Thank you very much, and welcome to everybody joining us on this call. Just like to draw your attention to page number two. Yesterday we issued a press release, announcing FDA's accelerated approval of TARPEYO, which was known as Nefecon during its development. Please note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. During this call, management may be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Calliditas's press release issued yesterday and the company's SEC filings. This conference call also contains time-sensitive information that's accurate only as of the date of this broadcast on December 16th, 2021. Calliditas undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. If you can please turn to the next page. With me on today's call is Calliditas's Chief Medical Officer, Dr. Richard Philipson, President of North America, Andrew Udell, and our Chief Financial Officer, Fredrik Johansson. If we can turn to the next page, please. Let me first give you a brief overview of Calliditas, which is now a commercial biopharma company with a strong pipeline. Our strategy is to continue building an orphan and nephrology-oriented company with a strong commercial presence in the U.S. TARPEYO is the, as you can see, our first commercial product. It's the first ever drug candidate to be granted an accelerated approval based on the surrogate marker of proteinuria. To our knowledge, the first ever accelerated approval granted by this particular division of the FDA. TARPEYO delayed release capsules was approved under an accelerated approval to reduce proteinuria in adults with IgA nephropathy at risk of rapid disease progression. Generally urine protein to creatinine ratio, UPCR, at 1.5 g/g. We believe that TARPEYO has the potential to become a new standard of care in the treatment of IgA nephropathy. Our goal is to present long-term data supporting disease modification upon completion of our Part B of the NefIgArd trial, which, as you're aware, is expected in early 2023. The company is public both in Europe and in the U.S. We have a strong cash position with a cash balance of about SEK 1.2 million as reported in our last quarterly report. With that, if we turn to the next page. As you know, yesterday we received the fantastic news that the U.S. FDA has approved TARPEYO under the accelerated approval pathway for the reduction of proteinuria in adult patients with primary IgA nephropathy. This approval represents a significant milestone for Calliditas, the IgAN community of patients, caregivers, families, all affected by this progressive kidney disease. Upfront, I'd really like to take a moment to express my personal thank you to the patients who have participated and still are participating in our global clinical trial. As well as the clinical investigators and their staff who worked alongside us and our CRO in advancing TARPEYO to this FDA approval. I would also like to thank and recognize the entire Calliditas team for their tireless efforts, persistence, and dedication to this pioneering development program over the last decade. Today truly is a special day for all of us. This pioneering journey did start quite some time ago, really by two Swedish physicians, Dr. Fellström and Dr. Hällgren It was started by an initial phase IIa study in 2008, which confirmed the approach, and then followed by the very first phase IIb study sponsored by a pharmaceutical company, a large study in 150 patients, which was published in The Lancet in 2017. In parallel, the company has worked on a pioneering effort to also try and pave the way on the regulatory side, which resulted and was supported by a publication of a meta-analysis of clinical interventions in IgA nephropathy in the American Journal of Kidney Diseases in 2016. This meta-analysis has become a component of the FDA's accelerated approval decision-making process. We are very proud of having been in the position to, in a small way, contribute to that. Last year, the company read out positive top-line data from our Part A of a global phase III study, which positioned us to really hopefully have the first ever approved treatment for IgA nephropathy. This is where today we sit with the final decision of having achieved an ability to bring this to patients. It's been a long, but it's been an amazing journey, and I want to thank everybody who's contributed to making this possible, including the FDA. If we turn to the next page. What did the disease landscape look like, which really was the driver behind this effort? As you know, IgA nephropathy is an orphan disease. There's a genetic predisposition that's required, but it's not sufficient. Mainly patients are typically diagnosed between 20s and 30s, and we do know that 50% up to 50% are at risk of developing end-stage renal disease within a 10- to 20-year period. Obviously at that stage, the only available result of that today is kidney transplant or dialysis. Despite IgAN having been known for quite a while, there is still limited published clinical data as well as information about prevalence and how patients are distributed across various disease states. We did conduct a prevalence study in Europe fairly early on that resulted in about 4 in 10,000. We estimate prevalence in the U.S. to be