Hello, everybody. My name is Martin, and I'm the CEO of Xbrane Biopharma. So I will do my best to run through an overview of the company. So we are in the business of developing biosimilars. So let's start to clear that concept. A biosimilar is a highly similar drug to an already approved biological drug. So it is then launched post-patent expiration and, of course, at the price discount. So a similar thing as generics to small molecules. And it's a market which is growing rapidly now, of course, on the back of patent expirations of biological blockbusters and also an ever-increasing penetration of the biosimilars on the market compared to the respective originator drugs on the back of an ever-increased confidence amongst physicians and patients to go for the more cost-efficient alternative. We currently have two programs in our portfolio.
We started off with a biosimilar to Lucentis, an eye drug used in treatment of mainly age-related macular degeneration. It's approved in Europe since November 2022. It was launched March 2023 in Europe by our partner STADA. And we have a very important date coming up on 21st of October this year, the so-called BsUFA date, the decision date by the FDA. So we hope for an approval, of course, and that would open up the U.S. market for this program. Then we have a biosimilar candidate to Opdivo under development, partnered up with a company called Intas, and it's currently going into clinic. And it has happened quite a lot in the regulatory landscape of biosimilars lately. Regulators, EMA and FDA, have agreed to waive the so-called Phase III trial, a big comparative efficacy trial that previously was required. So this changes the landscape radically.
We're able to reduce the development spend to about EUR 40 million and also reduce the timing somewhat. We were actually in the forefront of this development with our Opdivo biosimilar candidate. Then back to Ximluci, the Lucentis biosimilar, as I said, on the market, STADA, big German pharmaceutical companies commercializing the product, and we're getting, as per the agreement with them, 50% of the profit contribution on the sales. It's a big market, EUR 5 billion in Europe if we think about the class of drug VEGF inhibitors for retinal disorders. We believe we are addressing that full market. If we look at the performance since the product was launched in Europe, we have generated profit sharing of SEK 116 million accumulated, and I think we see quite strong volume growth, about 20% on average last quarter from quarter to quarter.
We are at the 8% volume market share if we only look at Lucentis and the Lucentis biosimilars that strict market. We do believe there's big further potential for us to take further volume share. We had an ambition when we went into this together with STADA to take 25% volume market share, and we still hope that we're going to be able to achieve that. Then, of course, the U.S. would add a significant additional potential for this product, EUR 9 billion of addressable market. We do believe when we model a bit, if we were to be taking somewhere between 10%-30% volume market share and reasonable price discounts, we would be able to generate some SEK 120 million-SEK 220 million annually in profit sharing. We have a partner, Valorum Biologics , that are going to commercialize the product in the U.S.
So in parallel with the expected approval, 21st of October, we're making preparations for launch and commercial supply to them. Yeah, exactly. And you never know with the FDA, of course, but we are optimistic that it will go well this time around. We had a CRL coming in April 2024, I think it was due to observations at one of our partners' manufacturing sites. It has since been addressed with a reconstruction that took place during the fall to address one of FDA's observations. And that site, as well as the drug substance site, was recently reinspected by the FDA. And we are optimistic that it will go well 21st of October. Then Xdivane, then a biosimilar candidate to Opdivo , immuno-oncology drug, current sales of about $9 billion, so a very big drug, expected to reach $14 billion by time of patent expiration.
We do believe we are in a good position given the size of the originator product and the competition from other biosimilar developers. We're one out of four biosimilar developers that have a biosimilar candidate to Opdivo , in clinic. And that, I think, is limited competition given the size of the originator product. We partner up with Intas, and they have a sales arm in Europe and the U.S. called Accord. And it's actually a quite sizable company. They're distributing about a third of all oncology injectables in Europe, and they've made strong inroads into the U.S. as well recently. So this was kind of a traditional deal we did with them, an upfront payment, some license payments that comes in on development milestones, and then a profit sharing mechanism after approval. It's a global deal.
We're currently doing the IV formulation, but a good thing with this partnership as well is that Intas is very much focused on also developing a subcutaneous formulation. Some of you maybe saw competing drug to Opdivo , Keytruda got their subcutaneous formulation approved in the U.S. a few days ago. So we'll see how much that transitions from IV to Sub-Q, but we will be prepared also to compete in the Sub-Q part of the market. And it's a clinical trial ongoing now. Intas is the sponsor of the trial, and we're happy for that. It's a sizable trial, at least from a budget perspective, 50 million EUR. They're investing into this trial, recruitment of about 340 patients in melanoma. And it's completely doable within this timeframe.
