Xbrane Biopharma AB (publ)

Thank you and welcome all of you who are listening in to our webcast in relation to the fourth quarter report of 2025 for X-Brain Biopharma. As usually, I will go through a brief operational update and Jane will thereafter go through the financials for the quarter and then we will have a Q&A session where you can either ask questions via audio or via the chat. So we're going to start off with talking a little bit about Xim Lucy, our biosimilar to the eye drug Lucentis which we have co-developed together with Stada and Stada is commercializing across Europe and select countries in the Middle East. It's a quite straightforward setup where we are splitting the profit contribution post production cost and sales and marketing expenses 50-50. The product is now launched across 24 countries out of which 20 in Europe and including the five big European countries. It is a significant market opportunity across Europe. We estimate the market size to about 5 billion And then we're talking about BGF inhibitors for retinal disorders. So that includes Lucentis and the Lucentis biosimilars. That's the dark blue chunk ranibizumab, which is the active ingredient on the bottom of this chart. But then also the other inhibitors. BGF inhibitors for retinal disorders present in Europe being ILEA and the biosimilars who now have been starting to be launched on ILEA and then Vabysmo and then also some usage of Avastin off-label. I think what we are seeing is a continued volume growth. We've seen about 7% overall volume growth last couple of years. But now what we're seeing is an increased competition, I think, mainly due to entrance of biosimilars to ILEA. Patent went off in November last year, and we've seen at least three by similar story having been launched and an additional five being approved and expected to be launched. And we are seeing an increased competition and an increased importance of price across Europe. And I think that's also reflecting what we're seeing with regards to sales evolution, where we saw constant volume when it comes to Ximilusi compared to Q3 2025, we are at about an 8% volume market share, looking at only the Ranevis market, so Lucentis and Lucentis Biosimilis, out of which Ximilusi is one. But still, compared to 2024, year-on-year 2025, we saw about 60% volume growth, a 20 volume growth q425 versus q424 so looking at it in a longer perspective we see still see a growth we have generated 160 million swedish crowns in profit contribution from this product out of which a little bit about 100 million having been paid in cash from our partner startup so far and as we've had for quite some time we have a significant inventory mainly consisting of drug substance at the net value of about 170 million Swedish crowns and our expectation is that this will gradually be converted into cash during the course of this year and next as we are producing and shipping more product to Stada. And in doing that, converting this drug substance inventory into cash. What we also are doing when it comes to Ksimiluse are important initiatives to reduce the production cost. As Jane will talk about later, we did a significant investment during the fourth quarter into cost reduction measures we believe that this is going to be absolutely crucial for us to be long-term competitive in the european market and something we we have to do but these things take some time and it will bear fruit from 2027 and onwards but that is the key focus for us right now to further bring down production costs to ensure long-term competitiveness of the product We're also working on resubmission of the BLA to US FDA. As some of you might recall, we received a complete response letter from FDA in October last year. In that complete response letter, FDA mentioned unresolved observations at one of the production sites involved in the supply chain. of Ximilusi or Lucomsi, which is the intended brand name in the US. We have since worked with this contract manufacturer to remedy these deficiencies observed by the FDA, and it's going according to plan. We are then planning for a resubmission next month to FDA. And we do expect the six months review process by the FDA as per guidelines. So therefore, we do expect a decision date or so-called SUFA date in September 2026. um and then shifting a little bit to our second program um ex divane by similar candidate to optivo which is one of the immuno-oncology products the pd1 inhibitor and it's used in treatment of several cancers it's a quite sizable product sells for about 9 billion us dollar currently expected to reach 14 billion us dollar by time of patent expiration which is in December 2028. And we believe we are in a good position here. As far as we can tell, we're one out of four by similar candidates which are in clinic and have a timeline which could allow a launch shortly after patent expiration of the originator. And we are working together with a partner, INTAS, on this program. HPREN, as you might recall, is responsible for the so-called CMC-related development activities that entails process characterization and validation on both the drug substance and drug product side. And we are working with one of the 10 largest contract manufacturers on this program where both of the production sites related to drug substance and drug product are approved by US FDA since a long time and have successfully catered multiple FDA inspections and are supplying commercial product to the US. So we believe that we significantly have reduced the risk in relation to the regulatory process with the FDA in relation to potential pre-approval inspections by the FDA and potential delays that could cause, as we've seen, an ex-inclusive program. So this is all going according to plan and our partner Intas have initiated the clinical trial and the recruitment of patients is ongoing and it's going according to plan. As you might recall, we are then doing a comparative trial in about 340 patients with melanoma. And yeah, recruitment is going according to plan, and it's a critical component, of course, of being able to meet the timeline of submission to US FDA latest Q4 2027. So far, we're keeping that timeline, and that is crucial, of course, in order to get this product approved by patent expiration, again, December 28th in the US, and have it launched shortly thereafter. We still believe that this product has a huge potential. We've talked about this before. We do believe in a profit sharing potential of about 1 billion Swedish crowns annually at peak. Here are a few scenarios dependent on what you choose to believe with regards to number of biosimilar competitors and the price discount versus the originator. But if you look at the history in the US with regards to biosimilars on oncology drugs, we can see that on average, biosimilars three years in had taken 75% of the volume. And we can see on the lower graph on the left hand side here how the prices decline over time, which is natural. but that they can go down to at about 50% or so below pre-patent expiration originated pricing some three years in or so. So we do believe given all this and if the competitive situation remains with Xtivine being one out of four biosimilars to Optivo in the US, we do believe that it can lead to more than a billion Swedish crowns annually being generated. And we had an external valuation firm also looking into this, confirming our forecasts and beliefs in relation to the potential of X-Train just recently, something which we most likely will get back to later during the year. So with that said, I will hand over to Jane to go through the financials.

