Yeah, good afternoon, ladies and gentlemen, and warm welcome from my side as well. We really appreciate your interest in our H1 results, and we will be happy to share a bit more details around the operational achievements of this time period, as well as the financial results and key indicators, which have been summarized already in the press release earlier today. As usual, and probably most of you know those slides in those settings, I want to remind you that our presentation may contain forward-looking statements that are based on our current expectations and assumptions, and which are always subject to certain risks and uncertainties. What will definitely remain unchanged and highly predictable is our entrepreneurial passion in the board and throughout the organization.
In appreciation of your time and interest, you have the complete board at your full disposal today. So Enno Spillner, our CFO, and me, will run you through the presentation. And Nicola Mikulcik, our Chief Business Officer, and Andreas Seidl, our Chief Scientific Officer, will join in for any questions that you might have in the subsequent Q&A section. Formycon is really well-positioned in the fastest-growing pharma segment, which is biosimilars. Why are biosimilars so attractive, with an expected annual growth rate of 17%? Now, looking back in my first 20 years of pharmaceutical career, I spent a lot of focus on the small molecules, but already at that time it was clear that the future in treatment of severe diseases is really with the biologics. And those highly complex protein structures really revolutionized the medical treatment of severe diseases.
So, but not many patients benefit from those revolutionary medications because they really come at very high prices. According to IQVIA, the global spend on biologics will rise to $660 billion by 2027, so the next five years. And recently or currently, the healthcare budget in the U.S., for instance, is dominated by 40% of biologic spend, with only 2% of patients getting those medications. And so a few of those biologics in the healthcare budget really bring the budget into serious trouble. So, that needs a solution, and how can we make these extremely helpful medications accessible to much more patients, and at the same time relieve the pressure from the healthcare budget? And the solution is biosimilars.
These are follow-on biologics with the same high level of quality, safety, and efficacy, launched after patent expiry at much more affordable prices. This provides really significant relief to the healthcare budgets. So far, since launch of the introduction of the biosimilars, there were healthcare savings of more than $40 billion across EU, US and Europe. There is a prognosis that by 2027, so in five years from now, there will be annual savings achieved by biosimilars of more than $100 billion. This will also come with a benefit, and that's what we see with the, with each biosimilar launch, is that also the patient access is increased, so many more patients get access to those medications at the same time as the medication spend is reduced. So we, as Formycon, are really proud that we contribute to that solution.
Formycon is really well set for playing a strong role in the growth journey of biosimilars. I mean, the core of that capability of playing a strong role comes with a pipeline. Having a look at the pipeline, this is one of my favorite charts because it shows several things. So the one thing is, we are working on six biosimilar projects in parallel. And you see, we are not a one-trick pony. We are really driving forward and progressing projects in parallel with a significant outcome. Three of those six are in late stage already.
The first one made it to the market already last year, our FYB201, Lucentis biosimilar, and two further ones to follow, one being in the regulatory procedures since end of June, the FYB203 Eylea biosimilar, and the other one, as we speak, close to the finish line of the submission to the EMA and US FDA. So in total, if you sum up the reference markets we are targeting with these six biosimilars, we are talking about more than $50 billion of reference sales. Also the next ones in the line, so the Keytruda biosimilar is pretty nicely advancing, and we are planning to enter the clinical studies next year. And also the two further ones, so we constantly thriving to expand the portfolio, which we started last year, which are still undisclosed, are really nicely progressing.
FYB207 COVID fusion protein has some changes in the decision. So we—our scientists have really developed a very attractive asset with multiple positive features. So first of all, 100% in vitro neutralization against all mutants that we tested. Secondly, that we have a prolonged half-life by smart molecule design. By the mechanism of action, we see that we are mutant resistant against further variants to come. And last but not least, we got the recent results from preclinical tox studies that the tolerability is really good. But the environment has changed, so the WHO has lifted the pandemic emergency status in May, and also the medical urgency has vanished.
That creates a tough environment for recruitment in clinical studies and also for strategic partnerships, which made us decide to limit the resources and the activities in 207 to certain activities in a very resource-restricted manner, speaking of patent applications that we pursue, scientific advice, and also partner search. In a nutshell, our clear focus will remain on biosimilars, and that's, of course, then also dominating the operational good news that we see in the first half of this year. Starting from 201, so this one is the first one in the market, and it's really outperforming the competitors in U.S. and Europe. We see, for instance, in the U.K., we have reached with our commercialization partner, Teva, a market share of over 40%, which is really remarkable.
