Welcome to Calliditas Therapeutics Q1 Report 2023. For the first part of the conference call, the participants will be in listen-only mode. During the question and answer session, participants are able to ask questions by dialing star five on the telephone keypad. I will hand the conference over to CEO, Renée Aguiar-Lucander. Please go ahead, Renée. Thank you very much, and welcome everybody to this Q1 2023 report. With me today, I have Fredrik Johansson, Chief Financial Officer, Richard Philipson, our Chief Medical Officer, and Andrew Udell, President of North America. Next slide, please. I'd like to just draw your attention to the disclaimer page. It relates to any forward-looking statements. I would like to refer you to the company's reports and other filings, including those which contain risk factors and other relevant information. Next page, please. Some highlights for Q1. In February, we received conditional marketing authorization from the MHRA for Kinpeygo, which thus became the first ever approved treatment for IgA nephropathy in the U.K. In March, we obviously had our main event for the quarter. We read out top-line data from the global, placebo-controlled randomized phase III study known as NefIgArd, which met its primary endpoint of kidney function expressed as eGFR. The trial was very successful and met the primary endpoint with a highly significant statistical P value of 0.0001. With regards to TARPEYO, Q1 saw a record number of new enrollments, reflecting growth of over 30% over Q4. In addition, the quarter also saw the largest ever increase in unique subscribers, resulting in a total of 918 unique nephrologists prescribing TARPEYO since launch. Revenues for the quarter amounted to SEK 191.4 million, with net sales from TARPEYO representing SEK 185.7 million of that, or just under $18 million for the quarter. Our outlook for the year remains unchanged, and we're very excited about the initial reactions we've had from KOLs, and with select nephrologists with whom we have had the opportunity to share the phase III data with. We really look forward to being able to share that data a bit broadly with the nephrology community going forward. Next page, please. About the NefIgArd trial. Richard will shortly provide you with the details from our top-line readout from the phase III trial. As I mentioned, though, we're extremely excited about the results, as really this focus on the top of the disease cascade, targeting this presumed origin of the disease seemed to generate not only an immediate kidney protective benefit but actually also have long-term durability. These strong results, we believe, will further support our thesis that TARPEYO is indeed disease-modifying in IgA nephropathy. It's even more exciting, obviously, this effect is being seen irrespective of baseline UPCR levels. We do believe that this data, once it does become more familiar in the nephrology community, is going to be have a very significant impact on treatment paradigm of IgA nephropathy. In addition to the eGFR data, we also saw a durable UPCR response, where UPCR levels remain below 30% reduction for the entire observational period of 15 months post the initial treatment period of nine months. On the basis of these data, we plan to file for full approval with the FDA for the entire study population of NefIgArd in July, with the regulatory decision to be expected in the first half of 2024. The exact timing of that decision is dependent on whether that regulatory process will be conducted under priority or standard review. Next slide, please. A quick pipeline update. We are on track to report out our biomarker data for the setanaxib head and neck cancer trial around mid-year this year, as we previously disclosed. We are still experiencing challenges in terms of recruitment of the TRANSFORM study in PBC. On the IPF, the investigator-led IPF trial is still recruiting on plan. In terms of the biomarker data, we're super excited about reading that out. We hope, obviously, that this proof of concept study will provide us with information that will be very helpful across all of the kind of different rare disease trials which are presently running. In addition, we've decided to expand our clinical pipeline with a study in Alport syndrome. That's an orphan renal disease where as of today, there are no FDA or EMA-approved drugs. We will, on the basis of extensive preclinical work, launch a clinical trial in Alport's involving approximately 20 patients. We hope to start that in the second half of this year. We also continue to explore the whole NOX inhibitor platform for other renal diseases, which we may be in a position to pursue later on. Next slide, please. With that, I'm going to hand over to Richard Philipson, who will take you through the top-line data. Thanks very much, Renée. Next slide, please. I'll start by briefly reviewing the phase III study trial design. The NefIgArd study enrolled