Formycon AG (ETR:FYB)
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Earnings Call: Q3 2023

Nov 13, 2023

Stefan Glombitza
CEO, Formycon AG

Good afternoon, and warm welcome to today's earnings call. We really appreciate your interest in our Q3 results, and we will be more than happy to share a bit more details around the really significant operational progress and achievements, as well as the promising financial results, which we summarized in a press release earlier today. As usual, 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. This time you can't see us via Teams, that's why we put some photos of the Formycon board on a chart. The combined track records and complementary skill sets of our team is really leveraging, in total, more than 100 years of relevant experience.

We are very passionate about biosimilars and have a strong entrepreneurial drive to steer the Formycon boat further on its successful journey in the attractive biosimilar space. Appreciating your time and interest, we, as a board, are completely at your disposal today. Enno Spillner, our CFO, and me, will run you through the key highlights, and Nicola Mikulcik, our Chief Business Officer, and Andreas Seidl, our CSO, will join in for any questions you might have in the subsequent Q&A section. Before we come to the detail, let me spend some words on our mission as Formycon. Our why, that's motivating us every day to go the extra mile. Biologics have revolutionized medical treatments of severe diseases since their introduction a few decades ago, and will do more so in the future.

But only few patients can really benefit from these, as they come usually with very high prices. You must know that the global spend in biologics will, according to IQVIA, rise to an unbelievable number of more than $660 billion in the next five years. Biologics, meanwhile, account for 35%-40% of total healthcare spend in U.S. and Germany, and reimbursement of only a few of those medications can really bring healthcare budgets into serious trouble. That's why most patients, even in rich economies, don't receive those efficient treatments at all. So how can we make those extremely helpful treatments accessible to more patients, and at the same time, relieve the pressure of healthcare budgets? It sounds like a quadrature of the circle, but there is a solution, and that's called biosimilars.

Follow-on biologics with the same high level of quality, safety, and efficacy, launched after patent expiry at much more affordable prices. This provides significant relief to healthcare budgets. Cumulative savings of more than $40 billion in Europe and U.S. have been achieved by biosimilars since their introduction, and the prognosis is, by IQVIA again, that by 2027, $100 billion of annual savings can be expected. Each biosimilar introduction, of course, also ensures an increased number of patients getting access to this highly effective treatment. That's partly up to 70% more patients that we see getting those medications after biosimilar introduction. We, as Formycon, are really proud that we are contributing to that solution, and we believe that we as a company are well set for playing a really strong role in this attractive and fastest-growing pharma, pharma segment.

If you look at our pipeline, you can see that Formycon is really one of the few pure-play biosimilar companies. And this chart is one of my favorites, as it really proves two things. The one, we have a rich pipeline, not a one-trick pony. And two, we are really executing reliably on our pipeline. If you look at our portfolio, we are targeting treatments of severe diseases in ophthalmology, AMD, for instance, a leading cause of blindness in the Western world, immunology with severe psoriasis, Crohn's disease, and the blockbuster oncology with Keytruda biosimilar. We're targeting reference markets of more than $50 billion in total sales in 2022.

Since the transaction, if you look at the ownership pillar, since the transaction in 2022 with ATHOS, four of our biosimilar assets are in 100% ownership by Formycon, and FYB201 is at 50% ownership with a joint venture with Polpharma. If you look line by line, our FYB201 program is, of course, most advanced. The biosimilar made it to the commercialization partners on the right-hand side already, and since launch, in total, more than 200,000 doses of our FYB201 have been applied to patients around the world. If you look at the next two lines, the other two more most advanced programs, they have passed successfully all the analytical, clinical, and manufacturing milestones and have already entered into regulatory procedure.

So in total, if you look at the three late-stage assets, having brought those programs in parallel to that stage, is really an impressive success for an organization of our size. And you can imagine how intense the first three quarters of this year have been. For both late-stage programs, 202 and 203, we are expecting approvals in 2024, and they're waiting to be marketed out by our commercialization partners in 2025 onwards. If you look at the next line, Keytruda, Keytruda is really the breakthrough in immuno-oncology treatment and is worldwide number one in sales by far. And we believe that our FYB206 biosimilar is positioned in the first line of competitors, as we are on track with entering the clinical studies next year.

