Good day, thank you for standing by, and welcome to Xbrane Biopharma presentation of year-end report 2022. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. If you wish to ask a question, please press star one one on your telephone keypad. If you wish to ask a question through the webcast, you can submit through the webcast chat. I would now like to hand the conference over to CEO Martin Åmark. Please go ahead, sir. Thank you very much, welcome all of you listening to our call, where we're going to present Q4 report of 2022 for Xbrane. First, just gonna provide a brief update on our different biosimilar candidates in our portfolio, progress we've made during 2022 and what's ahead of us during the course of 2023. We start with our Lucentis biosimilar. I think we've made great progress during 2022. Of course, most importantly, we got an approval from EMA for the product, so that it now can be launched by our partner STADA across Europe, which is going to take place this quarter. I'm going to come back to that in a later page. We worked a lot on the BLA for regulatory submission to FDA for approval in the US. As all of you probably are aware, we had to withdraw the BLA during the course of 2022, and we've been working since to complete it based on feedback from the FDA. We are now planning to resubmit the BLA during the course of this quarter. So I would say that this work is going according to plan, and resubmission will happen this quarter. We have also started the work to together with Stada, trying to take the product to other territories beyond Europe and North America. One such territory is Middle East and Northern Africa, where Stada has their own sales and marketing infrastructure. The process of seeking regulatory approval in this region has started. Stada submitted the file to the authorities in Saudi Arabia during this quarter, a couple of weeks ago. We are planning to submit the file in remaining key countries in Middle East and Northern Africa during the course of the first six months of this year. We hope that we together with Stada will be able to launch the product in this region the beginning of 2024, which is going to be very exciting, of course. We're looking beyond that as well together with Stada in Southeast Asia, where Stada also has their own sales and marketing infrastructure. We are also looking at other territories where we together need to find the third party distributors, such as in Latin America and China and Japan. That's very exciting, of course. I'll come back and talk a little bit more about the imminent launch of Ximluci in Europe. Going then to our Cimzia biosimilar candidate, we are now working together with our partner Biogen and our production partner AGC to scale up the production process and to produce a clinical material to target for this year. Also of course, Biogen is preparing for initiating the clinical trials on this biosimilar candidate. I hope that, during the course of this year, we'll be able to get back on hopefully successful scale up and production of clinical material, and that we then are able to, together with BioNTech, take the next step into clinic. When it comes to our oncology portfolio, first our biosimilar candidate Opdivo. Here during 2022, we made great progress. We have now finalized the process development here in-house at Xbrane at what we call pilot scale. We are now in the process of selecting a production partner. This has been a big job for us during 2022 to source and find a suitable production partner. We're now very close to finalizing that. Of course, the next step is as what we're doing with our Cimzia biosimilar candidate to do a tech transfer to the selected contract manufacturer and scale up the process and produce clinical material. I think that is a process of approximately 2 years. I think in the beginning of 2025, we're going to be in a position to take our biosimilar candidate into clinic. That is, I think a proper timing in order to be able to get approval by the time of US patent expiry, which is December 2028. That's really what we're targeting from a timing perspective. Of course, also very interesting work that we have ahead of us during this year is to design the clinical trial for this biosimilar candidate and engage in discussions with the regulatory authorities around that design. That's another interesting work for this year on this program. When it comes to our biosimilar candidates to Keytruda and Darzalex, we are finalizing the cell line development and are going into process development in-house here at Xbrane. We are going to finalize process development for one of these products during the course of this year and then be in a position to take a similar step into contract manufacture and take transfer scale up to contract manufacture like what we now are doing with our opioid biosimilar. That's gonna happen like beginning of 2024. I think we're making a good progress on our oncology portfolio. Of course, also, as we've said before, this is the timing where we optimally would like to find a commercialization partner. We're also in that process and discussing this portfolio with several interested parties. I hope that we can be able to finalize something, as we said before, also during the course of this year, which is of course very important for us to be able to get some co-funding in the form of license fees for this continued development. That's a brief update on where we're standing on the different programs. If you go to the next slide. Most important right