Thank you very much, and warm welcome from my side on behalf of the board, as well. We appreciate your interest in Formycon, and feel privileged that on such a sunny, warm, summer day, you, you're listening into our introductory call of the H1 results. So very much appreciated. As some of you might have heard already or read already in the press release this morning, we can look back at the first half with very encouraging results. In summary, the first six months showed strong performance in operations, but also in key financial indicators, partly even over-exceeding our expectations.
So we will spend the next, Enno and me, will spend the next 20 minutes providing you with more details on operational highlights, on financial details and results, and want to give you also an outlook on the encouraging news flow we are expecting for the second half of 2024. As always, in these settings, we want to make you aware that our presentation contains forward-looking statements, which are based on our current expectations and assumptions, and these is always, are always subject to change or might be subject to change in terms of unforeseen uncertainties and risks that might appear. If you look at the whole picture, too many patients with severe diseases across the globe are still underserved with biologics.
It's our mission as Formycon to change that and increase the access to very efficacious modern treatments through biosimilars. Implementing our vision to play a leading role in this attractive growth space needs basically two things: a clear strategic plan and also stringent and relentless execution. Laser focus on execution and excellence in everything we do, will maximize our assets step by step towards that growth trajectory. If you look at the schedule in our clear strategic plan, after a very successful 2023 with a lot of operational achievements and also financial strong performance, 2024 is another very important year, which is setting the ground for the next ignition stage. The first six months have been a bold confirmation that Formycon is delivering.
This is key and will be key in the future for getting into the next ignition stage, which is reflecting a sustainable profitability, and also will help us foster our pipeline and grow our pipeline continuously. Let's have a closer look to the achievements in the second quarter and also the plans for important news flow in the months ahead. What does that mean in detail? If you look at the late-stage programs, if you look at the FYB201, you see that we increased our global presence. We expanded to meanwhile 19 countries where we are launching and marketing via our commercial partners. We also had a successful transition from Coherus to Sandoz in the US.
Overall, we can say that we have a strong sales performance that could be kept on the same level as we saw last year at the end, and we even want to increase that momentum to further launches and countries in the next years to come, and also want to foster that by introduction of a pre-filled syringe next year. FYB202, our Stelara biosimilar, the ustekinumab biosimilar, we achieved together with our global partner, Fresenius, all supplements, fixed all the launch dates in the most relevant markets. And a very important, significant regulatory milestone we could announce on twenty-sixth of July with a positive CHMP opinion we got for our regulatory procedure in Europe.
67 days from that point in time, we're expecting an EC approval, so that will bring us to early Q4 2024 with the approvals for all European countries. At around the same time, we're expecting also MHRA approval in the starting point of Q4 2024. FDA, which is the dominating market in that product, we're targeting an action date end of September, which will then, in the end, bring us across the whole year, end of Q3, start of Q4, to a set of approvals which sets the weight, sets the pace also for launches, which we expect that in the year 2025. Our FYB203, Eylea biosimilar, set the starting point for the series of approvals with an FDA approval exactly at the action date of June 28. The regulatory procedures at EMA are progressing according to schedule.
When, together with the two approvals, when we get all the approvals as scheduled, we are again below the competitive average of regulatory time frames, which we, which we will achieve. And that is based on the high expertise of our teams, our regulatory teams, but also the experts responding to the many hundred questions of the agencies in parallel in very short time. For 203 , we're expecting also in the regulatory procedure of EMA, a CHMP opinion still this year, targeting then an EC approval 60 days later at early 2025. Marketing activities with multiple potential commercial partners have been progressing. We have could sign already with MS Pharma, which you know, might know from the 201, the ranibizumab biosimilar.
Also for the MENA region, there are some more local signatures for in within Europe, but for the big regions, we, we want to announce and communicate the signature in the next few months for commercialization with professional partners. If you look at the overall globe and, and map where that visualizes our global presence, you see that we have achieved already quite some launches and attractive, have entered attractive markets, 19 countries in total so far. And we are planning, as you see in the green, flag opportunities, that we wanna lift further potential and, get further potential from sales in countries where we expect approvals in the next months and years to come. You see also that we are marketing via our commercial, partners and regional specialists on the different brands, our FYB201 Lucentis, via biosimilar development.
