Thank you very much, and welcome to the Q2 report for 2022. If you would go please to page 2, which is the disclaimer page. I just would like to draw your attention to this page related to forward-looking statements, and refer you to the company's reports and other filings, including this which contains risk factors and other relevant information. If you turn the page. A couple of highlights for Q2. In Q2, Calliditas has achieved another major milestone, as we received a positive opinion from EMA, related to the conditional approval of Kinpeygo in Europe. The European Commission subsequently formally approved the product and issued our market authorization in July, which we're now in process of transferring to STADA, in order to enable the launch of Kinpeygo in Europe. Related to the approval and launch in Europe, we expect to receive milestone payments amounting to EUR 12.5 million from STADA, in the second half of this year. The results from the first full quarter of commercial activity, of TARPEYO resulted in $6.6 million of net sales, which we believe reflects the continued build in our commercial launch plan. We're very encouraged by the strong level of interest and engagement that we are seeing. You'll get some additional color from Andy later on in this presentation. In this quarter, we also reported dosing and randomization of the first patients in our proof of concept study in head and neck cancer, where we are studying the efficacy and safety of our lead candidate from our NOX inhibitor platform, setanaxib, in conjunction with pembrolizumab. If you turn to the next page. In terms of post-period events, we have amended the existing agreement that we have with Kreos, leading to significantly more flexibility around the drawdown of the final tranche under the credit agreement. We are happy to have a very collaborative and productive relationship with Kreos as we have with all of our partners, as we continue to execute and deliver on our plans. Finally, based on what we have been experiencing and seeing in the marketplace in the U.S., we're excited to announce that we plan to expand our sales team to 60, which we expect to be fully deployed at the start of Q4. As you may remember, to those of you who have been following these calls, we have always said and made it clear that we will assess as we get more information in order to ensure that if we do feel that we need to expand the sales force, that we would do so. We are really excited and find that this is very encouraging from our perspective, and we look forward to provide you with additional color as we continue to build our US franchise. With that quick introduction, I'm going to hand over to Andrew Udell, President, North America, to take you through some more details regarding our US commercial activities this quarter. Thanks, Renée. Moving on to slide five. I'm excited to discuss our ongoing launch progress and growth with TARPEYO in the United States. The receptivity from nephrologist, patient, and caregiver community remains extremely welcoming. It's abundantly clear that IgA nephropathy represents a disease with an unmet need, and those connected to the IgA nephropathy community seem enthusiastic about TARPEYO, a treatment that was designed specifically for this disease. During the second quarter, the unaided and aided awareness of TARPEYO continued to rise to 70% and 80% respectively. From launch through the second quarter, we have had 450 enrollments. Q2 enrollments more than doubled those from Q1. Our prescriber base also continued to grow to 314 total prescribers of TARPEYO since our launch. In addition, about 25% of these prescribers have written and enrolled multiple patients. As a result of our efforts, we ended Q2 with $6.6 million in net sales. This number more than triple Q1 and gives us approximately $8.5 million in net sales for the first half of the year, with many recent activities still expected to generate additional interest. Next slide, please. As anticipated, we have further improved our market access. According to publicly available resources, well over 80% of US lives are covered for TARPEYO. When we look at our TARPEYO-treated patients, we see that almost three-quarters are commercially insured. This slightly exceeds our pre-launch expectations. At the end of Q2, we had a greater than 80% reimbursement approval rate, and about a quarter of our enrollments were going through the reimbursement process. As expected, with this success, we need to add resources to our patient support program, TARPEYO Touchpoints, in order to address the increased volume and reduce the number of pending patients due to the reimbursement process. Next slide, please. Following the required FDA review of promotional materials for accelerated approval of approved medications, during the second quarter, we launched our branded campaign. In addition, during the quarter, we launched our unbranded IgA nephropathy patient portal called IgAN Connect. Both the branded and the ongoing unbranded campaign are directed to the appropriate audiences and delivered through several different mediums, including digital, print, face-to-face promotion. Our specialty sales team has continued to build on the results achieved in Q1. In light of the broad demand, we have initiated expansion of our sales force with the aim of further