We have also enriched our pipeline with two more programs, which are nicely progressing as well, and where we are able to leverage all the learnings from our late-stage program. Our laser focus will remain on really very efficient, high quality, and speedy execution of our biosimilars. By just listing the highlights across each program, you can imagine how intense these first months in 2023 have been, and we are really very grateful for the hard work of our teams, they have put into. FYB201, for instance, is outperforming and outpacing biosimilar competition both in U.S. and Europe, and our commercialization partner, Coherus, achieved in Q3 an impressive market share of 29%, with $14 million revenue in this quarter, and this accumulated to sales year to date of more than $70 million.

In the U.K., our product even surpassed volume-wise Lucentis, so that in total, across all markets, more than 200,000 units have been sold across the 16 countries where we have launched. So in the U.S., 14 new countries, and one in the Middle East. Of course, we're targeting further approval in attractive markets as we speak. We partnered our two biosimilars, Stelara biosimilar, globally with Fresenius Kabi, and we jointly could achieve a settlement with J&J for a launch date in the U.S. in April 2025, which puts us very close to others in the first launch group. The more than 330 dossier documents with over 10,000 pages went to EMA already, which accepted our file within a few weeks. The U.S. submission is on track, and there's more news flow to come soon.

A very similar status, looking at FYB203, is happening in our Eylea biosimilar program. The dossier preparation had to be managed in parallel to FYB202, and our U.S. submission has already been accepted by the FDA, putting the target action date of approval into June 2024. So leveraging the synergies, FYB201, in FYB201, we have a binding term sheet on commercialization with Coherus, of course, as well. The EMA filing will happen later this year, according to plan. Besides the two new programs, looking at the pipeline, FYB208 and FYB209, which are enriching the pipeline since last year and are progressing in preclinical technical stage, our full focus is, of course, on our FYB206, targeting the blockbuster immuno-oncology, Keytruda. Here we really feel ourselves in a very good competitive position as we have passed already Technical Proof of Similarity, as we have developed already a robust manufacturing process.

We've produced several GMP batches at scale, and we have aligned our clinical program with all relevant major agencies. We are very advanced in preparing the clinical start in 2024. In a nutshell, the development engine is running at full steam and delivered really remarkable progress across all programs. With that, I'm happy to hand over to Enno, who will guide you through the financial performance in Q3.

Enno Spillner
CFO, Formycon AG

Yeah, thank you, Stefan, and a warm welcome also from my end. Good afternoon or good morning, respectively. Now I have the great pleasure to introduce our Q3 or nine-month year-to-date financial numbers to you, where I will start with some considerations on the, on the P&L. In total, we are looking at a great Q3 as well as a very positive first nine-month year to date 2023, and the operational numbers are absolutely in the range where we expected them according to our plans. Let me start with the revenues, which showed a volume of EUR 16.4 million in Q3, and year to date, more than doubled, which is a great achievement, and which consists of three main pillars.

First of all, FYB201 shows licensing revenues, which total to EUR 2.2 million year to date on the top line, contributing here. Second, the success payment from our partnership with Fresenius Kabi, in context of our FYB202, drives revenues as well. And this revenue increased partially on one-time effects, so we received, as a reminder for you, the EUR 10 million earlier this year, and then another EUR 15 million, which we have technically achieved in Q2, and where we received the respective cash in Q3 of this year. And thus, the positive EBITDA is supported by some of these one-time effects, which also contribute sustainably to the currently positive EBITDA at this point in time, going forward.

Last but not least, reimbursement for FYB203 and FYB201 services, where we do work and provide services, and they are being reimbursed accordingly with a slight markup. As a consequence, a lso, our cost of sales increased significantly and originate from all three advanced assets, namely FYB201, FYB202, and FYB203. Our R&D expenses, again, always to be seen in context with our CapEx, as we can capitalize some parts of our R&D efforts if they have achieved respective majority and have achieved the so-called TPOS, or the technical proof of similarity. And the costs directly in our R&D line are originated from our earlier candidates, FYB207, FYB208, and FYB209. And in the bottom line here of this presentation, the capitalized costs are referring to FYB206, FYB206 in particular.

