Thank you. Welcome to this Q1 2021 report from Calliditas. If you turn to page two. Before we begin, given our listing on Nasdaq Global Select, I would just like to draw your attention to the forward-looking statement. Turning to page three. In Q1, the company reached a major milestone with the filing for fulminant IgA nephropathy with the FDA. It is the first ever submission for fulminant IGAN. It provides hope for thousands of patients living every day with this progressive disease. We subsequently received priority review from the FDA. We were also granted accelerated assessment by EMA in April. We continue to deliver on our plans. We will submit our dossier to EMA this quarter as previously announced, and we're very excited to engage with the regulatory agencies. We believe that we have a very robust data package, as we didn't just show significant reduction of proteinuria, but a clear impact on the actual treatment goal itself, namely stabilization of the kidney function by way of an interruption at the very top of the disease cascade using a local disease-specific and targeted approach. With that, just to remind everybody very briefly about the data, I'm going to hand over to our Chief Medical Officer, Richard Philipson. Thank you, Renée. Now moving on to slide four, provide a brief summary of the analysis of NefIgArd, of the pivotal phase III clinical trial of Nefecon. This analysis was performed on the first 199 patients enrolled into the trial who completed nine months of treatment. It is a randomized, double-blind, placebo-controlled study, the study is ongoing. In terms of the primary endpoint reduction in proteinuria, we saw a 31% reduction in proteinuria as measured by UPCR, urine protein to creatinine ratio in patients who received Nefecon 16mg at the nine-month time point versus a 5% reduction in patients who received placebo. Overall, there was a 27% reduction in UPCR in patients who received Nefecon compared to placebo at nine months, that outcome was highly statistically significant. In terms of the key secondary endpoint, we saw stabilization of eGFR at nine months in patients who received Nefecon 16mg versus a 7% reduction in eGFR in patients who received placebo. That equates to approximately a loss of four mils per minute in eGFR over the nine-month treatment period. Again, that comparison between Nefecon and placebo was highly statistically significant. It is also noteworthy that we continue to see the decline in proteinuria at the 12-month time point when patients had been off treatment for three months. In terms of tolerability, the treatment was generally well-tolerated. The safety profile was in keeping with phase IIb. Of particular note, there were no severe infections, as in contrast to off-label use of systemic corticosteroids, and we saw no adverse clinical effects on the cardiovascular or metabolic system. Moving on to slide five. I'd like to just briefly summarize the outcome of some biomarker analyses that have been performed based on samples taken from the phase IIb NEFIGAN trial. Taken together, these important analyses show modification of circulating biomarkers relevant to the pathogenesis of IgA nephropathy. Specifically, we saw in association with Nefecon treatment, reductions in galactose-deficient IgA1 levels and in IgA immune complexes. We also showed reductions in B- cell activating factor, which is a potent activating factor of B cells. Overall, we saw a clearly relevant impact on circulating pathogenic biomarkers in IGAN. Moving to slide six. In summary, in terms of the phase III clinical trial, we saw a robust demonstration of efficacy in terms of reduction in proteinuria and stabilization of eGFR in patients who received Nefecon with a tolerability and safety profile in line with the active ingredient as expected with the high first pass metabolism and therefore low systemic availability. Overall, in the clinical development program, we've seen high consistency of efficacy data across the phase IIb and phase III clinical trials enrolling a broad range of patients with IgA nephropathy. The eGFR stabilization that we've seen across these two large randomized placebo-controlled studies provides clear support for the disease-modifying effects of Nefecon. I'll now hand back to Renée. Thank you. If we turn to page two at slide number seven. In addition to the defining event of our regulatory filing, other events in the quarter included the full enrollment into the NefIgArd trial, which took place in early January. We're very proud as an organization to achieve this enrollment goal during the pandemic, and we look forward to the full readout in early 2023. The quarter also saw the first patient enrolled in the OLE study, this is the extension study in which patients can enroll in once they have completed the two years in the NefIgArd trial. We are excited about being able to offer Nefecon to all qualifying participants in the NefIgArd study in this fashion. We recently