Hello, everybody, and welcome to Xbrane's webcast in relation to our quarterly report for the third quarter of 2023. My name is Martin. I'm the CEO of Xbrane, and I have with me today also Anette, our CFO. We have a brief presentation that we are going to go through, and after that, there will be time for Q&A. To start off, we want to go through our key achievements for the first nine months of 2023. This year has so far been focused very much on supporting our partner, STADA, in the launch of our lead product, Ximluci, biosimilar to Lucentis in Europe. We have generated revenues so far of SEK 170 million for the first three quarters of this year.
The product is now launched across 12 countries in Europe, and we are tracking in accordance to the revised sales plan we established together with STADA after summer. Volumes grew 20% in the third quarter versus second quarter. That is volumes out to end users from STADA. So we're proud in what we have accomplished as a team in terms of bringing this product to market in Europe. We've also filed the BLA to FDA. We did that in April. It was later accepted for review by the FDA, and we have had the first mid-cycle review meeting with the FDA, with no major issues identified, and the regulatory process is proceeding according to plan. So we're very happy with that.
We also secured financing of SEK 375 million in June. As I said, we are on track now versus the revised sales plan of Ximluci in Europe. These are the key achievements for the first nine months of the year. Now, our current focus is to, as we've been communicating, in relation to the Q2 report and continuously, the focus is to get the positive cash flow as soon as possible, and in doing that, to minimize potential need for additional capital. We have a couple of important deliverables in relation to this. First one, of course, is to continue to support STADA in the sales uptake of Ximluci in Europe.
We do that via production, of course, of the product, but also to continuously work towards driving down the production cost and also to prepare for approval and subsequent launch of the prefilled syringe. Also, it's important for us to get approval for Ximluci in the U.S., targeted for April next year, and to secure a commercialization partner for the product in the U.S. This we expect will generate upfront payments and milestone payments on approval, and also, of course, as the product is launched, revenues from sales of product and royalties. Out-licensing of our Opdivo biosimilar candidate is also of importance, and we're working on that with several parties under active negotiation, and that we also expect shall generate license payments in terms of upfronts and several milestone payments.
BIIB801, our Cimzia biosimilar candidate that we're developing together with Biogen, here it's about production of clinical material, and in that, reaching an important milestone and also sales of clinical material to Biogen. So this we expect will generate a meaningful income during 2024. And then, as we communicated last week, we have introduced cost savings program, which we over time expect should generate savings of SEK 50 million on an annual basis. So all these measures or deliverables are very important with regards to, on the one hand, reducing costs for 2024, but also generate meaningful income. And, I believe there's a path forward if we're successful in all this, to get to positive cash flow latest by first quarter 2025, as we have previously communicated, without need of additional capital.
But of course, we cannot rule out delays in any of these deliverables, which would need to lead to a need for additional capital, but we're doing all we can to minimize that potential need. So here is an overview of our portfolio. We are developing biosimilar candidates to Lucentis, Cimzia, Opdivo, and Darzalex. And as you know, our biosimilar to Lucentis, Ximluci, is already on the market in Europe. And let's focus first on that, and to shed some more light on how the sales uptake is going in Europe. Ximluci is now launched in 12 European countries. You can see the countries on the map on the left-hand side of the slide. Most important countries from market size perspective, obviously being Germany, UK, and Spain. Further launches are planned during the course of 2024.
And, as we talked about in our last webcast, we have seen that the sales uptake is going slower than what we initially anticipated, but we established a new plan together with STADA after summer. And the important takeaway here, I think, is that we're tracking in accordance to that plan. As we've talked about before, what makes this take longer time than previously anticipated is the time required for education of physicians as well as payers in a biosimilar-naïve setting, an ophthalmology setting. But we are confident that over time we will work through this process, and we'll get to the potential of the product long term, which remains the same as we've talked about before.
