Thank you very much, and welcome everybody to the Q3 Report. With me on today's call, I have Fredrik Johansson, our Chief Financial Officer, Richard Philipson, Chief Medical Officer, and Mr. Andrew Udell, President of North America. If you go to page two, please, I'd like to draw your attention to the disclaimer page related to forward-looking statements and refer you to the company's reports and other filings, including those filings which contain risk factors and other relevant information. If we turn to page three, please. Some of the Q3 highlights. In this quarter, Calliditas has achieved another major milestone, as we received formal conditional approval of KINPEYGO in Europe. Subsequent to achieving this, we immediately started the transfer process of our market authorization to our commercial partner in Europe, STADA, in order to enable a swift commercial launch in Europe. During this quarter, we also received milestone payments amounting to EUR 12.5 million from STADA, as we have previously announced. The result from the Q3 commercial activity of TARPEYO resulted in $12.1 million of net sales for the quarter, which reflects the consistent build of our commercial launch plan. We're very encouraged by the strong level of interest engagement that we're seeing, especially since the publication of our Part A data, which Richard will cover later in the presentation, and Andy will take you through some more color with regards to our commercial activities also later in the presentation. Based on the visibility we have today on our pipeline of our expenses and revenues, we expect to have revenues in the range of $35 million to $40 million for this year. This is in line with our internal plans, and we expect strong continued growth based on recently published data, the importance of which really should not be underestimated, as well as additional data expected in the first half of next year. With regards to our activities, we've experienced a lag in site recruitment rates, which seem mainly to be due to continued backlog pertaining to COVID-19 and the reduction of staff levels at clinics and hospitals, which still really do not seem to be back at the level that they were prior to the pandemic. This has created an impact on our recruitment levels, and so we do expect the head and neck cancer data was pushed into first half of next year and the interim analysis also to be pushed in, to be conducted in the first half of 2024. If we turn the page, please. Looking at post-period events. Regarding events which took place post the period of Q3, I've already mentioned that there was a publication of clinical data in October, something which we've been very aware of, obviously, that physicians have been waiting eagerly for. Some of you might have had a chance to listen to Dr. Barratt or Dr. Lafayette discussing this recently. In early November of this year, it was the Kidney Week ASN, which is the largest kidney congress held annually. It's held in the U.S. It was well-attended, and we had a commercial TARPEYO-focused booth as well as a medical affairs booth there with a live presentation dedicated to pathophysiology, where the gut-kidney connection was presented by Dr. Appel, and Dr. Wadhwani presented novel approach of TARPEYO in light of the recently published data. There was also a biomarker presentation related, or a biomarker-related poster, from the NefIgArd study. It was a very positive experience, apart from obviously the very nice thing of seeing everybody in person again. I had the opportunity to interact with a large number of nephrologists who provided insights into their practice and treatment paradigms. Feedback on the Part A data was all extremely valuable input. With that, I suggest that I hand over to our CMO, Richard Philipson, who will take you through a brief overview of the data in question. Richard. Thank you, Renée. I'm now on page six. I'd like to start by saying how delighted we are that the results of Part A of the NefIgArd trial were published online by Kidney International on the nineteenth of October. I'd also like to extend my thanks and congratulations to all of the authors involved in producing this important publication that we believe will be a valuable resource for researchers and practicing physicians in IgA nephropathy. I will provide a summary of the key outcomes presented in the publication, but first will start with a description of the trial design. Next page. The NefIgArd study, which formed the basis for FDA's accelerated approval of TARPEYO, comprises two parts, Part A and Part B. Patients with biopsy-proven IgA nephropathy, proteinuria of greater than 1 gram per day, an eGFR of 35-90 mL/min, and with well-controlled blood pressure while on optimized RAS inhibition, were enrolled into Part A of the study and randomized to receive TARPEYO at a dose of 16 mg per day or placebo for a 9-month treatment period. The primary endpoint was assessed at the end of the 9-month treatment period. Treatment was discontinued, and patients were then observed for 3 months. Patients then entered Part B of the study, which is a 12-month period of observation without study treatment. A total of 200 patients were enrolled in Part A for the primary analysis of that part of the study, with the primary endpoint being changed from baseline in proteinuria. A key secondary endpoint was changed from baseline in eGFR. This part of the study read out with positive results in November 2020. The patient population for the Part A analysis had a median age of 44 years. Approximately 67% were male and approximately 86% were white. Blood pressure control on enrollment was excellent, and baseline UPCR and eGFR reflected the high-risk