Formycon Aktie

Good afternoon, ladies and gentlemen, and welcome to the Formycon AG Earnings Call Q1 2026. [Operator Instructions] Let me now turn the floor over to your host, Dr. Stefan Glombitza.

Yes. Thank you, and good afternoon, good morning, and welcome to everyone joining us today. Earlier today, we published our Q1 results for 2026. And before we move to the presentation, let me highlight just some key takeaways upfront. First of all, our financial performance in the first quarter clearly supports our full year guidance 2026, the year marking our entry into sustainable EBITDA profitability and continued scaling of the business.

In the year-on-year comparison, we delivered significant growth versus the first quarter of 2025, which is underlining both the robustness of our business model and the continued strength of our execution. Second takeaway from an operational perspective, we had a strong start to the year as well, achieving multiple key milestones across all 4 pillars of our Fit for Growth strategy with a key highlight, of course, of positive results from our CYP2D6 study in February. And third, on 15th of May, so just recently, we successfully launched our third pipeline product, CYP203, a biosimilar to Eylea in Europe, an important step in further expanding our commercial platform and another testament of our ability to deliver against our pipeline.

Over the next 30 minutes, Enno Spillner and me will walk you through our presentation and Nicola Mikulcik, our CBO, is prepared to cover respective topics in the Q&A. So let us begin, and thank you again for listening in today. As usual, before we begin, please note that our presentation and the Q&A both contain forward-looking statements that are, as always, subject to usual risks and uncertainties as outlined in the disclaimer you see.

Fit for Growth is our strategic compass to capture the tremendous biosimilars opportunity ahead. It is built on 4 pillars that directly translate into competitiveness, capital efficiency and sustainable long-term growth when executed in a disciplined and agile way. And let me briefly explain what is behind each of the 4 pillars.

Number one, geographic diversification. Europe and the United States are still remaining the core target markets. Formycon deliberately expands into high-growth emerging regions with increasing demand for affordable biologic medicines. Geographic diversification is a critical lever to both improve patient access and mitigate single market dependencies. It strengthens our resilience to geopolitical and pricing volatility. Our approach is anchored in partnerships, partnerships with strong regional players across MENA, LATAM, APAC and Sub-Saharan Africa so far, which is central to unlocking the full global potential of our assets.

Smart portfolio. Formycon's smart portfolio strategy is designed to build a robust commercial product portfolio out of a huge number of future LoE opportunities. A balanced mix of blockbuster opportunities with carefully selected niche assets creates a diversified and future-proof pipeline with strong partnership appeal and optimized risk return profiles. However, a pipeline only translates into commercial value through disciplined execution and consistently high probability of success. And that's where the next pillar kicks in.

Excellence and innovation are embedded in our DNA. It's the core to how we operate. Formycon has proven repeatedly that it consistently delivers high development and regulatory quality, accelerated approval timelines. So in a nutshell, a flawless operational track record. Building our deep biosimilar development expertise, we are also driving differentiated innovation. ranging from advanced drug device combinations such as the ophthalmic prefilled syringe, which we introduced for FYB201 last year and our recently approved auto-injector for FYB202 and further to streamline clinical development approaches, including the pioneering Phase III waiver for our pembrolizumab biosimilar.

Excellence in execution and innovation create first-mover opportunities and position Formycon as a trusted high-performance partner in biosimilars. Biosimilars are the fastest-growing segment, but attractivity also generates fierce competition. The excellence in execution and innovation, what I explained before, brings first-mover advantages. Lean development and manufacturing is key to stay competitive in the market over a long period of time after launch. So we are continuously challenging ourselves, how can we streamline our clinical and regulatory concepts? How can we better leverage digital and AI-supported processes. That way, we could already materially reduce development timelines and costs while maintaining the highest quality standards.

This step change in capital efficiency and scalability positions us well to capture the upcoming wave of loss of exclusivity opportunities with greater speed and returns. So in a nutshell, Fit for Growth is our framework and compass, combining global market diversification, a smart and selective portfolio, lean development and manufacturing and uncompromising excellence and innovation to drive sustainable and profitable growth. We will continue to execute with discipline and laser focus on this clear strategic road map.

This slide highlights how we systematically expand our global footprint and drive growth in a capital-efficient manner through strategic partnerships. On the back of a strong and proven development track record, Formycon has established high credibility, which is allowing us to collaborate with a broad network of leading regional commercial partners in markets with increasing demand for biosimilars. Our capital-efficient partnership-led commercialization model enables us to scale rapidly across regions and efficiently expand patient access to critical biologics worldwide.

We have here highlighted for this conference the new flags, which we could add in the first month of this year, be it new partnerships in certain territories for FYB206 or relaunch and new launches for FYB201 and of course, the very recent FYB203 launch in Europe. Strong partnerships turn our development engine into global, diversified and capital-efficient growth. Our confidence in the 2026 outlook is based on further tangible progress along our 4 pillars of Fit for Growth. Several value-creating milestones have been already achieved in the first months of 2026 in all 4 segments and more to come in the next quarters.

Coming to geographic diversification, we continue to expand our global footprint through targeted regional partnerships. Progress in early 2026 includes the launch in Brazil of FYB201 with Bioeq and the 206 license deal with Lotus across multiple APAC markets. Further license agreements are in negotiations and will follow.

Looking at our commercial portfolio, Cimerli has been reintroduced to the U.S. market in January. And Nufymco, our second FYB201 product with partner Zydus shall be added in the second half of this year. FYB203, and I mentioned that already in the beginning, reached a key inflection point with the settlement, enabling a European launch in May and a clear path forward in the U.S. in Q4. And on May 15, we finally brought the third product from our development pipeline to markets and patients in Europe, which is marking an important milestone in expanding our commercial portfolio.

Advanced state-of-the-art device technologies are creating added value and improved treatment convenience for patients. And building on the last year's ophthalmic prefilled syringe launch in FYB201, we will soon enhance our partners' FYB202 offering with an auto-injector following EMA approval, which we received in April. Driven by the pioneering Phase III waiver approach, FYB206 continues to progress as planned. We could confirm PK equivalence in February, which is a key element of the regulatory dossier, which we are preparing full speed.

Phase III waivers are generating significant savings. Our Fit for Future program delivers measurable impact beyond. Through streamlined processes, smart regulatory concepts and cost competitive CDMO partnerships, we have reduced our development timelines and costs for new programs already by around 30%. So taken together, Fit for Growth has moved beyond strategy. It's now firmly delivering execution and underpinning sustainable long-term value creation. On the back of a strong foundation, 2026 is about accelerating and scaling impact.

With that, I want to conclude my part of the presentation and hand over to our CFO, Enno Spillner, who has prepared a deep dive into the financial numbers of Q1. So thank you for your continued attention.

Yes. Thank you, Stefan, and I'll happily take it from here. Welcome, everyone, to our Q1 2026 call. And it's a pleasure to introduce our quite positive Q1 2026 numbers to you only 5 weeks after we introduced our year-end 2025 numbers. So you probably still recall some in-depth details. So therefore, we will only focus really on Q1 2026 performance.

That said, let's take a look at the oversight of our P&L, where we have good operational momentum, translating into a significant revenue growth and significant revenue increase. So revenues are on track and show a significant step-up versus Q1 2025, meaning more than doubling the revenue total compared to the respective quarter in 2025. Transformation of our revenue structure continues now with significantly more revenues coming in from efforts in commercializing our products. And our main revenue drivers are FYB202 and FYB206. This mainly includes upfront payments, milestones and royalties. And I'll come back to the details later on one of our next slides.

Looking at the cost of sales. The cost of sales in total are relatively stable compared to Q1 2025. We continue recording the regular amortization of FYB202, which makes about EUR 5.2 million in Q1 2026 versus EUR 6.2 million in Q1 2025. Would we adjust for this accounting measure, we would be looking at operational cost of sales of approximately EUR 10.7 million in Q1 2026 versus EUR 8.6 million in Q1 2025. Also here, we continue to recognize our transformation towards a more commercial-related setting with significant parts of cost of sales related to commercial efforts like, for example, prepayments for supply in selected cases. Also here, I will come back to details on one of the next couple of slides.

Looking at the R&D expenses. R&D expenses significantly reduced, especially with FYB208 having achieved technical proof of similarity and therefore, respective costs being capitalized since last fall of 2025. Thus, the currently relevant assets are FYB209 and in particular, 210, which are contributing into our R&D line. However, these 2 remaining assets are still less cost intense due to their earlier stage -- earlier development stage, and this triggers the overall R&D spend to reduce accordingly.

Coming to the EBITDA. Our EBITDA improved significantly by more than EUR 11 million compared to Q1 2025. This, of course, is consisting of different effects. Revenues increased significantly, as just mentioned, while costs or cost of sales still fairly stable or a slight increase and R&D and other expenses have been noticeably reduced. Continuous cost control, active management of our structural costs and some beneficial effects helped to reduce our other operational expenses in this regard.

