Good afternoon, everybody, and good morning to any potential listeners from the U.S., and welcome to this webcast by reason of the press release we published on Friday. My name is Anette Lindqvist. I'm the CFO of Xbrane Biopharma, and it's my pleasure to introduce today's presenters, Par Hyare from Valorum Biologics and Martin Åmark from Xbrane Biopharma. We will have a few slides to share with you today, and following those, we will open up for questions. Those of you attending on the phone, you can ask them live. Those of you attending through the webcast, you can ask your questions via the forum, so you write them up. So with this, without any further ado, Martin, over to you. Thank you, Anette. So, hello, everybody, and, we're holding this webcast, with the reason of, the news we released on Friday morning with the entered partnership with Valorum Biologics for commercialization of, our Lucentis biosimilar candidate, which is gonna go under the brand name Lucamzi in the U.S. And, just a little bit of a recap, for those of you who are not so familiar with us, we are, a biosimilar developer located in Stockholm, Sweden. We're solely dedicated to development of, biosimilars. You can see on the screen now our portfolio. The first, biosimilar we developed was indeed, this product we're gonna talk more about today, but we also have biosimilar candidates to Cimzia and Darzalex under development. So all in all, a portfolio which addresses EUR 26 billion of, originator sales. Just a few words about our Lucentis biosimilar, then Lucamzi brand name U.S., Ximluci brand name in Europe. We have a partnership with STADA around this product, co-development agreement, which was entered into 2018. Through that partnership, the product is launched by STADA in Europe, and we are in the process of getting FDA approval and hoping for subsequent launch in the U.S. That's where we're now, together with STADA, entering into this license agreement with Valorum Biologics. So just a few words about the partnership with Valorum. So essentially, we have, together with STADA, granted to Valorum the exclusive commercialization rights for U.S., for Lucamzi. The agreement entails a license fee of up to $45 million. Now, as is usual in this kind of arrangements, it's split up into an upfront payment and then regulatory and sales-related milestones, and then after that, we have an agreed royalty rate on net sales. We have agreed amongst the parties not to disclose further financial details around this agreement, but we feel that it's a good agreement for all parties with regards to the split of the economics and the future commercialization of the product in the U.S. What I think is important to remember here is that Xbrane is doing this together with STADA under the co-development agreement we have with STADA, and hence all payments coming from Valorum is shared 50/50 between STADA and Xbrane, according to that agreement. Then separately, apart from the strict license agreement, Xbrane and Valorum has entered into a supply agreement, under which Xbrane essentially is responsible for supplying finished goods of the product to Valorum, and we're doing that for supply price, which is essentially production cost, plus a double-digit markup. Yeah, that's the essence of the agreement that we now have signed, and we're now very happy to... since before STADA, but now also with Valorum Biologics, to take Lucamzi to the U.S. market and see it being launched and hope for that it realizes the commercial prospects we believe it has. Then, for you all to learn more now about who is Valorum Biologics, and how Valorum Biologics view the product itself and the market opportunity, I want to hand over to Par, CEO of Valorum Biologics, to go through a few slides here. Great. Thank you, Martin, and, I want to thank Xbrane and Stada for the partnership and for inviting me to join today. Valorum Biologics was really founded on the principle to provide value, to markets that are currently underserved. Despite 45 biosimilars approved in the U.S., there remains a significant opportunity within the marketplace. What I'll be reviewing today is our team, our focus, the U.S. landscape, and specifically, how we view, the anti-VEGF market within ophthalmology. Our team, very privileged to have a seasoned group of professionals join us on this venture. As you can see, very large pharma experience, quite a bit of experience launching multi-billion dollar brands in the marketplace, as well as developing them from preclinical all the way to global phase III, then eventual approval. As you can see, J&J, Merck, Genentech, Roche, across the slide deck. We also have recent biosimilar experience, particularly with our regulatory team and our manufacturing team, namely with Coherus' recent approvals, and also manufacturing commercial supply as well. Coupled with our extensive management team and our broad pharma experience, we are very pleased to have what we believe is a very unique combination of large pharma experience, added to us with large distribution experience. As you can see, we have past presidents from