Welcome to the Calliditas Therapeutics audio cast of teleconference Q4 2021. For the first part of this call, all participants are in a listen only mode. Afterwards, there will be a question and answer session. I now hand you over to Renée Aguiar-Lucander, CEO. Please begin. Thank you very much and welcome to this Q4 report. With me today I have Andrew Udell, President, North America, Chris Nye, VP Market Access, and Fredrik Johansson, Chief Financial Officer. I'd like to draw your attention to the disclaimer page on page two with regards to any forward-looking statements made and refer you to the company's reports on other filings, including those which contain risk factors and other relevant information. If you please turn the page to page number three. This quarter, Calliditas achieved a historic milestone in the company's history as we had our first commercial product approved in the U.S. under accelerated approval by the FDA. This is the result of our pioneering efforts in IgA nephropathy, which started over a decade ago, and we are delighted to be able to offer the first and only approved drug to this highly deserving patient population. The actual approval was provided on December fifteenth, and this is under the branding of TARPEYO. As I mentioned, it's the accelerated approval by FDA. The indication is to reduce proteinuria in adults with primary IgA nephropathy, IgAN, at risk of rapid disease progression. Generally, a urine protein to creatinine ratio above or equal to 1.5 gram per gram. As I mentioned, it is the first and only approved treatment for this orphan indication. The drug itself has been specifically designed to address the origin of this disease, with the hope and potential of being disease-modifying. Other things that happened in Q4, and we finalized our acquisition of the remaining outstanding share capital of Genkyotex, which is now a wholly owned subsidiary, as it was delisted from the Euronext stock exchanges. We also initiated a pivotal phase II/III clinical trial called TRANSFORM. This is now another kind of very similar trial in terms of size and ambition to the NefIgArd trial, in the area of PBC, which is another orphan indication, this time in liver. We randomized the first patient in February 2022, and we also initiated a phase II proof of concept after the quarter, in this quarter in the Q1. If you take the next page, other things that happened after the quarter, we announced the commercial availability of TARPEYO in the U.S., and shipping of product to patients was initiated immediately thereafter, which reflects a successful launch out of the blocks, and we will hear more about this later on in the presentation. In terms of the regulatory process with EMA, this is ongoing. We have submitted our answers related to the Day 180 questions. The target remains intact in terms of receiving an opinion in this quarter, which would then mean an approval a couple of months later, therefore in Q2. This is perhaps some of the key events during the quarter. I will now hand over to Andrew Udell, who's going to take you through some more information around the launch of TARPEYO in the U.S. Thanks, Renée. We should be on slide five. I have the distinct pleasure to discuss the work and execution of an experienced and well-prepared commercial organization. As stated on December 16th, we were ready. Actually, we were ready in September prior to the original PDUFA date. Before I go into details, I have to say the inbound unsolicited outreach has been overwhelming and incredible. This includes both the healthcare professionals as well as the patient and advocacy community. This is an eager audience. Next slide, please. The IgA nephropathy market is unsatisfied and represents a substantial opportunity. IgA nephropathy has an estimated prevalence between 130 and 150 thousand in the U.S. Over time, more than 50% of the patients progress to end-stage renal disease, which leads to dialysis and kidney transplantation, both of which are debilitating and extremely costly, with dialysis costing commercial payers in a range of $200,000 annually and kidney transplant over $440,000. Research has consistently shown that this is an unsatisfied market that is craving advancement and a treatment specifically designed for IgAN. In a survey of 188 nephrologists conducted prior to the approval of TARPEYO, 52% of the nephrologists indicated they believe there are currently few or no effective treatment options available. In addition, they anticipated 65% of their patients will progress to dialysis. Next slide, please. December 15, 2021, TARPEYO achieves FDA-accelerated approval. Once again, the inbound outreach and interactions with KOLs and patient organizations has been extremely encouraging. Immediately upon our approval, our websites go live. Our medical affairs team, which has been in the field for a few years, initiated a peer-to-peer launch outreach program to the top KOLs, and our contingent offers to sales representatives became effective. Next slide, please. In addition, of extreme importance, on December 15th, we launched our full-service patient and provider support and services program called TARPEYO Touchpoints. It is designed to streamline the access to TARPEYO for the appropriate patients. The program uses Biologics Pharmacy Elite models, which contains a hub and exclusive specialty pharmacy services integrated and all under one roof. This includes a dedicated team of care navigators, as well as designated rare pod team that contains nurses, pharmacists, and fulfillment and distribution team. Additionally integrated in these services for qualifying commercially insured payers, patients rather, sits our copay assistance program provided by CoverMyMeds from McKesson. Next slide, please. Our sales management was in place in the middle of 2021. Recruitment for our field was prioritized and based on representatives with rare disease, specialty