Hello everybody, and welcome to the webcast connected to the Q2 2025 report of Xbrane Biopharma. My name is Martin Åmark, I'm the CEO, and I have with me our CFO, Jane, also online. We will, as usually, go through the operational activities and then update for the quarter. I will start with that, and then Jane will take over and go through the financials for the quarter. Then we will have a Q&A session afterwards, in which you can, if you've called in, ask questions via audio or otherwise write questions in the chat. Let's start. I'm shifting here to the first slide. We will start to talk a little bit about Ximluci, our Lucentis biosimilar. I will shift over and talk a little bit about Xtovane, our Opdivo biosimilar candidate. As most of you that follow us know, we have one product which is being commercialized, and that is Ximluci, a biosimilar to Lucentis, an eye drug used in treatment of several severe eye diseases, mainly age-related macular degeneration. We have, since 2018, a co-development agreement with STADA, a German generics and biosimilar company. We're at about 11,000 employees or so. We have co-developed the product, and they are commercializing the product since March 2023, when we got an approval in Europe from EMA. The arrangement is that we are essentially sharing the profit contribution from sales and marketing of the product, 50/ 50 between the parties. Ximluci is now launched by STADA in 24 countries, out of which 20 in Europe and 4 in the Middle East. We are gradually getting to cover the majority of the countries in Europe, and we are also, together with STADA, expanding in the Middle East and broader Asia. We'll go through a little bit where we're at. Looking at Europe only, Ximluci had a volume market share of 8% in the quarter. That is looking at the ranibizumab market. Ranibizumab is the active ingredient in Lucentis. When we say the ranibizumab market, it consists of Lucentis, the originator product, commercialized by Novartis, and the Lucentis biosimilars on the market in Europe, out of which Ximluci is one. In that Ranibizumab market, Ximluci had an 8% volume market share. Looking at this from a growth perspective, we have historically been trending at about 20%- 25% quarterly volume growth. It was a little bit lower this quarter compared to the first quarter of 2025. If we only focus on Europe, we had an 11% growth in Q2 versus Q1 2025. If we look at all markets, including Middle East and Asia, it was a negative growth of 8%. That is due to a high shipment, which was done by STADA in Q1 for launch volumes in some Middle East countries. It will be a little bit... The shipments will be varying a bit in that region in the launch phase. It can cause some variability when we look at the growth from a quarterly to quarterly perspective, including all markets. If we look at the profit generation by Xbrane, since the launch of Ximluci, it has accumulated SEK 116 million. I shall now take the opportunity also to go through a little bit how we work with revenue recognition of Ximluci, because I do understand it might cause some confusion. We are shipping Ximluci finished goods to STADA under a supply agreement, under which we get paid a supply price, which equals our production cost. STADA is selling the product to end customers and generating a profit contribution. After subtracting the production cost and sales and marketing expenses, that profit contribution is split 50/50. We do revenue recognition of the income stream coming from the supply of finished goods and the expected profit share that that shipment is expected to result in when we do the shipment. For example, if in a given quarter we make a shipment to STADA of 100 units, just to make it easy, and we have a supply price of 100, and we do expect to get profit sharing of additional 100. When we make the shipment, we get paid 100, but we make a revenue recognition of EUR 200 per unit. If we make no shipment and if there is no adjustment needed to be made in relation to our expectations of the profit sharing to come from that shipment we did, there's going to be no revenue recognition in that given quarter. Looking at Q2 specifically, we did no shipments to STADA, and hence there was practically no revenue recognition, but we had a cash profit sharing coming in during Q2 at about SEK 10 million. Profit contribution from a cash perspective is still coming, but it's coming from shipments that were made a couple of quarters ago. Looking ahead, we are going to resume shipments as of this quarter, and I foresee that we are going to make shipments to STADA all the quarters in our forecasting period, essentially. Looking ahead, six to eight quarters, essentially. Of course, we will then make revenue recognition to the value of the shipment in addition to the expected profit sharing it will ultimately result in. You have to clear that out, and this is also described in our accounting principles in our annual reports for those of you interested and wanting to read more. Jane is also available to describe this further should this not have been sufficiently clarified. Good news also, due to shipments being resumed, is that we have a quite significant inventory built up on the Xbrane side of Ximluci, particularly drug substance. This was built up during the course of particularly 2023, but also to some extent 2024, as sales were progressing slower than anticipated, and we had quite some capacity booked with our contract manufacturers. We ended up producing more than what we shipped to STADA. Now, as shipments are being resumed, we're also starting to convert that inventory into cash as of the start of this quarter and onwards. That's good news. A net of prepayments that has been done from STADA, the value of that inventory is at about SEK 170 million, which we foresee to convert into cash essentially from now up until the end of 2027. That was an update on Ximluci in Europe. We're shifting over to the U.S. This is the big milestone we have ahead of us during the remainder of this year, I would say. We have a regulatory