Highlights from the quarter. Let's start with an update on our portfolio of biosimilar candidates. We have Ximluci, first, our Lucentis biosimilar, which is launched in Europe and under approval process by the FDA in the U.S. We're going to talk more about the sales progress in Europe later. But key upcoming milestones for this program is then related to us tying up a new partner for U.S. market. We have intentions of doing that during the course of this year, and then FDA approval, which we expect to take place second quarter of next year. Our second program, BIIB801, biosimilar candidate to Cimzia. Here we've partnered up with Biogen, so commercialization partner.
We are currently going through a process of scaling up the production process. We are producing the first so-called engineering batches during the course of this year, and then we're going to be producing GMP batches intended to be used in upcoming clinical trials performed by Biogen. We're gonna produce those GMP batches first half of next year. And then we have Xdivane, our Opdivo biosimilar candidate. Here, we have finalized the production process at pilot scale and demonstrated high analytical similarity at that scale. And we have engaged a contract manufacturer, and we're doing preparations for scale-up also for this program. We're going to be running the first engineering batch at the large scale beginning of next year already.
And this is to keep a timeline of being able to bring this program into clinic, beginning of 2025, which is, according to our timeline, in order to be able to bring this product to market by time of U.S. patent expiring December 2028. We're also going through a process of partnering to identify and tie up a commercialization partner. We still have the ambition to conclude that during the course of this year. So we intend to get back once that is done. Then we have our biosimilar candidates, Keytruda and Darzalex, which are in more early stage development still. Then getting back to Ximluci, and if we're looking at the non-U.S. market, I'm going to get back to the U.S. market later.
We can see on the left-hand side, quarterly sales evolution, when it comes to, retinal anti-VEGFs. So this is a market of some EUR 5 billion annually. Looking at the sales of Ximluci for the second quarter, it was at SEK 37 million, and out of that, SEK 0.4 million in profit sharing. So, as you probably recall, those of you who have been following us, we are generating revenue from Ximluci in three different ways. We are selling finished goods to our commercialization partner, STADA, at cost. So that's one stream. And then we are getting 50% of the profits generated by STADA in sales of the product.
And then license fees, which we hope to be able to collect from an upcoming U.S. partner, of course. And a couple of points on the sales evolution then of Ximluci. First, the product is launched by STADA across a multitude of countries. In Europe, they're representing some 35%-40% of this total market. Mainly, it has been about the U.K. and Germany in the second quarter, but the product was launched in, for example, Spain, towards the end of the second quarter. So we're looking forward to that opportunity. What we can see here is that the uptake of ranibizumab biosimilars, generally speaking, is slower than anticipated. I think slower than what we anticipated and than what our commercialization partner, STADA, anticipated.
And I think that is generally speaking for all the ranibizumab biosimilars across Europe, I would say. And I think there are two main reasons behind this, one being that this is the first biosimilar which ophthalmologists are facing, and more time is really required for education and explanation of the solid regulatory process that goes into approval of biosimilars, the clinical data, the comparative analytical data, in order for ophthalmologists to feel comfortable that the biosimilars have similar efficacy and safety to the originator product. The other reason is that I believe all the ranibizumab biosimilars currently on the market in Europe come in vials. So essentially, at the retina clinics, a nurse needs to extract the API from the vial into a syringe before injection.
The originator is by and large sold as a prefilled syringe. So that saves some 30, 40 seconds of nurse time, if you will, at the retina clinic. But it is an advantage, and I think that is also one reason why the uptake now is being a bit slower. We see that there is a transition from originator prefilled syringe sales to the vial, of course, of the benefit of the lower cost of the biosimilars compared to the originator product. But that process is also taking a bit longer than what we anticipated. So I think it's clear to us now, and we've had to slightly revise our forecasts for the remainder of this year and upcoming two years.