And also in the U.S., by far the biggest market, we see that Coherus, our commercialization partner, was Cimerli showing a strong performance, especially quadrupling in the second quarter after the assignment of the so-called Q code. This is the reimbursement code. So at the moment, the teams, the commercial teams, were able to achieve a market share of 17% with a tendency, of course, to grow. What also will make a difference in future is that we launched in 10 European countries in total and also in the first country in the Middle East, which will also create further sales in the future. Our FYB202 Stelara biosimilar could tick off successfully all the clinical programs, the phase I, early this year, and this also made a big boost also in our commercialization contract with Fresenius Kabi.
We expect significant, and we got already significant development and payments and also regulatory milestone payments under this agreement. The settlement with J&J, which was achieved with Fresenius and us, could secure the market entry date no later than April fifteenth. That is also a big success because that brings us into the first group of biosimilar launches in that year. Coming to Eylea biosimilar candidate, the next advance after the 201, we could already also tick off all the operational milestones, the clinical milestones, and we entered into a commercial partnership with a binding term sheet signature with Coherus in January. We also could completely complete the successful Phase 3 trial, and that led us in the end of June into a BLA submission at the FDA.
Yesterday, we could share the very good news and feedback from the FDA that after the 60-day review, first review period, that our file is accepted for further review, also with a comment that no severe issues have been identified so far. So really very positive across all three programs, major success, and you can only hardly imagine how much work and effort that stands behind all those successes, which we are proud of. The other programs are also pretty active. So 206, our Keytruda biosimilar candidate, has pretty well advanced into manufacturing at large scale already. So we are, as we speak, we are producing the next GMP product, next GMP batch, which is meant for a clinical study supply. The kickoff for the clinical study is planned for next year.
Of course, as always necessary and very important, we are aligning the clinical program set up with all the relevant agencies that later on have to receive the filing then. In FYB207, as indicated already, there was a strategic decision to reevaluate the changes that come from the external environment. There we, as said, we took the decision to continue the project, very limited activities, resource-sparing activities, but still, activities that might prevent the good work that has been done for the future. This means pursuing patent application, running scientific advice meetings with the authorities, and also searching for potential opportunities for outside funding. But to be clear, there will be no self-finance clinical study program that's going to be started from us in the current situation.
208 and 209, I cannot share a lot of details. They are undisclosed still, but you can be sure that also there, there's a big push in energy and, and a lot of, achievables and activities behind. So we are in the cell line development stage. We are selecting the, the contract manufacturing partners for the commercial manufacturing, and we have already quite some promising clone candidates in hand, which we then will evaluate and decide for the best clone in terms of quality and in terms of productivity. So all in all, I think a pretty good operational success.
So we're really proud and a lot of movement and deliverables that you might have expected, but we are always happy to deliver according to the expectation, and this is also true for the financial numbers. I'm happy to hand over to Enno, please.
Yeah. Thank you, Stefan, and also a very warm welcome to all of you from my end here. So good morning or good afternoon, depending on where you are. Today, I have the great pleasure of first time presenting H1 numbers to you here since I started. And I have also the great pleasure to announce very positive numbers to you, and that's what I would like to introduce to you on the next couple of pages or slides, respectively.
So let's start with the P&L slide, and here the comparison between 2022 and 2023 needs a little bit of a disclaimer, as it is a bit challenging to directly compare these numbers caused by the Athos transaction, which became effective May 1, 2022, and therefore changed the structure of the company quite considerably. And this is obviously affecting also our different P&L lines. For example, Formycon provided clinical service with a subsidiary, Bioeq GmbH, for six months in 2023, but only two months in 2022. And also our workforce increased by 10% on May 1, 2022, which obviously has an impact on our financials.
However, in any case, we are looking at a record H1, with revenues from development services, from success payments and first royalties coming in from licensing of FYB201, and showing here almost EUR 44 million in revenues. And, the revenue line also increased, partially driven by one-time EUR 10 million upfront payment received and out of our FYB202 licensing with Fresenius Kabi, just to be noted for you. The cost of sales in context of the more mature projects such as FYB202 and FYB203 delivering to these kind of costs.
The R&D expenditures is always to be considered if you are analyzing them in context together with our capitalized development costs, since projects can shift during their development from our P&L R&D line into the balance sheet, where they are capitalized, like for instance, FYB206, achieving the status. Below EBIT, we have obviously the earn outs and the at equity of our Bioeq AG, which has been added last year. And again, the positive EBITDA mainly increased so significantly due to the strong increase of our top line, of our revenue line, and therefore shows a very positive development compared to the previous years.