So the revenue for the quarter amounted to 9.1 million Swedish crown, where of 8.9 million Swedish crowns were referring to product sales to Stada. So the COGS amounted to 7.4 million Swedish crowns and was higher than expected due to some problems with production of one batch. This led to a gross margin of 18%, which would have been 39% had we not seen the problem in the production. We are expecting some continued deliveries installed during the upcoming quarters and have secured manufacturing slots with our production sites. As Martin mentioned previously, we're working on some cost reduction measures together with Stada to make sure that Ximilusi can stay competitive in the market as the competitiveness is being harsher and the prices are being reduced. The administrative expenses for the quarter amounted to 6.6 million Swedish crowns and the R&D to 17.8, of which 2.8 million Swedish crowns were referring to amortization of intangible assets and 3.5 million Swedish crowns refers to non-recurring R&D activities. 24.3 million Swedish crowns have been activated as intangible assets over the quarter. So the breakdown of the cash outflow and inflow looks like this. We had an incoming balance of 94 million Swedish crowns, more or less, and took a loan from Fenja in the beginning of October of 60 million, which was 57.6 net of transaction fees. The profit sharing from Stada came in at 13 million Swedish crowns, and we had some production of finished goods, which are not the same as the COGS, at 8 million Swedish crowns. Fixed cost amounted to 18 million Swedish crowns, And the investment of Ximnusi, the production cost-reducing activities, are mainly consisting of these 26 million Swedish crowns. And the X-Devein project, which was 25 million Swedish crowns due to CMC-related activities that we are contractually bound to conduct. The closing balance of the period was 86.6 million Swedish crowns. So if you look at the operating cash flow, it amounted to 68 million Swedish crowns, and it's very important to highlight that we have reduced the short-term payables from 538 million Swedish crowns per December 2024 to 53 million Swedish crowns per December 2025. And the long-term payables have been reduced by 38 million Swedish crowns.

Yeah, so the key takeaways in Ximilusi on 24 markets in Europe and the Middle East and volume market share maintained in Europe. We are focusing when it comes to Ximilusi on bringing down production cost and we believe that that will bear fruit in 2027. We are planning to resubmit the BLA when it comes to Ximilusi in March this year. And XDMA development is proceeding according to plan and we still target a submission of the BLA to US FDA second half of 27. So with that said, I think we are moving over to Q&A.