Standing out, of course, in the performance, is the huge market share in U.S., around the 40+%, or with the snapshot in IQVIA, and also U.K. market share, close to the 80%, which really reflects the strong commercial performance of our partners there, outpacing biosimilar competition by far. If you look at the mid to early stage development, also there we could announce very good progress this year in the first half. So we had the first patient in both studies, phase I, we call it DAHLIA, that's in malignant melanoma in patients, in oncology patients, and also the first patient in phase III, the LOTUS trial, in non-small cell lung cancer.
Both studies have been initiated in from June to July onwards, and we are looking forward to strong enrollment and progress in recruitment there. Those two starts of the clinical programs put us in among the front runners in this very important and attractive biosimilar asset, Keytruda, which exceeded already last year's sales of $25 billion in total. FYB208 and FYB209 are so far undisclosed biosimilar candidates, also targeting attractive markets and fast-growing markets. We can now say that we have identified clones with a superior stability, high productivity, and quality.
We always have to balance between high productivity and good similarity and quality, and they have been identified and transferred to our CDMO contract manufacturers, who will then further continue with process development and also focus on scale up to a commercial scale, which we want to use then also in the clinical studies to come. Next step, next milestone, is next year, the technical proof of similarity, where we can then set the goal for further scale up when it gets then in the scale manufacturing and also clinical program. So very exciting progress in those two early assets as well. I said in the beginning, we want to enrich our pipeline constantly because we want to bring biosimilars to as many patients in as many therapeutic areas as possible, and we're going to start FYB210.
We looked at a lot of opportunities that are out there for biosimilar development, and we nailed that down to a few candidates where we will take a decision in the next weeks, and we'll start FYB210 as a new kid on our portfolio as well. With that, I think that was just a glance on the strong operational performance and progress and milestones our team could achieve, and there's a lot to come in, we prepared the way for next milestones also in the second half. Before we come to that, happy to hand over to Enno to show what that means in financial numbers.
Sure. And, thank you, Stefan. A very warm welcome to everybody from my side for our H1 2024 call. I will introduce some of the major financial KPIs to you in the next roughly 15 minutes. We are looking at a very solid and very positive financial performance for the first half year of 2024, fulfilling our guidance and being on the way according to our internal budgeting plans. And on the next slide, I will provide some insight on the details or on the background of these numbers, respectively. And, let's start with a look at the P&L, which is fully on track and also with regards to the revenues. There's overall no surprises.
We have revenues in H1 2024 that are reduced compared against H1 2023, which was totally expected and also considered in our guidance accordingly. FYB201 royalties are adding up to EUR 3.8 million, which is a strong increase, basically tripling compared to EUR 1.1 million at the same time of 2023. FYB202 is recognizing deferred milestones of EUR 11.3 million, versus EUR 23.7 million in 2023. Please bear in mind that in 2023, the EUR 10 million upfront payment from Fresenius Kabi was included in this number, which was a one-off effect, which did not repeat this year, of course.
So deferred milestone recognition is slightly reduced compared to H1 2023, and this is simply for accounting reasons of the project as we are expecting the milestones to come in during the second half of this year. EUR 11.8 million development recharges for FYB201 and FYB203 are also included against EUR 19 million in 2023. Here development recharges reduced also notably due to the fading out of the development of the activities for FYB201 and FYB203, which per se are the good news, because obviously these assets are maturing into the market or have reached the market already. Cost of sales is fairly stable, FYB202 being at roughly EUR 15 million, and FYB201 / FYB203 in total being at roughly EUR 10 million. Other expenses is mainly derived from SG&A costs.
