Renee Aguiar-Lucander: Okay. So I actually don’t have at hand, the kind of breakdown of the enrollments in terms of new kind of prescribers versus existing but because obviously, there’s always the possibility that new prescribers would have prescribed for more than one patient. But I guess the best estimate really would be that out of 555 enrollment, at least over 300 of those would be kind of from new prescribers. The remaining kind of 200, the easy assumption is that these are kind of repeat prescribers. But again, I can’t guarantee that. But I think that would kind of be my best estimate at this point in time. In terms of the magnitude impact of KDIGO, I mean I think that that obviously could be quite sizable because, obviously, what’s been discussed or at least at different conferences, at podiums, et cetera, is, and it’s based on this longitudinal data is, is 1 gram an appropriate definition to use in the guidelines to define patients at risk of disease progression.
And I think what’s been discussed and debated is, again, in this forum is that maybe that should be reduced. So if that level is reduced to 0.75 or 0.50, then obviously, that would have a very significant potential impact on the addressable population that would be on label. So I do think that it could be a very significant trigger, again, probably not an immediate impact again. But certainly, I think, could have a very significant impact on the overall addressable market.
Annabel Samimy: Okay. And if I can get a little bit more into the [weeds] (ph). So I guess, we’ve spoken to a couple of KOLs, One of the things that stood out was that the way they selected some patients were the ones that had clear inflammation or inflammatory markers were the ones that were more suitable for TARPEYO treatment versus any of the RAS inhibitors. Do you have a sense how many patients that have UPCRs below 1.5 or in inflammatory state and the extent to which expanding that is going to really tap into that entire market or just a portion of the market who are more inflammatory? So maybe you can sort of, I don’t know, address that a little bit.
Renee Aguiar-Lucander: I think that’s actually a very difficult question to answer appropriately actually based on the information we have. I mean, I would say that we know that it’s a very heterogeneous disease. You can have patients that actually have a decline of eGFR with virtually no proteinuria. And I think the only relevant way, I guess, of looking at this would probably be a biopsy. But, Richard, do you have any comments on that?
Richard Philipson: Well, I think, and also I don’t think in the sort of commercial prescriber setting, we’re not necessarily going to have available to us all the information relating to the kind of aspects of the patient’s condition that you’re referring to relating to kind of inflammatory states, et cetera, so inflammatory biomarkers or levels of micro hematuria, et cetera, that’s not necessarily going to be information that we’re collecting and have available to us. So I think it would be difficult to really comment on that.
Annabel Samimy: Okay. And I guess one last simple question. Just to clarify, when you have discussions with payers, you said they like the label in hand, do they not have access to this label at this point? Is there another label do they need to physically put in their hand for them to pay attention?
Renee Aguiar-Lucander: So, I mean, obviously, the label language is now available. But obviously, they do not have to see anyone or meet anyone or have any meetings with regards to anything around the label unless you have a new label, which obviously, they have to go through a new kind of P&T committee. So it’s really more a matter of they have their own process that they go through, whether this is a new drug or a new label update or anything else that would drive them to have to have a P&T committee. So it’s really more a matter of how, they obviously have other things that they’re also scheduled, so when will they agree to put this on their schedule. So when will they actually agree to go through this, because there is a requirement for them to go through this kind of formal process and therefore, also then issue any kind of potential update or change of the rules that they apply based on this new label.
So it’s really kind of the same as when we originally started is that you can always do things on a medical exception basis, right. But obviously, it gets easier when you actually have gone through the P&T committees and there is a more standardized way for the payers to address a certain drug, which is why you can certainly, I mean, this will also depend a lot on kind of how much energy and persistence do the treating physician have to go through potentially these kind of appeals processes until those rules have been amended, and that is just difficult to say.
Annabel Samimy: Okay. Great. Thank you.
Operator: The next question comes from Arthur He from HC Wainwright. Please go ahead.
Arthur He: Hey, good morning, Renee.
Operator: [Operator Instructions]
Arthur He: Hey, Renee and team, congratulations on progress. Thanks for taking my question. So regarding the launch in China, could you give us some update on the preparedness on that part? And remind us what’s the Calliditas’s role to support the launch?