product, and nephrology market experience. Due to some recent market activities that included downsizing from some major companies, our sales managers were able to staff over 70% of our territories with representatives with nephrology experience. If you are familiar with this therapeutic area, you realize this is a big accomplishment since the nephrology space currently has very few branded products being promoted. As mentioned earlier, on December 15, our contingent offers became effective, and so prior to the end of 2021, we had accepted offers and had initiated onboarding for all territories. Our goal, which was achieved, was to initiate formal training the first week in January. Next. I'm sorry, same slide. Go back. In order to optimize the field force, we developed a sophisticated segmentation targeting and customer relationship management system to reach the top nephrologists that treat IgA nephropathy population. This, coupled with the nephrology experience of most of our field force, has enabled us to get out of the gates quickly. As you're likely aware, as per our January 28th press release, sales have commenced. In summary, we remain optimistic based on the facts that we have the convergence of an unmet medical need, a motivated audience, a first and only approved product that was specifically designed for IgA nephropathy, and an experienced commercial organization. I'd like to now turn it over to our Vice President of Market Access, Chris Nye, to take you through some additional market access activities and expectations. Next slide. Thanks, Andy. First, I want to provide some context for those who are less familiar with the U.S. access environment. There are thousands of health plans in the U.S. offered by commercial and government-sponsored health insurances. Commercial payers are insurers such as Aetna, Cigna, and UnitedHealthcare. Government payers are largely Medicare and Medicaid. Commercial payers still control more than half of U.S. lives. There is a pharmacy and therapeutics committee, generally called P&T committee, at each payer that reviews new treatments for formulary inclusion and utilization management. It typically takes three to six months for a P&T committee to review a new treatment after it becomes commercially available. During that time, payers often have default coverage or medical exception process in place to manage the new treatment. Once a P&T committee makes a coverage recommendation, it is reviewed periodically based on utilization experience. Next slide, please. We deployed our national account managers to engage with payer customers beginning Q3 of last year. We focused on 49 key payers that covers more than 80% of commercial lives. Research showed that a majority of IgAN patients has commercial insurances. Eight clinical presentations to inform P&T committee review were scheduled before the end of the year, with six of those already completed. Among those scheduled, a clinical presentation with us included three largest U.S. commercial payers, CVS, Cigna, and ESI. As expected, P&T committees started reviewing TARPEYO in late January when the product was commercially available. Our exclusive specialty pharmacy partner, Biologics, helps patients and providers to navigate the default coverage or medical exception process at each plan prior to a formulary coverage decision. Next slide, please. For a specialty product like TARPEYO, it is common for payers to set prior authorization requirements. Through our payer advisory boards and mock P&T committee review exercise, we anticipate requirements to include items such as biopsy-proven diagnosis, neph prescribing, optimal dose of RAS inhibitors, and having certain levels of proteinuria and or eGFR. We do expect providers to align with KDIGO clinical practice guideline when prescribing TARPEYO, thus the potential patients are likely to meet these requirements. I would now like to turn over to our CFO to take you through our financials. Thank you, Chris. Next slide, please. I will now present to you the financial overview for the full year of 2021, and all numbers presented to you are in SEK, as always. To start with, we present SEK 229.3 million in revenues for the period compared to SEK 0.9 million for the same period last year. The revenues originating primarily from the EUR 20 million signing fee received in connection with our licensing of Nefecon in Europe to STADA, and a milestone of $3 million from Everest that we received in the fourth quarter. Our total operating expenses for the period amounted to SEK 753.8 million, compared to SEK 388.6 million for the last year. Out of the total operating expenses, the cost for R&D increased by SEK 160.1 million to SEK 357.5 million, compared with SEK 241.4 million last year. Increase in R&D expenses originates primarily from the preparations and the product development for the second XC trials, where we have randomized the first patient in TRANSFORM PBC trial the other week, as Renée mentioned. The sales and administration expenses amounted to SEK 390.2 million for the period, to be compared with SEK 141.7 million for the last year. Increase of SEK 248.5 million between the periods was primarily related to the preparations for the commercialization of TARPEYO in the U.S. This leaves us with an operating loss of SEK 524.5 million for this period, compared to an operating loss of SEK 379.7 million for the same period last year. The capital used in operating activities for the period amounted to SEK 461.6 million, compared to SEK 309.2 million the previous year. The cash flow used in investing activities for the period was SEK 24.3 million, and this is mainly related to a milestone payment early this year for when we filed the license for the U.S. During the third quarter, we closed two transactions, where we first in July signed the $75 million credit facility with Kreos, and subsequently later in Q3 we made