And here we see a decrease in staff and capacities, which goes across various disciplines like IT, security, HR, compliance, BD, procurement, and others. Plus, we have also some increased consulting efforts in context of exploring strategic and financing opportunities. The expenses in H1 2023 included mainly FYB207, with almost EUR 5 million of spend. While we now in H1 2024 have mainly a reflection of the development cost for FYB208 and FYB209 as planned, and as they are increasing along the value chain that they are taking their development progress. And the consequence, the logical result of the above with the reduced revenues, no EUR 10 million signing fee from Fresenius Kabi, stable COGS increased R&D and increased the SG&A.
The EBITDA is being reduced, but this is absolutely in the range as we anticipated and planned for it in our budget. However, we have good news on the adjusted EBITDA. In H1 2024, the performance was better than anticipated, resulting in Bioeq or resulting from Bioeq H1 revenues being significantly above budget, while the OpEx being below budget. Overall, we saw net sales from FYB201 of roughly EUR 103 million in the first half of 2024, versus EUR 42 million in H1 2023, which of course is still reflecting the ramp up in 2023, but you see it's a significant step up. Briefly looking at the CapEx in 2023, this included mainly investment for FYB206, which was around EUR 10 million, and a smaller amount for FYB202, but only at the beginning of the year.
In 2024 now, we recognize basically 206 only, with mainly the preparation for the clinical studies. However, since this is again clinical prep work and starting the clinics, this is really triggering an increase of investment going forward. On the next slide, let us take a look at the group asset structure and the respective KPIs along our balance sheet. In principle, this is nothing really new. You have heard that in our year-end and Q1 report already. The main driver for changing the KPIs here is the share issue, which we concluded in February 2024, by welcoming our new anchor investor, Gedeon Richter, who invested close to EUR 83 million in cash against the 9.1 shareholding in Formycon. This has been driving our balance sheet total, which went up.
This has increased our equity, and obviously, this has also lifted our equity ratio. When looking at the liabilities, we recognize changes that are including the early repayment of our shareholder loan, which we did at the end of Q1, paying back EUR 20.5 million to our major shareholders. And we now hold a EUR 48 million credit line by our major shareholders, Athos and AOC, which currently remains untapped. Continued partial repayment of our earnout obligations is another factor, with roughly EUR 5 million as an impact, as cash flow comes in from FYB201 performance. On the other side, we experienced over time unwinding of our discount on our earnouts. And this is a counterweight, if you will, again, of roughly EUR 5 million.
Equity ratio, I mentioned, based on the reduction of our debt and liabilities and the increase of our equity, this number moved up to 61%. On non-current assets, we saw fairly stable at around 90%, also mainly influenced by the share issue on the one hand side, balancing all other effects, such as the shareholder loan, CapEx, EBITDA, and accrued revenues. Cash and cash equivalents, again, year-end of 2023, increased due to the just described effects, so that we have a fairly strong position here at the end of H1. Briefly, coming to a little bit more insight on the cash flow and also our working capital. The operating cash flow is mainly affected by the EBITDA, as I just mentioned, and the accrued revenues of EUR -12 million.
We have significant investment on the investing cash flow, close to EUR 17 million in CapEx of FYB206, while at the same time receiving some repayment from the loan from the Bioeq AG. Financing, I also described, the payback of our shareholder loan versus the share issue of EUR 83 million. So that overall, this is leading to a net increase of our cash flow to 13 or our cash flows of EUR 13.6 million. As a reminder, this position does not include the shareholder loan credit line, which we do hold, in addition. And a brief look also on the working capital, where current receivables and revenue accruals add to our cash position, while moderate current liabilities and accruals reduce our working capital.
Therefore, we do see a working capital being even stronger than our cash position at this stage. But let's take a look at the outlook and at our guidance for 2024, for the second half of the year in particular. On the outlook side, first of all, let me confirm that we are on a positive track from a financial perspective. During H1, we have achieved numbers as anticipated, and currently, we assume guidance to be firm for 2024 or even better. Effectively, this means that guidance for revenues and EBITDA will remain stable, thus unchanged. However, we upgrade our guidance for adjusted EBITDA as well as for our working capital. Revenue expectation includes license income from 201.