Renee Aguiar-Lucander: Sure. So obviously, the commercial launch will be carried out by Everest Medicines. And actually, as you may be aware, I mean, the CEO there actually has a very kind of substantial and significant experience from other commercial companies in China. And so I think actually that the team that’s been brought on board is actually quite impressive and seems to have a lot of experience in terms of launching products in China. In terms of the actual kind of activity, obviously, I think they have had — they have been preparing for this for quite a long time. And obviously, as we know, this is a much, much larger population than what we have here in Europe and the US. I guess my best kind of view is actually — when I went to Shanghai to kind of visit some of the nephrology units and some of the hospitals there.
I mean, it’s clear that a lot of these hospitals have large numbers of patients that they actually just kind of have on their roster and they’re very well aware of this kind of the potential arrival of this medication. So, I think that it’s really kind of a — it seems to have a good expectation. I think the early access program is very successful. And as far as I’m aware, the company is really targeting a launch in Q2 of this year. So obviously, we will not have any kind of direct involvement in that commercial launch.
Arthur He: Thanks for that color. And just a quick follow-up on the open-label study. Could you give us more color on what exactly the data set looks like regarding the size and the data point? Thanks.
Renee Aguiar-Lucander: So I guess that my understanding really is and Richard, you can correct me if I’m wrong. But this really is just — it’s an open-label study. So everyone obviously is going to be on drug. The inclusion criteria were very similar to the inclusion criteria for the Phase 3. So slightly lower kind of eGFR levels, but actually the proton cutoff was the same and so, I believe it’s about 120 or so…
Richard Philipson: 119.
Renee Aguiar-Lucander: 119 to be exact patients that have been enrolled into the trial. And our expectation is, obviously, because this data obviously has not been unblinded. So even if it’s an open-label study, obviously, we do not know what kind of treatment the patients had prior to entering this open label. But we would expect that the majority of these patients would be placebo patients as they still qualify as being kind of at risk. But we would also expect that there is a group of patients who will have — who will be retreated. And our assumption is that, that would be skewed towards those patients who probably had a more severe disease coming into the Phase 3. Since obviously, they might have had very significant improvements, both on kind of eGFR and proteinuria potentially.
But obviously, we’re still qualifying as being at risk after that kind of two-year period of been spending that in the Phase 3. So that is really — and in terms of the data, it’s really kind of very similar data. So it’s really proteinuria, eGFR safety. I mean it’s all kind of the similar data set from that perspective.
Arthur He: Thank you very much for taking the question. I’ll talk to you guys soon.
Renee Aguiar-Lucander: Thanks.
Operator: The next question comes from Christopher Uhde from SEB Enskilda. Please go ahead.
Christopher Uhde: Hi there. Thanks for taking my question. I just have a few follow-ups. So, I think in terms of average duration of therapy, I think previously, I believe, said it was around six to seven months so far. People are more prescribing along the lines of systemic steroids in terms of that. Are you seeing now that’s starting to improve since the data was presented in approval? And then my second question, you gave a little bit of flavor on retreatment for those who are already going nine months. But do you have any indications so far on the average frequency for the patients overall who’ve been getting TARPEYO? And I guess then my third question is, so in terms of the returning prescribers. I’m not sure how much you can say given what you’ve said earlier, but are you getting a sense of whether the prescribers who’ve prescribed previously are getting better at converting enrollments to treatments quickly like navigating the reimbursement sort of maize better, if you will.
Thank you.
Renee Aguiar-Lucander: Thanks. So in terms of the average duration, what we did is we followed this kind of patient cohort, and I think we reported this, I think, in Q2 of last year. That actually showed us at that point in time that the average treatment duration was about eight months. And so what we would be expecting, and I think we’ll probably follow a cohort shortly and try and see what that looks like maybe towards the end of the year, really kind of we would expect that to kind of be increasing at this point. And the reason why we’d be increasing is obviously partly as you say, there is that kind of habit that kind of still fits. And actually, I think it goes for almost all drugs and there is a sense of nephrologists that you try something for six months and then see kind of what happens.
So, I think that we would expect that to kind of continue to improve based on additional education, medical affairs, intervention, et cetera, to really explain the difference in terms of the local action, et cetera, of this particular drug. So that would be our expectation. In terms of retreatment, I think it is too early for us to kind of comment in any great kind of detail on that. We have seen kind of retreatment happening, but I think we’re going to wait in terms of collecting some more information on that before we really comment on it. In terms of returning prescribers, I wish that I could tell you that these kind of prescribers who prescribe before are getting better at it. Unfortunately, I’m not sure that that’s the case. I think it just comes from the fact that this is a rare disease, and so it might have been three or four months between them kind of prescribing it before and prescribing it now.