decided not to pursue the NefIgArd study in the second half of this year due to a combination of the significant delay of the study start due to this ongoing pandemic and recent interactions supporting alternative formats for achieving treatment paradigms post of potential approval. This was not a regulatory study. There's no bearing from a regulatory perspective. Finally, in Q1, we saw the successful readout of the setanaxib phase I study, which supports higher dosing going forward. Richard will shortly give you some more details around the pivotal trial, which we plan to start in the second half of this year. We continue to build out in the U.S., and as part of that, Andrew Udell was recently promoted to President of North America. Andrew's been with us for almost three years and has strong ties across the entire European organization, which I believe is a key component of building a successful transatlantic business. I will turn over to Andrew with no further ado, who will take you through some of our recent progress in the U.S. Thanks, Renée. If we're on page eight now. Over the last quarter, we've continued to grow our team, bringing on key members of our U.S. leadership team, which included a head of marketing, head of U.S. sales, and a VP of medical affairs. Our team will continue to grow significantly over the next several quarters as we prepare for commercialization in the fourth quarter of this year. With this growth comes the need to expand our office space. We are in the process of finalizing our lease in a substantially larger office space in New York City. Next page, please. As the slide shows, we have continued to meet our timelines. With an FDA action date of September 15th, we are preparing for commercialization in the fourth quarter of this year. Next page, 10, please. In our preparations, we continue to conduct market research and get further entrenched in the IgA nephropathy market. The trends continue to be encouraging. Over the next few slides, I'd like to highlight some recently completed syndicated research conducted by Spherix Global Insights. This research includes 188 nephrologists and chart audits of 468 IgA nephropathy patients. Slide 11, please. It is clear this is an unsatisfied market. 46% of the nephrologists rate IgA nephropathy as extremely challenging to manage in non-dialysis patients. 52% believe there are few or no effective treatment options currently available. The nephrologists anticipate that 65% of their current patients will progress to dialysis and end-stage renal disease. 53% of the nephrologists would like to replace the systemic steroids high doses as they're using for a treatment option. 80% believe that early intervention is critical to successful outcomes. This number has been growing. If you go to slide 12, please. When asked about the pipeline, Nefecon had the greatest unaided awareness by nephrologists, with almost half of them rating themselves as very familiar with Nefecon and the phase III results. This awareness has continued to increase from the last reporting period. Of these that rated themselves as very familiar, they indicated they are extremely likely to prescribe Nefecon for 70% of their current patients. Next slide. We continue to work to entrench ourselves in this market and educate and work on a disease awareness campaign, as you can see here, which launched earlier this quarter, and it can be found at iganephropathyculprit.com. With that, I think we'll go to the next slide and pass to Richard to review the clinical activities. Thanks very much, Andy. Now, I'm on slide 14. I'll summarize the clinical activities that are ongoing at present. In terms of Nefecon, the NefIgArd study, the phase III clinical trial, is fully enrolled as of January of this year, and we anticipate that the last patient will complete two years of follow-up in early 2023. In terms of setanaxib, we remain on track to start the phase IIb/III clinical trial in primary biliary cholangitis in the second half of this year. Similarly, we remain on track to start the phase II proof of concept study in squamous cell carcinoma of the head and neck in the second half of this year. We have ongoing setanaxib investigator-sponsored studies in interstitial pulmonary fibrosis and diabetic kidney disease, and the Nefecon open label extension is open, active, and enrolling patients. Moving on to slide 15, just to give some background about primary biliary cholangitis, the target of our setanaxib phase IIb/III clinical trial. This is a rare autoimmune disease with a high female preponderance, so the female to male ratio is nine to one, and it is a rare disease, and it affects around one in 3,000- 4,000 people. Characterized pathologically by gradual destruction of small intrahepatic bile ducts with clinical features which include debilitating fatigue and itching of the skin. Eventually, the condition progresses to cirrhosis with all of the attendant complications. Interestingly, in many patients, their initial diagnosis is made when they're asymptomatic, based on incidental liver enzyme abnormalities. Moving on to slide 16. There is and remains a clear unmet need in PBC despite existing therapies, in particular, with respect to the clinical features that I mentioned, such as fatigue and itching, both of which can be highly debilitating. 