Looking at the adjusted EBITDA, the group adjusted EBITDA amounted to minus EUR 3.6 million versus minus EUR 11.8 million in Q1 2025. This, again, is a significant EUR 8.2 million uplift against the comparable quarter in 2025, trailing our EBITDA, so to say. However, what is different this time is the fact that the adjusted EBITDA came out below our standard EBITDA. Since the adjusted EBITDA, in addition, only mirrors the performance of our joint venture, Bioeq AG, this reflects the started relaunch of FYB201 sales and marketing in the U.S. as well as the prefilled syringe implementation in Europe, triggering a negative contribution by our joint venture for the reporting first quarter of 2026.

Last point. Looking at the capitalized development cost here in Q1 2026, we are -- or we mainly contributed to the further development activities of FYB208 and FYB206. Please note, development costs for FYB206 continue to be capitalized partially, namely for the European Union or for Europe, while the U.S. part is being covered under cost of sales in context of our Zydus partnership. The clear decrease of this investment total is mainly due to the fact that FYB206 clinical trials were in full swing in Q1 2025, while in Q1 '26, this investment driver was mainly concluded and FYB208 is not yet in the clinic.

Let's take a closer look at the breakdown of our sales. Current development is clearly reflecting the aforementioned change in revenue structure. Recharges for development work of FYB201 and FYB203 continue to reduce significantly as the products do not require any major development work in a significant amount anymore. This part of revenue has been expectedly reduced by 50% to EUR 2 million. Royalties for FYB201 now need to reaccelerate after pausing marketing in the U.S. until end of 2025. Our U.S. partner now has to reengage into the U.S. market and rebuild respective market share, which may take some time. But we are optimistic seeing an acceleration here during the course of the year.

Royalties for FYB202 almost doubled. And while these sales revenues from IP202 are currently still developing modestly, we see positive trends from our partners' activities in the U.S., leaving us optimistic for further costs -- for the further course of the year 2026. In addition, we successfully achieved a further development milestone for FYB202 in context of the development of the auto-injector, which we do recognize in Q1 2026 as a one-off.

The new kid on the block are our revenues recognized in context of FYB206 derived from upfront payments, from milestone payments from different partners and from our FYB206 partnership or consequently from our FYB206 partnerships from Lotus, from Zydus and from MS Pharma. In total, this reflects continued structural change of our revenues for Q1 2026 in subsequent years with a good revenue mix from different products and revenue categories.

Also with regard to our cost of sales, we continue the same structural changes as just described in context of our revenues. Operational cost of sales remained fairly consistent for FYB202, also in context of some supply prepayments we had to cover, generating future revenues and upside. Please also bear in mind that the regular amortization of FYB202 considered under our cost of sales is neither EBITDA nor cash flow relevant and makes a significant portion of FYB202 total cost of sales.

Cost of sales for our recharge development efforts on FYB201 and FYB203 reduced once again significantly for both products. The new position of cost of sales for 206 is in context of our revenue recognition of our deferred milestones, and this contains the respective continued development costs for the U.S. development and targeted market approval.

Looking at our group assets in respect to structure. Our balance sheet total stands at a strong EUR 717 million, and the reduction mainly results from the net cash outflow and some prepayments that we have. Equity is reduced by EUR 15, 1-5 million, mainly due to the net result. And at the same time, our liabilities decreased slightly by net EUR 9 million, which is driven by 2 main effects. On the one hand side, trade payables have been reduced while contract liabilities slightly increased.

In consequence of the above, our equity ratio almost remained stable at a strong 53.7%. Cash and cash equivalents reduced to EUR 54 million at the end of Q1 2026, which mainly results from the aforementioned prepayments and other investment activities into our products, while major receivables from the earlier mentioned revenues were still due at the end of Q1 2026.

And this point is also a good segue for looking at our cash flow and our working capital indicators. Cash flow and working capital were determined by multiple factors. Aside from the operational result and continued capitalized investment into FYB206 and FYB208, some prepayments and orders influenced our net cash flow, as just already indicated. However, on the right side of the slide, you'll also see that our current receivables were also quite significant, totaling from various positions such as royalties, upfronts and milestones, reimbursements and prepayments totaling to EUR 28.9 million. On the working capital side, current receivables as well as current liabilities and revenue accruals were the most influential factors, leading to a Q1 2026 working capital of EUR 66 million.

Let's take a look at our guidance for the remainder of the year. Revenue-wise, we had a good start into the new year with positive factors from different products. Growth shall be driven by FYB202 royalties, which will continue not to grow linear, but more in waves depending on new contracts and orders coming in coordinated by our licensing partner. Furthermore, FYB206 is anticipated to contribute with further achievements of additional milestones in context of our further development work towards filing and approval, especially in the U.S. Please bear in mind that accounting-wise, these milestones will be recognized over time as deferred milestones. Thus, cash in and revenue recognition may deviate from each other. Also further partnering like the already before mentioned or announced Lotus partnership may be added to the FYB206 revenue recognition over the course of the year.

FYB201 is anticipated to reaccelerate again, as mentioned, especially with our second partner joined for the U.S. sales and marketing during the course of H2. FYB203 is launching in Europe and in the U.S. with U.S. starting in Q4 2026. Thus no significant impact to be expected from the royalty part, but some revenues resulting from remaining development recharges as well as handling the supply for the FYB203 product. So in essence, FYB202 and FYB206 being the 2 strong main pillars of our revenue guidance with FYB201 and FYB203 adding to the overall performance. Based on this planning, going concern should be secured at this point in time, and we can confirm guidance.

Let me conclude with the slide that you well know already from the past and just reconfirming to you that on the one side, our research coverage continues to be broad and well attended with the most of our analysts with a buy recommendation. Second, we have a stable commitment by our existing anchor investors who mainly remain unchanged compared to what we reported in previous quarters.

With that, at the end of my content of my presentation, and I would like to conclude with a couple of personal words today because you all know or many of you know the strong communication voice in our team here at Formycon. And Sabrina Muller, unfortunately, has decided to leave Formycon after many exciting years at the company. And we would just say a big thank you to Sabrina for her engagement, for her commitment and also for her great contact to you out there at conferences, at roadshows and with the analysts. Thank you, Sabrina, for your support over the time. It was a great pleasure.

And with that said, I finally hand back to the operator, being open for your questions and comments on our Q1 report. Thank you very much.

[Operator Instructions] So our first question, we have from Nicolas Pauillac, Kepler Cheuvreux.?

Hopefully, you can hear me. First of all, congrats on the results and all the best to Sabrina. It was really nice working with you. And so just a few questions on what you commented. Just a pretty simple one, but on the joint venture revenues, is it fair to assume that the Q1 was really purely a one-off effect and we should come back to positive contribution moving forward and it was just, let's say, launch momentum cost. So that would be the first question. And then just on 206, it would be nice if you could kind of give us what's the next big milestone in the development timeline that you guys have in mind? And what will be the, let's say, commercial milestone or development milestone that we should expect over the next maybe 3 years?

And also on that, what will be your assumption? And when do you think that you will be able to launch the drug, whether it's in the U.S. or in Europe? And lastly, the final is on the 208. We think that Sanofi is becoming more and more vocal about their ambition to kind of delay the LoE as much as possible. And I think now they are referring that they think they could get like up to 2 years of extra commercial opportunity in the U.S. How do you think about that? And was that kind of your initial assumption that it was going to go that way? And I will stop there.

Okay. That was 3 questions. I would like to start with the probably most easiest one. On 206, those next milestones are, of course, compiling all the different parts you need for a complete dossier for an FDA filing. So of course, a big portion, a big segment of that was the successful PK study results, but there are more so-called CMC parts from manufacturing, from stability, from similarity, analytical assessment, which will undergo scrutiny because of the Phase III waiver where we need good results, which we have in hand. So we were compiling that. I will not comment on the timing, but we are fast track on our way to the next milestone, which is the submission. And then usually, typically 60 days after submission, you will receive if the FDA is okay with the data that you submitted, the so-called file acceptance. And that would be then the latest point in time where we would announce this milestone. 208, maybe I hand over to Nicola, who's also overseeing the IP.

Yes. So we found that a quite bold statement from Sanofi and probably Regeneron also commented on that. It just shows that the patent fight starts really 5, 6, 7, 8 years before a potential launch. And this is a pretty normal situation in biosimilars these days. We can, at the moment, not confirm that 2 years' delay or what Sanofi has contemplated. We are, of course, constantly observing and working with outside counsels and so on, on the patent landscape along the development of our products and during regulatory phase. And it's really too early to comment in detail on those statements for us. But at this stage, we do not see a reason why we should become nervous about that. And the other question was on. . .

Was on the joint venture Q1 performance for Bioeq, so to say. And Nicolas, I think your interpretation is correct that we are assuming that this will swing into a positive performance for the subsequent quarters to come. It's a kind of regular not always matching inventory building and sales. So that's the typical behavior you see in some products. But nothing concerning. Okay. With that, Nicolas, are you fine with the responses?

Yes.

Next question is from Yi Chen, H.C. Wainwright.