And unfortunately, there’s been hundreds of patients in between that period of time for these nephrologists. So I do — I think it’s unclear at this point in time how much better they’re getting actually kind of submitting complete prescriptions. But we are still hopeful that we’re going to get there.
Christopher Uhde: Thank you, so much.
Operator: The next question comes from Johan Unnerus from Redeye. Please go ahead.
Johan Unnerus: Great. Thanks for taking our questions. The first one, considering the enrollment and the unique subscribers and also the price increase, it seems like the guide is rather conservative. Should we expect you to take a rather proactive approach during ’24 and perhaps update the guide more actively?
Renee Aguiar-Lucander: Yes, that would not be — that wouldn’t be an impossibility. I think that obviously, as we — as some of these things become clear, both in terms of how quickly we can get through P&T committees, when the KDIGO guidelines may or may not kind of become available, et cetera. And when it becomes a little bit more clear on that, I think that could certainly imply that we would kind of provide more and more accurate guidance as time goes on.
Johan Unnerus: Great. And this leads us to the second question. What about the regularities and time that these P&T committees tend to meet? And will that happen several times a year or when something is needed to be handled?
Renee Aguiar-Lucander: It does vary actually plan to plan. I mean, some of the bigger plans are more kind of structured. They may have like a quarterly meeting, et cetera, and otherwise might have monthly meetings. But yes, there is a certain cadence that they all have that in which case, they will obviously do more than just one drug, they have several kind of cases that they will kind of address in one meeting. But it’s not necessary — it’s unusual that it would be adhoc. It’s more kind of a structured process that is — that they have agenda for either then on a kind of mainly kind of quarterly basis.
Johan Unnerus: So later in the first half — during the first half, you should have some insight into this dynamic already?
Renee Aguiar-Lucander: Absolutely. And as I said, this is clearly something that within the organization, we are very focused on, and this is clearly something where we are working very actively at driving that process as much as we possibly can from the outside. But there’s a limit, obviously, to how much we can impact that, but there certainly is a lot of focus on it.
Johan Unnerus: And regarding the backlog relating to the private commercial pay. As you said, this is not an acute illness, but it is a chronic illness and specialists will continue to monitor the patients. The backlog is unlikely to disappear. There are very few alternatives.
Renee Aguiar-Lucander: Certainly, yes, there are kind of — there are a few alternatives. I think what you might find is that physicians get frustrated, they cancel it. They kind of meet their patients the next time in a couple of months, they kind of submit again to try and have better lack at this time. So I think it will be a mixture of those physicians who will have — be a little bit more patient and be willing to kind of go through the authorization process and some of those other prescribers who may kind of come back when they think actually the rules have been updated so that they don’t have to kind of jump through the same hope. So I think it will probably be a mix of those.
Johan Unnerus: Great. And finally, if I may, regarding the OP study, some of these patients will be repeat patients as you clarified earlier. Some of them will be a slightly more severe stage. Earlier in the studies, it’s been rather consistent that during the active period, the eGFR has been stabilized. Is that what can we expect from this early study? Of course, we have to wait for the actual results, but what should we expect?
Renee Aguiar-Lucander: I think from a mechanistic perspective, I mean, we wouldn’t expect it to be any different in the open-label extension that we’ve seen both in our Phase 2b and our Phase 3. So yes, we would expect to see a very similar outcome. We’re actually when patients are on treatment, it does stabilize their kidney function.
Johan Unnerus: Very good. Thank you.
Renee Aguiar-Lucander: Thank you.
Operator: The next question comes from Suzanne van Voorthuizen from VLK. Please go ahead.
Suzanne van Voorthuizen: Hi team. This is Suzanne. Thanks for taking my question. A small follow-up regarding the access friction that you mentioned to face in the first half. Should we expect you to update the market on the progress that you make with the payers as part of the quarterly earnings update? Or given its importance, could there be some communication about that separately on important milestones? And then I have another question after this one.
Renee Aguiar-Lucander: I think we’ll probably report as part of the quarterly update. I think, obviously, I mean there is something that we consider as being very important, then we can always — I mean, we could always consider doing something adhoc. But I guess my assumption would be that we would report on a quarterly basis as we have been.