Looking specifically at the main countries here in the UK, as you know, STADA's affiliate in the UK was awarded a frame agreement for sales of ranibizumab or Ximluci to NHS England. What is happening now is that the sales force is working through to convert the so-called trusts, so conglomerates of hospitals, which need to make active purchase decisions on the specific product. So it's a process of converting trust after trust to realize the volumes which are dictated in the frame agreement. In Germany, there are multiple ongoing commercial activities on different segments in the market, really, to try to drive further volumes. In Spain, there was a launch taking place in end of May, and we are getting initial positive feedback from clinics across Spain.
But it's also a process which is under build-up. So I think we have good and positive feedback from the clinics that are used Ximluci, but the process across these main countries and the other countries as well, is about converting or adding more and more clinics using Ximluci. Beyond Europe, there is a registration process ongoing across multiple countries in the Middle East, and we are also working actively to try to bring Ximluci to as many countries and regions in the world outside of Europe as possible. And from a market size perspective, if we're looking at the anti-VEGFs for ophthalmic purposes, outside of U.S., it's a market of about EUR 5 billion annually. Ximluci is launched in the countries you saw on the previous slide, and that represents some 35%-40% of this market.
Ximluci captured a market share of a half percentage point in the ranibizumab market in this region in Q3. So that was a market of EUR 350 million. So you can, with these two numbers, estimate the net sales of Ximluci in this region during third quarter. It was the second biosimilar in terms of net sales during the quarter, which of course is a sign of strength, and volumes are growing on a quarterly basis. We saw 20% volume growth in Q3 versus Q2. 25,000 units has been shipped from STADA to end customers, so far or up until end of third quarter, actually.
So I think we're seeing, again, positive signs in the right direction and that we are following the revised sales plan established after summer. Important here is that our belief in the long-term potential of Ximluci remains. We do believe that eventually, ranibizumab, ranibizumab biosimilars will take a, a corresponding share of the originator product sales or the ranibizumab market overall, of, you know, 70% or so, which is corresponding to what we've seen in other settings in oncology and in immunology, when biosimilars have been introduced to the market. It is, again, biosimilar-naive market setting, which makes it taking a little bit longer time, but we strongly believe that the end game will be corresponding to what we see in other settings.
We do believe, and this is our and STADA's ambition, that Ximluci will be the preferred choice amongst the ranibizumab biosimilars on the market. So the long-term belief in the product remains both for Xbrane and for STADA. From a development perspective here, we are going through the regulatory process in the U.S. We'll talk a little bit more about that. We're also working with development on the prefilled syringe. As you know, we've launched so far the vial, as have the other ranibizumab biosimilars in Europe. We are expecting to be able to launch a prefilled syringe first quarter of 2025, which we believe also will be important in terms of driving additional conversion of the market to biosimilars and specifically Ximluci.
Then looking specifically at the U.S., so this is a market of approximately $8 billion. It's a big market opportunity, and we really see good traction of ranibizumab biosimilars in the U.S. In Q3, ranibizumab biosimilars sold for approximately $50 million. So that really shows that the market is perceptive to the more cost-efficient alternatives, and, and, using biosimilars. We are now going through the regulatory process. As I mentioned in the beginning, that is proceeding according to plan. We've had the mid-cycle review meeting with the FDA. There has been no material issues identified so far, which could jeopardize the approval of Ximluci by FDA.
But important in this process is that we have upcoming pre-approval inspections of both the drug substance and the drug product sites in first quarter of next year. The so-called PDUFA date is in April 2024. In relation to this, we're also proceeding according to plan with negotiations with the future commercialization partner for Ximluci in North America. And we are very optimistic that we will have a commercialization partner in place, if not by the end of the year, Q1 next year, at least before the approval, so that we together can make the appropriate preparations and plannings for a subsequent launch of the product.
