Hello, and welcome to the Calliditas Therapeutics Audio Cast for Teleconference Q1 2022. For the first part of this call, all participants will be in a listen-only mode, and afterwards there'll be a Q&A session. I will now hand the call over to Renée Aguiar-Lucander, CEO. Please begin your meeting. Thank you very much, and welcome to this Q1 2022 report from Calliditas Therapeutics. If you turn to page two of the presentation, I would like to draw your attention to the disclaimer page related to forward-looking statements and refer you to the company's reports and other filings, including those which contain risk factor and other relevant sections of our public filings. On this call today, I am joined by Andrew Udell, President of North America, and Fredrik Johansson, Chief Financial Officer. If you turn to page three. As you are all aware, last quarter, Calliditas actually the Q4, I would say, achieved a historic milestone in our history. We had our first commercial product approved in the U.S., and it was the first time that the cardio-renal division of the FDA gave an accelerated approval in a renal indication based on a target marker of reduction of proteinuria. This became the first approved product for this rare indication. I would say due to excellent internal collaboration, commercial product was available very quickly, and we were in a position to ship commercial product already in late January, taking into account that we had obviously Christmas and New Year holidays in between. The results from the first two months of commercial activity is SEK 1.9 million of net sales in terms of TARPEYO. We believe that this reflects an excellent start to our commercial launch. We are very encouraged by the strong level of interest and engagement that we're seeing. Andy will provide you with some more details regarding this later on in the presentation. If you turn to page four. Just a reminder of some of the backdrop of the IgA Nephropathy Market. As I mentioned, this is a rare disease, with around 50% of those patients diagnosed, continuing to be at risk of progressing towards end-stage renal disease, which means dialysis and transplantation, despite receiving optimized supportive care. In terms of the prevalence of this rare disease, we've estimated it to be about 130,000-150,000 patients in the U.S., and therefore this results in kind of this core market of 65,000-75,000 patients taking t his progression rate or risk rate into account. It is extremely well-established supportive care paradigm. According to Spherix research, about 50% of patients are already on RAS blockade. That means blood pressure lowering agents, so this is the supportive care by the time that they get to a nephrologist. These specialists then ensure that these patients are on optimized care by providing individual dose titration based on the specific patient characteristics and needs. We also know that there is a clear correlation between higher levels of proteinuria in this patient population and the rate of disease progression. We do know that patients with higher levels of UPCR have a worse prognosis and outlook. We therefore believe that physician might be especially focused on these patients, which then might have seen a decline in eGFR already and may be experiencing more rapid disease progression. Again, finally, obviously nothing's ever been approved in this indication previously. There is no ICD-10 code available. Obviously, this is a market that is in development. If we turn to page five. Other things that happened in this quarter, we also saw the expansion of the licensing agreement we have with Everest Medicines to include South Korea. This resulted in a $3 million upfront payment. We're also very excited about the upcoming regulatory filing in China in the second half of this year with a potential approval of commercialization taking place therefore already next year, obviously subject to positive approval. We also in this quarter saw the first patient dosed in the pivotal PBC trial TRANSFORM, which was initiated at the end of last year. We're looking to enroll 99 patients in total in this global trial across up to 150 sites and plan to conduct a futility study in 2023 when the 99th patient has received 24 weeks of treatment. If we turn to page six, some of the post-period events. In the publicly available CHMP agenda for May, Calliditas is listed as up for an opinion for conditional approval of Nefecon in Europe. We expect to receive notification of the outcome of the CHMP discussions after the conclusion of this session. Subject to receiving a positive opinion on approval and issuing marketing authorization, which then would be taken by the European Commission, we would expect to then see that in Q3. As for previous communications, STADA is our European commercial partner, and as such is responsible for the commercial launch and related activities in Europe. As previously mentioned, obviously we continue post kind of period to see positive trends and development from our U.S. commercial activities, as well as the continuation of P&T committee meetings. We have a positive outlook on the continued commercial success of TARPEYO in the U.S. We're still obviously at a very early stage of our launch. Regarding setanaxib, we also announced yesterday that we now have also dosed the first patient in our phase II proof of concept trial in head and neck cancer. We