Ladies and gentlemen, welcome to the Calliditas Therapeutics Q2 2021 report. Today, I'm pleased to present the CEO, Renée Aguiar-Lucander, the CFO, Fredrik Johansson, and the President of North America, Andrew Udell. For the first part of this call, all participants will be in listen-only mode. Afterwards, there will be a question and answer session. Speakers, please begin. Thank you. We start at page 2 at the forward-looking statement. This presentation contains forward-looking statements. Any forward-looking statements in this presentation are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this presentation. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based or that may affect the likelihood the actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this presentation represent Calliditas' views only as of the date thereof and should not be relied upon as representing its views on any subsequent date. Thank you, Fredrik. Welcome everybody to Calliditas Therapeutics Q2 report. I will start the presentation on page 3. Just as a quick reminder of our development pipeline and ongoing clinical trials. The NefIgArd trial is, as you're aware, fully recruited. It is continuing on plan and is expected to conclude in Q1 2023. We also remain on track to start our clinical trials related to setanaxib in the second half of this year. The open label extension study continues to enroll patients as they complete the phase III study. With that, going to the next page. During Q2, the main highlights really related to regulatory events. In Q2, we reached a major milestone with the filing for conditional approval in IgA nephropathy with the EMA. Having received acceptance of accelerated review already in April, we expect to receive the first round of questions in Q3. We're excited to engage with the regulator during the coming months. Our interactions with the FDA is ongoing, and the review process is expected to conclude on the 15th of September, which is the target PDUFA date communicated to us by the agency. Consistent with previous presentations and interactions, we will not comment on what type of questions or interactions we're having with the FDA, nor will we comment on any potential inspections or audits or other related questions. After having just covered the main activities in Q2, I then go over and hand over to Andrew Udell, who is our President of North America. I'm sorry, actually, there is another page missing. Sorry. There is actually an additional page. Before I do that, I already got to other activities in Q2. Apologize for that. The other activities in the quarter. This is page five. Focuses mainly around operational execution across the board. A lot of which we are focused on the pre-commercial activities in the U.S., where we've made substantial investments in preparation for the potential approval of Nefecon. In addition, we've continued to prepare for the launch of our setanaxib studies, which are due to start in the second half of this year. Finally, obviously, we had resources directed at securing additional capital, both for the pre-commercial as well as the post-commercial phase of Nefecon, something which I will address in somewhat more detail shortly. Before I do that, we will now hand over to Andrew Udell, President of North America, who's going to cover a little bit about the market opportunity and these activities that we have been conducting in Q2 regarding putting us in a position for launch-ready. With that, Andrew, over to you. Thanks, Renée. On slide 6, I will start. We continue to be very encouraged by the results of our research in the market opportunity. As you can see on this slide, in a robust report of 468 IgA nephropathy patients in chart audits for these patients conducted earlier this year, patients arrive to their nephrologist upon referral already in CKD stage II or IIIa, 70% of these patients. That's upon diagnosis. About 70% arrive in CKD stage II and IIIa. If you want to add in CKD stage IIIb, you're over or at about 90% of the patients. When we look at the patients that do arrive to the nephrologist, when we look in what they're taking, the majority of them are already on supportive care. Greater than 50% of them are already on ACE or ARB therapy. If you ask the nephrologist, 88% of them are on an optimal dose in this unsatisfied market. Physicians see the patients 3 times a year. They conduct at least 1 lab test looking at eGFR or urinalysis. They are on multiple meds, as you can see here, almost 5 medications concomitantly. The nephrologists consider proteinuria, and especially eGFR, to be the most valuable measure when they're assessing their patients and their progress. If we go to the next slide, please. We continue to prepare for the earliest possible commercialization of our product. This includes market access, where our main objective is to reduce and minimize any barriers for patients to receive the product. We continue to finalize and work with our trade and distribution partners, which are world-class and well-known partners. We have national account managers that are already making calls on payers to prepare the market. We have launched our disease awareness campaign, as you can see here. As mentioned, that's been going on for a while. Our sales force readiness is well on its way with our sales leadership onboarded and our preparations right now, final preparations to onboard about 40 sales representatives to provide us the most ample and appropriate reach and frequency of the size of this audience. It's with that now I'll hand over back over to Renée on slide 8. Thank you, Andrew. Continuing on the next page, looking at post-period events. Post the period close, the company saw several significant positive events, which