about 130- to 150,000. It is well known obviously that higher levels of proteinuria in this disease correlates with a more rapid progression presents a worse outcome for those IgA nephropathy patients. We believe obviously this is consistent with the FDA's approach with regards to an accelerated approval to really grant us this approval on the basis that TARPEYO really has shown to be able to address this population that has a high unmet medical need. We're extremely excited about really having the first-ever approved drug candidate in this particular disease. We're very excited about the opportunity to bring it to patients. We obviously also look forward to the data that we will be able to get from completing our study. I also just want to remind everybody about the fact that obviously we are still in a regulatory review with the EMA. We would expect on the basis of the ongoing discussions to have a target of having an opinion in Q1 of 2022 from EMA. With this kind of background information, I would like to hand over to Richard to take you through the pathophysiology in the phase III trial design. Thank you, Renee. I'm Richard Philipson. I'm the Chief Medical Officer of Calliditas and I'm gonna begin by describing the underlying pathophysiology of IgA nephropathy, which is illustrated on slide seven. According to the predominant theory, the origins of IgA nephropathy lie in the gastrointestinal tract and more specifically the distal ileum, where follicles of lymphoid tissue known as Peyer's patches are located in high density. This lymphoid tissue produces secretory IgA, which is the first line of defense against gastrointestinal infection. Secretory IgA has a particular property in that it is undergalactosylated in the hinge region of the antibody, which makes it potentially immunogenic. While normally restricted to the gastrointestinal mucosal lining, in IgA nephropathy, the secretory IgA is found in the systemic circulation. Because of its immunogenic properties, when in the systemic circulation, it triggers an autoimmune response, and autoantibodies of IgG and IgA are produced, which bind to the hinge regions of the secretory IgA to produce immune complexes. These immune complexes circulate and are deposited in the mesangium of the glomeruli, the filtration units of the kidney. As a consequence of this deposition, an inflammatory response occurs and the glomeruli become leaky. They leak blood and protein into the urine. Over time, the glomeruli are damaged and become sclerosed, leading to a loss of filtration capacity and an inexorable decline in kidney function until end-stage renal disease develops. Moving to slide 8. Biomarker data from the phase IIb NefIgArd clinical trial was used to obtain new learnings on the pathophysiology of IgA nephropathy. Specifically, dose-related decreases in galactose-deficient IgA1 immune complexes and B-cell activating factor or BAFF, a cytokine that plays an important role in the proliferation and differentiation of B cells, were observed in association with TARPEYO at the end of the treatment period in this study, demonstrating a clear effect on these important circulating pathogenic biomarkers which were associated with IgAN. Moving to slide nine. This provides an overview of the NefIgArd phase III clinical trial, also called NEPH-301, which had two parts. Part A, which is the basis for accelerated approval, and part B, which is the post-approval follow-up to confirm the long-term renal benefit of the observed improvement in proteinuria. A total of 200 patients were required for the Part A analysis, which read out in November 2020, and a total of 360 patients are required for the Part B analysis, which includes the 200 patients already enrolled for the Part A analysis. Part B was fully enrolled in January 2021 and will read out in early 2023. To describe the design in more detail, patients with IgA nephropathy on optimized, stable RAS blockade were enrolled and randomized to receive TARPEYO, also described as Nefecon, 16 mg once daily or placebo for nine months. The primary endpoint for Part A, reduction in proteinuria measured by change in UPCR, was assessed following nine months of treatment. Treatment was discontinued, and patients were observed for three months before entering Part B, comprising a further 12 months of observation without treatment. Primary endpoint for Part B is eGFR measured over the entire two-year period of Parts A and B. Moving to slide 10, the baseline characteristics of the trial reflected the intended target population with a mean age of 44 years, 67.8% were male, and 85.9% were White. Baseline mean blood pressure of 126/79 mm Hg reflected the careful management of blood pressure control prior to enrollment. Baseline mean UPCR of 1.6 g/g and mean eGFR of 58 mL/min reflected eligibility requirements for the study. Moving to slide 11, with respect to the primary efficacy outcome in Part A of the phase III study, at nine months, there was a 34% reduction in UPCR in patients receiving TARPEYO 16 mg versus a 5% reduction in patients receiving placebo. With respect to safety, the majority of adverse reactions were mild or moderate in severity, and the most frequently reported adverse reactions, and by this we mean, reported