Welcome to the Calliditas Therapeutics Q4 Report. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing star five on their telephone keypad. Now I will hand the conference over to the speaker, CEO Renée Aguiar-Lucander, CFO Fredrik Johansson, Andrew Udell, President of North America, and Richard Philipson, CMO. Please go ahead. Welcome to the Calliditas Therapeutics Q4 Report of 2022. I would ask you to turn the page and initially just bring your attention to our disclaimer page. This is just related to forward-looking statements. I refer you to the company's reports and other filings, including those which contain risk factors and other relevant information. You can go to the next page. Thank you for joining us for this fourth quarter report of 2022, which concludes a very successful year for Calliditas, in which we commercially launched the first ever approved medication IgA nephropathy in the U.S.. There has been great interest from nephrologists for medication which targets the presumed origin of the disease and which does hold the potential of being disease-modifying based on early and significant impact on eGFR in patients at risk of rapid disease progression. To further support our top-line data, which we presented in late 2020, we published a full overview of the Part A data in October of 2022, in Kidney International, which was met with enthusiasm from physicians who took a special interest in the continued reduction of proteinuria in all patients who had been off drug for three months after the nine -month initial treatment, and the stabilization of eGFR patients at risk of rapid disease progression. Based on the many interactions with nephrologists at ASN, it became clear that eGFR data, as it becomes more and generally more available, this will clearly guide their treatment decision as their treatment goal is obviously to preserve kidney function of their patients. We're therefore excited as we approach the completion of the confirmatory portion of our phase III trial. We can go to the next page. From an overall corporate perspective, we reported total revenues in Q4 of SEK 429 million, which equivalent to approximately $42.4 million. Out of which TARPEYO sales represented SEK 167 million or about $16.1 million. For the year, that took us to total revenues of around SEK 803 million, equivalent to about $79 million. Out of which TARPEYO represented SEK 372 million or $36.8 million. We're very proud of this result, especially in a market that actually was defined by strong macro headwinds, including volatile capital markets, high inflation, increasing interest rates, and unfortunately, an ongoing war in Europe. Against this backdrop, we have been able to, over the last 18 months or so, raise over SEK 1.2 billion of non-dilutive capital, ensuring a successful launch of a first-in-class product into the U.S. market. I do truly believe that we have a lot to be proud about for 2022. We did decide during the year to also expand our U.S.-based sales team, and we have recently also brought them in-house into Calliditas, and we've clearly seen that this expansion has already had an impact towards the end of the quarter. We obviously continue to educate nephrologists as to obviously in the U.S. market today, we have an oral product which can be added to physician's choice of optimized RAS blockade and which is based on a well-characterized active ingredient with a differentiated approach of targeted treatment of the origin of the disease with a goal of specific downregulating IgA1. We believe that this has the potential to be disease-modifying based on our early data, and we do look forward to being able to share longer-term eGFR data from our Part B readout. We go to the next page, please. In December, we also reported that we had outlicensed Nefecon to Viatris for the Japanese market. This resulted in a $20 million upfront payment, with additional $80 million of development, regulatory, and commercial milestones. We're very excited about being able to further expand the global franchise of Nefecon and look forward to work with our new partners. In November, our other partners, Everest Medicines, had their China NPA filing accepted. And in December, also the regulatory body recommended a priority review for Nefecon in China, and we look forward to having some results from that regulatory review towards the second half of this year. And as you may know, there are a lot of biopsy-proven patients in China. The Chinese market, this is a very, very significant unmet medical need, and we look forward to working with our partners, Everest Medicines, to hopefully be able to address that need, once the regulatory review has been completed. In terms of our pipeline, we reported in the previous quarter that there had been a slowdown in terms of site activation. I'm happy to report that those have kind of picked up. Recruitment rates in our head and neck cancer trial has significantly improved. We are presently targeting the delivery of the biomarker data as we previously have guided on in this year. We're hoping to be able to do that sometime around the middle of the year, obviously depending on, you know, final arrangements for that readout. The PBC trial does remain challenging, and we've implemented a range of activities in Q4 and Q1. We will continue to work hard at trying to address some of the issues around kind of the somewhat slower recruitment rate than what we would like to see. In terms of further kind of financial highlights, obviously we did in this quarter report a positive operating profit in Q4 of about 32.5 million Swedish crowns, and obviously also positive cash flow from operations. That leaves us with a very strong financial position for the end of the year, with cash amounting to over 1 billion, almost 1.25 billion Swedish crowns and around $119 million. We believe on that basis, we're funded to profitability based on continued delivery of sales from TARPEYO and the Nefecon franchise globally. In terms of some post-period events, if we go to the next slide, please. Thank you. In February, the MHRA announced that they had granted a conditional market authorization of Kinpeygo for the United Kingdom. That CMA is in process of being transferred to our European partner, STADA, who obviously holds the commercial rights for that area. Also, obviously, based on the date of the completion of the last visit by the last subject in our phase III trial NefIgArd, we now have a clearer view on when we will be able to share with you the top-line data of our part B. We are presently targeting somewhere around the middle of March in order to be able to provide that information. This readout will obviously provide long-term eGFR data, you know, complementing really the eGFR data that we saw at nine months, which was both statistically significant and clinically meaningful. For the year of 2023, we believe that on the basis of what we're seeing in the market and some of the other points that Andy will be covering with you, we believe that we will have U.S.