So I think it's clear that this is gonna be more of a slower market build than what we anticipated. But I'm convinced that coming into 2025, when also we have the prefilled syringe, which we have under development, launched, it will be a great year. And I still believe in the long-term ambition that we have for Ximluci of generating EUR 100 million annually from this product. So we still have that final goalpost clear, but it's also clear that it's more of a slow build-up than previously anticipated for these reasons I've laid out. Beyond Europe, we're also looking into further opportunities.
We're going through a registration process in Saudi Arabia, amongst others, and we are looking continuously for opportunities to where we can take the product together with our commercialization partner, STADA. And, I think, yes, I guess, everybody's also wondering a bit about the actual performance of the products from a sales or market share perspective in Europe. And, it's a little bit still too early days. We're not fully convinced that IQVIA data is portraying a true picture at this low levels of sales of the ranibizumab biosimilars, and also is lagging quite some bit in time. But what we can say is that, Ximluci is number two amongst the ranibizumab biosimilars.
As you know, there are three ranibizumab biosimilars launched in Europe, and Ximluci is number two. So it's going slower for everybody. And in that bunch, I think that, you know, Ximluci is performing more or less as the others. And from a market share perspective, looking now at only the ranibizumab market, what we can say at least is from a value perspective, Ximluci is a bit under half a percentage point. So that's where we are now. And coming back to, you know, the profit sharing, is also so then, of course, that it's beared by still a rather low volume, and as a consequence, sales and marketing expenses on the side of STADA becomes high as a percentage of net sales.
So that's a brief update on European or non-U.S. markets for Ximluci. From a development perspective then, we, as you know, submitted the BLA for Ximluci in April this year. It was validated by the FDA in June, and we're now expecting approval in April next year. So we're currently going through the regulatory process. And this, of course, as you can imagine, is quite an intense work for us. We have upcoming pre-approval inspections at our contract manufacturers late this year, which we are together with them preparing intensively for, along with answering questions coming in from FDA, of course. Then we're going through the process of scaling up the drug substance process that is going by and large according to plan.
And that's also crucial, in order to be able to have the right capacity and the right cost, particularly coming into 2025, as I described, when I believe that sales are really going to be at the level which we anticipated to end up with previously. And the prefilled syringe, very important development for us, and that is expected to come to market to be launched first quarter of 2025. So that's an update on the development activities, and then coming to U.S. market. I think here, and we presented a bit about this during the summer as we had held a webcast in relation to the termination of the agreement with Bausch + Lomb.
I think what we've seen since then is that biosimilars had a good year, a good quarter in the Q2, with as far as we can tell, an 18% market share of the biosimilars in the ranibizumab market. So that was a sign of biosimilars picking up. And we have great hopes for beginning to participate in this market. We're confident in getting the approval from FDA, and we're going through now the process of tying up a commercialization partner. I think we're coming towards the end of the process of getting indications of interest of potential partners, so we're going into the phase now of more firm negotiation and due diligence.
I think it's realistic for us to anticipate being able to close a partnership during the course of this year. Very important work for us, of course, to navigate through the FDA approval and also to tying up a commercialization partner for U.S. We are focused a lot now on getting to a positive operating cash flow. And I think it has been expressed from some of you investors to for us to provide more transparency on the path towards positive operating cash flow. So that's what we intend to do here, and is to give as transparent view as possible on how we view us getting to positive operating cash flow.
So if you start from the top here, and we're looking at second quarter of 2023. We have a development organization now with about 90 employees, and we have our development lab established here in Stockholm. And we have a capacity to initiate one new development program annually. But this development organization has the cost of roughly SEK 35 million a quarter. That is a level of an organization we intend to maintain during 2024, but and coming into 2025. But rather to increase further the efficiency of the organization, we've been growing rapidly last years, and now is the time of consolidation and trying to become as efficient as possible.