bolstering our reach and frequency of contact, empowering our sales team to support the demand from the physician audience and increase the individual frequency of meetings and face-to-face interactions. Upon completion, as Renée said, we'll have 20 additional territories for a total of 60 territories. In summary, while still only five months since initiating our promotional launch, we remain enthusiastic about our progress and the receptivity the market has for TARPEYO. With that, I'd like to turn over to Fredrik to provide the financial review on the next slide. Thank you, Andy. I will now present to you the financial overview for the first six months of 2022, and all numbers are presented in SEK, as always. To start with, we present 113.8 million in net revenues for the period. For the same period last year, we did not report any revenues. This is the first full quarter we report net product sales following the TARPEYO FDA approval in December last year, with the start of sales end of January this year. Out of the 113.8 million in net revenue, net product sales from TARPEYO for the period amounted to SEK 81.6 million or $8.5 million, which we are very pleased to announce. As you remember, we also received an upfront fee in the first quarter from Everest Medicines of SEK 28.8 million, which was equivalent to $3 million for the extension of the Everest Medicines license contract to South Korea. Our total operating expenses in the second quarter was roughly in line with the first quarter, and with that, our expenses for the six months period amounted to SEK 529.0 million compared to SEK 310.2 million for the same period last year. Out of the total operating expenses, marketing and selling expenses increased by SEK 129.4 million to SEK 207.2 million, compared to SEK 77.8 million for the same period last year. The increase in marketing and selling expenses originates from us having a full commercial team in place from the start of Q1 this year, including our sales force, compared to the same period last year when we were just starting to build up the commercial organization. The cost for research and development increased by SEK 44.5 million to SEK 209.6 million compared to SEK 165.1 million for the same period last year. Increase in R&D expenses originates primarily from the preparations and ongoing operations for the setanaxib trials, where we randomized the first patient in the head and neck trial in the second quarter, and we now have the two setanaxib trials fully up and running. The administration expenses amounted to SEK 107.4 million for the period, to be compared with SEK 65.4 million for the same period last year. The increase of SEK 42 million between the periods was primarily related to general cost increase for administration due to organization growth and increased complexity being a company in the commercial stage. This leaves us with an operating loss of SEK 418.2 million for this period compared to an operating loss of SEK 310.2 million for the same period last year. The cash flow used in operating activities for the period amounted to SEK 416.7 million compared to SEK 267.1 million for the same period previous year. The cash flow from financing activities for the period was SEK 295.9 million, and this is mainly related to the drawdown in the second tranche of the Kreos loan of SEK 236.5 million in the end of the second quarter, and the exercise of the warrant program for 2018-2022 for close to SEK 64 million at the end of the first quarter. As of end of June, we continue to report a strong cash position of SEK 846.8 million, down from SEK 955.5 million from end of December. In addition to our cash at the end of the second quarter, we have $25 million remaining unused in the Kreos credit facility, where the third and last tranche of $25 million can be drawdown from now and up until December this year. As Renée was mentioning earlier, we expect EUR 12.5 million in additional milestones from our partnership with STADA in the second half of this year. The progress of the commercial launch of TARPEYO in the second quarter continued to support our view that based on our current operational plan, our current cash position and the amounts available under our loan facility, we believe we have sufficient funds for our planned operations and capital expenditures until we become cash flow positive, which currently is projected for the first half of 2023, subject to continued successful commercialization of TARPEYO. That was all for me. Thank you. Now back to you, Renée. Thank you very much. In summary, before we open up for questions, we are extremely happy and proud about the conditional approval that was achieved in Europe of Kinpeygo, making it the first and only treatment that's approved for IgA nephropathy in this region. The net revenues of $6.6 million in the US for the quarter reflects a tripling of revenues compared to Q1, which we believe is really kind of encouraging growth in prescribers as well as in enrollments during Q2. We continue to see a broad interest from US-based physicians and patients. As we've mentioned, previously as well in our calls, is that, you know, the same, you know, challenges remain obviously, and especially product reimbursement process is challenging for some nephrologist offices. This is not an area that has been used to, you