Calliditas Therapeutics AB (publ) Q3 2023 Earnings Call Transcript

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November 7, 2023

There are 12 speakers on the call.

Operator

Welcome to Caliditas Q3 Report 2023. Now I will hand the conference over to CEO, Rene Aguilar Lukhandar. Please go ahead.

Speaker 1

Thank you, and welcome to this Q3 report. I am joined here today by Richard Phillipson, our Chief Medical Officer Frederick Johansen, 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 the full approval of TROPEO with the FDA based on our full Phase 3 data And also support our partner, Stata in filing for standard marketing authorization with EMA.

Speaker 1

The FDA granted us priority review in August, And our target PDUFA date is December 20th. We also saw the publication in The Lancet of our successful Phase 3 results, which was very well received by the nephrology community. And 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 5 posters and 3 oral presentations, which we shared with the audience there. Rachel 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 TARPAIO revenues coming in at CHF26,300,000 or CHF284 1,000,000 based on 367 new enrollments and 197 new prescribers in the quarter.

Speaker 1

As expected, we're also seeing some very robust growth in enrollments reflected early in Q4. The combination of the strong Phase 3 data, the radar publication and other events in the GM 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, Cetomaxi was granted ODD and Alport syndrome in both Europe and the U. S. Whilst with regards to events post Q3, we saw the filing with the MHRA with Stata and an approval in Macau for Everest Medicines.

Speaker 1

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 to the nephrologists from across the U. S. We also had to got to listen to a multitude of relevant presentations and poster presentations, And we're able to gain insight into the early and continuing formation of clinical practice involving GN patients and the experiences of clinicians and patients with Tarpeo. It was a very positive experience with a lot of great insights and positive feedback on the use of Tarpeo in the real world setting.

Speaker 1

There is 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 Richard Phillipson, who will take you through some selected information regarding our posters and abstracts.

Speaker 2

Thanks very much, Ray. Next slide. So we're delighted to have had a strong presence at 2 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 2 conferences, a total of 12 posters and 4 oral presentations were given. In addition to educational satellite symposia, demonstrating our commitment to IgA nephropathy and rare kidney diseases.

Speaker 2

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 NEFA Guard Phase 3 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 neficon compared to placebo. It is particularly noteworthy that this outcome was irrespective of baseline UPCR and overall is supportive of the long term treatment benefits of nephicon.

Speaker 2

We also presented at ASN a modeled analysis of clinical outcomes of patients in the NETIGAR trial compared with the matched registry cohort receiving supportive care only. We use the NEFA Guard 2 year eGFR total slope outcome to calculate A hazard ratio for the clinical outcome of kidney failure, eGFR less than 15 ml's per minute or sustained doubling of serum creatinine Using the income meta analysis as reference, this analysis showed a predicted median delay to the clinical outcome of 12.8 years when comparing Neficon with placebo. Approximately 50% fewer patients are predicted to have a clinical outcome within 10 years, Again, when comparing Confirming previous findings from the Phase 2b Nefigant trial. As you know, circulating immune complexes containing poorly galactosylated IgA When deposited in the mesangium of the glomerulus, elicits an inflammatory response and drives the decline in kidney function seen In patients with IgA nephropathy. We have shown in samples taken from 160 patients in the NEFA Guard trial The neficon significantly reduces levels of circulating immune complexes throughout the treatment period compared to placebo, supporting the disease modifying effect of the treatment.

Speaker 2

In collaboration with Professor Jennifer Dressman of the Goethe University in Frankfurt, we also presented data on the in vitro dissolution profile of Nephicom compared to other budesonide products specifically Entercort, Boudinafalk and Euceris. Under bio relevant in vitro experimental conditions, we observed that the 4 formulations had distinct release profiles. When using Methicon as a reference, we demonstrated that the 3 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 full products to be pharmaceutically or therapeutically interchangeable. Finally, I'm very proud that we presented preclinical data supporting the potential clinical efficacy Acetinaxib in the rare hereditary kidney disease, Alport syndrome.

Speaker 2

This work was carried out in collaboration with Professor Rachel Lennon of Manchester The university, a recognized global leader in Allport syndrome research and treatment. We used a COL-four eighty three knockout mouse model of Allport syndrome And shows statistically significant effects of setonaxib 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 Phase 2 clinical trial in Alport syndrome by the end of this year and have recently received orphan drug designation I'll now hand over to Andrew Udell.

Operator

Thanks, Richard. Next slide.