But still to then, being able to gradually introduce additional products to our pipeline to leverage that capacity we have in the current organization. And then during second quarter, we had quite high expenses in relation to our three first biosimilar candidates, the Ximluci, BIIB801, and Xdivane. In relation really to mainly process scale-ups ongoing, as I talked about in the introduction. These are very capital-intensive processes as we're working with contract manufacturers. They're expensive from a raw material perspective, but also from a service fee perspective to the contract manufacturers. So that's why we have a high burden on the operating cash flow in the second quarter due to these simultaneously ongoing processes.
Now, looking into 2024 for Ximluci, the scale-up for the drug substance process shall be completed during that year. And the scale-up and production of clinical material for BIIB801 should also be completed during 2024, and the program should be handed over to Biogen. So, the development expenditures for these two programs should be significantly reduced during the course of 2024. And then looking at Xdivane, here, it's about a scale-up process ongoing, as I described, but in 2024, we're also going to be producing clinical material for an upcoming clinical trial here. Rather, our ambition is, as we've stated before, to tie up a commercialization partner and get a significant portion of co-funding from such a partner coming into 2024 and onwards, of course.
But, all in all together, these expenditures from a development perspective on, on external contract manufacturers, should be significantly reduced, during the course of 2024. Then still, we have a component in, second quarter of, 2023 of inventory build-up of about SEK 40 million for Ximluci. So that's ongoing production of commercial material for Europe and the U.S. That's also going to be balanced out, during 2024, as we've built up together with, our partner, STADA, sufficient levels of, of safety stock. Then it's gonna be balanced out, during the course of 2024. Then looking at, the income side here, as we talked about, income from Ximluci in terms of profit sharing, in Europe was SEK 0.4 million in the second quarter.
This, as we've talked about, we expect significantly shall increase during the course of 2024, and particularly into 2025, as the prefilled syringe is being launched. We also expect, of course, an income stream coming from Ximluci U.S., in terms of upfronts and milestones from a U.S. partner, which we intend to sign up during the course of this year, and then profit sharing from launch and onwards. And with the BIIB801 program, we also expect income generation during 2024, due to sales of clinical material to Biogen as per the agreement with Biogen, and also a milestone payment is triggered by successful scale-up and production of clinical material.
So that's also a very important program for us, for our income generation in 2024. And altogether, we strongly believe that these three sources of income shall be able to cover up for the costs we have for our development organization, which we have on the top here, about, you know, SEK 35 million a quarter, SEK 140 million a year. And I'm convinced that we'll, we'll get there. We came out this morning with a separate press release, where we updated the timing of getting to positive operating cash flow, before end of first quarter 2025.
We can get there, as early as second quarter 2024, but as you can understand from this picture, we're dealing with quite some uncertainties, some of which we have under our control, others not fully. So it's safer for us to now put a, a timing ambition of getting to positive operating cash flow within a timing range, which we're very, very comfortable with, being able to accomplish. So I hope that that portrayed a better picture of our path to a positive operating cash flow to all of you. And then taking a step back, I mean, we have very important milestones coming up here during the course of the coming 18 months, really, looking at this, this list.
Getting North American part of Ximluci, the FDA approval for Ximluci, scale-up and production of clinical material for BIIB801, out licensing of the Xdivane program, and then getting to positive operating cash flow. So, quite a lot of key milestones that we're going to deliver on, and we are fully confident that we're going to get there. With that said, I think I can leave over to Anette to go through some of the details from a financial perspective, and then, of course, we're going to get back on Q&A towards the end.
So thank you, Martin, and welcome to the financial section. My name is Anette Lindqvist, I'm the CFO of Xbrane. So before we dive into some of the numbers, I would like to remind everybody the way that we generate revenue from Ximluci, and as Martin then spoke about earlier in his presentation. The first one is that according to a supply arrangement, we say we sell to STADA at cost. So everything that we ship, we invoice at cost to STADA, and that obviously has a significant then noticeable margin reduction. So our margin development is not really for us as a company as the same as you would recognize in other companies. So that's the first thing to notice.