45% of patients show inadequate response or are intolerant to UDCA, the first-line therapy. In terms of second-line therapy, obeticholic acid can in fact worsen the pruritus. Setanaxib is well-positioned as a potential treatment in PBC. It has a unique mechanism of action with anti-inflammatory and anti-fibrotic properties. It has demonstrated benefits in a phase IIa clinical trial, in particular with respect to effects on fatigue and liver stiffness. It's clearly pharmacologically active, but with also an unremarkable safety profile. In terms of the clinical trial that we have planned on slide 17, this will be a study in early PBC. It's a 52-week randomized, placebo-controlled, double-blind, adaptive phase IIb/III clinical trial. The primary endpoint is based on reduction in alkaline phosphatase, and we will be studying two doses of setanaxib, daily doses of 1,200mg and 1,600mg a day, administered as add-on therapy in patients with early PBC, with elevated liver stiffness and intolerance or inadequate response to UDCA. We'll enroll approximately 318 patients in up to 150 investigational centers in North America, Europe, Israel, Australia, and New Zealand. We will be performing an interim analysis comprising approximately 30% of the planned sample size once the 99th randomized patient has completed the week 24 visit. This is expected in the first half of 2023, with a final data readout in late 2024, early 2025, or the current timelines predicated on FDA feedback on the protocol, which is expected. I will now hand over to Fredrik. Thank you, Richard. Good afternoon, everyone. I will present to you the financial overview for the first quarter of 2021, and all numbers presented to you are in million SEK, as always. To start with, as expected, we report a net loss for the period. Our total operating expenses for the period amounted to SEK 150.8 million, compared to SEK 72.8 million for the same period last year. Out of the total operating expenses, the cost for research and development increased by SEK 36 million to SEK 90.1 million, compared with SEK 64.1 million for the same period the previous year. Increase in R&D expenses originates mainly from the increased number of patients participating in the NefIgArd trial, as the NefIgArd trial was fully enrolled in January this year. During the quarter, we also started adding expenses related to preparations and product development for the setanaxib trial, which Richard was mentioning are planned to start in the second half of this year. The sales and administration expenses amounted to SEK 58.8 million for the period, to be compared with SEK 18 million for the same period last year. The increase of SEK 40.8 million between the periods is primarily related to the intensified preparations for commercial and affair activities in the U.S. as we continue to invest and prepare to be ready to commercialize Nefecon once the U.S. U.S. New Drug Application is approved. This leaves us with an operating loss of SEK 115.8 million for this period, compared to an operating loss of SEK 72.3 million for the same quarter last year. The cash flow used in operating activities for the period amounted to SEK 134.2 million, compared to SEK 18.8 million for the previous year, where we received a milestone payment from Everest amounting to $5 million. Our cash flow used in financing activities was SEK 9.6 million since we continued to purchase minority share in Genkyotex. During the quarter, we reached about 90% in ownership, and we aim to reach 100% as soon as possible. For the quarter, we had a financial income of SEK 14.6 million due to unrealized foreign currency gains from cash accounts, including SEK growing slightly stronger against SEK as of the end of March. Finally, our cash position remains solid as we had a cash position of SEK 867.4 million at the end of March. That was all for me. Now back to you, Renée. Thank you, Fredrik. In summary, we're positioned to be the first approved treatment for IgA nephropathy. We've been granted priority review and accelerated assessment. We've shown significant impact on the underlying kidney function in IgA nephropathy with the potential for disease modification. We are progressing on plan across all key aspects of our business and look forward to engaging with regulators, continue to develop our pipeline, as well as continue building our U.S. capability. With that, I hand over to the operator for questions. The first is from the line of Yigal Nochomovitz of Citigroup. Yeah. Hi. Thank you very much for taking the question. Could you comment at all on the ideal label language that you believe will be