I just would like to touch on very briefly. We secured a strong commercial partner in Europe for the commercialization of Nefecon. This is obviously in line with what we have been communicating previously. We're very excited to welcome STADA to the Calliditas team. We're truly delighted to have secured such a strong partner for the commercialization of Nefecon in Europe. We also signed a credit agreement which provided access to a total of $75 million of non-dilutive financing to the company, out of which $25 million is accessible post-signing and the remainder subject to FDA approval or certain revenue levels being achieved. Finally, we successfully closed the top-up round of equity at about a 4.8% discount, raising SEK 324 million, representing less than 5% dilution, with the majority of the issue being taken up by our significant existing shareholders. Collectively, these initiatives ensure that we are well-capitalized for a successful product launch subject to accelerated approval. It also puts us on a path towards being cash flow positive potentially in the medium term and mitigates the need for a capital raise in the near term, which is also reflected by the 90-day lockup we signed as part of the recent financing. We have thus removed the risks related to macro events or other issues potentially impacting capital markets in the second half of the year. We believe that being well capitalized, we can now have full control over the successful commercialization of Nefecon over both the near and medium term. If we take a go to the next page, just before I hand over to our CFO, Fredrik Johansson, just a brief summary overview, in terms of year to date. Obviously we read out positive data from our phase III study in November of last year. We presented the overall profile of the study population, primary endpoints, as well as the overall safety profile. We have had our filings accepted by both the FDA and EMA for approval. Both of these are being reviewed on an accelerated basis. We believe that we have a very robust data package with a differentiated mode of action targeting the origin of the disease with the potential for disease modification, addressing a significant unmet medical need in this patient population. We also believe that we have a significant lead over other development programs taking place in IgA nephropathy at this point in time, and we look forward to receiving the response from the regulatory agencies with whom we are engaging at the moment. With that, I'm going to hand over to Fredrik Johansson, who will take us through the financials. Thank you, Renée. Next slide. Good afternoon, everyone, and good morning. I will present to you the financial overview for the first 6 months of this year. All numbers are presented to you in millions SEK, as always. To start with, as expected, we reported a revenue for the period. Our total operating expenses for the period amounted to SEK 310.2 million, compared to SEK 139.4 million for the same period last year. Out of the total operating expenses, the cost for research and development increased by SEK 62.6 million to SEK 165.1 million, compared with SEK 102.5 million for the same period previous year. The increase in all the expenses were even exposed from the NefIgArd trials, where the NefIgArd phase III study and the open label extension study are ongoing, and the preparations and product development for the setanaxib trials, which are planned to start later this year. The sales and administration expenses amounted to SEK 114.2 million for the period, to be compared with SEK 36.8 million for the same period last year. The increase of SEK 106.4 million between the periods is primarily related to the intensified preparations for commercial and medical affairs activities in the U.S. as we continue to invest and prepare to be ready to commercialize Nefecon in the U.S. in Q4 if approved. This leaves us with an operating loss of SEK 310.2 million for this period, compared to our operating loss of SEK 138.9 million for the same period last year. The cash flow used in operating activities for the period amounted to SEK 267.1 million, compared to SEK 85.4 million for the previous year. Remember, last year, in the beginning of the year, we received the China deal milestone payment from Everest amounting to $5 million. The cash flow used in investing activities for the period was SEK 18.8 million. This is mainly related to our milestone payment for the setanaxib license. Our cash flow used in financing activities was SEK 10.3 million, since we continue to purchase minority shares in Genkyotex. We now own over 90% of the shares in Genkyotex. We have recently initiated a squeeze-out process to reach 100%, which will have its way in the fall. We had a strong cash position at the end of June of SEK 709.3 million. After the close of the quarter, we completed an equity raise of SEK 324 million before transaction costs. In Q3, the EUR 20 million initial payment under the European commercialization agreement for Nefecon was payable. We also expect to be able to draw down the $25 million under the $75 million loan facility we signed in July with Kreos Capital, and to draw down an additional $25 million after potential U.S. approval of Nefecon. Based on our current operational plan for current cash position and amounts available under our loan facility, we believe we have sufficient funds for planned operations and capital expenditures until we become cash flow positive. This currently is projected for the first half of 2023, subject to Nefecon receiving accelerated approval in the U.S. and its successful commercialization. That was all from me. Now back to you, Renée. Thank you very much. I think that concludes our presentation. We are happy