Second, we have the profit sharing with partners, which is a net-net EBITDA share. So this is after. So it's production net sales, minus production cost, minus sales and marketing expenses, and then we split that. So it's a net EBITDA contribution. In Q2, which we'll come on to, we still see a fairly large part as in a percentage that these numbers are fixed and relatively high versus the low volumes. And the last one is, of course, the license proceeds from partners, as we're now working with a new partner for the U.S. So looking at the Q2, then we have supply to STADA at cost of SEK 37 million, and we have a positive profit split of SEK 0.4 million.
So for the second quarter in a row, despite large activities, and as low volumes, we still see a profit EBITDA, which I think is important. The last is SEK 14 million, that's been with us for a while. That's an accrued income when we signed the agreement with Biogen for BIIB801. That's SEK 14 million, and that's really the last quarter where we can recognize that profit, before we see any new milestones coming from Biogen. So cumulative revenue in 2023 is now SEK 130 million, out of which SEK 85 million is coming then from Ximluci. Looking a bit about the cost side and comparing like for like, we have increased our operating cost base with about 50%, and we are versus last year.
Last year, we were capitalizing a bit regarding Ximluci. We are not capitalizing anything now for Ximluci because we moved into a commercial phase. So the development cost we see for Ximluci is launch activities, and also majority being development of the prefilled syringe, as Martin spoke about earlier. We are also accelerating the progression of BIIB801 and Xdivane, where we are preparing clinical and preclinical material and transferring to be transferred to contract manufacturers. And also, as Martin then alluded to earlier, these costs will be significantly reduced. We are in a hectic phase right now. We have three major programs going on. Hence, two of which will be almost completed and fully reduced in 2024, and for Xdivane, co-funded by a co-commercialization partner, as we did with Ximluci.
Still, the majority of our cost base is R&D activity. It amounts to SEK 87 million in the quarter, which is round about 89% or close to 90% of our total cost base, and the G&A is round about 11. The reclassification, as I spoke about this, for those of you who's been with us for a while, you would recognize that we started to do that in July 2021, and then we ended as we approached commercial launch, and that's also when we started to depreciate on the value in total. So when we leave the quarter, we have SEK 105 million on the balance sheet related to Ximluci, which in my world, I would say is a very, very small versus the potential market value. So a lot of activities are going on.
It's an intensive development phase for the company, progressing our, our portfolio towards the next milestones, and that's also noticeable in the financials, of course. As I mentioned, then the total company expenses expensed in the P&L, and as reported, have increased with SEK 40 million. Majority of the expenses related to Ximluci are commercial and launch activities, including development of the prefilled syringe. Hence, none of those being capitalized. Second production of the clinical material for BIIB801, and then also progressing preclinical development material for Xdivane, Xdivane, and Xdarzane, and for both BIIB801 and Xdivane to be ready to be moved to contract manufacturers. Our cash position, we'll leave first at the left, you can see a diagram that shows our cash at quarter by quarter.
We leave Q2 with SEK 316 million in June, and that's, of course, a result of the capital injection we did in Q1, both from a convertible bond, but also from an emission. Our operating cash flow is on the left, is SEK 142 million in Q2. As Martin said earlier, we are in a capital-intense development phase, as also stated in our business plan for 2023. It's primarily a stock build of Ximluci, and prepayment for raw materials, and to our production partners, both to a degree, co-funded by our partner, STADA. And then, expenses for upscaling production processes for the remaining portfolio. And with that, I think we leave back to Martin for Q&A.
Yeah. So we welcome first any questions from people dialing in.
If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from Fredrik Thor from Redeye. Please go ahead.
Hello, and thank you for taking my question. Maybe can you just summarize a bit, how the cash runway has been affected, by the, yeah, for a long time to reach cash, cash flow continuously, so that. Thank you.