-based revenues from TARPEYO somewhere between $120 million-$150 million. We believe that, you know, strong top-line data from Part B could provide momentum to this uptake, as the long-term eGFR data certainly will provide further insight into the potentially disease-modifying activity of TARPEYO. With that, if we go to the next page, I will hand over to Richard Philipson, our Chief Medical Officer, who will take you through a little bit more detail around the Kidney International publication, which I mentioned in the beginning, and which obviously has generated a lot of interest broadly in the nephrology area. Thank you very much, Renée. If we move to the next slide. I share Renée's delight that the results of Part A of the NefIgArd phase III clinical trial were published online in Kidney International on the 19th of October of last year and subsequently in this year's issue two of the print version of the journal. I'd like to summarize the results presented in the publication. Moving to the next slide. As a very brief recap, Part A of the NefIgArd trial enrolled 201 patients with IgA nephropathy and randomized them in a 1-to-1 ratio to receive Nefecon 16 mg once daily or placebo for nine months, with three months of post-treatment observation off treatment before patients continued into Part B of the study, which comprised a further 12 months of treatment. All patients were on optimized RAS blockade, with median baseline proteinuria and eGFR reflecting a population of patients at high risk of kidney disease progression. After nine months of treatment, there was a highly statistically significant 27% reduction in proteinuria measured by UPCR in patients receiving Nefecon compared to placebo, with stabilization of eGFR and a 3.87 mils per minute treatment benefit compared to placebo. When we look at the one-year eGFR slope improvement, which compares the eGFR slope in patients treated with Nefecon versus those treated with placebo, we see an improvement of 3.37 mils per minute, representing a preservation of eGFR of approximately 70% of the maximum possible effect. This effect is consistent as it is in line with what we saw in the phase II study, and importantly, it compares favorably with other treatments studied in IgA nephropathy. For example, treatment with the SGLT2 inhibitor dapagliflozin in patients with IgA nephropathy results in a calculated preservation of eGFR after 12 months of only 26% of the maximum possible effect. The safety of the treatment was in line with what was expected for a targeted release formulation of budesonide, and importantly, there were no severe infections requiring hospitalization. In summary, overall treatment with Nefecon resulted in clinically important improvements compared with optimized supportive care alone. Moving to the next slide. An important observation relating to the effect of Nefecon on proteinuria in the Part A study population is that the effects were not immediate, with no discernible effect following three months of treatment. Rather, the effects become apparent at six months, with a continued and cumulative improvement at nine months. Of particular note, proteinuria continued to improve even after treatment had been discontinued at nine months. At 12 months, after three months off treatment, there was a 52% reduction in proteinuria versus baseline. Moving to the next slide. When we look at improvements in proteinuria associated with treatment with Nefecon, we see an interesting observation in patients with higher levels of baseline proteinuria. Specifically, we see an earlier separation of the proteinuria curves so that after only three months, there was a 14% reduction in proteinuria in Nefecon-treated versus placebo-treated patients. It's nevertheless important to emphasize that all patients in the Nefecon treated group showed improvements in proteinuria irrespective baseline proteinuria levels. Moving to the next slide. This earlier improvement in proteinuria translated to early and divergent eGFR curves in these patients. eGFR declined by over 10 mils per minute over the 12-month period in the placebo group, compared to a reduction of only 1.1 mils per minute in the Nefecon group, a difference of nearly nine mils per minute at 12 months. Again, it's worth noting that eGFR remained stable during the three-month follow-up period when patients had discontinued treatment, with no evidence of deterioration in eGFR during this three-month follow-up period. Moving to the next slide. In summary, for the Part A data, Nefecon met primary and key secondary endpoints in the NefIgArd Trial Part A. The effects of Nefecon on proteinuria, gradual and cumulative, with continued improvement after discontinuation of treatment. In patients with higher baseline proteinuria, an earlier beneficial effect on proteinuria is observed, which translates to clearly divergent eGFR trajectories with stabilization of eGFR in Nefecon-treated patients. That concludes my part of the presentation. Thanks, Richard. Slide 15, please. The fourth quarter was another strong quarter to finish the first calendar year of the commercialization of TARPEYO. Quarterly net sales of more than $16 million brings us to $36.8 million in net sales after the first 11 months of promotion. We had 310 new patient enrollments in the quarter, which has the 2022 total more than 1,000 enrollments, which were written by over 640 unique nephrologists. We continue to see the average enrollments per prescriber growing, and we anticipate this rate will continue to grow as many of the nephrologists now have patients on therapy for several months and experiencing positive results, as was demonstrated in our clinical trials that Richard just reviewed with you. As it relates to market access, as mentioned last quarter, we really reached our target of over 90% of U.S. lives having coverage for TARPEYO in the middle of the year, which we are very proud of. The payer mix has reached a steady state without much change from the last quarter. Approximately three-quarters of our patients have either private commercial insurance or are cash paying customers, with the remainder of our business coming from government-insured patients. TARPEYO Touchpoints and the high quality of our patient service programs are extremely important to us and continue to exceed industry standards. Nevertheless, we continue to assess our program to identify areas of improvement and to determine if additional resources are needed to maintain this high level of service during a period when our patient population continues to grow. Our targeted reach and promotional programs remain effective, as demonstrated by the awareness of TARPEYO growing to over 90% of nephrologists in market research surveys conducted prior to the end of 2022. Most important and rewarding to us during the fourth quarter and early this year are the increasing number of success stories that are being reported as more and more patients have taken TARPEYO for extended periods of time. Next slide, please. 