population enrolled into the study. I'll say a little bit more about Part B later in this presentation. Next slide. With respect to the key outcomes of Part A of NefIgArd, TARPEYO demonstrated a statistically significant and clinically meaningful reduction in proteinuria at 9 months with stabilization of eGFR. Specifically, there was a 34% reduction in UPCR for TARPEYO-treated patients versus a 5% reduction in placebo-treated patients. The difference was highly statistically significant. Patients receiving treatment with TARPEYO showed a minimal loss of eGFR, 0.17 mL/min over 9 months, compared to a loss of just over 4 mL/min in placebo-treated patients. The majority of adverse reactions were mild or moderate in severity. The most frequently reported adverse reactions were hypertension, peripheral edema, muscle spasms, acne, dermatitis, weight increased, dyspnea, face edema, dyspepsia, fatigue, and hirsutism. It's worth noting that there were no reports of severe infections requiring hospitalization. Next slide. When we look at the profile of proteinuria change over time, it's apparent that the effect of TARPEYO is gradual and cumulative, with the benefits of treatment on proteinuria emerging over the first few months of treatment. Proteinuria continued to improve through to 9 months when treatment was discontinued. Importantly, a further improvement in proteinuria was seen at the 12-month visit when patients had been off treatment for 3 months. At 12 months, there was a 52% reduction in proteinuria versus baseline, or 48% when corrected for placebo. We also noted that proteinuria reduction was consistent across all baseline subgroups, including baseline proteinuria and baseline eGFR. Next slide. Turning to the profile of eGFR change over time, we saw early separation of the eGFR curves with an initial modest increase in eGFR in patients treated with TARPEYO. The separation of the eGFR curves was maintained throughout the treatment period and again, importantly, was also maintained at the 12-month visit when patients had been off treatment for 3 months. Next slide. When we look at subgroups of patients with higher levels of baseline proteinuria who are at particularly high risk of disease progression, we found that there was a more pronounced treatment benefit on eGFR. Here we see presented the eGFR trajectories for a subgroup of patients with baseline UPCR greater than or equal to 1.5 g/g. It's worth noting the particularly rapid decline of eGFR in patients receiving placebo, with a loss from baseline of over 8 mL/min at 9 months. In comparison, TARPEYO-treated patients had essentially stable eGFR with a loss of less than 1 mL/min over the 9-month period. The eGFR trajectories of the two treatment groups clearly diverged, and the separation between the two groups was maintained at 12 months. Next slide. As already described, Part B of NefIgArd is a post-approval, observational, off-treatment follow-up to confirm the long-term renal benefit of the observed proteinuria reduction. The final analysis will be performed on approximately 360 patients, which includes the 200 patients that comprise the Part A analysis population. The primary endpoint will evaluate kidney function through eGFR change measured over the two-year period. Completion of enrollment of these 360 patients was achieved in January 2021, and we expect the final readout in the first half of 2023. Next slide. Finally, I will briefly mention the open label extension to the NefIgArd trial. This open label extension or OLE is open to all patients who complete the two-year NefIgArd trial, but it is optional. Eligibility requirements for entry into the open label extension are broadly similar to the pivotal trial. In particular, the proteinuria requirement is the same, but there's a slightly lower eGFR limit of 30 mL/min. By the end of quarter three, approximately 180 patients had opted to enter screening for the OLE, and the screen failure rate had been approximately 41%. The most common reason for screen failure is proteinuria level below the required minimum of 1 gram per 24 hours, which represents 61% of all screen failures. As the pivotal NefIgArd trial remains blinded, we can't draw any conclusion from this observation, apart from the fact that low levels of both proteinuria and eGFR are the main reasons for screen failure. We look forward to unblinding the NefIgArd study once it is completed, which will provide us with further insight into these observations. I'll now hand over to Andy for the commercial update. Thanks, Richard. Please go to slide 15. The third quarter was another quarter of solid growth as we continue to build on our success from the first half of the year. Quarterly net sales of more than $12 million brings us to more than $20 million of net sales in the first eight months of promotion. As announced after last quarter, we began expansion efforts in July. This growth included the addition of 20 sales territories, which gives us a total of 60 sales executives, expanding our reach and call frequency to our target audience. We are impressed with the caliber of talent we continue to attract, most of which coming to us with rare disease and nephrology experience. While the onboarding and training took place during the quarter, we anticipate to begin to feel the impact of the additional educators in the fourth quarter. September enrollments were strong after the anticipated slower July and August summer holiday period, with a quarter total of enrollments of 281. Prescriber receptivity remains positive as we grew our prescriber base to 480 unique prescribers since launch. This total includes addition of 166 new prescribers during the third quarter. In addition, we