Yeah. As we've talked about during this call, there are quite a few things which we are planning to accomplish during the course of the remainder of this year, including two important partnerships, one for Ximluci U.S., and the other for Xdivane. And of course, they're gonna be important from cash runway perspective. Our plan is still that with the capital we raised in Q2, we shall be able to manage to get to positive operating cash flow.
But again, as you probably have understood, during the course of our presentation, quite a few things which we need to deliver upon, and if we do that, we shall manage to get to positive operating cash flow with the current cash position.
Okay. Thank you. And a final question from me. You've previously mentioned that, you know, the production capacity has been the key limiting factor. Has that changed now when it's simply more about the slower than expected uptake of biosimilars, or is that still the key limiting factor?
That has changed. It's clear to us now, as we've talked about in this call, that sales uptake is going slower than anticipated, and that buildup is now the limiting factor rather than production capacity at this moment.
Okay. Thank you very much. That's all for me.
The next question comes from Dan Akschuti from Pareto Securities. Please go ahead.
Hello, Martin, and thank you for taking my question. So the first question would be, tied to the previous one as well. Like, if you assume no partnerships, I'm sure you budget the capital need that you have to bridge to for that additional year until profitability. What is that amount you would expect without new partnerships? And do you expect to cover that with an increase in debt similar to the previous financing?
Yeah, I mean, in the plan we had when we raised capital in Q2 next year, we were counting on certain milestones, payments from Bausch + Lomb due on FDA approval. And we need to tie up a U.S. partner with similar terms, if you will, with regards to let's say, upfront and milestone payments for that plan to still be intact. I'm confident and optimistic we'll be able to do that during the course of the year, but that's also a determining factor for our cash runway.
Okay. And how do you explain the difference between the sales in March and the months of April, May, June, then? Is that mainly due to very irregular orders, or?
I think it is a gradual increase in monthly sales, that's clear. So it is a gradual buildup, which is going in the right direction, although slower than anticipated. I understand this is hard to read, and we had all the intentions to become more transparent on being able to portray that sales ramp-up of the product. Because what you see now is kind of the profit sharing from STADA, in which you also have the sales and marketing expenses, which also is a component which is varying as they are, you know, regulating their efforts in different markets to maximize the sales essentially. But there is a gradual ramp-up taking place and we're going to be more transparent on that going forward.
As far as what we can tell now, we are at about, or slightly below 0.5 percentage point of European ranibizumab market.
Okay, thank you. The last question is on the prefilled syringe, which I guess is part of the reason why the biosimilars are not taking up that fast for Lucentis, considering yeah, the original product is kind of in a superior presentation versus the biosimilars at the moment. Is the timeline for that still intact? I remember that was first half of 2024.
We're planning for a launch, first quarter of 2025. So that plan and timing is intact.
Okay, first quarter of 25, you expect to launch the prefilled syringe?
Yeah.
Okay. Thank you. Thank you.
The next question comes from Sebastiaan van der Schoot from Van Lanschot Kempen. Please go ahead.
Hi, team. Thank you for taking my questions. You mentioned that due to uncertainties, that you moved the guideline for cash flow positivity now to before Q1 2025. But there are quite some moving parts with the Ximluci launch, Biogen milestones, and the sale of Xdivane. Can you just comment on which of these elements are most important to get to that cash flow positivity? And also, can you comment on how confident you are that you will achieve these elements within the next year? Thank you.
Sure. So if I look at, again, at the cost side of this, this is in our control, so to say, since we're going through this cost-intensive processes of scale-up on these three main program, I think you're seeing, again, the slide where we talked about path to positive operating cash flow. So that's within our control, and I'm convinced that we're going to, you know, get to significantly reduce the development expenditures during 2024 as these processes comes to an end. I'm confident also in us being able to tie up commercialization partner for Xdivane within this timeframe, so we can get significant co-funding. Then coming to the income side, and I agree with you, there are some uncertainties on all these three sources of income.