We believe in the dialogues we've had so far with potential partners that there are good prospects for a third ranibizumab biosimilar entering the market, and good reasons to believe that a third entrant can gain a significant share of the market. Looking both at the existing ranibizumab market, including the biosimilars, but also the market opportunity in off-label Avastin and also Eylea and Lucentis. I think there are good signs for this. We saw the other day that CVS, for example, took out Eylea in their formulary for benefit of ranibizumab biosimilars. So I think that is a sign that also the Eylea part of the market is addressable for ranibizumab biosimilar, and as you know, and as you see here, is a very sizable market opportunity.
Coming to our broader portfolio, we have an increased commercial focus, generally speaking, around our portfolio. We want to focus on what can generate revenue in the short term, and that has led us to terminating the development of Xtrudane and our Keytruda biosimilar. We have chosen to prioritize Xdivane, our Opdivo, Opdivo biosimilar candidate, as our immune oncology biosimilar to proceed with. We believe this is the right thing to do. It's the first PD-1 inhibitor to go off patent, and it's a very sizable market. EUR 13 billion of originator product sales estimated in 2026. There is more limited competition, as far as we can tell now, when it comes to other biosimilar candidates under development for Opdivo compared to Keytruda.
It seems to me that most other biosimilar developers have gone for Keytruda and done that at neglecting Opdivo as a biosimilar opportunity. So we believe we are in a good position there. We've also had good progresses in our development of our Opdivo biosimilar candidate. We have established the process internally. We've demonstrated good analytical similarity across a panel of close to 50 quality attributes, and we have scaled up the production process to our 200-liter fermenter scale, which we have in-house. For those of you who have visited us, you have been able to see that, and this is the first program we are scaling up to that pilot scale. So I think that demonstrates scalability.
We went from five-liter fermentation scale up to 200-liter fermentation scale, and the process was robust in that scale-up, which gives us comfort ahead of the upcoming further scale-up and production of clinical material to take place during the course of next year with our selected contract manufacturer. Then, if we look at our Cimzia biosimilar candidate, BIIB801, which we are developing together with Biogen, it's a very important year, next year, where we are going to produce clinical material, and we expect that this program shall generate meaningful revenues for us during 2024 in terms of milestone payments and income from sales of clinical material to Biogen. So it's a very important program for us, again, from a short-term revenue perspective.
Then we are continuing with the development of Xdarzena and Darzalex, biosimilar candidate, as previously planned. And this more commercial focus of our portfolio, as I discussed, has also led us to introduce a cost savings program, termination of Xtrudane, led to freeing up some resources in the organization. And this is a program which we expect or plan should generate SEK 50 million in annual savings once fully implemented. And to be very specific here, what we're talking about is the reduction of some 38 positions. 20 of them are consultants, which we have had a process of phasing out gradually, already from the end of second quarter and onwards. There were four vacancies, employees that had resigned, which we're not filling up again.
Then we've had to reduce 14 positions, which are occupied by permanent employees, unfortunately, unfortunately. This, of course, has been a very tough decision for us to make, and it's a very tough process to go through. It is necessary for us to be able to get the positive cash flow as soon as possible and minimizing potential need of additional capital. We are retaining a core team of 75 employees, and that is an organization which is sized and equipped to be able to develop on our current development portfolio, as described, and also with an R&D organization sized to be able to develop one new biosimilar candidate annually. However, introducing new programs into the portfolio, we are going to wait with until we feel that we have the financial means to make such investments.
This program will be realized gradually, from this quarter onwards, but the full savings effect we'll see in third quarter of next year. So with that said, I'm going to leave over to Anette to go through, more details around the financials for the third quarter.
Yes. So thank you, Martin, and hello, everybody. My name is Anette Lindqvist. I'm the CFO of Xbrane since some years back now. The first slide I want to share with you and to spend some time on is really on our revenues. We understand. We are the first to acknowledge that our revenues is a bit difficult to understand. So hence, let me take you through that. The net revenues created in the quarter, SEK 59 million and SEK 171 million year to date, reflect the fact that we have managed to put Ximluci on the market, late March. It's now been on the in the market for six and a half months, up until September. It has been generated net positive profit each quarter from day one.