here, right now, of course, the imminent launch of Ximluci in Europe and the U.K. This is very exciting, of course, for the whole team here at Xbrane. As you can imagine, this was a development that started in 2015 really. Many people has been deeply involved in this development during the last 7 years or so. You can imagine the excitement when this finally can come to market and be beneficial for patients. This is a big market opportunity, EUR 4 billion market, roughly speaking, in Europe, if you think about it as retinal anti-VEGFs. That includes then the sales of both Lucentis and Eylea in Europe. That's roughly EUR 4 billion. That's really the way we view the addressable market for this product. It's a market that's been growing, with some 8% per year for the last couple of years. We believe it's going to continue to grow and actually, grow quicker than historical, at least from a volume perspective going forward due to the launches of biosimilars to Lucentis. We have worked very closely with STADA during 2022 to prepare for the launch. Of course, one part of that has to do with producing the launch material, which is coming to an end now, and also for STADA to prepare their organization for the launch. I think that's, we're very confident that STADA will do a great job in commercializing this product and that they're now prepared for a good launch. They have vast experience from launching and commercializing biosimilars in Europe with a handful of products on the market for quite some time actually. So they have an established organization, of course, and long experience from these launches. We're very confident that they're going to do a great job in this launch as well. It's important that this is a product which are going to bring a great value to patients and to the society. Updated to product which is equivalent to Lucentis with regards to efficacy, safety, dosing, administration and so on and so forth. Lucentis is the product which the community has great experience with and vast amount of experience and clinical data on usage of Lucentis which brings comfort to the product amongst the ophthalmologists. However, of course, Ximluci is going to be a much superior option to Lucentis and Eylea in this setting. It's going to be a much more cost-efficient alternative, which is really the main point here, of course. We've seen what that can do in launches of biosimilars and other classes of drugs. We've seen, you know, treatment dates per cost increase by 100% or double essentially, the years after launch of the first biosimilar and massive savings being realized for the payers. This is then, savings that can be redirected to more novel and hopefully more efficient treatments. I think this is a product which will both increase accessibility in Europe now initially for this kind of treatment and realize huge savings, big value for patients as well as society. Sartorius really leveraging their long heritage and experience and reputation as a high-quality supplier of biosimilars and other pharmaceuticals across Europe. I think that brings comfort for different stakeholders in the market. Also that we have for the European supply chain, I think also helps, which brings comfort into the quality of the product. We're very excited and looking very much forward to the launch, which is now going to take place in a couple of weeks only. We are of course then going to update further on that in the call for our Q1 report. Also we are going to participate in a couple of capital market day arranged by Redeye on 31st of February. Aktiespararna in Spånga in March, and a couple of other events. Also in those meetings and events we'll also speak more and more about how the launch is progressing. Hopefully we can interact with all of you as shareholders in the company these different occasions. We're also growing from an employee perspective. Coming out of Q4, we were about 80 employees in the company. I think we're doing that with maintaining strong culture and of course the spirit in the company. We are certified a Great Place to Work with a very high score on the so-called Trust Index, what they're measuring. I think a great accomplishment by the team here today to maintain that while growing as quickly as we are. I think we have an easy time still to find and recruit talent out. I think the company has a good reputation in Sweden. I think we've benefited also historically from kind of lot of reductions in the industry leading to talent coming available in the country. That's good to see as well. With that said, probably I'm going to leave over to Annette to provide an update on the financials. Thank you very much, Martin, good morning everyone. Can we take the first slide on the Yes. For those of you who's been with us for a couple of times now, you would remember that we have out on the expense side, a bit of an awkward, you could say an awkward view that we capitalized some of the R&D expenses as of July in 2021. That means that it's hard to tell from a cost perspective, really how much is spent. If we look at what expense on the P&L, we have a number of things. First of all, Ximluci, a much less part of the total spend is now put on the balance sheet because Ximluci is really moving into the commercial phase, then the costs don't really justify to be capitalized any longer. Second, preparatory commercial activities for the launch have accelerated as a natural because of the imminent launch in a couple of weeks. We also see intensified activities across the remaining