much, and to this Q1 2024 report from Calliditas Therapeutics. My name is Renée Aguiar-Lucander. I'm the CEO of the company, and I'm today, today joined by Fredrik Johansson, our Chief Financial Officer, Richard Philipson, our Chief Medical Officer, and Maria Törnsén, our President of North America. Next page, please. I'd like to draw your attention to the disclaimer notice, which covers forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and I refer to public filings, including those containing risk factors. Next page, please. I'd like to take you through some of our Q1 highlights, which included the appointment of Maria Törnsén as President of North America, who brings over 10 years of rare disease experience to Calliditas, including multiple product launches both in the US and ex-US. Following our full approval in December last year, we were able to roll out new marketing materials to a fully trained field team in February, introducing the new indication of reduction of loss of kidney function to nephrologists in the US. In February, we also announced that the USPTO had issued a new patent covering TARPEYO, with expiration in 2043. In March, we could also announce that the FDA had granted us seven years of orphan exclusivity for the new indication, which expires in December of 2030. Finally, we also saw the approval in Singapore of Nefecon, which will be known as Nefegan. Next page, please. In terms of commercial highlights for the quarter, this—I want to... From a commercial perspective, this quarter was another record quarter in terms of enrollments, with 705 new enrollments, reflecting a 27 increase over the pre-previous quarter, in which we saw a 51% increase. This continued strong demand is very encouraging, and we continue to see strong demand for the product in the market. As expected, we saw somewhat of a lighter quarter from a revenue perspective due to the typical reverification process, but this quarter also saw something quite unexpected in the form of a cyberattack on Change Healthcare, one of the three providers of claims processing in the U.S. We use one specialty pharmacy, Biologics by McKesson, which exclusively uses Change Healthcare, which due to the delays in processing, due to this cyberattack, led to a negative impact on the quarter of approximately $4.7 million, resulting in net product revenues for the quarter of $26.8 million. We do not expect this to have any impact on our annual revenues, as these revenues are not lost, but merely pushed out in time, which is also borne out by the strong start to Q2, reflected by net product revenues quarter to date of approximately $25.5 million, with an additional five weeks to go in the quarter. The team is, during the quarter, undertaking a very substantial number of P&T committee meetings, and we're starting to see some plans update their rules, but our expectations remain that the majority of plans will update their rules in the June-July timeframe. We're also hopeful that EMA will review and make recommendations regarding a potential full approval of Kinpeygo at their next meeting. In the period post the quarter, we also were excited to see the commercial launch in China by our partner, Everest Medicines. Next page, please. Other post-period events. We did have a positive readout of our phase 2 proof of concept trial in head and neck cancer, which Richard will give you a little bit more information on, but we saw statistically significant benefits in progression-free survival as well as overall survival. There's also an R&D day that's been scheduled for May 30 to provide some additional information around setanaxib. We also had supportive open label extension data, which was presented at ERA. There were several abstracts presented at the ISN World Congress of Nephrology, which, again, Richard will cover shortly. There was also a new patent, in the form of a notice of an allowance that was received for setanaxib in the area of cancer. And as I already mentioned, there was the commercial launch in China by Everest Medicines. Next page, please. So in conclusion to this section, just wanna highlight that we are very excited about what 2024 will bring following the successful start in Q1. That includes the potential full approval of Kinpeygo in Europe, the commercial build-out in China, with the potential for Nefecon to be included in negotiations related to national reimbursement already this year, potentially. The readout of setanaxib data from the phase 2 trial in PBC, which we expect to be able to share with you in Q3. The readout from a phase 2 investigator led study in IPF, which we're hoping to be able to share with you in Q4. Reimbursement decisions expected for additional countries in Europe by our partner working with that, Stada. And then we're also hopeful that we will see the start with phase 3 study in Japan, with Nefecon by our partner, Viatris. And obviously, we're certainly looking forward to continued strong growth of TARPEYO in the US market. And with that, I'm going to hand over to Richard Philipson. Thank you very much, Renée. So next slide. I'd like to start by talking briefly about our recent conference attendance. Next slide. We're delighted to have had a strong presence at the World Congress of Nephrology, a conference organized by the International Society of Nephrology, which was held in Buenos Aires from the thirteenth to the sixteenth of April this year. We presented four posters and also held a sponsored symposium, where Doctors Richard Lafayette, Laura Mariani, and Heather Reich presented and discussed the evolving landscape of eGFR and proteinuria surrogate markers in IgA nephropathy. We very much valued the opportunity to meet with nephrologists from the U.S. and also from many other countries, where we were able to talk about IgA nephropathy and hear about their experiences in managing the condition. I'd like to highlight some of the data and analyses that we presented at this conference. Next slide. One of the important observations that we made in the secondary analysis of the phase 3 NEPHIGARD trial was that the time to 30% reduction in eGFR or kidney failure was significantly delayed in patients treated with Nefecon. This analysis was presented