Looking at the statement of financial position, here, if you can see that the current versus non-current split is more or less identical in the assets and versus the liabilities column, so to speak. And the non-current liabilities consist mostly of earn outs, which is in the range of EUR 270 million, and deferred tax in the range of roughly EUR 130 million. We have a very strong equity position, which even increased during the course of this year, thanks to the EUR 17 million capital increase conducted in February of this year. And we are also observing some moves from non-current liabilities into current liabilities, which is just the course of the terms of these respective liabilities within our balance sheet.
Looking at the statement of cash flows, and here I would like to draw your attention in particular to the cash flows from financing. I already mentioned just the one major impact that we have observed here, which is obviously the net effect of the EUR 17 million capital increase. On the other side, we have a EUR 20 million partial repayment of our shareholder loan, which was returned to our shareholders immediately after conducting the capital increase of EUR 17 million. Cash and cash equivalents standing at a very solid EUR 37 million, which does not yet consider the latest Fresenius Kabi success payment of EUR 15 million, which we received for the successful completion of our Phase 1, where the payment came in after the reporting period.
So cash reach should bring us clearly into the second half of 2024, based on our current planning and assumption and the underlying costs that we see going forward. Looking at the working capital, which also increased significantly, and this is especially due to the current receivables. Again, referring to the success payment that I just mentioned, that is one of the key drivers here in this positive development. Looking at some very important KPIs, well, most of them have the comparison basis dated December 31, 2022. So really, most of the KPIs show either stable status or even an increase, plus recording an increase in our share capital, obviously.
So the balance sheet total increased to above EUR 900 million, driven by the capital increase from our financing activities, but also from the capitalization of some of our development efforts, where I just described to you that they will not necessarily always end in our P&L, but can also be activated or capitalized in our balance sheet. Both effects are lifting our equity to a solid equity ratio of 47%. And furthermore, reduced liabilities, also due to the partial repayment of the shareholder loan, are further supporting this trend. Let's look at the guidance 2023, where we are fully on track.... And the most recent development can now be shown in more detail.
So we are becoming more precise with our guidance, translating it into final numbers or corridors respectively. And again, as Stefan already indicated, we can really confirm that things are well underway and that we have ticked all main boxes that we wanted to achieve, so far. And therefore, we are able to even slightly increase our guidance for 2023, as indicated on this slide. This means revenues or revenue expectation is in the range of EUR 75-85 million, including approximately EUR 4.2 million license income from FYB201, where we have seen in the first half of the year 1.3 millions. The EBITDA, here it is important to notice that we are looking at a very positive H1 with EUR 7.3 million euros positive.
However, we are expecting a -EUR 5 million to -EUR 15 million negative EBITDA for the full year. First of all, we want to significantly accelerate the investment into assets like FYB208 and FYB209. This will lead to a higher loss, but we also have some one-off effects, like the upfront payment from Fresenius Kabi in H1, which obviously really lifted this particular first half year. The net income in 2022 was highly impacted by the one-off ATHOS transaction, where I was just referring to on the previous slide. And if you would really read the comparable numbers, then you should take roughly -EUR 53 million as the starting point in 2022.
And on that basis, we are now guiding -EUR 20 million to -EUR 30 million expected for full year 2023. The net income will also be dependent on our WACC development, so weighted average cost of capital. Here, our assumption is that we are facing the same financing and interest situation as for the half year 2023. However, as you all know, certain things are moving in the capital markets here right now, so this is potentially subject to change, and we had a brief description in our full report on the sensitivity, what a change of WACC may mean for our financial net income performance.
The at-equity contribution, by the way, from our joint venture is expected of roughly EUR 3 million for the full year, 2023. My last slide is with reference to our shareholder structure and our shareholder performance, our share performance. But this is not the part I would like to draw your attention to, rather than comparing once again, the numbers on the lower left of the slide. And as you can see, and compare once again, against our long-term key financial figures, that we are really nicely developing our financials in 2023. Reviewing the current actuals and also considering the outlook as I just indicated it to you.
So really looking forward to a continued growth of the financial performance of Formycon in 2023 and hopefully also beyond. With that, I'm at the end of my brief financial introduction and would like to hand back to Stefan. Thank you very much.
