Xbrane Biopharma AB (publ)

Hello everybody. My name is Martin. I'm the CEO of X-Brain and I'm here together with Jane, our CFO. So we will go through the highlights of our Q1 report 2026. I will start with an operational update and Jane will thereafter go through the financials. So we will start with Eximluci, our Lucentis biosimilar, and we will then go through some highlights in relation to Extivain, our Optivo biosimilar candidate under development. SimluSim is launched across 24 countries in Europe and the Middle East. It's a product which we have partnered with Stada. Stada is commercializing the product across these different countries. And it's a quite simple setup where we share the profit contribution post production cost and sales and marketing expenses 50-50. It's a sizable addressable market if we look at it as anti-VGF products for retinal disorders. We have of course then Lucentis and the Lucentis biosimilars. That's the dark blue chunk in the bottom of this graph on the left hand side. Active ingredient Ranibizumab and then we have Other competing molecules, ILEA and VABUSMO, and some off-label usage of the cancer drug Avastin. But it's all in all a market opportunity of 5 billion euro, which is growing on the back of an elderly population driving increase the need for these kind of drugs and also to some extent more cost-efficient options coming to the market within the Renovismab or Lucentis biosimilars as well as ILEA biosimilars. Looking now specifically on Xim Lucy and the performance last quarter, important to note is that we have a constant cash profit sharing coming in in Q1 2026 in relation to fourth quarter of 2025. So we'll see a little bit later in the presentation when Jane go through cash flow that we had 13 million swedish crowns coming in um cash wise this quarter that was the from from the fourth quarter and we'll have a similar amount as a result of sales this quarter um but the volumes have gone down slightly compared to to last quarter but it's a result of a focus on maintaining profit margin level and maintaining the profit contribution in the market where we actually are seeing prices going down and a quite high degree of price competitiveness within this market segment. And we are, as we've talked about before, going through several measures to reduce our production cost. And we believe that that is going to bear fruit in 2027 and onwards. And our estimation is that that can unlock further volume growth for us. But for now, we are going to have to focus on maintaining the profit margin with the current production cost that we have. still have an inventory of mainly drug substance which we are now gradually converting into cash as we are shipping more product to our partners data and that will take place during the course of this and next year so it's 170 million Swedish crowns which we expect to gradually be converted into cash Then US, we released the press release last week. We resubmitted the BLA to FDA. As you might recall, we had a complete response letter in October last year and that was due to one of our contract manufacturers having unresolved observations from an inspection performed by the FDA during last year. And that site have now worked through those observations and have submitted the documentation to the FDA. where all the actions in relation to the observations have been finalized and the related documentation submitted to the FDA. So we now expect a regulatory timeline of six months and we'll have to wait and see whether FDA chooses to re-inspect this specific site or not and we'll have to get back when we know when the specific Vesufa data, the decision data is going to be by the FDA and the activities leading up to that. Then shifting gear to ExDevane, our EvoBuy similar candidate. We're quite excited about this program actually. It's going according to plan towards a regulatory submission to US FDA second half of 27 to enable an approval second half of 28. and an ability to launch the product in the beginning of 29 provided of course a timely approval and that is the point in time when the patent on Opdevo expires. It's an ongoing clinical trial with the recruitment going according to plan. and we're also in parallel going through all related CMC activities process characterization and validation of both drug substance and drug product processes and worth to mention here as well we are working with a well-established contract manufacturer for this program with long history of supplying commercial pharmaceutical products to the US and having successfully gone through FDA inspections for related products. So we feel quite comfortable in that we have reduced that development risk, if you will, having learned quite a bit from our Ximilusi program. In relation to financing of the development activities, we released a press release this morning where we have agreed with our partner Intas in relation to financing on specific CMC-related activities which are under X-Brain's responsibility and in the original license agreement were under X-Brain's financing responsibility. Now Intas have agreed to partly finance these activities and that will take place during the course of this and next year and will accrue with an 18% add-on on these respective expenses which they're paying for per annum. And then when we are entitled to profit sharing, when the product is on the market, those expenses will be deducted prior to exchange receiving any profit sharing. In connection with this, Intas has also been granted an option to make a one-time lump sum payment corresponding to 40 months of forecasted profit sharing. And they can do that at any point in time during the course of the license. And if they were to do so, that would then release them from the obligation of paying X brain any further profit sharing from sales of the product. We have, though, a period from this point six months ahead where we If we were to be able to arrange other suitable financing that we could essentially repay whatever interest would have paid at that point in time and then reverse this option to make this one time lump sum payment. So that's the essence of this arrangement. And in connection with this, we also engaged a company called Venture Valuation, an expert in valuing pharmaceutical products. And they had a look on the prospects of Xtivane. under the fundamental assumption that the product is approved and could be launched beginning of 29 in the US and up on European patent expiration mid-2030. They made what they thought were reasonable assumptions with regards to overall market opportunity, biosimilar volume penetration, price discounts, and market share of X-Devane, looking at how oncology biosimilars have developed historically in the US, the level of expected competition for this specific molecule, and so on and so forth, and then applying the profit sharing levels which X-Brain are entitled to from this program. came to let's call it the base case with over the course of 10 years from 29 to 2038 accumulated profit sharing of close to 10 billion Swedish crowns out of which a third would be related to the first four years and if you take that expected profit change during the course of these four years and calculate the net present value in the beginning of 29 using a 15% discount rate, you end up at 4.4 billion Swedish crown. We did this valuation in connection with this amendment which were done with Intas and it's to give some kind of guidance on what 40 months of profit sharing could be worth should that one time lump sum payment option exercised by Intas as I described on the last slide. So I think that was the essence from an operational perspective and we can then shift over to the financials. So I hand over to Jane.