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 Philip Einerson from Red Eye. Please go ahead.

Hi, everybody. So a few questions on my end. I'll start by asking relating to the revenue figure. And just to confirm, is it correctly interpreted that there was no profit split in Q4 and that the revenues relate pretty much only to the shipment of finished goods to Stada?

That is more or less accurate, yes.

Okay, thanks. And the second one, I'm a little bit curious if you could help me understand on the inventory levels and help us calibrate expectations for shipments throughout 2026 or at least maybe the coming quarters here. What's the reasonable expectation to have?

I mean, I said we have a net inventory value of 170 million Swedish crowns related to Ximluci and our expectation, which is grounded on our production schedule during the course of this year and the next year, we believe that absolute majority of this inventory shall be converted into cash when 2027 comes to an end. That's the current plan, at least. So it's probably as much as we can say.

Okay, that's clear. So I'm also a little bit curious, I understand it's maybe hard for you to be too specific or say too much, but I'm thinking about the launch of ILEA biosimilars and the impact you're seeing as you touched upon on Lucentis biosimilars. I mean, what's the recent expectations for the coming quarters here?

Good question. I mean, what we are seeing for sure is an increased price pressure, I would say, across the market and that being due to launch of ILEA biosimilars or increased competition. for other reasons within the RANABIS MOB segment hard to tell but that for sure we're seeing and I think we need to well we're trying to focus on what we can impact on our end which is to bring down the production cost which again is going to be absolutely crucial in mid to long-term perspective but apart from that I think it's currently in a situation which is a little bit hard to predict how volumes are going to develop in the course of this year and next.

Just a short follow-up there. As you mentioned, you're working with startups to reduce production costs and increase the gross margin of solution. But when do you expect this to be sort of materialized or do you have an expectation on that?

Starting to be materialized in 2027.

Okay, good. So the last one on my end is a little bit on the cost expectations. Would you say that Q4 is sort of a good starting point for the coming quarters or do you see an increase from here?

On the cost side?

Yeah, exactly.

I mean, I think now we have an organization post everything what we did during the course of last year with the investments of part of the organization to Alvatec. And after that, we also did a few recruitments. But now we have an organization which we believe is perfectly fit for our endeavours during the course of the next coming years to execute on the one hand the development responsibilities on X-Divane but then also to execute on these important aspects of Xim Lucy on the cost reduction measures as well as the BLA and a future hopefully launch in the US. So I think, you know, Jane showed 18 million Swedish crowns of fixed costs, which entails personnel, general administrative expenses and so on and so forth. I think that's a reasonable expectation on a quarterly level I would say for 2026. It's going to somewhat be reduced but i would say marginally due to you know shift out of consultants in favor of of employees but i think that's that's a reasonable level to kind of forecast from okay great great 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 questions at this time, so I hand the conference back to the speakers for any written questions and closing comments.

Yeah, so I have one written question, which is referring to an out of stock situation in Sweden. And it says that the company, Yeah, I think that the question is, why do we have an out-of-stock situation in Sweden? And the simple answer is that we provide products to Stada, who is the responsible party of commercializing the product into the markets. Depending on... demand and price levels in the different markets, start to make the decision on where to deliver the product. Sweden is a market where you have tenders with the hospitals. So in case you did not win a tender with a hospital, there is really no reason to maintain a stock level in Sweden, which would be mainly the reason why it's out of stock. I hope this answers the question. Let's see. There is also one other question. What about the PFS?

Yeah, as we also discussed in the last quarterly call, we have put the pre-visual injunction Lucy on hold as of now. And instead we are focusing our limited resources on these cost reduction measures, which we're going through since we deem them to be more important, essentially for the product and the company for the time being. yeah that was all questions online okay um if no further questions we're going to end the call now but we are available or phone or email should you have any follow-up questions and otherwise thank you for now and wish you all a good day thank you