Yes, thank you, Enno. Back to your comment, you're just new to the block, but you are already mastering the numbers, so thank you for the good overview. I would like also to amend the financial outlook with an operational outlook for the year to come. So we are in the midst of the second half already and full of energy and also capabilities to push the program further ahead and deliver more news flow and operational activities. So starting with the 201, we foresee further product launches. So we will come closer to 15, more than 15 countries where our product is already facing patients. Stelara biosimilar, as we speak, our teams are compiling the last documents for submission in FDA and EMA regulatory procedures.
This is planned for the end of this quarter still. Of course, we always have to wait also for the subsequent acceptance period to get the final go. For Eylea, I mean, we got the final go for U.S., and there's still the E.U. submission outstanding, and we are also still in negotiations with commercial partners because this is a really attractive assets where we want to pick the best commercial partner for creating maximum revenues there. Our Keytruda biosimilar, which is the next one in the line, as said, makes really nice progress.
So we have further at scale manufacturing plans for this clinical supply, and we are in detailed fine-tuning and negotiations with the alignment discussions with the agencies to really be assured that we have the best clinical program that we can start the next year onwards. And 208, 209, as said, working with cell line development, have a lot of different pools of cell line pools and try to pick the best one in terms of production and quality and similarity. And of course, with that, also hand over to the CDMOs for process development, which is closely guided by us. So a lot of deliverables and good news to come and to expect.
And with that, I think I want to, in a nutshell, summarize where we are. And Formycon is clear focusing on biosimilars, and that will not change. And we believe that we are really, as one of the few pure-play biosimilar developers, well set for this attractive pharma segment and growth market, which is a wonderful, for me, very powerful combination of, on the one hand, business attractiveness, but on the other hand, also having a lot of social and ethical benefits, which translates into the ESG language, into a very strong S. And this is also encouraging on top of, of course, the business prospects. And we have to summarize our capabilities and why we believe that we are really well set for making a strong argument in this attractive market.
This is that we really have shown capabilities with our first product that made it to the market already. We have also a remarkable rich pipeline of 6 biosimilar assets, where 3 of them are in late stage, very advanced already. We have also a potential to address really a growing market and want to expand that pipeline, constantly adding to the new ones last year or the further ones in the future. We are operating in a smart, efficient, hybrid business model, where we really take advantage of our in-house and very strong in-house expertise in R&D and work with selected partners in commercialization and manufacturing.
Last but not least, and this is one of the key elements for me always, that we are the agile, the speedboat, very entrepreneurial, very driven and experienced management and operational team, and also including the very experienced supervisory board. That makes us really confident that we will continue to write the success story for Formycon. With that, I hope we could provide you with some more helpful additional explanations around the encouraging half year results, and are open for any questions you might have.
Ladies and gentlemen, we will now begin the Q&A session. If you would like to ask a question, please press nine and star on your telephone keypad. In case you wish to withdraw your question, press nine and star a second time. The first question comes from Brian Balchin from Jefferies. Please go ahead with your question. Mr. Balchin, your line is open. You may ask your question.
Hey, thanks. It's Brian Balchin from Jefferies. I've got three questions. The first is a modeling question on similarly, just so we know how to forecast it quarter-on-quarter. So in 2Q, Coherus booked $26.7 million. Formycon then booked in licensing income, EUR 0.9 million, and then 0.2 million in as an equity investment from the Bioeq 50% share. So can you just help us by clarifying how to actually model those two lines going forward? Just so I think most have a simplistic 15% of Coherus's sales hitting top line. So yeah, just clarification on that would be helpful. That's the first one. Second is, net profit came in at EUR 1.8 million for the first half, yet guidance for the full year is EUR -20 million-EUR -30 million.
Presumably, this implies a big negative non-cash hit in the second half. Can you just help clarify that and what that relates to? And then finally... is there still an expectation to partner out FYB206 in the next 9 months? That's it. Thank you.
Okay, thank you, Brian. Thanks for joining the call. I mean, I understood three questions. The first two are financially expert-driven questions, which I meant to hand over to Enno, please.
Good. Yeah, Brian, great pleasure having you on the call, and thank you for joining. To your first question on the modeling. So you, first of all, maybe for clarification, we are referring to 15% of the Coherus sales. This is when the deal receives or achieves peak sales. So that is at the highest momentum of this transaction. In particular, for 2023, we will see a kind of an up ramp-up scenario where we are not yet fully there in that regard. We will have, as you can see, a certain portion coming through the share of the top line, as reported and also as just indicated for the second half. On that basis, you can calculate this part.