the first draw down of the $25 million tranche. We also completed a new share issue of 2.4 million shares in the third quarter, raising gross SEK 325.4 million for transaction cost. Our cash flow from financing activities in the period amounted to SEK 435.2 million, primarily due to the above transactions. We therefore report a strong cash position at the end of the year of SEK 955.5 million, which is almost in line with last year's SEK 996 million. Please also note that we have a $50 million remaining unused in the Kreos credit facility, where the second tranche of $25 million can be drawn down, up until June this year. That was all for me. Now back to you, Renée. Thank you, Fredrik. As you can tell, we are very excited about the consequences of the success in Q4. We are well-positioned to have a very exciting year, I would say, in 2022. With that, we're going to open up for any questions. Operator. Hello. Thank you. If you have any questions for the speakers, please press zero one on your telephone keypad. We have a first question coming from Maury Raycroft at Jefferies. Your line is now open. Good morning. This is [Faizin] on for Maury. Are you providing any specifics on sales or launch expectations for 2022? I think at this point in time it's probably a little bit early, 'cause as you heard, basically we're about, you know, kind of, four weeks into the launch. I think it's probably going to be a little bit early to do so. I think all we can say is obviously that, you know, we're very encouraged by what we're seeing, and you know we see all of the signs I think it's been a very kind of successful launch out of the blocks. I do think that obviously it's still very early days, and so I think we will probably hold off on providing any guidance until we report. I think the earliest we can do that is probably when we report Q1 results. Okay. Makes sense. Also, can you elaborate on the recent feedback you had with the EMA regarding the Day 180 questions? Were there anything specifics they were looking for, or everything is pretty much general as we expect? I think from our perspective, you know, there was not much surprise in terms of the questions. As always, you know, I wanna caveat that with the fact that this is a regulatory process and so we can't really draw any conclusions from the questions that we received or make any assumptions on the basis of any kind of potential approval. Got it. Thank you. The next question is coming from Annabel Samimy at Stifel. Your line is now open. Hello, Annabel Samimy? Your line is now open. There seems to be an issue. We will skip to the next one, which is coming from Yigal Nochomovitz at Citi. Your line is now open. Hi. Hi, Renée and team. Thank you for taking the questions. Renée, I just wanna get a better understanding of the addressable population, because that would be obviously the patients that are at risk for ESRD progression. Now, in our work, you know, we've looked at the literature and we've seen a percentage somewhere in the range of 30%-40% of the IgA patients are at risk. I think you cited something a little bit higher, 50%, maybe 65%. I just wanna get a better understanding You know what that true number is with regard to those that are actually at risk for ESRD progression. Thank you. Well, why don't I start and see if Andy might have anything to add? I think that in terms of I think we fairly consistently have stated, and this is obviously based on, kind of the available, research and materials out there. I think that, you know, it is an uncertain number, in terms of exactly how many patients are at risk of progression. This comes from the fact that obviously it's an orphan disease, and there really isn't any, reliable kind of, third party source or anything that we can, you know, specifically quote. But I think that we've kind of consistently, quoted the fact that, you know, up to or just above 50% of patients, are at risk of progression, who are diagnosed with this disease. I think that, you know, if there is any better, you know, information out there, I think, you know, we will learn more as we actually kind of commercialize this product, and get better access to real data. I think as of right now, I think that, you know, we don't have any better source than the ones that we have, you know, previously communicated, which is, you know, around 50% of the patients do fall into the kind of KDOQI guidelines view on patients who progress. That's great. With regards to the launch, I mean, obviously there are a lot of moving parts with the drug launch. What do you believe are sort of the key things that you have to get right in the launch to you know, to ensure a successful launch out of the gates and a successful brand going forward? Andy. I think it really starts with market access and medical affairs. As you heard from Chris, and as I discussed earlier, market access is really key. Having this hub, this patient services and this limited to exclusive, I should say, distribution model really streamlines things and makes it overcome a lot of barriers that are potential to fall through the cracks for patients to receive their medication. I think that getting that right is essential. In addition to being fortunate to have Chris, the person that manages that, she comes directly from actually working at a specialty pharmacy and in doing this and has managed several programs. She's actually physically located geographically close to the hub and specialty pharmacy. We're very comfortable and confident in that. That's the first thing. That's off and running. The second thing I'd say that's key is certainly, you know, a field force with experience calling on nephrologists, and we've done a lot of work and supplying them with the right message and materials, which I think that they will have all in place. So far indications have been positive that we are segmenting and targeting plans have been pretty