Finally, looking at the EBITDA, and after nine months, we still remain slightly positive, mainly due to the significant increase of our revenues. That said, here again, to remind you of the particular contribution from the Fresenius Kabi partnership. Q3 standalone would have been slightly negative at EUR -2 million, as expected, and therefore, also the outlook for the whole year will be slightly negative, but I'll come back to that later once we look at our guidance. Looking at the bottom line of our P&L, we have for Q3 one special one-off effect, which is non-cash and non-operational, but a financial effect.

Reviewing, as we do on a regular basis, our long-term financial model, in this case in particular for FYB201, we updated the respective numbers, the assumptions, and also the information that we received externally and internally, combining this with our estimates, going forward. And this update triggers two opposing trends, namely an adjustment of our goodwill model, for joint venture Bioeq AG, which is negative at approximately EUR 39 million. And on the other side, we have a positive effect of a decrease of our fair value of our earn-out obligation, which is above EUR 100 million. So in total, this brings a significant net positive financial effect into our books, and again, this is non-cash driven.

And then on the last, very last line, again, as I said, we continue to heavily invest into assets where we can capitalize our respective development costs. This is, for instance, FYB206, as the main driver in this block today, as we have, during the course of this year, achieved the status where we can capitalize the cost for FYB206. This is again, obviously part of our development efforts, where we keep investing into our pipeline. Let's take a look at some of our balance sheet positions, and let's start with the non-current assets, which are adjusted for the value adjustment from Bioeq AG, as I just indicated before. At the same time, we continue to capitalize on FYB206 while we develop this asset.

Cash and cash equivalents standing at almost EUR 36 million and, compared against EUR 10 million at the end of last year. And this effectively means a stable or almost stable cash position against our H1 2023 numbers, where we reported, EUR 36.9 million of cash being available. And one of the major cash drivers in the third quarter was certainly receiving the EUR 15 million success payment from Fresenius Kabi, which we received early in Q3. Formycon's equity capital increased to EUR 500 million in Q3 due to the highly positive net result, based on the effect that I just described or summarized to you on the previous slide. The major change in the non-current liabilities results from the same effect. Our earn-out liabilities reduced significantly and, consequently affect our balance sheet.

But still, our non-current liabilities mostly or mainly consist of our earn-out obligations and of deferred tax liabilities that we anticipate. Looking at some KPIs from our financial structure and from our balance sheet. In total, we stay with the total equity and liability position of roughly EUR 878 million, which is an increase against end of 2022 of roughly 3%, but it is also a decrease against EUR 913 million, which we stated in context of our H1 2023 reporting. Equity, as I mentioned, increased due to the equity raise in February, as well as the one-off effect, the financial effect that I described earlier, and the same again is true for our liabilities.

These effects in total increase our equity ratio to a very strong 57%, which also indicates a 10 percentage points step up against our recent H1 numbers. Let's take a look at our guidance, and here we are looking at an overall very positive operational outlook and can therefore confirm our guidance with regards to our operational KPIs. This means revenues, here we still aim to achieve a range of EUR 75 million-EUR 85 million for the year. On the other side, we continue to invest into our assets and really push forward significantly our pipeline.... This goes along with respective costs on all lines in the P&L, and this will certainly affect our EBITDA, as we thus expect still negative EBITDA in the range of EUR -5 million to EUR -15 million. Thus unchanged, also here in our guidance.

Same is true for working capital, where we expect to be positive in the range of EUR 15 million-EUR 25 million. However, reducing from the stages that we showed in our Q1 H1 numbers, and also here from the Q3 status, as you can see in the second line. The only change within our guidance comes from the aforementioned non-cash adjustment effects, which influence our financial results to the positive, and therefore require us to update our guidance for our net income accordingly. Here we now expect a swing into the positive with a range of EUR 50 million-EUR 60 million, rather than EUR -20 million-EUR -30 million. So a really significant change. Please also bear in mind that the net income also continues to depend on our WACC development, so weighted average cost of capital.