So as Martin said, that is something that we feel is a key achievement for us. Looking at the quarter, looking at the diagram, I want first to highlight that the gray area in the bottom for the previous quarters represents out-licensing, accrued income from Biogen. That was the deal we made last year, and that was phased and accrued up until June this year. So from this quarter, we don't have any out-licensing deals before we secure one of the agreements that we spoke about. So this is the total sales reflect supplies to STADA at standard cost and profit split, and those combined amounts to SEK 59 million.
Our aim is to share more and more market data in these calls, meaning what STADA sells in the marketplace to patients and to end users. This is totally different from our revenues presented here, because these are shipments to STADA that we reflect in the revenues and also then obviously the profit share. I also want to highlight the deliveries, as we spoke about in earlier calls, happen irregularly. So we could have one delivery in the quarter, we could have two, we could even have zero. That means that will be an irregular presentation in terms of the revenues. So a traditional growth is very, very difficult to read anything out of these numbers. We also can...
What we also can say is we sell at standard cost, hence our gross margin is impacted by production and currency variances. For the four million delivered in the quarter, we had a share of currency variances due to our costs mainly in euros. Looking at the company expenses quarter-over-quarter, Q3 last year, those have increased by SEK 32 million. But for those of you who remember, we actually capitalized some of the R&D expenses last year. And compared to second quarter of this year, we have actually had a reduction in costs. For Ximluci, I would say that cost mainly is regulatory activities and also development of the PFS. Those are obviously not capitalized.
For BIIB801, we have costs for production of clinical material, mainly related to drug substance, tech transfers to CMOs, and also raw materials used in those activities. And then also for Xdarzena and Xdivane, costs related to progressing preclinical development activities. We expect that the total company costs, OpEx, mainly, will start to, we will see some already from the savings scheme delivered in Q1, with full implementation then in Q3. So those you would gradually see on this graph. Cash flow. We leave the quarter with SEK 167 million at hand, which is basically what we had last year, almost the same amount at this time of the year. Our operating cash flow amounted to SEK 125 million in the quarter. Out of this, Ximluci represent about 70%.
That's mainly related to, again, to the PFS development, regulatory commercial activities, and inventory buildup. We also spent, in terms of cash flow, a significant amount in prepayments to our suppliers that obviously they will benefit from, from next year. We also wanted to take the opportunity to do a bit of a recap on our outstanding convertible bond. We secured a bond, this bond of SEK 250 million in, in June at a conversion price of 93 SEK. The deals we made are quite favorable, looking at the marketplace or the market environment, now. We have favorable terms interest rate of 6% up until estimation of FDA approval, so hence April next year, and thereafter, it's zero.
We have a remaining duration of 44 months when we leave September. Generally, amortization are in equal installments every second month, but they can be deferred, and they can be accelerated. The next amortization is now due in December, and whether we, as a company, it's our decision whether we should progress that in cash or in shares, and we want to do that as the best for the company. So far, the first one we did in June, July, we did in cash, and the next one we did in shares in September. We also, at time of this report, shared our financial calendar. This year, we have been very, very late. We acknowledge that, and it's for good reasons, as we have discussed on previous occasions.
It is due to the fact that we have sales reports, revenue reports that come from STADA, and they have in the contract, 45 business days before they need to issue that report to us. However, we have, during the year, worked with STADA, and we have now a very, very good process in place. And so we are happy to say that we are back to where we were last year. So hence, you can see that we have moved forward our report dates quite significantly in the first, second, and second quarter next year. And by this, I think that was my last section, so then back to you, Martin.
