Please go ahead. Thank you very much, operator, and good afternoon and good morning to all participants. A warm welcome to today's webcast, held in light of today's very positive news flow, where we as a company, Egetis, intend to submit a marketing authorization application for Emcitate to the European Medicines Agency based on existing clinical data. This is a great opportunity for us as a company, but also a great opportunity for the patients suffering from MCT8 deficiency. Next slide, please, operator, and the subsequent slide as well, please. We're now at slide three. For those who haven't had the privilege to meet before, I'm Nicklas Westerholm, and I'm the CEO of the company. With me today, we have Kristina Sjöblom Nygren, Chief Medical Officer, Yilmaz Mahshid, Chief Financial Officer, Christian Sonesson, Vice President, Product Strategy and Development, Henrik Krook, Vice President, Commercial Operations, and Peder Walberg, Operating Director of the Board. Next slide, please. During today's call, we will cover, among other things, an overview of Egetis Therapeutics and our lead candidate Emcitate, obviously with the focus that we announced this morning, where we plan to submit marketing authorization application for Emcitate to the EMA based on existing clinical data. We will remind ourselves of MCT8, the condition MCT8 deficiency, a detrimental condition, and the available clinical data we have at hand. We will also leave ample time for questions and answers at the end. Operator, next slide, please. Egetis Therapeutics, a specialized late-stage orphan drug development company solely focusing on rare diseases and treatment for the same. We have two assets in late-stage development today, Emcitate and Aladote, both operating in a very attractive orphan drug segment, which comes with features like shorter lead times, fewer patients required in clinical trials, and higher probability of success. That in combination with a substantial commercial opportunity for both our assets. In addition to that, we see a clear path to market approval in both Europe and U.S. in the coming couple of years for both Emcitate and Aladote. Furthermore, a key strategic intent for the company is that we're planning to launch both our assets through a small and focused in-house commercial organization in Europe and U.S. Considering that we are addressing a field of rare diseases, this is fully realistic, and we believe that the commercial infrastructure required to commercialize our products in the U.S. and Europe will be in the region of 40-50 people when fully established. On top of that, then how I personally believe we try to differentiate ourselves is the core expertise we have in late-stage orphan clinical development, registration and commercialization. I believe that is reflected in today's news, where I really can compliment the team in the achievement, where we have successfully navigated the complicated regulatory landscape with the ability now to submit for marketing authorisation application in Europe. Next slide, please. Let's turn our attention to the overall pipeline very quickly. We have the lead candidate Emcitate for the treatment of MCT8 deficiency currently in phase III. We also have Aladote for the prevention of acute liver injury caused by paracetamol poisoning. Here we are planning to initiate a pivotal study in the first half of 2022, pending the COVID-19 situation. Next slide, please. Let's turn our attention to Emcitate for the treatment of MCT8 deficiency, a detrimental condition with high unmet medical need and no available treatment on the market today. Starting off from a clinical perspective, we have the first clinical trial completed in 2018, with the results published in 2019, the Triac Trial I. That illustrated significant and clinically relevant effects. In addition to that, we have had good progress during the second half of this year, where we were able to announce new real-world data that was published in The Journal of Clinical Endocrinology & Metabolism that confirms the long-term efficacy and safety of Emcitate in MCT8-deficient patients. This is a cohort study that has followed 67 patients up to 6 years. With this data at hand, that obviously triggered a more intensified interactions with regulatory authorities that led to the news published today. Furthermore, we have a Triac Trial II ongoing. It's an early intervention trial in young subjects, where we dosed the first patient in December 2020. Focus here is on the neurocognitive development, aspects of the disease. The recruitment is progressing well. We have a couple of patients still yet to recruit, but we are expecting the recruitment to be completed in the Q1 of next year. If you look at it from a regulatory standpoint, Emcitate received orphan drug designation in Europe and the U.S. in 2017 and 2019 respectively. Furthermore, we have a U.S. Rare Pediatric Disease Designation that was received back end of last year, which makes us eligible for a priority review voucher at approval in the U.S. Obviously, this voucher comes with a value for us as a company since the value can either be kept but also potentially be sold as a sponsor to others. Also during the autumn, in October, we received Fast Track designation by the U.S. FDA. Last but not least, today's news that we intend to submit marketing authorization application for Emcitate to EMA based on existing clinical data. If we turn our attention to the commercial side and the prevalence of the disease being an ultra-rare