This is Katie on for Yi. Could you give us an idea if your EBITDA guidance range can be achieved with the current trajectory for 201, 202 and 203 alone? Or are you going to require 206 to hit some more milestones in licensing for this year? And for 206, if it's required, what's the contingency plan if those deals take as long to close as some of those deals in 2025 did?

Yes, I'll start that and the others might chime in. So of course, the guidance and Enno alluded to that also in the year-end and guidance session, does include 206 milestones and deferred milestones. This is part of our business model. And I think it's good revenue, although not coming directly from commercial market. We are counting on that. It's not based on -- it's basically most of the milestone amounts that are planned in our guidance are deferred revenues from achievements, not additional deals. So additional deals would come on top with existing deals where we have continued milestone success payments that are deferred over the period. Of course, if we don't manage to achieve those milestones, then it's a different thing, but it's not -- it does not need additional deals.

Maybe to briefly add to that question and as a reminder to everyone, as Stefan just mentioned a couple of times, this is deferred revenue recognition. So really, what we're basically doing, we are bundling all relevant milestones up to market approval in the U.S., putting them into one bucket, if you will, and then deferring over the whole period until we achieve that goal. And in that regard, it's even more logic to have them implemented into our guidance because they are kind of going over the year. And against that, we are also booking the respective development cost. So it's not really volatile in terms of, let's say, achieving in Q1, the clinical milestone for the delivered PK study and then somewhere between at the end of the year or so other milestones in context of filing, for instance. So it's not that volatile or digital, but it's deferred over time.

Next question we have from Simon Scholes, First Berlin.

I've got 3 questions. First of all, I was wondering if you expect any further non-206 milestones during the rest of this year? And then secondly, I was wondering if you expect that 2/3 of 206 development will continue to be booked in COGS for the rest of this year. And can you give me an idea of what total capitalized development expenditure for '26 might be? And am I right in assuming -- presumably, I'm right in assuming that nearly all of the capitalized development expenditure relates to 206, and that's it.

Okay. Happy to start with the first one. So any further non-206 milestones, not foreseen for now. Of course, that gives us also the flexibility for an opportunity -- upside opportunity if we strike deals, but we need the flexibility not to be forced into synergies because we want -- we need that to deliver our guidance. So we're clear from today's point of view, guidance is not having any non-206reated milestones.

Yes. And then with regards to the breakdown, currently, the assumption is that, again, as we indicated, roughly 2/3 of the cost will be in context of the investment, will be in context of the U.S. engagement and roughly 1/3 then for Europe. And the total COGS, so to say, that we are anticipating here under this partnership is in the range of, yes, EUR 15 million to EUR 20 million, let's keep it that way, that we are kind of anticipating here for 2026.

Is it -- are you expecting 2/3 of that 15 million, 20 million to be in COGS?

Yes.

And the other 1/3 in capitalized?

Yes, roughly. Just as a rule of the thumb, we will not guide. . .

That would suggest that you're not going to be hardly going to capitalize anything for the rest of this year because you've already done 6.

Say again.

If you're doing 15 to 20 -- if you've got total development expenses for 206 million of 15 million to 20 million this year and 2/3 is in COGS. I mean that suggests you will hardly capitalize anything during the rest of this year.

No, no. I just -- when I said 15 million to 20 million, this was only COGS. And bear in mind, 208 million also being capitalized.

[Operator Instructions] We already have our next person. Again, Mr. Nicolas Pauillac.

Sorry for the follow-up question. I was just looking at your slides and one of the 4 pillars that you flagged for the next stage is going to be the geographic expansion. How should we think about what will be the ideal mix in terms of geographic split going forward between the U.S., Europe and international? And is there a reason to think that maybe the U.S. is not where is the largest opportunity for biosimilar today? Just trying to figure out how you are building the, let's say, development stage in the future.

That's a question that is hard to answer, Nicolas. I mean, of course, the strategic pillar means that we have to do all of that. So stay focused on EU and U.S., and they will remain for the next years, of course, the key markets in size and budget, health care budget that needs to be reduced by biosimilars. But we see more and more, we should not overlook and we put a lot of emphasis on the additional markets so that we reduce the dependency from EU and U.S. And you see already, let's say, that in some of the -- and that's really also product-specific and very partner specific for 201.

For instance, we have very strong among the top 3 countries is one of the countries of the MENA region. So we see that already tangibly in some of the markets. For sure, it will take another 5 years plus until we see those regions kick in significantly and replacing Europe and U.S. But for sure, that's the journey that trend is significant. And I would say it's an add-on opportunity to fully leverage our value of the assets because the developments are -- can be used unilaterally for all regions. So it's a very capital-efficient way to leverage those with financial -- with commercial partners everywhere. And as we do not have to build commercial workforce and sales force in those countries, our partnership model is the right thing to do to increase the global reach.

Probably one thing we can add, and this is that some of those smaller markets are from a patent perspective, easier to tackle. And therefore, this helps us to get started earlier and get our supply chain in full swing in preparation for the larger markets. That's also a strategic element in this whole discussion, but it very much depends really on the product and also patent situation in each and every market. So. . .

Thanks, Nicola, for that addition, especially for 206 that will be relevant because we have the first-mover advantage, and we can leverage those opportunities.

The next question is from Alexander Zienkowicz, [ MVP ] Research.

And we cannot hear you in case you are speaking.

I hope you can hear me. On FYB202, could you provide more color on the positive signals that make you optimistic? And is this directed at the U.S. specifically? And could you elaborate on international performance perhaps?

Yes. I mean there was, let's say, a recent announcement that makes us happy, of course, and that was that Fresenius Kabi's strong U.S. team recently secured a contractual agreement for Otulfi with a large federal buyer. So that adds to our positive mood there. And similar to the Civica script exclusive distribution deal, which was entered into last year and which will continue, of course, and which was the main driver for strong performance in Q4 last year. This new federal agreement just is also a very positive trend because it opens up new channels and customer segments and will -- is expected to strengthen Otulfi's U.S. performance already in the second half of this year. That's the one positive momentum.

And in Europe, -- of course, in general, we are seeing a fierce competition, especially in tender-driven markets and countries. But also there, with the recent announcement in France, we see encouraging momentum, our partner, Fresenius Kabi for further growth. And that's not only the introduction of a substitution, which in general is supposed to drive the biosimilar adoption, but also contract wins, recent ones, including the country's largest retail pharmacy, which was also stated in the Fresenius Kabi earnings call, the Fresenius earnings call, where Otulfi is positioned as #1 product. So those 2 elements are driving our optimism that we will see growth in FYB202 and already tangible increase this year so that we are confident with our guidance.

So at the moment, there seems not to be any further questions. So I will end now the Q&A session. Thank you.

b

Yes. Thank you. And finally, I would thank -- like to thank you, the operator, our Investor Relations team with a special big thanks to Sabrina, my Board colleagues and especially everyone who joined today's earnings call. Thank you for your continued interest and your trust in Formycon. We remain fully committed, as you know us, to delivering sustainable growth and creating long-term value for our shareholders. And ultimately, also, let's not forget, to the benefit of the patients worldwide. Thank you for joining us today.

Good afternoon, ladies and gentlemen, and welcome to the Formycon AG Earnings Call Full Year 2025. [Operator Instructions] Let me now turn the floor over to Dr. Stefan Glombitza.

Yes. Thank you for the introduction, and good afternoon, good morning, and welcome to everyone joining us today. Before we begin, allow me a brief note on timing as this year's publication of our results came later than usual. The transition of our financial system at year-end was a necessary step, but it required additional diligence in close coordination with our auditors to ensure the highest quality and reliability of our financial reporting. We appreciate, therefore, your patience in this process.

Earlier today, we published our full year 2025 results. And before we go into the presentation, let me highlight 3 key messages upfront. Number one, in a dynamically and for sure, demanding market environment, we clearly outperformed our guidance for EBITDA and working capital, which is underlining the resilience and quality of our business model. Even though revenues were lower and partly shifted into the new year. Number two, operationally, 2025 was a highly successful and transformational year for Formycon with multiple key milestones achieved across all 4 pillars of our Fit for Growth strategy, which I will explain later in a bit more detail.

And third, 2026 has already started strong with positive PK results for our FYB206 Keytruda biosimilar as well as an agreement with Bayer, clearing the path for the launch of our third biosimilar FYB203. Over the next 30 minutes, Enno Spillner, our CFO, and me, will walk you through our presentation. Nicola Mikulcik and Andreas Seidl are prepared to cover respective topics in the Q&A.

With that, let us begin, and thank you again for joining us today. As usual, before we begin, please note that our presentation and the Q&A contain forward-looking statements subject to the usual risks and uncertainties as outlined in our disclaimer. Now let's come to Fit for Growth. The biosimilars market continues to evolve rapidly with more than 100 biologics losing exclusivity over the next 10 years. In this dynamic environment, success requires 2 things; a clear strategic compass and disciplined execution, knowing where to play and how to win. Fit for Growth is our strategic framework to capture this opportunity. It is built on 4 pillars that directly translate into competitiveness, capital efficiency and sustainable long-term growth. Let me take a moment to explain in more detail what underpins each of the 4 pillars.