portfolio for C11008, the biosimilar candidate to Cimzia, where we are with Biogen, and we are accelerating that work to be able to provide the API chemical material. Then the rest of the oncology portfolio as well. Looking at G&A only, that have increased by $5 million, that is really continuing to build the company as Martin said. Next slide. If we compare, like for like on the cost side, the red bar in the bottom being what is capitalized, you really see how much that is put on the balance sheet for Ximluci. That said, the costs still have increased with roughly around 30-35 million or 44%. The total value on the balance sheet as of now for Ximluci is $102 million, which is obviously, needless to say, far from its market value. The next slide please. From a cash perspective, we leave the quarter with $194 million in cash. That is obviously including the capital raise that we did in November. That actually generated SEK 170 million before transaction costs. Obviously, this is a result of significant prepayments that we've done to our CMOs to be able to provide raw materials both for the stock build or raw materials for the oncology portfolio for Cimzia, for BII11100A and also for stock build for Ximluci. Looking forward, we communicated in the report that we have also the aim to outside look for a commercial partner or development partner for the oncology portfolio during 2023. By that, I'll leave us back to Martin. Yeah, I think that brings us to an end of the phone presentation, so we can open up for Q&A. Anyone who wants to ask a question over phone can do that now. Ladies and gentlemen, we now begin the question and answer session. If you wish to ask a question, please press star one one on your telephone. We have one question from the phone. The question is from Mattias Häggblom from Handelsbanken. Please go ahead. Your line is open. Thank you so much Mattias Häggblom from Handelsbanken. I have a few please. So I'm curious to hear if we would isolate cash flow from Ximluci, only how long from launch in Europe to break even from a cash flow point of view, would you expect that to be? I guess it's earlier than for the group as the group carries G&A plus R&D expenses for the other projects. That's the first one. I'm going to add another one. Yeah. As we've said previously, we target to reach break even for the company first quarter 2024, and that still holds true. If you were to isolate the Ximluci break even would appear earlier, as you say, the G&A expenses. Exactly when that would occur, we cannot exactly comment on. That's fair. Then you state again, the target of reaching cash flow positive in 2024. Help me think of the path from the base in 2022 of an outflow of close to SEK 200 million to the positive. Should we think about a more kind of linear improvement, or is this gonna be very back-end loaded as you reach the inflection point in turn cash flow positive? I think it's not going to be completely linear. I think it's gonna be more of an uptake during the second half of this year because as naturally there are scale economies in particularly I would say in the sales and marketing part of the Ximluci P&L, so to say. When we gain more volume as per planned during the during the course of second half of this year, I think that's when you kind of will see a pick up a more quicker pick up in terms of getting towards cash flow positive. That's one piece. The other piece is, as we also wrote, in the quarterly report, that we need to be successful in finding a commercial partner for the Oncology portfolio during the course of this year in order to get to cash flow positive stage during first quarter of next year. As we spoke about, we're getting into for the biosimilar candidate process of scale-up production clinical material, which is a rather capital intense process and following the timelines which I'll go into that process for the other two biosimilar candidate in Oncology portfolio from beginning of next year. Naturally, that whole portfolio will, if we are continuing the development, it would consume quite a lot of cash. We need to have a commercialization partner in place towards the end of this year who carries part of that burden in order for us to reach that goal of getting cash flow positive, Q1 of next year. That's clear. The final one I had, any updated thoughts on timelines, to first-in-human, for BIIB801? Yeah. I think, we're looking towards first half of 2024. That's clear. That's all for me. Thank you. Thank you for your question. We will now take the next question. The next question from Dan Akschuti from Pareto Securities. Please go ahead. Your line is open. Hello, everyone, thank you for taking my question. One question would be regarding supply chains and commercial supplies. Can you confirm that this is all going well and in place and not, that there is no risk from that side for any delay of the launch in Europe? Yeah, I can confirm that that's going well, and there is no risk with regards to delay due to material supply. Okay. Thank you very much. That is clear enough. Another question is, as we heard this week that Biogen, with its new CEO, seems to have some thoughts about strategic reorientations that would also potentially include the biosimilars portfolio that they have. Do you have any mitigation strategies in case Biogen would decide to divest its biosimilars portfolio? As of now, I would assume that you don't feel anything in terms of your interactions with Biogen. I mean, we have of course talked to Biogen about this after their