process ongoing for Ximluci, or the brand name of the Lucentis biosimilar is going to be Lucumsi in the U.S. That's the right thing, Lucumsi in the tagline. We had the BLA submitted December 2024. Formally, the regulatory process was initiated in April by the FDA, and we now have a PDUFA date 21st of October. We have an ongoing reinspection of our drug product site or our contract manufacturer's drug product site as we speak. It's going to be concluded this week, and we have a reinspection by the FDA starting mid-September or so on the drug substance side, also owned and run by a contract manufacturer. Of course, an approval is contingent upon successful reinspections. I think we, on our end, are cautiously optimistic. Those of you who have followed us know that these sites were inspected as a result of our application in the first quarter of 2024. There were some observations, particularly on the drug product site, which led to a required reconstruction of the site. That has now been done, as far as we can tell, successfully. Hence, we do believe that the observations that the FDA had have been successfully resolved. Hence, we are cautiously optimistic that this time we will get an approval. We will not communicate anything immediately post these reinspections. As is natural in such an inspection, you get some observations from the FDA, and then you have a 30-day timeframe to resolve those or respond to those observations to the FDA. It is going to be a little bit of a guessing game to judge whether any of those observations potentially can be of a probability nature or could be an issue for probability of the product. We are not going to go into that guessing game and communicate in relation to the reinspections, but rather await the actual decision date, which again is on the 21st of October, and then communicate as we receive communication from the FDA. We have our partner, Valorum Biologics, who are going to commercialize the product in the U.S., and we are working with them to make the proper preparations to get the product launched post-approval. After an approval, what needs to be done is to get the so-called Q code, which essentially allows the eye clinics to get paid from Medicare immediately upon receiving the product. That is going to be crucial ahead of a launch, and it's a six-month timeframe to get the Q code. There is no risk in getting the Q code or not. It's just a bureaucratic process, but it needs to be done. A launch can happen six months post-approval, so we have the timing of that cleared. Now, looking at the U.S., we are still very optimistic about the opportunities for Lucumsi in the U.S. It's a very sizable market, about 8 million units of VEGF inhibitors for retinal disorders being shipped each year. From a value perspective, about $10 billion market. It's a very sizable market. It's a dynamic marketplace. A lot of things are happening. As I think we talked about last time, Sandoz with their Lucentis biosimilar withdrew from the market. We will see if they're getting back during the course of 2026 or what is happening. We think that this has left a void when it comes to Lucentis biosimilars, and we're very optimistic in being able to fill that void with Lucumsi together with Valorum. We've been calculating on some scenarios what different volume market shares could mean, as you see in the table in the bottom corner there. We do believe that this could result in somewhere between SEK 120 million- SEK 220 million in annual profit sharing to Xbrane. They're a little bit dependent on what you choose to believe from a volume market share perspective. Volume market share in the ranibizumab market and the average selling price are factors. We're optimistic. First things first, of course, the approval by the FDA is absolutely critical, October 21. We'll get back then with the communication, of course. Moving over to Xtovane. I think this program, this is a biosimilar candidate to a cancer drug, Opdivo, a very sizable originator product, about $8 billion of annual sales expected to reach some $13 billion by the time of patent expiration in the U.S., which is the end of 2028. We partnered this program up with Intas last year, and we are working according to the development timeline. Now the clinical trial is being initiated. The clinical trial is being run by our partner Intas, and it's a trial in which about 340 patients with melanoma are going to be recruited. It's a streamlined trial in comparison to existing biosimilar development guidelines. We're very happy to be successful in dialogues with both EMA and FDA to achieve this. As a primary endpoint, we're looking at comparative pharmacokinetics, and we are very confident that this trial can be concluded in time. We have, or Intas has, and we have supported them to submit a clinical trial application across a handful of countries. We have approval in the first country already, which is triggering a development milestone of EUR 2 million according to our agreement with Intas. That is then going to be recognized as revenue in Q3 and also being paid, hopefully, in Q3. This is going according to plan, and we're all very much focused on getting to a submission Q4 2027 in the U.S. to get an approval towards the end of 2028 and then being able to launch at the time of expected patent expiration of the originator. We are still very optimistic about the prospects of Xtovane. We still see, what I would say, limited competition from other biosimilar developers given the size of the originator product. Our base case assumption is that Xtovane will be one out of four biosimilars by patent expiration. If you look at how biosimilars in the oncology field have developed in the U.S. three years post-launch, they've had an average of 75% volume market share together. We see nothing that would change the situation with Xtovane or Opdivo biosimilars generally compared to the historics when it comes to oncology biosimilars. Looking at counting on that and the expected competition, a fair volume market share would be up to 19%. We've