in a poster at WCN and is also well-illustrated in a figure on the right of this slide, demonstrating a 55% reduction in the risk of an event in patients treated with Nefecon compared to placebo-treated patients, which was statistically significant with a p-value of 0.0014. It's also noteworthy that this treatment effect was consistent, irrespective of baseline uPCR category, with hazard ratios of 0.51 and 0.42 for the below and above 1.5 gram per gram uPCR categories. Other posters presented additional analyses from the NEPHIGARD trial. These posters included a subgroup analysis indicating that Nefecon was efficacious and well-tolerated, irrespective of White or Asian race. A poster described the beneficial effects of Nefecon on eGFR slope in patients with lower levels of baseline proteinuria, and finally, a poster describing quality of life outcomes. Next slide. So I'd now like to move on and talk about the recently announced results of the company's phase 2 proof of concept study in squamous cell carcinoma of the head and neck. Next slide. As a brief reminder, this was a randomized, placebo-controlled, double-blind phase 2 study investigating the effects of setanaxib 800 milligrams twice daily in conjunction with pembrolizumab, 200 milligrams IV, administered every 3 weeks. Patients with recurrent or metastatic squamous cell carcinoma of the head and the neck, and with moderate or high levels of cancer-associated fibroblasts in the tumor, were randomized to receive setanaxib or placebo on top of standard of care pembrolizumab. The tumor biopsy was taken prior to randomization and again, approximately nine weeks after the start of treatment. Treatment continued until disease progression. For brevity, I'll subsequently describe the treatment groups as setanaxib or placebo, but please remember that these randomized treatments were both given in addition to pembrolizumab. Next slide. The study was conducted at 37 sites in seven countries. The last patient was randomized on the 25th of October 2023, with data collected until all randomized patients had at least 15 weeks of follow-up. The primary analysis comprised 55 randomized patients and included 38 progression events, which was in line with our target for the statistical analysis. The treatment groups were well-balanced at baseline, and importantly, no patients were excluded from any of the analysis sets, nor were there any important protocol deviations that were considered likely to impact efficacy. Next slide. We observed statistically significant improvements in progression-free survival and overall survival. Median progression-free survival was 5 months in setanaxib-treated patients, versus 2.9 months in placebo-treated patients. The hazard ratio for this outcome was 0.58. In other words, patients treated with setanaxib had a 42% lower risk of experiencing disease progression at any time during the study. At 6 months, 92% of setanaxib-treated patients were alive, compared to 68% of placebo-treated patients. The respective percentages were 88% and 58% at 9 months, and the hazard ratio for this outcome was 0.45. In other words, patients treated with setanaxib had a 55% lower risk of death at any time during the study. We also saw a higher percentage of setanaxib-treated patients achieving a best response of at least stable disease. 70% of setanaxib-treated patients showed a best response of at least stable disease, compared to 52% of placebo-treated patients, and the responses in setanaxib patients appeared to be more durable. It was very pleasing to see a corresponding increase in CD8 positive T-cells in tumor tissue in response to setanaxib treatment, which supports the mechanism of action of setanaxib in solid tumors and indicates an increase in the immunological activity of the tumor. There was no significant difference in the primary endpoint of best percentage change from baseline in tumor size. From a safety point of view, the tolerability of setanaxib when given with pembrolizumab was generally good, with no new safety signals identified. Next slide. So in summary, we saw statistically significant improvements in progression-free survival and overall survival, with more durable responses in setanaxib-treated patients. There was an increase in intratumoral CD8 positive T-cells in setanaxib-treated patients, which is in line with the mechanism of action of setanaxib and indicates an increase in the immunological activity of the tumor. Finally, setanaxib was generally well-tolerated when given with pembrolizumab, and there were no new safety signals. So I'd like to now hand over to Maria Törnsén. Thank you very much, Richard. Next slide, please. As you recall, in Q4 2023, we had our strongest quarter since launch, with 555 enrollment forms. And in the first quarter of 2024, we continued to see a very strong demand for TARPEYO, with 705 enrollment forms received by our patient services hub, TARPEYO Touchpoints. During this quarter, we also have 354 new prescribers, which is another record since launch, and we now have close to 2,000 healthcare providers who have prescribed Tarpeyo. We believe the strong demand we're seeing is an early sign of the impact of our full approval, our new label, with the removal of the UPCR criteria, and physicians recognizing the impact Tarpeyo has on reducing the loss of kidney function. Our total sales for Tarpeyo in Q1 was $26.8 million. As Renée mentioned earlier, Q1 was impacted by seasonal changes due to the open enrollment period in the U.S., as well as the cyber attack on Change Healthcare, and this does not impact our 2024 guidance. As you can see from our estimated quarter two sales to date, we've seen a very strong revenue in the first 8 weeks of the quarter, with approximately $25.5 million of net sales. Next slide, please. In the first quarter, we launched the full approval of Tarpeyo with multiple commercial and medical activities. As a reminder, Tarpeyo is the first and only product approved by the FDA to reduce the loss of kidney function for patients at risk of progression. Our field teams are trained on our new label and are promoting it to healthcare professionals. We have also launched various new patient educational programs and materials. For