As we've talked about, the rate of pickup of Ximluci in Europe, FDA approval, and then sales progress in the U.S. for Ximluci, and then, of course, the scale-up process for BIIB801, that needs to be successful, of course. But I would be saying that looking at first quarter 2025, all of these three sources of income have the potential to take the company to positive cash flow, and that is to say, to bear the cost of the development expenditures of about SEK 35 million a quarter. And now, our plan, of course, is to be successful in all of these three, that they're all three are contributing in a meaningful way to the income generation by then.
But given the uncertainties in these three components, we choose to prolong the formal goal post, if you will, to end of first quarter 2025. Although, as I said, it can occur earlier, but we're confident that we'll get there, latest by end of first quarter 2025.
Okay. And can you maybe give some insight into how certain or confident you are that you will achieve the upscaling for the Biogen milestones and also the sale of Xdivane? Like, how far are you in the process? When can we expect to hear more about these two elements?
Yeah. You know, I'm confident that we'll get there. A scale-up process typically goes that you do two, three engineering batches to set the process, replicate it at small scale, at large scale. And typically, from first engineering batch, there are certain things you need to correct, and then you need to do, you know, second and or third engineering batch, and then go into GMP. I'm confident we'll get there. I cannot rule out, of course, you know, the timing aspect of this, that we maybe need to add another batch according to or compared to the plan. But we've gone through a scale-up process for Ximluci to a scale which is larger than what we're going to for BIIB801, so I'm confident we'll get there.
So, just exactly, you know, how many batches do we have to do and the timing aspect of it. And the same goes for Xdivane, although I would be saying that that is more of a standardized process, which shall run more according to plan. It's a more standardized process, essentially, for a scale-up. So that's probably what I can comment on, and we are going to get back on the BIIB801 program in relation to scale-up during first quarter of next year. So then we can report back on where we are and be more confident on exact timelines for that.
Okay, great. Thank you so much.
As a reminder, if you wish to ask a question, please dial star five on your telephone keypad. There are no more questions at this time, so I hand the conference back to the speakers for any closing comments.
So, now, we have a couple of questions that came in, here over the chat. So let me go them through and do my best to answer to them. First, I'm going to read the question. "So from your point of view, 2024 will be a year that will just go by without any major happenings. As a shareholder, I should be looking forward to 2025, correct?" Well, as I said, there are quite some milestones which we are going to deliver upon during the remainder of this year and in 2024, including, important partnerships for Ximluci U.S., Xdivane, then we have the FDA approval process of Ximluci. So I think we have quite a few important milestones that are going to happen.
During 2024, you will see a gradual increase of income generation and us getting, maybe already in 2024 to positive operating cash flow, and but definitely a ramp-up of the income generation. So wouldn't say that 2024 would go without any major happenings. That's not for sure the way that I view it. Again, as I said, looking into 2025, from kind of, us getting to the ultimate goalpost, which we have been portraying, for Ximluci of this target of getting to EUR 100 million, I think you need to be looking at 2025. So, you know, if that's what you would be looking for, ultimately, as a shareholder, I think the goalpost needs to be, towards 2025.
Okay, next question. Can you elaborate on STADA's cost of sales and marketing? What's the fixed, variable cost split? Can we expect an increase in cost of sales and marketing when sales go up? So, as I spoke about, currently, the sales and marketing expenses are borne by rather low volumes, which then make them high from a percentage perspective, that we for sure expect to come down as sales are being ramped up in a quite significant way. So these are by and large, by and large, fixed costs, so dedicated sales reps out there in Europe. So they will be kept at the current level, but decreased as a percentage of net sales.
Next question. Out of the 10-15 previously mentioned interested Ximluci U.S. partners, how many are still interested? Oh, I think we are looking at the list of 5-10 partners having or potential partners having expressed interest at the moment. But we're working that through, and we're still waiting, as you know, confirmation of interest from some partners. But you know, we've already received commercial proposals, the first commercial proposal, so I think we're moving this process along to be able to to close something during the course of this year.