continue to see the average enrollments per prescriber grow. We anticipate this rate will continue to grow as many physicians now have patients on therapy for several months and are experiencing positive results, as was demonstrated on our clinical trials. As it relates to market access, we've reached our target of over 90% of U.S. lives having coverage for TARPEYO, which is impressive for a specialty company. The payer mix has reached a steady state without much change from last quarter. We have less than 25% of our business coming from government-insured patients and the remaining being either private commercial insurance or cash-paying customers. During the quarter, we added resources to our TARPEYO Touchpoints dedicated team in order to maintain the high service levels for increasing patient population. Our reach and promotional programs remain effective, with awareness of TARPEYO growing to over 80% of nephrologists in market research surveys. The final highlight of the third quarter was IgA Nephropathy Foundation's SPARK Patient Summit meeting. The interactions with the advocacy group leaders and patients continues to motivate and provide encouragement to our team and the potential this market represents. Next slide, please. These last several weeks post Q3 have been encouraging. The receptivity and reaction to the NefIgArd publication and information Richard reviewed with you has been nothing short of extremely positive from the nephrology community. This was demonstrated with inbound notifications upon publication, as well as in person during the annual meeting of the American Society of Nephrology that Renée had mentioned earlier. The in-person ASN meeting was a great opportunity for us to reach, educate, and interact with our target audience. The traffic at our booth and attending our sponsored educational events was impressive. The nephrology market is clearly eager to learn more and more about IgA nephropathy and how TARPEYO best fits for their patients. As our first patients are nearing the nine-month mark, we're hearing of more and more TARPEYO patient success stories. We anticipate these successes, coupled with further nephrologist and patient experience, will result in continued growth of TARPEYO over the next several months as we eagerly anticipate the results of Part B of the NefIgArd trial in the first half of 2023. I'll now turn it over to Fredrik to provide you the financial overview. Thank you, Andy. Let's continue to slide 17. Good afternoon and good morning, everyone. I will now present to you the financial overview for the first nine months of 2022, and all numbers presented to you are in SEK millions, as always, unless otherwise stated. To start with, we achieved SEK 373.8 million in net revenues for the nine-month period. For the same period last year, we reported revenues of SEK 198.2 million. This is the third quarter we report net product sales following the TARPEYO FDA accelerated approval in December last year, with the start of sales in January earlier this year. Out of the SEK 373.8 million net revenue, TARPEYO net product sales nine-month period amounted to SEK 205 million or $20.7 million, whereof SEK 123.4 million or $12.1 million came in the third quarter, an increase of 94% compared to the second quarter and was in line with our internal expectations. In addition, we recorded SEK 163.8 million for the nine-month period in revenues relating to out-licensing transactions, where we in the third quarter recorded SEK 135 million in revenue from STADA for the conditional approval and launch in EU. As you remember, we also received an upfront fee in the first quarter from Everest of 28.8 million, which was equivalent to $3 million for the extension of the Everest license contract to South Korea. Our total operating expenses for the nine-month period amounted to SEK 821 million compared to SEK 505 million for the same period last year. In the third quarter, our total operating expenses was SEK 292.2 million. Compared to the second quarter this year, our OpEx have increased by around SEK 20 million quarter-over-quarter, which is mainly attributable to the current FX headwind we still see due to the weaker SEK against both the US dollar and euro. Out of the total operating expenses for the nine months, marketing and selling expenses increased by SEK 214.3 million to SEK 323.3 million compared to SEK 109 million for the same period last year. Increase in marketing and selling expenses originates from us having a full commercial team in place from the start of Q1 this year. The cost for research and development increased by SEK 55.3 million to SEK 312.5 million, compared to SEK 257.2 million for the same period previous year. Increase in R&D expenses originates primarily from the ongoing operations for the SET and EXCEED trials. Our operating loss amounted to SEK 454.4 million for the nine-month period, compared to an operating loss of SEK 302.3 million for the same period last year. For the third quarter alone, we had an operating loss of SEK 36.2 million, compared to an operating loss of two hundred and nine point eight million for the second quarter. The cash flow used in operating activities for the nine months amounted to SEK 541.4 million, compared to SEK 300.3 million for the same period previous year. For the third quarter, the cash flow used in operating activities amounted to SEK 124.7 million, compared to SEK 225.2 million for the second quarter. This is an improvement of almost SEK 100 million between the quarters, and it was mainly driven by an increased net sales of TARPEYO. As of September 13, we report a strong cash position of SEK 736.2 million, down from SEK 846.8 million from the second