patients with biopsy-proven IgA nephropathy, proteinuria of 1 g per day or. An eGFR of 35 to 90 mL/min and with well-controlled blood pressure whilst on optimized RAS inhibition. Immunosuppressive therapy was not permitted during the study. Changes to antihypertensive medications were discouraged. Patients were randomized to receive TARPEYO at a dose of 16 mg per day or placebo for a nine-month treatment period. An interim analysis of change from baseline in proteinuria in the first 199 patients enrolled and treated for nine months formed the basis for accelerated and conditional approval in the U.S. and Europe respectively. The final analysis of the NefIgArd study is based on 364 patients, full analysis set for efficacy, treated for nine months and followed up for a further 15 months without investigational treatment, with a primary endpoint of average change from baseline in eGFR over the entire 24-month period of treatment and observation. Next slide, please. In total, 395 patients were randomized into the study. This includes an additional 29 Chinese patients required for local Chinese regulatory purposes only. The safety analysis set of 389 patients includes all randomized patients who received at least one dose of study medication. The full analysis set, comprising 364 patients, is the data set used for efficacy analyses performed for the globe study. It's noteworthy that only just over 10% of patients withdrew from the study at any time, indicating a good rate of retention of patients in the study and early discontinuations are broadly similar in the Nefecon and placebo treatment groups. Next slide, please. Moving on to demographics. Overall, the enrolled patient population is clearly representative of the intended primary IgA nephropathy population. Disease characteristics describe a clinically relevant high-risk population. Treatment groups are balanced with regards to baseline characteristics, of note, blood pressure was well controlled at study entry. There's been an increase in the proportion of Asian patients in the study population since the release of data from the interim analysis reflective of the active recruitment of patients in China. Next slide. Primary endpoint of time-weighted average change from baseline in eGFR during nine months of treatment and 15 months of observation was... On average, during two years of treatment and observation, the loss of eGFR was 2.47 mils per Nefecon, 16 mg versus a loss of 7.52 mL/min for placebo. There was therefore an average treatment difference of 5.05 mL/min favoring Nefecon, a result that was highly statistically significant. Next slide, please. Several different supportive analyses of eGFR total two-year slope were performed. These are all statistically significant with improvements in slope estimated to fall in the range of approximately 1.8 to 3 mL/min per year. The differences in two-year total slope observed between Nefecon and placebo are considered clinically relevant since all of the estimates are well in excess of the difference per year required to predict clinic meaningful treatment effects on the composite endpoint of end-stage kidney disease, eGFR less than 15 mL/min or a sustained doubling of serum creatinine as published by Ink et al. in 2019. Next slide, please. When we look at the eGFR outcomes in placebo-treated patients at nine months, there was a decline in eGFR of approximately 8%, corresponding to a loss of approximately 4.6 mils, which increased to a decline of 21.5% or 12 mL/min by 24 months. In contrast, in patients treated with Nefecon, eGFR was essentially stable compared to baseline at nine months, and by 24 months there had been a decline in eGFR of 11%, corresponding to a loss of approximately 6 mL/min. In summary, nine months of dosing with 16 mg of Nefecon in 364 patients resulted in 50% less loss of kidney function compared to placebo at 24 months. Next slide, please. Turning to proteinuria, we've seen a cumulative improvement in proteinuria in patients treated with Nefecon versus placebo during the nine-month treatment period, which continued to improve at 12 months. At month 24, proteinuria levels in patients who had received Nefecon were still at a reduced level, similar to that observed at the nine-month time point. Next slide. In summary, the primary endpoint of average change from baseline in eGFR over the two-year treatment and observation period was met and was highly statistically significant. Supportive analyses of two-year eGFR slope were also statistically significant and are clinically relevant. All estimates are well in excess of the threshold required to predict clinically meaningful treatment effects. The treatment benefit on eGFR was apparent across baseline UPCR subgroups, and a sustained proteinuria effect and long-lasting eGFR treatment benefit was observed even after 15 months off treatment supporting disease modification. Now next slide turn to safety. When