Xbrane Biopharma AB (publ)

We will usually go through a brief operational update related to the quarter and Jane will thereafter go through the financial highlights. First, a snapshot of our development portfolio. First, our Pius Simla to Lucentis, which is under the brand name Ximluci on the market in Europe and select countries in the Middle East and now recently got approved by the US FDA under the brand name Lucamsi. We have a partnership with Stada for the European market and a partnership with Valorum for future commercialization in the US. Second product, Extivane, by a similar candidate to Optivo, partnered with Intas Accord. And we recently announced that the Pivotal Clinical pharmacokinetic trial was fully recruited. So we're looking forward to watch clinical readout Q2 next year, followed by submission of VLA to US FDA. and then xDAR-SANE, our DARS-LX biosimilar candidate, which is in more early stage development, partnered up with John Biologics, which is conducting process development currently. And in parallel to that, xBrain is seeking commercialization partners for that product. But we'll go through this a little bit more in depth one by one and starting then with Lukamsi US. We're very happy of course with the recent FDA approval and we're now going through preparations with our partner for launch during the course of next year. Here's a snapshot of the market and I think the right way to look at this is VEGF inhibitors for retinal disorders. That's a market of about 9 billion euro with about 10 million units being administrated annually across the US. So very sizable market. There are about 16 products in that market as far as we can tell. 6 branded products or originated products and 10 biosimilars both on Aliyah, and Lucentes. So I think for us, this poses a big opportunity, of course. It's a very sizable market. And even if we were to capture just 1% of that market, it could reach sales up to 100 million US dollars. So it's a very sizable market. And we are now, together with our partners, forming the commercial strategy for the product. So it's a little bit too early to say how this will pan out, but we can know that Given the dynamics in the US market, new entrants are actually favored in the segment of products which goes under Medicare Part B due to the structure with reimbursement on the buck with a list price before you have an average sales price established, which is essentially the list price minus the discounts which are given. So I think these dynamics typically favor new entrants because you're We are quite optimistic that this will go well and we will make the most out of this opportunity together with our partners. What lies ahead of us before a launch is above all, of course, production of material. We're going through that during the remainder of this year, essentially. Then preparations with our partner Valorum, of course, which relates to applying for the so-called Q code, which is We believe a launch can take place. But as I said, this is really something we do now in collaboration with our partners, Stala and Valorum. And then a few words about Europe, as I said, Ximulusi, which is the brand name in Europe, has been on the market since 2023 across 24 countries in Europe and the Middle East. Stala is commercializing a quite simple structure. We have co-developed the product together with Stada and we're sharing the profit contribution 50-50. And here is an historical graph with the profit share essentially that has gone to X brain over the quarters since launch in Europe. And we have an accumulated profit sharing of about 145 million Swedish crowns. Thank you very much. Thank you very much. So that's why it's a little bit of a variation quarter by quarter. But I think if we look at this where we stand now, it's generating, you know, about 50 million Swedish crowns a year in profit sharing. With that said, 6% volume market share, then looking at only the cannabis market, so that's a share of the total VGF inhibitor market. And we have talked about before going through several cost reduction measures. We believe that that is... It's crucial to bring down the production cost given an increasing competition and this will bear fruit second half of next year essentially and we believe then that this could unlock further growth opportunities across Europe and Middle East. We also have a remaining inventory position of 149 million Swedish crowns, essentially mainly drug substance gradually being converted to drug product and sold to Stala mainly. And we believe that that will be converted during the remainder of this year and next year essentially to cash. So that was an overview of where we stand with regards to Lecance or Ximilusi and shipping gear over to X-Devane or by a similar candidate to Optivo. So this is then targeting the whole PD-1 inhibitor market, so essentially Optivo and Keytruda and that's about 40 billion euro in annual net sales, so a massive market opportunity. And to be noted, Opdivo goes off patent first, so that's December 28 in the US, and Keytruda patent lapses some six months after. But we do believe there's an opportunity for biosimilars being there day one post-Opdivo patent expiration to also capture market share from Keytruda. It's a massive market opportunity and we believe we are well positioned from a timeline perspective in this race towards patent expiration. From a competitive perspective, we know Amgen already submitted their BLA to the FDA. But I do believe that we are second in that group of expected biosimilars having fully recruited our pivotal clinical trial. and then we have three other biosimilar candidates under development and in clinic. So eventually we do expect to see five or so biosimilars to Opitivo on the market but it's really about being there in the first wave or preferably immediately upon patent expiration which we really do believe that we're going to be able to be. And in partnership with Intas Accord in relation to this product, we believe we have a very strong partner for commercialization. Accord, which is a sales subsidiary of Intas, has a very high market share in Europe when it comes to I'm calling them injectables and it's also establishing themselves in the US with an acquisition done of Coheros, Pegfield, Gastin, Biosimilar a while ago and also a handful of products on their way to market. So we believe we have a strong commercialization partner and that Accord will do a fabulous job in commercializing this product. And again, from a timeline perspective, we are now going through, on the one hand, all the CMC-related activities which are remaining, so that is drug substance, drug product, process validation and characterization, which is going according to plan. Again, the PIVOTA clinical trial was fully recruited, 340. Patients in melanoma and we're going to have an interim readout in Q2 next year and then we are planning for submission of the BLA to the FDA mid next year really to prepare for having an approval and be in a position to launch by patent expiration end of 28. So I think this is going very much according to plan currently and we're very excited about the prospects of this And moving forward, I think a natural question to have and a question we often get is why should we believe that this by-similar candidate is going to be approved on the first attempt by the FDA given the delays we've had with Leucamze and it's a fair comment. But I think it's important to look at this in a little bit more detailed manner. What held us back with LUCAMSI was really related to GMP issues at the contract manufacturers. It was related to unresolved observations from inspections by the FDA. We had two CRLs due to that, as you might recall. But FDA, in the first BLA we sent in, did not have any comments in relation to the clinical development nor the whole analytical comparability package, which are two other important aspects of the BLA. So we've learned from this when it comes to X-Devane, and we work with one of the top Siavash Bashiri, Jane Benyamin There are potential issues with FDA related to inspections at manufacturing sites and I do believe there is high probability that we're going to get approved the first time when we submit the BLA to FDA. So we're quite excited about this program and it could be very valuable to X-Brain. We've shown this slide before. We have Venture Valuation, which is an independent pharmaceutical product valuation company. Siavash Bashiri, Jane Benyamin Siavash Bashiri, Jane Benyamin Siavash Bashiri, Jane Benyamin Siavash Bashiri, Jane Benyamin Siavash Bashiri, volume market share as well as price decline and applying those curves or trends if you will to this situation in combination with the expected competitive situation essentially and then applying the relevant you know cost structure and profit sharing mechanism if you will All that together, their estimate was that this could generate above 100 million euro in profit sharing at its peak to H-Brain, which of course would be fabulous and a very sizable opportunity for us. So we're very excited about this program and what it could do for patients, of course, but also for H-Brain as a company. Then moving on to Ekstar saying this is more early stage as I mentioned, but we're quite excited about this program as well. It's addressing a very sizable originated product now at about 14 billion US dollar actually. And we are navigating this through without having to invest further into the program from experience perspective. So essentially the arrangement here is that joined by Logix, which is a prominent and Biologics CMO with sites in both the US and China. They're going through process development of this bisimilar candidate and the target to get towards comparative analytical demonstration mid next year, after which we can take this program further to watch scalar production of clinical material and go into clinic and so on. In parallel, EXPREN is seeking a commercialization partner like the partnerships we've done with Stada as well as Intas in the past. We're seeking a similar structure with a partner that is interested to commercialize this by a similar candidate once approved. So early stage, but quite interesting opportunity still. So to summarize, key takeaways from this quarter, Ximilusi launched across 24 countries in Europe and the MENA, generating about 50 million Swedish crowns per year in profit sharing for us now. And we are going through cost reduction measures which will bear fruit second half of next year, and we hope unlock further growth opportunities. Lucansi, FDA approval and now going through preparations for launch during the course of next year together with our partners. And then for ExDevane, the pivotal pharmacokinetic trial was fully recruited in October. and we are moving in a timely fashion towards day one launch in the U.S. late 28. And then early development with X-Star Zane and we are working through establishing a deal with a commercialization partner. So these are the key takeaways from an operational perspective of the quarter and I therefore hand over to Jane to go through the financial highlights.