in the label? What claims do you believe you will see in the label? I have a separate question on setanaxib, but I'll wait on that one. I guess why don't I start and maybe Richard will have more detail as well, and maybe Andy also have a comment. I guess obviously, we are not in label negotiations as of yet. Obviously I think that our view is obviously that, we would like to have as broad a label as possible, which I think that the data and the trials that we carried out will support. Richard, maybe you want to. No, I agree. I think we would expect to be negotiating a label where the basis of the indication would be for treatment of primary IgA nephropathy, with a clear description of the clinical trial outcomes in the relevant section of the product information. I would add one thing to that I think that's very important and is very encouraging to us is that the nephrologists are telling us in research that when we show them a profile that has no claims, just has the actual data from phase II-B or phase III top-line data, they understand the product. They understand these are the endpoints and the measurements that they are comfortable with and that they routinely assess on these patients. They understand the clinical results, and these don't contain claims in these product profiles that we use in research. Okay. Thank you. I just had a question about the mechanism of action for setanaxib. Could you just help us understand how setanaxib could simultaneously be playing a role in treating an autoimmune condition like PBC and at the same time potentially having a role to treat a cancer such as head and neck cancer? Yeah. It's interesting. NOX1 and NOX4 lie at the center of a critical pathway, involving reactive oxygen species and the transition of fibroblasts to an activated myofibroblast. That activated myofibroblast has important role in many different fibrosing conditions, hence the potential application in primary biliary cholangitis. It's also important in oncology because an important cell involved in the phenotype of many tumors is the cancer-associated fibroblasts, which phenotypically is very similar to the myofibroblasts. Essentially they're very similar in terms of their phenotype. There's a clear rationale, and indeed there's some very nice published data supporting the potential application of setanaxib in tumors with high cancer-associated fibroblast density within the tumor. All right. Thank you. Thank you. Our next question comes from the line of Maury Raycroft with Jefferies. Please go ahead. Your line is open. Hi, good morning and thanks for taking my questions. You mentioned that you decided not to pursue the NefIgArd extension study [inaudible]. Sure. I think that it's really a combination of the fact that obviously the study start has been very significantly delayed due to the pandemic. This is something that we had originally really planned to start enrolling patients in Q2 of last year. Obviously it's quite a delay. Secondly, I think obviously, things have moved on since. I also think that in terms of interactions both with market research, payers, nephrologists, et cetera, a lot of the kind of interactions that we've had, I think that it's clear that based on where we are now in our development, there are a lot of other options, which probably are more appropriate at this point in time, in terms of just looking at treatment paradigms. This was never a regulatory study. This was really just more kind of on the health, economic support, et cetera. I think based on where we are now, there are other options which I think would serve us and the patients better. Got it. That's helpful. I was just wondering if you think a partner update in the E.U. can be made this quarter or next quarter, and if you can provide any more perspective into what the partnership could look like and what the goals are for the partnership. Sure. Yes, we have initiated an organized process in terms of finding a good partner in Europe for a commercial partnership. I think we're very encouraged by the activity that we've seen in this process. I think that it's progressing very well. It's always a little bit difficult to give an exact timing because there's obviously other parties on the other side. Timing is always really a function of when we ultimately get to the best outcome for everybody. I think that it's all developing very well, and we're very confident that we will find a good commercial partner for our product in Europe. Okay. Thanks for doing my question. Thank you. Our next question comes from the line of Edwin Chung of H.C. Wainwright. Please go ahead, your line is open. Hi. Thanks for taking my question. Congrats on the very successful quarter. 