we look specifically here at the nine-month treatment period overall we saw a pattern of adverse events in the safety analysis set that was similar to the interim analysis and which has previously been described in our publication in Kidney International and which is also described in product information. The most frequently occurring adverse events occurring in 5% or more Nefecon-treated patients and 2% or higher than placebo were peripheral edema, hypertension, muscle spasms, acne, upper respiratory tract infection, face edema, increased weight, dyspepsia, arthralgia, and increase in white cell count. It's important to note that any ongoing adverse events typically resolve at the end of treatment, and common adverse events occurring during the 15-month follow-up period are generally unremarkable, with a similar frequency of reporting in Nefecon versus placebo treatment groups. Next slide. In summary, overall, the adverse event profile was similar to that reported in the interim analysis. The most commonly reported adverse events observed with an increased frequency compared to placebo were peripheral edema, hypertension, muscle spasms, and acne. Majority of these events were mild or moderate in severity, adverse events led to discontinuation of studied drug in fewer than 10% of Nefecon-treated patients. When we looked at objective measures of mean weight and blood pressure, these showed non-clinically relevant, fully reversible changes. I'll now pass over to Andy Udell. Thank you, Richard. Next slide. While our $17.8 million in net sales were impacted by the typical end-of-year early patient refills and patient insurance changes at the beginning of the year, the Q1 of the year saw substantial enrollment and new prescriber growth, which are both key leading indicators for future net sales growth. March was a record month in sales and enrollments, pushing the quarter total to 408 patient enrollments, representing a 30% growth over Q4. In addition, we had 276 new nephrology prescribers prescribe TARPEYO during the quarter, which is also a record, and as of this report, now totals over 1,000 unique prescribers during our first 14 months of promotion. We also continue to grow the number of patients and are improving the speed at which they are receiving TARPEYO. During the quarter, 85% of patients enrolled in TARPEYO Touchpoints, excluding those still waiting for an insurance decision, received TARPEYO. This conversion rate is consistent with the rate reported for full year 2022. As time goes on, we have more and more patient success stories and patients that have reached nine months of treatment with TARPEYO. While treatment length can be variable, as we see more patients completing nine months on treatment, we observe that the majority of those that completed nine months remained on therapy beyond this. We believe this reflects the risk-reward profile of product as more and more of these patients will benefit from the consistent clinical results demonstrated in our trials. Next slide, please. Commercial and promotional efforts regarding the full data from the NefIgArd phase III clinical trial won't take place until after regulatory filing and approval. However, as announced early this month, we have several late-breaking oral presentations and posters accepted for the European Renal Association Congress coming up in June next month. These presentations and posters will provide further information and build upon the impressive results that Richard just reviewed with us. As you would suspect, the peer-to-peer conversations and reactions to the data by advisors and investigators is extremely positive. The next three quarters have additional key nephrology meetings and conferences providing opportunities for further data exchange and presentations as we continue to assess the results of the NefIgArd phase III study. With that, I will turn it over to Fredrik to provide our financial results. Thank you, Andy, good afternoon and good morning, everyone. I will now present to you the financial overview for the Q1 of 2023. As always, all numbers presented to you are in million SEK unless otherwise stated. To start with, we reported SEK 191.4 million in net revenues for the quarter. For the same period last year, we reported net revenues of SEK 49.7 million. TARPEYO net product sales for the Q1 amounted to SEK 185.7 million or $17.8 million. In addition, we also recorded SEK 5.7 million for the period in revenues related to partners, primarily from Kinpeygo royalties from STADA. Our total operating expenses for the Q1 amounted to SEK 362.4 million compared to SEK 257.5 million for the same period last year. Compared to the Q4 r last year, our OpEx decreased by SEK 26.3 million in Q1. In comparison, if we remove the effect in the quarter from a weakened SEK and increased Social Security accruals from option programs due to increase in our share price in March, we would have