Welcome to Calliditas Q3 Report 2023. During the questions and answers session, participants are able to ask questions by dialing star five on the telephone keypad. Please limit yourself to one question. If you have more questions, please send an email to ir@calliditas.com. Now, I will hand the conference over to CEO Renée Aguiar-Lucander. Please go ahead. Thank you, and welcome to this Q3 report. I am joined here today by Richard Philipson, our Chief Medical Officer, Fredrik Johansson, our Chief Financial Officer, and Andrew Udell, President of North America. I would like to draw your attention to the disclaimer page, which covers forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended, and I refer you to public filings, including those containing risk factors. So looking a little bit at the Q3 highlights. So during the quarter, we filed for full approval of TARPEYO with the FDA, based on our full phase III data, and also support our partner, Stada, in filing for standard marketing authorization with EMA. The FDA granted us priority review in August, and our target PDUFA date is December twentieth. We also saw the publication in The Lancet of our successful phase III results, which was very well-received by the nephrology community. As we subsequently attended the IgAN conference in late September in Tokyo, we saw a lot of enthusiasm for the data, as well as for the supporting five posters and three oral presentations, which we shared with the audience there. Richard will give you a brief overview of some selected abstracts later in this call. On the commercial side, as expected, we saw some summer-related seasonality effects in Q3, with TARPEYO revenues coming in at $26.3 million or SEK 284 million, based on 367 new enrollments and 197 new prescribers in the quarter. As expected, we're also seeing some very robust growth in enrollments reflected early in Q4. The combination of the strong phase III data, the RADAR publication, and other events in the GN space, we believe, are all combining to generate a very favorable momentum, which we also had an opportunity to experience at Kidney Week, where also we had an opportunity to present additional posters and make oral presentations. In terms of some post-period events and pipeline updates, with regards to our pipeline, during Q3, setanaxib was granted ODD in Alport syndrome in both Europe and the U.S. While with regards to events post Q3, we saw the filing with the MHRA, with STADA, and an approval in Macau for Everest Medicines. However, the most impactful important event was the recent ASN meeting, the Kidney Week in Philadelphia. We were able to meet with a very large number of practicing nephrologists from across the U.S. We also got to listen to a multitude of relevant presentations and poster presentations, and were able to gain insight into the early and continuing formation of clinical practice involving GN patients and the experiences of clinicians and patients with TARPEYO. It was a very positive experience with a lot of great insights and positive feedback on the use of TARPEYO in the real-world setting. There's a real sense of momentum building for the treatment of IgAN patients, and we are excited and energized coming out of ASN and look forward to continue building on our category leadership position. With that, I'm going to hand over to our Chief Medical Officer, Richard Philipson, who will take you through some selected information regarding our posters and abstracts. Thanks very much, Renée. Next slide. We're delighted to have had a strong presence at two recent global nephrology conferences, the 17th International Symposium on IgA Nephropathy in Tokyo and the American Society of Nephrology annual meeting in Philadelphia. Over the two conferences, a total of 12 posters and four oral presentations were given, in addition to educational satellite symposia, demonstrating our commitment to IgA nephropathy and rare kidney diseases. I'd like to highlight some of the data and analyses that have been presented at these meetings. Professor Richard Lafayette presented analyses of the NefIgArd phase III trial at ASN last week. The focus of the presentation was the time to 30% reduction in eGFR or kidney failure, which was a secondary endpoint of the trial. The time to this composite endpoint was significantly delayed, with a 55% reduction in the risk of achieving this event in patients treated with Nefecon compared to placebo. It is particularly noteworthy that this outcome was consistent irrespective of baseline UPCR, and overall is supportive of the long-term treatment benefits of Nefecon. We also presented at ASN a modeled analysis of clinical outcomes of patients in the NefIgArd trial, compared with a matched registry cohort receiving supportive care only. We used the NefIgArd two-year eGFR total slope outcome to calculate a hazard ratio for the clinical outcome of kidney failure, eGFR less than 15 mL/min, or sustained doubling of serum creatinine, using the INCA meta-analysis as