market research, we know that patients appreciate Tarpeyo's 9-month treatment course with no REMS requirement, as it provides them with the freedom to complete a course and see the long-term benefits. Our medical team have been engaged in multiple scientific exchanges and participated at congresses. At WCN in April, we had presentations highlighting the eGFR results and impact of quality of life experienced by patients in the clinical trial. And finally, our market access team have been busy engaging with payers, educating them on our new label, the inclusion of the eGFR data, and removal of the uPCR criteria. Next slide, please. We're very excited at the opportunity ahead of us. We see a very strong demand for Tarpeyo, both from existing and new prescribers, who recognize Tarpeyo's positioning as a disease-modifying therapy in IgAN. Our focus is on continuing our promotional efforts with our expanded field team and drive scientific exchange at large conferences. We're eagerly awaiting the update of the KDOQI guidelines and estimate they will be published in the second half of 2024. These guidelines have the potential to broaden the definition of the at-risk population and also support the use of Tarpeyo as the only fully approved drug with impact on eGFR. As mentioned earlier, we're continuing to focus on engaging with US payers to ensure that their policies reflect the new label. We have already seen one of the largest payers in the US, UnitedHealthcare, update their policy in May, and we are anticipating that the largest payers will update their policies mid-2024. This should facilitate access for patients and reduce market access barriers. With that, I will hand it over to our CFO, Fredrik Johansson, to talk about our financials. Fredrik? Thank you, Maria. Next slide, please. I will now present to you the financial overview for the first quarter, as always. The numbers presented to you are in million SEK, unless otherwise stated. To start with, we report SEK 295.5 million in net revenues for the quarter. For the same quarter last year, we reported net revenues of SEK 191.3 million. Tarpeyo net product sales for the quarter amounted to SEK 278.3 million or $26.8 million, which is a reported increase of 50% from the same quarter previous year. As Renée mentioned, the Change Healthcare cyber attack had an estimated negative impact on our revenues in the quarter of approximately SEK 4.7 million, or approximately SEK 50 million. This revenue is not lost, but will roll forward into the next several months. Therefore, we update you today on the progress to date for Tarpeyo in the second quarter, and we were very encouraged to report that the preliminary Tarpeyo net sales in the second quarter to date amounts to SEK 25.5 million, which are almost already at the level at the reported Q1 Tarpeyo net sales, with approximately 40% of the quarter remaining. The remaining SEK 30 million in revenues in the quarter is related to our partnerships, primarily from royalties for Europe, from Stada. For the same quarter last year, we had royalty revenues for Europe of SEK 4.4 million. Our total operating expenses for the quarter amounted to SEK 485.3 million, compared to SEK 362.4 million for the same quarter last year. The cost for research and development increased by SEK 24 million in the quarter to SEK 150.6 million, compared to SEK 126.7 million for the same quarter previous year. This is primarily related to our pipeline, where we just had a positive readout in head and neck and have two more expected data readouts this year, including the readout in PVC, which is expected in the third quarter. Moreover, as we had four trials running, including the open label extension, and the head and neck, which are close to be completed, also from a cost perspective, and the PVC and Airport trial, which are running with full speed. The R&D cost between the quarters may be somewhat lumpy and less linear this year, but as previously communicated, we expect R&D costs for the year to be broadly in line with the previous year. The cost for sales and marketing increased by SEK 72.9 million in the quarter to SEK 240.1 million, compared to SEK 167.2 million for the same quarter previous year. The increase is primarily related to sales and marketing of the brand in the US, where we, during the quarter, continued our work to leverage the market opportunity for the Tarpeyo full approval we received at the end of last year. This included costs related to completely new marketing materials due to the new indication. As previously communicated, we started this investment in the commercial organization already in Q4, and we have particularly strengthened the sales, marketing, and market access functions during the first quarter. We made an operating loss in the quarter of SEK 203.8 million, compared to a loss of SEK 180.1 million for the same quarter last year. The cash flow used in operating activities in the quarter was SEK 198.2 million, compared to SEK 231.9 million from the same quarter previous year. This leaves us with a net decrease in cash in the first quarter of SEK 207.5 million, and we continue to have a healthy cash position of SEK 810.3 million at the end of the quarter. At last, I wanted to bring to your attention that we leave our 2024 total net confidential net sales estimate unchanged at between $150 million-$180 million for the year. That was all for me. Thank you. Now back to you, Renée. Thank you very much. Next page, please. There we go. So, just some key takeaways for the quarter. As you've heard, this was another record quarter, both in terms of enrollments and new prescribers, with 705 new enrollments and 354 new unique prescribers. We have seen an improved product protection of Tarpeyo in the form of both orphan exclusivity as well as patent protection, with the new patent expiring in 2043, covering Tarpeyo and orphan exclusivity in the U.S. for the new indication expiring December 2030. As Maria has shown, there continues to be strong demand for Tarpeyo, with this disease-modifying mechanism, and we believe that the recent setanaxib data clearly supports its antifibrotic effect, and we are looking forward to and excited about the upcoming readouts in