quarter. In addition to our cash at the end of September, there is $25 million unused in this Kreos credit facility, and we expect approximately SEK 160 million in cash payments from milestones from STADA and Everest in the fourth quarter, where the STADA milestones were recognized as revenue in the third quarter. The progress of the commercial launch of TARPEYO in the third quarter continued to support our view that based on our current operational plan and our current cash position, we believe that we have sufficient funds for our planned operations and capital expenditures until we become cash flow positive on a monthly basis, which is currently projected for the first half of 2023, subject to continued successful commercialization of TARPEYO. Next slide, please. Just let me give a quick summary of the financial key takeaways, on the revenue side, it was very encouraging that we saw TARPEYO net sales of SEK 123.4 million to $12.1 million. The growth of 94% from Q2 was very encouraging. It's also encouraging that we managed to see the milestones of SEK 135 million from STADA recognized in Q3. The 20 million increase in operating expense between the Q2 to Q3 was mainly FX driven due to the weak SEK. Cash used in operating expenses significantly improved from Q2 - Q3, mainly driven by an increased net sales of TARPEYO. We think that we are well-founded with a cash position of SEK 736.2 million. Please be aware that approximately 110 million of the STADA milestones that was recognized in revenue in Q3 are due for payment in Q4, and hence was not included in that September cash position. I think this was all for me. Thank you. Now back to you, Renée. Thank you, Fredrik. If you turn the page to page 19, these are just some key takeaways, which we've already now have gone through. Basically, we are very pleased with our results and progress during Q3 in this very first year, after achieving approval of TARPEYO. The fact that we've achieved over SEK 35 million revenues to date with product sales representing over $20 million, makes us very encouraged about the future. We continue to penetrate the nephrology prescriber base, and as Andy mentioned, we are starting to now hear very positive patient experiences from the field. I'm confident that we have the right team in place, ensuring that we will continue to execute on our plan. as Fredrik mentioned, in Q3, we do see lower net cash burn compared to Q2, also when just taking product sales into account, which we expect to continue in Q4 and onwards, making us set for a very stable, financial position. With that, we're happy to take any questions that there might be. Operator? Thank you. If you wish to ask a question, please press zero one on the telephone keypad. If you wish to withdraw your question, you may do so by pressing zero two to console. Our first question comes from Jon Berggren from Kepler Cheuvreux. Please go ahead. Your line is now open. Hello. Thanks for taking my question. I was wondering, I mean, in the report, you mentioned 730 patients enrolled from January to the end of Q3. I'm wondering how many of these 730 patients were actually on treatment at the end of Q3. Thank you. I think that at this point in time, we're not really separating this out. The reason for doing that is that it's a multifactorial process from actually going from enrollment down to receiving revenues. This is mainly due to the fairly complex healthcare system in the U.S., which really requires a you know fairly extensive process for all specialty products to really go through verification, et cetera, in order for shipping to take place. Obviously, we provided some of those metrics as Andy's gone through. It does become not very helpful at this early stage to provide this. Once we're actually in a more stable state, I think this is a number that we'll be happy to report on. Thank you. Just another question on R&D costs. I was wondering if you could provide a split on how much you're spending on Nefecon relative to your setanaxib programs. Thank you. S ure. We are not separating this in our report, but since we are sort of on the last mile of the Nefecon studies, we of course spending less R&D costs on the Nefecon program and with two setanaxib programs ongoing and fully running, the majority of the R&D costs are going towards the setanaxib. Thank you. Thank you. The next question comes from Yigal Nochomovitz from Citigroup. Please go ahead. Your line is now open. Hi, team. This is Ashiq Mubarack on for Yigal Nochomovitz. Thanks for taking my questions. I just wanted to ask about the timing of your NRDL listing in China by Everest, and if that's even part of the commercial strategy. If so, maybe what would you expect in terms of pricing discounts in China? Maybe what has Everest publicly said about the launch in China, if anything? Thanks. Sure. Obviously, as they're as Everest has become closer and closer to filing in China, they've obviously spent some more time also doing more market research, et cetera. This is also why they've shared with us in terms of their estimate now biopsy-proven patients in China, that number is somewhere estimated to be around 5 million, which is obviously, significantly higher than what we had been aware of previously. In terms of the actual pricing, et cetera, we don't have any access to that at this point in time. Actually, I can't share anything with regards to that with you at this time. My assumption is that Everest is still working on those on that. In terms of the filing, obviously they, the target has always been for them to file and get an acceptance, you know, first half. Obviously now it's in his Q4 period is what we would expect. Obviously, if the filing is