Peter Greenleaf: Obviously, I can’t predict where the guidelines will go, but I’m hopeful that they will be somewhat in line with where EULAR is, which, with emerging therapies and pipelines starting to show productivity for many companies within our space today, you’re going to have to address novel therapies and novel treatment approaches. And I think there’ll be consistency, although I can’t think for that group as they do their work. But we’re predicting that they’ll address more aggressive use of novel therapies. I guess just to rewind back, prior to the EULAR guidelines and new ones being published, when there was the old approach to EULAR, KDIGO and ACR, there are several things in there that reinforce really important components for us.
One is, doing consistent diagnosis for SLE patients. We believe only about 50% of SLE patients that visit an office practice on any given day get a urine screen for lupus nephritis. The guidelines have always been consistent that every time an SLE patient visits the office, they need to be screened. We see that as a huge driver of potentially newly diagnosed or existing patients that aren’t currently getting diagnosed. The second is treating to target and trying to reach certain proteinuria levels by three months and six months and a year, target levels that we know today rheumatologists and nephrologists don’t aggressively treat to. And aligned with our data, we’re the only product that actually shows consistent performance at those levels aligned to the guidelines.
So, there’s a lot of gems within the guidelines that if we can just get physicians treating more, I guess more in a more congruent fashion, that we can actually see the market start to grow. Your last question of whether they’ll incorporate the new data, published data is usually what they look for. And the extension data has now been published. The AURORA study has been published. The biopsies and poster form, we’ll see when they actually publish these guidelines. We’re working hard to get the Biopsy study published too, but usually they point at published data, not stuff that’s been an abstract or poster. Sorry for the length of the question or answer. Do you have another question, Ed?
Ed Arce: No, that’s it. Thank you.
Peter Greenleaf: Thank you.
Operator: Our next question is from Sahil Dhingra with RBC Capital Markets. Please proceed.
Sahil Dhingra: Hi, this is Sahil for Doug. I have two questions. My first question is on the comment made in the prepared remarks that there were some higher discontinuation this quarter. So, is it related to summer seasonality to a degree or is it more dependent on where the patients are on the, for how long the patients have been on the drug?
Peter Greenleaf: It’s the latter. I think you have to think about this in a dynamic, as you model it, think about it in a dynamic fashion. And during this quarter, we saw more patients who have seen therapy for longer periods of time. And obviously the discontinuation rate for patients who’ve been on drug for 12 months versus patients who have been on drug for nine months, if you see a higher average of them in a quarter, you’re going to see higher discontinuation rates. There’s no, that we can tell summer rationale as to why it was more just a mix of the patients in the quarter. You have another question?
Sahil Dhingra: Yes. Thank you for that response. And my second question is related to the prescribers. I know this was asked before, but if you could provide more color. I think in one of the earlier calls you had mentioned that 55% of the prescribers are not repeat prescribers. How has that trend changed given the new data that we have on hand? Thank you.
Peter Greenleaf: The short answer is we’ve seen improvement across the board and we see less patients than 55% now, a higher percentage who are prescribing more than having a higher dependence upon, first time tries, initial tries. So as I said the reason we haven’t, because we segment this data pretty, we do a lot of quant on this. We haven’t rolled that out primarily because, we think we give a lot of data and this one I think is important, at least at this stage, to keep a little closer to our best in terms of the competitive set that’s out there. But I can tell you that whether it’s depth of prescription and or total number of prescribers, we’ve made meaningful movement on both fronts during the quarter.
Sahil Dhingra: Thank you.
Operator: Our next question is from David Martin with Bloom Burton. Please proceed.
David Martin: Good morning. Thanks for taking my questions. The first one is a follow up to the question Ed asked. Have you made any progress in getting the nephrotoxicity language changed on the U.S. label based on the AURORA extension and the Biopsy data? And when the U.S. guidelines are crafted, do you think they’ll be affected by that language in the label or more by the EULAR type language?
Peter Greenleaf: I can’t predict where the agency is going to go, but I can reinforce to everyone on the call that we announced in June that we had submitted this data to the U.S. FDA. It was expected the extension data and the Biopsy data as sub-study and extension study were both expected from the agency. We’re hopeful that this will be incorporated in a meaningful way into the label here in the U.S., but we can’t predict where the agency is going to land on it. And we’ve not heard back anything from the agency at this stage.
David Martin: And do you think the guidelines are swayed by the label that much or not?
Peter Greenleaf: No, I think it’s a published data.
David Martin: Okay. Second question. Do the restarts require new PSFs?
Peter Greenleaf: The restarts require new PSFs? No.
David Martin: Okay. And last question. What pricing did you get in the European countries where you got the pricing?
Peter Greenleaf: We can’t speak specifically for every country. And sort of it’s Otsuka’s domain, so I’m not sure how much of this they want to disclose. But I can just give you the color that in terms of appropriate pricing as we see it in terms of reference pricing would be novel therapies like Benlysta. A negative outcome would be getting pricing in the generic set like a Trolomus [Ph] or something like that.
David Martin: Okay. Fair enough. Thank you.
Peter Greenleaf: Thank you, David. It appears that that’s all the questions we have for today. I want to thank you all for your time and we’ll look forward to talking to you again next quarter. Thank you very much and have a great day.
Operator: Thank you. This will conclude today’s conference. You may disconnect your lines at this time and thank you for your participation.