AmerisourceBergen, McKesson, and Cardinal Health. Mark Santos, Mike Cunningham, Joe DePinto have literally built some of the largest distribution and specialty networks here within the U.S. If you're familiar with U.S. commercialization, over 97% of all drugs sold within the U.S. falls somewhere within those big three umbrellas. Either it's through their specialty wholesaler or through specialty pharmacies. So we have the unique convergence of big pharma and distribution to guide our strategies and to basically optimize our pipeline as we look at new assets to bring in. Coupled with the big pharma and distribution expertise, we have Wall Street executives that have helped co-found the company. Tim Opler, who was a partner and co-founder in Valorum, but also was a partner and co-founder in Torreya Partners, an investment bank in New York, which was then sold to Stifel Financial. Tim is a serial entrepreneur, and has started dozens of companies himself, raised over $1 billion in the public markets. Dave Barrett himself is also a Wall Street executive, that has raised multi-billion dollars over his career and started a number of companies with a number of successful exits, and both are guiding our financial efforts with fundraising, et cetera. Our focus is clear with our first few assets, namely, Lucamzi in the U.S. We are focused on regulatory approval to get to commercial. We are going to, from our first few commercial assets, build significant P&L, which will offer us the opportunity to add additional programs, and become a market leader. And as I mentioned, within the U.S., there remains a significant unmet need across existing markets that have biosimilars approved, and most importantly, across markets that have not seen biosimilar entry yet. The next slide is a nice schema from a recent report presented by IQVIA. In the U.S., you have $260 billion worth of biologic market opportunity. Currently, the top bolded middle square shows you the opportunity that is currently facing biosimilar competition, about $40 billion or so. At the time of this publication, that represented 12 molecules. Currently, we have 14 molecules that have biosimilar competition, and of the most mature markets in the U.S. sit in the oncology space. Currently, just a handful of commercial parties are commercializing within that market segment, where we see significant opportunity for multiple entrants, given time of entry. But most importantly, the middle bar here that represents almost $200 billion worth of future biosimilar competition, approximately half of that market is being addressed by current developers today. Where we see Valorum literally sitting kind of in the middle of that, is we have the opportunity to take advantage of markets that are commercially ready today, build our P&L. But aspirationally, we really look forward to providing value and developing and partnering with global partners to bring biosimilars into the U.S., where markets are currently not being served. I've had the privilege of speaking to many KOLs that treat patients within some of these segments. These biologics have transformed the way these patients are treated today, but in many cases, it's been decades since they've seen any price relief. And we look forward to providing that value in the future through our organization and through our partnerships that we will create globally. In addition to the market opportunity, the U.S. dynamics are changing quite significantly. Since our first biosimilar approvals, the FDA has moved significantly and advanced its learnings of biosimilars from a regulatory approval perspective. But also, as of recently, as just a month ago, had leveled the playing field, and the FDA had called on Congress to eliminate the interchangeable designation that was originally provided. Now, what this does is basically provide interchangeability to all biosimilars that are approved. Once approved in the U.S., all can be interchangeable, given their safety, efficacy, and more importantly, their bioequivalence to the reference product. In addition to the regulatory tailwinds, we are also seeing legislative updates that provide more incentives to biosimilar usage. Despite your political preference, all parties want healthcare costs to be reduced. Within the IRA, the incentive has been increased for biosimilars. So for qualifying biosimilars, they can be reimbursed at a higher rate than the reference product. Once that has been achieved, that can maintain for a five-year period. So the similar perspective here, one, the U.S. market is large, and significant opportunity remains within the commercial markets today, but most importantly, for tomorrow, the regulatory and legislative changes are supporting new entrants, and provide a fruitful opportunity to bring biosimilars into the U.S. Our pipeline, led by the partnership with Xbrane and STADA, has a tremendous opportunity to provide value in the near term. We do see Valorum as a multi-asset program, with significant opportunities to launch multiple assets over a ten-year business model. Our second asset is rounding phase III as we speak, and