FYB202 continues to deliver success payments, accrued or deferred, as we described before, and the remainder comes from development recharges, with approximately one-third from our FYB201 and two-thirds from FYB203. So the three typical pillars of our revenues continue, however, slightly shifting from development recharges to the other parts of the important performance. The EBITDA, the reduced revenues and the increased development activities for FYB208 and FYB209, plus, as Stefan just mentioned, kicking off FYB210, which will make in total these three assets, roughly EUR 20 million, all this together will lead into a higher loss in 2024, and therefore, we remain with our guidance at -EUR 25 million to -EUR 15 million EBITDA.
However, the adjusted EBITDA, due to the better-than-expected performance by FYB201, or the BioEq and Bioeq performance respectively, year to date, which we recognize through our at-equity line, we are looking at an upside or upsized outlook, for this particular part. This means that, our at-equity result is now expected at +EUR 20 million for 2024, instead of +EUR 10 million, as we have indicated at the beginning of the year. Hence, the adjusted EBITDA expectation increases by EUR 10 million, and consequently, we increase our guidance for our adjusted EBITDA now to -EUR 5 million to +EUR 5 million. That's the range that we are referring to.
Also with regard to the working capital, for the reasons that I described on the earlier part of my slides, it is clear that we have good arguments to increase our working capital guidance. In addition, due to the FYB202 milestone payment, which from a revenue perspective is already recognized, but that is now anticipated to positively impact our liquidity in 2024, instead of Q1 2025, due to an earlier EU approval for FYB202, which is now expected simply earlier than assumed, and Stefan briefly showed that on his slides. So this is another positive effect. Additionally, better payment terms were negotiated for the clinical development cost for FYB206, leading to a deferral of significant payments to the following year.
So here we have two further positive impacts on our working capital, and we, therefore, now expect a working capital result of EUR 35 million-EUR 45 million, and there's the new guidance. Overall, we continue to strive to achieve midterm EBITDA profitability, turning Formycon into a sustainable and profitable company. Therefore, it is absolutely paramount to add FYB202 and FYB203 to our revenue generation over time, where we are on a very good track, if we look at our current performance and our current planning. And 2024 continues to build a platform in this regard with receiving a respective market approval for these two important assets.
Looking at Formycon at the stock market, and here, just, reminding ourselves of our shareholder structure, which is in principle, unchanged, since Gedeon Richter joined us in February of this year, holding 9.1%. So that in total, we have about 58% of shares in the hands of our key anchor investors to whom we are all very close and where we have a regular interaction with them, and approximately 42% are being now accounted to the free float, which, of course, also includes remaining shares from the founders and from the management. On the analyst side, we have successfully added, during 2024, 4 new analysts so far, namely Berenberg, Hauck Aufhäuser Investment Banking, ODDO BHF, and RBC.
This clearly also reflects or indicates the increasing international interest, which Formycon is generating, more and more across the industry. So, the overall capital market, as you know, from an environment perspective, continue to be challenging these days for life science companies, for small and mid-cap companies, as well as for not yet profitable companies. So, for us, a very challenging environment, but therefore, we continue to be very present at diverse conferences, road shows, and other equity capital markets related events, making sure investors have good access to Formycon and, our management, and trying to be very transparent to our interested shareholders and potential investors. Now, on the next two slides, briefly wrapping up, on, what you can expect for the next couple of months, going forward.
As Stefan already described on his first part of the presentation, we have clearly seen great news, and we have really walked the talk that we have been guiding on. First patient in for phase one and phase three on FYB206, our Keytruda biosimilar. Having the FYB203 Eylea biosimilar for the US, achieved absolutely on time, and also very recently received a positive CHMP opinion for our Stelara biosimilar of FYB202. So many important boxes ticked already, but we are also heading for more crucial news flow. So, stay tuned in the next couple of months going forward, as we are expecting approval for our Eylea asset in Europe, as we are expecting approval for FYB202 in the US and in Europe.