our clinical pipeline related to our rare diseases. Finally, our total revenue guidance remain unchanged and reflecting strong growth expectations of $150 million-$180 million for the year for the entire Nefecon franchise. And with that, we're happy to take questions. If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Maury Raycroft from Jefferies. Please go ahead. Good morning. This is Yao on the call for Maury. Can you maybe talk about how many new patients Tarpeyo you have seen so far in the second quarter? For the SEK 25.5 million revenue in the second quarter, which day was the cutoff date, and was the SEK 4.7 million included in it? What are some of the additional assumptions and drivers behind the reiterated revenue guidance for 2024? I'll have a follow-up question. All right. Well, those were four questions. Let me see if I can start with those. So in terms of the actual, kind of the, the SEK 4.7 million, let's start there. So obviously, they will be, kind of—it's something that will catch up over the next several months. So it's not something that's necessarily only going to be in Q2. It'll probably be go both over Q2 and Q3. As the quarter hasn't ended, we're not really in a position to be any more precise about, you know, where we might have seen what coming in from kind of the, the, the kind of the cyberattack. So I think that's going to have to wait until the quarter is actually completed. In terms of the... We're not going to report on any other aspects of Q2. I think we felt that this was a kind of a bit of an exception, because obviously, the cyberattack was something that was outside of our control, and it was kind of like this technical issue. So we wanted to provide some insight into kind of the quarter to date, and that is truly quarter to date, so that is as of the reporting date. And so that's. I think that covered all of the questions. Yeah. Thanks so much for that. Then I guess the second question is, can you maybe provide some additional color on the phase 3 open label extension data for TARPEYO? How do the data inform the treatment gap and timing for starting a second course of therapy? Also, are the data consistent with what you're seeing in the real world? Thank you so much. I'll hop back in the queue. So the data will be presented at the upcoming ERA-EDTA. Mm-hmm. I think that as we mentioned in the press release, what we've seen is kind of consistent trends and patterns as we saw in the original phase three trial. So I think that we'll be happy to kind of take more questions or discuss this maybe more at the R&D day when we cover some of those aspects as well, and where we will be joined by Professor Barrett. ... Hello? The next question comes from Vamil Divan from Guggenheim Securities. Please go ahead. Great. Thanks for taking my question. So I just had one other follow-up on the Change, the $4.7. To just so I understand the dynamics there. So those patients have already received the product, it's just a matter of getting the reimbursement now, getting the payment. There's no risk that they sort of may not end up getting the product. I just want to confirm that, if you could. And then my other question is on, just so the prescriber base that you're seeing obviously a nice increase in the number of new prescribers. Is there any change that you're seeing now in terms of which sorts of prescribers are writing for the product, given the broader label, just in terms of academic based physicians versus more community-based doctors? Any sort of insights in terms of where the prescriptions are coming from now would be helpful. Thank you. Maria, you want to take that? Sure. So maybe I'll first address your first question on Change Healthcare. So Change Healthcare is one of the largest claims processes in the U.S. They process approximately one-third of U.S. lives. And the way it works is that every single time you have a new claim, as you need to get a new prescription, either a new patient or an existing patient that is going to get another shipment, they need, you know, our pharmacy need to confirm that the patient still has coverage from their insurance. And that is what Change Healthcare is providing through their online system. And as the system was down, it created some issues in terms of verifying insurances. I want to reassure you that all patients have still received drug. We didn't lose any patient per se, but it did provide a bit of delay of approximately 10 days when we were unable to verify the insurance for the patients. But that's why Renée mentioned earlier that, you know, the revenue is not lost, that it's going to come, you know, over the coming months, and we're going to catch up on that gap that we experienced in the first quarter. With regards to your second question, so prescribers, you know, we're very happy that we're seeing both new prescribers but also existing prescribers, you know, prescribing to additional patients. I don't think we've seen any change in terms of academic versus community nephrologists, but we've always had prescriptions coming from both groups. I guess you can say that, you know, we're both seeing a healthy growth in terms of new prescribers, but also in existing prescribers identifying additional patients. Okay. All right. Thank you very much. You're welcome. The next question comes from Yigal Nochomovitz. Please go ahead. Hi, this is Ashkan for Yigal Thanks for taking our questions. I'm just wondering what you're expecting for the updated KDIGO guidelines. I'm assuming that will broaden the definition of that at-risk population and reflect the updated label language. I'm just curious what you expect will be specifically included and if you really view that as a sales inflection point, especially with the new prescribers. Thanks. Yeah. So I think we are expecting the KDIGO guidelines to at least come up for kind of public review at some point in time in Q3. And I think that we have no knowledge of exactly what is going to be in those guidelines, but what we have heard and what we observe in different conferences and interactions with a lot of KOLs is clearly that there is a concern, generally, that the existing level of one gram per gram may not kind of truly reflect the