Here, our current assumptions for the current guidance is that the WACC stays unchanged compared to June 30, 2023. Obviously, we will keep monitoring that in the context of the year-end reporting. That's it from the financial perspective, and then taking a brief look at our share development. Obviously, as you all know, share and capital markets are very volatile these days, and this is also true for our share. So shares are hovering quite significantly while seeing fairly low liquidity on average daily trading volume. However, currently we see a swing to more liquidity catching up again, so that's clearly positive.

Clearly also during the course of the year, we had clearly positive news flow, and Stefan alluded to some of the great achievements that we could manage during the course of the year, and hopefully also more news flow to come. Therefore, we expect also more liquidity in the share going forward. We also welcome M.M. Warburg as our new analyst, added to our group of analysts here, and taking coverage of the share since September of this year. A great welcome to the team from M.M. Warburg . And with that, I'm at the end of my presentation and have the pleasure of handing back to Stefan, who will conclude on the last slides. Thank you very much.

Stefan Glombitza
CEO, Formycon AG

Yes, thank you very much, Enno. Let me just complete the outlook from the operational perspective. So we are coming closer to year-end, but still have a lot of passion and energy left to push our programs further ahead and provide the deliveries according to the plan and to the promises. Just highlighting the number FYB201 launches and further launches and approvals in attractive territories. Of course, the progress in the key regulatory procedures we have initiated in FYB202 and FYB203, targeting approvals next year in 2024, as well as the first oncological patient in our FYB206 clinical study in 2024. So a lot of highlights expecting expected, a lot of operational excellence needed, and you can be sure that there's a lot of passion and a lot of experience to drive the further operational successes as promised.

Formycon's clear focus is and will be biosimilars, and we, as a, one of the few pure-play biosimilar developers in Europe, we believe and strongly believe that we are well set for a strong role in the fastest-growing pharma segment, biosimilars, which is really meant to bring huge benefits, both financially and ethically. We have proven our capabilities with the first product, which we were able to launch on the market in 16 countries, have a strong pipeline with really three late-stage assets addressing multi-billion target markets. We are covering the whole value chain in a hybrid model, combining our very strong R&D capabilities with selected and reputed partners in manufacturing and commercialization. We pick the best. Last but not least, we have the experience, the resilience, and the passion in our agile speedboat team to really execute on this big growth opportunity.

So I hope we could provide you with some helpful additional explanations around our encouraging Q3 results, operationally as well as financially, and are, of course, open for any questions you might want us to address in the next minute. So handing back to the operator, please.

Operator

Thank you very much. Ladies and gentlemen, if you would like to ask a question, please press nine and the star key on your telephone keypad. In case you wish to cancel your question, press nine and the star key again. Please press nine and the star key now to state your question. And the first question comes from Brian Balchin from Jefferies. Please go ahead.

Brian Balchin
Research Analyst, Jefferies

Hey, guys, it's Brian here from Jefferies. Well done on the progress. Just got a question on the Athos earn-out liabilities. Can you just help... I'm not sure if you mentioned this in the opening remarks, but can you just help us in terms of how to think of that going forward? Because I think first half, the expectation was that you'd get a significant negative non-cash effect in the second half, which is why you then maintained your net result. But this has since changed. So I'm just starting to think about it; it seems like it's quite an unpredictable component of the P&L. So if you can just help us with that in terms of modeling for 2024, that would be great.

Stefan Glombitza
CEO, Formycon AG

Yeah. Hi, Brian. Thanks for joining and thanks for the good question. So may I hand over to our finance experts, Enno?

Enno Spillner
CFO, Formycon AG

Yes, a pleasure, Brian, having you on the call here today, and to answer your question, obviously. So indeed, what we have to say is this whole deal in 2022 was based obviously on certain assumptions and respective underlying models with regard to the overall value of the assets, as you know, running your own rNPV models. And obviously, derived from that, also certain earn-out obligations, which correlate to the overall performance of the asset. Which is the great advantage of such a deal, because only if we are successful with the assets or the more or less successful we are with the asset, this also determines the amount that we pass on to our partners, which I think is a key factor to acknowledge.