Obviously, as Stefan indicated already, we are also aiming to achieve or to lock in the commercialization partner for FYB203 to market Eylea from next year onwards. Last but not least, also Stefan commented on this already, development of FYB210 to be started very soon, so that and broaden our existing pipeline going forward, then making it a pipeline of six very attractive, sorry, seven very attractive assets going forward in parallel. In essence, my last slide, we remain fully committed, fully focused on biosimilars. We have all the very substantial ingredients to make this a successful company, which has an excellent development platform with a good track record, which is now even growing with 202 and 203 around the corner. Commercialization is growing, hopefully 202 and 203 accelerating soon.
And we are moving in a highly attractive, fast-growing biosimilar market, which will be a pillar that in the, in the health chemistry, that is coming to grow and coming and growing, and it will stay for, for good. So, certainly a very key market that we are working on. So, we are really working hard on entering Formycon into the next stag e, of the Formycon growth story. And as you could see on the previous slide, we have all the news flow and all the basics available to achieve these targets. And with this, I conclude my part of the presentation and hand back to Stefan, who will guide you to the Q&A session. Thank you very much.
Yes, thanks. Thanks, Enno, for adding details on financials, but also summing up what we can expect and what the analysts and investors can expect from Formycon in the next months to come. With that, we want to conclude our presentation and are, of course, happy to receive all your questions in the Q&A section. So back to the moderator, please.
First up is Simon Scholes from First Berlin. Over to you.
Yes, good afternoon. Thanks for taking my questions. I've got three. First of all, on the share of the loss from Bioeq. And I realize there's no one-to-one correspondence between the impact of 201 on the top line and on the associates line, but I mean, you've had a 2.6 swing in 201 on the top line, and you've had a 20.9 swing in the equity accounting number. So I'd be very grateful if you could help me understand what's going on there.
Then I was also wondering if you could let me know what might happen with the success payments relative for FYB202 in the second half, and also, I mean, and also subject to approval, of course, what we might, what we could expect in 2025. And then the last question is, can you give us a steer on the timing of the launch of 202 in Europe, subject to approval? Thanks.
Yeah, thanks, Simon. Let me take the last one, and then I hand over to Enno for the financial details. So timing of launch, of course, you would expect that we can name something, but we've done together with our partner, Fresenius. We reached a settlement with J&J, but there is confidentiality around the date, so we can unfortunately just let you know that we got a CHMP opinion. This is the 90+% probability that we get the EC decision in 60 days after, which will set the stage. We also are ready with regards to launch supply and supply chain preparedness of the launches, but the date when we will be allowed to enter according to our settlements, we cannot name, unfortunately.
So with that, hand over to Enno, please, to answer the questions on the 201 top line equity difference and also on the success payments of 202, please.
Okay. Then, I'll try to answer your question. And, I hope I got your question correctly, but let me try to answer here. So first of all, I'm referring to your quick question on FYB201. Q1 2024 results were actually a little better than initially reported, because in Q1 2024, we obviously had to book based on estimates, as we had not yet the final numbers, which means the numbers were slightly higher in the range of EUR 6.8 million for Q1. And consequently, we are looking at a performance of roughly EUR 8 million in Q2, and this increase against Q1 remains also from some other performance from milestones received from the MENA region and within Bioeq.
For the second half year, we expect a slight decline, and our colleagues from Bioeq expect a slight decline in market sales volume and the range of probably 10%, and continuing slight price pressure for the second half of the year. At the same time, H1 Bioeq included the one-time impact that I just briefly referred to, so that's why we are a little bit conservative for the second half of the year in our assumption. So this balance, so to say, between H1 2024 and 2024, is market expectation overall, which have been upgraded by Bioeq, clearly against our initial planning. This is also why we're increasing our guidance. However, they still assume a slight decrease with regard to volume and pricing.