know, continuous introductions of new products, new approved products, new specialty categories. Obviously, as a consequence of the pandemic, in many cases, restrictions still remain with regards to access to many of the hospitals and clinics. That's really something that, you know, as we continue to build our experience, you know, we are getting increasingly better at addressing and finding solutions for. In terms of achievement of the target of US lives, obviously, we have achieved that target also with, you know, well over actually what we were expecting at this time. We look forward to the continued growth of TARPEYO as more patients are able to gain access to the drug, which has been specifically designed to address this rare disease of IgA nephropathy. With that, I'm happy to turn it over in order to take any questions that there might be. Thank you. If you wish to ask a question, please press zero one on your telephone keypad. If you wish to withdraw your question, you may do so by pressing zero two to cancel. Our first question comes from Johan Bergen at Kepler Cheuvreux. Your line is now open. Hello. Thanks for taking my questions. I have two. The first one, now when you see that over 80% of your scripts are covered for TARPEYO, could you describe what the consensus for prior authorization requirements look like, and if there aren't changes to what you saw after the first quarter? Then for second question, I think last quarter, you mentioned that only one patient had canceled treatment without payer coverage. Can you please just update the number now after Q2, please? I'm sorry, I just didn't hear exactly. Sorry. The consensus of what? Sorry. For prior authorization requirements, the consensus, what do they look like? If there aren't changes to what you saw after the first quarter. Oh, okay. Great. Well, Andy, why don't you go ahead and take that question. Sure. Look, I feel like we've met our expectations for a specialty product. As we anticipated, it's covered under a higher specialty tier. Generally speaking, the product has to be written by or in consultation with a nephrologist, has to have a patient with a biopsy diagnosis of IgA nephropathy and on blood pressure-lowering medicine. That seems to be consensus. The answer to your question, it really hasn't changed since we launched. As far as your second question on canceled patients, I don't have the exact number due to prior auth. But I can tell you, as I mentioned, we're getting greater than 80% reimbursement or approval rate so far through the process and processing. So that's well above expectations for most products at this stage. Okay. Thank you. Thank you. Our next question comes from Ludvig Svensson at Erik Penser Bank. Your line is now open. Thank you, Calliditas team, for taking my question. Would just like you to clarify the dynamics behind the enrolled patients, actual patients on drug, and when you book sales for these patients. That would be very helpful. Thank you. Sure. Well, I guess I'll take it initially, and Fredrik can address the revenue approach. Obviously, what we are recording and what we can share is obviously the number of enrollments, which really is like the prescriptions that are written by physicians. As Andy's pointed out, there is a wide, you know, range in terms of how long it will take for those patients to get on drug. There is obviously, in any point in time, really, you know, a portion of these patients that are in process, because there is always going to be requests for information for specialty products. I think, you know, the numbers that we have provided from that perspective is really kind of what we can share at this point in time. Fredrik, do you wanna address maybe the booking revenues? Yeah. We book the revenue when we ship the product to our specialty pharma. That means that they have sort of expected shipments. Yeah. That's Yeah. I mean, this is like we mentioned this as well before. Obviously, there's only one specialty pharmacy. I mean, it's not like you have a massive stocking effect because there's lots and lots of, you know, pharmacies that's sitting on drug that may or may not kind of be expected to go out. I think there's a fairly, you know, streamlined, I would say, process here, where obviously the specialty pharmacy can order additional kind of drugs on a very kind of, you know, ongoing basis. Yeah. I'd echo that. Andy It's just, you know, they're not gonna sit on tons of medication. They have the ability to order as frequently as they want, the specialty pharmacy. Okay. Perfect. Thank you. That's helpful. For my second question, you previously guided for rebates of 15%-20% on the gross price. Is that what you're actually seeing now that you're in commercial state, so to say? Fredrik, maybe you wanna take the definition, and maybe Andy, you wanna follow up. Yeah. What we said is that we expected a gross to net in that range. That is not including sort of any expected large rebates. I think you can probably expand that, Andy. Well, just from the contracting rebating basis to date, we have not entered into rebate and contract or any rebate or contract agreements that haven't been mandated by regulation, as it relates to payers and insurers. Okay. Got it. Thank you, guys. Thank you. Our next question comes from Maury Raycroft at Jefferies. Your line