Pillar 1, geographic diversification. Beyond its core markets in Europe and the U.S., Formycon deliberately expands into high-growth emerging regions with increasing demand for affordable biologic medicines. Strategic partnerships with strong regional players in MENA, LatAm, APAC and Sub-Saharan Africa maximize the global value of each asset, reduce our single market dependencies and thus strengthen resilience against geopolitical and pricing volatility.

Formycon's smart portfolio strategy, Pillar 2 combines disciplined asset selection with focused execution with the ultimate goal to build a strong commercial product portfolio. By balancing blockbuster opportunities with carefully selected niche assets, we create a diversified and future-proof pipeline with strong partnership potential and optimized risk return profiles. Pillar 3, excellence and innovation are core to how we operate. Formycon since years consistently delivers high development and regulatory quality, accelerated approval time lines. So in a nutshell, a flawless operational track record. Building on our deep biosimilar development expertise, we also drive differentiated innovation from advanced drug device combinations like the ophtha prefilled syringe to streamlined clinical development concepts like our pioneering Phase III waiver in 206.

Excellence in execution and innovation creates first-mover opportunities and positions Formycon as a trusted high-performance partner in biosimilars. Pillar #4, lean development is a core enabler of our platform. By optimizing our clinical and regulatory concepts and leveraging more and more digital and AI supported processes, we materially reduced development time lines and costs while maintaining the highest quality standards. This approach enables a step change in capital efficiency and scalability and positions us well to capture the upcoming wave of exclusivity opportunities with greater speed and returns.

In summary, we continue to execute with discipline and laser focus on a clear strategic road map. Fit for Growth combines lean development, a smart and selective portfolio, global market diversification and an uncompromising excellence and innovation to drive sustainable and profitable growth. This slide illustrates how we grow our international scale to unlock global growth through strong partnerships. No single company can address all the upcoming opportunities in this fast-growing biosimilar space with, as said, more than 100 biologics running out of exclusivity in the next decade.

Through an attractive pipeline and high credibility from our proven development track record, we are able to engage with a broad network of strong regional commercial partners who need our biosimilars in their portfolio. This is a capital-efficient partnership-led commercialization model and enables us to scale rapidly across regions and efficiently expand patient access to critical biologics worldwide.

Looking at the growing number of marks here on this slide in emerging markets, you see already the positive impact of our geographic diversification strategy, preparing today the growth of tomorrow. So in a nutshell, strong partnerships turn our development engine into a global diversified and capital-efficient growth.

With that, I want to conclude the strategic and operational part and hand over to our CFO, Enno Spillner, for the long-awaited financial details.

Yes. Thank you, Stefan. Happy to take over. Welcome, everyone, also from my side to introducing the 2025 year-end numbers to you and of course, also providing an outlook for 2026 and the respective guidance. However, today, I would like to first start with an apology for our year-end 2025 reporting time line, which was stretched beyond the usual time frame. We had a couple of reasons here. We had changes in the financial team plus some health challenges with some of our colleagues. We had the technical adjustment that Stefan was already alluding to, namely the introduction of our new ERP system in January 2026, seeing the go-live, which took a lot of attention and capacity and we experienced extended review and reconciliation processes in the context of our year-end process and some of the parts that made it very challenging to maintain the time line as initially anticipated.

But let's take a look at the financial outcome at the first slide on a high-level summary. Revenues are below what we had targeted for 2025. And due to the transformation of our revenue structures, revenues were clearly expected to be reduced against 2024. This was already guided accordingly. However, we anticipated a higher compensating effect from some factors which did not fully develop momentum in the range we assumed, and I'll come back to that on one of the next couple of slides.

Regarding cost of sales, also here, we saw an associated reduction against 2024. This is mainly due to the fact that we continue recording the regular amortization of our FYB202, which makes about EUR 25 million in 2025, something we only recorded during Q4 in 2024. Would we adjust for the accounting measures, we would be looking at operational cost of sales of approximately EUR 16 million for 2025 versus EUR 47.5 million in 2024.

R&D expenses, here, the main assets of relevance are FYB208 for the main cause of the year 2025, FYB209 and then FYB210. The most investment intense of these 3 assets is FYB208, which successfully achieved the TPoS, technical proof of similarity with the end of Q3. And for Q4, respective investment into these assets was already capitalized. The remaining assets, FYB209 and especially FBYB210 are still less cost intense due to the early development stage, and this triggers overall the R&D amount to reduce accordingly.

Looking at the EBITDA, which improved significantly. Here, while revenues reduced by approximately EUR 25 million, as just indicated, we do recognize a direct counterbalancing effect of significant reduced cost in the range of approximately EUR 18 million, for example, development costs for FYB201 and FYB203 and R&D costs. The effect on cost reduction and the better-than-expected performance results from reduced cost of goods, but also from very strict cost management across operational costs, but also investment, higher-than-anticipated capitalized development investments and some timing shift in development costs into the next period.

Please also bear in mind that the regular amortization of FYB202 considered under our COGS here is neither EBITDA nor cash flow relevant and makes a very significant portion of our overall COGS. With regard to the adjusted EBITDA, our group adjusted EBITDA amounted to minus EUR 2.3 million and was, therefore, significantly above our forecast range. In addition to the just mentioned EBITDA effects, this was mainly attributable to upfront payments, which Bioeq received in connection with the new Zydus partnership for FYB201/NUFYMCO, which came in very late in 2025.

The earnings contribution from FYB201 via the joint venture of Bioeq amounted to EUR 1.4 million, and this was significantly below the prior year, and this is mainly or primarily due to the significant decline in revenues following the temporary pause of marketing of the product in the U.S.

Lastly, looking at the capitalized development cost. The capitalized development costs in 2025 are mainly contributed to the clinical development activities of FYB206. The clear increase of this investment is due to the fact that FYB206 clinical trials were recorded for the full scope of 2025, whereas in '24, the activities were only started midyear. In Q4 2025, also FYB208 achieved TPoS as just already indicated, and consequently, respective development costs are being capitalized as well.

Looking at the overview of our guidance. Sales are clearly below our guidance, and I will comment on this in context of the revenue slide on the next page. EBITDA, adjusted EBITDA and working capital are significantly better than anticipated. And here, the main reasons for the EBITDA effects from sales on the one side, but very intense cost management, higher capitalized development costs and development costs to be incurred to a later point in time as the major building blocks. The adjusted EBITDA, as I just mentioned, mainly benefits and profits from the positive development of the Bioeq performance, especially with the latest deals. And working capital, here, of course, we have to recognize the successful proceeds of EUR 70 million from our new corporate bond, which positively influenced this.

Advanced payments under the first commercialization partnerships of -- for FYB206, which still reached us in late 2025 are certainly also supportive to this performance. Let's take a closer look at the breakdown of our sales. And for 2025, this is consisting of 3 pillars; a, service development recharges; b, upfront and milestone payments; and c, royalties. Current development is clearly reflecting our change in the overall revenue structure if you look from '24 moving into '25. Recharges for development work on FYB201 and FYB203 continue to reduce significantly as products mature successfully. This is expected and planned or was expected and planned. However, development compensation still stood for a significant portion of our 2025 revenues, but not at all a comparison against what we saw in 2024.

Deferred milestones from FYB202 in 2024 have completely faded out in 2025 due to the successful approval of the product in fall 2024. This was also expected and planned accordingly. Product sales for FYB202 were a one-off effect in 2024 and thus not expected to repeat in such an amount in 2025. FYB201 royalties reduced mainly due to the pausing of the marketing for the product in the U.S., as just mentioned before. And therefore, in total, revenues in 2025 declined comparing against 2024, which was expected and also reflected in our guidance for '25. This effectively also means a significant structural change of revenues for '25 and in subsequent years. And in the regard, we recognized first strong signals of change in 2025.

So FYB202 royalties generated for the first time revenue in the amount of EUR 9.7 million in '25. These incoming royalties are not yet in a range to compensate for the other revenues. However, it became already one of our main pillars of our 2025 revenue generation. And it is, of course, anticipated to grow further, but I'll come back to that later.

Upfront payments and milestone payments from FYB206 partnering with Zydus and [ MS ] Pharma are contributing significantly to our 2025 revenue performance as well. This is highly exciting as it reflects the huge potential and the huge upside behind FYB206 as our next growing asset. So why did we come or why did we come out short of our guidance despite assuming in Q3 2025 that we still would reach our target? This consists of a couple of reasons. First, prolonged negotiations related to the conclusion of additional partnerships, including, for example, FYB206 for APAC, which required additional time due to the optimization of our economic terms.

Our new Lotus partnership for 206, which has been announced in Q1 2025 is one of these examples, which we realized in the meantime. Furthermore, milestone payments originally expected in the fourth quarter of 2025 were moved from a recognition point of view into the first quarter of 2026, where they will be recognized. Last but not least, and despite a strong fourth quarter in 2025 and a strong uptake, revenues from the commercialization of FYB202 developed less dynamic than anticipated in Q4 and thus also contributed to this deviation.