at a frequency of 5% or higher in TARPEYO-treated patients and with at least a 2% higher rate than placebo, were hypertension, peripheral edema, muscle spasms, acne, dermatitis, increase in weight, dyspnea, fatigue, and hirsutism. The frequency of these adverse reactions are presented in the following slide 12. Overall, the pattern and frequency of adverse reactions are in keeping with what we expect for budesonide, are broadly aligned with what was seen in the preceding phase IIb study, and we believe that these types of events are manageable in this patient setting. On the next slide, slides 13 and 14, we provide an overview of the indication and important safety information for TARPEYO. TARPEYO's full prescribing information is now available at tarpeyohcp.com. I'll now hand over to Andy Udell. Thanks, Richard. I'm Andy Udell, President of North America. I joined Calliditas a few years ago while we were still recruiting for our phase III clinical trial. Now I am truly excited to officially say the Calliditas U.S.A commercial team is ready to launch the first and only FDA-approved treatment that was specifically designed to address many of the treatment challenges for IgA nephropathy. We believe we have a wonderful product, an experienced and outstanding commercial team, and the right strategy in place to successfully launch TARPEYO early in the first quarter of 2022. Slide 16, please. As Renee stated earlier, IgA nephropathy has an estimated prevalence between 130,000 and 150,000 in the U.S. Over time, more than 50% of the patients progress to end-stage renal disease, which leads to dialysis and kidney transplantation, both of which are debilitating and extremely costly, with dialysis costing commercial payers in the range of $200,000 per year and kidney transplant over $440,000. Next slide, please. Research has consistently shown that this is an unsatisfied market that is craving advancement and a treatment specifically designed for IgA nephropathy. In a recent survey, 46% of the 188 nephrologists surveyed rated IgA nephropathy as extremely challenging to manage in non-dialysis patients. 52% of them believe there are currently few or no effective treatment options. They anticipated 65% of their patients will progress to dialysis, and 80% believe early intervention is critical to successful outcomes. Next slide eighteen, please. What kind of familiarity exists for our product? The top half of this slide looks at the most recent survey of 100 nephrologists conducted a few months ago by Spherix Global Insights. When we look at unaided awareness, we see our product has more than four times the awareness than any other agent in development. Of those with moderate or greater familiarity with our product, 92% rated the product highly positive in likelihood for success in IgA nephropathy. In addition, in the same survey, our product is the highest-rated product as the first most desired when compared to all products in development. Going back to the larger survey of 188 nephrologists, the nephrologists that rated themselves as familiar with our product also rated themselves extremely likely to prescribe a product with our clinical profile for 70% of their current IgA nephropathy patients. Slide 19, please. As stated earlier, we are ready to commercialize. The last three months have provided our team more time to fine-tune our launch preparations. We have an extremely experienced leadership team in place with the average tenure of almost 20 years. Our functional leaders have held management and leadership roles at both large pharmaceutical companies like Pfizer, Merck, Sanofi, Bayer, BMS, as well as several smaller biotech companies. In addition, we have partnered with some of the leading industry agents and vendors over the last few years to assist in securing an efficient yet optimal launch strategy. Sales territories were filled with contingent offers that became effective upon approval, FDA approval. Our trade, distribution, and patient support services are all operational. Our launch campaigns have been developed and tested both for in-person and remote interactions. Over the last several years, we've worked closely with an eager, enthusiastic, focused, and receptive nephrology and IgA nephropathy advocacy community. We are ready, and we're very excited. Next slide, please. Our medical affairs team has been at it for a few years now. Our MSL team has established relationships, we are well-published and active at relevant congresses, and we have worked closely with our advisory boards on how to best address and educate our audience. Next slide. Market access is vital, and we have done extensive work in this area over the last few years. It began with the establishment of the optimal trade and distribution path, which led to partner selection. After an extensive process, we have selected two of the industry best in ICS, from AmerisourceBergen and our exclusive specialty pharmacy, Biologics by McKesson company. Our national account managers have been in the field over the last few months, holding and arranging meetings with payers in order to educate them on IgA nephropathy, and this will be the first time a company has approached them to treat this rare disease. The wholesale