is now open. Hi, thank you for taking my questions, and congrats on the progress. I was gonna ask a question about just the sales force expansion to 60. Can you talk more about what drove the decision to expand? And do you expect this to be the final US sales force size, or could there be additional adjustments as you advance in the launch? Sure. The general kind of view is that, you know, I think that we have, you know, we did a lot of this work prior to launch. I think we've been following up on this very, very closely. I think that the number that we have now kind of arrived at, I think, you know, from, you know, from my perspective, you know, I would not foresee that declining growth significantly from, you know, from here. You know, we can always be surprised, which is fine, but I guess I don't really expect to expect that to happen. Andy, maybe you wanna talk a little bit about Sure What kind of drove that discussion. Sure. Hey, Maury. It's pretty straightforward. Excuse me. We've seen a broad demand in the prescriber base of TARPEYO, and we wanna increase our reach and frequency to our audience. That's it. It's as simple as that. We assess things constantly. We're constantly looking at things, targeting, segmenting, and you wanna get the appropriate reach and frequency to your audience to optimize things. As far as the future, like Renée said, I don't see large changes. But maybe we'll be pleasantly surprised that we might need something, should things continue to grow. I don't know, but not foreseen in the short term. Got it. Okay. Also wanted to check to see if you're providing any more specifics on sales or launch expectations for the rest of the year? I mean, we have kind of, you know, had a lot of discussions around, you know, whether we can do this. I think that, you know, what we're seeing is, you know, this, you know, a strong kind of, you know, growth in enrollments. There is this obviously, you know, it's difficult to kind of predict the conversion and the rate in terms of when those will actually turn into revenue. This is obviously also reflected in the range that we see among both our analysts of, you know, SEK 30 million-SEK 50 million for the year. I think, you know, it's difficult for us to kind of at this point in time, I think, be, you know, super specific in terms of where we would expect to kind of end up for the year. Got it. Okay. Last question for me, just wondering if you can provide more granularity on how the drug is being prescribed in the real world with regards to label and inclusion, exclusion criteria from the phase III. Also, if you're getting any newly diagnosed IgAN patients? Andy, do you wanna take that? Sure. It's early and I think it varies. I can't really give you very much specifics on that, unfortunately. I think we haven't heard feedback that differed from what we've said all along, which is, you know, these patients, some of them are diagnosed. It's a heterogeneous progressing disease, right? Some of them are already diagnosed, and they're more severe or more rapidly progressing at diagnosis, and some, it takes some time. I think that the product has been positioned appropriately and, you know, similar to what we've talked about all along. I think, you know, it is. I mean, I think seeing is also the fact that obviously, you know, it is up to the physician to really decide whether they feel that this patient is at risk of a rapid progression. There is a broad variation in terms of what we see with regards to, you know, different patients that the physicians have considered to be appropriate. Okay, thanks for taking my questions. Our next question comes from Neena Bitritto-Garg at Citigroup. Your line is now open. Hi, Renée and Andy. How are you? I just had a question regarding some of the prescription trends. It's interesting that in Q1 you had 111 prescribers and you had almost the same number of enrollments, 234. You know, ratio of prep one to one. Then in the Q2 you had triple, 314 prescribers and also triple the number of enrollments, 315. Again, one to one ratio. What is the implication for that? Does that mean that every time you get a new prescriber you get one new patient, or is there a different interpretation? Andy, do you wanna start? Then I can- Yeah, sure. I think there's a different interpretation in the sense that about a quarter of our prescribers have written for multiple patients. I think you know this is a disease that they're not calling up their patients unless the patients which happens which patients do go to the prescriber. They're seeing them on their normal cadence. Okay. They see these prescribers quarterly. As we reach prescribers and these patients come in, you're seeing a cadence of you know patients coming in and get put on drugs. While I understand your numbers and your math, I think I can tell you that about a quarter of these prescribers have multiples of patients on drugs. Okay. Yeah. I think also we see the number of 314 prescribers is total number of prescribers over the you know. It's not necessarily all new prescribers, if you understand what I'm saying. Okay. What's your understanding in terms of the total number of expected prescribers in the U.S. that you intend to reach eventually? So we- Yeah, go ahead, Andy. Oh, sorry. No, no, I was just gonna say. No, go now. To maintain our