Coming to the cost of sales. Also with regard to cost of sales, we are recognizing similar structural changes as just described in context of our revenues. Operational cost of sales reduced significantly for FYB202, going down by approximately EUR 15 million and the reverse amortization for FYB202 saw the first full cycle in 2025 and thus increased from approximately EUR 8 million in the fourth quarter of '24 to EUR 25 million in 2025. Again, not EBITDA relevant, not cash relevant, just as a [indiscernible].

Cost of sales for our recharge development efforts on FYB201 and FYB203 reduced by approximately 60% from roughly EUR 25 million to EUR 10 million. In total, our cost of sales reduced by approximately the [ 1/4 ]. And on this slide, and you have seen a similar slide in the last year on our FYB202 valuation, it's just to make transparent to you the change in our value assumptions here. And probably most important to you is the upper line, the intangible asset of FYB202, which we tested in an impairment test, reducing the respective volume by EUR 60 million, which is not EBITDA relevant. However, we have compensating effects. First of all, the deferred tax liability needs to be adjusted as well, which then triggers this to be in a net cash generating unit with an impact of minus EUR 46 million. And as you recall, we have an earn-out obligation or liability on top, which then also is reduced accordingly and reducing our respective payments in the future, which in total makes it a net impact of EUR 41 million net.

Let's take a look at some of our group asset structure KPIs, which we summarized for you. Our balance sheet totals are at or do remain at a strong EUR 740 million. And the light reduction mainly results from reduced noncurrent assets, while, for example, our cash position increased. Equity is reduced by EUR 63 million, mainly due to the net result. And the same or at the same time, our liabilities increased net by roughly EUR 30 million or 10%, which is driven by 2 main effects. On the one hand side, we do have successfully raised our first bond, adding EUR 70 million of our -- to our liabilities. On the other hand, our earn-out obligations have been reduced due to, a, payback; and b, adjustment of our valuation model for FYB201 and for FYB202, which also indicated a reduction in our earn-out obligations. In consequence, our equity ratio is adjusted to a strong 54%.

Cash and cash equivalents increased to EUR 68.8 million at the end of 2025, which provides us a solid starting point for 2026 and the respective operations and also helps us to secure going concern. Cash flow and working capital on the next slide. These are, again, influenced by multiple factors. The net cash from operating activities was positive in 2025, different than in 2024, by the way, and mainly influenced by an increase in contract liabilities as well as an increase in trade payables, while we saw a decrease in contract assets. Net cash from investing activities reflects our strong engagement into FYB206, especially our clinical activities showed approximately EUR 50 million of investment and also FYB208 contributed to this effect with approximately EUR 4 million in Q4 2025.

At the same time, we were receiving EUR 15 million from Bioeq, repaying further parts of their shareholder loan to Formycon. On the working capital side, current receivables as well as current liabilities and revenue accruals were the most influential factors, leading to a working capital of EUR 70 million, which is above our guidance.

Let's take a look at our guidance for the full year 2026 and what you can expect. Overall, we will see a strong and very significant increase of our revenues, which are anticipated in our planning from EUR 45 million in 2025 to a range of EUR 60 million to EUR 70 million in 2026. While development recharges from FYB201 and FYB203 will continue to fade out, we will see a significant increase in commercial revenues, for example, from significant royalties and milestones, underlining our change in our revenue structure. What will be the major building blocks for this? First of all, royalty income from FYB202 will continue to grow significantly and should build one of the most significant pillars within our revenue recognition structure. These revenue may be a bit volatile over the quarters as our royalties do depend on contracts signed by our sales partners with their respective clients and when they fill their respective stock. But the trend should be positive and clear.

The second very significant building block will become our new kid on the block, if you will, from a revenue recognition perspective, at least FYB206. Achievable milestones in context of our further development work towards filing and approval, especially in the U.S., shall contribute significantly to our 2026 performance. Also further partnering like the already announced Lotus partnership for parts of the APAC region, but also other regional partnering may add to the FYB206 revenue performance.

FYB201 is anticipated to show an upswing in royalties again with Sandoz resuming sales for the U.S. already in January of this year and Zydus starting in the second half of this year as our second partner for sales and marketing in the U.S. Please bear in mind that development recharges will continue to reduce on the other side. FYB203 is expected to launch in Europe and in the U.S. in this year with U.S. starting in Q4 2026. Thus, no significant impact to be expected from the royalty part, but the major part of revenues coming from our remaining development recharges as well as handling the supply for FYB202 -- sorry, for FYB203 product. So in essence, FYB202 and FYB206 will be the 2 strong main pillars of our revenue guidance, pretty much on a comparable level with FYB201 and FYB203 adding to the overall picture.

Regarding our EBITDA for 2026, we do assume a positive EBITDA in the range of up to EUR 10 million. It is our goal to turn operationally positive this year and then continue a sustainable growth path from here, growing our EBITDA profitability. Our adjusted EBITDA is expected to come out even better than EBITDA with a range of EUR 5 million to EUR 15 million as Bioeq should accelerate its performance once again against the relaunch of FYB201 in the U.S. and actually [indiscernible].

Our working capital is expected to come out in the range of EUR 20 million to EUR 30 million, considering no financing activity for '26, but reflecting our continued investment into capitalized assets like FYB208 and partially FYB206. Based on this planning, going concern was also confirmed by our auditors, and it goes without saying that we have [indiscernible] continuing with significant saving efforts and cost control efforts to manage the cost side within our organization, also securing EBITDA profitability.

Then I would like to draw your attention to a completely different aspect of Formycon, namely our first-time report on our ESG activities and measures, which at this point in time is voluntarily and therefore, not yet fully audited. However, it summarizes as an extended report, all our activities in the field of ESG, which are certainly important to many different stakeholders, like our employees, like our industry partners, but potentially also to shareholders and investors. It provides a good overview on our activities and also our goals and our anticipated and planned initiatives for ESG across all different contexts that go along with that, and it also summarize respective risk aspects that we measure in this context.

Last comment on our share overview slide, so to say, and just here to remind you that we continue with some major key and anchor shareholders, which in total makes slightly above 50% of our total shareholding. And this is a very stable part of our shareholding structure. We continue with a broad setting of analysts moving forward, which we ideally intend to extend further this year and keep the shares traded and in parallel, obviously, also having the bond listed under its own ISIN number.

And with that, I conclude my part of the presentation and would like to hand back to Stefan. Thank you very much.

Yes. Thank you very much, Enno, for providing us a lot of insights into the financial numbers. Just want to conclude also and add on operational topics for the outlook 2026. 2025 was a transformational year in 2 key aspects for Formycon. First, in Q4, we passed the inflection point towards sustainably positive EBITDA, which Enno alluded to as well. And secondly, we made major progress in the operational transformation across our 4 strategic levers, as I lined out in the Fit for Growth strategy initiative.

Our confidence in the 2026 outlook is based on further tangible progress across all those pillars. Several value-creating milestones that I have depicted some of them have been already achieved in the first month of '26. Regarding geographic diversification, we continue to expand our global footprint through targeted regional partnerships. Progress in early 2026 includes, for instance, the FYB201 launch in Brazil with Biomm and also the mentioned deal with Lotus across multiple APAC markets for FYB206. Further license agreements, of course, will follow along those lines.

Looking at our commercial portfolio, as Enno mentioned, CIMERLI has been reintroduced to the U.S. market in January by Sandoz and NUFYMCO, our second FYB201 brand with a partner, Zydus shall be added in the second half of this year. FYB203 reached a key inflection point with the settlement enabling a European launch in May, so close to date and a clear path forward to the U.S. in quarter 4. At the same time, looking at the young portfolio, we are preparing the next wave of new portfolio additions for the second half of 2026 as well. Driving or driven by the pioneering Phase III wave approach, FYB206 continues to progress as planned, and we could confirm in February the PK equivalence data, which are a key element to the regulatory dossier, which we are preparing.

For our Dupixent biosimilar manufacturing scale-up is advancing, and we have received already positive early feedback from the agencies on our streamlined clinical development approach. In parallel, our Fit for Future program, which is a part of the pillar lean development, delivers measurable impact. Through streamlined processes, smart regulatory concepts and cost competitive CDMO partnerships, we have reduced development time lines and costs for new programs by around 30%. So taken together, Fit for Growth is no longer just a framework. It is translating into execution and sustainable long-term value creation. 2025 was about building the foundation, 2026 is about scaling results.

With that, I want to conclude the presentation and hand over to the moderator for the Q&A section. Thank you for your attention.

[Operator Instructions] And the first question comes from Natalia Webster from RBC.

I have a couple, please. The first on your 2026 revenue guidance for EUR 60 million to EUR 70 million. Are you able to provide a bit more of an idea of how much of this depends on FYB203 royalty specifically? And then how much of this you're expecting from the U.S. versus other regions? Then just touching on the impairment for FYB202. Are you able to walk us through your updated assumptions underpinning this revised valuation and broadly what you're assuming in terms of market share and pricing evolution over the mid- to long term?

And then secondly, on FYB206, if you're able to provide any more detail on your expectations in terms of milestones, how much you're expecting from the development side versus the partnership side? And if you're able to provide any idea on the expected timing of these, that would be helpful?