to take questions to the extent that there are any questions. Thank you. If you do have a question for the speakers, please press 01 on your telephone keypads. Now, first question comes from the line of Yigal Nochomovitz of Citigroup. Please go ahead. Thank you. Hi, Renée and team. Thank you very much for taking the questions. Renée, could you talk a bit about how your commercial launch strategy may or may not differ between the U.S. and Europe? Are there features of the IgA patient population when comparing the U.S. and European markets that may necessitate a different marketing approach for Nefecon? Thank you. Sure. In terms of the approaches to the European and the U.S. market, obviously they differ in the way that from the U.S. perspective, we are planning to launch and commercialize Nefecon ourselves in that market. Obviously from that perspective, we have conducted a lot of market research and spent a lot of time and effort to try and understand that market to the best possible ability that we have. In Europe, obviously, we are going to commercialize with a partner, and so that launch strategy will really be decided and managed by STADA rather than by us. I think obviously we will be collaborating and sharing information, et cetera, but I think that really is the fundamental difference. I don't think that so far we have not seen or experienced any significant differences in patient populations or in how patients necessarily are being treated in the 2 different regions. I think so from that perspective, we wouldn't necessarily expect there to be any significant difference in how those programs get deployed. I think obviously the main difference is really who will be driving the strategy around the actual launch details. Great. Thank you. Our next question comes from the line of Maury Raycroft of Jefferies. Please go ahead. This is Farzin on for Maury Raycroft. Thank you for taking our questions. How are you thinking about your commercial investment trajectory, and what milestones are you looking to achieve in order to trigger a new tranche of investment? I'm sorry. In order to trigger what? A new tranche of investment? Sorry, is that what you were- Yeah. For the next upcoming year, how are you thinking about the commercial investment trajectory? Okay. Well, why don't I start and then Andy, please feel free to add from your perspective. Obviously, our investment in the commercial launch is something obviously that we have spent a lot of time doing, even as I said, a lot of market research, a lot of interactions on the market access side. I think we have spent a lot of time also defining sales territories and really trying to get as granular as we possibly can be in terms of identifying and finding these patients effectively in order to have as successful launch as possible, obviously, in terms of commercialization. I think it's really been built mainly on all of the market research activities, market access interactions that we've had to date, which we think puts us in a very good position to have some visibility on how we should affect and drive a commercial launch to be as successful as possible. Andy, do you have anything you want to add? Not too much other than if the question is how things are going to change over the period of time of 12 months, there is a lot of demand right now, and it seems like it's certainly a very hungry market for products to help this unsatisfied patient population. As is typical for a launch, it takes a little time for payer approval and that's a constant process that we will continue to pursue to improve market access. We're encouraged about all the research and everything that we've done to date and what we're hearing. Got it. The other question was, you're not making comments on the regulatory review process, but is it safe to assume that everything is on track and all the questions have been answered satisfactorily so far? We're expecting the decision to come out on the targeted PDUFA date as communicated. Okay, thanks. Our next question comes from the line of Annabel Samimy of Stifel. Please go ahead. Hi. Thanks for taking my question. I had a couple. First, I guess, as you're approaching commercialization, have you had any further discussion with payers on pricing and have your strategies changed as the competitive landscape is evolving? Now that you're approaching commercialization and you're, I guess, putting the payer's feet to the fire and really providing that access, have they continued to view budesonide as a different steroid rather than one that will have to come after they step through other steroids? I guess that's the first question. The second is, I guess I know it's difficult to compare studies, but maybe you can remind us what the profile of your patient population was in the NefIgArd study versus that in sparsentan's study that just read out. I believe you had patients that were not responsive to ACE and ARB therapy anymore. Does that mean that patients were really maxed out on their proteinuria reductions and can you really think about these two groups as different patient populations? Thanks. Okay. Thanks. Andy, why don't you address the first question. Sure. address the second one. Sure. Well, we continue to do our work. It's a process to launch and work with the payers, and to date, we continue to be further and further actually encouraged with these discussions with payers. We have advisory boards and done a lot of work, and are encouraged, as I said, on how they view us. Nothing's really changed in that aspect. We still see things moving towards what we've indicated in the past, if not more encouraging. As far as them viewing budesonide or requiring step through these decisions, we look at the patient population, we