Furthermore, please bear in mind that the investments for the PFS activities, which I also mentioned in the last call for FYB201, are also still due, which also impact the result of the financial performance of our joint venture in Bioeq. So these are other criteria that are included in this consideration, and I hope that answers your question. FYB202, the success payments, again, as a reminder, we have the effect that we received milestones already in 2023, of the total EUR 25 million, EUR 10 million upfront and EUR 15 million for successful completion of our phase one trial. And we are now expecting also further milestones once we receive approval in the U.S. and in Europe during the course of this year.
All this has been basically considered in one basket and is now recognized over time until we achieve this performance obligation of receiving market approval in the US and Europe, and therefore we see deferred revenues. In 2023 and 2024 year to date, or including H1 2024, we have approximately EUR 48 million in revenues that have been recognized, while so far EUR 25 million in cash payments have been received, which means EUR 24 million revenues or future milestones have been deferred, so far. With regard to 2025, we cannot yet give any precise guidance on the anticipated performance of 2-2, as this will obviously also depend on the planning of our partners, and also depends on when and how quickly we can start and ramp up the product performance here.
Okay. Can you give me an estimate, though, of how much or how large the success payment might be, that you might recognize in H2 of this year?
You mean for FYB20 2?
Yes.
No, I can't. I cannot guide in detail on the number.
Should we just assume then 11.3 for the full year? And it's presumably going to be a lot, it's going to be significantly larger than that.
Yeah, as I said, we have already revenue recognized of EUR 40 million, EUR 49 million, but we had 23.7 last year. Sorry, 37 million last year. And so far, we have already up to EUR 49 million. And, and obviously, if we are receiving more of, of, of the milestones over time, we are recognizing the remainder of, of these milestones.
Okay. And then can you, can you tell us how much the main milestone was in Bioeq in the first half?
No, it was a minor milestone, and again, it went into Bioeq, so it's not a milestone that we received, but this is a Bioeq milestone where we have to share 50/50 with the other joint venture partner.
I mean, presumably, that did impact the Bioeq result.
Yes, it did, but it is not unusual.
Okay. Okay, well, thanks very much.
Pleasure. Pleasure. Sorry.
Thank you. Next up is Ben Thielemann from Berenberg. The floor is yours.
Yeah. Hey, guys, this is Ben. Also 3 questions from my side, if I may. Actually, all of those go to Enno. Sorry for that, Stefan, but, maybe we can start with the first one. It's actually on your guidance on at equity. You just lifted that a week ago. Now we should forecast probably or expect probably EUR 20 million in at equity in 2024. But if I look at H1, we're nearly at EUR 15 million already. So to make the EUR 20 million, we would need to see, like, EUR 2.5 million each in Q3 and Q4, which is significantly below Q2. It is actually quite a bit below Q1 as well.
So should we read the EUR 20 million at equity result as rather cautious guidance, or what visibility do you have that at equity is gonna be significantly below H1, going to be in H2? Thank you.
Yeah, this is because, as I mentioned before already, this is because we are not just basically slicing in four quarters and then adding up the total performance. But we do have some other factors in there. And for instance, the development cost for the prefilled syringe will also affect the performance and the result of our Bioeq joint venture. So we do not only have income from the at equity holding other than the Bioeq, but you obviously also have costs, and these can and will increase probably more in the second half of the year as the PFS activities will increase in this regard and have associated costs.
So it's not so much about a less significant performance, but it's probably more about other cost factors influencing the result of Bioeq and therefore our share in this at equity result.
Yeah, Ben, is that fine for you? I mean, on top of that, there's the one-time milestone payment, MENA, which also adds to that difference in the first half and second half. But that explains mostly of that.
Am I still there? Ben?
Oh, sorry. Can you hear me again?
Yes.
Yes.
Oh, sorry. I, I muted myself. It's a muscle reflex. Yeah, thank you.
Mm-hmm.
That was, that was, that was clear. Maybe question on the revenue guidance then.
Mm-hmm.