look forward to continuing enrollment with a target of providing biomarker data on interim basis before the end of this year. Just to remind you, this is a placebo-controlled phase II trial, which is targeted to read out next year. Related to this, we're actually excited that research articles related to setanaxib's effect of CAF, or cancer-associated fibroblasts, was part of the illustrious group of most cited articles from the American Association of Cancer Research journals in 2021 and 2022. With that summary, I'm going to hand over to Andrew Udell, our President of North America, who will take you through some more details regarding our commercial activities this quarter. Thanks, Renée. On slide seven, I'm excited to share with you our progress on the U.S. commercialization and launch of TARPEYO. Let's go to the next slide eight. As a reminder, the U.S. represents a large market with a substantial unmet medical need. Disease prevalence for IgA Nephropathy is estimated between 130,000 and 150,000, with over 50% of the patients progressing to end-stage renal disease. Prior to the launch of TARPEYO, a large survey of nephrologists estimated 65% of their IgA Nephropathy patients are likely to progress to dialysis. As Renée stated earlier, we estimate our core market to be between 65,000 and 75,000 patients. In addition to the size of the market, end-stage renal disease, which includes dialysis and transplantation, is extremely debilitating and costly, costing hundreds of thousands of dollars per patient per year. As a result, you can imagine, prior to the launch of TARPEYO, in a survey of 188 nephrologists, the majority indicated the feeling that no or few treatment options were effective for these patients. Next slide, please. Calliditas has been preparing for the approval and launch of TARPEYO for a few years. We were ready to hit the ground running once gaining FDA approval in December. Our commercial leadership team has extensive, relevant, and successful launch experience. In addition to our in-house team, we have partnered with the industry's top companies, consultants, and agencies to ensure a robust, efficient, and impactful launch for our first-in-class product. Our sales force was onboarded, trained, and deployed prior to the end of January, just five weeks after approval. Not only did these representatives come to us as veterans of rare disease and specialty sales, but the majority joined us with nephrology market relationships and experience. In addition, our market access team of national account managers were in the field prior to our approval, and as you'll hear in a bit, have done an outstanding job working with the largest payers. Next slide 10, please. At approval, we launched our white- glove, full-service patient and provider support program called TARPEYO Touchpoints. The full-time dedicated care navigators and designated rare pod team has been essential and successful with patient communication and navigation of benefits investigation and verification process. In addition, the integrated hub and specialty pharmacy model at Biologics has been able to ensure that all appropriate financial assistance programs are applied for the appropriate patients. Next slide, please. As a reminder, we were FDA approved on December 15 and announced our first sale and prescription filled near the end of January. After only two full months into our launch, independent from our marketing and digital programs, our sales forces directly contacted or reached over 4,000 nephrologists. At the end of March, we had attained 134 unique patient enrollments. The patient enrollment includes a physician-written prescription and enrollment form to our hub. These came from 111 unique prescribers. As Renée stated earlier, our net sales for Q1 was $1.9 million. As we are now in mid-May, I can say that our enrollments and number of unique prescribers continue to grow at an accelerated rate. I should note that all this has occurred prior to the very recent initiation of a branded promotional campaign, which required pre-approval by the FDA prior to launching. Market research and early feedback of this campaign, of this promotional campaign and program, has us very encouraged on the impact this will have. Next slide, please. How have we done on the market access front? As is common for most all launches, health plans take on average around six to nine months to review a new product for coverage and formulary placement. As of our first four months, we are pleased to report that several key targeted large accounts, including Cigna, Express Scripts, and Humana, began covering TARPEYO on their predominant formularies. In addition, TARPEYO is covered by Medicare Part D and Medicaid patients with the mandatory coverage date of April 1st. We estimate at the end of April, over 50% of all U.S. lives have coverage for TARPEYO. While we are certainly pleased with our progress, I need to stress that prior to payers establishing coverage policies, the medical exception process still enables appropriately deemed patients access to TARPEYO. As mentioned, our patient services program, TARPEYO Touchpoints, helps navigate the process for patients and physicians. Really impressive, as a result to date, only one enrolled patient in our program has canceled due to a payer and coverage issue. Next slide, please. Since our launch, we remained impressed and encouraged with the inbound