effective, as to the initial reaction we're hearing. You know, calling on the right targets with the right message and the right frequency should give you the right results there as well. All in all, I think we're, you know, very encouraged, as Renée says, that out of the gates here, you know, and I think that those are the things. We're measuring every possible thing you can imagine, but those are the things that are of most importance. I think I just wanna add there obviously that, you know, the senior team that we have here in the U.S., you know, has considerable experience in doing this before. It isn't the first time that any of them is launching a drug or, you know, doing this, which I think is important. I also think obviously we have been planning and putting this organization in place for well over two years now. I think we are as well prepared as we possibly could be. Thank you. The next question is coming from Erik Hultgård at Carnegie. The line is now open. Yes. Hi there. Thanks for taking my questions. I have a couple if I may. First, I understand it's very early days. You've been commercially available for only four weeks, but could you provide us with some early indicators of the progress to track the launch? Say something about number of prescribing centers, number of prescriptions, anything, any color on that would be very helpful. Second to that maybe, at what time point do you believe that you are more confident to be able to evaluate whether the launch has been successful or not? At what time point do you feel confident to sort of see that the launch is above or below expectations? Finally, maybe on costs for Fredrik for 2022, if you could comment on the level of SG&A and R&D costs that we should expect at least directionally from Q4. Thank you. Sure. So I think that, you know, in terms of early indicators, again, I think it's not I mean, it's really not gonna be helpful to provide at this point in time any, you know, specific numbers. I think that, you know, what we, you know, hopefully have conveyed and will continue to convey this is exactly that as far as the launch is concerned, we believe that, you know, we are having a very successful launch. We are confident that the launch has gone very well to date. Having said that, obviously, you know, it is early days, and as we all know, this is not a kind of a disease area where there is a lot of metrics available, codes available, or other information that we can compare to, or kind of successfully reference to, as we are the first company to launch in this indication. Obviously, as I think we've been trying to communicate, there's been a lot of inbound interest. I think there is a significant unmet medical need in this indication. As I said, you know, our belief is certainly that, you know, in the early days of this launch, it has gone to plan and it's going, you know, it's been very successful. You know, again, it's early days. I will see. Do you want to add anything before we go on? No, I would say there's a lot of things we measure that have different timelines. I mean, you heard Chris a little earlier. From a payer standpoint, you're on the timeline of the payers. You know, sometimes they have different set schedules where they're reviewing the product. So his timelines may be different in certain aspects. We have immediate timelines for reach and frequency of our sales force. There are different measures and ways we look at this over time, but certainly the key is that it takes time to overall measure a successful launch. I just wanted to add that. Right. When it comes to the cost base, we expect an increased cost base for next year for, of course, R&D. We do have the two setanaxib programs running next year. What we expect is approximately a sort of increase from 2021 year's level of around 30%-40%. When it comes to sales, marketing and G&A, we of course will have a full commercial organization in place for a whole year. We expect the sales, marketing, and G&A all together to be an increase of around 70%-80%, I would say, from the 2021 year level. All right. Thank you. That's really helpful. The next question's coming from Rami Katkhuda at LifeSci Capital. Hi, guys. Thanks for taking my questions. I guess, first, can you remind us how often the KDIGO guidelines are updated and the potential of getting TARPEYO on them? Sure. Actually the KDIGO guidelines were recently updated. In that process, which actually took a you know fairly significant period of time, there was also a decision made at the kind of board of KDIGO. Which is why it took a bit longer, is that they also were in the process of having more of a digital process in terms of updating them. It is our understanding that they will therefore be able to update them more rapidly going forward. I don't know, Andy, if you have any you know additional comments to that, but we would expect you know the KDIGO guidelines to take this approval into account within a reasonable time period. Yeah. I would just echo that and as well as that we have been working with. If you look at the names of people that are managing that or discuss and help determine these guidelines, they're all the names of this small community that specializes in treating IgA nephropathy, and they're very familiar with us and the product. It's on the radar screen, and it's just hopefully you know, sooner than later. Got it. Just quickly switch gears. In the TRANSFORM study, should we expect to see data at the interim, or is it more of a futility analysis to get to kind of the phase III portion of the trial? It is designed as a futility analysis, so we would not expect to provide any data at that period of time since it has this adaptive design, which will allow us to basically just seamlessly go from phase IIb to phase III. Got it. Thanks, guys. The next question coming from Johan Unnérus at Redeye. Your line is now open. Thank you. Johan