correct patient population as being defined as being at risk. So I think there is a kind of, in our view, a significant probability that that level may be reduced. To what level? I don't think that we know. Certainly, I think that would obviously just further broaden the kind of target market, as in our label, it does cover patients that are considered to be at risk. Okay, understood. Then in terms of the European story, at this point, I guess we're waiting for you know some new commentary. I'm just curious what the remaining steps are, and if there's any reason to think that the EU might push back on a full approval, or if your expectation is that everything should be smooth sailing from this point on. It is our expectation that we, that Kinpeygo will receive a positive opinion from EMA. However, as all regulatory processes, you kind of never know until you know, and there's, you can never be sure of what's exactly going to happen, but that would certainly be our expectation. And we're hopeful that EMA will take this up on their agenda in their upcoming meeting. So if that is the case, there is a possibility that there would be a positive opinion fairly shortly. And then obviously there is that kind of 67-day kind of delay between a positive opinion and the actual kind of formal decision by the European Commission. Got it. Thank you very much. Thank you. The next question comes from Annabel Samimy from Stifel. Please go ahead. Hi, everyone, thanks for taking my question. So just following on the KDOQI guidelines, you did mention that those seem to the guidelines, obviously, are potentially identifying this at-risk population, but you said that it could also include Tarpeyo specifically, as a potential treatment. Do you have any sense as to how they might talk about Tarpeyo within these guidelines? And then secondly, I was just curious, you know, we've all been focused on how long patients are staying on treatment, whether it's below nine months, above nine months, but is this really the wrong way of thinking about it? Are you now using this nine-month treatment period as a selling point, I guess, especially in light of the competitive environment that seems to be evolving with only chronic therapies available for these patients, or possible for these patients? Can you just talk about, I guess, how you're using that nine-month treatment period as a possible selling point as opposed to sort of a guideline for treatment? Thanks. With regards to the KDOQI guidelines, so obviously we are clearly expecting Tarpeyo to be part of the guidelines. And I think that the guidelines obviously are based on kind of scientific evidence, which is ranked, you know, based on kind of like by a third party, really, who provides the author with that kind of a ranking. And so we believe, obviously, that our data is very strong, and that it will be recognized in the guidelines, in terms of the fact that we have, really, you know, in our view, kind of a disease-modifying, immunomodulating effect on B-cells. And so this is something that we would expect to hopefully be reflected in the guidelines, but as to exactly how that treatment paradigm will be expressed and discussed, we don't, at this point in time, have any insights into how that exactly would be kind of described. In terms of 9 months, and I'll have Maria also comment on that, I guess my view is actually that there is a very significant benefit from a patient perspective, which sometimes I think is forgotten in some of these conversations. Where obviously, the vast majority of patients are actually diagnosed between the ages of 20 and 40. 40% of these patients are female, and for, from pretty much most or if not all of these kind of treatments, there is an issue in terms of becoming pregnant if you are on any of these chronic treatments. I think that this is actually an extremely important issue for a very large and important part of this patient population. So yes, I do think that there could be a very substantial benefit of actually being able to hopefully delay dialysis, keep patients out of dialysis, hopefully, with intermittent treatments, rather than forcing all patients to be kind of on chronic treatment. But from a kind of, you know, for sales perspective, so, Maria, do you have any comments? Yes. So I would say, you know, it's two things. I mean, first, you know, we know that what our label says is that the recommended duration is nine months of therapy, and that is also what we provide in all of our promotional materials and all of our communications to our field teams. We also know from market research that this is something that patients appreciate. Going back to what Renée mentioned before, this is a lifelong disease, fairly young patients, and we see in market research that patients really appreciate this nine-month course, with extended benefits, and that that is something that they see as, as a benefit in treating their their disease. So it's definitely something that is appreciated by patients from what we can see, and also something that physicians recognize when they prescribe Tarpeyo. Okay, great. And just one more follow-up question on the KDOQI guidelines. Do you have any analogs as to what kind of impact that could have when a drug is specifically included in the guidelines, as opposed to just say, you know, identifying an at-risk population, something that's more general? You know what? I wish I did have something off the top of my head that I could provide you with. It's an excellent question. But I don't necessarily have an analog, but I do think obviously this is a rare disease, and I think it is something where these nephrologists are not highly specialized in subcategories of nephrology. So it's actually a very, you know, it's a, it's quite a, you know, it's quite a feat to be a nephrologist and cover everything that kind of relates to nephrology. So I do think that these guidelines are going to be very impactful, because I do not think that many of the KOLs who are often kind of maybe interviewed or, or discussed in, in this kind of setting, that they are very representative, in terms of the broader nephrology community. So, my guess is the broader community nephrology community of