inquiries, patient awareness, and enthusiasm that's been expressed on social media and through the patient advocacy groups. This is extremely motivated and dialed-in patient audience that has thirsted for treatment specifically designed for this rare disease. Next slide, please. In summary, during this initial period, we remain extremely pleased with our results and progress. I am confident we have the right team of launch experts in place that have and will continue to execute our plan. The positive trajectory and trends, coupled with the recent launch of our branding campaign, has us enthusiastic and encouraged. I would now like to turn it over to Fredrik to review our financials beginning on slide 15. Thank you, Andy, and good afternoon and good morning, everyone. I will now present to you the financial overview for the first quarter of 2022, and all numbers presented to you are in millions SEK. To start with, we present SEK 49.7 million in net revenues for the period. For the same period last year, we did not report any revenues. This is the first quarter we report net product sales following the TARPEYO FDA- accelerated approval in December last year. Out of the SEK 49.7 million in net revenue, we are proud to present that net product sales from TARPEYO in the quarter amounted to SEK 18.0 million. During the quarter, we also received an upfront fee from Everest of SEK 28.8 million, which is approximately $3 million, for the extension of the Everest license contract to South Korea. Our total operating expenses for the period amounted to SEK 257.5 million, compared to SEK 150.8 million for the same period last year. Out of the total operating expenses, marketing and selling expenses increased by SEK 74.5 million to SEK 93.9 million compared to SEK 90.4 million for the same period last year. Increase in marketing and selling expenses originates from us having a full commercial team in place from the start of Q1 this year, including a sales force, compared to the same period last year when we were early in our journey building up our commercial capabilities. The cost for research and development increased by SEK 23.2 million to SEK 113.3 million compared to SEK 19.1 million for the same period previous year. The increase in R&D expenses originates primarily from the preparations for the setanaxib and ongoing operations, I should say, for the setanaxib trials, where we just randomized the first patients in the head and neck trial earlier this week. Now, we have the two setanaxib trials fully up and running. The administration expenses amounted to SEK 48.5 million for the period, to be compared with SEK 39.4 million for the same period last year. The increase of SEK 9.1 million between the periods was primarily related to a general cost increase for administration due to the organization growth and increased complexity of being a company in commercial stage. This leaves us with an operating loss of SEK 208.4 million for this period compared to operating loss of SEK 150.8 million for the same period last year. The cash flow used in operating activities for the period amounted to SEK 191.4 million compared to SEK 134.2 million for the same period last year. The cash flow from financing activities for the period was SEK 60.1 million, and this is mainly related to the exercise of the board program 2018-2022 at the end of the quarter. As o`f March 31, we continue to report a strong cash position of SEK 825.4 million, down from SEK 955.5 million at the end of December. In addition to our cash, we have $50 million remaining unused in the Kreos credit facility, where the second tranche of $25 million can be drawn down until June this year and an additional $25 million until December this year. This successful start out of the gates of the commercial launch of TARPEYO continues to support our view that based on our current operation 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. Now back to you, Renée. Thank you very much. We're excited, as you can hear, about the start of our commercial launch and believe that we're very well positioned to see continued approvals and commercial success complemented by exciting data from our pipeline over the next 12 months as we continue to execute on our plan, which we have consistently done over the years. With that, let's open it up for any questions from anyone online. Thank you. If you do wish to ask a question, please press star one on your telephone keypad. If you wish to withdraw your question, you may do so by pressing star two to cancel. Our first question comes from the line of Yigal Nochomovitz from Citi. Please go ahead. Hi, this is Carly on for Yigal. Thank you for taking our questions. We have two. First, can you help characterize the initial patients where TARPEYO is being used? Should we assume nephrologists are largely adhering to the 1.5 UPCR cutoff suggested in the label, and any other, you know, criteria docs are using to determine whether to try TARPEYO in a particular patient? The second question is on the competitive landscape. I guess, can you talk about how you intend to position TARPEYO relative to sparsentan, given that drug could be entering the market, potentially by the end of this year? Thank you. Thanks. I guess just a clarification. I will have Andy cover me, but there is actually not a cutoff of 1.5 in the label. It actually says generally. I think it's actually left up to