decreased by the OpEx by additional SEK 21 million for a total decrease of SEK 47 million between Q4 and Q1. The cost for research and development increased by SEK 13.4 million in the Q1 to SEK 126.7 million, compared with SEK 113.3 million for the year previous year. The increase in R&D expenses originates primarily from the ongoing operations for the setanaxib trials and the preparations for the start of the ALCO trial. The cost for sales and marketing increased by SEK 73.3 million to SEK 167 million compared to SEK 93.9 million from the same period previous year. In Q1, we now have the cost for the full extended commercial team, which would be compared to the same period last year, which we were in the Q1 of commercialization. The above led to an operating loss for the Q1, compared to SEK 208.4 million for the same period last year. In the Q1, cash used in operating activities was SEK 231.9 million, compared to SEK 191.4 million for the same period previous year. This leaves us with a net decrease in cash in the quarter of SEK 237.8 million, and we have a very healthy cash position at the end of the quarter of SEK 1 billion and SEK 13 million, which we believe is sufficient to take us to profitability. That was all for me. Thank you. Now back to you, Renée. Thank you, Fredrik. Just some key kind of summary takeaways to finish off the presentation, after which we will take questions. As you heard from Richard, we had very strong eGFR data, really showing a kidney protective effect and a positive readout from phase III NefIgArd trial, which we believe support disease modification from the treatment of Nefecon, which are branded as TARPEYO in the U.S. and Kinpeygo in Europe. We will be filing for full approval for the entire study population, which is planned for July this year. STADA is expected to file with EMA for full approval also in the second half of this year. As you heard from Andy, we had record numbers of enrollments for the quarter and the highest ever growth to date of new prescribers in Q1. We also which resulted in revenues of SEK 191 million in total and TARPEYO sales of SEK 185.7 million. We also got MHRA conditional approval of Nefecon, which provided the first and only approved medication for IgA nephropathy in the U.K. With that, I'm going to hand over for any 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. Our first question comes from the line of Yigal Nochomovitz from Citi. Please go ahead. Your line is open. Hi, team. This is Ashiq Mubarack on for Yigal. Thanks for taking my questions. Just the first one on the TARPEYO guidance. Seems like you're assuming some significant acceleration of growth in the remainder of 2023. Can you talk about some of the dynamics behind that and what you think the key drivers will be? It seems to hit the midpoint, you're gonna need to achieve some pretty significant growth rates. Just wondering what your thoughts are on how that might appear quarter-over-quarter for the next two or three quarters. Thanks. Sure. I'll start, and then Andy can fill in with any other additional details. In terms of what we've seen, obviously, this quarter already is really a high level of enrollment together with, you know, significant growth in kind of new prescribers. As we've kinda mentioned before, already in the kind of Q4 report, we were talking about the fact that we're hearing more and more kind of success stories from patients, and there's more and more kind of peer-to-peer recommendations amongst nephrologists. This obviously provides leverage into the entire system. We also believe that in addition to that, we will, by actually kind of getting this kind of phase III data out into the nephrology community, not in a kind of commercial fashion, but just merely from kind of abstracts and oral presentations at conferences, or manuscripts, et cetera. We believe that this data truly is groundbreaking, and we've certainly had the feedback that we've had from KOLs, who have we been able to share some of this data with, really support the fact that this is truly disease modifying, and we believe will have a significant impact on the treatment, kind of paradigm. That's really, I think would be the driving force from my, from my perspective. Andy? Andy, do you? Yeah. Anything to add? I mean, I would just echo everything Renée said. I think that you're gonna start to see, beginning with ERA-EDTA, the full trial results hit the podium. I think then people will enjoy and see the reaction to the data as we have with advisors and people that have been brought in to assess the data with us. I think that that's one, certainly one catalyst, as well as more and more successes. Patients that were started late in 2022 will start to see, you know, a lot more of those success stories with new prescribers. You heard about the large number of new prescribers at the beginning of this year in the Q1. I think that these things will build on itself