Yes. Thank you, Natalia. There are 2 finance questions and 1 partnership question, 206, maybe we start with -- in the different order with the 206 partnership question. I may hand over to Nicola, our CBO, we can give you to that. On the timing, maybe I answer that first. I mean, as I said, we have achieved positive results in our Phase I study, driven by the Phase III waiver. That gives us the opportunity to close out the clinical program and go fast track with full emphasis on our submission preparation. There are, of course, other elements that are part of the dossier.

And please understand that we cannot share a detailed timing of the submission, but you can be sure that we are on it. And the partnerships, I mean, we started already with the U.S. partnership last year. We have also [ stopped ] the deal with Lotus on APAC, and there are more regions that we can expect. And Nicola, maybe you can comment on how the interest looks like and what our position is there.

Yes, happy to do so. So we clearly see there is strong interest from Europe. We are currently focusing first on the LatAm countries because of patents expiring earlier. So that's our territory where we are very active right now, plus Europe, we have started also negotiations there. So these are the 2 big regions which we are tackling this year. And the question was also, I think, about milestone projections, right? Was that -- should I...

I can comment on that. And so first of all, welcome, Natalia to the call once again. So with regards to 206 milestones, basically, the vast majority of our revenues that we are expecting for 206 in 2026 is milestone driven. Of course, we may see some upfronts from partners like just the indicated Lotus or some other local regions, but this is probably not comparable against the milestones that we are expecting from development and regulatory activities going forward.

And this will be, as I said, one of the key pillars for our overall revenue recognition. We can unfortunately also for confidentiality reasons, not dive on the details, but the milestones are probably typical milestones that you would expect along further development and filing strategy towards market approval then in later years. And in that regard, these milestones will probably be in total can be a significant double-digit amount, which could make in the range of close to 1/3 of our total revenues, just as a rough indicator.

And on 202, as I said, this is the other major pillar of our revenue recognition. And here, certainly, the major impact is expected from royalties going forward during the different quarters. Again, here, it's a little bit difficult to estimate which royalties will come in which quarters as this will be volatile. So don't expect that necessarily to go on a linear line moving forward. And we have seen that last year also in 2024 with Q4 being exceptionally high compared against the other quarters.

So here, we, in total, are also expecting a double-digit number, which could be in total -- could make another 1/3 of our total revenues of our organization for next year in that range as a rough orientation. That's as far as I can bring it down from the revenue perspective. In terms of your questions on the impairment, of course, we have reviewed all major markets, in particular, the U.S. and Europe in our evaluation over the next couple of years. I cannot guide you on price and units or volume expectations.

Also, our partners would not be happy if we disclose this here. But this fully includes a long-term planning for the next couple of years in separated markets. And certainly, what I can say, U.S. remains the major revenue driver in our anticipation, but also U.S. remains as the major challenge. And maybe Nicola can say something later to that because the PBM market considerations are opening up, but still slowly, and that is the hurdle to our revenue generation.

Can I comment a bit on the U.S.? Yes. So just for the U.S., I mean, we still have the situation that roughly 70% of the market in volume is still with the originator with Stelara. It depends a bit on which sources you use because not all volume data is very precise for the U.S. But there is still a significant market on the brand and on the originator and the biosimilar competitors are now fighting to open up this space. And in that space, we expect more and more volume becoming available.

But as explained already in the past, this goes slower than what was originally projected in the industry. And therefore, yes, it's a marathon and not a sprint. So we have to continue with Fresenius Kabi with our partner there to gain share out of this more and more opening space to make this a long-term success and cash contributor and revenue contributor to our company.

And the next question comes from Katherine Degen from H.C. Wainwright.

This is Katie. I'm on for Yi Chen at H.C. Wainwright. I apologize if this has already been answered. My connection is not fantastic. Now that you guys have PK results that are successful, can you kind of quantify if the optimized terms you guys were looking for resulted in higher upfront payments for that 1Q '26 or if you had to trade some of that upfront cash for higher long-term royalties?

Yes. Maybe -- I mean, Andreas to comment on the PK results, so to say. But as we usually have it, a partnering deal of this kind always consists of 3 pillars, namely upfront, which we received in Q4 2025 and also then respective development milestones/commercial milestones and then obviously, royalties. And we tried to negotiate a very balanced deal here, which still has very significant upside on the long end, which we consider highly attractive. where is already recognizing double-digit million in Q4 of 2025 for upfront and milestones. And again, as I just indicated, already for '26, also having significant potential for further development milestones.

So we think all 3 parts are well covered, and do reflect the true upside of this asset as this is -- or the major deal triggering these revenues in the last year and also for this year is coming from the U.S. partnership. APAC is not yet fully covered. And also LatAm, for instance is not yet addressed and in particular, Europe is not yet partnered as well. So ideally, there's more to come during 2026 and 2027 also from that perspective, adding future deals to what we have already.

And the next question is Nicolas Pauillac from Kepler Cheuvreux.

Congrats on the results and this very interesting guidance. Maybe if I can just come back on 202 and kind of play around your answer, but would it be nice to have a view on how do you think this U.S. market is going to evolve because we still see that this is going to -- at least right now, is looking like the Humira biosimilar market. So 3 players are kind of taking it over with the private label deal. So when you do your forecast, what do you assume that this is something that kind of get blown up and so you can secure market share. So that will be the first question.

And then also still on the U.S. market, but on 201 this time. Could you kind of give us some insights into the strategy of this kind of double product commercialization that you are kind of building? What's the idea beyond that? And how should we think about it when we look into the future? And then lastly, on 203, also on the U.S., sorry, for the focus, but how confident are you that we are not going to kind of run into a similar situation to what happened with CIMERLI moving forward? So that would be the 3.

Yes. Thank you, Nicolas. Very interesting questions, of course. Maybe I get a start and then Nicola to chime in additionally. So 202, I mean, Nicola outlined already what's the situation there in the PBM market. I mean we have seen significant sales in Q4 following Fresenius Kabi's exclusive U.S. distribution deal with CivicaScript. So that shows that single deals can make a difference in both directions. So there's a lot of momentum or potential in there as well, also given the fact that 70% -- around 70% are still with the originators, so still accessible to biosimilars. It remains a stepwise approach to remove Stelara from the formularies.

And -- I mean, on top of the regulatory streamlining support for biosimilars, the clear ones from the FDA and the U.S. government, we also see the momentum shifting and the policy focus in the U.S. increasingly moving beyond this streamlining regulatory framework toward improving market access. And we saw some announcement also from PBMs and so on and some additional pressure and bills going to the Congress so that there is a momentum that goes in the right direction.

Again, timing when that will come and how that opening will happen, that's hard to predict. And that's why we put -- we believe that the assumptions we took in our second impairment now after being more than a bit of 1 year in the market, appropriately reflect what is visible and controllable today. So rather than what might become possible under more favorable structural conditions.

So that's kind of the pendula we have moved towards a realistic reflection based on one -- more than 1-year market reflection, well seeing the positive momentum in the market. Fresenius Kabi U.S. is focusing relentlessly on coverage gains with the direct contracting like with the commercial plans like the Civica deal. And in the European market, there's also gaining traction in France and Germany, for instance, and also there. I mean, you have probably realized that in Germany and France, there's pharmacy substitution being introduced, which will, of course, increase the price pressure, but more importantly, also lead to an overall increase of the biosimilar penetration. And especially with our 2 partners there, well-known 2 brands being strong in the space of the pharmacy substitution, we expect additional momentum for both brands. So given that situation, I think we have a realistic view with some potential for future growth of 202.

On the 201 U.S. strategy, I mean, there, at least we are happy that it's been reintroduced. CIMERLI is back to the market since January. And we also complemented that by a second brand, NUFYMCO with partnered with Zydus. So we can also have 2 complementary market strategies, which will also stabilize and grow that market accordingly. I cannot share more details, of course, on the different strategic approaches. But coming back to 203, I mean, yes, there's -- each partner has a different strategic approach to the buy-and-bill market. And with a partner Valorum, it's not expected that they go the same path as we did for CIMERLI. So I would not expect a similar dynamics or a similar action coming from Valorum on 203.

Okay. Super clear. And maybe if I can just squeeze a final one. On the going concerns, does that include every -- the new investment that you will have to put into 208 when it moved into clinical study and the rest of the pipeline?

Yes, I can confirm that. So our current assumption triggering the going concern or resulting into a positive going concern is. The current cash reserves that we had at the end of the year, EUR 68.8 million, plus the assumed revenues that we have going forward should carry the organization based on the current portfolio as you see it today in our pipeline being covered from a development perspective. So 208, 210 million and so on and also the remainder, by the way, for 206 being covered under this aspect. If we would go significantly beyond that from a portfolio perspective, then this is a different story.

And the next question comes from Simon Scholes from First Berlin.

I've just got a couple of questions. First of all, on the 206 milestones, I mean you did EUR 17.2 million last year. And I gather from what you've been saying you expect it to be at least the same or higher this year. I mean, last year, you had the marketing agreements in the U.S. and MENA, I think, and this year, Asia Pacific. So are you expecting Europe and Asia Pacific together to exceed the milestone from the U.S. and MENA?