acquisition cost of TARPEYO will be $14,160 for a 30-day supply. We have priced TARPEYO according to the value it offers patients and toward reducing IgAN disease burden on society. Value was assessed according to clinical, economical, and societal benefits, factoring both established and innovative treatments that are currently available. We believe health insurance will provide broad coverage of TARPEYO, and Calliditas is committed to help ensure all appropriate patients will have access. To that end, we've developed a robust patient support program that offers services, assistance, and resources for patients, all designed to minimize the time between when a prescription is written and when a patient begins to take the medication. Next slide, please. Our full-service patient and provider support program is called TARPEYO Touchpoints. As mentioned, it's designed to streamline access of TARPEYO for the appropriate patients. The program uses Biologics by McKesson's PharmacyElite model, which has the hub and exclusive specialty pharmacy services all under one roof. We have a dedicated team of care navigators, as well as designated rare pod team that contains nurses, pharmacists, and fulfillment and distribution team. In addition, our Calliditas director that's managing this group has launched, led, and managed several rare and specialty programs over her career. Next slide, please. Slide 23. Moving on to our field force. Our head of sales joined us early in the year and has brought on tenured sales management team. They have spent the last several months recruiting territory representatives based on rare disease, specialty product, and nephrology sales experience. This was extremely important to us as we anticipate both in-person and remote interactions with our target audience. We believe we have a sophisticated segmentation, targeting, and customer relationship management system in place to provide the tools necessary to hit the ground running. Our onboarding and training timelines are realistic, and we're confident we would begin face-to-face promotion early during the first quarter. Before I pass it over to Fredrik, I want to conclude by thanking our outstanding team at Calliditas. While some of us have been on this mission for a few years and some for only a few months, we are all dedicated and remain laser-focused on what is most important, which is preparing to bring TARPEYO to the deserving IgA nephropathy community. With that, I'll turn it over to Fredrik. Thank you, Andy. Let's turn to the financial slide. Next slide. I just want to start to remind you that at September 30 this year, we had a healthy cash position of 1,163.8 million SEK. As you may recall, in July this year, we signed a $55 million credit facility with Kreos Capital. The first tranche, $25 million, was drawn down in the third quarter this year. The second and third tranche together, $50 million remains of the facility to be used in 2022. Out of this 50, in today's well, yesterday's EMA approval, the second tranche of $25 million has been made available for us to draw down. The third and last tranche of $25 million can be drawn down until the end of next year, subject to certain revenue milestones and coverage metrics. In addition, please keep in mind we also have a source of potential income and milestones from our collaborations with Everest in Greater China region and with STADA in the E.U. Based on our current operational plan, we expect the current cash position and amount available under our loan facility. We believe we have sufficient funds for planned operations and capital expenditures until we become cash flow positive, which is currently projected for the first half of 2023, subject to TARPEYO being successful in commercializing in the US. Now back to you, Nina. Thank you very much. Just some brief closing remarks before we open this up to questions. As you've heard, obviously, we are delighted that the strength of our interim data package supported the FDA's decision to grant us an accelerated approval, enabling us to address the patient population with a clear unmet medical need. We believe that TARPEYO's differentiated approach in targeting the disease has the potential to have a significant impact on the progression of this orphan disease amongst patients at risk. We are immensely proud of being pioneers in this indication, and today successfully reaching the point where years of development and dedicated pursuit of a treatment finally can reach patients who today have no approved option to address this devastating disease. This is truly a fantastic day for patients in the entire IgA nephropathy community. Thank you very much for listening, and we will now take questions. Our first question comes from the line of Maury Raycroft at Jefferies. Please go ahead. Your line is open. Hi. Good morning, and much congrats on the update. Starting off, I was wondering if you can talk more about your pricing strategy. Do you have estimates for how net pricing could look? How should we be thinking about duration on treatment? Sure. Why don't you take the pricing related questions, et cetera, Andy? I think we feel strongly that we're gonna get broad uptake and coverage for our patients. I think we feel that we've done our work here, and that this is gonna offer the appropriate benefits of the product and the value based on this price is how that was determined. We think that uptake is gonna be strong. The other part of your question, I guess, was how you should think about a net price. I think we're very lean and operational here, and I think it's a typical product that you would assume for this category, how you do look at net pricing. Yeah. Got it. I can feel you on the end of that we expect sort of the gross to net to be in the ballpark of 15%-20%. 