Speaker 3

As anticipated and seen last year, The Q3 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, Tarpeo achieved net sales of $26,300,000 We had 367 new enrollments bringing the 2023 total to approximately 1200 enrollments. In addition, during this period of accelerated approval, we continue to see new prescribers with almost 200 new prescribers for Tarpeo in Q3. Importantly, we continue to have a very strong conversion rate with 86% of patients enrolled in Tarpeo touch points Receiving Tarpeo year to date. Next slide please.

Speaker 3

The 3rd quarter contains significant milestones and events for CLEDITAS. Receiving priority review from the FDA puts us on target for December 20 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 nephigod study were published in The Lancet and the iGan Conference took place in Tokyo.

Speaker 3

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 Tarpeo. 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 TARPEO 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 Tarpeo.

Speaker 3

During the Q4, as we move towards an anticipated full approval, we are expanding our Kaliditas US team in order to support and strengthen our category leadership position. This includes the addition of both internal and 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. So with that, I'll turn it over to Frederik Johansen for our financial overview.

Speaker 4

Thank you, Andy, and good afternoon and good morning, everyone. I will now present to you the financial overview for the Q3 of 2023. And as always, all numbers presented to you are SEK1 1,000,000 unless otherwise stated. To start with, we reported $294,600,000 in net revenues for the quarter. For the same quarter last year, we reported net revenues of $206,100,000 And please note that in the comparison quarter last year, a milestone of €135,000,000 from Stata was included.

Speaker 4

Zapero net product sales for the quarter amounted to $283,600,000 or $26,300,000 which is a reported increase of 130% compared to the same quarter previous year. For the 9 months period, TAPER net product sales amounted to 728 $500,000 or $6,800,000 In addition, we also recorded $11,000,000 in revenues in the quarter related to partners, primarily from royalties based on Kimpago sales in Europe. Our total operating expenses for the quarter amounted to 4 €39,200,000 compared to €292,000,000 for the same quarter last year. The cost for research and development increased €77,000,000 in the quarter to €179,900,000 compared with €102,900,000 for the same quarter previous year. Increase in R and D expenses ranges primarily from an impairment cost of €32,000,000 and the increased clinical activities for the NOx platform, including the ongoing trials in head and neck cancer and PBC.

Speaker 4

And we also see some costs for the preparations for the OPOG trial. While we changed our trial design of a transformed study in PBC during the quarter to a Phase 2b only with anticipated readout mid next year, A shorter study has the potential to significantly reduce the planned R and D cost of the trial for BOS2425, but we had some additional cost in this quarter originating from the change in the study of our practice of SEK 20,000,000. We can consider these additional transformed costs and the impairment costs previously mentioned to be of onetime nature for this quarter. The cost for sales and marketing increased by $34,400,000 to $107,500,000 compared to $116,100,000 for same quarter previous year. The increase is primarily related to the cost for sales and marketing of Tareo in the U.

Speaker 4

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 €159,600,000 for the quarter compared to €36,200,000 for the same quarter last year. In the Q3, cash used in operating activities was CAD 62,500,000 compared to CAD 100 and for the same quarter previous year. This leaves us with a net decrease in cash in the quarter of $72,800,000 and we continue to have a healthy Cash position of $786,900,000 or approximately $73,000,000 at the end of the quarter, which we believe is sufficient to take us to cash flow breakeven. That was all for me.

Speaker 4

And now back to you, Mona.

Speaker 1

Thank you, Frederic. 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 Tarkayo. We saw continued revenue growth in Q3 coupled with low net cash burn resulting in a strong cash position.

Speaker 1

And we confirm our revenue guidance for Tarpeo of $100,000,000 to $120,000,000 for the year of 2023. I also want to reiterate the strong sense of growing momentum, positive momentum from ASN really focused on this increased awareness based Partly of longitudinal data related to the regression of IgA patients, other public publicated 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 there is a need to treat this patient population. So with that, we look forward to Q4, our PDUFA date and obviously the rest of 2023. With that, we're ready to take any questions.

Operator

Comes from the line of Vamil Divan from Guggenheim Securities. Please go ahead. Your line is open.

Speaker 5

Great. Thanks for taking my questions. 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.

Speaker 5

So I'm wondering if you can just sort of give us a little bit more details on either of those. 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 sort of 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're seeing that you're getting from the advisory board and all that that you're holding And at these medical meetings, maybe it's not yet translating to the community side.

Speaker 5

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. Thank you.

Speaker 1

Andy, do you want to start that?

Speaker 3

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 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.

Speaker 3

As far as the investment and increased investment, We really I'm not going to go into all the details, but I think we from a sales force sizing, that's the easiest number that people Here and listen to an appropriate support there. We're moving to around a 70 person sales force, okay. But I think it's very important To note that we've been very deliberate as we've said, this is not this is in areas where we feel there's an appropriate need and access. And we've done 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 Between the ad boards in these communities, this is the first time we're when we interact with people right now, this is the first time that they're learning About the data.

