Welcome to Xbrane Biopharma Q1 Report 2026. During the questions and answer session, participants are able to ask questions by dialing pound key five on their telephone keypad. I will hand the conference over to CEO Martin Åmark and CFO Jane Benyamin. Please go ahead.
Hello, everybody. My name is Martin. I'm the CEO of Xbrane, and I'm here together with Jane Benyamin, our CFO. We will go through the highlights of our Q1 report 2026. I will start with an operational update, and Jane Benyamin will thereafter go through the financials. We will start with Ximluci, our LUCENTIS biosimilar, and we will then go through some highlights in relation to Xdivane, our OPDIVO biosimilar candidate under development. Ximluci 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. It's a quite simple setup where we share the profit contribution post production costs and sales and marketing expenses 50/50.
It's a sizable addressable market if we look at it as anti-VEGF 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. Then we have other competing molecules, Eylea and Vabysmo, and some off-label usage of the cancer drug Avastin. All in all, a market opportunity of EUR 5 billion, which is growing on the back of an elderly population driving increased need for these kind of drugs. Also to some extent, more cost-efficient options coming to the market within the ranibizumab or LUCENTIS biosimilars as well as Eylea biosimilars.
Looking now specifically on Ximluci and the performance the 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. We'll see a little bit later in the presentation when Jane Benyamin go through the cash flow that we had SEK 13 million coming in cash-wise this quarter. That was from the fourth quarter, and we'll have a similar amount as a result of sales this quarter.
The volumes have gone down slightly compared to last quarter, but it's a result of a focus on maintaining profit margin level and maintaining the co-profit contribution in a market where we actually are seeing prices going down and a quite high degree of price competitiveness within this market segment. We are, as we've talked about before, going through several measures to reduce our production costs. We believe that that is going to bear fruit in 2027 and onwards. Our estimation is that that can unlock further volume growth for us. For now, we are going to have to focus on maintaining the profit margin with the current production costs that we have.
We still have an inventory of mainly drug substance, which we are now gradually converting into cash as we are shipping more product to our partner STADA. That will take place during the course of this and next year. It's SEK 170 million, which we expect to gradually convert into cash. U.S., we released a press release last week. We resubmitted the BLA to FDA. As you might recall, we had a complete response letter in October last year. That was due to one of our contract manufacturers having unresolved observations from an inspection performed by the FDA in June last year.
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.
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. We'll have to get back when we know when the specific PDUFA date, the decision date, is going to be by the FDA and the activities leading up to that. Then shifting gear to Xdivane, our OPDIVO biosimilar candidate. We're quite excited about this program actually. It's going according to plan towards a regulatory submission to U.S. FDA second half of 2027 to enable an approval second half of 2028 and an ability to launch the product in the beginning of 2029, provided of course a timely approval, and that is the point in time when the patent on OPDIVO expires.
It's an ongoing clinical trial with 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. Worth to mention here as well, we are working with a well-established contract manufacturer for this program with a long history of supplying commercial pharmaceutical products to the U.S. and having successfully gone through FDA inspections for related products. We feel quite comfortable in that we have reduced that development risk, if you will, having learned quite a bit from our Ximluci 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 Xbrane's responsibility and in the original license agreement were under Xbrane'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. Then when we are entitled to profit sharing, when the product is on the market, those expenses will be deducted prior to Xbrane 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. If they were to do so, that would then release them from the obligation of paying Xbrane any further profit sharing from sales of the product. We have though a period from this point and six months ahead where we, if we were to be able to arrange other suitable financing, that we could essentially repay whatever Intas would have paid at that point in time and then reverse this option to make this one-time lump sum payment.
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 Xdivane. They, under the fundamental assumption that the product is approved and could be launched beginning of 2029 in the U.S. and upon 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 Xdivane, looking at how oncology biosimilars have developed historically in the U.S., the level of expected competition for this specific molecule and so on and so forth.
Then applying the profit sharing levels which Xbrane are entitled to from this program and came to, let's call it the base case, with over the course of 10 years from 2029 to 2038, accumulated profit sharing of close to SEK 10 billion, out of which 1/3 would be related to the first four years. If you take that expected profit sharing during the course of these four years and calculated as net present value in the beginning of 2029 using a 15% discount rate, you end up at SEK 4.4 billion.
We did this valuation in connection with this amendment which we're 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. I think that was the essence from an operational perspective, and we can then shift over to the financials. I hand over to Jane.
Yes. The revenue for the period amounted to SEK 17.3 million, whereof SEK 17.2 related to product sales of Ximluci to STADA. The COGS or the profit margin amounted to 39%. During this coming quarters, we expect more production sales as we have production spots planned, and we have also started the production on sites. 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 SEK 17.6 million, and the R&D expenses amounted to SEK 9.9 million, whereof SEK 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. As you can see, we received SEK 13 million of the profit sharing from STADA related to Q4 2025. The production of the finished goods, which will be shipped during the second quarter, amounted to SEK 4 million. The fixed costs of admin and R&D, as explained on the last slide, amounted to SEK 17 million. Some small investments have been made on Ximluci, among other things, to reduce the COGS, as explained, and also some expenses have been invested into the Xdivane projects. The closing balance of cash was SEK 66.7 million at the end of the quarter. Here you can see the operating cash flow, which were amounted to SEK 8.5 million in Q1. As I mentioned, the cash amounted to SEK 66.7 million at the end of March 2026.
Yeah. The key takeaways from the quarter, Ximluci on launched in 24 countries. We have concept market share of 8% from a volume perspective in Europe. We are working on several initiatives to bring down the production cost of Ximluci. 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 seeing reduced price levels overall. We have resubmitted the BLA to U.S. FDA, and we expect a six months regulatory process. We hope for a decision date and of course, an approval during second half of this year. Xdivane development is being advanced and up on [audio distortion].
Okay. There seems to be no question from the [audio distortion]. We have one question in the chat here. How likely is it that Intas will use the 40-month 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. It's really impossible for us to estimate that likelihood. I think actually that was the only question on the chat.
With that said, we will then close down the call and we are here and available over email or phone should there be any other questions. Otherwise, we are looking forward to next time in a quarter's time and have a great day all of you. Thank you.