poises ourselves for a nice multi-asset launch over the years to come. We have several other programs that we were talking to global parties with, that are in various stages of development and various stages of diligence, and look forward to adding to this slide here in the near future. So specifically within the anti-VEGF market opportunity in the U.S., we have seen a number of launches as of late. Ranibizumab biosimilars have made their first entrant within the ophthalmology space. Vabysmo from Roche is definitely making some strong inroads with a bispecific approach, and high-dose Eylea from Regeneron has also been recently launched within the year. Despite all of the entrants, you can clearly see a tremendous opportunity for growth year-over-year. Global data projects this market, given the aging population and other dynamics, to significantly grow, surpassing $20 billion in sales by 2030. We've also noted some of our competitors on the Eylea biosimilar front have faced some patent challenges, which may provide opportunities for another ranibizumab biosimilar to provide value, not only in the Lucentis space, but potentially moving into other market opportunities as well, across that anti-VEGF market opportunity in the U.S. So market is big and is growing, and a percent of this market today will be a very big value, as the market increases over time. Specifically, within the ranibizumab biosimilar opportunity, we do see a really nice case example from Coherus. They recently launched their ranibizumab biosimilar, and as you can see, really started to ramp up sales, particularly in the last few quarters. The big jump here from Q1 2023 to Q2 2023 was the addition of the reimbursement Q code. That provides U.S. providers certainty of reimbursement, efficiency of submitting that reimbursement claim. Prior to that, they were dealing with a miscellaneous code that is cumbersome and offers some delay in reimbursement. So once that reimbursement code was established, they were able to maximize the value of the biosimilar and the commercial opportunity, and we see that it has created a significant opportunity in the quarters following the reimbursement code. We see this as a very good signal and a path forward for another entrant. We are clearly not the only folks that like a ranibizumab biosimilar. As you can see, earlier in the year, Sandoz, who recently spun off from Novartis, had purchased that asset from Coherus as Coherus was shifting focus into its core businesses and moving specifically into oncology, for $170 million upfront. It's interesting to note that that $170 million acquisition was for less than 50% of the gross profits. As Coherus had licensed that program in, they were paying royalties north of 50%. So, a ranibizumab biosimilar has shown to be effective, shown to penetrate that anti-VEGF space within the ophthalmology market, and clearly has shown a lot of value that is attracting attention, and we feel this path forward and these examples give us strong confidence for commercial uptake for Lucamzi in the U.S. And clearly, the market opportunity will support a third entrant. So with that, Martin Åmark, I think I've got one more slide with a summary. Yep, great. So, to summarize the brief overview that we provided, experienced and dedicated team to focus on the launch in the U.S. Clearly, given the market opportunity within the U.S., it can support an additional ranibizumab biosimilar. Together, all three, Xbrane, STADA, and Valorum, we believe, create an optimal partnership to secure FDA approval and the eventual launch of Lucamzi in the U.S. Look forward to taking questions. ... Okay, so thank you, Par. Thank you very much. This, then, was the presentation that we aim to share with you today, and we open up for question. So as a reminder, those of you on the phone can just ask questions live, and those of you on the Webex, that you can push written questions, and I can see them just coming in as we speak. So but first of all, we open up the telephone line. So please, operator. 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, everybody. So my first question is, targeting you, Par, if that's okay. Yeah. It would be interesting to hear Valorum's take on Lucamzi being sort of a late entry compared to other ranibizumab on the U.S. market, and what are the indications of that, from your point of view? Yeah, no, Filip, thank you very much for the question. I think the opportunity, really, you kind of point to the historical trends, right? So, one key dynamic is that Lucamzi is gonna be launching into a reimbursement environment that has shown success in the U.S., particularly in the oncology market opportunity. So this is a product that's reimbursed under Medicare Part B. It's under the medical benefit, and it's incident to physician. If you look at the sales trends of other biosimilars that have launched within similar dynamics, second to third to fourth entrants, by year 2 or 3, have garnered north of double-digit market share points. And given their success, we feel... Given the similar dynamics of reimbursement, we feel that a third entrant