1st, a regulatory question. We know Nefecon is under priority review. Could you know the PDUFA date, when and how often are you going to meet with the FDA in this review process? In particular, when is the mid-cycle review session? What is your current thinking on a possible outcome for Nefecon? I have a 2nd question on the Nefecon commercialization. You have made some key appointments in the U.S., and the team has been doing great work to prepare for the U.S. commercialization. I wonder if you could share with us your current U.S. strategy, including sales and marketing. Also importantly, any new thoughts and feedback on the U.S. pricing. Thanks. Let's hope I got all of these things down. I will try to address the regulatory side, and Richard, please feel free to add. Obviously, I believe that in terms of obviously the PDUFA date or the target date for the PDUFA is the 15th of September. We were informed at the end of April, obviously, that we've been granted priority review. Actually, I don't remember off the top of my head in terms of the mid-cycle date. Obviously, it's a fairly short review period in total from May to September. Obviously, there also needs to be label negotiation in there somewhere. Regards to an Adcom, obviously, if we had been informed that there was a plan for an Adcom, we would obviously have communicated that. Obviously, there was no such communication from the FDA at the time of the granting of the priority review. I guess considering the very short time period that we're talking about here between May and September, I guess that in our view, it's not particularly likely that there suddenly would be an Adcom announced. I think the FDA generally tends to announce that well in advance in order to allow the company also to be prepared for such an Adcom. Obviously, the FDA has some work in order to organize these Adcoms as well. Not to say that it's impossible, but I guess in our view, it would be highly unlikely at this stage based on the communications that we have had so far from the regulators. I think that was on the regulatory side. I think in terms of the U.S. preparations, I'll hand over to Andy to answer those questions. Sure. I think your 1st question was on the sales force. As we've indicated, we continue to build to about a sales force of 40. We brought on head of U.S. sales, could bring on sales management. Right now we're in the process of looking for those folks. As I said, we're building to a sales force of about 40. As far as pricing, you asked, we continue to do our work on the market access area. As the Spherix research that I discussed earlier indicated, a large percentage of these patients in the chart audits, about 63%-73% of the IgA nephropathy patients have commercial insurance, which is encouraging. We continue to hear from the payers that they recognize the product and are pinning it towards the high cost of end-stage renal disease and dialysis of the 50% of patients that progress to end-stage renal disease. In 2019, we conducted some work with IQVIA using our phase IIb data. As we've previously indicated. We tested price ranges that exceeded $100,000 there, but price range between $55,000 and $85,000 for a course of therapy seemed to be managed appropriately without any barriers to access for patients, meaning it would be required to be written by a nephrologist and the patient would have to have an IgA nephropathy confirmed indications or a kidney biopsy. We continue to be encouraged, continue to do our work to develop a value-based pricing strategy and recent launches also in this area, in the space. There was a product that was recently launched, an oral product targeting nephritis, provided good clinical value that has a price of about $12,000 per month. We continue to be encouraged at the opportunities and as we do our work here to finalize it. Thank you. Our next question comes from the line of Annabel Samimy of Stifel. Please go ahead, your line is open. Hi, everyone. This is Nicholas Rubino on for Annabel. Thanks for taking our questions. First off, will we see the 12-month proteinuria data, basically just to better extrapolate progression in the future? On setanaxib, in the PBC trial, it looks like the primary endpoint is just going to be an ALP rather than GGT and ALP levels we've seen before. Why was the GGT dropped? In head and neck, can you give us a sense of how that clinical trial is going to be designed? Thank you. In terms of the GGT, I guess that was something that was the endpoint that was used in the phase llA trial, which Genkyotex designed and ran earlier. Obviously, the approvable endpoint in PBC is not GGT. It is actually ALP. That is obviously the endpoint that we have chosen is the approvable endpoint in PBC, as this is a pivotal trial, obviously registrational, and that is why that endpoint has been chosen. In terms of the head and neck cancer, I guess that is something that we are still working on and there is quite a lot of preparation going on there. I think it is something that we would hope to share with you in much more detail in our next quarterly call, really. Rich, I'm happy for you to give an outline of what we're thinking about there, if you want to, before we address the 12 months. Sure. As