I mean, you're guiding for EUR 55 million-EUR 65 million now for the full year. And according to my calculations, there should be like a milestone recognition of a low double-digit EUR million amount in H2. And if I then forecast roughly 2 million in quarterly royalties run rate, and then if I look at development compensation in Q1 and Q2, is it fair to say that we're probably gonna end up more in the lower half of your revenue guidance rather than in the upper half of that? Or do you see that, for example, the country entries you plan to do, or your commercialization partner plans to do with a biosimilar to Lucentis is gonna push revenues a little bit stronger in H2, and then we're going to be around midpoint or maybe even in the upper half of that.
Yeah. So, the operating success of FYB201 is largely reflected in the at equity result as just described. And the royalty stream, which is reflected directly in the revenue line, has less of an impact and is therefore within the corridor of our guidance from what we see today. Again, on the planning and on the forecast, we depend on our partners how they indicate their models to us. But that is certainly a key factor here on the revenue line. So we feel comfortable within the range. I would not say we are on the upper end or on the lower end.
But the other part that is obviously to consider the revenues that we are generating in context of reimbursement of cost for FYB201 and FYB203. These numbers can always go up and down a little bit, as the development of these projects can move, and therefore, it's always hard to exactly guide on the exact numbers. So therefore, I think we still feel comfortable to be well on the way with this range and maybe even daring to say we are more towards the upper end from what we have today. But I mean, the reason why we have a corridor is that there are certain uncertainties from the different products that we cannot totally predict or control from our end.
Mm-hmm. Okay. Okay, that is clear. Maybe one more question on capitalized R&D. I know you already mentioned that we should expect roughly EUR 17 million throughout 2024 related to,
T o your biosimilar, to Keytruda. Can you maybe give us some color? What can we expect in total capitalized R&D in 2024? Is it fair to say that the EUR 70 million related to Keytruda is the largest chunk of what we can expect to be capitalized, or should we aim for, I don't know, a low double digit, sorry, a high double-digit EUR million amount? Like, what on top is coming in terms of capitalized R&D on top of Keytruda?
Yeah, sure. So, in principle, it's only about Keytruda, yeah. Because that is currently the only asset that is being capitalized. Two eight and two or nine are still too early, and then also two ten. So they will go through our R&D line and the other ones are anyhow, again, already revenue generating or basically done. So, there's no capitalization there, or they are in partnerships where we have then, if we recognize the revenues, then we have also to put the costs accordingly into costs and cannot capitalize them. So, two, six is the only one that we have here, or the major one, and we commented in earlier calls that we are expecting total costs for the clinical phase 1/phase 3 in the range of EUR 120 million-EUR 150 million.
As we are starting during the course of the year, you could probably expect EUR 50+ million total for 2024, capitalized invested into 206 in 2024.
Mm-hmm. Okay. Okay, perfect. Thank you very much. I'm going back into the queue.
Thank you. Thanks, Ben. Open for next question.
Yes. So next is Yi Chen from H.C. Wainwright. Over to you.
Thank you for taking my questions. My first question is, could you give us a rough... Hello?
Yes. Yes, we hear you. Hey there.
Hi.
Could you give us a rough estimate as to when you could provide us with an update regarding the potential commercialization of 203, and also whether the patent situation in the U.S. and Europe could be different, thereby leading to a different commercial date for 203 in the U.S. and Europe?
Yes, happy to do so. So, regarding the commercial partner, I indicated already during the presentation that we are in a very competitive process with several potential interests and opportunistic commercial partners. So it's a highly attractive asset, and together with Klinge Pharma, we are in the final selection process and comparing the conditions and final negotiation phase. We are expecting in the next few months that we're going to sell additional deals to what we did with MS Pharma on the MENA region and some country-specific deals for EU and UK and US. So that's expected in the next few months to come. And, regarding patent, I mean, that's a very difficult one. You know that we are in the midst of litigation procedures.
We see preliminary injunctions. We see court cases. We see... We are clubbing or teaming up in the defense group, I would call it, with very reputed biosimilar competitors, in that case, partners in the litigation process with Amgen, Celltrion, and Samsung. We are expecting in the next weeks and months, more clarity. I mean, it's throwing down to the 865 formulation patent. And we are of the opinion that we have good arguments in place and that we have professional experts representing our case there. So in the end, we still have the same launch plans, which would also consider a launch still in 2025 as possible.