also, in this scenario calculations in the table, been calculating with up to six biosimilar competitors, which could lead to 30% volume market share. Of course, one would have to model different discounts on the pricing side compared to the originator. One could see also how the average sales price is trending downwards from the launch of the first biosimilar and the years thereafter. Even if we calculate with a 70% discount to the originator and 30% volume market share for Xtovane, it could result in SEK 1 billion of annual profit sharing coming into Xtovane. This is really the big upside, I would say, for the company. We are very much focused now on getting this product together with Intas Pharmaceuticals, approved in time, first in the U.S. That's a brief operational update. With that, I will hand over to Jane to go through the financials. Yes. Hello. The revenue for the second quarter amounted to SEK 39.9 million with a gross margin of 100%. This revenue is 100% attributable to the license agreement with Intas Pharmaceuticals with regards to the Xtovane program. There were no revenue recognized from any shipments or any profit sharing, as mentioned by Martin, due to our revenue recognition model. The profit from the discontinued operations, the divestment to Alvotech, amounted to SEK 185 million, and the EBITDA from the discontinued operations amounted to SEK 210 million. The expenses for the quarter, one must remember that two months were normal operations, including the R&D and the full organizations with more employees. The total administration expenses for the second quarter amounted to SEK 18.3 million, including SEK 9 million from non-recurring items in connection to the transaction with Alvotech. The R&D expenses amounted to SEK 26.3 million, and SEK 48.9 million were capitalized in different programs that we are working on. The transaction with Alvotech was finalized in the beginning of June, and we are now looking at fixed costs of approximately SEK 12.5 million quarterly from the third quarter and onwards. This is a small chart of the cash effect from the transactions with Alvotech, just to try to explain a little bit. We had an opening balance of SEK 25 million. The proceeds from the Alvotech transaction were SEK 275 million, and SEK 5 million were retained by Alvotech for later payment. The convertible bond was settled fully by Alvotech with SEK 153 million, and built-up accounts payables connected to our main CMOs for SEK 90 million were settled as well. The other operating accounts payables amounted to SEK 47 million, which leads to a closing balance of SEK 6 million, more or less. We had a directed share issue, which was conducted in the third quarter, in the beginning of July, which amounted to SEK 240 million prior to transaction costs. As I mentioned, it was settled in the third quarter. That's why it's not included in our books here. As I mentioned, the cash equivalent was amounting to SEK 6 million at the end of the quarter, and the operating cash flow amounted to SEK 65 million. Thanks, Jane. To summarize, takeaways from Q2: Ximluci launched in 24 countries, 11% volume growth in Europe, Q2 versus Q1 2025. Xtovane is progressing according to plan. We have a EUR 2 million development milestone being triggered due to clinical trial application being approved in the first country, and the clinical trial is underway according to plan. As Jane described, the transaction with Alvotech was concluded, and we were able to reduce our debt position in a quite significant way as a result of that. We executed a directed share issue of SEK 24 million, but closed in July, as Jane mentioned. Now, looking ahead, the priorities coming up here: of course, Ximluci, U.S. FDA approval on October 21. That's what we're very much focused on now. The preparations leading to a launch by our partner Valorum Biologics in the U.S. is a big, big priority. We will continue to support STADA in the continued penetration of the European and Middle East market. We have a couple of important initiatives together with STADA to continuously drive down the production cost of Ximluci to stay competitive in the long-term perspective for this product, as well as the pre-filled syringe variant, which we are working on actively. On the Xtovane side, apart from the clinical trial, which now is being run by our partner Intas Pharmaceuticals, Xtovane has the development responsibility related to process characterization and validation, which we are actively working on now to get that development activity also concluded well in time for a Q4 2027 submission to U.S. FDA. Those are our ongoing priorities here. With that said, I think we can stop the formal presentation and open up for questions. I guess we start to see if there are any questions from people calling in. If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Filip Einarsson from Redeye. Please go ahead. Hello, Martin and Jane. Thank you for the presentation. I thought we could start on the volume sold out in Europe compared to previous quarters. Could you just elaborate a little bit more on that, please? Yeah. If we look at the volumes being sold by our partner STADA Arzneimittel to end customers in Europe, we had a growth of 11% compared to Q1 this year. If we look at total markets within which the product is launched, including the Middle East, it was a negative growth of 8%. That was due to a pretty sizable shipment they did in the Middle East in Q1, considered as launch volumes, if you will. Thereby, some variability and also to be expected going forward from these recently launched countries in the Middle East. Okay. It's not, would you say, primarily demand-related? No. It was related to, call it, the discrete initial shipment in the Middle East, which was not repeated in Q2, but are probably going to be resumed, but at different levels in different countries, Q3, Q4. It is a little bit hard to predict exactly at what levels. Okay, good. I'm also curious if you could expand on the initiatives to improve production costs. We are working actively