2023 promises to be another exciting year of growth for TARPEYO and our commercial organization. While we felt the initial positive impact of the expansion of our field during the fourth quarter, we look forward to the full impact from the impressive commercial team that we've assembled. TARPEYO demonstrated a clear reduction in proteinuria, the early impacts on eGFR demonstrated in Part A are unprecedented and extremely important. In addition to the increasing positive patient experiences, we, along with the nephrology community, anxiously await the results of Part B to gain increasing information on the lasting impact of TARPEYO on this chronic kidney disease. We anticipate this information in the first half of 2023 and look forward to sharing the results with nephrologists and the IgAN community. Lastly, we are enthusiastic about the progress and availability of TARPEYO in the U.S., Kinpeygo in Europe, and Nefecon as it grows around the globe. IgA nephropathy is a rare orphan disease. The global patient and KOL experience and education will be important in the continued growth and success of the brand and our company. With that, I'm going to turn it over to our CFO, Fredrik Johansson. Thank you very much, Andy, and good afternoon and good morning, everyone. I will first present to you the financial overview for the fourth quarter of 2022, and thereafter present the full year numbers for 2022. As always, all numbers presented to you are in SEK million, unless otherwise stated. To start with, we are proud to report SEK 429 million in net revenues for the quarter. For the same period last year, we reported net revenues of SEK 31.2 million. In the fourth quarter of the TARPEYO commercialization, TARPEYO net product sales for the quarter amounted to SEK 167.3 million or $16.1 million. A growth of 36% compared to the third quarter. We also recorded $260.2 million for the period in revenues related to transaction with our partners. Especially from the $20 million U.S. dollar signing fee from the Viatris outlicensing deal, but also from a $5 million regulatory milestone from Everest relating to China. Our total operating expense for the fourth quarter amounted to $388.7 million compared to $253.3 million for the same period last year. Compared to the third quarter this year, our Opex did increase by around $96 million from Q3. This increase is mainly due to certain costs related to our marketing activities were concentrated into Q4 instead of spread out over both Q3 and Q4. Certain one-time costs and also a cost increase in the quarter from our ex-expansion of our sales force in Q4. I'm very pleased to report that our increased revenues for the quarter led to an operating profit of SEK 22.5 million for the fourth quarter, compared to an operating loss of SEK 218.5 million for the fourth quarter 2021. In the fourth quarter, we also had a positive cash flow from operating activities of SEK 230 million, compared to a negative cash flow used in operating activities of SEK 161.3 million for the same period previous year. The positive cash flow was mainly achieved through we received payments in the quarter from our licensing activities and from the increase of the TARPEYO sales. In the fourth quarter, we also made a last drawdown of $25 million from the Kreos loan facility, which is now fully utilized, bringing our cash flow from financing activities in the fourth quarter to $282.6 million. This leaves us with a net increase in cash in the quarter of $511.2 million and a very healthy cash position at the end of the quarter of $1.249 billion. We take the next slide. Just a quick summary of the financial key takeaways from the full financial year of 2022. For the full year of 2022, we are very happy to report $802.9 million in net revenues for the period. This is a growth of 20-50% for the year compared to 2021, where we reported revenues of SEK 229.3 million. TARPEYO net product sales for the year amounted to SEK 372.2 million or $36.8 million. Revenues related to outlicensing transactions and royalties were SEK 427.4 million compared to reported revenues from outlicensing transactions for the full year of 2021 of SEK 229.3 million. Our total operating expenses for 2022 amounted to SEK 1,209.6 million compared to SEK 753.8 million for the full year of 2021. Out of the total operating expenses for the full year of 2022, marketing and selling expenses increased by SEK 335.6 million to SEK 515.2 million, compared to SEK 179.6 million for the full year of 2021. Increase in marketing and selling expenses originates from the commercialization of TARPEYO in the U.S., including our sales force compared to 2021, when we were in preparation mode only prior to the start of the commercialization. The cost for research and development for 2022 increased by SEK 57.2 million to SEK 414.7 million, compared with SEK 57.5 million for the previous year. The increase in R&D expenses originates primarily from the ongoing operations for the setanaxib trials. The cost for administration for the full year of 2022 increased by SEK 48.9 million to SEK 259.5 million, compared to SEK 210.6 million for 2021. The increase in cost between the years was primarily related to general cost increase for administration due to organizational growth, increased cost for compliance, and increased complexity being a company in the commercial stage. Our operating loss improved by SEK 102.5 million and amounted to SEK 421.9 million for the full year of 2022, compared to an operating loss of SEK 524.5 million for 2021. The cash flow used in operating ex-activities for the full year of 2022 amounted to SEK 311.4 