really the physician to kind of look at what rapidly progressing at risk of rapid disease progression might mean. But Andy, why don't you take the answer to the first question, and I will address the second one. Sure. I really can't give you specifics other than, you know, as Renée said, there's a guide, you know, there's an indication, and the physicians have patients that they see that they feel are immediately appropriate. I don't have the specific lab data for these patients, but I can tell you that once again, the uptake has been quick for many, many different physicians, nephrologists, that have these patients in mind when they see them. They are getting enrolled. As I said earlier, they're not being kicked out or canceling due to payer restrictions by any means. That's all I can really say about these initial patients. With regards to your second question, you know, with regards to sparsentan, I think in order to kind of, you know, in any intelligent way, you know, answer that question, I think we would need to see some data from that trial. Obviously, that would include, you know, some eGFR data. It would include obviously what concomitant medications were given, because obviously immunosuppression was allowed in that trial. Also, I think, you know, this is obviously a drug that has a fixed kind of combination of RAS blockade, and so again, it would actually kind of mean that physicians would have to, you know, really change the way that they are doing things today. I think that we really need all of those things to get a better understanding of you know, how that would impact the market. You know, again, personally, you know, this is a market that, you know, really has had no kind of, you know, approved drugs for a very long period of time. You know, my assumption is that there was never anyone who thought that there would only be one drug that would be approved in this indication forever. I think that there is a lot of room, again, depending on the profile, the label, the data, on what actual kind of patient population may or may not be approved under accelerated approval. By taking all of that into account, you know, I certainly think that there is, as we've seen in many other rare indications, that there's certainly room for two and even three, you know, different, you know, approaches. Again, you know, ours is more kind of targeted and local at the actual origin of disease. Other ones might be more systemic, so there might be benefits and drawbacks, combinations, that will be very valuable for physicians to use. Again, you know, before we actually have some idea of some of these things, it's, you know, it's difficult to be, you know, any more specific than that. Okay. Got it. That's helpful. Thank you so much. The next question comes from the line of Maury Raycroft from Jefferies. Please go ahead. Hi. Congrats on the progress, and thanks for taking my questions. Just wondering if you're providing any specifics on sales or launch expectations for the rest of 2022, and what can you say about what you're seeing in April and early May so far on the backdrop of COVID dynamics? In terms of kind of guidance, I think actually, I mean, this is not really sufficient. We don't really have enough data because, again, we can't really rely on other products out there or ICD-10 codes or anything else to really predict. I think what we want to do is we want to be pragmatic, and we want to give some guidance that actually kind of would make some sense. From that perspective, you know, it's hard to do. Fredrik, you know, please go ahead and give your view on what we can and can't do from a guidance perspective. Yeah. I think we need to make sure, as Renée's saying, that our guidance is useful, and therefore, I think we need additional months under the belt, seeing the trends. Hopefully, we may be possible to give a guidance after the second quarter, start to see clear trends. We have to take that as we go. Got it. Makes sense. Just to, quick question for the... I guess following up on that, for COVID dynamics, what kind of an impact is that having on the launch so far? Sure. Andy, do you want to take that? Sure, sure. I mean, we launched in the beginning part of this year, so the environment's been generally stable and consistent since we launched. I think we've discussed before, and obviously, the results are the results. We feel that we're doing very well. As we've discussed before, we hired a very experienced sales force, and a lot of them have already been in this nephrology space, the majority of them. We really have gotten access. There's a lot of interest, and the uptake, as you could see by so many unique prescribers, they understand the concept. It's not a long, you know, process for them to understand the benefits of the product. It's hard to comment exactly on the future, but so far to date, we're very pleased with how it's gone. Got it. Okay. Maybe just a quick question. For the 134 patients enrolled, do these include any patients who completed part B of the phase III study? I guess, do those patients leave the study and then go on to commercial drug? Actually, I don't. We wouldn't have that information because we wouldn't actually know, you know, who the patients are that, you know, were part of the trial. We don't have access to that information. Actually, we're not in a position to know that. Okay. Understood. Thanks for taking my