during the launch growth year. Got it. That's super helpful. If I can ask one more. You alluded to patients at this point, the majority of the patients on TARPEYO staying on treatment longer than nine months. Are you able to give us any more detail on that, maybe how much longer than nine months they're staying? Sure. If there are any challenges with the reimbursement associated with that. Thanks. Sure. Just to be clear, length of treatment can be variable, okay? What we are seeing is, it is still early to talk about long and length of treatment here, what we are seeing is those that have completed nine months seem to stay on a little longer in the majority of those patients, okay? There are success stories of patients that are more mild, let's just say, that may stop after seven, eight months, and those are deemed as successes. We just want to provide that feedback in the sense that it's panning out almost exactly how market research since for the last five years has told us, which is the nephrologists are gonna treat this disease based on the patient, okay? They're gonna treat if it's patient starts and is a much more severe patient, and they're doing well and they're avoiding dialysis, they're going to stay on treatment if they're tolerating the medication, okay? If not, if they're, if they are a more mild patient or earlier in the disease, and they're doing well, and their proteinuria is well below the threshold for them considering them at risk, they would stop. They continue to see these patients, and should the patient start to progress again, they would treat again. The last part of your question, just as far as payers, no, we have not seen any issues or concerns as far as coverage with that. If there are requirements, we would certainly make sure a patient didn't discontinue or have any interruptions of treatment. I think that that provides it. Your last question, actually, you had a point about how long. It's way too early for us to tell how long they go on for, these patients. Very helpful. Thanks very much. The next question comes from the line of Maury Raycroft from Jefferies. Your line is open now. Hi, thanks for taking my questions. As a follow-up to the earlier guidance question, I'm wondering how does your latest commercial data shape your assumptions for upper or lower ends of revenue guidance for this year? Are you relying more on keeping patients on drug or getting new patients on drug? I mean, I think that in terms of what we're kind of concentrating, I mean, obviously it's both. I mean, obviously, I think that there's going to be a, as Andy mentioned, there's going to be a combination of, you know, shorter duration treatments where actually the physicians have achieved their treatment goal. There also seems to be, I think a higher number than what we were initially expecting, who actually are staying on drug, you know, longer, you know, longer than what, than the nine-month kind of initial treatment cycle would indicate. I think that there will be, you know, clearly there's kind of a combination there. I think in terms of from our perspective, I think our role really is to educate the market, and to actually try to just get this information as well as the, the data that we published fairly recently, October, November, really, from the interim analysis. Even get that kind of, you know, truly kind of, you know, penetrating the community so that there is, you know, sufficient information about the drug out there. I think that's really what we are, what we are kind of, focused on. In terms of the, so in terms of the guidance, I mean, I think it's certainly kind of, you know, easier from this particular quarter, to say that, you know, it's clear that, you know, hitting the upper end of that guidance might be kind of somewhat challenging. I do think at the end of the day that, you know, the reactions that we are getting, again, from nephrologists relating to this data, I think is very, very important and quite unique. I still think that, you know, we'll have to wait a little bit longer than from Q1, to be able to kinda give you a proper answer to that question. Got it. That's really helpful. One other question. Just wondering if you can elaborate on next steps for pursuing full approval? Do you need to have another round of a pre-NDA regulatory feedback in order to file? What are your expectations for the review timeline? Obviously, I think that with this data, which is extremely clear, I mean, both in terms of statistical significance and clearly also in terms of clinical relevance, if you look at kind of what's being published and what's out there. You know, we're not planning to have any, you know, kind of, you know, clarifying meeting with the FDA. It's a very consistent response across the entire study population. As I said, a very kind of clear and crisp data. We would file and the timing for filing really that we're targeting is July. In terms of