look at a lot of patient history, these charts, and we don't see, once again, a lot of barriers to access for these patients based on what has been done today. I don't think that people are going to require people start a new course of steroids or something that's not approved. That would be a little surprising to us, prior to using a product that was specifically designed, tested, and approved for a specific disease. Okay. With regards to the second question, with regards to any kind of differences with regards to the two studies. Again, based on the kind of published design and methodology paper on the PROTECT study, I guess that what we can read out is obviously that the proteinuria is the same in terms of over a gram of proteinuria as an inclusion criteria. There's a slightly lower eGFR cutoff in the PROTECT study in terms of it being 30 milliliters. There's also no limit on the upper end of eGFR in the PROTECT study. Other differences regards inclusion obviously relates to blood pressure. In the NefIgArd study, patients with 140 over 90 or higher would be excluded, as they would not be considered to be well controlled with regards to their blood pressure. There's a difference there. In the NefIgArd study, obviously, we did not encourage treatment with additional antihypertensive agents, and we did not allow for systemic corticosteroids or other immunosuppressive therapy to be used at the discretion of the investigators. To what extent these have any impact or not, obviously, it's difficult to say, but I think that really is the only answer to your question I think that I can provide, which is that generally the inclusion/exclusion criteria are very similar. I think those are the differences that we have identified based on the kind of public information. Okay. Great. Thank you. Our next question comes from the line of Romi Katkhuda of LifeSci Capital. Please go ahead. Hi, guys. Thanks for taking my questions. Two for me. I guess first, can you provide any indication on how STADA is thinking about the pricing and commercialization plan for Nefecon in Europe? Secondly, given their somewhat complementary mechanisms, do you envision Nefecon being used in combination with sparsentan in the real-world setting? In terms of the STADA question, I think that it's a little bit too early. We very recently concluded our interactions with them. I think we're starting to engage with them on an operational basis to address some of these questions or explore some of these questions. I don't think at this point in time, I have a clear answer to how exactly they are planning to proceed in the European market. Obviously they have significant resources across all the European markets, and they have a lot of experience in terms of launching products in Europe. Again, I don't have any specific detail of that yet. I think we will be able to provide that as we progress the collaboration a little bit further. In terms of any kind of assumptions or comments around use together or not, I guess that the data that we have so far, it seems very promising with regards to Travere. I think that in terms of, we need to understand quite a lot more in terms of both the impact on eGFR, and the study population, the use of concomitant medication. All of these things I think are important to get an understanding of before one can have any kind of comments on that. However, in theory, I don't see any reason why they couldn't be used together. I think ours obviously has a local focus in terms of the origin of the disease. I think that should be able or could be able to be combined with any other systemic approach. I think in general, we wouldn't see why that would be necessarily a problem. Makes sense. Thank you. Our next question comes from the line of Johan Unnerus of Redeye. Please go ahead. Thank you for taking my question. It's more of a follow-on, since the subject has been discussed. Yes, the results from sparsentan caused a lot of uncertainty, obviously. One difference is that they include patients with filtration rates that are more impaired, I guess more like 3B in that context. Are you focusing more on patients that have less impaired filtration? Can you take the view that it's rational to begin with Nefecon being a local targeted therapy with more, perhaps, support in the less impaired filtration? Again, I think it's very difficult to have any kind of clear view on this because all we have at the moment is really just top-line data related to proteinuria. I think that the changes between 30 and 35 in eGFR are obviously clear. What impact that might have, we'd have to actually see the data in terms of subgroup analysis or stratified information to see if there is any particular subgroup that has a different kind of approach or a different effect or not. I think at this level, with the very limited top-line data that's come out, I think we're not really in a position to comment on anything until we see far more detailed information and as well, obviously, some impact on the eGFR. Long-term filtration rates in 2023 would be most interesting then for both you and them, I guess. Yes. I think that obviously we have provided some information on eGFR at nine months, which we believe is very supportive. I think that it would be interesting, obviously, for us to see the longer-term impact as well in early 2023 on the population for sure. I think this goes for all development programs in IgA nephropathy. Obviously, we are all trying to treat the underlying kidney disease, and hence I think, the impact on eGFR is obviously important under any circumstance. Yes, we are obviously looking forward to the longer-term outcome data that we will see in 2023 as well. Thank you. Excellent. Our next question comes from the line