reference. This analysis showed a predicted median delay to the clinical outcome of 12.8 years when comparing Nefecon with placebo.... Approximately 50% fewer patients were predicted to have a clinical outcome within 10 years, again, when comparing Nefecon with placebo. We also presented biomarker analyses confirming previous findings from the phase II-B NEFIGAN trial. As you know, circulating immune complexes containing poorly galactosylated IgA, when deposited in the mesangium of the glomerulus, elicit an inflammatory response and drive the decline in kidney function seen in patients with IgA nephropathy. We have shown in samples taken from 160 patients in the NefIgArd trial, that Nefecon significantly reduces levels of circulating immune complexes throughout the treatment period compared to placebo, supporting the disease-modifying effect of the treatment. In collaboration with Professor Jennifer Dressman of the Goethe University in Frankfurt, we also presented data on the in vitro dissolution profile of Nefecon compared to other budesonide products, specifically Entocort, Budenofalk, and Uceris. Under biorelevant in vitro experimental conditions, we observed that the four formulations had distinct release profiles. When using Nefecon as a reference, we demonstrated that the three other formulations are statistically dissimilar. Taking into account differences in indications, doses, duration of treatment, and dosing conditions in conjunction with the differing dissolution profiles, we conclude that there is no basis to consider the four products to be pharmaceutically or therapeutically interchangeable. Finally, I'm very proud that we presented preclinical data supporting the potential clinical efficacy of setanaxib in the rare hereditary kidney disease, Alport syndrome. This work was carried out in collaboration with Professor Rachel Lennon of Manchester University, a recognized global leader in Alport syndrome research and treatment. We used a Col4A3 knockout mouse model of Alport syndrome and showed statistically significant effects of setanaxib when given in conjunction with supportive care, renin-angiotensin system blockade. We saw changes in biochemical outcomes and also histological outcomes, such as sclerosis and fibrosis. We plan to start a phase II clinical trial in Alport syndrome by the end of this year, and have recently received orphan drug designation in both the U.S. and Europe. I'll now hand over to Andrew Udell. Thanks, Richard. Next slide. As anticipated and seen last year, the third quarter was impacted by summer seasonality, which is caused by vacation and holiday time for both patients and nephrologists, which reduced the volume of patient visits with a disease like IgA nephropathy. During the quarter, TARPEYO achieved net sales of $26.3 million. We had 367 new enrollments, bringing the 2023 total to approximately 1,200 enrollments. In addition, during this period of accelerated approval, we continue to see new prescribers with almost 200 new prescribers for TARPEYO in Q3. Importantly, we continue to have a very strong conversion rate, with 86% of patients enrolled in TARPEYO Touchpoints receiving TARPEYO year to date. Next slide, please. The third quarter contains significant milestones and events for Calliditas. Receiving priority review from the FDA puts us on target for a December twentieth PDUFA. As we've mentioned, it isn't until FDA full approval and label changes that we can commercially promote new information to the prescribing nephrologists. Until that time, nephrologists learn of the data through peer-to-peer interactions, publications, and scientific meetings, which were described by Richard. As you heard, during Q3, the full results from the NEFIGAN study were published in The Lancet, and the IgAN Conference took place in Tokyo. I want to reiterate, we have seen during these industry conferences and at advisory boards, the overwhelmingly positive reaction this data has had on nephrologists when introduced to the strong clinical results of TARPEYO. Next slide, please. We are very excited at the opportunity ahead of us. We're just back from an action-packed ASN, where the energy and momentum for IgAN and TARPEYO was palpable. The interactions were productive, insightful, and keep us motivated to serve this patient population with a disease-specific treatment for IgA nephropathy like TARPEYO. During the fourth quarter, as we move towards an anticipated full approval, we are expanding our Calliditas U.S. team in order to support and strengthen our category leadership position. This includes the addition of both internal and external-facing team members in medical affairs, marketing, market access, and sales. As we have done since launch during the accelerated approval, we are deliberate in our growth that is directly sized to appropriately support patient and physician demand, increase our reach, and maximize the market potential. With that, I'll turn it over to Fredrik Johansson for our financial overview. Thank