with STADA and our contract manufacturers to essentially bring down production costs. What we're doing there is to look at measures to increase productivity, both in the drug substance production process as well as the drug product production process. That includes a lot to reduce waste, for example, of drug substance in the drug product process. That is to say, when you're filling the drug substance into vials, to reduce losses of drug substance and increase the productivity, essentially. These are important measures to bring down the production cost, as well as negotiating with our contract manufacturers on better pricing and so on and so forth. A number of different initiatives, all with the ambition to bring down the production cost. Okay, got it. Could you also give us an estimate on when we should expect this to maybe be visible in the numbers? Yeah, I think all these are going to lead to gradual decreases in the production cost. I would probably have like a two-year time horizon for this to be fully materialized. Right. Could you provide us an update on the current operations relating to the pre-filled syringe? Is there anything new there? We're still working actively, finalizing, I would say, the development, which entails validation of the sterilization process of the outer surface of the syringe. We are looking towards submission in EMA next year as a variation to the existing approval. Okay. With the cash coming in that came in in July, should we expect Xbrane to operate as a debt-free entity, or how should we view the use of this liquidity? Yes. You should view it as we post that transaction are going to further reduce our accounts payables so that we, after that, are operating with a normal working capital, if you will. A normal accounts payable position for the running business. As you probably recall, we accumulated quite some debt to three of our main suppliers or contract manufacturers the last 18 months or so. What Jane described, we paid off quite some part of that debt. We are going to, with the proceeds coming in from this directed share issue, repay the final part of that and then operate with, let's call it, a normal working capital position. Great. That was all on my end. Thank you for taking my questions. As a reminder, if you wish to ask a question, please dial the pound key five on your telephone keypad. There are no more questions at this time. I hand the conference back to the speakers for any closing comments. We have two questions here in the chat. Let us take these questions. First one, do you expect more cash flows such as the Alvotech deal to be recognized in the coming quarters? I would not have such expectations. We currently have two active programs, which we've described in this call, the Ximluci program as well as the Xtovane program, which already are partnered, Ximluci with STADA and Valorum, and then Xtovane with Intas. There are some agreed-upon development milestones in those agreements, which will be coming in and recognized in coming quarters, including the €2 million milestone from Intas, which we talked about in Q3. We foresee no additional deal in coming quarters of that nature. That was that question. Next question, some confusion on the market volume for Ximluci in the report. Let's try to address that. Ximluci is a biosimilar to Lucentis, and we talk about in some place what the size of the originator product is, and that is at about EUR 1 billion. We also talk about the total market potential, if you will, or total addressable market, more correctly said, which includes all products which are VEGF inhibitors for retinal disorders. That amounts to about EUR 13 billion. It's a little bit different market definitions, if you will. Next question here. What is your expected cash runway? With this directed share issue we recently did, and provided we get an FDA approval on the 21st of October and related income streams, which we expect from our U.S. partner, we do believe that we can manage from a cash perspective going forward. If it should be so that we would not get an approval from the FDA, that would have to be reviewed, and we would have to get back post such potential news. Next question here. You estimate SEK 12.5 million fixed cost from Q3 and forward. What total cost can we count on, i.e., what is not calculated in the fixed costs? When do you estimate becoming cash flow positive? The fixed cost, which we refer to of SEK 12.5 million, is related to personnel and normal kind of administrative expenses. What we do on top of that is investing in certain development activities and particularly going forward on the Xtovane side, where again we have the responsibility for process characterization and validation, which we are doing together with a selected contract manufacturer. That is an investment of about SEK 200 million, which we previously have communicated, and an activity which is running essentially from now and up until mid 2027 or so, towards the end of 2027. That investment, though, is being capitalized according to our accounting principles, again described in our annual report. It is not taken as a cost, but rather as an investment. I hope that clears the picture. The question on becoming cash flow positive, again, I think it's dependent on potential FDA approval and timing of the launch of Ximluci or Lucumsi in the U.S., as well as progress of European sales. I think we've also talked about previously the timing of being able to convert Ximluci inventory to cash versus this investment we are now doing over the coming years in Xtovane. The relative timing of these two cash in and out streams are going to dictate that. I think it's better that we get back post 21st of October on an overview of when the company can become cash flow positive. Good. I think that concluded the questions we had coming in also over the chat. Jane and myself, we are available over phone or email should you have any further questions. With that said, we thank you all for listening in and posing questions, and have a good rest of the day. Thanks.