Next question: Can you confirm that Xbrane products are tested for the requirements to be designated interchangeable? Okay, so the topic of interchangeability, one need to distinguish between U.S. and Europe. In the U.S., we haven't submitted the file yet to include an interchangeability designation, because we believe that is not of material importance for this product in the U.S., since it's not sold via the pharmacy channel, but rather the hospital channel or the retina clinics. In Europe, the concept of interchangeability is taken on a country-by-country basis, and it's too early to say. I know that, for example, Germany and France are experimenting in some categories of products with interchangeability, but not including ranibizumab. So I don't expect actually interchangeability designation in Europe for ranibizumab biosimilars in any country in the coming years. But again, I do not believe that to be of material importance, either in Europe.
It's important for other categories of products which are going via the pharmacy channel. Next question: Are you going to publish the quarterly report earlier from now on and forward? It is obvious that information is leaking to the market. How can this be prevented from the company's side? Well, I would not agree to that, that information would be leaking. We are, of course, working strictly according to more regulation to keep everything related to quarterly reports intact within the group, within the company that is working with the quarterly reports. I think rather probably the decline that one saw in the share during the course of August was more generally market related. But yes, we have the intention to publish the report earlier.
We choose during 2023 to put the quarterly report rather late, since there are many things which are new to us related to the reporting, including sales reports from a commercialization partner STADA and incorporating that into the reporting and so on. But yes, we have the intention of reporting earlier. Next question: Can you indicate how many potential partners have expressed an interest in partnership in the U.S. market with Ximluci? I think this we, we responded to. You mentioned that Lucentis is sold in an advanced form, which is easier to apply to the patients. When is Xbrane coming with a similar version of Ximluci? Yeah, that's the prefilled syringe, which we are planning to launch first quarter of 2025.
Next question: I noticed that BIIB801 timeline keeps being pushed forward. When do you expect to enter clinic? So initiating the clinical trials is on Biogen's responsibility. I do think, though, that if we now are successful in producing the clinical material, first half of next year, I think towards end of 2024 is realistic to expect an initiation of clinical trial for that program. Next question: How large stock of Ximluci can we expect under normal circumstances? Yeah, so I think actually we're getting towards a level which we anticipate the getting into the production of Ximluci. I think all in all, although I realize that our balance sheet is can be quite complicated to dissect, if you will.
But we have about SEK 200 million bound into inventory or production of Ximluci, out of which, roughly speaking, half is actually covered by our partner, STADA, in terms of prepayments for batches to be delivered. So that was, roughly speaking, the way we were anticipating it to look like, actually. Next question: How material partner payment for the U.S. are you expecting? It's too early to say, actually. We'll have to get back to this one, but we're expecting to be able to match at least the terms what we had with Bausch + Lomb agreement. Next question: Why does the prefilled syringe take so long to develop? Well, here, it's not necessarily about the development per se, but also related to timing of launch in relation to existing IP.
The next question: Xbrane has quite high inventory. Is there risk regarding that could not be sold to STADA if market uptake stays low? Actually, fortunately, here, we have long shelf life. We have five years of shelf life of the drug substance and three years of the drug product. So I think that risk is actually rather low. But of course, an exercise for us is to continuously look into our production plan and tie that in relation to the most recent signals we're getting from the market and the forecast from our commercialization partner, STADA. Next question: With income being pushed forward, significantly higher expenses, what's the financing plan going forward? Do you expect additional raising of capital in the coming year? So this, I think we responded to.
I think delivering on all aspects what we have in the plan, we should be able to manage. But also, as we've talked about, there are quite some things, some of which contains uncertainty, which is not entirely within our control, including, you know, the continued timing of ramp-up of sales of Ximluci in Europe. Next question: Can you comment on sales progress in Great Britain related to the frame agreement? Yeah. So Great Britain is going slower again than anticipated. And what's happening under the frame agreement, which was signed with NHS, is that still each trust in Great Britain needs to be converted.