Yes. So, the revenue for the period amounted to 17.3 million Swedish crowns, where 17.2 related to product sales of Simuluso to Stada. And the COGS, or the profit margin, amounted to 39%. During this coming quarters, we expect more production sales as we have production slots planned and we have also started the production on site. During this next coming quarters, we're also working, as Martin said, on cost reduction measures to reduce cost of goods and be more competitive in the market. The administration expenses amounted to 17.6 million Swedish crowns and the R&D expenses amounted to 9.9 million Swedish crowns, where of 2.7 million relate to amortization of intangible assets, both of which are in line with our expected expenses. This is the breakdown of the cash flow. You have seen this before. And as you can see, we received 13 million Swedish crowns of the profit sharing from Stada related to Q4 2025. The production of finished goods, which will be shipped during the second quarter, amounted to 4 million Swedish crowns. And the fixed costs of admin and R&D, as explained on the last slide, amounted to 17 million Swedish crowns. Some small investments have been made on Ximilusi, among other things, to reduce the COGS, as explained, and also some expenses have been invested into the Extivain project. The closing balance of cash was 66.7 million at the end of the quarter. Here you can see the operating cash flow, which amounted to 8.5 million Swedish crown in Q1. And as I mentioned, the cash amounted to 66.7 million Swedish crown at the end of March 2026.

Yeah, so the key takeaways from the quarter. Exim Lucy launched in 24 countries. We have a constant market share of 8% from a volume perspective in Europe. We are working on several initiatives to bring down the production cost of Exim Lucy. That's really the most important thing for that program right now and it's really to ensure the long-term competitiveness of the program in the market where we are um seeing reduced price levels overall we have resubmitted the the bla to usfda and we expect the six months regulatory process um so we hope for a decision date and of course an approval during the second half of this year And X domain development is proceeding according to plan and we are targeting BLA submission second half of 27. So with that said, I think we are shifting over to questions and we'll start with any potential questions from people calling in.

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okay there seems to be no questions from people calling in we have one question in the chat here how likely is it that the interest will use the 40 months option and if when in time really impossible to answer that question. We cannot estimate the likelihood of Intas choosing to exercise this option or when it would occur. It would depend on multiple different factors such as timing of approval, the level of competitiveness at that point in time and how the market has developed up until then. So it's really impossible for us to estimate that likelihood. um so i think actually that was the only question on the chat um so um with that said we will then close down the call and um we are here and available um over email or phone should there be any other questions and um otherwise we are looking forward to next time in the course time and have a great day all of you thank you