has significant opportunities, and not to mention that the anti-VEGF market continues to grow. So as we gain a certain percentage of market share, the overall pie just gets bigger. So we think the opportunity is pretty attractive. Okay, that's clear. I have a few more, if that's okay. Yeah. So, would it also be interesting to hear from you some context to Valorum Biologics, sort of, you know, financials and underlying funding? Yeah, no, great question. So we are a newly founded organization. We have significant resources to get through the task at hand. We have also engaged Ladenburg, in New York, a reputable bank, to secure a $150 million revenue interest financing facility, to support the launch of Lucamzi and additional assets we look to bring in, and then launch as well. So we see ourselves very well-funded, very well-resourced, with a lot more to come, to support the U.S. entry. Great. And also, in the press release, it is stated that. This is maybe more to Martin, but, anyway, you state that the Valorum is, I quote, "The ideal partner to commercialize ranibizumab in the U.S." Could you elaborate a little bit on why you think that is? Yeah. Well, as we have presented today, Valorum has a very experienced team with the right network in order to be successful, we believe, in commercializing this product. And then we are ourselves an entrepreneurial organization. This launch is crucial for us, and I like the fact that it's equally crucial for Valorum, and I'm sure that it's gonna have the absolute highest priority and focus of the team of Valorum to make this a success. Perfect. And also, while we're on the topic, it'd be interesting to hear if there's been any developments on the front with the FDA and the CRL since we spoke last time. Yeah. No, this is a topic which we are going to get back to in due course as we get more information. Okay. That's clear. All for me. Thanks. Thank you. As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. There are no more phone questions at this time, so I hand the conference back to the speakers for any written questions and closing comments. So thank you, Operator. Then, the first question of these is really around the Valorum part, so it comes from Peter Harmer. So when was Valorum founded? Valorum was founded in an interesting time right as COVID was initiating, and the global dynamics were changing. So Valorum was founded early 2022 with Tim Opler and I, and as stated, we really saw the opportunity with the unmet need, and as we were exploring that opportunity, it was such an unmet need, we had to go find people to develop these biosimilars that aren't currently being developed. So we quickly shifted focus to identifying commercial-ready assets, which are not easy to find, which we've been fortunate enough to find a few here recently and move the task forward. But a newly minted team for sure. ... So thank you. The next one is, and I think you touched upon this already, coming from Don. So how is Valorum sales organization organized, and how many people do you have at that organization? And also, related to this, does Valorum today have enough capital to market all of this in the U.S.? Yeah, no, great question. So we have a dozen or so staffed employees with probably an equal number of consultants to help us with the task at hand. We will scale up as we get nearer to launch, as we prepare U.S. entry at different stages for obviously efficient management of resources. We are well-resourced today, and as I mentioned, we're very fortunate to have Ladenburg setting up a $150 million revenue interest financing for us, which will more than support the launch of Lucamzi, but most importantly, bring in other programs with multiple assets in the near future. Yeah. So thank you. There are a lot of questions coming in, again, related to the FDA timing, how are we going to work together, the three parties. So maybe Martin, if you want to kick off on that, and then so we could preempt that conversation then. As I said, we're not going to be able to comment further on timing of resubmission of the BLA, but we're very pleased now to have the partnership with Valorum and that we now can work together, Xbrane, Valorum, and STADA together with, of course, our manufacturing partners to bring the BLA to resubmission as soon as possible. But we need to get back on the specific timing. Par, do you want to add anything? Yeah, yeah, definitely. So, I completely echo Martin's perspective, and as we've been engaged for quite some time now, we're very impressed with Martin and the team and clearly with Stada as well. We feel that Valorum will be additive in this process. We have direct lines to the FDA through our internal team and/or through consultants. We've recently been through biosimilar approvals, particularly with our regulatory and our manufacturing teams. So we are actively assisting where we can and providing additional value where we can as well. So I think together we make a stronger team for sure. Related to this, can you say anything about your, your confidence in, in, in the approval process? Yeah, definitely. So, as