audience size of the market, it seems to be about 37 to about 4,000 doctors, we'll call it approximately, that are writing for the vast majority and seeing the vast majority of IgA nephropathy patients. That would be your target point in general. Okay. Can you just remind us in terms of the competitive positioning versus your competitive drug, the Travere, Farxiga, what is the differentiation that you can you know that your field force is pitching in terms of how TARPEYO differentiates from Farxiga? I mean, I guess at this point, obviously, you know, there isn't, and there certainly shouldn't be any kind of marketing of a drug that hasn't been approved. We don't actually have a lot of information as to what the profile of that drug looks like. I think that it's, you know, we don't really get those kind of questions from physicians. I don't think the physicians are really kind of thinking about it, quite honestly. I think the physicians are kind of dealing with what they have at hand, and what alternatives they can, you know, use today. I think, you know, once we actually kind of see the profile, you know, if Filspari is approved, and we also then obviously hopefully will get a little bit more information around, you know, the actual profile of the drug and what the label says. I think that will, you know, facilitate, you know, a discussion in terms of how physicians may be using, you know, the two, you know, different drugs in patients. I think obviously, as we know, it's a, it's a heterogeneous population, and, you know, my assumption is that there will be, you know, combination treatments. There'll be certain patients that, you know, physicians believe are better suited for one or the other. But obviously, this is a market that really, you know, has not had any approved drug. I guess I would hope for all of our benefits that actually the market is big enough for you know for two drugs to do incredibly well considering that that you know this should be a significant market opportunity where I'm sure you know physicians will find the right patients and appropriate patients for different profiles of drug. Got it. Okay. Thank you. Our next question comes from Dan Akschuti at Pareto Securities. Your line is open. Hello, Calliditas team. Thank you very much for taking my question, and congratulations on the great progress that you're showing, and I think that reflects the need for increase in sales personnel to further capitalize the sales. Just some questions on the expectations on the European side. The launch is expected during the second half. Do you have any more precise guidance that you could give? We are in the process of transferring the market authorization holdership, which is a requirement before STADA is in a position to launch. What I can say is I think that this is an administrative process managed by the regulator. I think so far it's been going very smoothly. And, you know, we've not had any delays or any issues. We launched this administrative process, you know, literally at the time that we received approval. It is difficult for me to say exactly when that will be transferred because it's really up to the kind of the administrative process of the regulator, which is why whether that will happen in, you know, September. It's very difficult for me to say because it's just we're not in control of that process. Okay. Thank you. You don't have any bottlenecks on the commercial supply side. It's that both for the U.S. and Europe, secured to kind of serve the big demand that you see an increase in demand? Yes. We are actually. We don't foresee at this point in time any kind of supply issues, not in the U.S. nor in Europe. I think we have, you know, had a good team in place that has done a good deal of planning. From the visibility that we have right now, I think we feel pretty, you know, very good about that. Okay, great. Thank you. Could you comment a bit how the enrollment has been going on in the holiday period now over July and early August? Yeah. I mean, I think as expected, you know, enrollments, you know, kind of remain at a good level. You know, it is a summer period. We're not really expecting any kind of additional acceleration from where we are until, you know, the end of the summer. Because as Andy also mentioned, obviously, you know, a lot of these prescriptions and enrollments come from the kind of normal cadence in terms of when physicians will see patients. As you can imagine, you know, some patients are on holiday during the summer period. I think we're encouraged about the level that we are at. I think we're expecting hopefully to see an acceleration, you know, at the end of the summer period. Okay, thank you. If you could share any feedback that you've gotten maybe directly from some patients or physicians on how their patients are doing on drug. Has there been any, like, dropouts or... I mean, I'm not aware of any. I mean, I think that the only access we have to that is probably through social media commentary, potentially. But Andy, why don't you comment on that if you have any additional Yeah, I mean, it's early. Yeah, look, it's early. The average patient's gotten around 2 refills, the average of all our patients. It's hard to make any general comments there. But as Renée said, I mean, we listen and we haven't seen anything abnormal or