15%-20%. Got it. Very helpful. Also, the label seems generally broad. I'm wondering if you can talk about messaging strategy based on the label. It also comments generally 1.5 gram per gram on proteinuria. Will that wording impact prescribing and ultimately the opportunity? Sure. I think that Andy will take the details on this. I think that obviously, with regards to the label, as you said, I think that it's broad. It's generally really gonna be driven obviously by the physician's assessment of patients kind of at a risk of kind of more progressive disease. I think that this is obviously, as we've said, also kinda consistent with the FDA's approach in terms of accelerated approval. Andy, with regards to the messaging, et cetera, why don't you cover that? No, I think that our label, as you said, really points towards the patients at risk and provides a range, and for the prescriber to make that decision, as it's indicated there. The other thing you Maury, you had asked earlier about duration. You should think to look at duration. I think what's been pretty consistent for us is while the initial course, we certainly are recommending nine months. Physicians have told us in research that, how they're gonna use this product, which is, you know, it's gonna be based on a patient-by-patient basis, and they'll have to determine that after that nine months to see if the patient's getting increased benefits, as well as their tolerating the medication, things of that nature will determine whether they continue or whether they stop and then start again based on seeing these patients as frequently as they do. I think finally, just to add to that, obviously, you know, what we have always assumed is, you know, if we were to get an approval in this indication, that we would always expect physicians to obviously start with patients who are at risk, who are really kind of, you know, the most kind of, you know, those patients most at need. I think again, this is very consistent with what we would have expected, you know, irrespective, actually, of the kind of, you know, pointing to higher proteinuria patients. That is actually where we would have expected this to be used anyway, in its initial, you know, 12-24 months, simply because that is the most obvious, obviously, patient group into which to launch this drug. Got it. Truly helpful. Maybe one follow-up. Do you have an estimate on what proportion of patients would stay on treatment beyond nine months? No, I don't think that is something that we can have a view on at this point in time. I think it's a bit early. I think we'll have to wait and see a little bit in terms of kind of, you know, prescriber behavior on that before we can have a view on that. Got it. Okay. Congrats again, and thanks for taking my questions. Thank you. Thank you. Thank you. Our next question comes from the line of Annabel Samimy at Stifel. Please go ahead. Your line is open. Hi. Good morning. I just want to lend my congratulations myself. I guess following up on a couple of those same questions, if you can quantify for us, do you have a sense of the population who is most at risk of progressive disease? Or maybe if you can just get, you know, specific about it. Like, do you have a sense of the percentage of patients who have greater than 1.5 UPCR just so we can frame who might be most appropriate for this medicine? I guess I'll start and then, Andy, you can add to this. I mean, I think that, you know, first of all, obviously it's important to kind of, you know, clarify that obviously this is not a cut-off. This is generally in that kind of range. Obviously this is for patients with higher levels, and also obviously at risk of more rapid disease progression. I think that makes the, you know, the quantification of this as, you know, quite difficult because I think it will be physician assessment that is going to drive this or, you know, prescribing, you know, the prescription of this drug. I think the only thing that, you know, we can kind of point to, in this case is, as you know, unfortunately, there isn't massive amount of independent data, you know, exactly describing this patient population. Obviously, as you can see in the label, and as Richard has covered, you know, the mean, UPCR in our trial was 1.6. Again, coming back to the fact that this is obviously more of a, an indication in terms of generally 1.5, I think it really will come down to, you know, the assessment of physicians as to, patients who are at risk, of a more, you know, rapid progression. Okay, got it. Maybe you can talk about. I guess we're finally seeing the AE profile in detail now. As you've stated in the past, it does have similar side effect profile to other