nephrologists will very much appreciate and refer to the guidelines and to get some insight into how they might treat these patients. Okay, great. Thank you. The next question comes from Christopher Uhde from SEB. Please go ahead. Hi there, Christopher Uhde from SEB. Thanks very much for taking my questions. I just wanted to check in, in terms of what, what can you tell us about the rate of conversion in the quarter from enrollments to actually dispensing medicines? And then I had a question on setanaxib, what are your thoughts preliminarily for a phase three trial design when you go to the FDA for an end of phase two live ad? In particular, I'm curious about the number of arms, but other comments would be great as well. Thanks. So with regards to kind of setanaxib, I think that obviously we probably would not go to the FDA on our own with regards to kind of any progression on the oncology side. I think our preference would be to, you know, use this time right after the kind of clinical data to engage with potential partners, with other interested partners, and gain a bit of insight into, you know, which, which way would kind of be the most, effective and efficient way to kind of take this forward oncology, as we don't have any plans to really kind of do that on, on our own. I also think that if it's an anti-fibrotic effect, that this obviously could very well have or, or would be expected to have a very similar kind of effect in, in solid tumors, such as pancreatic cancer, et cetera. So there might be other kind of solid tumors that partners would choose to kind of go into, not necessarily just head and neck cancer. So I think that this is something that we will interact with a variety of parties, which we have plans to do over the next kind of couple of months. And really, I think on the basis of that, we will kind of jointly decide on kind of what steps we may or may not take, in the kind of near term related to oncology. Okay, thanks. That's clear. In terms of rate of conversions, we don't really kind of provide any specifics around that. But obviously, I think what we are kind of seeing, and we can talk a little bit about the kind of like potential market access friction- Yeah that we're seeing today. Yeah. So I would say the way I would look at it is that we have a very strong demand for Tarpeyo. We get a lot of enrollment forms, as you've seen from what we've reported today. In the US, patients need to go through the prior authorization process, where, you know, we verify the benefits and see if their payer will cover Tarpeyo. The situation we're in right now is that we have a full approval label with a broad label. But as we mentioned, not all of the payers have updated their policies. And some of the largest payers, we expect to update their policies mid-year, which is why we have guided that, you know, the second half of the year is going to have a stronger revenue. So we don't provide no specific conversion rates and how quickly a patient converts from an enrollment form to on therapy, because it depends on the type of insurance that they have. But I think the way I would look at it is that we have a very strong demand, which I think is a lead indicator for future growth and future revenue for the brand. All right. Thanks very much. The next question comes from Suzanne van Voorthuizen from VLK. Please go ahead. Hi, team. Thanks for taking my questions. First of all, can you comment on the operating expenses? How should we think about how those will develop coming time for both R&D and SG&A? And, perhaps, especially with regards to the sales and marketing expenses, can you clarify what drove the increase and, how to think about the run rate going forward? And, then I have a follow-up question. Yeah, thank you. I'll, I'll take that. So starting with the R&D cost, as I, as I said earlier, we expect some lumpiness between the quarters on the R&D cost, but, you know, overall for the year, we expect them to be broad in line with the previous year. And for the sales and marketing expenses, what we see now from Q4 to Q1 is kind of a, I think it was around 20% increase. And I believe you think that we have now taken, I mean, most of our investment, and I believe that the first quarter is kind of representative. I would think that for the year, you should expect kind of a 15%-20% increase from the level of the full last year. Got it. That's very clear. And then maybe a question on setanaxib. Now with the recent data in oncology signaling a potential anti-fibrotic effect, for the upcoming readouts, can you give some context on what you would like to see there? The interim futility in PBC is probably straightforward, but, yeah, maybe some thoughts that you can share on the IPF data, the study design there, and thereafter, the Alport data, what would be success in your view? So, I think in terms of the PBC, obviously overall, we, you know, apart from, you know, kind of the endpoints and the secondary endpoints, I mean, we're also in that we are looking at things like FibroScan. That would obviously be another really interesting kind of component of kind of validating this, you know, anti-fibrotic effect. So I think there'll be quite a lot on the PBC data that will complement what we've seen kind of from the, you know, from, from kind of the head and neck cancer trial. IPF obviously is a really interesting, and I think we've—as we've reported out, I mean, we've also seen in the interim readout from the head and neck cancer, we saw that that was one of the pathways that was modulated, in that kind of smaller group of patients. And so I think that would obviously be something that's very exciting. The drug trial that's being run right now, as you know, is an investigative study, and it's also run at a kind of half the dose of what we're using in our other clinical trials. But clearly, I think any signal that we could get from that in terms of efficacy would be really exciting. And so this is obviously why we're hoping that we can get to see that data kind of in Q4 of this year. We will spend a little bit more time on this, clearly in our R&D day. So the whole point really of the R&D day is to provide a little bit more thinking about this. We will take you