So trust is a conglomeration of hospitals, really, and you need to have a sales process of the product for that trust, and that's an ongoing process. And STADA has a good sales force presence in the U.K. and are working towards that. But again, it's back to the general picture we portrayed over Europe. It's going a bit slower than anticipated. Have you any information of ranibizumab sales during first months of Q3? That's really too early to comment on. We have to get back on that one at the release of the Q3 report.
Next question: Are the Ximluci production scale-up activities only for the vial, or will they also benefit the syringe when it is launched? And is the risk of building up too much vial-based stock if the syringe is the preferred presentation going forward? So the scale-up process we're going through now is related to drug substance, so that benefits both presentations. The drug substance is later on filled in either vials or syringes. Given the long shelf life of the vial presentation, I don't think it's a high risk of building too high stock with the vial. We still believe at the end, even in 2025, that the vial will be constituting a very significant portion of the sales. So I think that still will be a presentation of importance in Europe.
Next question, negotiations to replace Bausch + Lomb. How many interested parties, how are the potential commercial terms relative to original terms, timeline, and so on? I'm misreading the question, it's quite long here. It's related to the outlicensing process for Ximluci in the U.S. I think we've discussed that already. Also related to cash flow outlook, which I think we have talked about already. Next question. You mentioned it take the nurse longer time to prepare Ximluci. What's the implication of that? Well, Ximluci, again, comes as a vial, and so does the other two ranibizumab biosimilars approved in Europe. And of course, what the nurse needs to do then is to, with a syringe, extract the substance into a syringe for the physician to perform the injection.
A prefilled syringe, the nurse can hand over directly and of course to the physician. Studies have been done on this, and I think it has been demonstrated that you're saving 30-45 seconds of nurse time in having a prefilled syringe rather than a vial. So the benefit, I think, is small, you know, from a time-saving perspective, and we are seeing a transition from prefilled syringe to vial ranibizumab biosimilars because the costs for the drugs are so much lower than the originator. But it is an aspect which is hampering the sales pickup, and there is an importance in us launching a prefilled syringe in beginning of 2025 to have that full suite of presentations for a competitive package. Next question.
For Ximluci product sales, quarter-on-quarter, clearly of some sales is just customer building up inventory. How's the sellout compare, and what are expectations for product sales for the rest of the year? I think this is again a question we need to get back to, as we have a couple of quarters under the belt here. And we also have reliable data from IQVIA or similar source in order to be able to portray a good accurate picture of the sales ramp-up. Next question: Can you please remind what were Bausch + Lomb terms that we could at least expect? Thank you. So Bausch + Lomb paid an upfront payment of $5 million when they entered into the agreement.
Apart from that, we didn't disclose exactly the milestone payments. But, I think roughly speaking, the upfront constituted some 15% of the total license fee, if you will, and then there was a gross profit-sharing mechanism agreed upon. Next question: Does STADA provide you with information regarding the distribution of sales of Ximluci in each country market in Europe? Can you elaborate on the status of sales in Great Britain? I think here we elaborated on Great Britain already previously. Are you going to pay the convertible interest payments in shares now to preserve cash? I think the answer to that question is that the intention is yes, that we have the intention to pay back in shares up until the point we get to positive operating cash flow.
Next question: Could you comment on Xdivane scale-up? How much capital is it going to-- it is going to require in coming quarters? Well, it's an ongoing process. As I said, first engineering batch at full scale is gonna be done first quarter of next year. So it's going to be more capital intense in 2024, but again, we're confident in being able to tie up commercialization partner, and in a significant manner, share that investment with such a partner from 2024 onwards. Okay, so those were all the questions. And I thank you all for calling in and participating and asking great questions. We're always here, and you can reach me or Anette over email or phone, if anything was unclear or if you have further questions.
With that said, I think we can close today's webcast.