million, compared to SEK 461.6 million used for 2021. Our cash from financing activities were SEK 576 million for the full year of 2022, compared to SEK 435.2 million for 2021. This leaves us with a net increase in cash for 2022 of SEK 259.5 million, compared to a net decrease in cash for 2021 of SEK 50.8 million. Finally, and again, we are very happy with the cash position of SEK 1.249 billion at the end of the year. That was all for me. Now back to you, Renée. Thank you. As I mentioned upfront, 2022 was a very successful year for Calliditas. We saw overall revenue growth in 2022 of 250%, reaching over 800 million Swedish crowns, which shows obviously strong revenue from the year, both from product sales and partner income. In terms of the TARPEYO revenues, it came in line with our guidance, which we had provided, of around $37 million for the year, and $16.1 million for the quarter. There is clear excitement in the nephrology area around our ability being able to share our Part A data. It was very clear from interactions at the ASN. I think it is considered very interesting in terms of the specifics of the data which Richard covered previously, which seems to stand out from other product, potential product candidates. In terms of the sales force, as we mentioned, we did expand this towards the end of the year. We are seeing continued penetration into the prescriber base and look forward to, you know, having continued growth in uptake in 2023. In terms of commercial partnerships, obviously we mentioned in Japan, where we outlicensed Nefecon to Viatris in IgA nephropathy, obviously in an additional kind of non-dilutive cash raise of $20 million. Also, obviously, very importantly, we look forward to work with our new partner and expand the Nefecon global franchise. In China, as I mentioned, the NDA was accepted towards the end of last year, and we're looking forward to the regulatory review process and the ultimate decision which we expect to happen towards the second half of this year. In terms of guidance, obviously, we mentioned that, you know, based on these patients, we're seeing really kind of the beginning of, you know, patient success stories, you know, peer-to-peer recommendations in the market. That kind of momentum, you know, in combination with streamlined market access, the published data that came in towards the end of last year, we're expecting net sales of TARPEYO in the U.S. Of between $120 million-$150 million. With that concludes the presentation, and we're happy to take any kind of questions. If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from Maury Raycroft from Jefferies. Please go ahead. Hi. Good morning. This is Farzin Haque from Maury. You're projecting a strong year- Strong ....guiding to $120 million-$150 million. Can you walk us through the assumptions that went into it, like potential treatment duration beyond nine months, PSF, EU sales, and potential competition too from Travere getting approved? I think that obviously there, you know, there are a multitude of a variety of kind of inputs into that estimate. I think that obviously it is based on, as I kind of briefly mentioned, you know, we are now having patients on drug for a longer period of time. We're, you know, we're hearing a lot more about, you know, kind of patient successes, you know, physician successes. There's a buzz in terms of peer-to-peer recommendations. Obviously also the data that fairly recently got into the, you know, got into the market, you know, from our kind of publication. Obviously we are expecting additional kind of data this year, which we also believe can impact momentum of the uptake. You know, very specifically in terms of exactly when these kind of, you know, when the momentum really picks up and how it goes, etc., is difficult to judge. I think in terms of, you know, any other kind of potential approval, we don't really think that's gonna have any real impact on our, on our kind of projections for 2023. Okay. Thank you. The other question is on the expectations for the eGFR data from the Part B, like, and how much, and how you think it'll impact the label from a disease-modifying claim perspective? Obviously, that's going to really be judged in conversations with the FDA and EMA. I think that's, you know, that will truly just depend on kind of the strength of the data that we see coming out of that trial. Okay. Thank you so much. The next question comes from Annabel Samimy from Stifel. Please go ahead. Hi. Thanks for taking my questions. Congratulations on the progress. Just in terms of the success stories that you're hearing, and some of the anecdotals, have you started seeing patients staying on drug for longer than nine months? I mean, the drug's been out for, I guess About one year now. I think you can have some metrics around that. Are you seeing them stay on drug beyond nine months? Are there restrictions around patients getting treated if they're responding well? Just a little bit of color around that. Then, you know, when you think about the eGFR data, if it's positive, do you have any additional initiatives for new educational efforts around that to change the label and for, you know, work with payers and, you know, potentially improving terms or ease of onboarding or facility if that data actually come out positive? Any kind of work that you're doing there to streamline the process? Thanks. Great. Andy, do you wanna take the first one? Yeah, sure. I'll comment on the duration of therapy. You're absolutely right. We are now seeing patients that have been on therapy greater than nine months, while it's obviously the first patients that were on product. The good news is, what we're seeing is it really seems to be determined by the physician, right. This is a heterogeneous progressive disease, and as we've always said, we want these decisions to be made by the nephrologist, the treating physician. We are seeing now we have definitely a good portion of patients that are on for more than nine months and some that stop at nine months on treatment. I think this is gonna be based on patient to patient. Like you said, the market access, you know, it hasn't been a barrier to this. These patients are able to continue, as long as they qualify, you know, and they're still taking their medication there. In terms of kind of the eGFR data point that you mentioned, obviously, yes, we do have, you know, quite a lot of activities in preparation for that data. Yes, I mean, obviously that will be a kind of a separate FDA review, with a full kind of 360 patients, and obviously