The other one goes through the joint venture, which is where the other part of the profit share goes into. However, that joint venture is obviously facing other costs from administration and also from supporting the supply chain, which includes obviously also certain HR costs, which is a rather stable position. We have also some additional development costs for some activities that we pass on. The passed on revenues is recognized on our side. However, the cost is in the joint venture. And last, but probably also very important to consider, is that we have the amortization of the PPA activated assets here going over the next years to come, which is a linear amortization, which started already early this year.
And therefore, kicked in on our results in the joint venture. But the revenues were not that great, therefore coming in from Coherus and therefore, this was negative in the first half of the year. And therefore, or in the first quarter. In the second quarter, this is already kind of close to breakeven, if you will, and then we should see positive numbers if Coherus continues to deliver as they indicated and forecasted in the numbers. So it will ramp up from there going forward. So I hope that helps a little bit, separating for you the development and also the ramp-up that is going to follow.
With regards to the net profit that we will see negative in the second half of the year is also associated to certain effects from the respective amortization and these kind of activities that we will see going forward. And that's obviously the other part that is key is here, the relation to our earn-outs, where we have certain obligation to serve to our partners which are related to the transactions from last year. That's the two major positions where this is coming from. And the first-
Very helpful. Thanks.
For the third question, I hand back to Stefan.
And I could answer, but I immediately hand over to Nicola. She's much more in the details on the partnerships, on the commercialization.
Thanks, Stefan. Yeah. So, the question was about our plans for partnering on our Keytruda biosimilar. Whether there is a plan in the next, I think, nine months, what's the time frame? I can say we see quite some good interest in the product, global interest. We are already having some initial discussions for this program. We, of course, would like to safeguard as strong as possible partner with this program, and I think we do not want to rush into a deal. But, of course, it's, in this case, more likely that we enter in an earlier deal than what we did so far on our current programs. Just to assure that we will have early on in this quite competitive space, a very strong global partnership, hopefully. So that's the plan.
Whether this happens really within the next nine months, I cannot predict because we also do not feel under pressure at the moment, but we are heavily working on that, of course.
Got it. Thank you very much.
Nicola. Yeah. Thanks, Brian, for the questions. Who would go next?
The next question is from Alexander Galitza, HAIB. Please go ahead with the question.
Yes, thank you very much for taking the questions. Maybe the first one, just to clarify the breakdown of H1 revenues. So EUR 44 million was the revenue for the group. Did I hear you right, that in H1, you have booked only EUR 10 million of success payments? So then you have around about EUR 2 million from other commercials, so royalty-related revenue, and the rest, EUR 32 million, would be then development revenues. Is that how you break down?
Yeah, Alexander, thanks for the question. So if that's the only question you would have, I would be happy to hand over again to Enno.
Yes, and a pleasure to have it, Alexander, welcome, on the call. So the pay-down payment here is the EUR 10 million. That is definitely one part of it. In context of the total development or the net total development cost, but total revenues from FYB202, we are looking at EUR 23.6 million from the different factors, including the EUR 10 million. We have seen EUR 1.2 million from the license agreement with FYB202, as I just indicated. Sorry, FYB201, as I just indicated, and EUR 20 million, which is reimbursed for development activities that we are running for our partners.
Okay, thank you. And, then I have a few other questions, maybe on the 202 . So for the launch of 201 , you obviously have ensured an extremely favorable competitive positioning for your partners, especially in the U.S. Maybe to the extent you can comment, maybe you could speak to the relative competitiveness of the first to market Stelara biosimilars from Amgen, Alvotech, and yourself. How do you see this market shaping up? And whether you see scope for any meaningful differentiation there.
Yeah. Thanks, Alexander, for that question. Maybe I start that, and maybe Nicola might chime in. So in principle, what we can say, of course, we do not know all the details of the competitive products, but we can say from our own product, we have really a competitive range of dosage forms and all what you need there. We're also working on differentiation, which I cannot disclose too much in detail. We're also having a, I think, competitive and reliable supply chain, together with the fact that we could achieve, together with Fresenius, the settlement that puts us into the first wave.
There's also a big chance that many of these formularies and these PBMs, they always wait for a bunch, the first bunch of competitors to address and fix their formularies. And with Fresenius also having already in this space of immunology and PBM market, having the first product launches in U.S. before our product launch will come with the Stelara biosimilar, I think they get a good understanding and will pay the market already for the next product in that segment to come. So I feel that we are, together with Fresenius, well-positioned, but of course, I cannot disclose more on differentiations between the different competitive products. Nicola, anything to add?