mentioned, we've been working with the team quite extensively in our diligence and in our review clearly of the BLA application, and the CRL subsequently after. And the key things that we see is probability of success. It has significantly been de-risked during the BLA review. As Martin noted on his WebEx post the receiving of the CRL, it's important to note that the FDA did not ask for any additional data as it relates to biosimilarity or bioequivalence. All that data was provided and validated. The other key point is that there was no additional clinical PK/PD or efficacy data required after a 582-phase III patient trial that met all of its endpoints, and the remaining issues we feel are addressable, not major or critical in nature. So we feel we have a very de-risked program with a near-term commercial opportunity. Excellent. Thank you. So, moving on to Lucentis and, that the fact that that is showing a decline in sales, how do you view that? Will that impact your prospects with Lucamzi? The anti-VEGF space is an interesting market. So it's one, it's significantly large, and it's growing in sales and in units. For market research that we've conducted and is available in the public domain, it's clear that physicians, when asked, given the specifics of the patient, the history, the disease burden, et cetera, do see the need for a ranibizumab product here in the near future and potentially in the distant future as well. It's also very clear to see that with all of the new entrants, and as I discussed with ranibizumab biosimilars, the bispecific, the high dose from Regeneron, you do see a very nice uptake of the ranibizumab biosimilar from Coherus. Despite the new entrants and the shifting clinical landscape, there is a need for anti-VEGF therapy, clearly, and ranibizumab appears to have a very strong mainstay today and likely tomorrow as well. Excellent. Thank you. Another one question coming in from Don. How are you going to take any market from Avastin in the U.S. despite the price difference? I'm sorry, that was Avastin? I'm sorry. Avastin, sorry, sorry. I pronounced it in Swedish, sorry. Avastin, yes, correct. ... Avastin, yeah, so we, the one thing about the, off-label, bevacizumab, clearly a lot of challenges for market research. It suggests that 40% of all units sold, in the U.S. constitute with off-label, or compounded or spontaneous use of, of approved Avastin. And there have been, in recent times, as recent as Q4 and Q1 of this year, FDA has sent out, recall notices to many, compounding pharmacies, given some issues that were noted at those site inspections, and has historically been, plagued with safety issues and potential lack of efficacy. So we believe that an approved biosimilar that's shown, bioequivalence in safety and efficacy, in an anti-VEGF market, has the ability to potentially move across other anti-VEGF opportunities. That was noted in the Coherus earnings calls prior to them divesting to Sandoz. So we do see a potential upside in the ranibizumab biosimilar going across other markets outside of just the Lucentis. So can you share any development, Martin, around the PFS, the prefilled syringe, and then also for Par, how important is the availability and the timing of that syringe? Yeah. Development is going as per plan with an envisioned launch in Europe first quarter of 2025. We shall note, though, that Lucentis biosimilars in the U.S. has been much more successful than in Europe despite only coming in format of a vial, as in Europe. So, the lack of a prefilled syringe doesn't seem to play that big of a role as we've seen in Europe, but I would love to hear Par's comments on that as well. Yeah, Martin, we agree. Currently, again, noting the recent success with the second ranibizumab approved, but the first really to show traction. They are in a vial put up. They do not have a prefilled syringe and have shown good market uptake. I think that gives us good market intelligence as we assess the market moving forward. Clearly, there are advantages to a prefilled syringe, but at this point, that has not been a detriment to success in the U.S. We'll continue to work with Xbrane and monitor the need of a prefilled syringe in the U.S., given market research and our boots on the ground. But at this point, it is definitely, definitely not limiting the uptake in the U.S. markets. Excellent. So, related to that, what type of due diligence of both the product and Xbrane as a company have you done? And then, based on that, could you consider then further collaborations in the future? Yeah, absolutely, absolutely. I think the main key takeaways are just we, as an organization, are impressed with the quality of the team, the dedication of the team, the success of the team, the validation of the product, the platform with an approval in Europe and a pending approval in the U.S. We clearly love the platform and the pipeline, and we see this as a first of many collaborations, where we bridge these programs to the U.S. and have successful commercial launches. So we envision this being a very successful and fruitful partnership for many years to