And then, as you continue with such a project and start collecting data, from, from internally, from general sources, but obviously also from our partners, from time to time, have to review the model accordingly and then compare against to your original product or your original planning. And typically, this is done in context of the planning for the next year, like now in the budgeting process. And here we now have adjusted the long-term model going forward, which lasts, lasts for many years, and adjusting here all the information or putting in all the information that we can receive. And in this case, this means that overall, the expectations slightly decrease also to certain price developments going forward, and in such model based on the latest information that we have received.

Since it's such a long-term running model, changing these numbers, they bring in significant impacts. This means on the one side that we bring down the value of the asset, as I described to you earlier, in the range of roughly EUR 40 million. But at the same time, the obligation for the earn-out towards our partners also reduces. In this case, as the model currently is structured, is over proportional compared to the value of the model, and therefore, we have these two counteracting effects, if you will, which net out with a very positive result, and that has a big leverage. We try to be conservative here, so what we ideally want to avoid is a roller coaster that we every quarter go up and down.

Therefore, maybe this is on the conservative side, but as you rightly guess, we will have to review on a regular basis. This is simply our obligation, and whenever we think there's significant change or adjustment required, we will have to do so. They then obviously will impact our financial model or our financial lines in our P&L, and therefore, also can impact our net line in our P&L. This is, by the way, obviously, one of the reasons why I, as a CFO of biotech companies in the past and the present, always prefer having the EBITDA as our key reporting line in this regard, because I think this really clearly reflects on the operational performance of an organization, rather than the net result, which can very often carry these special effects.

I hope that answers your question.

Brian Balchin
Research Analyst, Jefferies

Super helpful. Thank you very much.

Operator

The next question comes from Dr. Christian Ehmann from Warburg Research. Please go ahead.

Christian Ehmann
Equity Analyst, Warburg Research

Hello, everyone, and thanks for taking my question. I'll follow up a little bit on the FYB201 question from my colleague. So, you mentioned a decrease in price expectations for your model. I'm curious, how satisfied are you with the current performance of Coherus BioSciences in the U.S.? And what are your expectations for the next years going forward, and how happy are you with the current state of the development? Thank you very much.

Stefan Glombitza
CEO, Formycon AG

Yes. Thanks, Christian, for your question. I could answer a lot, but even more, even better, so Nicola could do so, if I may hand over to Nicola. Nicola Mikulcik, CBO, being in close contact with Coherus every week.

Nicola Mikulcik
Chief Business Officer, Formycon AG

Yes, hello, Christian, Nicola speaking. We are concerning the U.S. performance of Coherus; we are very satisfied. They have achieved within 13 months on the market a 29% share in the overall ranibizumab market, which I consider a very strong performance. We believe that they are really putting. They have probably, with their first product, Udenyca, learned how to act in the buy-and-bill phase, and we are taking advantage of this, of this experience. I think they are really much better performing than the competitive competition. Still, what we see is a higher price pressure than what we expected and what we had planned for originally in our models.

As Enno described, the factor, what or the responsible factor for that is, that really we saw an extremely strong launch from Vabysmo, from Roche Genentech, in this therapeutic area, which led to higher discounts than previously assumed. They launched the products at almost par with biosimilar products, and therefore, I think that is, yeah, that caused our also our more cautiously forecasting going forward. And in Europe, it's of course a similar effect. Also here, we have a bit more on the market, which led to more aggressive pricing, especially in some of the very price-sensitive markets. And this is, I think, the main aspect of this correction in our planning.

Christian Ehmann
Equity Analyst, Warburg Research

Okay, thank you very much. And if I may, a follow-up on that. You mentioned more competitive pricing. Do you think this is something specific to the area of indication we are talking about, ophthalmology, or do you think, sorry, not ophthalmology, but do you think this is transferable to the overall market of biosimilars, so we see a more pronounced battle for lower prices in the future? What's your opinion on that?