Nothing special.
Satisfied with my-
No, that, that, that's helpful. And maybe last question from my side is, regarding your plans to potentially, establish in-house commercial capabilities and also possibly infrastructure. Do you have, somewhat more concrete plans already in this regard that you could share, or is it, too premature?
I think it's the latter one, so it's still too premature. Of course, we have already thought in that direction by having this co-marketing arrangement in the Fresenius deal for Germany and other markets. So it's clearly going into the strategic option, but we, among other strategic options, we have now achieved a really robust platform, and we, there are a lot of options that are showing up and which we are currently deeply assessing, and one of those might be into forward integration and commercialization. That's, but I cannot tell you about timing and dimension, but that's clearly on our minds. We have to, let's say, crunch a bit more numbers, what that means and when, and in which extent that makes sense.
But yes, we want, but we cannot share more details when and in which extent.
Thanks so much.
Not yet. Not yet, but we'll come out in after we completed the assessment.
Understood.
Was that completely answering all your questions, Alexander?
Think so.
Think so? So next one, maybe.
Yes. So the next question comes from Nicolas Guyon-Gellin , Kepler Cheuvreux. Please go ahead with your question.
Hi. First of all, congratulations on the result for this H1. So I have two questions. The first one would be regarding the timeline development for 206. You announced that you plan to launch it into clinics in 2024. Do you think that it's more likely to happen in the first half or in the second half of the year? And then maybe a second question regarding 203. Will you need to do a settlement agreement prior to the commercialization, or we can expect a launch right after the approval of the FDA, which will take place in April next year? Thanks.
Yeah. Thanks, Nicolas, for the good question. So, let me start with the 206 clinical program. I mean, it's not a one bang clinical start, so it will even start already this year with prep work. I cannot openly disclose the exact date of when the first patient will get into those studies because it's a bundle of studies. But yeah, just state that we are-
Okay
... heavily working on it, and a lot of activities are happening now already, and all is directed towards a very competitive timing for the end of the study for submission, if that helps.
Okay.
And on the settlement, yeah, I mean, that's at least what we see, it's more and more regular that the innovators and also the biosimilar applicants do not want to fight and feed patent attorneys and lawyers with millions across IP interpretation fights. And that's why the usual standard, which we will see in future also, is those kind of settlement deals. And it was probably hardly noticed that also in 201, we had a settlement discussion which made us launch in U.S. in October, although we got the approval in August. So that's standard, and you can be sure, I mean, that we will also there do our best and perform like for 202, together with our partners to make the best deals out there.
The best, let's say, prerequisite for that is that you have a good product, that you have a favorable IP position. Then, I mean, usually that starts with a so-called patent dance after you have submitted. 202 was even a bit better than that. So we expect with the submission that's starting already of 203, that the so-called patent dance starts and the negotiations will continue. And the settlement is expected-
Okay.
Definitely, yeah.
Okay, and maybe one last question, if I may. Regarding the dynamic in Europe, so you said that you had a strong performance in UK. How will it translate to your revenues for 2023? Do you expect it to be slow because UK might be the only contributor, or we can expect some other region to, to as well?
Yeah, thanks. Maybe Nicola, who is close to the-
So if I understood correctly, and the question is, how so you say there is a relatively slow start in Europe, and what will be the projections? Did I get that correctly?
Yeah, that's correct.
... So, in Europe, it's a pretty staggered launch approach in different countries because of different timelines for pricing and reimbursement, and U.K. was the front runner. Meanwhile, we have, as Stefan mentioned, launched in 10 countries, but some of them, we had a launch only in May, June, and therefore, it's really, we are just in the really very early phase of market formation. What I can say is that in many markets, we are still alone on the market. In some markets, we see competitors who have officially, formally launched, but really no competitive pressure at the moment from our biosimilar competitors. Of course, we see quite some fighting with the originator.
But that's the current situation, and of course, we expect that revenues will step by step now increase this year and next year, and will probably peak in two years from now in Europe. But that's-
Okay. Very clear.
Yeah. Yeah. Okay.
Okay. Thanks very much.
Thank you, Nicolas.
The next question comes from Simon Scholes, First Berlin. Please go ahead with your question.
Yes, good afternoon. Thanks for taking my questions. I've just got two. Firstly, on 207, I mean, you've talked about keeping the costs for development of 207 down. I was just wondering if you've revised your expectations on development costs for 207 since you've last reported at the end of May? That's the first question. And then the second question is, I was just wondering if you could give us some indication of where you expect costs for the JV to be for the full year.