through all of the kind of different designs in the pipeline, and I think obviously, also talk a little bit more about what we might be expecting to see or what we would think would be kind of a, you know, positive to see. But I think generally in the PBC, I would say apart from the obvious kind of things, I think really it's the FibroScan that we're really interested in seeing. And I think also really the, the possibility of having a statistically significant effect on fatigue, I think is something else that we'd be very excited to see. So I think that those are probably the, the two things. Got it. Thank you very much. The next question comes from Johan Unnerus from Redeye. Please go ahead. Taking our questions, just a few add-ons. You mentioned that one private insurance PNT committee has taken a decision already, and you expect several to follow by mid-year, July, sort of. What can we expect from that on the back of full label? Do you expect to see reimbursement with without prior authorization? Sorry. Maria, do you want to take that? Sure. So, the insurance company, as you refer to, it's UnitedHealthcare. They cover approximately 13 million U.S. lives. They made an update to their policy in May, which reflects our new label. You know, we have a broad inclusion criteria, removal of UPCR criteria, the recognition of the impact on eGFR. So, exactly in line with what we expected. I still believe that Tarpeyo will require prior authorization in the majority of cases. That is very typical of the U.S. Most rare disease, highly specialized drugs have a prior authorization in the majority of cases. But I think the anticipated, you know, the positive change that we are anticipating is that it will be easier to get that first approval because their policies will be aligned to our label. So, but it will still require prior authorization by expectation. Great. And you also extended your commercial team and the support team, presumably partly to support this review and, of course, work with a specialist. Can you perhaps give us some more flesh, what, that requires or what do you work with since the team is in place since February, I believe? Yes, of course. So we took the decision in Q3 last year to expand our field team, and some other type of functions in anticipation of a broad approval. We now have today 70 rare disease account managers, so these are sales specialists in the field. We have, in addition, hired thought leader liaisons. We have expanded our market access teams, in terms of bringing in-house our field reimbursement managers and our national account managers. And we've also expanded some of our home office functions in marketing to support, you know, our field team with materials and also with digital efforts. So in total, we now have approximately 100 people in the field in the US, to support the full approval and the promotion of Tarpeyo. Excellent. And finally, from our side, this cyberattack, it seems to be handled well, even though it was substantial, especially on Change Healthcare side. Perhaps you can give some feel for what you sort of—what measures you've taken and preparation if something similar would happen again. So I think obviously this is a third-party provider, and obviously once when these things happen, there are always quite a lot of follow-up activities, particularly on the Change Healthcare side. I mean, we know from kind of, they've been actually also gone to Congress and had kind of to explain themselves as to what happened there, et cetera. So I think on their side, they have certainly announced that they have taken actions to try to avoid that this can happen again, but exactly what those details are, we are not privy to. Yes, and is there something that you have done on your side to perhaps mitigate vis-à-vis Change or? There's very little we... If possible. We can't really do anything because it's really kind of Biologics that cover our hub. So we can only kind of try and collaborate with them and look at their systems, et cetera, what they might do. But actually, it's very difficult to do anything as a kind of third party, because obviously, this really relates to the situation of the Change Healthcare. Yeah. Excellent. Thank you. Thank you. The next question comes from Rami Katkhuda from LifeSci Capital. Please go ahead. ... Hi, guys. Congrats on the progress, and thank you for taking my questions as well. I guess for setanaxib, do you have any hypotheses as to why you didn't see changes from baseline in tumor size in conjunction, I guess, with the PFS and OS benefit? And then, did you measure the CPS score for these patients, and could those values have influenced the overall results? Richard? Yeah, sure. So, I think in this kind of setting of what we were evaluating, we were looking at this treatment on top of pembrolizumab. Pembrolizumab itself is not typically a drug that we would use to, you know, that is used to shrink tumors. What you see is the longer-term benefits in terms of progression-free survival and overall survival with pembrolizumab. And what we're seeing when we add setanaxib on top of that, is we're seeing, evidence that patients, when they respond, more patients, receiving setanaxib tend to achieve stable disease. And those responses, when they are achieved, are more durable. So, you know, I think when we were setting up the study, I think, you know, progression-free survival ideally might have been chosen as a primary endpoint, but we also have to approach it from a feasibility point of view and what's reasonable from a sort of sample size calculation point of view. Changing tumor size is a sensitive way of detecting a clinical effect. So from a sample size point of view, it was a pragmatic decision to use that endpoint to allow a reasonable sized study and a feasible study. But nevertheless, we had sufficient power to detect changes in PFS, and indeed, that's what we did. So I mean, overall, in summary, what we're seeing is, is a kind of increase in patients achieving at least stable disease and the durability of those responses being longer in patients who receive setanaxib. I don't think that there's anything that would indicate... We did have a CPS score requirement to get into the