And then on CapEx, I was wondering if you could provide -- I mean, you did EUR 54 million in CapEx last year. I was wondering if you could give us an idea of what the magnitude of that number might be this year and what the emphasis of spending of that expenditure might be, which products?

Yes. Thanks, Simon, for the questions. Maybe I'll take the first ones. I mean the 206 milestones are not only down payments for deal signature. So the milestones are deferred over a period, and they include also development milestones achievements like, for instance, the positive PK results added already to -- or will add to milestone payments that will come during this year. So it's a mix of down payment for new deals, but also in addition, milestone payments for existing deals based on development progress. That's number one. CapEx goes to my neighbor.

Yes. So CapEx was a particularly high this year, 2020 -- last year, sorry, 2025 due to the significant investment into the clinical stage of 206. For 2026 operational year, we have an expectation of less CapEx as 210, for instance, is not yet clinical. 208 is getting ready or being prepared, but yet not fully exposed despite the respective costs being capitalized. And we have some remaining activities under 206 also being capitalized, but that's not a major volume. And therefore, total CapEx invest at least from an investment perspective for developing our products is reduced -- clearly reduced compared to what we had last year.

Currently, there are no further questions. [Operator Instructions] That is not the case, and that concludes the Q&A session. And I will hand back to Dr. Stefan Glombitza for some closing words.

Yes. Thank you. And finally, I would like to thank the operator, of course, our Investor Relations teams for all the preparations, my Board colleagues for joining in for the answers and especially everyone on the call who joined today's earnings session. So thank you for your continued interest and trust in Formycon. We remain fully committed to delivering sustainable growth and creating long-term value for our shareholders and ultimately to the patients worldwide. Thank you so much, and have a good afternoon.

Good afternoon, ladies and gentlemen, and welcome to the Formycon AG Earnings Call 9 Months 2025. [Operator Instructions]

Let me now turn the floor over to Stefan Glombitza, the CEO of Formycon.

Yes. Thank you for the introduction, Beatrice. Good afternoon, good morning, and warm welcome also from my side. We appreciate your attendance and interest, as always, in Formycon's Q3 earnings call.

Earlier today, we already issued a press release providing detailed insights into our Q3 and 9-month performance. In short, I'm pleased to reaffirm our full-year guidance across all key financial indicators. Revenue and EBITDA remain on track, while working capital remains at the elevated level from our half year update.

During the third quarter, we achieved several highly accretive operational milestones across all programs. Just to pick out one, most notably, we successfully completed patient recruitment for our Phase I clinical trial of FYB206 Keytruda biosimilar, an achievement that positions us in a very competitive spot for this highly attractive and important PD-1 segment in oncology. Building on pioneering Phase III waiver secured earlier this year, this milestone unlocks substantial first-mover advantages.

Financially, Q3 results reflect the commercial ramp-up phase for Otulfi, being only a few months into its launch. In Q3, we are already seeing growing traction in key geographies. And these results align with our phasing assumptions for this transformational period. We anticipate significant revenue generations and events in Q4, reinforcing our confidence in meeting the 2025 full-year guidance, and we will come to that.

Over the next 30 minutes, we will provide additional context on both the operational achievements and the financial performance, along with an outlook for the coming period. Enno Spillner, our CFO, and I will guide you through the key facts in our joint presentation. Nicola Mikulcik, our CBO; and Andreas Seidl, our CSO, are also here and will join in for the Q&A session to address any questions you may have.

Let us start with the presentation now. As usual, in those settings, I'm starting with the legal disclaimer on forward-looking statements during our presentation and the Q&A section. Our strategic road map remains unchanged. We continue to execute with discipline and laser focus on our growth trajectory. 2024 was pivotal for Formycon, with 2 additional biosimilar approvals laying the groundwork for the next stage of acceleration. And this progress positions us to achieve sustainable profitability as soon as these products gain traction in the key markets. Our ongoing operational successes build a solid foundation for transforming Formycon into a leading biopharmaceutical company.

Let me just comment on the FDA's recent move towards streamlining biosimilar development. This promotes faster, more cost-efficient pathways, thus creating tremendous opportunities, playing strongly to our advantage. With the recent regulatory movements, comprehensive analytical characterization and similarity assessments are becoming even more critical. And these represent core differentiating strengths of Formycon's development platform. We are excited to leverage these.

Our products already are improving the lives of patients worldwide. As commercial revenues continue to grow, they will further fuel our pipeline and expand access to vital medicines, advancing our mission through the strength of our development powerhouse. Supported by the positive momentum in the biosimilars market, recent encouraging signals from the U.S. regulators and the strong potential of our pipeline, we are at an inflection point pivoting toward profitable growth.

Our target remains unchanged; achieve sustainable EBITDA profitability ideally as early as 2026. The biosimilar segment, while still relatively young, is evolving rapidly and undergoing dynamic changes and everybody sees that. This creates tremendous opportunities and the underlying momentum is unmistakably one of growth. In such a dynamic environment, having a clear strategic compass, knowing where to play and how to win is essential. And our operational and commercial activities are guided by clear strategic drivers, essential levers that are flagged here and that position us for long-term success.

There is significant geopolitical momentum underway everywhere, underscoring the importance of geographic diversification. Expanding into high-growth emerging markets and building a broad network of regional marketing specialists enables us to capture opportunities globally and maximize the leverage of our developments. We intensified our diversification efforts and will continue to do so because this is laying the foundation today for tomorrow's growth.

Excellence in pipeline selection remains critical. That's undoubted. Identifying the right assets then advancing with focus and conviction. The current initiatives on streamlined development and the improved regulatory policies create compelling business cases now for targeting reference products in the niche-buster category while helping to address the significant biosimilar demand.

Our strong backbone is deep, deep biosimilar development expertise, which also serves us as the basis for innovation as another key differentiator. Advanced technologies such as our ophthalmic pre-filled syringe delivers superior product features for patients and health care professionals. But innovation for us also means shaping science, challenging the existing policies, influencing regulatory frameworks through creative pioneering approaches such as the Phase III waivers. These initiatives not only provide significant savings like the high double-digit millions in the FYB206 program, but they also enable faster, more cost-efficient development across our pipeline.

Building on our extensive experience from the 3 approved programs, we are streamlining development processes as we speak, supported by targeted AI deployment and continuous refinement of our approach. We are constantly reshaping our organization, reflecting these important improvements like the Phase III waivers in our operational model. As a result, Formycon can now deliver its biosimilar pipeline at greater speed and at lower cost. And this will finally allow us to fully leverage our platform and capitalize on the unprecedented number of loss of exclusivity opportunities in the coming years. Throughout the first half of 2025, we communicated a series of achievements and thanks -- really big thanks to the strong performance of our operational teams, we have further enhanced our value proposition across our pipeline.

Let's have a closer look at our operational achievements in Q3. For 201, Q3 marked 2 significant milestones in our strategic road map: innovation and diversification. The introduction of the first ranibizumab biosimilar and especially designed ophthalmic pre-filled syringe represents a major step forward after a demanding development journey. This pre-filled syringe delivers a safe and more convenient way of administration to the retina specialists and their patients with severe ophthalmologic diseases. It underscores our commitment to advancing ophthalmic care.

Executing on our diversification strategy in emerging markets, our partner, Bio Usawa, achieved the first registration for FYB201 in Sub-Saharan Africa and is preparing for launch in a remarkably short time. We are excited and feel honored to help address the high unmet need for affordable biologic treatments in regions where such options have been virtually non-existent.

FYB202 is gaining commercial momentum step by step. A key highlight, of course, of Q3 was Fresenius Kabi's exclusive distribution agreement with CivicaScript. Together with our partner, we anticipate incremental sales in Q4 from this arrangement. Fresenius Kabi is pursuing conventional and partly innovative ways, targeting health plans in non-exclusive and exclusive settings, including distribution models such as the exclusive agreement with CivicaScript. The pharmacy benefits landscape in general is evolving and the trend strongly, by the way, supported by the U.S. government continues to accelerate biosimilar adoption.

Looking globally, the product has been launched in 20 countries as of today and market penetration in key European markets continues to progress. And we are confident that our commercial partners will leverage their strong sales capabilities and brand reputation to drive market share gains and access for patients across Europe with severe immunological diseases.

For FYB203, additional commercial partnerships have been secured for Latin America and Australia, complementing our global coverage. All partners are in the wings for a staggered launch as soon as the IP conditions allow. And a major milestone in this context was the settlement agreement with Regeneron, paving the way for a U.S. launch in Q4 next year.

For FYB206, the year began with a breakthrough news, positive regulatory feedback from FDA, allowing us to waive the Phase III clinical efficacy study for our Keytruda biosimilar. This shifted the recruitment time of patients in our Phase I PK study on the critical time path for submissions in the first countries. In July already, we announced last patient in, meaning recruitment for the FYB206 clinical program is now complete and we expect final Phase I results as early as Q1 next year already. This unique time advantage positions us extremely well for this highly attractive asset, a fact that is evident in multiple licensing discussions. So in parallel to our development focus, we are very busy with putting in place our commercial partnering network. And we expect to sign licensing agreements for certain geographies still in Q4, with others following in 2026. Just to say, our priority remains securing the best possible partnerships for this asset in each region rather than rushing deal signatures.