of Christopher Uhde of SEB. Please go ahead. Hi there. Thanks for taking my question. It's sort of looking forward to the next steps beyond IgAN, and taking the focus on budesonide here or Nefecon here. My first question is, in terms of the AIH and PBC projects, I think, well, to contrast them a little bit with IgAN, where it's, I think, very clear that, to me at least, that you've got trial data where your targeted approach on treating the source of the disease in IgA nephropathy is a little bit different from the AIH and PBC, where you're targeting the liver, and therefore, any budesonide, a generic budesonide as well should, in theory, be able to get the same amount of budesonide to that site. Is there, let's say, the same protection against interchangeability in those two diseases, would you say, as there is in IgA nephropathy from generic budesonide? Sorry, long-winded question. No, that's fine. I guess with regards to PBC, we have decided to proceed into a pivotal phase II/III, not with Nefecon, but with setanaxib. Obviously, based on the phase IIa information that was obtained on setanaxib in PBC, we have made adjustments and obviously also been in conversation with the regulators. For PBC, we will really go forward and take it forward with regards to setanaxib at this point in time. With regards to AIH, we have been in conversations with the regulators in the U.S. regarding this. Also in that particular program, most likely we would look to use Dr. Falk, which we in-licensed some time ago, because obviously, again, that was the actual compound that has clinical data, and there's a trial basically that's been performed already in AIH that showed benefit over standard of care. I think that that's really kind of our plan in terms of both AIH and PBC at this point in time. Okay, great. That really clarifies that. Can you just comment at all on a bit more detail on the status of discussions with regulators around the AIH? For both the EMA and FDA. Actually, we're not in conversations with EMA on this. This is purely kind of U.S. program that we're looking to do. In terms of those interactions, we've had good feedback. I think that we feel reasonably confident that we're able to agree on kind of a late-stage program in AIH. There is additional interaction that is required in order for us to be able to provide any kind of guidance in a public forum. I'm going to have to come back to you on that. Okay, thanks. Can you just explain, by the way, why you wouldn't be seeking to work with the EMA on this? Again, because actually it's a licensing agreement, we only have the rights for the U.S. Okay, great. Thank you very much. Thank you. Our next question comes from the line of Edwin Zhang of H.C. Wainwright. Please go ahead. Hi, thanks for taking my questions. Congrats on all the progress. A question on EU. You have a commercial partner in place in Europe. I wonder if you could comment more on the selection process and if there's something new that you have learned on the Nefecon opportunity in EU. In particular, what is your current thoughts on EU pricing in average compared to the U.S.? Thanks. Sure. We conducted a kind of a competitive process with regards to selecting our partner for Europe. This was a process that had a fairly large number of different parties involved. I think it was a very robust process, and we had some very hard choices to make towards the end of that process. In terms of the selection of STADA, I think that this is something, obviously, STADA is a very large organization, and it is privately held, but it's over 12,000 staff. Their revenues are in excess of SEK 3 million on an annual basis. They're very profitable, and they have a very strong presence across Europe, and particularly a very strong presence in Germany, which is obviously a key market when it comes to launching products in Europe, also with regards to pricing. This is obviously also something that we believe is strategic for them in terms of their focus that they are building up their pillars, both in terms of kind of OTC as well as specialty products. I think this is a good fit with regards to the efforts and resources that they're investing in their specialty product division. In terms of pricing, again, obviously this process ended fairly recently. I think we're going to have to wait a little bit in order to give STADA a little bit of time to provide more guidance in terms of how they look at potential pricing in Europe. Again, I think we're going to have to come back to you with more information on that. All right. In the U.S., I assume you have passed the manufacturer facility inspection at this time. In terms of production, are you ready to meet the market demand after the approval? Hope that the pandemic does not impact the supply chain and the drug production. Thanks. We feel that we are very well prepared on all fronts with regards to supply of product for the commercial launch. I think that there are obviously a lot of activities and a lot of things that have been planned and put in place over a very long period of time in order to ensure that we are in a position to do that. Obviously, there are always things that can happen in a supply chain, clearly. I think that we feel very good about where we are in terms of the preparations that we've made on the supply chain side. Great. We look forward to the positive news in the coming weeks. Good luck. Thank you. May I remind everyone that if you would like to ask a question, please press 01 on your telephone keypads. There are no further questions at this time. Please go ahead, speakers. Thank you very much. Thank you all for participating in this Q2 report. We look forward to speaking to you again at the end of the next quarter. Thank you.