you, Andy, and good afternoon and good morning, everyone. I will now present to you the financial overview for the third quarter of 2023, and as always, all numbers presented to you are in SEK million, unless otherwise stated. To start with, we reported SEK 294.6 million in net revenues for the quarter. For the same quarter last year, we reported net revenues of SEK 260.1 million. And please note that in the comparison quarter last year, a milestone of SEK 135 million from STADA was included. TARPEYO net product sales for the quarter amounted to SEK 283.6 million, or $26.3 million, which is a reported increase of 130% compared to the same quarter previous year. For the nine-month period, TARPEYO net product sales amounted to SEK 728.5 million, or $68.8 million. In addition, we also recorded SEK 11 million in revenues in the quarter related to partners, primarily from royalties based on Kinpeygo sales in Europe. Our total operating expenses for the quarter amounted to SEK 439.2 million, compared to SEK 292 million for the same quarter last year. The cost for research and development increased by SEK 77 million in the quarter to SEK 179.9 million, compared with SEK 102.9 million for the same quarter previous year. Increase in R&D expenses originates primarily from an impairment cost of SEK 32 million and the increased clinical activities for the NOX platform, including the ongoing setanaxib trials in head and neck cancer and PBC. And we also see some costs for the preparations for the OPVO trial. While we changed our trial design of a TRANSFORM study in PBC during the quarter to a phase II-B only, with anticipated readout mid-next year, a shorter study has the potential to significantly reduce the planned R&D cost of the trial for both 2024 and 2025. But we had some additional costs in this quarter, originating from the change of the study of approximately SEK 20 million. We can consider this additional TRANSFORM cost and the impairment cost previously mentioned to be of one-time nature for this quarter. The cost for sales and marketing increased by SEK 34.4 million to SEK 107.5 million, compared to SEK 116.1 million for the same quarter previous year. Increase is primarily related to the cost for sales and marketing of TARPEYO in the U.S., where the marketing activities has been intensified and the sales force has been increased compared to the corresponding period of the prior year when we had a smaller sales force. The above led to an operating loss of SEK 159.6 million for the quarter, compared to SEK 36.2 million for the same quarter last year. In the third quarter, cash used in operating activities was SEK 62.5 million, compared to SEK 124.7 million for the same quarter previous year. This leaves us with a net decrease in cash in the quarter of SEK 72.8 million, and we continue to have a healthy cash position of SEK 786.9 million, or approximately $73 million at the end of the quarter, which we believe is sufficient to take us to cash flow breakeven. That was all for me, and now back to you, Renée. Thank you, Fredrik. So just to summarize, in terms of some of the key takeaways for this quarter, we are starting to see a much broader impact from the publication of the full phase III data in The Lancet. And we've also obviously continued to provide supporting data, both for the local mode of action and long-term benefits of treatment with TARPEYO. We saw continued revenue growth in Q3, coupled with low net cash burn, resulting in a strong cash position. And we confirm our revenue guidance for TARPEYO of $100 million-$120 million for the year 2023. I also want to reiterate the strong sense of growing momentum, positive momentum from ASN, really focused on this increased awareness of basic partly of longitudinal data related to the regression of IgAN patients, other public- published data coming out of the general GN space, and also just the general sense from nephrology community that there is an increased sense among that that there is a need to treat this patient population. So with that, we look forward to Q4, our PDUFA dates, and obviously the rest of 2023. With that, we're ready to take any questions. If you wish to ask a question, please dial star five on your telephone keypad, and please remember to limit it to one question. The first question comes from the line of Vamil Divan from Guggenheim Securities. Please go ahead. Your line is open. Great, thanks for taking my question. So I have a couple just on the commercial side, if I could. One is, you mentioned that there's been a little bit of a turnover in the sales force, and then you've also sort of mentioned that you're looking to increase your investment here going forward to drive the commercial uptake. So I'm wondering if you can just sort of give us a little bit more details on either of those, or what sort of drove maybe some of this turnover, and then kind of how- where do you see the added investment making an impact? Is it more in the sort of thought leaders, academic