accepted, then the indications that we've received from Everest is because they have breakthrough designation that they would expect a review period of no more than 12 months. That would put a potential approval towards the second half of next year. I think this is it is very exciting. I think, as we mentioned before, obviously this is a strong contributing factor, quite common for younger people in China to actually have IgA nephropathy as a reason for their dialysis. I think that it would be super exciting to actually have a drug available there as well to address this you know fairly large patient population. I think we're going to have to you know we'll share with you once we hear from I think from our partner in terms of what their plans are with regards to you know other metrics of their commercialization. Totally understandable. Maybe one more on the launch in Europe. I know you're not being this specific necessarily on timing. G enerally, can you give us any color on how far away the actual launch is? Is maybe year-end a reasonable assumption or is that more of a 2023 thing? No, they have actually. STADA has launched. They've launched the product. They've launched it in Germany. It is now available in Germany. It is one of the few countries in Europe where you're actually able to launch immediately, more or less immediately after approval. The other countries in Europe require a negotiation with regards to pricing and market access, et cetera. We would expect STADA to roll out the product in other European geographies or in other European countries as those negotiations progress. The product has been launched. It was launched in late September, early October, if I'm not mistaken, in Germany. Got it. I assume we'll see some revenues flowing in this quarter from that. Maybe last question for me, just in terms of the US launch. I guess in order to hit the midpoint of your sort of guided range, it seems like you might see a little bit of deceleration in the fourth quarter, in terms of US sales. I'm wondering what's behind your fourth quarter assumptions. Was there a component in of inventory stocking that may drive a little bit of a slowdown in the fourth quarter? Thanks. No, there's no inventory stocking component. I'm not sure that we are expecting any deceleration in Q4. I think it's more a metric in terms of the time it takes just to from enrollment to revenue generation. Andy, maybe you want to take this. No, I would agree with your assessment that it's not at all a deceleration. I think we're looking to continue the growth and that target would mean a very healthy fourth quarter. G reat. Thanks for all the color. Thank you. The next question comes from Dan Akschuti from Pareto Securities. Please go ahead. Your line is now open. Hi, everyone, and thank you for taking my question, and congrats on the great numbers. One question on the unique prescribers. How many in percentage are there less in the US? Is it that you're around that 20% of the available prescribers currently, or? I'm sorry, can you repeat that? Sorry. The unique prescribers that you have reached thus far, how much in relative, like, how much in percentage does that represent of the prescribers available in the US? Oh, I see. Sorry. Andy, do you wanna take that? I mean, in terms of our target of 3,500 or 37. I t's not even 10% or it's a little bit more than 10% of probably what we would anticipate at peak of prescribers. This is, you know, not every prescriber is equal, in other words, as far as their prescribing, their patient load, etc. We're very pleased with the amount of prescribers that have already initiated patients on TARPEYO. Thank you. The follow-up on that, could you give us some color on the incentive model for the sales force and when we can expect that the 20 additional FTEs are fully trained? Is that already now in end of Q3? Yes. What are the lessons learned maybe? Let's learn from the first quarters, and do you have any plans that you could share and that could increase the efficiency of your sales force? Good questions. The answer is they were all trained in the field. They're in the field. They're fully compliant and trained, and that took place during Q3. The timing, I think, we think we're gonna. Well, some you feel impact quicker than others. A lot of that is due to relationships and when they've been in the space prior. The fortunate part for us is that the vast majority of the 20 new sales executives come with experience in this market. We're very pleased with that. As far as lessons learned, this is a process that takes continued education and repeat calls. Some are quicker uptake than others and they like to see the data and we're pleased with the fact that now we have a publication that provides this data. If they wanna see the peer-reviewed journal indicating exactly the results or further than what we can promote, quote-unquote, for the reps, that's also beneficial. I think there's a lot of positive momentum coming out of Q3 that we've seen at the very beginning of Q4, and I think the impact of the increased reach and frequency coupled with the data will be exciting. Plus, I think the last piece of it really is the successes we're starting to hear. I think there are prescribers that you can understand, they put a patient or two on the product. They wanna wait a few months to see the success, and once you build on that, and if you see a success with some patients, you're gonna wanna expand your usage. We're starting to get to that point now. Thank you. The last follow-up, considering that there are still a lot of prescribers out there left, do you see possibility that you would increase the sales force next year additionally? Do I see