anything to date. Okay, great. Thank you. One last question on sotagliflozin. Are the timelines there still intact? We get a bit of a first glance at PK data later this year and safety and efficacy a bit later. I think that in terms of the recruitment, I think, you know, it is as all of these things, I think they are challenging in terms of, you know, getting, particularly getting sites to actually kind of, communicate and kind of get on the track in terms of getting everything, in line and open, and able to screen patients. I think it's still early in the process, we don't have any reason at this stage to adjust the timelines. We'll have to wait and see a little bit later and see if we need to push them out, you know, if that becomes necessary. Today we don't really have, you know, information that would warrant us to change our expectations. Okay. Thank you very much, and congratulations again for the great progress. Bye. Thank you. Our next question comes from Erik Hultgård at Carnegie. Your line is open. Thank you, and congrats on the progress with the U.S. launch. I have a couple of questions. First, going back a little bit on the previous question on where what type of patients that are getting TARPEYO. I know it's early in the launch, but could you talk a little bit about prior dapagliflozin or SGLT2 exposure? I was just wondering how TARPEYO fits in that algorithm. That's my first question. My second question is whether the addition of 20 sales reps will increase the sort of targeted prescription base or is it almost entirely to increase the frequency? Related to that, how do you measure or do you measure conversion of core frequency to prescription? Is there any KPIs there you would like to highlight? Are you underperforming in any way in that conversion that is leading to the repricing of the sales force? Thank you. Okay. Well, I guess I'll take a general comment and then hand over to Andy to describe it. I think just one point that's probably worth noting is obviously that, you know, we don't really get access generally to, you know, the history of all these patients in terms of what they may or may not kind of have been on or be on, et cetera. I think it's not something. You should not assume that we have, you know, detailed, you know, background or medical charts of these patients that are being prescribed the drug which makes it, you know, difficult for us to you know kind of answer, you know, these kind of specific questions. In terms of SGLT2s, I mean, I think again, you know, this is a group of physicians that, you know, generally are used to, you know, trying quite a lot of different things that are available to them. I would expect that they are, you know, trying SGLT2s as well. I can't say that we've heard anything specifically around that use that would, you know, drive any kind of of decision-making or anything, any concern at all from our side. Andy, maybe you can comment. No, I'd echo that as far as the information we get. Excuse me. The patients, I'm sure this is. There are patients that may be on SGLT2s as well as our product. We're not seeing it as a requirement or anything like that. Different physicians have different protocols on where they would place them, but we're not privy to all those. As far as the sales force, the additional 20 reps, it's probably a combination of both reach and frequency. Obviously, when you have more sales territories, you have more sales reps, you have smaller territories, so they're able to increase the frequency for those that are important and the reach to reach some additional physicians with some frequency as well. As far as KPIs you asked, we measure everything. You know, that's what goes into our analytics and what determines our sales force sizing. Okay. Thank you. Thanks. Our next question comes from Rami Katkhuda at LifeSci Capital. Hey guys, congrats on the progress, and thank you for taking my questions. A couple quick ones from me. First off, I guess, is there a subset of nephrologists that are waiting for results from part B of the NefIgArd study? Do you expect, I guess that eGFR data to kind of expedite the uptake of TARPEYO? I mean, you know, this comes from, you know, obviously talking both to our medical affairs team and commercial team. I really don't think that that is something that we have run into, actually. I think it's actually on the other side. I think, you know, physicians are delighted that there actually is a drug that is approved for this indication. Obviously this is by far, you know, most amount of information that they've had, related to other, you know, to, you know, how this drug actually works in this disease. It's not anything that we have run into, though I am sure that, you know, if you call up a, you know, physician, certainly, you know, the more data, the better. I don't think I've ever heard a physician say that, you know, they're happy with what they have. I'm sure that, you know, they would like more. I don't think that I certainly don't have the impression that this in any way, shape, or form is stopping people from using an approved product. Andy, I don't know if you have a different or maybe you have some more additional insight. No, I would echo that. I don't think I'm sure there are physicians that want more data, as you said, and there always are. At this point, in