steroids. Maybe you can help us understand. It happens less frequent, apparently, with TARPEYO. Maybe you can help us understand the extent to which the AEs are tempered with TARPEYO versus other systemic steroids. Yeah. Again, obviously, this is, you know, as I'm sure you're aware, obviously, the systemic availability of budesonide is quite different from systemic steroids. Richard, why don't you? Yeah. I mean, I think you've seen the slide describing the more common adverse reactions. I think as we said before, there are no surprises here. This is absolutely in line with what we'd expect to see with budesonide, broadly in line with what we saw in phase IIb program, you know, typically characterized by generally mild or moderate in intensity, the majority, and in line with that kind of systemic cosmetic kinds of effects, of course, of systemic corticosteroids, and certainly quite different to high-dose systemic corticosteroids, where you see that pattern of serious infections, bone effects or GI effects, etc. Yeah. I think also to point it out, obviously, you know, these are, as Richard has said, it's mainly mild and moderate. Obviously, there are no kind of clinically relevant impact really on the metabolic or the cardio, you know, cardiovascular system, which again, is, you know, generally not the case with kind of, you know, systemically dosed steroids. The difficulty here is obviously also that, you know, we have very, very poor actual data on what the safety profile is of systemic steroids, as that never seems to actually be, you know, provided in any greater detail. I think it's clear that this is a very, you know, manageable side effect profile, particularly, you know, these are obviously patients, you know, who are progressing towards dialysis and transplantation. Again, I think, you know, very, very manageable from that perspective. If I could just ask one more follow-up question again, regarding pricing. At nine months, this is about a $127,000 drug, and I guess you're going to have a gross-to-net, which is great. I mean, you've talked about $55,000-$85,000 range before with possibility of being higher. I guess $55,000-$85,000 was what payers were receptive to. You know, how will those conversations proceed at this level, I guess? What makes you comfortable that that's the right pricing strategy? Thanks. Sure. We guided the 55,000-85,000 was, that was in 2019 and based on a phase IIb profile. What we've seen over the last couple of years is the value and the perception, and as the product became real, unaided the anticipation and the value that they saw due to this high price of dialysis and transplantation seemed to grow as far as the anticipated and expected price based on this value. That's, you know, we've done a lot of research. We feel, insurance will provide a broad coverage. The cost to patients, you know, will be dependent on insurances. But we wanna make sure we've developed this robust program to offer these services and assistance and we wanna make sure that all patients will certainly have access. Okay, great. Thank you. Thank you. Our next question comes from the line of Edwin Zhang of H.C. Wainwright. Please go ahead. Your line is open. Hi. Thanks for taking my questions. Congrats on the TARPEYO approval. A really remarkable journey and achievement. My first question also on the real-world utility based on the label. Will doctors prescribe TARPEYO to patients as long as their UPCR is over 1.5? We know TARPEYO is now the only approved drug, but we also know that RAS inhibitors are widely used off-label. In the clinical trial, I think the patients are also on stable and max dose of RAS inhibitor. Please help us understand the dynamic here. Sure. I'll take a stab at that, and then, Andy, maybe you can follow up. Again, I think that obviously the 1.5 grams was a pre-specified subgroup. And this obviously is, you know, an easy kind of group to indicate as kind of an example of these patients who have higher levels of proteinuria. And again, to be clear, I think that, you know, these are patients that physicians, we believe that physicians will prescribe this drug to patients who are at risk of having a more rapid disease progression. We know that that is correlated with higher levels of proteinuria. However, the label obviously does not provide for a specific cutoff, but generally an indication of the fact that, you know, these patients should have higher levels of proteinuria. Again, I think this is going to be a physician assessment that's going to be driving this. Andy, do you have anything to add? No, I think that's exactly right. The way the label reads and the assessment of these patients, it's gonna be on a patient-by-patient basis. I think that they're. It's just basically their definition of what is at risk, and they start looking at how that's defined, as they look at the UPCR, as being one of the measures. Okay. My next question, what do we expect to see in the next several months or quarters? What's your strategic focus to quickly penetrate and build up the market? Also, what are the feedbacks from your interactions in the commercial peers, especially for the formulary positioning? Thank you. Andy, do you wanna take that? We always anticipate when