Yes. So the key takeaways from this webcast and for the quarter, we're proud to have supported the launch of Ximluci across Europe. We are happy to see that we are tracking accordance to the revised sales plan we established with STADA after the summer. We see growth Q3 versus Q2 of units shipped really from STADA to end customer of 20%. And we are in 12 countries, but launches in more countries are going to take place during the course of next year. And priorities going forward, as we've talked about, is to get to positive cash flow as fast as possible, and preferably without need of additional capital, and if so, to minimize that potential need.
What is important in that process is that the uptake of Ximluci in Europe goes now according to the revised plan, and we shall do all to support our partner, STADA, in that, with regards to continuous production cost reductions and introduction of the prefilled syringe, particularly. The regulatory process in the U.S. is of very high importance, of course, to get the FDA approval in time, to establish a U.S. partner and then support that partner in subsequent U.S. launch of Ximluci. The out-licensing of Xdivane, our Opdivo biosimilar candidate, is also very important from an income generation perspective in short term, as well as delivering on milestones on BIIB801 versus Biogen and established contract with them to from a short-term revenue generation perspective.
So these are the key takeaways, and, probably in relation to that, we are opening up for questions. So I think we start with questions.
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 Sian Hammer from Jefferies. Please go ahead.
Hi there. Thank you for taking my questions. I have a few. So just on your Cimzia biosimilar, what's your confidence in it entering the clinics, perhaps towards the end of 2024? And secondly, what's your confidence in your partnership with Biogen and carrying forward the biosimilar to commercialization? And finally, how long would it take to run a combined phase I, phase III trial? Because from our understanding, you can integrate the aspects of the phase I into the phase III. So how long would it take to run all of that together? Thank you so much.
Thank you for the questions. First of all, we have high confidence in being able to support Biogen with clinical material during the course of next year for them to enter clinic if it's late 2024 or beginning of 2025. So we have high confidence in being able to achieve that. I think what you're referring to in your second question is the publicly communicated externalization plans of Biogen's biosimilar business. We have no further knowledge or information around that than what it's publicly communicated from Biogen. We feel a high confidence in that whoever is potentially eventually acquiring that business will see the value in our Cimzia biosimilar candidate and continue to invest behind it and bring it to market.
We shall remember here that this program is the only biosimilar candidate under development targeting Cimzia, and this is still a EUR 2 billion product, so it's a sizable opportunity. We have also, over time, had significant incoming interest from other parties, which I think tells a sign of the general commercial interest in this asset. Sorry, what was the last question?
Combined phase I, phase II.
Yeah, yeah. Good. The exact clinical program for this product, we'll have to wait and see, and it's going to be subject for discussions with the regulatory authorities. As you probably know, there is an ongoing discussion, even within the regulatory authorities, with regards to waiving phase III trials altogether for biosimilars. And this product specifically is a TNF inhibitor, and we have quite a lot of experience on biosimilars to other TNF inhibitors. And we, for this product, have very strong analytical data, we believe. So I think that is a possibility of having phase three waived. And otherwise, I think it's perfectly feasible to be running actually two separate trials, one phase and one phase three in parallel.
You can do that since you can go straight into phase three trials with biosimilar candidates, like we did, for example, with our Lucentis biosimilar. So I hope that answers your questions.
Is it okay if I ask one more question?
Of course.
Thank you so much. Just on Ximluci, are you expecting to gain interchangeable designation from FDA? Thank you so much.
We haven't now, in the current BLA submitted, submitted an application for interchangeability designation. However, we are considering to do that immediately after approval.
Thank you so much.
The next question comes from Felicia Rittmar from VL Kempen. Please go ahead.
Hi, thank you for taking our call. So I have a couple of follow-up questions on how you record the sales for Ximluci and how that is reflected in the income statement. So first question, is it correct that the profit sharing for the third quarter is about SEK 4 million?
Anette, do you want to take this question?
Yes, yeah. Yeah, I would be happy to. No, that's not correct, because as said, we sell at standard cost in our cost of goods sold, not actual cost. So that means that we have, first thing, we have production variances, and also more significantly this quarter, we also have currency variances impacting the combined sales from at cost and profit share.