general from the uptake we've received and the amount of prescribers prescribing and enrolling patients, I don't think people are really sitting on the sidelines. Market research shows that as well. It confirms that they're not sitting on the sidelines waiting for a long period of time or a lot of usage before they're gonna give a trial or start putting patients on our product. Got it. Makes sense. Once again, congrats on the EU approval. I guess, can you touch upon the interactions with the EMA there and whether the label is kind of more stringent when it comes to the UPCR language compared to what the FDA put out? Yeah, no. I think that, and I think we've mentioned this before, obviously, I mean, there is a slight distinction between, you know, how EMA potentially looks at this versus the FDA, which is that the EMA has not kind of communicated that they've accepted proteinuria as a surrogate marker for, you know, in this disease. They really do look at the totality of the data as they do kind of for all orphan indications. I think it really goes towards the strength of our overall data package. Obviously also, you know, the EGFR data that we're able to show during the, you know, treatment period, et cetera. I think that it was, you know, I would say there was a reasonably smooth process with EMA. I think that they actually have quite different approaches in terms of what they look for and what they are concerned about to some extent. There are obviously also, you know, several kind of, you know, commonalities. I think is probably the only difference, kind of technically between the agencies. I think, you know, maybe that is what led to that more kind of stringent. I also know that EMA was very clear about the fact that this was a predefined sub-analysis, and they really felt strongly that they just wanted to stick within whatever was, you know, predefined. Makes sense. Thank you. Our next question comes from Jacob Mekhael at Kempen. Your line is open. Hi there, and thanks for taking my question. My first one is, are you seeing that patients that were enrolled in Q1 continue treatment into Q2? My second one is, what is the length of a prescription? Is it one month, or do doctors prescribe for nine months, and then the patients get dispensed every month? Yeah, no, I mean, obviously, you know, in order to kind of get to these revenue numbers, obviously there is, you know, an assumption obviously that, you know, patients are continuing on drug, and they are getting monthly refills. There may be some variation there. I don't know if Andy, you have any more details, but, you know, clearly, you know, most prescribers, you know, would use the nine-month period, is my assumption, or ten-month period. Then after that, you know, make any adjustments or additions, as they kind of see how their patients progress, you know, during that period of time. Andy, I don't know if you have a better. Yeah. You know, view on that. No, I think that's exactly right. To your first part, patients enrolled in Q1. Certainly, as I mentioned earlier, the average has been 2 refills, but we have patients that have been on longer. The highest, we have someone that's had 7 refills already. Obviously that patient started in Q1. As far as the prescriptions, the doctors, nephrologists seem to be prescribing overall for the 9-month treatment is the goal on the prescription. Obviously, they need to get refilled each month, but they bill for 30 days at a time, typically, which is most typical. Okay. Thank you very much. Our final question in the queue comes from Annabel Samimy at Stifel. Your line is open. Hi. Thanks for taking my question, and I imagine most of the news already. I did have some questions on the reimbursement challenges you're seeing. I mean, higher than 80% approval rate is pretty good. What exactly what kind of reimbursement challenges are you still seeing? I guess to that effect, are you seeing any improvement in the time from patient enrollment to prescription fulfillment, or is the onboarding of these patients been streamlined over the course of the quarter as you're going through this process? I guess the final question, also still regarding reimbursement, and you don't really know this yet, but, do you envision that after nine months you will have challenges from payers because the data really only goes out to nine months? Do you expect that patients will have to, I guess, re-prioritize, or will they just be able to continue to get prescriptions as they did before? Maybe you can address those questions. Thank you. Andy, do you want to take this? Look, I think as far as I'll start with the first part as far as coverage, I think, and the challenges, I think this is exactly as we anticipated and expected for a specialty product, okay? What's been consistent and consensus, as someone asked earlier, is certainly that it needs to be written by a or in consultation by a nephrologist. These have to be patients that have this diagnosis of IgA nephropathy and be on blood pressure-lowering medication, which all comes from our phase III trial, right? Exactly how we position patients. It's after that it would vary from plan to plan. You see different, sometimes they'll look at the UPCR and other measures, and others don't. It really varies after that. As you said, the good news is above expectations. We