centers? Is it more on the community? I'm also wondering, maybe there's—is there some sort of disconnect between the positive feedback you seem to be getting from, you know, the advisory boards and all that, that you're holding and at these medical meetings, but maybe it's not, you know, yet translating to the community side? So wondering if maybe that's in some way tied to what you're looking to do to drive uptake on the community side of things. So thank you. Andy, do you want to start that? Sure. So, as far as the sales force, and our increased investment, I mean, there's typically turnover in sales force. I think the statistic is roughly around 5% per year. So we had some, some turnover in the summer. And I think we also initiated some of that, really in areas where we felt we needed a heavier concentration, with greater nephrology background. As far as the investment and increased investment, we're really... I, I'm not going to go into all the details, but, but I think we, you know, from a sales force sizing, that's the easiest number that people hear and listen to, and appropriate support there. We're moving to around a 70-person sales force.... Okay? But, but I think it's very important, to note that we've been very deliberate, as we've said. This is, you know, in areas where we feel there's an appropriate need and access, and we've added a lot of other individuals for support programs, and to reach some of these accounts and larger accounts, as well. And I think you're right, as far as the disconnect. It's between, you know, the ad boards and the community. This is the first time... when we interact with people right now, this is the first time that they're learning about the data. So it's an ad board, or if it's at these conferences. So they haven't—this is their initial reactions to this, and that hasn't translated to, first of all, regulatory, new regulatory indication and approval yet, and to the community. So this will come with time. So it's not a disconnect, it just takes time, which is basically, I guess, would be normal. So I think that hopefully answers your questions. Okay, thank you very much. I'll get back in the queue. Thanks. The next question comes from the line of Yigal Nochomovitz Please go ahead. Your line is open. Hi, Renée and team. Thank you for taking the questions. I just had a question on the assumptions for the guidance. It seems like to get to the lower end of the guidance range, you'll need about a 20% quarter-on-quarter growth for the last quarter. Can you just discuss your assumptions around that? Is it being driven by the reversal of the seasonal weakness, as you mentioned, the reinforcing of the sales force, or potentially even the full approval later this quarter? Thank you. Of course. So I think that it is clearly a combination of a couple of things. So obviously, it is the fact that, you know, we are kind of adding some resources. We have been kinda adding towards the end of this kind of last quarter, towards the sales force as well, which does obviously kind of help in terms of reach and frequency in general. But also I think it is really this kind of the fact that the data was really published in April. It does take a little while for it to kind of penetrate, you know, into the community. And I think we are feeling very comfortable about the range that we've provided. And we are seeing, as I've kind of mentioned, a strong kind of beginning of Q4. So I think it's a combination of all of these things. And importantly, also supported by, I think, a really important conversations among nephrologists based on this kind of longitudinal data that was both presented at the ASN. There was a poster by Kaiser Permanente that was kind of discussed a lot. The real-world studies discussed a lot. I think nephrologists are really kind of taking a hard look at their IgAN patients, and really kind of thinking about, you know, treatment rather than providing kind of, you know, ACEs and ARB standard of care, those kind of more supportive care items. So we do think that there is a momentum that is building there, and I think so it's a combination of all of those things. Then with regard to the 197 new prescribers, are you able to assess in the market how many of those, their choice to add TARPEYO to the treatment paradigm was based on seeing the Lancet publication recently? There really isn't any way for us to know that. There's really no way for us to kind of have a sense of that. And also, I mean, the Lancet publication came out in August. And so I think we would probably expect that the consequences or kind of any change in behavior really would fall, you know, kind of now. You know, it takes a little while for them to do this. And I think that it also means. I mean, I think again, the whole kind of interaction between nephrologists, there's a lot of peer-to-peer discussion, communication. There's quite a lot of patients who are now have, you know, very good outcomes. You have a lot of good stories from, you know, successful