I can probably add to this, that we are no longer going forward, going to separately disclose what we generate from sales of product and from the profit sharing from STADA. And that goes in line with our ambition to become more and more transparent with regards to the end sales from STADA to end-to-end customers. And if we're going to be more transparent on that, we cannot provide full transparency into the actual profit sharing we are receiving from STADA. So, I hope that also gives a little bit of background.
Okay. Yeah. Thank you for the clarification. And then, my final question is, can you provide a bit more guidance on when we can expect the first milestone payments on the Xcimzane biosimilar? And do you think that will be enough to provide runway into, the first quarter in 2025?
We expect that, during 2024, it is not solely going to be enough. We need to be generating revenues, across more of these income-generating deliverables or aspects, which I presented on a previous slide, including that sales uptake of Ximluci in Europe is tracking according to plan, license proceeds expected from a U.S. partner, and also from a future partner for Xdivane.
All right. Thank you so much for taking my questions.
Thank you.
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 written questions and closing comments.
Thank you. So, Anette, do we have any questions over the chat?
Yes, we do. The first thing, first question, I believe that you just responded to, but that is, "How much was profit sharing fraction in Q3 of Ximluci?" And that was exactly what you just spoke about a minute or so ago. The second one is, "Is there updated timeline regarding Xcimzane upscaling?
It's going to take place during the course of 2024, including production of clinical material, which then entails running of several GMP batches.
Those are going to be sold to, Biogen, right? For significant amounts.
Yes.
Next question: "Is cash flow effect from terminating Keytruda biosimilar front-loaded, linear, or back-loaded towards end Q3 2024?
So, we have not made a substantial investment into that program. It is below SEK 10 million, what has been invested so far into that, into that program. But there will be no future cash flow effects on that going forward.
Next question, on the amortization, I believe. The cash situation looks very worrying at the moment. What is the plan for repaying the maturing bond? At this time, we will see another issue of shares made, at a big discount or temporary funding available through other sources?
As we have described in the presentation, our focus is to get to positive cash flow as soon as possible, and we do all we can to get there without need of additional capital, but it is contingent upon us delivering on the different income-generating aspects, which I talked about, including Ximluci sales update in Europe, Ximluci FDA approval and US partner, and license proceeds from our Xcimzane and Opdivo biosimilars respectively. However, we are of course also having active dialogues with current and potential future investors, both on equity and debt side, and to see if we have to refinance the company somehow, try to do that in the best possible way.
Next question: What is your take on Ongavia's relative success in the U.K. during Q3 by 50%? It seems to be more of a pricing issue than hesitant ophthalmologists.
Well, I think what one needs to remember here that this product came to the UK market first in summer last year and had some time to convert several important trusts or conglomerates of hospitals and under an agreement with NHS. So there was a timing advantage there. Now we see that Ximluci is tracking well with regards to market share gains in the UK market in relation to Ongavia.
Next question, is the figure of 25,000 doses for SEK 170 million during 2023 so far correct? It equates to more than 6,000 SEK per dose and seems very high. Is the high gross margin solely reliant on the scale-up other than to-
Yeah. That is not the, the correct math to be doing. Our sales of SEK 170 million the first three quarters of this year relates to sales of units to STADA and profit sharing from STADA. The 25,000 units refers to STADA's sale to end customer. And of course, there is an inventory buildup that can take place in between. So it is not the right math to try to do.
No. The SEK 170 million, if I may add, is also from out licensing accruals made in the first and second quarter.
Yeah.
Is the high gross margin solely reliant on the scale-up?
No, I think that here, it's more related to some variances on the production side and the currency effects, as Anette mentioned, and also, a gradually increasing profit share coming in from STADA. Effects from the scale-up, and lower production cost thereof, we expect to kick in, earliest by the latter part of next year.