announcement earlier this week. They remain committed to this program we're working on together with them and to their biosimilar business generally speaking. They don't view it as core and looking for another home. We have the trust in that part of the value in that business is the development portfolio, including our Cimzia similar candidate and bidders or buyers for that business also will view it in that manner and are going to want to continue to invest in to continue development together with us on that program. That's kind of the signals we're getting and what we're planning for. Of course, I know we have no more clarity on timing of this than the public market, let's say. We'll have to wait and see how that goes. I think it's only when eventually, this business gets a new home, so to say, we can reevaluate if we're facing any other kind of risk in relation to that and how we, in that case should act. Okay, thank you. one more question would be, yeah, related to the prefilled syringe. It's, I know I ask this often, but I think that would be a key differentiator obviously, and everyone is trying to somehow work on it. I just understood from the presentation that there have been more expenses related to the development of the prefilled syringe. Could you give us maybe any kind of timeline when that could appear? Yeah, exactly. I agree with you. I'll just take a step back for everybody. We're now launching Ximluci as a vial and the originator, Lucentis, has two presentations, one vial and one prefilled syringe. We've been working on the prefilled syringe for quite some time, that development is coming towards an end. We are considering when we could submit that initially in Europe. When we think about the BLA, it will be the vial only, the prefilled syringe will come as a variation to that application. I think that one could reasonably expect that this would be earliest, you know, second half of 2024 with regards to a potential launch of the prefilled syringe across Europe and the US. Okay. Thank you. That is very helpful. The last question on the oncology portfolio, has it passed the cell line development stage? Yeah, exactly. The Opdivo biosimilar candidate, we finalized the process development at pilot scale here and we're now getting into the stage of tech transfer and scale-up together with the CMO. We're in the, we're at the end of that selection process, so we're going to come with an announcement as soon as an agreement is signed with the selected contract manufacturer, like what we did with the Cimzia similar candidate when we signed an agreement with AGC on that one. On the two others, on the Keytruda and the Darzalex biosimilar candidates, we're finalizing the cell line development, and we're now going into process development here at our in-house lab. The first of these two products, we expect that we've, we're going to have finalized, the pilot scale process development, for the end of this year. Okay. Thank you. We could probably expect the partnership sometime in 2024 then I guess for that? Well, our aim is, and our target has always been try to do a portfolio deal. Try to out-license this whole portfolio as a package should say. We have enough ambition, as an ambition to do that during the course of this year. That's really the ambition for all of these three products. Okay. Thank you very much. Thank you. Bye. Thank you for your question. We will now take the next question. The next question from Joseph Hedden from Rx Securities. Please go ahead. Your line is open. Hi. Good morning. Joe Hedden from Rx Securities here. Just wondering if I could ask your thoughts on the competitive environment for Ximluci, with a couple of biosimilars already approved in Europe and, you know, your thoughts on the dynamics and, are there any others behind it? Perhaps some kind of thinking on your internal estimates of what proportion of the anti-VEGF market in Europe you think you can capture in the long term. Thanks. Yeah. Well, this picture hasn't changed so much actually during the years when we've talked about this. There are two other biosimilars to Lucentis approved in Europe. It's the program with German developer Formycon and their commercialization partner, Teva, and then Samsung Bioepis with their partner BioNTech. There are gonna be three biosimilars to Lucentis in Europe. That has been our expectation, so to say, for quite some time. We are targeting, and we do believe that we together with Stallergen will be able to capture, let's call it, our fair share of that market. So sort of the generated biosimilar market to Lucentis. We think about it strictly as the Lucentis space. We've showed that graph many times in our presentation how the penetration or the volume share of the biosimilars versus the reference products have evolved over time after launch of the biosimilars. You know, after 3 years or so, I think all, in all of the situations the there's market share of above or penetration of above 60% volume-wise. You know, that's our expectation is that over the course of 3 years that the biosimilars to Lucentis will really take, you know, up to 70%-75% we believe of, you know, the Lucentis sales. That then we together with Stallergen will capture a sort of that generated biosimilar market, of course, as you of course understand with the price discounts to the originator. Our expectations haven't really changed that much, now when we are at the launch in comparison to, how we've described, we think this will pan out, in the last couple of years. Okay. That's