I've already mentioned, I think the hypothesis is based on some very strong preclinical data relating to cancer-associated fibroblasts in tumors. We know in head and neck cancer, there's a significant population of patients with head and neck cancer that have tumors with high numbers of CAFs. Clearly, we want to focus on a population of patients with head and neck cancer with high CAF levels. Again, from preclinical data, we know there are some interesting effects relating to the benefits of immunotherapy in head and neck cancer and potentially how modulating CAFs can improve responses to immunotherapy. I think those are the kind of areas we're looking at in greater detail now. As I say, hopefully we can share further details at the next update. In terms of any kind of data beyond and above what's been publicly released, we are very constrained since this is an ongoing trial, which just continues to be blinded. I think that it's very clear that the regulators are very keen that limited data is shared externally at this point in time. I think that we have provided earlier, I believe in our R&D day. Obviously we do not have the 12-month data for the entire population since obviously there was only a subset of patients who had reached 12 months at the time of the database lock. What we have been saying in terms of proteinuria, obviously, is that based on the trends that we saw from that group of patients who had reached that time, that we would expect the cohort to basically have a result in terms of overall treatment effect, be somewhere in the mid-40s, so somewhere between 42%-48%, as a treatment effect at 12 months. Obviously this is just an estimate based on a trend seen in a partial population. I think that's really all that we can disclose at this point in time. I think it's been very clear that any further disclosure of any other information is not something that we're going to be able to do. Okay, great. Thank you very much. Thank you. Our next question comes from the line of Rami Katkhuda of LifeSci Capital. Please go ahead, your line is open. Hey guys, congrats on the updates. Thanks for taking my questions. While it's early, are there any key learnings from the launch of the product Andy was mentioning that may apply to Nefecon? I'm sorry, can you repeat that? Are there any? Key learnings from the launch that Andy was talking about that may also apply to Nefecon. All right. Andy, do you want to take that? I think it's early to really project or make any conclusions. Sorry. Andy, you're disappearing. We can't hear you. For some reason, you're going in and out. We can't hear you. I think it's difficult to make any conclusions at this early time in their launch for us. The only thing, we continue to monitor the whole market and how things are going on in this interesting time of a pandemic, and the marketing mix. Those are the kind of things that we are looking at right now, but it's hard to draw any conclusions from this recent launch. Got it. Quickly, can you remind us where you stand in terms of manufacturing capacity for potential launch at the end of the year? In terms of the manufacturing situation, it's the same kind of formulation commercially that we're going to use as we used for the phase III. We're not expecting any moves or changes or other kind of complications. Otherwise, we're just working as normal in order to try to again, execute on the plans that we've had in place for a while, that we will be in a position to launch in Q4, which is the earliest possible time that that could happen. Sounds great. Thank you. Thank you. Our next question comes from the line of Hampus Ekström, who's a private investor. Please go ahead. Your line is open. Thanks for taking my question, congratulations on the priority review designation. I was wondering if somebody could elaborate on the risk for Calliditas that other modified release budesonide medicines already approved for other indications, such as Budenofalk or Cortiment, could be used off-label for IgA nephropathy pending an approval of Nefecon in either the U.S. or the E.U. Sure. Obviously this is an orphan indication to start with. Obviously in an orphan indication you do have market exclusivity, which obviously is relevant relative to this in terms of not being able to have any kind of competition from other potential parties with a similar substance, the same substance mode of action. That gives a seven-year market exclusivity in the U.S. and 10-year market exclusivity in Europe subject to approval. Secondly, obviously, these kind of formulations have been formulated to target completely different diseases. This is a Crohn's disease. Crohn's disease actually exists in your entire gut. These formulations are different in terms of why they have been formulated the way that they are. They are basically approved for 9mg for use for three months. I think there also has never really been any clinical data ever produced in this. Finally, it is not