that possibility? Yes. You know, we don't close off the possibility to anything. It's not the plan. It really isn't the plan right now, but there's a way that you assess that and you look and you see, are we reaching enough people with the right frequency? We're constantly looking at this information, and it is not in the plans today to expand further. Thank you very much. Thank you. The next question come from Jacob Mekhael from Kempen. Please go ahead. Your line is now open. Hi there, and thanks for taking my question. I'm just curious if there are any factors that can predict why the approval process may take longer for some patients compared to others. Maybe if you can provide any color on the challenges that patients experience in the process to get approval. Sure. Andy, do you wanna start? I'll follow up. Sure. You know, as you know, in the States, there's thousands of different plans, and they have different policies that they go through. That's one factor right there that can make the approval process take different amounts of time for different patients. But every time there's an approval for every specialty product, you have to remember there's several players involved. You have the physician, you have the patient, and you have the payer. Okay? Some payers require different levels of evidence or information, so that can take time. Sometimes it requires the physician to provide this information. That could take time, and some of the offices are more equipped than others to handle providing this level of evidence. There's also parts of that which contacting the patient, you wanna coordinate the shipment date and exactly when they're gonna receive it to make sure that they're there to receive their medication. There's a lot of different factors that can add up and cause differences. We've been very pleased to date with those that are receiving their medication, that it's under 30 days. I think if you look at industry standards, I feel pretty good at where it currently sits, but as I've indicated in prior quarters, we're not gonna be satisfied with that, and we're always looking for ways to make it more efficient, quicker, so that when the prescription is and the patient is enrolled, that we can get them the medication as quickly as possible. I would say that one of the things that we have heard as well as experienced, you know, from nephrologists is obviously that they, you know, they are not necessarily, you know. They don't have huge amounts of specialty products that have been approved over the last 10 years. For some of these offices and for some nephrologists, you know, having to deal with administration related to any specialty product, you know, is something, you know, different and relatively new. This is something where, again, we have, you know, made sure that we make sure that we have enough resources in the TARPEYO Touchpoints and in the hub to really try and make this as easy as possible for them. I do think that this is a little bit of a novelty, and obviously this is something that they're going to have to deal with with any product that comes to market here. That is something where we have specifically, you know, in terms of lessons learned and some of the things, that we've listened to, taken on board and actually again, we're trying to be as helpful as possible in this process 'cause it's unfortunately just a structural issue with regards to US healthcare. Thank you very much. All clear. Thank you. The next question comes from Rami Katkhuda from LifeSci Capital. Please go ahead. Your line is now open. Hey, guys. This is Oliver from LifeSci on for Rami. Congrats on the updates, and thank you for taking my questions. I just have two questions today. First, while the launch is still early, have you identified any trends in the patients receiving TARPEYO? Second, is the expanded sales force fully deployed and what proportion of nephrologists treating IgAN are being reached? Andy, do you want to take those? Sure. As far as the specific patients, it's too early to give you trends. You have to remember that there's one product that's actually indicated now and so this is where their usage has been pretty broad, meaning patients are coming to us both first diagnosed as well as those that have been diagnosed, you know, several years earlier. We have some that are more severe than others, and some that have less. I can't really give you too much color, unfortunately, on the trends in the patients. I know we are seeing more patients per prescriber and that kind of stuff will typically increase over time as comfort levels. S ome people wanna start with their most severe patients, and then they'll move to more, to less severe probably as they get more and more comfortable. As far as the expansion, the sales force and reach, I think was the question, you know, that is typically. There's a lot of factors that go into that, obviously, geography, etcetera. We typically have formulas that we use when you're looking at a specialty sales force as far as their number of calls they can make in a day and the number of different unique prescribers and how much you want their frequency. You want a higher frequency from some prescribers versus others. There's no exact number that I'm really gonna discuss now, but we feel that the expanded 20 provides us really, really strong reach, and the appropriate frequency that we're gonna need. Got it. Thank you very much. Thank you. The next question comes from Annabel Samimy from Stifel. Please go ahead. Your line is now open. Hi. Thanks for taking my question. I just wanted to ask about the data that you presented at ASN as well as the publications. You mentioned that there was very enthusiastic