with the endpoint, as communicated in terms of eGFR. Yes, our expectation is that that may very well lead to, you know, expansion of label or a different label, 'cause obviously we would be able to kinda have slightly, you know. We will have different data to support some of that development. I don't know, Andy, if you have any additional comments on market access, et cetera. Yeah. Sure. Part A, you know, once it's published and or part B, I should say, once it's announced and then published, there is, we are permitted to share some of this information certainly with payers in confidential. I think we're been very pleased with our management to date, but certainly, obviously it could only improve from there with positive data. We do anticipate sharing it as soon as is possible, and hopefully that'll have some even further favorable treatment. Okay. Great. Thank you. The next question comes from Yigal Nochomovitz from Citigroup. Please go ahead. Hi, Renée and team. Thanks. Can you comment, I know it's early in the launch, but can you comment at this point on what your market share looks like in the United States? You referenced some of the statistics for the prescribers, it's 42, and the enrollments, 1,039. Can you connect that to your guidance in terms of how many prescribers you would expect by the end of 2023 and the number of enrollments by the end of 2023? Thanks. Obviously what we've said before is really, I mean, when we've done our mapping, our market research and a lot of work before we kinda launched, we really identified that, you know, probably the prescribing universe that really is kinda the most relevant for us would be around 3,700 to 4,000 nephrologists. Obviously from that perspective, you know, we're really only kind of, we have a very small amount. We're really kinda scratching the surface in terms of where we, you know, what we can do with regards to that based on where we are on our first kind of 11 months of commercial activity. Obviously there's, in the actual kind of, you know, enrollment and prescribers, there's obviously this combination of refills and actually kind of patients staying on drug is then, well, new enrollers, enrollments, et cetera, and obviously then when those enrollments actually happen. I think it's very, very difficult at this point in time, to kind of share that because it's a multitude of factors that go into that. Okay. Just on the duration question, is it fair to assume that pretty much everyone that's starting is going through the nine months, or is there a discontinuation rate that you're observing that's, for some patients it's less than nine months? I think it's hard to answer that, obviously 'cause patients are continually moving through the process. I think as far as discontinuation rates, it's probably similar to assume, similar to our trial in phase III. That's probably the best I could give as far as estimates on discontinuation rates. Okay. Then just going back to the part B data, I mean, sort of asked before, but maybe asked a different way. Could you kinda characterize how you would frame the base case for what that eGFR data would look like? What would the bull case look like for that data readout? Also what might be the less optimal bear case for that readout? I guess obviously, I mean, you know, we're looking for, you know, for two things obviously. One would obviously be to kind of see, you know, the duration or durability of the proteinuria reduction. We do have the three-month kind of, you know, already kind of across all patients that we're seeing between the nine and the 12 months. The question is really now, will that be persistent, you know, across the entire population, in some of the population? Obviously, it is a heterogeneous group of patients, or we know that they kind of develop in a heterogeneous way. I think obviously the longer we can see that kind of protein or a reduction or continued reduction, I think obviously, you know, that would make us... That would be kind of a, you know, go towards a stronger and stronger case the longer that we can show that. In terms of the, you know, the other aspect is obviously then, you know, eGFR. I think obviously again, you know, the longer that we can show that there is kind of a, you know, a difference in eGFR kind of trajectory between kind of the treatment group and the placebo group, then obviously again, you know, that goes towards kind of, disease modification. I think that those are kind of the obvious kind of, you know, directionally what we would, you know, what we would find would be, you know, what we'd be looking for, kind of in the trial. I think it really comes down to, you know, is this really a kind of very homogeneous population? Is it heterogeneous? You know, are we gonna see slightly different kind of, you know, things depending on kind of what type of profile these patients had when they came into the trial, et cetera. I think that would really kind of be my view. I don't know, Richard, do you have anything to add? No, I don't think so. I think that really summarizes the position pretty nicely actually. Okay, great. Thank you. The next question comes from Chien-Hsun Lee from Pareto Securities. Please go ahead. Hi. Congratulations on the great progress with TARPEYO and also on the upfront and milestones received from global partnerships. My first question is that, do you see a need to increase the sales force further considering the competitor just gained FDA approval, that would start with a bigger sales force? Andy, do you wanna? Sure. We assess this kind of information on, at different points and currently there's no plan to increase our sales force. I would say that if it made sense in optimizing the product and the brand, we would certainly consider doing so at some point. There's no set plans on doing so at this point. Okay, thank you. Regarding the European market, could you provide some thoughts on the sales uptake? Is the sale truly reflected on the royalty income in 2022? Do you have any discussion with STADA that you are able to provide? Andy, do you wanna answer? Sure. I think that the information is our partner's pleased with the uptake to date. You know, they launched in September, and data shows that they have just shy of about 70 patients on therapy before the end of the calendar year, which puts them on mark for where they estimated they would be. They feel very encouraged at this launch so far in Germany. I didn't hear the second part of the question. Can you repeat that? Is the sales truly reflected on the royalty income