We're very much targeted together with Intas to submit the BLA in Q4 2027 in order to be approved Q4 2028 as the patent expires in the U.S. of Opdivo . That's December 28. So we want to have a launch early 2029, and the timeline allows for that. What could this mean for us? I think this program is really the big upside in Xbrane. If we look at the development of biosimilars, commercially speaking, in the U.S. lately, and we look at biosimilars to oncology products, we've seen that after three years, they've taken some 75% of the volume on average. That's on kind of the upper right-hand side, that graph. You can see also price, of course, drifts downward over time. Maybe starts at 20% down versus the originator and then goes down maybe to 70% down over time.
But if we kind of do some scenario analysis here and we count on somewhere between four to six biosimilars eventually, then if you just count on six, that would mean that it would be a 13% volume market share, 70% down in price. Still, it would mean SEK 1 billion in annual profit sharing to Xbrane. So even with rather conservative assumptions, it's a big, big upside for us. So we're very excited about this program. And some of you maybe that follow us maybe also noted during the spring, we did a transaction with one of our peers on Iceland, Alvotech, and sold off one of our programs as well as our laboratory activities. And that has made a couple of things with us. We have reduced our fixed cost base radically.
We've also been able to, with the proceeds, offload quite some debt from the balance sheet. So actually, if we look at the first half of this year, excluding the divested business, we were running a profitable business, actually. And we also did a directed share issue that was actually settled in July. So it was at the beginning of Q3, we raised SEK 240 million. So we are in a much better financial shape than what we have been the last two years or something like that. So that's that, probably. Brief overview of the company.
Thank you. I've had some questions here from the audience, and one is actually about the asset sale and the recent restructure, if there was anything that you didn't have time to say here. Because the question is, how are you realigning the cost structure and focus to ensure a sustainable financial performance?
Yeah. I mean, we are currently at an annual fixed cost base of about SEK 50 million. And that was already realized now in July after the transaction was closed, and the related employees and the lab and everything went over to Alvotech. And we intend to maintain that at that level. At the same time, of course, we have profit sharing coming in from Ximluci Europe. We hope, of course, that we'll have a U.S. approval and that Ximluci will be launched mid next year and we gradually get more profit sharing from there. We have an inventory of about SEK 170 million of drug substance for Ximluci, which we now also are transitioning into cash as we are producing and shipping more product to our partner STADA.
So I think that that puts us in a good position and it will also make it possible to cover the investment we still need to do in Xdivane, which is going to be done during the remainder of this year and during next year.
Staying with the U.S. here, are you concerned about the potential future drastic price cuts of pharmaceuticals in the U.S.?
Concerning, it's a given when it comes to biosimilars. But I do think there's a possibility of starting with a list price, which is quite high. And I think $1,300, at least compared to Europe, high, $1,300, I think it's reasonable to start with. And then it takes 12 months before you actually have an ASP. And that provides a period where you can benefit from actually giving discounts, but still the clinics are reimbursed on the list price. So that gives a very beneficial situation first 12 months. But then for sure, average sales price will drift downwards. Let's see where it ends, but it's probably going to be below $500, say, five years' time or something like that. But that's just the nature of the business.
Question here, asking you just to summarize the key strategic objectives in the U.S. and what steps, what further steps you're taking to sort of move beyond Europe?
When it comes to Ximluci , of course, the U.S. is the most important market, but then also we're working actively together with our partner STADA to get approvals in certain countries, in particular the Middle East. We already have approvals in four countries, but probably have another six or so to come, and we're going to try to make the most out of those markets. STADA have their own infrastructure in most of these countries, so we're quite optimistic, then we have discussions ongoing and see if we can do something in Latin America, Canada, and a few other territories, so hopefully we can bring this product also to a few other countries.
And how will the platform efficiency and sort of cost-saving advantages shape the competitive positioning on the market, especially as biosimilars become more common?
Yeah, yeah. Production cost is really going to be key in this industry going forward. And we see prices going down quicker than what I think most anticipated, particularly in Europe. So we need to be really focused on production cost. I think we have a benefit, and that has always been our strength in our IP and our platform, which enables what we believe higher production or productivity, really, and thereby lower production cost. But we need to also be focused on working with partners from the production perspective, which are cost-efficient. And we also need to look beyond Europe, if you will. I think when it comes to Xdivane and Opdivo biosimilar candidate, we're well set. We work with CMOs in Europe, which already have FDA approval so that we can ensure to be approved in time.
But then also production will take place by our partner Intas in India in the long run, which of course will be done at a more cost-efficient manner.
I think that's all we have time for, actually. Thank you so much, Martin.
Thank you.