Nicola Mikulcik
Chief Business Officer, Formycon AG

So we see really very different behaviors of the originators in different therapeutic areas. This was a bit of a surprise in this case. But I think it is probably a specific topic here, because the concentration of the decision-makers is very high in this retinal space, and potentially that leads to a more price-aggressive behavior overall. But at the end, I think we have to always assess case by case and observe how the next products will develop. So a bit of a crystal ball answer. Sorry.

Christian Ehmann
Equity Analyst, Warburg Research

Sure, I understand. Thank you very much.

Operator

The next question comes from Simon Scholes from First Berlin. Please go ahead.

Simon Scholes
Senior Analyst of Biotech and Resources, First Berlin

Yes, I want to go. Thanks for taking my question. I've just got one. It's also on the earn-out liability. And I think I heard you say that you've left your WACC assumption unchanged since the 30th of June. I was just wondering if rising interest rates also played a role in the change in the earn-out liability in Q3?

Enno Spillner
CFO, Formycon AG

Yeah. Yeah, thanks, Simon.

Stefan Glombitza
CEO, Formycon AG

Direct hand over to you now.

Enno Spillner
CFO, Formycon AG

Guessing that I would get that question, I started already talking. Welcome, Simon. So indeed, we saw a very significant impact here for the first half of the year. And that's what we also reported in context of the H1 numbers, where we adjusted accordingly. So far, for the second half, we have not seen such a significant impact. Obviously, we will review once again in context of the full year report then, but it was not a significant requirement in context of the Q3 reporting to apply.

Simon Scholes
Senior Analyst of Biotech and Resources, First Berlin

Okay. So, I mean, the main impact on the earn-out liability in Q3 was, as you've already said-

Enno Spillner
CFO, Formycon AG

Yes.

Simon Scholes
Senior Analyst of Biotech and Resources, First Berlin

... said, pricing assumptions.

Enno Spillner
CFO, Formycon AG

Yeah. I would not necessarily say pricing, but really the overall review of the model, this is really long term. Obviously, if you adjust these things and push things a little bit forward and backward, then you have different factors influencing. But clearly, pricing of this, of the individual units, I think, has a really significant impact here, and then you adjust accordingly. I mean, what maybe to mention that context as a reminder, and we wrote it also in the press release, there have been, by now, more than 200,000 units being sold worldwide, so to say, and clearly north of 100K in the U.S. So we are very happy with the overall performance in that regard and also see a really good pickup here, going forward.

Simon Scholes
Senior Analyst of Biotech and Resources, First Berlin

Okay, thanks very much.

Operator

Okay, there are no further questions on the telephone line, so let me hand back over to your host for the questions from the webcast chat.

Stefan Glombitza
CEO, Formycon AG

Yeah, we had some question in advance, which we are happy to answer with that, so as well. So the first question was around our portfolio, that we kind of indicated that we want to expand our portfolio by new projects every 12-18 months. Happy to answer, and the period has already passed without any news. Happy to take that one on my own. So actually, if you look at our reasons or the starts of new programs, 208 and 209, we even preponed the start of 209, if you look at that. So we started both at the same time and 209 earlier than expected and anticipated. It's just, let's say, to bring us in a better position.

Also, earlier start means also that we have more opportunity to look at the patent landscape and eventually also file own patent applications. So the earlier you started, the better. If you keep that announced sequence of portfolio additions, FYB208, FYB209, FYB210, every 12-18 months, we would have to start FYB210 then in the second half of 2024, which is our current plan. So we kind of kept the plan, even anticipated one, and we'll continue in that sequence, if the funding allows, of course. That was the first one. There was one, I think we answered already. There's another one, production costs in FYB201, FYB202, FYB203. Are these production costs recognized on the balance sheet under cost of sales? Balance sheet sounds like financial topic. Enno, if I may hand over to you? I somewhat guessed that.

Enno Spillner
CFO, Formycon AG

Thank you, Stefan. Yeah, and I mean, here it's really, I guess, about understanding how this is structured. And we are clearly, or our incentive is clearly on the net sales. So we normally structure the deals in a way that we really focus on the net sales. That means that we have no production costs in our balance sheet or in our P&L, and consequently, also no producer stages, if you will, with Formycon as a company, as our partners pay for the respective manufacturing and also take the respective risks, which then means no risk on our side from a production perspective for neither of the assets, two oh one, two oh two, or two oh three. This is clearly carried forward to our partners.