use of TARPEYO by physicians. And for that to build and kinda really spread in the community takes, you know, a little while. So, I wouldn't expect to see the consequences really in this quarter, but more kind of in Q4 and onwards. Yeah, and certainly not for Q3, those prescribers that you talk about. That's not... That would be too soon. Okay, thank you. The next question comes from the line of Dan Akschuti from Pareto Securities. Please go ahead. Your line is open. Thank you for taking my questions. One would be on Europe. Could you share some details on why the launch is going very slow there by STADA? Yeah. So I think that obviously in Europe, you do have this kind of added complication of having to kind of negotiate reimbursement rates with, you know, with individual countries. That can really be quite a long process. I also think that there's been kind of a perception, at least in Europe, about wanting to see kind of maybe more long-term data prior to kind of engaging in some of that conversation. And so that data obviously was available as of March. So I think that those are probably kind of two reasons why we're seeing what we're seeing. We are aware, obviously, of the fact that, you know, there are quite a few, quite a lot, I mean, quite a few kind of, negotiations ongoing in parallel at this point in time in order to kind of roll out, in more kind of geographic, areas in Europe. I think we should also add that they just received reimbursement from NICE, which is an important milestone and very recent happening. Okay, thank you. And, follow-up on that would be in Germany, specifically. Do you know of any specific challenges there since it is launched since September last year? So again, I think the only thing that I can think of, obviously, is the, I mean, the EMA kind of label is slightly different in terms of that it does give a very more kind of a, you know, line in the sand in terms of the actual kind of subgroup population. So there is less, I guess, flexibility in terms of potentially prescribing, you know, to patients that are around that kind of cutoff. So I think that that might, you know, might have something to do with it, but otherwise, I don't have any insight specifically. I don't know, Andy, if you have any insights. No, I agree. The feedback is it's a very strict interpretation of their label there. You know, they're not displeased with the progress to date. They have about 200 patients in a year and change. But this is once again, as Renée said, this is due to a, you know, conditional label and a strict interpretation of that, so. Okay, thank you. And another question would be that, are you expecting further increase in R&D costs? And, what was the rationale for the decrease in sales and marketing costs in Q3, or the reason for that? And do you expect that to pick up again in Q4? We're not expecting increased R&D costs, per se. I think that what we're experiencing is just kind of a bit of a lumpy, lumpy kind of effect in terms of some of these effects that relate to the fact that we're going into it kind of ending some of these trials, reading them out, and obviously, mainly the redesign, if you like, of the protocol around the TRANSFORM study. And so we've made no kind of additional plans to invest or to have any kind of additional costs apart from what we've already kind of communicated. So I would actually ascribe this more to kind of a certain lumpiness in these costs rather than anything that you should you know ascribe too much to, quite honestly. Okay, thank you. And regarding sales and marketing costs, they decreased this quarter, and do you expect them to increase again in Q4? And why did it go down in Q3? I'm sorry, I had a little bit of a hard time hearing you. Are you, are you referring to marketing costs going down? Yes, in Q3. Do you expect them to increase again in Q4? Why did you spend less in for sales and marketing in Q3 versus Q2? Yeah, I think it's just a coincidence. I'm a bit reluctant to give any guidance for the rest of the year on the sales and marketing side, but I think we, as Renée has said, we don't expect any major increases for the year on the new investments we- Yeah ... we are planning for. So again, I mean, you know, it's... I don't think anyone should read too much into kind of, you know, kind of quarterly changes at this time. We're obviously still kind of in a launch mode, and I think, you know, things go a little bit up and down but, you know, I don't think that there is any particular reason for it, really. Okay, thank you. Thanks. The next question comes from the line of Maury Raycroft from Jefferies. Please go ahead. Your line is open. Hi, thanks for taking my questions. I was wondering if you can provide more perspective on the ongoing supplemental NDA review. Has FDA requested any additional analyses beyond what has been published in The Lancet, such as any data from your open label extension study? And if you had label discussions, or are you in the process of having