positions to really get to all the addressable patient population. And that is mainly because the vast majority of patients reside in community centers. So that’s where the majority of the patients come from. Another question was regarding what is the patient profile? Well, this is overall a younger patient population. And that’s what we also see reflected in the patient that [indiscernible] FILSPARI. Basically, patients in their 40s predominantly male.
And then I think also from a coverage perspective, I think it’s relevant. This is about 70% of the patients have commercial coverage which also speaks to the younger patient population. Then I think another part of the question was co-medication and SGLT2. Well, we have a significant amount of patients that also receive SGLT2 inhibitors. I think that is kind of like becoming the golden standard. Physicians are generally seeking [indiscernible] immunosuppressive therapy treatment option. And I think the novel standard of care moving forward is really FILSPARI that includes the RAS inhibition as well as endothelium, but also adding SGLT2. So that is something that we are achieving in practice. And then I think the last question where you started with was compliance and persistence.
We haven’t spelled that out, but it’s the compliance rates are very high compared to what you would typically see in chronic use treatments in cardiovascular disease or oncology. So high compliance rates, but we haven’t specified that specific number after certain amount of time. So I hope I covered all your questions on this one.
Eric Dube: Okay. Yes. Thanks, Peter. Maybe just a little bit of context for what we’re hearing consistently from patients. Once they start therapy, they have a very positive experience. They appreciate the level of support that our patient services provide, but perhaps even more important, they are seeing a very consistent reduction in their proteinuria. Oftentimes these patients who are at high risk of progression struggle to see reductions in proteinuria that are meaningful with other therapies. And so they’re very pleased to see those reductions with FILSPARI that oftentimes happen very quickly in after initiating which we believe is a core part of that compliance rate. Of course, it’s a very easy one today oral therapy non immunosuppressant. All things that we know are important to patients. And we believe that’s going to be a core part of building a very robust base of business upon which to grow over time.
Vamil Devan: Okay.
Operator: Thank you. Your next question comes from the line of Alex Thompson with Stifel. Alex Thompson, your line is open.
Alex Thompson: Great. Thanks for taking my question. I guess a little bit more on sort of broader commercial dynamics. Could you provide a little bit of context around any inventory or pricing dynamics, headwinds or tailwinds in the quarter?
Anupam Rama: Sure. Alex, thanks for the question. Peter, we’ll hand that one over to you.
Peter Heerma: Yes, I would say from an inventory perspective, I don’t think we see any different patterns than what you would expect in the second year of launch. So I don’t think there’s too much to speak to on that one. And then I’m missing the other component. You talked about pricing dynamics. Yes other than the growth to net this sounds like you have a little higher in the first quarter of every year and that’s among the industry. So I don’t think it typical FILSPARI. I don’t think we have seen any particular dynamic from a pricing perspective.
Anupam Rama: Great. Thanks.
Operator: Your next question comes from the line of Laura Chico with Wedbush Securities. Laura Chico, your line is now open.
Laura Chico: Hi, good afternoon. Thanks for taking the question. I have one on kind of a longer-term outlook for FILSPARI. A Japanese competitor recently completed enrollment in their phase 3 IgAN study. And we obviously have some other anti-APRIL targeted agents moving forward. But as you mentioned, FILSPARI will likely be in the KDIGO updated guidelines. So I guess I’m trying to understand here in this kind of ’25-’26, and beyond period, how are you still thinking about FILSPARI utilization as the treatment landscape is changing, particularly if there is a pull forward in diagnosis and earlier treatment?
Eric Dube: Yes, Laura, thanks for the question. This is one where we’re particularly excited about the long-term outlook for FILSPARI given that it is a very unique position within the treatment landscape and how it works in the treatment of IgA nephropathy. I’ll ask Jula to provide a bit more detail on that.
Jula Inrig: Yes, thanks, Laura. I think it’s really great to see innovation for a disease that’s had very little innovation for many years. And additionally, I think it’s exciting to see a potential replacement for the historical role that steroids have played and I think that’s a lot of what we’re going to be utilizing these add-on treatments in the future. But I would say first and foremost, as I said in my comments, you’ve got to address the activation and injury in the kidney that is present at diagnosis and needs to be treated long term. And that’s what FILSPARI offers. They also, as Peter said, they’re going to continue other supportive foundational medications because this is a lifelong disease and that might be an SGLT2 inhibitor for CKD, but essentially, FILSPARI replacing the role of RAS inhibitors.
And that’s really aligned with what the KOLs are saying, the guidelines are saying is that you’ve got a treatment that’s been compared head to head to historical foundational treatment and FILSPARI is superior to that. And then you can potentially add on additional medications, just like we’ve added on steroids historically to RAS inhibitors. You can add on a B cell or complement inhibitor on top of the foundational role that FILSPARI should play.
Laura Chico: Thanks very much.
Operator: Thank you. Your next question comes from the line of Ed Arce with HC Wainwright & Co. Ed Arce, your line is now open.
Ed Arce: Great. Thanks for taking my questions and congrats on the strong order of progress. Three questions for me. Hopefully, this doesn’t get too long. The main one is really about what seems likely coming out of KDIGO and then your PDUFA Date on the 5th of September. Given there’s no cases of DILI and the REMS monitoring could be softened and likely with proteinuria as in the EU and given the KDIGO guidelines are looking that way. All of this points to a much more accepting label going forward. And so the question really is if those do come to pass what would be your view on the potential for an acceleration further from the growth rates that you’re seeing so far? And then just a couple of quick questions on the model. First, around Thiola, I think the decrease this quarter was largely impacted by the generic entry earlier this year.
I just wanted to confirm that that’s your view and then lastly, the 65 million in process R&D, I think you said that was due to a first patient enrolled in the HCU study. I just wanted to confirm that. Thanks so much.
Eric Dube: All right, Ed. Thanks so much. So first question, we’ll hand over to Peter. So Peter, how do we see KDIGO and the labeling driving growth as we move forward?
Peter Heerma: Yes, I would say it allows for a broadening of the addressable patient population. I mean, it’s right now the U.S. label states patients that are at risk of rapid progression with a general proteinuria target of 1.5. I’m expecting that would go down in our label when we have the full approval. But then I think additionally to your point on KDIGO as you were alluding to it earlier we are anticipating a more aggressive treatment target with regards to proteinuria. And I think that also allows for a broadening of the patient population and you mentioned earlier like the evolving landscape, you have more entries that may come into the market. It is really a market in development I would say. It was more confirmatory biopsies more early on. And I think it allows for a greater continued growth opportunity for us playing in this item.