Stefan Glombitza
CEO, Formycon AG

Thanks, Enno, for, for these clear comments. The other question was around the earn-out and 5 1 expectations, which was, I think, satisfactorily answered by Enno and Nicola. There is, I think, one left, why assuming debt capital? Another one for Enno, please.

Enno Spillner
CFO, Formycon AG

Yes. Seems to be my day today. So yes, we also briefly stated in our press release that we are reviewing or monitoring opportunities for additional debt financing, and this is simply in context of really maintaining full flexibility on an operational level, making sure we can move at full speed. And as Stefan also just briefly described to you, really pushing in 209, for instance, going forward here with our product. And second, also planning for more assets to come. So for instance, we have in our budget for next year, the 210, which we still have to select, but it's reserved in the budget. And also for instance, 2026, we have another asset to be kicked off, at least according to our financial planning.

So this is meant really to maintain speed, to maintain and secure flexibility. And also maybe one point to mention here, we really want to push hard for 206. Stefan mentioned that Keytruda has a huge opportunity, and we really try to make everything possible and feasible within Formycon at this point in time, to push the asset and start the clinical activities next year. And that comes with very significant financial commitment, partly also upfront, and this is something where we have to secure sufficient headroom, that we don't get too tight from a financial perspective.

Stefan Glombitza
CEO, Formycon AG

Thanks, Enno. There's one via the net, a complex of questions around the Eylea high dose, 8 mg, dosage form or introduction. Gonna start, and maybe Nicola might chime in. So yes, there is, of course, there will be—we see that Regeneron will try to shift part of the market to the high dose, to the higher dosage form with the extended treatment. It's from my personal opinion, it will gain certain market share. On the other hand, the Eylea or AMD market is anyhow expanding, so there will be room for more, competition. I would consider, it's probable that as soon as the biosimilar competition moves in, that this shift will go back to the 2 mg.

Because you have to see, okay, there's more convenience by a less frequent dosing, which might not be welcomed by all retina specialists if they want to see their patients more often. On the other hand, higher dose means four times dose towards the 2 mg. So of course, the safety data on the 2 mg are, of course, much more intense than on the 8 mg. So let's look and see how that evolves. And finally, I mean, the market volume will be again changed, and dynamics will be changed with the biosimilar entries. So in a nutshell, we take that, of course, serious.

There will be a certain share of doctors and patients that will be switched to the 8 mg, but we don't see a very significant impact on our sales performance, which we expect for Eylea. That's our consensus. Nicola is nodding, so that means nothing to add to that. Quick question? No, no further questions anymore. So let's... So the very straightforward on the commercialization, as Coherus further struggling in the end, going bankrupt. I mean, of course, we ask for your understanding that we cannot comment on any market share market performance of a third-party company. What we already said before and emphasize that, we are really satisfied with the Coherus performance with our Cimerli.

And Cimerli will also be in the focus and one of the key success drivers for Coherus in the years to come. So we are pretty convinced that the focus of Coherus will be on Cimerli, on the performance as such. And what Nicola always tells me, and I'm partly participating in those calls, they really put a lot of. We have the impression that there's a lot of focus and resources put into the Cimerli performance, and that's what's in the end counting. And we—for sure, this is an important market and commercialization in the U.S. for Cimerli is important asset for us as well, and we will make sure that this performance will go on and that necessary measures will be taken to ensure that.

But other than that, please understand that we cannot comment on another company's performance and outlook. So with that last, last call for questions, the slide is empty. So that's on me then to finally really thank the EQS team, the operator, for organizing all that, of course, in support of our investor relations team. Happy, of course, always having my board team members with me, so thanks for that as well. And a special big thank you to everybody in the audience for participating in the call, which also shows your interest for Formycon, which is really a pleasure for me. So thanks a lot, and see you latest at the next earnings call.

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