disease of roughly 1 in 70,000 males translates into a patient population in the Western world estimated to be in the region of 10,000-15,000 patients. In light of today's news, focusing on Europe, we see a patient pool of more than 5,000 patients in Europe alone. When it comes to pricing, as a company, we don't disclose our detailed view on pricing as such for Emcitate, but we believe it's important to calibrate the price point we see or the price range we see in this setting. Analogous orphan drugs are usually priced at premium. If you look at drugs with similar disease severity, an ultra-rare condition, as well as having the same treatment benefits we expect to have, good analogs here to look at would be Spinraza for SMA or Brineura for CLN2. Furthermore, we don't see any competition in clinical development today. We're working very focused on disease awareness, together with key opinion leaders around the world. More important, we have more than 130 patients already being treated with Emcitate on a so-called named patient use or compassionate use basis. This is, of course, very important to us 'cause, one, it verifies the unmet medical need. Two, it gives belief that physicians or treating physicians see Emcitate as a very viable or promising option as a treatment for this condition. Last but not least, it also provide an opportunity to generate additional data outside our clinical development programs. Next slide, please. Focusing in on today's news then. Based on recent regulatory interactions, we as a company conclude that available data from the Triac Trial I trial and the recently published long-term data will be sufficient for marketing authorization application in Europe. What that means, which is really positive, is that having all clinical data required for a regulatory submission already at hand substantially and significantly reduces the remaining risk for Emcitate in Europe. This is, of course, a great opportunity, as I mentioned before, both for us as a company, but also for patients. When it comes to timelines, as we mentioned in the press release, the timelines will be communicated as soon as all parts of the regulatory dossier are confirmed. worthwhile calling out, and again, very important that we have dialogues with other regulatory authorities to obtain their view on the current available clinical data and its implications for a regulatory submission in other jurisdictions. Obviously, noting that we have the same standpoint from a company perspective that the data would be sufficient for a market authorization. Last but not least, let's turn our attention to the Triac Trial II, and let me there first state that the confidence in the Triac Trial II from a company perspective remains. We have some good data on neurocognitive development aspects of the disease already in the Triac Trial I. Here, with the ongoing Triac Trial II, that will continue. We're aiming to further establish the effects of early intervention on the neurocognitive development aspects of the disease. With that, I will hand over to Peder Walberg that will walk you through MCT8 deficiency and the current clinical data. Yes, good afternoon and good morning. This is Peder Walberg. A brief recap on the disease as Nicklas already- Sorry, we are now on slide 10. As Nicklas mentioned, MCT8 deficiency is a detrimental condition without existing therapies today. It's a genetic disorder which affects about 1 in 70,000 males. It's an X-linked disorder, so it's a male-only disorder. MCT8 is a transporter of thyroid hormone, and having a dysfunctional MCT8 transporter means that thyroid hormone is unable to pass into certain tissues and cells in the human body. Patients with MCT8 deficiency will have two sets of problems. They will have hypothyroid symptoms from tissues which are dependent on MCT8, including the central nervous system and the brain. They will have hyperthyroid or thyrotoxic symptoms from organs which are dependent on other thyroid hormone transporters. It's a complex phenotype and they both contribute significantly to the morbidity of the condition. We know that they have a pronounced neurocognitive phenotype, but we also know that they have a pronounced problem also from the cardiovascular symptoms, for example, systemic and also in terms of body weight, et cetera, which contributes really to both morbidity and actually more so mortality of this condition. We can move to the next slide. Slide 11. In 2019, we published the results for the Triac Trial I. This was a study looking at 46 patients of all ages with MCT8 deficiency, and the focus here was looking at the T3, so the thyroid hormone circulating values which are high in MCT8 deficiency, and see if we were able to correct those and normalize these values with MCT8 therapy, and also that this then translated into an amelioration of the thyroid hormone status of the various tissues. Going to the next slide 12. This demonstrates the primary endpoint, which was the circulating T3 values in the patients, and the red dots signify the values at inclusion, and the blue band here is the normal range. As you can see, we are able to normalize essentially all patients in their circulating T3 values with high significance, and these are values at T12. We also know that this correction or normalization of T3 values is rapid, literally within weeks, and then sustainable up to 12 months. Looking at the table below, we can also state that this normalization of T3 values in serum translates into an amelioration of the thyroid