the... We will request priority review, as this is kind of a supplemental filing. Obviously, it's always up to the regulators to, based on the workload that they have and other considerations, to decide whether they will do the priority review or the standard review. The difference there is obviously six months review time for priority and 10 months review time for standard procedure. Got it. Makes sense. Thanks for taking my question. The next question comes from Sushila Hernandez from ZKB. Please go ahead. Your line is open. Thank you. This is Sushila for Zuzanna. Thank you for taking our questions. Do you already see an uptake in prescriptions after the top-line phase III results? Also, could you elaborate on how you expect your operating expenses to develop over the quarters and what will be the drivers? Thank you. Sure. I mean, I think that obviously this is really between. The Q1, you know, would be way too early to see any impact from that. Really, I mean, the real impact really is going to be in 2024, because we are not really able to commercially promote on the basis of the new data until there's been a regulatory approval and an updated label. I think the only kind of benefit that I think we will have is just as I mentioned before, that through kind of oral presentations at conferences, at abstracts, at other kind of manuscripts, et cetera, I think that will start making its way into the kind of nephrology community really in the second half of this year. 'Cause that will really start with the ERA-EDTA, which takes place in the middle of June. Fredrik, I will hand over the second question to you. Yes. We don't give any guidance on the operating expenses, but looking at the start of the last year's OpEx of SEK 1.25 billion. We of course also see an inflation effect in our operations. This year also we do have the extended sales force on board for the full year. We also start getting programming now. I think that is the drivers what we will see in addition to last year. Okay, thank you. The next question comes from the line of, Rami Katkhuda from LifeSci Capital. Please go ahead, your line is open. Hey, guys. Rami? Yeah. Thanks for taking my questions as well. Two quick ones from me. First, has the expanded sales force been fully deployed, and when do you expect to see the impact of that on TARPEYO sales? Do you plan on running any post-marketing studies with Nefecon and IgAN to evaluate longer term dosing, retreatment, combination with SGLT2, et cetera? I guess I can handle the first part about the sales force. Well, while they certainly have been deployed, meaning they're in the field working, this takes time to build relationships and establish, you know, your routes and who you're seeing and priority calls and learning your territory. While they come with most of them come with nephrology experience, you're gonna see more and more uptake as the year wears on. They were in the field deployed in November, all of them. I think you're gonna start to see them hit their stride soon. As far as the other stuff, I'll let Renee comment. Sure. Richard. With regards to additional studies, that is something that we are looking into. We are having kind of internal discussions with regards to what type of studies may be most useful from the kind of nephrologist and patient perspective. Also whether those potential studies are best run, kinda managed, by the company or whether there are some investigator-led studies which would be, you know, would better serve that purpose. We are discussing that, at this point in time, we haven't made any decisions with regards to any additional studies, it's certainly something that we're looking into on the basis of having read out the full phase III data. Got it. Thanks so much. The next question comes from Dan Akschuti from Pareto Securities. Please go ahead. One question would be regarding the mentioning that you saw a record enrollment in December. How did that translate into sales? Were some of that maybe not the book then in January? Could you comment if you see the same growth as you have seen now in March, also in April and May? Thank you. I want to clarify the first part please, Andy, and I'll take the second. Just, we did not see a record enrollments in December. In December, in, the record enrollments was for the quarter, for Q1. Typically, for us, if you get an enrollment in one month, you start to see later at the beginning of the month, it's usually our fill is right around or less than 30 days. It takes a little bit to realize the income from an enrollment. The record enrollments, just to clarify, was during Q1, and March was in particularly strong. In terms of, in a kind of continuing, I think we're very encouraged, by the level of enrollments that we are seeing, post Q1. Okay, thank you. Another question. How is Everest Medicines planning for launch, assuming approval in the second half? Are they ready to launch directly, or