here. Thanks for taking my questions. First one, can be relating to the P&T and the PA review and prior authorization. You allude to that this process could be completed already Q2, Q3. That seems to be going good. How confident are you in that process? I can take that. Historically, when we look at the market basket of new products coming to the market, it is typically around a Q2, Q3 post-launch that the product sees a significant increase in terms of P&T conclusions. That's why we give that as a time point for assessment. That's good. Presumably that it's important to have that in place before and to run some of the launch into that. Well, after that, until we can gauge if the launch is successful or not at this stage. Of course, you will have the filtration feedback coming out next year. I'm sorry. Sorry? No, I was referring. Yes, I was thinking about the aspect of judging if the launch is a success or not to have this PTPA review completed and also perhaps to also get security filtration data that will emerge next year. That will be important to fully assess if the launch is successful or not. I see. Okay. Yeah. I think in terms of the launch itself, I think that obviously as Chris has already mentioned, I think that around kind of Q2, Q3, you know, that will be a significant period in terms of having, you know, in terms of market access, and clarity around that. That I think will obviously, you know, additionally help any kind of launch activities and any kind of trajectory at that point in time. I think that in terms of judging the success of the launch, as I mentioned, I think obviously it is, you know, at this point in time, it's early days. You know, we hope to be able to give you some more insights, when we report Q1 results. At that point in time we will be able to maybe give some indications on a market access basis. As Chris has indicated, it's probably more likely to be slightly later in the year that we have all, you know, the majority of these decisions. With regards to the eGFR, I would say that, you know, in terms of any kind of coverage or acceptance or prescriptions, et cetera, I don't think that that's something that the market or healthcare professionals are waiting for. I think it's obviously a very important metric which will complement our accelerated approval and obviously hopefully lead to, you know, a full approval in a broad patient population based on that data. That data will obviously not be available until 2023, but I would say that data is not really connected or related to the launch of the product today, which really, you know, is very kind of capable and able to be, you know, fully launched on the basis of the accelerated approval, which we have at this point in time. Obviously it will further strengthen and be a positive event next year, when that data becomes available. That is our expectation. Yes. Thank you. A clarification relating to that. I think in some places you mentioned second half of the year and then more lately first half of the year in terms of that feedback. If, perhaps you can clarify if it's first half of the year? In terms of the data coming out of the NefIgArd trial, obviously this would be the completion of our entire phase III program in IgA nephropathy that is expected to take place, you know, in early 2023. That is still our expectation. Obviously that would follow. That kind of data or completion of that program would then be followed by a regulatory submission for full approval with the various kind of regulators. That approval, you would then expect, if on a normal kind of timeframe, to have that decision, either kind of, you know, end of next year or maybe, you know, early the year following. I think that that's the timeline we have consistently been providing guidance on, and I don't think that there you know there's absolutely no reason to believe at this point in time that that would change. The one caveat that we always have obviously is you know the any kind of impact by you know from COVID-19 or other you know similar types of events that is outside of our control. Excellent. Finally, even the label is useful and wide and covering some 50% it seems like that could fall into this category. Even though it's very early days still, of course, is it possible to say anything about the likely initial patients? Are they, is it likely to be proactive centers perhaps looking to, you know, preventive aspects or is it the more severe patients or is it patients that are sort of deteriorating faster that are more likely to be early takers, so to speak? I think I can answer that. First, obviously it's early and all our research, we are the first indicated product. All our research showed the protocol and where the nephrologists were gonna put this product in their treatment protocol. In other words, they were gonna use supportive care and then after that there's nothing else indicated so that seemed to be the proper place of placement for their first patients. Human nature in most launches is to start with your more severe patients in adoption. All our research showed that people understood this, the design of the product, the product, they were familiar maybe with budesonide used in asthma. The adoption I think is gonna be quicker 'cause of the comfort level that they have there. You know, I think I have no answer for you on the first patients that are on the product already, as their exact profile, but that's what all our research points to. Excellent. Thank you so much. I remind you that if you want to ask a question, you will have to press zero one on your telephone keypad now to enter the queue. There are no further questions at this time. Please go ahead, speakers. Thank you very much. Thank you very much for all, from all of us to all of you. Thank you for your interest in our Q4 report and we really look forward to speaking to you again when we can present our Q1 results. Thank you.