Yes, and as we can see, during the third quarter, we have resumed shipments to Stada, giving us a revenue of total 54.8 million Swedish crowns, where 54.6 million Swedish crowns are referred to shipments to Stada. Kogs amounted to 45.8 million Swedish crowns, giving us a gross margin of 16%. We expect continued shipments to Stada during the course of the coming quarters. And as Martin mentioned, we are still working on cost reducing measures to reduce cost of goods and give us a more competitive cost of goods of production costs in 2027 and onwards. The administrative expenses amounted to 5.4 million Swedish crowns and the R&D expenses to 13.4 million Swedish crowns, where 2.7 million Swedish crowns referred to amortization of intangible assets. 15.7 million Swedish crowns have been capitalized as intangible assets during the third quarter of 2026. Here you can see the cash flow breakdown for the third quarter. So 6 million Swedish was received from profit sharing from Stada for the second quarter. Production of finished goods of Ximilusi amounted to 3 million Swedish crowns, which will give us and has given us revenue during the third quarter and also in the upcoming quarters. Fixed costs amount to 17 million Swedish crowns and are referred to salaries, social security, IT storage, etc. Ximilusi sales gave us 39 million Swedish crowns and came from accounts receivables for the second quarter and also sales during the third quarter. Development costs amounted to 5 million Swedish in cash flow and ex-devane to 3 million Swedish, referring to CMC-related development costs. So the cash balance closed at 37.4 million Swedish crowns, which all in all gave us an operating cash flow for the quarter amounting to 4.1 million Swedish crowns.

Excellent. So we thereby close the formal presentation and open up for potential questions coming in from business calling in.