do we need to assume a few months until they launch after approval? Thank you. I think that it'll be a similar situation as the one we had in Europe, because obviously we are the market authorization holder, as we actually was the sponsor in that trial. There will be a requirement to do kind of a handover from a market authorization holdership perspective. That may very well result in a couple of months of delay between kind of the actual approval and the first kind of shipment of product. Okay, thank you. The last question. You reached around 2,000 prescribers now. There are around 10 times as many around there. In the US, what are your plans to accelerate the pace of reaching them and educating them? Do you see a change now with the full data since March? Do you wanna take that, Andy? Yeah, sure. Just to be clear, while there may be over 10,000 nephrologists, many of them don't treat IgA nephropathy patients, and they're not in the clinics that see these patients. We believe that that number is in the 4,000 range to cover the vast majority of nephrologists treating these patients. over 1,000, you can do the math and these typical markets are 80%-20%, you know, 80% of the load comes from about 20% of the target. that gives you a better sense of the size of the market as far as prescribers. As far as the data and those kind of things, as we keep saying, I mean, you're not gonna see the impact of the full data from NefIgArd trial. You guys are more in tune, those on this call listening to it than many of the nephrologists because it hasn't hit their, you know, inbox yet. As Renée said, we're not permitted to promote on this. These will come out in peer-to-peer meetings, congresses, and the first one of those is next month in the middle of the month in Milan at ERA-EDTA. Thank you very much. The next question comes from Ingrid Gafanhao from Bryan, Garnier & Co. P lease go ahead. Your line is open. Ingrid? Ingrid, do you have a question? We'll move to Vamil Divan from Guggenheim. Your line is open. Hi, this is Arseniy on for Vamil. Thanks for taking our questions. Maybe expanding on some of the prior questions about these new prescribers translating into sales. Have there been any shifts this quarter in the gross to net or the Medicaid channel contribution or any other factor besides this delay from enrollment to shipment that kind of impacted sales this quarter? No. I would say no. There's no change on gross to net or anything like that this quarter. Maybe one more. Very dramatic growth in the number of new prescribers. How should we think about the rate at which the old prescribers are enrolling new patients? Because based on the numbers this quarter, it looks like the majority of new enrollments obviously came from the new prescribers. Yeah, I think... Mm-hmm. Yeah, I think it's variable depending on their patient load, you know, and some see more patients than others and some are faster adopters than others, and some nephrologists may try a product on a patient or two and do their own kind of clinical trial, meaning to see the success. Sometimes it takes a few months before they start to write their next patient or the patient after that. There's no real set answer. We may have a new prescriber now that becomes one of our, you know, big fans that writes a lot of it. It's just. There's no set answer to that. Sorry. Understood. Can I- All right. Thank you. I'll get back in touch. I think it's just worthwhile pointing out obviously that there are, this is a rare disease, and a lot of these physicians don't have, you know, a huge number of patients necessarily. That's obviously why it is important to kind of, you know, continue to penetrate the actual prescriber universe as well as obviously, you know, continuing to support those prescribers who have already written prescriptions and who have patients on drugs. Obviously we do that by, you know, having our hub services and providing a lot of these, you know, additional support to the community as well as education. Understood. Thank you. The next question comes from Arthur He from H.C. Wainwright & Co. Please go ahead. Your line is open. Hi, everyone. This is Arthur from H.C. Wainwright & Co. Thanks for taking my question. I guess, my first question is for Nefecon in the Japanese market. When could we hear more regarding the development strategy and timeline for Nefecon in Japan? I don't, I don't have, you know, an exact time to provide to you. You know, there are quite a lot of ongoing discussions and collaborations with regards to, you know, kind of establishing the most effective way to kind of, you know, design that kind of program. I'll have to get back to you once I actually, that's been a little bit better established, but it's certainly being worked on very actively. Obviously it'll have to kind of be after we hear back from the regulators in terms of their acceptance of the proposed development program and