have greater than 80% approval rates, right? That's really encouraging, and that's what we kind of look at. Now, as far as enrollment, are we seeing improvements in times? For those that are being processed, we're seeing on average, there's a wide range, right? What we have been seeing on average, those are less than 30, and that is trending down. I have to say, I mean, that's while we're really proud of that is good at this point if you compare to other products typical to ours, we're never gonna be satisfied with that, okay? If I told you it was 10 days, I'd want it to be 7 days. We're constantly working on doing that to get the medication to the patients as quick as possible. As far as the nine months, I think you asked, would the patient need a renewal or something? What did you ask? I'm sorry. Will the patient- Yeah. I mean. Start to restrict them after that nine-month period. I think what's gonna happen, obviously we haven't hit that point yet, but as far as from the payers' review and how they're handling it is it's really 10 months, right? 'Cause there's a taper period, and that varies. That also will probably vary plan to plan. I think it's too early to tell what exactly will happen, right? I think what we'll see is, it's gonna vary plan to plan, and I think patient to patient. Remember, these, some of these patients start, and they may have 4 grams of proteinuria, and they're still, you know, they're still gonna be looking to see where they are at that point, you know, the payers. I think, you know, if they still qualify and meet the criteria, I don't see why they wouldn't get re-approved for another course of therapy or extended. Okay. Great. Thank you so much. Our next question comes from Christopher Uhde at SEB. Your line is now open. Hi there. Congratulations on continued progress. So in terms of coverage and approval rates, just continuing on that, I guess previously you talked about how in general the process works, that you get authorization sort of more or less automatically while negotiations are being finalized. How confident are you that you know this situation in terms of you know reimbursement as it is at the moment, you know, 80% and so on, approval rates will continue once it is finalized with the various payers? Second question I have is, it sounded I couldn't quite catch it, but do you have any comments on discontinuations so far? Do you think it's worth considering an additional formulation with you know that would allow you to have fewer pills to improve adherence? Thanks. I think. Do you want me to? Yeah. In terms of the last question in terms of kind of discontinuation formulations, I mean, I guess that, you know, this is fairly early. I guess what we would expect, right, is probably that, you know, discontinuations would be, you know, not dissimilar to what was in the clinical trials. I mean, if there are discontinuations, my guess is that they'll be single digit. I think that's probably, you know, fairly typical would be my guess in terms of medications. You know, not all patients end up wanting to take their medication. That I guess would be, you know, our expectations. We certainly haven't seen anything that would, you know, that would say that that is not a realistic expectation. In terms of formulation, I mean, that is obviously something that, you know, we're always working on, you know, life cycle management and improvement and all of this. That's something that, you know, we would have as kind of part and parcel of our, you know, of our kind of future plans. Obviously not something that one would expect to do, you know, immediately after kind of approval or launch. As far as your comments on the 80%, I'm not sure if you realize there's two 80%s here. One is the outcome. Over 80% of US lives are covered, so that has had an outcome. The other is those going through the process already, over 80% of those that have had outcome have been approved. I think this is the managed markets or the payer information is generally real-time. It's pretty far down the line now. We're very pleased, I should say, with where we've landed on a lot of these plans. While it certainly will continue, there are thousands of plans, we're gonna see little ticks up in the future. I think we're very pleased at where we sit today. These are really strong numbers. No, absolutely. I guess what I'm wondering is, will you know, as plans get finalized, will the 80% approval rate continue. Is really the question. Well, this is real time. We gave you this. This one has been. As of now, I don't see why that would change. I mean, the patients are the same. If they've made their decision to plan, this is what they've decided how they're gonna cover the product, and 80% are getting reimbursement approval for those that have come to a conclusion already. I don't see why. You know, we're very pleased. I don't see why this would change dramatically, as far as the reimbursement approval rate. Yep. Thanks, Andy. No, I think that's yeah. We would not expect that to change. Thank you. Thank you. We have no further questions on the phone, so I'll hand it back to the speakers. Thank you very much. Thanks a lot for all your questions. We appreciate them. Thank you for listening in to our Q2 report, and we look forward to speaking to you again hopefully in November. Thank you.