feedback from the physicians. I guess can you if you could get a little bit more granular in terms of how they responded to that, does that do they express any motivation to keep patients on treatment longer, keep it intermittent based on what their observations are, and have any of the drugs that they have used to date shown this continued benefit post-removal of treatment, that they would start to think about how to use this drug differently? I guess as a carry on to that, does this give you any further, you know, what does this potentially mean for Part B? Does it give you further comfort that the Part B is gonna read out positively or I guess what kind of extrapolations can you make? Thank you. Why don't I start and I'll hand over to Richard. I think that obviously what we heard at ASN and in other interactions, the key here is obviously that in all CKD, not just in IgA nephropathy, but the experience from the treating physician as well as this comes through in a lot of the larger analytical papers that have been published, et cetera, a significant and durable proteinuria reduction is something that physicians really assume will lead to a benefit for their patient. That's really how they've been treating this patient population for a long time. This differentiated profile, and to answer your question at least we have not met anyone so far. I have not met anyone anyway so far, that can show that any other drug that shows this particular profile in terms of that you get this significant continued benefit when you actually withdraw the drug. I think the benefits are obviously, an early benefit in terms of eGFR is obviously very good. Most drugs actually have a negative impact on eGFR to start with. That was kind of a positive. The fact that the continued kind of proteinuria reduction, I think is seen as, you know, very intriguing and very interesting by physicians. The fact that it's that's significant and durable, and obviously this is what we ultimately have to wait for Part B to see how long of this durability we have. I think those are really the things that they find is extremely interesting. I think the last part is obviously the eGFR stabilization really from an immediate perspective in these patients at risk of rapid progression is obviously also something that they find very important because these patients obviously at the end of the day it is all about trying to preserve kidney function in all of these patients. Proteinuria is obviously, they look at that as a forerunner to that effect, obviously. Before we go into Part B, maybe I'll hand over to Richard to reflect on what interactions you may have had with physicians. Thanks, Renée. Well, I think it's very similar. I mean, I echo your comments. I think the profile of effects that we see are intriguing and differentiated, and in particular, the cumulative improvement in proteinuria that we see during the treatment period. As Renée has already said, I mean, I think a particularly important observation is the continued improvement in proteinuria after patients have discontinued treatment. That's also reflected in data that I showed, which also confirms the maintenance of separation of the eGFR curves after discontinuation of treatment. I think there's a great deal of positive reflections on that from the physician community. I think that, certainly, obviously, we're not gonna provide a prediction of exactly what will happen in Part B, but I mean, it certainly makes us comfortable that the study is well-designed, that we're seeing the appropriate, and relevant treatment effects in terms of improvements in proteinuria. We've already seen that translate through to stabilization of eGFR, and we're, you know, we're very encouraged at what that means in terms of the final analysis of Part B. I would just add the final piece there is obviously just in terms of the only thing that we can do is really then look at what the screening criteria, what we're seeing in the open-label extension. What we've shown is obviously that there is a significant portion of patients, obviously, you know, who had proteinuria below one gram, where obviously the entire population did have proteinuria above one gram at the start of the study. You know, it is speculation, obviously, because it's still blinded, but I still think that it's a very interesting observation. That is obviously what we're seeing in a fairly significant number of the patients. Great. That's very helpful. Thank you. Thank you. The next question comes from Maury Raycroft from Jefferies. Please go ahead. Your line is now open. Hi. Congrats on the quarter and progress, and thanks for taking my questions. You mentioned 180 patients went into screening for the open-label extension, and there was a 41% failure rate there. Can you clarify if all of those patients did not qualify because of the low UPCR less than one gram? Or what are the other reasons for screen failure? Can you remind, what are some of the measures you're collecting and objectives for the open-label extension study? Sure. I'll let Richard take the second part of that study, I mean, that question. In terms of the screen failure, basically what we've said is that out of the 180 patients who are screened, 106 are enrolled, and the remainder screen failed. For those patients, the biggest reason for screen failure really over 60% was the fact that they did not qualify in proteinuria. They had proteinuria of less than 1 gram. The second most significant reason was that they had too low of an eGFR. Their eGFR was below the 30 milliliters per minute. There is a range of other, you know, kind of reasons. Those were the two kind of, you know, most significant reasons for screen