in 2022? Do you have any discussion with STADA that you're able to provide? Yeah, that's pretty much it. Okay. Sorry. The last question is that the R&D cost sits over 100 million SEK. Can we expect that to remain stable over the coming years? What is the strategy with that partner fit in the next stage? Do you plan to partner or do you plan to finance both indication by yourself? Sorry. Can you repeat that question? It was R&D costs. If I understand you correctly, you're asking if the R&D costs are going to stay the same. Is that, was that your first part of the question? Yeah. Yeah, yeah. Yeah, exactly. Yeah. We would expect it to stay in the ballpark basically. We do have a new program with Alport, which will increase the cost a little bit, but there will be no material increases for this year, we think. In terms of our ongoing plans for, you know, doing development ourselves or with partners, which I believe was your second part of the question. Obviously, what we've communicated before is if they're rare disease programs, and Alport is something that's, you know, fits very well into our existing franchise. It's a, you know, a renal asset. There is really nothing approved in Alport. Really a significant unmet medical need, and we're super excited about being able to start that clinical trial. Obviously PBC is another rare disease where we believe that, you know, we could commercialize that ourselves, again, not in all geographic territories, but in select geographic territories. Head and neck cancer is obviously different because that really is a parallel, kind of if you wanna call it a parallel, path that really is more to characterize the mode of action of this drug, because there's so much kind of preclinical data that exists in head and neck. You know, to the extent that the biomarker data that we read out, if we get very strong biomarker data from that trial, we would not plan to take, you know, that R&D effort onwards, which would then go into potentially several, you know, several kind of, you know, solid tumor types, and would be a very, very significant R&D program. We would then look to really partner that asset to the extent that there would be strong data and there would be interest from big pharma to do so. Okay, great. Thank you very much for taking the question. The next question comes from Ingrid Gafanhão from Bryan, Garnier. Please go ahead. Hi, everyone. Good afternoon. Thank you for taking the question. I have a couple, actually. First on the price, I know you disclosed the SEK 14.2K sort of in the beginning of next year. Should we expect any price increase for this year? What would be reasonable number to assume? Then I have a follow-up. We did take a price increase at the end of January of 6.8% in line with increased costs and inflation and those type of factors that go into these kind of decisions. Okay. Thanks, Andy. I think for a follow-up, you did mention that you're still quite far from reaching the number of unique prescribers as you have for your target physicians. At the moment, what is keeping you from actually increasing this number a little bit faster? Is it a matter of sales force size or just time that you need to get to those counts? This is a rare disease, it's not like they don't see the patients every day. We see the physicians, and it's a process that they go through. It's an educational process. No one's talked to them before about IgA nephropathy, the source of the disease. This data is unique to them, seeing something like this. It just takes time. Different physicians have different adoption rates. Some are adopting slow as far as one patient at a time, where others put multiples on. I don't think it's... I think it's going very well. I don't think it's slower than we thought as far as reaching our target. You have to cast this wider net to get these prescribers onboard. Thanks. If I may ask one quick, last question on the financials as well. You mentioned that you have enough cash to reach profitability. Would you feel comfortable with saying when that could be possible or how you're looking into that? No. We will not specify a specific time point. I mean, as you see, we do have a certain range in our guidance and also, we are also starting the Alport program, so adding on a little more cost to it. We are not specifying that to a specific quarter. It is clearly kind of our direction and our focus obviously to get there. I mean, that hasn't changed at all. It's just difficult to kind of, again, know when this momentum is really gonna pick up, this kind of peer-to-peer and when we're gonna start seeing that kind of... Which we have started to see, but it's difficult to kind of judge exactly the impact of that. You know, our kind of focus and direction there is obviously still, you know, clear. All right. Thank you very much. The next question comes from Rami Katkhuda from LifeSci Capital. Please go ahead. Hey, guys. Congrats on the progress, and thanks for taking my questions. Two quick ones from me. In your guidance, do you expect net sales of TARPEYO to kind of continue linearly growing, or is that inflection point going to be around successful Part B data or full approval by the FDA, et cetera? With regards to market access, are you seeing big differences between commercial and Medicare lives or are coverage and prior auths similar across the board? I think that to some extent, you know, uptake is partly organic. It's, you know, this is kind of based on, you know, just kind of education and people understanding and understanding the mode of action and seeing patient successes. I think there's a kind of an underlying kind of, you know, uptake and growth. Obviously we are expecting, you know, all physicians, you know, wanna see more data. We're expecting obviously that that would be kind of, you know, could provide additional momentum to do that. I personally don't think that the, that the ultimate approval, per se, would be kind of a major, change, apart from obviously the label impact. That could obviously be, you know, quite significant. In terms of kind of the way the physicians will be using it in the meanwhile. I don't know, Andy, do you have a different view? No. I think pretty much all the factors that you say go into things over the year in uptake, meaning they're going to certainly get increased comfort. Part B would be certainly another catalyst. I think it's just time that will take care of increased growth with increased successes. You asked about market accesses and the difference between the different channels. Just to