hormone status in the affected tissues. We have standard markers for thyrotoxicosis, such as weight for age, cardiovascular measures, and also indicators of liver and kidney markers of thyrotoxicosis, which all go in the right direction and signal that these organs are ameliorated and experience an improvement in thyroid hormone status with therapy. We can move to the next slide 13. As Nicklas mentioned, we also have some data on the neurocognitive development in these patients. As many of you will recall, we can see that in the youngest patient groups, below four years of age, we see some clear dynamic in the neurocognitive development following therapy. While in older patients above four years old, we do not see much dynamic at all, and we believe this translates into a window of opportunity wherein you are able to affect the neurocognitive development in patients with MCT8 deficiency. As you also may recall, the ongoing Triac Trial II focuses on early intervention in patients as young as below 30 months of age, so 2.5 years, so aiming at even lower age. The reasoning there is that the earlier intervention, the better in terms of efficacy. Going to the next slide. Coming back to what Nicklas described, the cohort study, which was published during autumn, quite exciting. 67 new patients with MCT8 deficiency have been followed for up to 6 years. These patients have been evaluated according to the same principle as we had in the Triac Trial I. Looking at the same measures essentially. Coming already to slide 15. This patient cohort consists of two different sources. We have first patients who were part of the first Triac Trial I who have now been followed for a longer period of time, up to 6 years, 27 such patients. We also have 40 completely new patients who were directly recruited into our named patient program and followed for as long as they were treated. They together formed this 67 patients. As you can see on the right, this adds considerable experience for us, both in terms of long-term exposure, but also in terms of spread across age groups, where we add a number of patients, primarily in the younger patient groups here, which of course are important for regulatory discussions and to be able to evaluate the data in that young patient group. What do we see from this data? Coming to slide 16, and this is then a mirror reflection of the graph we saw for the Triac Trial I. The red dots being the baseline values and the blue arrows signifying the values at the last visit, and the last visit is up to six years following the first initiation of therapy. Essentially we see the same picture as in the Triac Trial I. We are able to normalize more or less all patients and keep their T3 values steady within the normal range or below if that's the target up to the last visit, which could be six years. You can see on the right that the results look durable. Also coming to the next slide 17, we are able to show that we can replicate the data we saw in the Triac Trial I also in the new patients which came into the trial and essentially see a very similar picture with normalization of T3 and amelioration of the tissue thyrotoxicosis across tissues in these patients. What this adds is of course a completely new data set of more or less the same size as the Triac Trial I, where we are able to replicate the effect seen. The second is that we are able to tell that these effects are durable up to six years. For the parameters where that's relevant, we also see continued improvement in parameters such as, weight for age, for example, which continues to improve over time. This is, we believe a very strong, data set taken together. Moving to slide 18, this is what we then intend to present to the regulatory authorities and what we discussed in our pre-submission meetings, last week, that the, planned, MAA for Europe would contain data from three sources, the Triac Trial I, the, cohort study, which is the long-term follow-up study we just discussed, and also a natural history study which was published, last year, which is important to really establish the natural history and to have a good comparator, in such a rare disease as MCT8 deficiency. As you can also see from this slide, the trial will continue. It will remain important to really establish the neurocognitive effects of early intervention, and it will be added to the dossier when the data is available, but not upon submission. With that, I hand back to Nicklas to conclude. Thank you very much, Peder. Operator, if you don't mind moving to the next slide, please, and also to the following slide. We're now at slide 20. To conclude, based on the very strong data and robust data Peder just mentioned from the TRIAD1 trial, as well as the recent long-term data that was published, we believe after interactions with the regulatory authorities that the data we have at hand are sufficient for marketing authorization in Europe. That has a significant impact on the reduction of risk for MCT8 in Europe, from our perspective. We will update the market when it comes to submission timelines as soon as all parts of the regulatory dossier has been confirmed. We're having dialogues with other regulatory authorities in the same manner as we have had with EMA to get their views on the available clinical data and implications for regulatory submissions in those jurisdictions. Furthermore, as Peder mentioned, and very important, Triac Trial II is important to us. It will continue, it's ongoing, and it's there to further establish the effects