study, but I don't think there's anything there, that would indicate patients responding differently, with respect to their baseline CPS score. What we do see, is that when patients receive treatment with setanaxib, we see evidence from various biomarkers, and transcriptomic analyses, that we see an increase in the immunological activity of the tumor. Got it. That makes sense. And then, I guess switching gears a bit, have the baseline characteristics of patients being prescribed Tarpeyo changed at all with the full approval, or is it still too early to tell? Maria? Well, great question. I think, if you look at the patients that we received prior to the full approval, we did receive patients that were below the 1.5, that was the cutoff. So, I think we're seeing a broader... You know, it's early days, but we're definitely seeing a broader group of patients being prescribed Tarpeyo, and I think you can see that in the enrollment numbers that we've reported. Physicians that, you know, previously prescribed to one patient may have a second patient now that is eligible for treatment. So we're starting to see the positive signs. I think it's too early to say, you know, the type of patient and, you know, what is the profile look like, since we only have a few months of the new label. Sounds good. Thank you very much. Thanks. The next question comes from Erik Hultgård from Carnegie. Please go ahead. Hi there. Thanks a lot for taking my questions, and congrats on the progress. 2 questions from my side. The first maybe for Richard on the setanaxib head and neck data. So I was just wondering if you have discussed the data with any opinion leaders, and if you're getting any initial feedback on the PFS and OS data, more specifically, the clinical relevance of the 2-month extension of the PFS. Any view there would be helpful. Then also, when we could expect to see the peer-reviewed publication for the data or any presentation at the scientific meeting? Then finally, on CDC, I was just wondering if you could update us a bit on the competitive situation, and highlight the key competitive programs in the clinic that we should monitor. Thank you. Okay. Yeah. So definitely we've spoken to external experts, and we also have very experienced people working with us who worked in large pharma oncology settings. And I think both from that point of view and from the external expert point of view, they consider these outcomes in terms of progression-free survival impressive. I think one of the reassuring things that we observed is that the patients who were randomized to placebo and received pembrolizumab, the behavior of those patients in terms of these longer-term outcomes, like PFS, was exactly as has been seen in other studies. So we know that our control arm was behaving very, in a very expected way. There's nothing unusual about that control arm, so we're seeing an augmentation, apparent augmentation of benefit when we add setanaxib on top of that treatment. And yes, definitely, those outcomes are considered impressive. ... We will be preparing a publication, and we will hope to present the data at ESMO later this year. So, regarding your question on PBC, so obviously there is, at this point in time, really the dominant kind of area in PBC that's being kind of focused on are the PPARs at the moment. They're in kind of regulatory review. I think that there is an expectation that both of those candidates may very well achieve approval this year. So I think that that's probably where the... And I think there are other kind of similar PPARs kind of in development. I would say that the way that we've obviously looked at kind of the PBC is not to kind of be an all-comer for PBC. That's not the way the trial is designed either. So it's really kind of stratified for patients that have a higher score in terms of a reading of FibroScan. And so actually, we have a trial that is specifically targeting a particular kind of patient group. And so I think from our perspective, this is really about looking at either those patients that have a more kind of compromised, I guess, kind of a more, you know, fibrotic from the view of looking at FibroScan kind of liver disease, and/or really looking at these patients in terms of fatigue, which is a really debilitating and very broad kind of issue for all of these patients. So I think that those are the two kind of components that we really look at kind of complementing with. So we are not positioning ourselves as kind of, you know, kind of directly competing, you know, with the PPARs or with Ocaliva for that matter. Which is also why in this trial, we've actually allowed patients to come in with both Ocaliva as well as bezafibrate, et cetera. So, so I think that that's really kind of a, a slightly different, positioning that we have. But those, I think, are still... Those two kind of drugs is really what I think the main, focus of, of, for, for-- if you're anyone looking at PBC at the moment. Thank you so much. The next question comes from Arthur He from H.C. Wainwright. Please go ahead. Hey, Renée and the team. Thanks for taking my question. I just had a quick one. Could you guys give us more color on the launch in China for the Nefecon? And I believe you still provide the drug as of now. How is that going to evolve in the upcoming years or quarters regarding that part? Thanks. Yes. So actually, it's a little bit early for us to have any feedback really from them, and obviously, it was launched really a week or two ago, really, kind of in China. But it is something obviously that we're super excited about, and we are just as curious as you are in terms of how that will develop. So the... But yes, and obviously, because China, it's not a rare disease, and it's a much kind of bigger patient population. In terms of supply, you're correct. You know, we are obviously not directly, but through our existing kind of CDMO relationships, we are providing supply also to China. And I don't see that changing in the near term. My expectation would be that in the near term, we would certainly still continue to play that role. Oh, great. Thanks, Renée. I'll talk to you guys soon. Okay, thanks a lot. I think that was the last question for this particular session.