come. Excellent. Then again, I think you probably have, Par, responded to this, but do you have any concerns on how a new company, such as Valorum, can compete with the larger U.S. players, Roche, Biogen, and Sandoz, marketing Lucentis biosimilars? Will you compete on price? No, I would, I would actually, I would actually challenge that they would have a hard time competing with us, given our expertise, with the distribution and the, powerful combination of our pharmaceutical experience, launching multiple, you know, multi-billion dollar brands, but most importantly, our distribution expertise with our board. We're very fortunate to have, the names that we do with Mark, Mike, and Joe, the expertise and the knowledge they hold, and, the connection to the networks is quite unique. So we are uniquely positioned, likely positioned at par with any of the large players, given our presence with the key stakeholders. So we think we would be a formidable competitor, and I think the question may be pushed back on them, how will they compete with us moving forward, given our expertise? Excellent. Then I can see on the chat that they are asking for Pareto Securities just joined in on the phone, so please go ahead. The next question comes from Dan Akschuti from Pareto Securities. Please go ahead. Thank you for taking my questions. Actually, everything has been answered so far, but I would have a follow-up. Like, if you could elaborate a bit on the competitive edge you would have over the ones that have now established themselves already on the market, or are you targeting different segments, for instance, like the, I think I read a bit about the off-label use that was seen, for instance. Are you having a specific strategy in mind, where you can fill parts of the market that currently have not been addressed that much? And also, how you differentiate yourself? And maybe another point, what your view is on the interchangeability discussion, which seems to be, you know, about to be removed. Yeah, thank you. Yeah, thank you. I'll try to take the questions from top to bottom. I think the first question was really related on market strategy and focus, and where do we compete and where do we not? I do believe that the market in front of us has given us a pretty nice roadmap to success. One thing to really note is within the ophthalmology space, the over 50% or so, close to 60%, are large practice providers. These are very efficient large providers, multi-sites. Many of them are private equity-owned, and they are very efficient in managing their businesses, and that gives us an opportunity to be very strategic and very lean. So the number of customers that have already responded to biosimilars, we can call them early adopters, we have the opportunity to map that out. Now, sometimes not being first and being second or third is an advantage. We see that roadmap, and I think we'll be able to take advantage of that roadmap. And to your point around other potential markets, the Avastin comes up quite a bit. We did note in the Coherus earnings calls that they did start to see some erosion there, and we do expect to see some of that as well. But our footprint will be lean. Given the high concentration of consolidated accounts, it's really going to be a distribution and contracting strategy that will drive a lot of success. Given the roadmap ahead of us, we feel high probability of success of maintaining our goals. Thank you. So thank you, Dan. So, another one coming from the web, the Webex. And this is probably for you, Martin, to explain a bit further. Xbrane has started a deal 50/50 in the U.S., so what is really the startup part of the commercialization in the U.S.? So what is really the agreement structure? So we entered into a co-development agreement with STADA in 2018, and under that agreement, we have co-invested 50/50 into the development of the product for global territories, essentially. And actually, STADA held the commercialization rights to the U.S. before now entering into the license agreement with Valorum. So that, of course, has been STADA's part of this. Now, under that co-development agreement as well, with STADA, Xbrane had the supply responsibility, which we hold in relation to Europe, and we're going to hold in relation to the U.S. now directly versus Valorum. So hence, given the agreement structure, proceeds from Valorum, as I mentioned, will be split 50/50 under that co-development agreement with STADA. Thank you, and are there any news you can share something how Ximluci is progressing in Europe? This, we need to defer to our upcoming webcast in relation to the Q1 report. Yeah. And that, I think, concludes the questions on the chat. So, Operator, are there any more questions coming on the phone? I think we then can probably conclude the call. So we can thank everybody for calling in, and we thank particularly Par for taking the time to present Valorum, and looking forward to a fruitful collaboration. And if you have further questions, don't hesitate to reach out to any one of you, and we'll do the best we can to answer. Good. Yeah. Thank you. Thank you, everybody.