of early intervention on neurocognitive development aspects of the disease. With that, I hand over to the operator to start the question and answer session. Operator, please. Thank you, if you do wish to ask questions please press zero one on the telephone keypad, if you wish to withdraw your question you may do so by pressing zero two. Our first question comes from Adam Karlsson with Aurelia Partners. Please go ahead. Hi, guys. Thanks for taking my questions. A couple if I could. Just a first one on the sales force, you said 40-50 people once fully developed. Just to check first, was that across the U.S. and E.U. And was that for both Emcitate and potentially Aladote if approved? Secondly, how much, if any, of the sales force is already in place and when do you expect it to be largely complete? Thank you, Adam, for two very good questions. The first one is very simple to answer. It's 40-50 full-time equivalents across Europe and U.S. One can assume roughly 20 in the U.S. and roughly 20 in Europe, and then a couple of people based at the headquarters. We haven't started to build up the infrastructure. Obviously, we have appointed Henrik Krook as leading the commercial organization. Henrik has been working very intensively during this year with pre-commercial activity, so to say, especially focusing on disease awareness and starting to build up the value dossier. We see the buildup of a commercial infrastructure stepwise going forward. Obviously, being a small company, we need to do that in a careful way. We see a stepwise buildup starting at some point next year that will mature into 2023. Okay, A question, and you correct me if this is a wrong assumption to make, but presumably you would increase your operating cash outflow as regulatory activities ramp up, and you begin to build a sales force in 2022 and onwards. What can you say about the trajectory of your cash burn rate, and your cash runway? Yeah. No, thank you, Adam. You were breaking up a bit, but I think I got the gist of the question. We reported SEK 173 million in our Q3 release. We have clearly stated before that this cash is sufficient to bring our candidates towards market approval. However, if and when the company decides to fully build out an internal commercial infrastructure, new funds will be needed. I think you'll see that funds will be needed at some point in the future. Having said that, though, I think it's important to recognize that when we are building the commercial infrastructure, it's a slim organization, it's 40-50 FTEs that we see being built up over time, in a stepwise fashion. Furthermore, also important to recognize that as you know, we are eligible for a Rare Pediatric Disease Designation or eligible for a Priority Review Voucher, which of course will help us from a cash perspective in the not-too-distant future. Okay, great. Hopefully you can hear me okay. A question on that Rare Pediatric Priority Review Voucher. Do you have a sense, or are you able to give an indication on kind of when in time following a potential approval that you would have that voucher, how soon after approval is that granted? I think it's difficult to give you an exact time point. If you look at precedents, and that's the only thing I can refer to, you're looking at a couple of months after the approval to make sure that all the bureaucracy and the hurdles are jumped through. So one could assume a couple of months after a potential approval in the U.S. As you know, Adam, from before, it's evident from past transfers that the market value for an individual PRV is approximately $100 million. Great. Thanks. A question on pricing. You gave the example of Spinraza and SMA as a reasonable comparator. How much in terms of neurocognitive benefit does that price comparison imply? What would you need to see in Triac Trial II to support comparable pricing to Spinraza? And then separately, assuming a kind of a worst-case scenario of Triac Trial II failing to show a neurocognitive benefit, what would you then benchmark your price against in such a scenario? Yeah. Thank you, Adam. I think that's, excuse me, I have a bit of a croaky voice. I think that's a very good question. I think let's start off with the amount of data we have already at hand is very good. I think we see value already with the data we have at hand and the substantial benefits we can provide to this patient population. I think also worthwhile recognizing that we have, bear in mind, though limited, but also some neurocognitive data as illustrated in Triac Trial I. I think, of course, for us, it's important to show the effects, and it will be important going forward in the neurocognitive development. But I think from our ambition, it's very clear that the price we are seeking after approval is based on a full indication with positive impact on neurocognitive development. Okay, great. Perfect. Thank you very much. That's all for me. Our next question comes from Dan Akschuti with Pareto Securities. Please go ahead. Hi, everyone. Thank you for taking my questions. One question regarding the efforts in the U.S. Can you share some more insights how the discussions with the FDA is ongoing, and also on that and the disease awareness efforts that you have started also with the webpage that you launched, how this is ongoing in the U.S. and in Europe? Thank you, Dan, for your questions. I fully appreciate that you're asking, and I'm sure you fully appreciate my answer that we don't comment on ongoing interaction with any regulatory authority. What I