Thanks, Simon, for the question. So on 207, do you asking for, first question is development spend compared-
Yes.
to the last publication in May?
Yes.
May I have the-
Have you, I mean, have you revised down your plans over the last few months?
On the cost side, we have obviously anticipated some costs which are also remaining, going forward for the year, but nothing major. We will just complete the work that Stefan described to you, which comes with certain costs. But there's nothing going beyond that really, and obviously also not expecting anything on the reimbursement aside from a revenue perspective. Obviously, we do have grant activities there, where we recover a certain part in the cost going forward. Yeah.
Okay.
Yeah. I mean, that's just to, I mean, it's of course meaningful that we complete the packages-
Yeah.
or do the last investments, which are really not super high. But it... Of course, if you started a preclinical study or stability or whatever, it's of course clear that you need the reports to make it really an attractive package, but that is it. No further activities started, being started operationally, other than we anyhow described pursuing the patent applications, which of course makes a lot of sense to keep up the IP value, and then also scientific advice negotiations with which, where we anyhow paid the fees already.
Roughly for the remainder to come for this year, you would be looking something at around EUR 5 million cost.
Okay. Great.
Yeah.
With regard to the cost for the joint venture, as you were asking for the full year, or I would ask differently or answer differently, what is the result? We are roughly in total expecting plus EUR three million positive contribution from these joint venture activities for the full year.
Okay. Thanks very much.
You're welcome.
The next question comes from Stefan Reichenberger, Apaton Finance . Please go ahead with your question.
Hello, ladies and gents. I'm Stefan, and I have some questions on the plan for the next projects, new projects, for 2024. Do you expect two new projects or only one? What are your plans in on this side? And another one is the question of the staff. Are you expecting to enhance your number of the staff? And the next one is on 203, are you expecting similar development with 201, so a strong U.S. part and a more weak E.U. part in the in Europe?
Yes. Thank you, Stefan, and thanks for dialing in and for your questions. So new projects, of course, as you know me, I would love to start 5 of them next year, right away. But, of course, we have to balance with the funding and the revenue flows, that come in. What I can say is that we, we indicated over time that we're going to start every 18-24 months, a new one. So for now, I would foresee, and we are always in the portfolio assessment, but intensifying that so that we would expect to start a new one next year, with a certain precaution.... of course, under the assumption that the revenue flows come as we expect.
In terms of staff, I mean, there's always, we foresee some further additions, but in a very reasonable manner. So that means I would say that we might increase to 250 employees, so plus 20%, roughly. And that comes from more angles. So the one is, of course, expanding the pipeline, but also other programs will get in a less intense phase, so less balancing out. But also ramping up some of the commercial and supply chain activities and bringing experts in there, and also prepare potentially for the ideas on uplisting or whatever we might have. So in the range of 20%.
Okay. And the third one on 203, parallel to 201, US strong and Europe more weak, the start?
That's hard to read without crystal ball. So at least in Eylea, you see, and probably better to hand over to Nicola. In Eylea, we see at least the same share distribution, more or less than with Lucentis from the reference market. For sure, U.S. will be dominating and strong, and also there with a partner and the payers knowing our product or our product quality from two oh one will definitely be a door opener for Europe. Hard to predict, probably easier than for two oh one to enter the market. But Nicola.
Yeah, thanks. Thanks for the question. I mean, first of all, we can say that the market is three times the size, yeah, of Eylea, for Eylea. So, the ranibizumab or, or Lucentis is at the moment, about $2.8 billion, while aflibercept is, or Eylea is almost $10 billion, I think it's $9.8 billion last year. And from the, I think from the market formation, I assume that it will go faster, especially in Europe, because there you have still some retail markets.
And I think once you have the connection with the doctors and the network, and then the doctors have the first time been approached by a biosimilar, these specialists in ophthalmology, I think the second time it will be easier to appreciate the value and also the quality of a biosimilar. So I think it's a bit of a learning experience or learning curve, which we hope our customers will show.
Okay, thanks a lot.
You're welcome.
We have one follow-up question from Alexander Galitsa. Please go ahead with your question.