Speaker 3

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, 1st 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 that hopefully answers your questions.

Speaker 5

Okay. Thank you very much. I'll get back in the queue. Thanks.

Operator

The The next question comes from the line of Shigal Nochomovitch. Please go ahead. Your line is open.

Speaker 6

Hi, Renee 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?

Speaker 6

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.

Speaker 1

Of course. So I think that it is Clearly a combination of a couple of things. So obviously, it is the fact that we are kind of adding some resources. We are we have been Kind of 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 into the community.

Speaker 1

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, the real 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 radar study is discussed a lot.

Speaker 1

I think nephrologists are really kind of taking a hard look at their IGAM patients And really kind of thinking about treatment rather than providing kind of ACEs and ARBs 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.

Speaker 6

And then with regard to the 197 new prescribers, are you able to assess in the market how many of those Their choice to add CERPAO to the treatment paradigm was based on the single Lancet publication recently?

Speaker 1

There really isn't any way for us to know that. There's really no way for us to kind of to 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 kind of now. It It takes a little while for them to do this.

Speaker 1

And I think that it also needs 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 having very good outcomes. You have a lot of good stories from successful use of TROPEO by physicians. And for that to build and kind of really spread in the community takes a little while. So I wouldn't expect to see the Consequences really in this quarter, but more kind of in Q4 and onwards.

Speaker 3

Yes. And certainly not for Q3 of those prescribers that you talk about, that's not

Operator

The next question comes from the line of Dan Aksut from Pareto Securities. Please go ahead. Your line is open.

Speaker 7

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 start up?

Speaker 1

Yes. So I think that obviously in Europe, you do have this kind of added complication of having to kind of negotiate reimbursement rates 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. So that data obviously was available as of March.

Speaker 1

So I think that those are probably kind of 2 reasons why we're seeing what we're seeing, But we are aware obviously of the fact that there are quite a few kind of negotiations ongoing in parallel at this point in time in order to Kind of rollout in more kind of geographic areas in Europe.

Speaker 3

I think we should also add that they just received reimbursement from NICE, which is an important milestone and very recent happening.

Speaker 7

Okay. Thank you. And a 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?

Speaker 1

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 line in the sand in terms of the So there is less, I guess, flexibility in terms of potentially prescribing to patients that are around that kind of cut off. So I think that that might have some But otherwise, I don't have any insights specifically. I don't know, Andy, if you have any insights.

Speaker 3

No, I agree. The feedback is it's a very Direct interpretation of their label there. They're not displeased with the progress to date. They have about 200 patients In a year and change. So but this is once again, as Renee said, This is due to a conditional label and a strict interpretation of that, so.

Speaker 7

Okay. Thank you. And another question would be that Are you expecting further increase in R and D costs? And what was the rationale for the decrease in sales and marketing Costs in Q3 are the reason for that? And do you expect that to pick up again in Q4?

Speaker 1

Queue. We're not expecting increased R and D cost per se. I think that what we're experiencing is just kind of a bit of a 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 cost 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 ascribe too much to quite honestly.

Speaker 7

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?

Speaker 1

I'm sorry, I had a little bit of a hard time hearing you. Sorry, are you referring to marketing costs going down?

Speaker 7

Yes, in Q3. And do you expect them to increase again in Q4? 4 and why did you spend less in for sales and marketing in Q3 versus Q2?

Speaker 4

Yes. 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 Roni said, we don't expect any major increases for the year on the new investments we

Speaker 1

that we

Speaker 4

are planning for.

Speaker 1

So again, I mean, I don't think anyone should read too much into kind of Quarterly kind of changes at this time. Obviously, still kind of in a launch mode and I think things go a little bit up and down, but I don't think that there is any particular reason for it really.

Speaker 7

Okay. Thank you.

Operator

The next question comes from the line of Maury Raycroft from Jefferies. Please go ahead. Your line is open.

Speaker 8

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 have you had label discussions or are you in the process of having label discussions currently?

Speaker 1

So there has been no request for any information Outside of the Phase 3 data set. And in terms of Label negotiations, we would expect them to start shortly.

Speaker 8

Got it. Okay. That's Helpful. And 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?

Speaker 8

And what about disease modifying language based on the off treatment profile?

Speaker 1

I think it's very difficult to say at this point in time until we kind of have received comments from the agency once they have fully reviewed The files, I mean, I think it's very difficult to say. I think that from our perspective, I think data is pretty straightforward. I think that the 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.