failure. Richard, do you wanna take the second part? In terms of your other points then, for this study, you know, the data collected will be similar to the data that we collected in the pivotal study. We'll be evaluating the effects of treatment on UPCR and eGFR over the nine-month treatment period, as well as other outcomes. Obviously, safety and tolerability will be collected, so safety data will be collected. Got it. That's helpful and makes sense. I had another question too, just for the phase III Part B off treatment data. Is there a bar for what proportion of patients you get into a complete remission or for a certain amount of durability that you need in order to make claims around that and add that to your label? Or if you can just talk about what additional changes to a label you could make based off of the Part B data. I guess that the most obvious, I guess, obviously, in terms of Part B really would be the impact on eGFR, right? Obviously, in terms of what we have to date really is kind of just the impact on proteinuria, which as we all know, is a surrogate. I think this is really considered, you know, more of a hard endpoint than proteinuria reduction generally by the regulators. I think that, you know, that data is, you know, obviously gonna be critical in terms of disease modification, for example, right? W hat are you going to be able to say exactly around disease modification is difficult to have a view on here. I think that's obviously a one avenue. I think that another avenue is, as you say, in terms of if we can show, you know, have some views at least on the durability of response and the the consequences of that on eGFR is obviously also going to be something I think that everyone's going to be very interested in. I think that, you know, how long will this effect last? Because obviously this is more unique focus on the treating the origin of the disease, and so I think there's a lot of interest around that. I do think that physicians in general are very positively inclined towards, you know, increasing that proteinuria reduction over time, which is what we've seen, and obviously also then the durability of it. I think in terms of what we can see in the label, as always, I think that's gonna be, you know, ultimately a negotiation with the regulators, which is always very difficult to have a view on at this point in time. I think those are the type of areas that we will obviously be discussing with them. Got it. That makes sense. That's helpful. Thank you for taking my questions. Thank you. The next question comes from Johan Unnérus from Redeye. Please go ahead. Your line's now open. Thank you for taking my questions, partly follow-ups. In the patients that were in the extension OLE group from 74 did not follow up, and earlier you clarified that 61% or, well, 45%-ish did not continue due to the proteinuria levels. The other 29%-ish, can you say anything to what extent the group that had too low eGFR represents in this group? Well, again, as I said, because it's blinded, this is speculation because we won't be able to unblind this trial until the completion of the phase III program as a whole. One could obviously speculate and assume that, you know, there are some patients who would have been in this trial for 2 years, who would have entered into the trial, with a fairly low eGFR, and may therefore over the 2-year period be in a situation where their eGFR is below 30. If it was below 30, they would not be included in the open label extension. As we've seen, there obviously are patients at risk of rapid progression who've had, quite a significant decline in their eGFR. That I think. Again, that would be speculation. We don't at this stage say we can't say if it's five or ten or whatever. It's the second largest group. Yes. Also, you have of course now a fair amount of patients that have been treated more than 25 months. Is there any indication of a second dose for any of these patients or is this also sort of blinded? I'm not sure what that means. All patients obviously have been treated for nine months and are then observed after that period of time. Obviously, are you referring to. Obviously for those patients who go into. Yes, I'm thinking about the group that has completed the 24 months and there must be a fair amount of patients that have done that now. Yes, exactly. Exactly. That's what we refer to as the patients who have exited that study out of those who have finished the trial of two years. That's where we're saying 180 have screened for the open label extension, and 106 as of the end of Q3 were enrolled into that study and are therefore receiving an additional or their first kind of treatment of nine months. Obviously that's not enough. We do not know whether this is patients who are retreated or whether these are patients who were in the placebo group and therefore are getting their first treatment. That is something that we don't know since the trial is blinded, but 106 of them are, as of now, enrolled in that open label extension. Of course, the patients themselves wouldn't know, of course, if they had a second dose or the first. Yes. No, I think that was all for me, and congratulations on good results. I think as earlier answers were alluded to, it's a bit early on the dynamics between unique prescribers and number of patients, and it was also very useful to get a feel for the dynamics between prescribers and sales and the time that takes at this stage, anyway. Thank you. Well, thank you very much. With that, thank you very much to everybody who's participated, and we'll look forward to sharing our Q4 report with you in February. Thank you very much.
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