launching a product, obviously, the first patients and the initial uptake is gonna be with patients that are more severe, let's just say. We do believe that will be the initial uptake over the beginning. We plan to be in the field very early in the first quarter and that uptake will begin right after that. As far as our interactions with payers, you know, once again, the goal in our work is to have access for patients, right? And not have that to be a barrier. We feel that they will manage it appropriately based on the value that the product brings and for the right appropriate patients. We feel comfortable we're gonna get some good broad coverage. Once again, we're gonna make sure patients have access to the product. Here, obviously, the goal here is obviously to provide a drug and a medication that, you know, has the potential to delay, you know, onset of dialysis and/or transplantation. That obviously does hold a very significant value for the payer community. Thanks. Congrats again. Thank you. Thank you. Thank you. Our next question comes from the line of Nikhil, sorry, Yigal Nochomovitz of Citigroup. Please go ahead. Your line is open. Hi. Thank you. Thanks, Renée, and congrats on the approval. I have two questions. Can you just clarify the agreement with the FDA on Part B for the eGFR? I mean, do you just need to hit the primary endpoint of that Part B for it to get the full approval, or is there some, you know, minimum delta on eGFR that you also need to achieve? I was curious, why did the name of the drug change? What was the problem with Nefecon? Why couldn't it stay Nefecon? I wish it could have stayed Nefecon, first of all. That would have been great. I would have preferred that strongly. Actually this is obviously the regulators. It's an incredibly complex process to actually get a name approved, believe it or not. It has to have, you know, be unique in a lot of different aspects and not be able to be confused with a variety of things. Unfortunately, Nefecon didn't qualify as an acceptable name by the regulators. We're very happy with the name that we have, but obviously you're right, it would have been great if we could have continued to use Nefecon. With regards to the Part B, obviously, I mean, that is something that we have an agreement with the design and the outcome of that trial with the FDA since the beginning of starting this trial. You know, we're committed to kind of, you know, like continuing it and completing it as agreed. I mean, there's really been no kind of changes to that trial design. Okay. Thanks. Thank you. Our next question comes from the line of Rami Katkhuda of LifeSci Capital. Please go ahead. Your line is open. Morning, everyone. I wanted to pass along my congratulations to the entire team as well. Just a quick one from me, but can you provide more details into TARPEYO Touchpoints and specific tactics on how that'll be used to help patients access treatment more easily? Sure. TARPEYO Touchpoints is a full-service patient and provider program. It's a hub. It's physically gonna be located and integrated with our specialty pharmacy under one roof. We have dedicated teams for our product and our program. What's typical, what's standard in a program like this is when a patient gets a prescription from their physician and they get into the program, they register into the program. They will have a case manager and someone that will work with them to get them through the benefits verification process, kinda like white glove service, to make sure that they have everything, that they're prepared, and they will send medication, and they will keep common touchpoints with the patient in order to make sure the patient is tolerating the medication. If the patient has any questions about dosing, things of that nature, so they can walk through with the patient, through this entire process. Awesome. Thanks. Thank you. Our next question comes from the line of Ingrid Gafanhão of Kempen. Please go ahead. Your line is open. Hi. Good morning. Good afternoon, everyone. One more congratulations to the entire team. I have a couple of questions, if I may. I don't know if you have disclosed that, but who is actually going to be manufacturing TARPEYO for you, and where is that manufacturing going to be based, geographically? Yes. No, we have not disclosed it. But it is a U.S.-based very large manufacturer who we have been working with for many years who will be manufacturing the product for us. All right. I was just wondering, does this approval actually trigger any milestone payment from STADA or from Everest? Was there anything attached to this, to this U.S. approval specifically? Yes. We will have a milestone payment based on this approval. The amount of that will show up in our Q4 report. All right. If I may, one last question for Andrew. Can you comment a little bit, or just highlight to us how is the reimbursement landscape for IgA nephropathy patients? In general, what kind of insurances are these patients covered by in the U.S.? Sure. I'll start with the last part as far as this is generally a commercial population between 63%-75% have commercial insurance. As far as the landscape today, there's really no management that doesn't exist, right? There's nothing that's