great. Thanks very much. Thank you for your question. There are no further question from the phone. I will come back for question from the webcast. Good. We will proceed with the questions that came in here over the chat. First one, you mentioned launch volume for Ximluci have been manufactured. Does this include also release process? Can you comment on this? Yes, it includes also release process, so this is, you know, remaining risk in the production of launch volume. Next question. How competitive does the situation in Europe look like with Cimzia first biosimilar in market? As far as we can tell, I described just now the other biosimilars that are approved in Europe to Lucentis. I think that one of them has been launched in select countries, and the other one is being launched approximately at the same time as what is expected with from Ximluci. The next question, could you further clarify Ximvza timeline, if it is on time, and if any problems or delays have occurred, will the completion be more like H1 or H2 2023? Does Ximvza probably cause R&D costs for the full year 2023? Okay. Yeah. I described a little bit the timeline there on previous question that first half of 2024, I think you can expect the clinical trials to commence on this biosimilar candidate. Really during the course of this year is about scaling up and producing clinical material. Yes, this program will consume more R&D costs during the course of this year. As we've said before, when we reach the first milestone and have completed our obligations versus BioNTech with regards to the development. This program will go into cash flow positive stage. It's not gonna happen, or it can happen towards the end of this year than the beginning of 2024. That's really the way it looks like. It will consume more cost and cash during the course of this year. Okay, next question. Congratulations for completing Xdivanee pilot scale process. Does this completion mean that also analytical similarity to Opdivo have been now evaluated for Xdivane process in pilot scale? Can you comment a bit about the volume of competition situation? There seem to be not many publicly announced development programs. Yes, I mean, when we conclude the when we conclude the the the production process at pilot scale, we also ensure that we have a sufficiently high degree of analytical similarity to the original or to process into the scale-up. Yes, to that question. The competitive situation, I think it's too early to talk about really. I agree, there are not that many publicly announced development programs, but I would be very cautious to read too much out of that because there can be companies developing biosimilars to Opdivo without necessarily being too public about it. I think really we should wait until, you know, beginning of 2025 or so when biosimilar candidates to Opdivo are most likely are going to go into clinic, then the situation will be much clearer. The next question. Since you're moving in the process upscaling of Xofigine, can you confirm that you have achieved bioequivalence? Okay, that was yes. Previous question. Well, bioequivalence, we have achieved an analytical similarity. If so, can you talk about how big your yield increase has been? No, this we're not going to talk about the yields for competitive reasons. Next question. Have you received all the necessary documentation from your suppliers in order to resubmit to FDA? Yeah, answer to that question is yes. We are finalizing everything and we stick to the plan to resubmit to FDA during this quarter. Next question. How is it that we haven't applied for 450 1 in the U.S. yet? Okay. For that question, we need to take a step back. We submitted the BLA originally in March last year, but had to withdraw it due to some information deficiencies identified by the FDA. We announced that in May last year, and we have since in a dialogue with FDA worked to complete the file in accordance to general advice that we have re-received from the FDA. We're now in the process of being able to resubmit the BLA. Next question. Are you expecting any milestone payments under 2023 regarding Xofigine or BIIB801? Our expectation is now that the first or next milestone is going to come during first half of next year for this program. Any updates regarding Primm Pharma? Not really as of now. We're continuing the process of trying to divest this business. We have meanwhile reduced the cost to almost zero in our Italian subsidiary. It's actually cash flow positive from that situation. We're still working on trying to divest it and no other immediate updates on it right now. Next question. Given your current capacity in R&D, when do you estimate that you will add the next development project? As we said that we have an ambition to start 1 new program annually, we stick to that ambition. However, we started actually two new programs in the end of 2021. I think it's only towards the end of this year we are going to be able to bring in a new program in our portfolio. Good. Okay. I think that concludes also the questions which we received over the chat here. We're always available for further questions should you have any. You can reach out to us over phone or email. As said previously, I hope that we get opportunity to meet and interact at one or several of these capital markets events we're going to participate in the near-term future. With that, I think we can thank you all for participating and conclude today's call. That concludes the conference for today. Thank you for participating.