Speaker 1

So I think it's very difficult to say, but I think we have an extremely strong data sets, very consistent. There's not really much 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.

Speaker 8

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 3. Do Do you have an understanding as to why the treatment effects were larger despite similar patient baseline characteristics in this patient population?

Speaker 8

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?

Speaker 2

Yes. I mean, I think there could be different reasons for that one as you've just outlined. I mean, it is a different patient Population and Asian population, so and the rate of disease progression may be faster in that population. Overall, it's a smaller cohorts as well. So there's more inherent there's more variability in the data set.

Speaker 2

So then maybe that may be some contribution to what we're seeing as well.

Speaker 8

Got it. Makes sense. Okay. Thanks for taking my questions.

Operator

Next question comes from In the line of Arthur Haigh from H. C. Wainwright, please go ahead. Your line is open.

Speaker 9

So just follow-up on the Chinese market. Recently, have you been in discussion with ARREST regarding the regulatory time line as well as the initial the pricing strategy with an outcome in China, which we expect to be launching the next year.

Speaker 1

So we have not heard anything from them that would indicate that anything is different From the expectations that we've had all the time, which is that 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, I. E.

Speaker 1

We would transfer our market authorization holding etcetera 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 going to have to be kind of up to them I think to disclose once they kind of have the approval in hand.

Speaker 9

Sounds good. Thanks for the color. And just a quick one on TAPEO. So

Speaker 5

After

Speaker 9

the spartan 10s failed in the EGFR data, did you see during the In your experience, did you see any patient kind of a switch from spasentan to nefrikam or is there any Color, you can provide. Appreciate

Speaker 1

it. That's really not kind of data that we have access to. We don't really know which patients are on Or sent in and etcetera. So we wouldn't really know whether there was any switch with regards to that. We wouldn't have access to that information.

Operator

The next question comes from the line of Annabel Samimi from Stifel. Please go ahead. Your line is open.

Speaker 10

Hi. Good morning, everyone. I just want 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, There's always some friction points.

Speaker 10

Is it resonating with them or our conversation 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 for the nephrologists. Thanks.

Speaker 1

Andy, do you want to cover the market access piece?

Speaker 3

Sure, Sure. Well, I can give you the duration of treatment answers that we really have no updates. This is not something that's going to change quarter to quarter other key. 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?

Speaker 3

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.

Speaker 3

So I think that that will change over time over the next 6 to 12 months as the label changes And guidelines changed, but there's no set timing.

Speaker 10

Okay, great. Thank you.

Operator

The next question comes from the line of Rami Katkoda from LifeSci Capital. Please go ahead. Your line is open.

Speaker 5

Label extension, you previously mentioned the potential for post marketing studies to evaluate longer term dosing, combination approaches, etcetera. I guess any update on that front and whether you still plan to pursue those opportunities?

Speaker 1

No, I think that these are kind of 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 A lot of conversations ongoing and a lot of these are obviously also driven directly by nephrologists. They're keen to kind of use the product. They want to have some more key information in terms of kind of various treatment paradigms. So this is something that's a very kind of constructive Even positive kind of conversation that we're having with nephrologists, but we haven't yet kind of firmly agreed On any specifics around that, but we would expect that we will obviously conduct some of those kind of Phase 4 studies going forward.

Speaker 1

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 Cifanexip 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 clarify this to any kind of Phase IV trial.

Operator

The next question comes from the line of Johan Ullnerus from Redeye. Please go ahead. Your line is open.

Speaker 11

Great. Can you hear me? Yes. Excellent. Thanks for taking my questions.

Speaker 11

Just a follow-up to begin with. On the label review 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.

Speaker 1

Yes. I mean, again, I mean, I think that the data set is very clean and very straightforward. And as we've said, actually, we don't see we see the very consistent effect across the entire data set. So from that perspective, we wouldn't expect There to be any basis for limiting the population from that perspective.

Speaker 11

Interesting. Yes. And also follow-up regarding China. Should we expect any Milestone on the back of this approval?

Speaker 4

Yes, we have milestones for China. But As earlier communicated, we don't see them as material in the view of the company's

Speaker 11

Okay. And also, if I may, on the profile of your unique Subscriber and specialists, 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

Speaker 1

I don't know, Andy, do you want to take that?

Speaker 3

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 on who's prescribing. There are

Operator

no more questions at this time. So I hand the word back to you, Renee.

Speaker 1

Thank you very much, and thank you all for listening into this Q3 report, and we look forward sharing our full year results as well as our Q4 numbers in due time. Thank you.

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Calliditas Therapeutics AB (publ) Q3 2023
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