indicated for IgA nephropathy in this space, so there's really no management today. All right. Thanks, Andrew. Thank you. Thank you. We have time for one further question that comes from the line of Erik Hultgård of Carnegie. Please go ahead. Your line is open. Hi. Thank you so much. Congrats on the approval. I guess most of my questions have been answered already, but I have one question on the side effect profile and specifically the hypertension that was seen in the phase III study. I was wondering what was the definition of hypertension according to the phase III protocol? And how does this number 16% incidence, how does that compare with systemic steroids? And maybe second to that, maybe if you could comment a little bit on sort of the trends of hypertension in the patient. Was it transient or did you see a continued trend upwards in hypertension for these patients? Thank you. Thanks for the question. So I think as you maybe know from previous studies, the requirements for entry into the study were that patients required good levels of blood pressure control and were excluded if the blood pressure was greater than 140 over 90. Now there's actually no specific definition for hypertension when an investigator reports it as an adverse event. So you know, I think in a way, adverse events are a crude way of measuring blood pressure versus actually the objective measurements of blood pressure during the clinical trial. We certainly did very careful blood pressure monitoring during the trial. We have that kind of objective measurements, and that is the basis for our statements that we've made, that we do not see any adverse clinical effects relating to the cardiovascular and metabolic systems. I think broadly, as you said already, you know, I think the pattern of adverse events, including hypertension, what we'd expect to see for budesonide with low levels of systemic exposure, and it's a pattern that's quite different from what we see with higher dose systemically available corticosteroids such as prednisone. All right. Thank you so much. Thank you. We actually have time for one further question. That's from the line of Christie Udell at SVB. Please go ahead. Your line is open. Hi there. Thank you very much for taking my question. I guess, so since it's only one, I guess I need to focus on the label, because I'm just trying to square how the FDA was maybe thinking with what we know from the KDIGO guidelines and elsewhere, because if I'm not mistaken, the guidelines from KDIGO say that the threshold for high risk of progression is over 0.75 grams per day despite supportive care, which I guess would appear to be about half of what the generally 1.5 on the label is. It's also interesting to me because the guideline also suggests that. Excuse me one second. Greater than one day. Yep. Is there a question here? Yeah. As I said when I started, I was wondering if you could kind of try to give us some insight into how the FDA was thinking about this. Is this actually a broad label, as it's been said on this call, or is this trying to be keeping things narrow during at least the long-term follow-up study period? I think that this is a label obviously that gives a fair amount of. It hands really this over to the practicing physician, right? I think the practicing physicians are kind of in this position and used to really assessing their patients as to you know are these patients at risk of a more rapid disease progression. I think what you can see is obviously it's been very well established that you know patients with a low level of proteinuria do not necessarily progress particularly rapidly. It can take a long time for those patients to progress. While we also know that higher levels of proteinuria do you know do kind of correlate with a much more rapid disease progression. Therefore we see this as a higher level of unmet medical need. Again, I think this is an appropriate label for an accelerated approval. I think it's consistent with what the FDA wants to try and achieve with an accelerated approval. I think that it's a label that I would say really kind of again, it hands over the you know the judgment here really to highly qualified nephrologists who are used to treating these you know these type of patients. I think we are delighted with this label. I think that you know we would not refer to this as a narrow label. We would actually say that this is in line with what we would actually have expected physicians to those type of patients that they would have chosen to treat most likely in the beginning of the launch of the very first product approved into this indication. I think, you know, it is very consistent with, you know, the FDA's approach and purpose of the accelerated pathway. Thank you. Yeah, I think we are. Sorry, go ahead. Sorry. I was just gonna say we've come to the end of our time for questions, so I'll hand back to you for the closing comments. Great. No, I just really wanna thank you all. Thank you for participating in this webcast. We are delighted for patients. We're now going to start really turning our focus to commercializing this and getting this out into the market and into the hands of deserving patients with IgA nephropathy. Thank you very much for participating.