But more than that, we will see from all the litigation procedures, we will see in the next two weeks and months.
Got it. My follow-up question is, at which point, will you consider disclosing the reference drug for 208, 209, and 210?
I think in one of the last calls, I promised to do that still this year. That's, we will keep that promise.
Okay. Thank you.
You're welcome.
The next questioner is Alexander Galitsa from Hauck Aufhäuser Investment Banking. Over to you.
Yes, thank you for taking the question. I have one on 202. It's obviously a hugely important asset for you and will get increasingly more attention as we go into commercialization. I'm just wondering if you could maybe share some thoughts on the upcoming sort of race to commercialize this asset. We have seen that, for example, in Humira market, that Sandoz partnered with Cordavis to enter the PBM market. And I think the dynamic was that the largest share of the market was taken up by one product, which was the Sandoz product.
Just if you could share some thoughts as you think about the Stelara biosimilar entering the market, could there be a similar sort of dynamic where the first one to partner would sort of have the larger share of the market and others would be struggling to get access or any kind of thoughts on that matter would be helpful?
Yeah, thanks, Alex. Good question. I think what is positive already in this Humira adalimumab case is that after a very weak start, we see now, I think it's now 19% biosimilar share in Humira, so that really makes a difference in the PBM market. It's opening up, which gives us really good indication and prognosis for our Stelara biosimilar, which is playing in the same field with the same payers and the same network of stakeholders. Hard to say how the pattern will evolve. I can just say that one of the main reasons we choose Fresenius as a partner is that they have not only adalimumab, they also have launched tocilizumab, which is in the same PBM therapeutic area field, and they're increasing their network of accounts and also payers.
So I think the contracts will not be just written when there is a launch date that will happen before. And as Fresenius is a strong partner also with building up the network with three assets, two assets now, and the third one was ustek inumab. We could think of bundle these or whatever, which brings an advantage to Fresenius. As also having a strong reputation in the U.S. market, which is in hospital, a key driver as well for success.
Thank you.
How it will look like, hard to predict, but we are pretty convinced, talking with the Fresenius team, that they are strong in there.
Understood. That's helpful. Thank you.
You're welcome, Alex.
The next question comes from Sean Hammer, from Pep Race. Please, it's your turn.
Hi there. Thank you for taking my question. I have two. Could you please tell us when we should expect more detail on 208, 209, 210? But more specifically, what the assets are based on. I mean, I'd assume for 210, this might be during 2H, following a development initiation. And then secondly, are we to expect a partner for FYB 206, following the initial phase 1 data in 2026? Or do you think you'd continue to keep the asset wholly owned until you reach that commercialization stage? Thank you.
Yeah, you're welcome. 208, 209, I think I've indicated that, that we will announce that. We're planning to announce that. We so far just said it's in the immunology space. It's highly growing assets, attractive assets, which will for sure end up also in the $10 billion+ range, according to our estimates at the patent expiry. We want to disclose them in the next months to come by the end of the year. And then, second part was, I think, partnering 206. You rightly say, we want to stay on that asset as long as possible, as long as revenues and incomes and cash position allows us to do so.
We see a lot of interest also as we are among the front runners, and there will not be that many companies offering that asset, and everybody who has a commercial sales force is interested in getting that biosimilar. So we balance that out with our cash position. So far, it's planned next year, 2026; however, the cash reaches, but as long as possible to stay on the track.
Thank you very much.
You're welcome.
Thank you. There are no further questions.
Thank you. So with that, I think we are nearly on spot, on time. I thank you very much, investor relations team, of course, for preparing all that, moderator for installing, and technically perfect setup. And of course, everybody who listened in and spent time with us and for the good questions. I hope we could answer everything and could convince you and show you again that we, Formycon is delivering and that we are on a very good growth path, and a lot of good news ahead of us. So thanks for participating.