Yes, thank you for taking the follow-up. Could you please repeat the, the cost, expected cost for the full year for the JV? I couldn't hear it properly. And that's the first follow-up, and the second follow-up, just, one last time on the COVID product. Could you maybe, speak to, how do you evaluate the chances to, have this product partnered, given the change in the framework with really little urgency now to have the next COVID drug? Do you think there is a business case for this product, sort of as a preventative measure? Or do you think that, that there should really be, and the next emergency in order for this product to really, be partnered and, be brought to the clinics? Thank you.
Thank you, Alexander. Maybe first one back to Enno.
Yeah. Happy to get back to the cost of the joint venture, which I also didn't answer that way because I said, well, only what is the contribution at the end of the day of the joint venture, and that is anticipated with roughly three million positive for the full year, 2023. In the first half of the year, we saw a negative result of roughly minus EUR 6.2 million at the equity line, and therefore, obviously, the second part of the year will be significantly positive with EUR 8.7 million. That's our current estimate. Again, depending on the performance of Coherus as one significant contributor here.
But there you can already see how the ramp-up of the performance, in particular in the U.S., is impacting the joint venture to the positive, and therefore, we will have, hopefully, a development over the years to come, more into the positive. Then maybe as we are speaking on that, to clarify a little bit the history of this project. The profits here, for those who are not so familiar with this project, are coming through two lines. One part is contributed directly into the revenue line. That's the number of EUR 1.3 that I was referring to before for the first half of the year.
The other part of the success share goes through this co-owned joint venture, where we own 50%, and this part is now to accelerate over time so that we will have these positive factors coming in.
Thank you.
Thanks, Enno. Yeah, and back to the 207 , I mean, it's at the moment we just see that the appetite, strategic appetite for a COVID treatment discussion and also strategic finding a strategic partner is pretty challenging because the overall urgency and attention is not going there. Of course, there would be still a medical need, and you could have a lot of scientific arguments that this is a very good product, but at the moment, we just don't see that. What might change that? I mean, of course, what you mentioned, nobody, no human being would hope, but that would, of course, change again the discussion and the appetite. So far, we don't see that, and we also in the current situation would have also problems to recruit patients in a setting.
So there's the other two arguments where we see at the moment that we have to deprioritize that.
Thank you. Just to confirm, there were no capitalized costs associated with 207, is that correct?
No.
No. Clear, no.
Thank you.
You're welcome.
There's no more questions here in the audio conference, so I hand back for other questions from the web chat.
There are two questions in the chat room that we may also answer, and I will take the first one, which is the question, why are the direct licensing revenues received from Coherus only in the 3%-4% range, for FYB201? And this is relatively easy to explain. Again, a little bit of history. Again, this asset was transferred last year by contribution in kind into Formycon from others. So others paid for the development of this particular asset in the beginning, and therefore, we have not full commercial ownership, but only a certain proportion of this. And this is a staggered deal, so the more this asset ramps up, the more we are eligible for receiving higher royalties.
At this stage, it's still in the single digits or in the moderate single digits, while the product has to ramp up. Second, as I just mentioned before, we will have a split of the success shares. Not everything is coming, of the success, is coming through the top line, and where these 3.2% or 4% are referring to, but the other part of the success is transported through our joint venture and then coming through the equity line below our EBITDA line. That's why this is this split here.
Yeah, second question on the EYLEA high dose. I mean, that can be clearly answered with yes. So there will be, of course, an influence on the addressable market. EYLEA, this is a typical life cycle management activities, which is not surprising. We're observing this long. It will get a market share for sure, if nothing happens unexpectedly. This might change back when the biosimilars will come in, how big that market share will be, how big the convenience advantage of 12 to maximum 16 weeks treatment period, versus the 8 milligram of the 2 milligram, which can be also with a treat and extend schedule, be prolonged. It's a big question. I mean, you also have to consider that the toxicity and the side effect data of the 2 milligram are over decades.
This is a new dose. This is four times the dose with a bit of a higher injection volume, so it remains to be observed. I would say, prognosis, it will get a market share if it's maybe in the range of another serious, but similar competitor, we will see. But for sure, it will change the addressable market, but you also, you also will see, that the, that, the market of the AMD is growing and that there will always be new, new molecules, which are lot more or less successful because it's very attractive and it will be growing. So enough space for us, I would say, for a biosimilar launch.
So with that, I think it's on me to close and thank you all for your attention, but, of course, not only to the audience, also to the EQS team, to our communication investor relations teams, that really put a lot of hard work to make that happen, and work out pretty well. Thank you for all your questions and all your interest in Formycon, and we promise to deliver a news flow in the next coming months that will make you happy. Thank you.
Thank you very much.