label discussions currently? There's been no request for any information outside of the phase III dataset. In terms of, you know, label negotiations, we would expect them to start shortly. Got it. Okay, that's helpful. What are your expectations for the label beyond the UPCR and eGFR changes? I guess, do you expect the hematuria benefit to be in there? What about disease-modifying language based on the overall treatment profile? I think it's very difficult to say at this point in time until we kind of have received, you know, comments from the agency once they have fully reviewed the files. So I think it's very difficult to say. I think that, you know, from our perspective, you know, I think data is pretty straightforward. I think that. You know, we see a very pronounced effect, and we see it across the entire study population. I think that in terms of, I think generally the FDA, I would say, is generally cautious around disease-modifying language. But we will see kind of how they would look at this, in the context of kind of where they are in their, kind of exploring of accelerated approvals and full approvals in this indication. So I think it's very, very difficult to say, but I think we have an extremely strong data set. It's very consistent. You know, there's not really much, you know, just like nothing gray in this, so we would expect it to be a fairly kind of straightforward discussion, but it is always very difficult to know exactly what the agency will allow to be incorporated in the label or not. Got it. Makes sense. And last, quick question, just based on your ASN data. You had the Chinese patient cohort data from the global phase III. Do you have an understanding as to why the treatment effects were larger, despite similar baseline patient characteristics in this patient population? Does it have to do with this patient population just progressing faster on disease? Or if you can offer some perspective, that would be helpful. ...Yeah, I mean, I think, you know, there could be different reasons for that one, as you've just outlined. I mean, it is a different patient population, an Asian population, so, and the rate of disease progression, you know, may be faster in that population. Overall, it's a smaller cohort as well, so there's more inherent, you know, there's more variability in the data set, so then maybe, that may be some contribution to what we're seeing as well. Got it. Makes sense. Okay, thanks for taking my questions. Okay. The next question comes from the line of Arthur He from HC Wainwright. Please go ahead. Your line is open. Hey, hey, Renée and team. Thanks for taking my question. Just follow up on the Chinese market. Recently, have you been in discussion with Everest regarding the regulatory timeline as well as the initial, the price, pricing strategy with the Nefecon in China, which we expect to launch, to be launched in the next year? So, we have not heard anything from them that would indicate that anything's different from the expectations that we've had all the time, which is that, you know, there is a decision expected before the end of the year. So that, as far as we are aware, and we are obviously in contact with them on an ongoing basis, that is what still is expected. So we would expect to get a decision from the NMPA before the end of the year. So and after which, obviously, we would go through the same process that we did in Europe. We would transfer our market authorization holding, et cetera, to Everest Medicines in order for them to be able to start commercializing. We've not had any kind of disclosure from Everest at this point in time in terms of any pricing. And so I think that's that's gonna have to be kind of up to them, I think, to disclose once they once they kind of have the approval in hand. Sounds good. Thanks for the color. And just a quick one on TARPEYO. So, after the sparsentan failed in the eGFR data, did you see, in your experience, did you see any patient kind of a switch from sparsentan to Nefecon, or is there any color you can provide? Appreciate it. That's really not kind of data that we have access to. We don't really know which patients are on sparsentan, et cetera, so we wouldn't really know whether there was any switch, with regards to that. We wouldn't have access to that information. All right, so no problem. Thanks for taking my question. The next question comes from the line of Annabel Samimy from Stifel. Please go ahead. Your line is open. Hi, good morning, everyone. Thanks for taking my questions. Just wanted to know if you had any update on the average duration of treatment. And then also, with regard to all the data that's coming out, published and at medical meetings, how are payers responding to some of this published data in terms of removing any friction points? I know it's pretty well covered, but there's always some friction points. Is it resonating with them, or are conversations sort of awaiting more formal approval of a new label or a change in practice guidelines? Can