questions. I'll hop back in the queue. Thanks. The next question comes from the line of Annabel Samimy from Stifel. Please go ahead. Hi. Thanks for taking my question, and congratulations on the good start. I'm just curious to know how physicians right now are responding to any of the PA requirements. Are you finding that the steps being put in place are particularly onerous, especially for those payers that you haven't contracted with yet? I know that you mentioned that physicians aren't necessarily seeing the 1.5 UPCR as a cutoff, but are payers using that as any kind of restriction for any of these patients for coverage? Andy, do you want to take that? Sure. I just want to comment on one thing you said, plans that we haven't contracted with yet. We're not rebating, so we're not contracting really with any plans. It's just them making a P&T decision. But look, TARPEYO is being managed by commercial payers in a similar way to other specialty medicines, and this is as expected. They include, you know, their management includes, typically, it has to be written by a specialist on label use, quantity limits, and sometimes prior concomitant treatments. We haven't seen any real surprises there, number one. Number two is, you know, yes, some are going to require the limits of eGFR proteinuria. They base it on phase III trial criteria and things of that nature as well. The easiest thing to say to folks is that people enroll in our program, and the physicians are helped with this White -Glove service with our hub. They liaise, these case managers, between the patient, the physician, and the payer. They can get them through this process, and we haven't been receiving any negative feedback or people dropping out of the program due to payer management. So far, we've been very encouraged, and it's all been kind of expected, and that is typical for all products, all specialty products, I should say. Okay, got it. If I could just follow up with some of the feedback that you're getting from the field. I know it's too early to say whether patients are responding to the drug, but have you been hearing anything from the field whether patients are finding the drug to be more tolerable than what they've had in the past? Is TARPEYO behaving from a tolerability perspective as we would've hoped for? Do you have any feedback from that perspective? Yeah. Andy? Yeah, the answer is no feedback. I mean, once again, it's really early and everything's been encouraging, positive. We listen on social media and we haven't heard anything negative as far as that's concerned. So far so good. Okay. If I could ask one more question. You mentioned that there's only been one rejection so far. Do you have a sense of what the timing is for most patients to be ushered through the process of how TARPEYO Touchpoints is compressing that time? Yeah. Is it happening more rapidly than you would've expected? So I- Andy? I can answer that. Yeah. We monitor every single thing, and the answer is yes. It's been improving and will improve. We have metrics and things that we shoot for. I think it's as expected. Remember how this disease is. Oftentimes, it's very variable, and so the patients, as long as there's good communication between patient and physician, they're in the queue and they will get their prescription. It's just so it can be variable at this beginning stage, especially for the plans and how they're managing this. Until you get your stride and understand exactly how each specific plan manages it, the time just only gets shorter, but until you learn those management techniques. Okay. Got it. Thank you so much. Okay. The next question comes from the line of Rami Katkhuda from LifeSci Capital. Please go ahead. Hey, guys. Congrats on the progress, and thanks for taking my questions as well. Two quick ones for me. I know it's early, but given that TARPEYO is kind of the first approved therapy for IgAN, do you expect to bolus patients early on or a more consistent growth of enrollment forms over time? Andy, do you want to take that? Yeah. I think the answer is there's really been no bolus. I think we're judging it as, remember, these patients go to see their physician 3x, 4x a year, and it's at that point that they're being assessed on their progress, on their decline in kidney function, their eGFR and proteinuria. It's at this point that they make changes to their prescriptions and their treatment. I think the biggest takeaway that you should get from this is that there's so many unique prescribers that the adoption is quick, okay? It's not like that they're calling up everyone in their database, in their practice and getting them to come in for a prescription. It's during the cycle. Th ey've immediately adopted and understand where this product fits and how it benefits the patients. Got it. Since IgAN patients are generally younger, do you guys have any estimates on what percent of the patient population are covered, excuse me, under commercial plans versus Medicare? The only thing I could say to that is the market data. It's too early to give any, you know, real sense of anything. We just know from overall market data, syndicated data before we were, you know, available that it's in the 65%-low 70s as commercial. I would assume that the trend would be the same, since that's the overall population mix. Makes a lot of sense. Thank you, guys. Next question comes from the line of Dan Akschuti