25,000 units are said to be shipped from STADA after launch in March. Can you please clarify if is a unit equivalent with the vial?
Yes.
Next question: Have you underestimated the entry barriers, considering the weak sales of Ximluci?
Yes, I think in the beginning, when the product was launched, we underestimated the time it would take in a biosimilar-naïve market to educate the different stakeholders, physicians, and payers to drive conversion. We underestimated the time that would take. However, as we've described in this call, we are convinced that eventually we will get to a similar penetration or conversion rate, what we've seen in, for example, oncology or immunology settings, that biosimilars take beyond 70% of the volumes of the originator product. So we're confident we will eventually get there, but this is more of a slow build than what we initially anticipated by the time of the launch of the product.
You mentioned expected revenues from BIIB801 clinical material. How will these be structured, the revenues?
... structured, it essentially sales of material as per agreement to Biogen. So it will be logged as revenue and a related production cost in connection to that.
Any estimate when a phase 1 can begin?
As it was a previous question, I mean, earliest late 2024, otherwise beginning of 2025. That's the best estimate we can give now.
With starting point in Q3 cash burn, how will that burn be impacted Q4 and onwards following the cost-saving program? Clarification would be helpful.
How the cost savings program will impact-
With the cash burn.
So these savings of SEK 50 million are going to be materialized gradually from the fourth quarter until full effect third quarter next year. But important to note, when you look at our cash flow, there are other very important fluctuations, and a lot of our cash flow has been related to activities we do with contract manufacturers, frankly speaking, for all of our programs. And that's something which we also are trying to optimize, and of course, in the cash flow, there's also an income component, which we've talked quite a lot about in the call, which we're trying to optimize as well. And I guess our expectation is that cash flow for this quarter will be negative, but not of the same magnitude as the cash flow in the third quarter.
And then, the cash flow will be significantly improved, again, provided we're successful in delivering on these different aspects we talked about in this call that are important from a short-term revenue generation perspective.
Any comments on number of patients' adherence? Are patients prescribed Ximluci continuing the treatments with your brand?
I think this is too early to say. Something which we wish to be able to track going forward when the product's been on the market for some longer time.
What is the present view on the Ximluci cash flow from the STADA deal that was originally thought to be EUR 1 billion, three years after launch, after global launch?
Yeah, that also entails the U.S. market, just to be clear, so three years also post U.S. launch, and it was always contingent upon the view that ranibizumab biosimilars would take beyond 70% of the originated product sales, and that Ximluci would take its fair share or fair third, if you will, of that market. So I think that fundamental view still holds true, and we hope we get there within the timeframe of three years post U.S. launch. So we're going to be talking about coming into 2027.
Yes. On the slide with markets where Ximluci is launched, France is missing. Any comments on activities there?
Correct. France is, of course, a very important market in Europe, and it's a market where we hope a launch can take place during the course of next year. It is a market which we're aware the prefilled syringe is of high importance, potentially of higher importance than in some of the other markets. So we are hoping on being able to see a penetration of that market once we have the prefilled syringe approved and launched.
Can you share any more details on why you think the sales in Europe will pick up in 2024?
Because it is a process which takes some time related to education of the different stakeholders involved, and we see traction. We see that sales are growing. We had a 20% volume growth, Q3 versus Q2, and we just need to continue this trend to get to the numbers in 2024, as per our revised sales plan from after summer together with STADA.
Is inventory build-up and then subsequent cash flow in effect now completed? What can we expect for the next coming quarters?
Yes, I think that our inventory on the balance sheet should be expected to remain rather stable at the current levels.
Yep. No, I would agree because with the also the launch of the PFS, that will build up as well. So that was the last question on the chat moderation slide.
Excellent. So, then we thank all of you who listened in and asked and posed excellent questions to us. We remain available for any further questions over email or phone, and we look forward to talk again in relation to year-end report coming up in February. Thank you.