can say is that obviously the position we had and the discussion we had with the European Medicines Agency, we're looking at it from our point of view in the same way in the discussions with the FDA. We will update the market as soon as we can and as soon as we have landed in a path forward with the U.S. FDA. When it comes to disease awareness, again, you rightly so stated that we have started to invest more in those type of initiatives. We are... have launched a disease awareness webpage. We are approaching through my head of commercial key prescribers across Europe and U.S. Actually we've been emailing, pushing and having dialogues with up to 10,000 physicians, pushing messages in the educational effort across Europe and U.S. in the pediatric endocrinology and the pediatric neurology community. We are also being present. I have scheduled to be present at 5 conferences next year, which we were delighted about. Very much so, and hopefully touch wood that the conferences will take place. Obviously, we need to recognize that we're focusing on disease awareness. It's not promotion, so there are some boundaries we need to operate in. I think a reflection though would be our named patient use program. We really see that we have had continuous good inflow on new patient requests from physicians of actually requesting access to Emcitate as a treatment. We continue to see that a couple of requests per month, and that's, I think, a good token on the situation we're in, that the physicians are starting to appreciate this, that they are starting to further understand the disease of MCT8 deficiency. Thank you. That was all, from my side. Thank you, Dan. As a reminder, if you do wish to ask a question, please press zero one on your telephone keypad. Our next question comes from Joseph Hedden with Rx Securities. Please go ahead. Good afternoon, and thanks very much for taking my question. Just on the named patient program, can you confirm how many patients are currently participating under that? I just wanted to get some clarity on what the process would be should you be granted an EMA approval. Are you then in a situation where you're waiting for individual reimbursement decisions before moving patients across from the named patient program, or is there some other process? Thank you, Joseph. Today we have somewhat slightly north of 130 patients on the named patient use program or compassionate use program, and in more than 25 countries. I think that's a really good start. I think it's very important to recognize that when it comes to providing treatment under a named patient use program, that's very much different to having an approved treatment on the market. In Europe, as an example, it's a country by country conversion from named patient use to a commercial drug, and that's a process we have to walk through in the different countries in Europe. Perhaps I can, this is Peder, perhaps add a bit. I don't know if this is a recent previous question, but historically there were sometimes gaps when you got a product approved and you kind of fell between because you didn't already have the commercial reimbursement while you had reimbursement for named patient use, for example. I think many countries have realized this and there are now bridges in place in most countries, but it is a country by country approach. We need to make sure that we are able to keep the patients on therapy and, of course, during that process, which is something we are well aware of, but it's definitely possible. Okay. In terms of where the patients are currently distributed, where would the initial focus be for those discussions? We have a quite broad distribution of patients. I mean, many of them are in the EU, but definitely not all. Many of the patients outside of EU wouldn't be affected by an EMA approval. We are obviously targeting where we have the patients. We are navigating the systems. We will be navigating the systems. Again, I mean, it's a rare disease which makes it possible to have a really kind of tailor-made approach for each patient rather than really looking at the country level. I'm sure we will be able to manage the transition in a good way for patients. Okay. I just wanted to get a better idea on timeline, if possible. You mentioned that you will some other components of the dossier. Looking to confirm those. Could you just say relatively what is needed, what left is required to do, and how long do you expect that to take before you can file roughly? Thank you, Joseph, for the question, and apologize in advance for the answer 'cause I'm not gonna give you the detailed answer you're looking for. But as you know, to put together a submission package is a large effort across all different areas of development. From our perspective, this will include some further regulatory interactions in the new year to confirm our plans in other areas outside the clinical space, which will need to be held before I can comment on detail. Having said that though, we're currently accelerating such efforts in any way we can to complete the dossier as soon as possible. I have to come back to you, Joseph, with that. Okay. Thanks very much to you. Thanks, Peder. Thank you. We have no further questions. I hand back over to Nicklas. Thank you, operator. Thank you all for your attention today. You will find the webcast playback and the presentation at the company webpage later on today. Thank you for your attention. With that, we conclude today's session, and I wish you all a good rest of the day. Thank you.