something that we hear or see about or hear that from the market or from nephrologists, that this has been used. Obviously if you are trying to experiment with some of these formulations, which are formulated for completely different diseases, and at much lower concentrations, you will most likely end up having to give those type of doses at multiples of what they have been approved for. This obviously then most likely will give you significant and severe side effects depending on how much higher than the approved dose you are forced to go in order to see any clinical effect. Since the formulation of Nefecon is so highly targeted and focused really on the area of Peyer's patches. I think I'm not sure what the purpose would be to again go backwards and start exposing patients to exploratory off-label drugs, which up until now have clearly not been proven in terms of efficacy or safety. Okay, thanks. Can I just have a quick follow-up on that? This seven-year market exclusivity in the U.S. and 10-year in the E.U., is that also for the indication? Even if somebody has an approved agent that could be used, they would not be able to do it for that particular label. That's correct. It is for that indication that you have a market exclusivity for that indication for that period of time. This is why no one actually can promote or market that, and also therefore cannot be reimbursed for that indication. Perfect. Thank you. That answers all my questions. Thank you. Thank you. We currently have one further question in the queue. That next question comes from the line of Johan Lövis of Redeye. Please go ahead. Your line is open. Thank you for taking my question and congratulations again. Sorry if this is partly a repeat, but I actually left the call briefly. As I understand it, you seem to be far advanced in securing a European partner. Is that correct? To be the first question. Yes, we are running a process in order to select someone to be our commercial partner. Yes, we are in the middle of running that process now. Also you are stepping back from the plan to initiate the NEFEX-EXTEND. Can you explore, give a bit more color on that decision, please? Sure. I think in terms of the, again, that study was meant to be initiated quite some time ago. Obviously due to the pandemic, there's been kind of continuous delays. Obviously where we are now in terms of we have priority review, accelerated assessment. We are positioned to be the first-ever drug to be on the market. We have obviously been in quite a lot of interactions in a variety of forums. I think it's become quite clear that there are other alternatives which probably will be better for the patients, may be significantly faster, might be a better way of achieving some insight into the treatment paradigm, which really was the purpose of NEFEX-EXTEND, as it was not a regulatory study. We believe that there are other options which would be preferable. Again, better alternatives to achieve the same outcome rather than the NEFEX-EXTEND trial. We can expect more information on that side perhaps when you get more feedback and experience from the clinics next year. Yes. I'm sure we're going to be providing additional information later on in the year in terms of some of the complementary activities that we may be undertaking. Yeah. Also your pre-market or market study that you presented earlier, some 63%-75% or thereabout of the future existing patients seems to be commercially insured. How much of that segment is in play before actually securing reimbursement? I'm not sure what you mean by are they in play. I mean everybody's in play, both commercial and government subsidized. It's just a matter of they determine on their formularies and the out-of-pocket costs and those things for the patients. Yes. We're not segmenting or removing anybody from our market. That's just indicated the large commercial population is favorable when you're looking to commercialize. How should we frame it before reimbursement? Obviously, you approach a large part of that segment. We're going to approach all the largest PBMs. Yeah We have people that are going to begin calling on payers in that market as early as this summer. Yeah. How many will you be able to approach, say, one or two months into post formal approval? Well, most of them don't provide an approval right off the bat. They'll cover you until they make a decision on formulary, and that could take three months, six months. It really is plan dependent, we'll be calling on all of them as much as we can and often as we can. They have their own pace on certain things, but that's typical for any product in the market. Yeah. Excellent. Thank you so much. Thank you. As there are no further questions coming through at this time, I'll hand back to our speakers for the closing comments. Thank you very much for participating. Thank you for the questions. I look forward to catching up with you again at the next quarterly report. Thank you.
Loading workspace