be clear, there's two things. Number one, as far as coverage is concerned, over 90% of U.S. lives. The coverage is great for even the government subsidized as well as commercial patients. That's all U.S. lives. When you look at our specific book of business, where the patients come from, when I discuss around 70% or almost 75% if you want to look at that's private insurance and cash paying patients versus the government subsidized. Does that make sense? Definitely. I guess with prior auth, it's pretty much the same. Yeah. There's similar types of coverage. You know, it's as you would anticipate a specialty product being covered and that's how it's been across both commercial as well as government subsidized. Got it. Thank you, guys. The next question comes from Erik Hultgård from Carnegie. Please go ahead. Hi, guys. Thanks for taking my questions. I have two, if I may. First, some of your peers or competitors are considering doing studies, combination studies with SGLT2. I was just wondering, from a mechanistical point of view and also return on investment point of view, is that something you're planning and does it make sense? Then just a quick follow-up on previous question on price hike. The list price increase in late January, do you expect that to sort of fall down to the net price line as well? Thank you. I guess I'll have Richard give his view on this as well. I guess in terms of the SGLT2s, you know, this is very complementary. I mean, we are a locally targeted, you know, medication. We're not kind of really focused on the systemic distribution of the drug. We know obviously today that there, you know, there are quite a few patients who are on SGLT2s today and also on TARPEYO. When we talk to physicians, I think, you know, a lot of the, you know, all the physicians that I've personally been in contact with anyway and talked to, you know, would consider this to be highly complementary. I mean, SGLT2s are obviously they're approved in CKD, not specifically in IgA. I don't think people look at them as being kind of, you know, disease modifying or anything like that, I think. I think they're very safe, and I think they do obviously provide some, cardiovascular protection, you know, general cardio, you know, cardioprotection, etc. We do already see that, you know, being used in quite a lot of kind of patients already with TARPEYO. As I said, it seems to be kind of a positive view from the nephrologist perspective. I don't know, Richard, if you have, anything to add. Yeah. I mean, I think, you know, we have an active internal program looking at potential studies that we can undertake to develop franchise for Nefecon, and certainly we're interested in, you know, other treatments that are available. I completely agree with Renée's comments. There's absolutely no reason why Nefecon can't be given on top of an SGLT2 inhibitor. The mechanisms of action are completely different, but they're complementary. You know, I think it's something that we're actively watching and considering. As far as the price increase and its impact, I'm not sure I completely understand the question, but I mean, in general, the patient out-of-pocket costs are typically a percentage if it's coinsurance or it's a set amount. We have zero out-of-pocket costs for commercially covered patients, and no patient will ever not receive our medication due to affordability. It's not gonna have an impact on patient out-of-pockets, really, from that aspect. Sorry. It was more related to sort of gross versus net price. The 6.8% price hike, do you expect like a similar increase in net price or are there higher rebates coming in? Yeah. No, no. We don't contract with payers, number one. It won't have. It should have a similar. We're not gonna see a change, any noticeable or anything change from the gross to net that you should use in your calculations. Thank you so much. The next question comes from Sebastiaan van der Schoot from VLK. Please go ahead. Hi, team. This is Sebastiaan dropping in for Suzanne today. Thank you for taking my questions, congrats on the progress. A couple of questions from our side. For the phase III part B readout for the eGFR result, assuming that you will meet the primary endpoint with the statistical significance, from conversations you have with the physicians and KOLs, what is the difference from eGFR that would be considered to be the minimum bar and clinically meaningful, and what would you consider to be a strong eGFR result? Then I have a follow-up question. Well, I'll take a crack at that, and Richard, you can complement that. I mean, I think that my view is actually talking to a variety of physicians that there isn't a specific number or a minimum bar that they would be looking at. I think it is more about kind of actually what, you know, what can you see in terms of, you know, what's the difference in eGFR kind of development in the placebo versus the active arm. I don't know, Richard, if you have a different experience in your interactions with KOLs. I mean, no, I broadly agree with that. It's not like the external KOLs experts have some magic number in there head that says this is the eGFR that you have to achieve. Below is not good, above is good. I think it's about, clearly we need to meet our primary endpoint for the study. There's also a number of different, important secondary endpoints and supportive data. I think we need to take a holistic look at the information that we get from the outcomes of Part B and look at all of that information. I don't think you can simply say this is the number that we have to achieve. Okay. Got it. Can you maybe elaborate on the statistics for what difference is the trial powered on eGFR? Well, I mean, we don't typically comment on the sort of the detailed statistics of the clinical trial, to be honest. Okay. Got it. The final question is on the Alport trial. I was just wondering what the biological rationale and the preclinical data is that supports testing setanaxib in the renal space? Richard, do you wanna- Take that? Yeah. Please do. Yeah, sure. I'll try and answer that reasonably briefly. In summary, Alport syndrome is a rare hereditary genetic disease. There's a clear genetic defect in Alport syndrome. It's a disease of collagen. Patients with Alport syndrome develop a progressive renal failure relating to a glomerulonephropathy, where a significant component of that is a podocytopathy and fibrosis. We know maybe you've heard from previous presentations that setanaxib has a very important role in fibrogenesis relating to its effects on LOX