from Pareto Securities. Please go ahead. Hi, everyone. Thank you for taking my questions and congratulations for the impressive start. Just one small question is on the FTE currently on the sales force, and if you plan to expand that, if we should look forward to any specific marketing campaigns, promotions that you have planned? So- Andy. I- Take that? Just from that. Yeah. Look, it's early. We've always said before we launched, we had as much data as we possibly could being first to this space without an ICD-10 code and a lot of real granular information. Since everything was treated with generic blood pressure-lowering medicines and those kinds of things, it was hard to really size this perfectly. I still believe that we have sized it correctly, and certainly we monitor everything during a launch. We're very close to every single measurement, and we have certain triggers that if it makes sense and optimizing our sales force would be to increase it, then we would consider that, absolutely. We're just, once again, when you have a product in an accelerated approval, the FDA requires that your promotional campaigns are submitted and reviewed prior to your use. We're very, very excited that we're just launching an actual promotional campaign, which means, you know, the branding and everything, right now. This is just going out now. We're excited to see the impact of that. Once again, it's nine weeks of sales force calling on physicians so far. We're, you know, it's too early to really give definitive answers on anything like that. Okay. Thank you very much. Just one follow-up question is, you mentioned in the slide you see that the acceleration of the Q1, do you continue to see that now in May as well? I think that was to date, you know. Once again, we're pleased. We're just trying to give you the trends since the end of the quarter because it was early. Okay. That covered from the quarter to today. Thank you. If I may, one last question. Did any of the patients that have been given the drug stop the treatment? I'm not sure that we even have that kind of, I mean, it's so early, I'm not sure that we've actually seen that at all. I don't think not as far as I'm aware, actually. I mean, I can go and dig into that, but I mean, I don't think that we've gotten to the point, yet where that would actually kind of be the case. Okay. Thank you very much, and all the best. Thanks. Thank you. We have one more question from the line of Johan Unnérus from Redeye. Please go ahead. Thank you for taking my questions and congratulations. A good start and also sensible to not provide a guide at this stage, perhaps then after Q2. Interesting with the classification of the patient profile, it seems to be rather open. Is there any indication that it's being used, how to put this, surprisingly preventive at this stage, or is it too early? Preventive. Well, I think obviously in terms of the trial that we ran, this was really for patients that are considered to be at risk, and that would kind of follow the, you know, inclusion/exclusion criteria of the trial. That is the kind of patient population that is the basis of the approval and the discussion. I think that, you know, it's really within that kind of patient population. I think all of those patients would probably be deemed by definition to be at risk. Given the early uptake, the prescriber seems to be rather proactive. Yeah. I mean, again, I think we're, you know, we're delighted by the fact that, you know, this is a, as Andy just mentioned, you know, it is a broad kind of prescriber base, if we can say that this early kind of in the process. It does kind of talk to, you know, the rate of adoption, here, which I think is, you know, very encouraging. It's clearly a lot to do about the commercial coverage part of the market. I think you alluded to 65%-70% of the patient population is likely to be from the commercial side, and you have already really made good progress. What to expect towards the end of the year or midyear in terms of covering commercial lives? Andy, I don't know if you want to take that, but I think it's difficult to judge. Go ahead, Andy. Yeah. No, it's difficult to judge. It's, you know. This is typical. What's typical is six to nine months post, you know, approval and launch to see the majority of them make their P&T decisions. We're pleased with the speed at some of the larger plans. I think that we're on target for, you know, that timeline to have most of the decisions made for coverage. Once again, I think it's real important to understand that just because they haven't made a decision yet doesn't mean that a patient does not have access. There is a medical exception process, and patients with plans that haven't made final decisions yet are still eligible and able to get the product. Excellent. Finally, sort of more of a technical point. When do you actually record the sales? Fredrik? Yes. We are recording the sales when the ownership is transferred to a specialty pharmacy. Excellent. Thank you for taking my questions. Thanks. As there are no further questions, I'll hand it back to the speakers. Thank you very much to everybody who tuned into this Q1 presentation from Calliditas Therapeutics, and we look forward to presenting the Q2 numbers to you in August of this year. Thank you very much. This concludes our conference call. Thank you all for attending. You may now disconnect your lines.