you just talk about the work you're doing on that front? And do you need to change practice guidelines to really get full adoption from the nephrologist? Thanks. Andy, do you want to cover the market access piece? Sure, sure. Well, I can give you the duration of treatment answer, is that we really have no updates. You know, this is not something that's going to change quarter to quarter other than, you know, as we continue to say, it's being used to match the disease progression in most nephrologists. So, but as far as the payer response, it's a process, right? So we have been getting some meetings already with payers. You try to get as many touch points as you can. So the first one came with top-line data, then the full publication, and then we'll obviously have a new indication. And then followed by that, we're anticipating guidelines to be updated, probably early next year, sometime in the first half of next year. So, there's no changes of substance today that we really would discuss, but it's a process, and I think we're pretty encouraged that in certain areas of management, some of the friction that's created is a direct result of the current label. Okay? So, I think that will change over time, over the next, you know, six to 12 months as the label changes, and guidelines change. But there's no set timing. Okay, great. Thank you. The next question comes from the line of Rami Katkhuda from Life Sci Capital. Please go ahead. Your line is open. Hey, guys. Thanks for taking my questions as well. I guess in addition to the open label extension, you previously mentioned the potential for post-marketing studies to evaluate longer-term dosing, combination approaches, et cetera. I guess any update on that front and whether you still plan to pursue those opportunities? No, I think that these are kind of, you know, normal discussions, obviously, that we have since we have a product on the market. But we haven't kind of resolved on anything specific yet. But obviously, there are quite a lot of conversations ongoing, and a lot of these are obviously also driven directly by nephrologists. You know, they're keen to kind of use the product. They wanna have some more, you know, information in terms of kind of, you know, various treatment paradigms. So this is something that's a very kind of constructive and positive kind of conversation that we're having with nephrologists. But we haven't yet kind of, you know, firmly agreed on any specifics around that. But we would expect that we will obviously conduct some of those kind of phase IV studies going forward. But in terms of—so actually, kind of in terms of data that we will kind of more formally release, that really is the open label extension, which we hope to be able to do in the first half of next year. And then obviously, together with the setanaxib data, that will also kind of happen in the first half of next year. So those are the kind of planned data releases for now. But we will keep you updated, obviously, as to when we kind of embark or have kind of all the details clarified as to any kind of phase IV trials. Got it. Thanks so much. The next question comes from the line of Johan Unnérus from RedEye. Please go ahead, your line is open. Great. Can you hear me? Yeah. Excellent. Thanks for taking my question. Just a follow-up to begin with, on the label review, in the FDA meeting, is there any reason to not believe that they would align to your study design earlier? There's obviously a more narrow label in the conditional approval than in the study. Yeah, I mean, I mean, I think that, you know, the data set is very clean and very, you know, straightforward. And as we've said, actually, we don't see... You know, we see the very consistent effect across the entire data set. So from that perspective, you know, we wouldn't expect there to be any basis for, you know, limiting the population, you know, from that perspective. Interesting. Yes. And also a follow-up regarding China. Should we expect any milestone on the back of this approval? Yes, we have milestones for China, but as earlier has earlier communicated, we don't see them as material in the view of the company's financing. Okay. And also, if I may, on the profile of your unique subscriber and specialist, as of today, would they be sort of, normal across the board profile, or would you say that you have tendency to have more larger centers or smaller centers, or? I don't know, Andy, do you want to take that? No, I think it's generally spread out. There's no real formula for that, or give you anything that's of substance as far as differentiations and who's prescribing. Very good. Thank you. There are no more questions at this time, so I hand the word back to you, Renée. Thank you very much, and thank you all for listening in to this Q3 report, and we look forward to sharing our full year results as well as our Q4 numbers in due time. Thank you. This concludes today's call. Thank you very much. Have a nice day. You may disconnect your lines.