enzymes through LOX inhibition and the inhibition of the generation of reactive oxygen species, which are important in activating fibrogenic pathways. From that point of view, there's a clear underlying rationale, and we have supporting preclinical data from a relevant Alport mouse model that does indeed support that hypothesis. If you like, we now have preclinical data that provides a sort of biological, biochemical, histological outcomes that support that thesis that setanaxib could have beneficial effects in Alport syndrome. Okay. Got it. Thank you very much. The next question comes from Johan Unnérus from Redeye. Please go ahead. Thank you for taking my questions, and congratulations on the good quarter. Very interesting with these, continuing dosing and, well, I guess eventually second dosing. Could you remind us regarding the Part B if, we can get any more insight to the need or use of extended dose or second dose? Yes, I'll start and then maybe Richard can complement. Yeah. In the Part B, obviously we are not kind of, we are not redosing as part of the protocol in the Part B. It really is just an initial treatment and then there is a follow-up period, which is observational. As I think I mentioned in the Q3 report, obviously there is an open label extension that's available for patients who have concluded the Part, the phase III. Once they've been in the study for two years, they have an ability to then enroll into an open label extension where all patients will be given active treatment for nine months. As I think we've mentioned, there obviously there is a fairly significant number of screen failures and those are the vast over 60% of those are even related to the fact that they, the patients actually don't qualify, due to the fact that they do not have, one gram of proteinuria. They're not considered strictly according to KDIGO guidelines to be in that kind of higher risk population. There will obviously be patients who will have enrolled into that open label extension. We will be getting additional information from that study, which obviously is also still blinded and ongoing. Once that study obviously, once we are able to kind of look into that study, that is probably more likely to give us some more information around retreatment, et cetera. Obviously I'm sure that in the Part B we will be, we will see some trends and see some information regarding how proteinuria reduction performs, and eGFR, et cetera. Richard, do you wanna complement on that? Sure. Just to make sure it's clear how the open label extension performs. It's open label in the sense that everyone who gets into the open label extension receives active treatment. But is blinded in the sense that investigators and patients don't know what their original randomized treatment was in the pivotal study. As Renée says, that gives us an opportunity to get some really interesting information at the end of the study, and we expect that study to complete in early 2024. We expect to be able to see the performance of patients who did previously receive Nefecon and then have received a second course in the open label extension compared with patients who received placebo. In the original study, went on to receive their first course of Nefecon in the open-label extension. Some very interesting information will come out of that follow-up study. Excellent. This is, to be expected in the first half of 2024 or thereabout? Yes, most likely, I would, I would think. Even if it's still relatively early days, but is there any sort of take from real life in terms of continuing usage? Is still... Well, the first patient has been on 11 months, but it's still obviously very early days. The second part of that question can be also if there is a sense of changing characteristics in the patients. Quite often, when a new product is launched, it tends to be the more sort of severe patients. As time goes and specialists feel more comfortable, they may also opt to treat perhaps some less severe patients. Andy, do you wanna take that? Yes. I think if I heard you correctly, as far as on the length of therapy, those folks that are on it a longer period of time, we're not seeing, you know, anything different with those patients. They're tolerating the medication, and we're not hearing back anything noteworthy of patients that have been on longer than the nine months. Your comment about patient population for the physicians and uptake. Yeah, I think that naturally, I think when a new product launches, a physician will try something on maybe a more severe patient, and then they'll move to more of a comfort zone or additional patients with it, with success that they achieve with the patient population. That's what we were talking about earlier. I think we're starting to get these success stories more and more from our field reported back to us on patients, and that can only encourage physician prescribing and wanting to treat additional patients. Finally, it's clear that market access is great, awareness is great. Is there any sort of change in unique prescriber characteristics in terms of the level of specialists? Or are we seeing more activities among specialists closer to the patient, or is it more larger centers that is more dynamics or is there sort of great interest across the board? I would say there's, there hasn't been a change in that makeup. A lot of times that's an individual physician adoption comfort level and when you see them and how often, that determines their uptake. Over time, we've just seen an increase in new prescribers, as you would anticipate. That's a lot of times left on their, based really on their adoption comfort level and their understanding of the product, the clinical information. Some wanna see more information than others. There's really no one answer, as far as that's related. I don't think there's any difference in the new prescribers. I will say, though, our targeting, our segmenting and targeting has been pretty accurate as far as who we anticipated would be the higher, enrollers of patients. That seems to be accurate and targeted, which is who we call on the most with our sales force. Finally, any surprises in the feedback from the sales and marketing team or commercial clinical team? Yeah. No, no real surprises, no. Nothing of note. No. Okay. Thank you. Great. Thanks. That's it. There are no more questions at this time, so I hand the conference back to the speakers for any closing comments. Thank you very much for participating in this Q4 Call for 2023. We look forward to talking to you again for Q1 of 2023.