we have not yet done that. I'm gonna have to come back to you about that when we have more information. Sure. No, no, no issues, Renée. Thanks for the color. My second question is, could you give us a little update on the enrollment for the PBC study and remind us what's the data set we could expect for the initial update for interim readout? Thank you. Sure. In terms of the interim readout, that interim readout is a biomarker readout. It's a subset of the patients. This is in the head and neck cancer trial. Subset of those patients, we will have matched biopsies. We will actually then be able to, you know, have a biomarker related readout, which really looks at the microenvironment of the tumor. We're doing this obviously to really do this as a translational study from what we've observed in the preclinical models that we have, obviously with a view to seeing a similar effect in the clinic. That's really something that is still expected to be around midyear, kind of July-ish probably. That's still on track. I think this will be something that we really look forward to. We think it'll be very exciting to see if we can actually kinda show that translational effect, which we believe will have an impact and be very helpful, you know, across kind of the different rare disease programs that we're presently running. In terms of PBC, this is obviously a larger study. At the moment we're running the phase IIb portion of that adaptive design. We are recruiting patients, and the view is that the target is for the first half of next year to actually then select the dose, which would be the kind of the dose level for the phase III portion of that trial. Oh, thanks. Thanks for the color. Thank you. The final question comes from the line of Johan Unnérus from Redeye. Please go ahead. Your line is open. Thank you for taking our questions. I hope you can hear me. It's a follow-up. Of course, unique subscriber is a prerequisite and very important, but the ratio between enrolled patients and unique subscribers seems to be fairly steady. It's like north of 1 1/2 Should we expect that to pick up going forward? Andy, do you wanna take that? I think it's hard to answer that question in the sense that, as I said before, Like any market, there are people that see a lot more patients and treat a lot more patients than some others. There's value obviously in someone that even writes a few prescriptions, has a few patients. Obviously there's more value, you know, in a prescriber that has a larger patient load. Yes, I would expect it to grow, but at some point, you know, when the denominator keeps growing with ones at the beginning, it's hard to, you know, change that ratio. We have plenty of prescribers that write for several patients. Yes. You pointed out that the sort of 80/20 rule applies in this area as well. Do you recognize an element that some of the specialists sort of go ahead with the first patient and then wait for experience and clinical real-life experience before moving ahead? Absolutely. You see that, you know, everyone's different as far as their level of adoption, but we do see prescribers, certainly nephrologists, that will try it and wait for results. And, and this is not something that you see 24 hours later that the patient's, you know, substantially different. That, those kind of trials, those individual trials by prescribers sometimes take a few months. Absolutely see that. A few short ones. The COGS is slightly higher in the quarter. Should we expect it to come down a bit? Not that it's a major point, but it is an important point. Fredrik, do you wanna take that? Yeah, I can take that. I think in the quarter, Q1 of last year, we'd had a extremely low cost of goods sold and also in the remainder of 2022. I think we are at a normal level now. That's welcome clarification. What about the break even? You alluded to that earlier. I think earlier you mentioned perhaps mid-year 2023. Is that still feasible? I mean, I think what we kinda guided to a couple of quarters ago is actually obviously that our whole, we are clearly targeting to become profitable this year. We don't wanna stick that to a particular quarter or particular kind of time 'cause it is very dependent on this kind of acceleration and the curves, what the curve and from the revenue perspective actually looks like. I think that, you know, we will, you know, I think it would be highly unlikely that we will do that in Q2. I think it's definitely something that's a core focus for us and that we continue to drive towards. We certainly think that that's still possible as we sit here today. Do you expect to reach break even on run rate, during 2023? Yeah. Yeah. Okay. Thank you. There are no more questions from the telco at this time. I hand the word back to you, Renée. Well, thank you very much for listening to our Q1 2022 week report, and we'll look forward to catching up again when we report our Q2 numbers. Thank you.