FYB208 demonstrates highly attractive cell line characteristics, and we successfully achieved the so-called TPoS milestone technical proof of similarity. This is an essential gateway to manufacturing scale-up and to clinical development with elevated probability of success. So looking at all the achievements in Q3 even, our strong operational momentum will continue to generate positive news flow also in Q4 and beyond. And these achievements form the foundation for future revenues, the lifeblood of our growth journey.

And with that, I want to conclude the strategic and operational part and hand over to our CFO, Enno Spillner, for financial details.

Yes. Thank you, Stefan, and welcome, everyone, to our Q3 2025 numbers call.

It's a great pleasure having you on the call, and I will certainly also provide our outlook for the remainder of the year. But let's start with a look at our P&L, which is on track to what we anticipated for Q3 2025 so far. And looking at the revenues, which are in range of what we expected for Q3, namely at EUR 10.5 million for the respective quarter based on our guidance, which we provided end of March of this year. Due to the transformation of our revenue structure, revenues are clearly reduced compared against the first 9 months of 2024.

Furthermore, I reiterate on what we indicated already in previous calls and especially during our H1 call, we will see a very backloaded and therefore, Q4 focused revenue performance in 2025. Details, I will have on the following slides. Cost of sales increased against Q3 2024. And while this might be a bit surprising at first sight, it is to be considered that more than 50% of cost of sales stem from FYB202's regular amortization, which simply didn't exist in the first 9 months of 2024.

Would we adjust for this accounting measure, we would be looking at operational cost of sales of approximately EUR 18.5 million for the first 9 months of 2025 versus EUR 32.5 million in the first 9 months of 2024, thus a massive reduction of costs. R&D expenses reduced compared to 2024 due to possible phasing of development costs for our early-stage projects as we do have more time to develop these. Major costs do come from FYB208 early-stage development.

EBITDA is about in the same corridor than last year. This is due to savings and phasing, along the previous positions I just described and due to the effect that the before-mentioned amortization is neither EBITDA nor cash flow relevant. Adjusted -- or the adjusted EBITDA declined significantly due to the reduced equity result coming from our joint venture Bioeq, which is running our FYB201 performance. With Sandoz pausing its U.S. activities for Cimerli effective Q2 2025 and Q1 sales being on the lower end, there's little contribution from this joint venture during the first 9 months of 2025. The capitalized development costs in 2025 have fully contributed to the clinical development activities of FYB206. The clear increase of this investment is because FYB206 clinical trials started in June 2024 only. Therefore, no major relevance in the first half of last year.

Let's review the breakdown of our sales, consisting now of 4 pillars: a, development compensation; b, upfront and milestone payments; c, royalties; and d, and that's new supply. As indicated during our H1 call already, the new category supply represents sales as a manufacturer of FYB202 for retained countries and FYB203's supply chain management. Both haven't been recognized as revenues in the first 9 months of 2024 yet. Current development continues to reflect our change in revenue structure.

While recharges for development compensation on FYB201 and FYB203 continue to reduce as products mature successfully, deferred milestones from FYB202 have completely faded out in 2025 due to the successful approval of the product in fall 2024. FYB201 royalties reduced mainly due to the pausing of the marketing of the products in the U.S., which we assume to resume in Q1 2026, by the way.

In return, FYB202 generated $3.7 million of revenues, including milestones from retained countries, showing an acceleration comparing against Q1 and Q2 of this year. While royalties for the first 2 quarters totaled in the range of $1.5 million, we recorded $1.6 million in Q3 alone, thus developing into the right direction.

In total, the incoming royalties are not yet in a range to compensate for the other effects, but we see 3 positive factors pointing into the growth direction. FYB201 to return for marketing in the U.S. during Q1 2026, also according to public information by Sandoz. FYB202 expected to further accelerate revenue in Europe and the U.S. in particular; and FYB203 with a settlement now in place for the U.S., starting sales and marketing during the course of Q4 2026.

Also with regard to our cost of sales, we are recognizing similar structural changes as just described in context of our revenues. Operational cost of sales reduced significantly for FYB202, going down by EUR 8 million, plus cutting more than 50% of cost of sales for FYB201 and also FYB203 cost of sales being reduced due to fading out of our development work.

On the other side, we do record a new position for FYB202's regular amortization. This EUR 18.8 million amount is neither EBITDA nor cash relevant, as I mentioned already, but significantly influences our cost of sales. Adjusted for this amortization, our operational cost of sales reduced by more than 40%.

Let's review some group asset KPIs. Our balance sheet totals at a strong EUR 789 million. The increase mainly results from an increased cash position derived from our new bond facility. Equity is reduced by EUR 59 million, mainly due to the net result. And at the same time, our liabilities increased by EUR 76 million or 25%, which mainly is in context of the issuance of our bond. Please let me remind you that the rest mainly are earn-out liabilities, which do correlate to the performance of our products.

Consequently, we only have to pay these once we receive respective cash inflows, especially from FYB201. Therefore, these liabilities are no hard or no fixed liabilities with regard to the final numbers. Furthermore, we do experience a technical effect from non-current liabilities, resulting from a change in our WACC from 10% down to 9.3% being used to discount the earn-out obligations. In consequence, our equity ratio slightly drops, but remains with a solid 51%. And cash and cash equivalents adjusted to almost EUR 80 million at the end of Q3 2025.

Cash flow and working capital were determined by multiple factors. Net cash from operating activities was quite balanced between our negative EBITDA and a positive impact from trade receivables. Net cash from investing activities reflects our strong engagement into FYB206, showing a EUR 32 million investment, while at the same time, receiving more than EUR 12 million from Bioeq, repaying further parts of their shareholder loan to Formycon.

Net cash from financing activities was mainly affected by the bond versus some earn-out payments. In addition, on the working capital side, aside of the strong EUR 80 million cash position, current receivables as well as current liabilities and accruals were the most influential factors, leading to Q3 2025 working capital of EUR 83 million.

But let's get back to our financial guidance for the remainder of the year. It is obvious that with revenues of EUR 19.5 million recognized for the first 9 months of 2025, aiming for EUR 55 million to EUR 65 million for the full year still looks ambitious. However, we remain positive, as Stefan already indicated just now, to achieve the revenue guidance for the full-year 2025 based on 2 main revenue drivers.

First, regarding FYB202, we are receiving positive signs from our commercialization partners for a further increase in revenues and thus, royalties for Formycon. This is especially true for the fourth quarter of 2025, also based on indications made by Fresenius Kabi during their recent Q3 call that they are anticipating incremental sales with Otulfi in Q4, following the exclusive U.S. distribution agreement with CivicaScript.

Second, we continue to push for indicated conclusion of first licensing partnerships for 206, and we are progressing well in positive discussions with various industry players, which may become our future partners for FYB206. Not yet a done deal, but we consider it realistic to conclude accordingly still this year. That said, and to be very clear, we will not sign a deal for any price, but we want to come out within our expected range for commercial targets. Otherwise, we would rather sign at a later stage than participating -- partnering at a suboptimal terms or conditions.

So in essence, Formycon expects a strong and very dynamic fourth quarter due to the before-mentioned 2 main effects, plus continued revenue contribution from FYB201and FYB203. Overall, we confirm our guidance for 2025. Revenues for 2025 will be backloaded due to market grip of FYB202 and expected licensing deals for FYB206. Full-year EBITDA will benefit from the expected positive revenue performance during the fourth quarter of the year.

Adjusted EBITDA also should reverse slightly based on an underlying roughly plus/minus 0 at-equity result of our Bioeq joint venture. And working capital will -- or was already uplifted in H1 2025, mainly due to the successful bond financing. This should remain unchanged. Liquidity, with the additional EUR 70 million gross from our bond issuance, leaves us with sufficient cash to fuel the development of our current pipeline and achieving EBITDA profitability.

Just 3 points very briefly on this slide. Engagement of our existing anchor investors remains very stable. Comparing trading volume from 2024 versus the first 9 months of '25 shows an approximately 4x increase of our average share liquidity. And one comment on research coverage. As many of you probably know, quite a few changes are taking place within the German small and mid-cap banking community, including research capabilities being reduced.

In this context, Hauck & Aufhauser as well as M.M. Warburg informed us that they will cease their research activities and therefore, discontinue their coverage on Formycon. This will happen the latest at the end of this year. We, of course, regret these measures. I would like to sincerely thank the respective analysts for constructive dialogue and a very good interaction, and hope to meet them again very soon in another context.

With that said, I'm at the end of my part of the presentation and would like to hand back to Stefan for a final summary. Thank you very much.

Yes. Thank you, Enno, for the helpful financial insights.

So let me conclude with an overview where we are positioned. So with 3 pipeline assets approved, 2 already marketed and the third one poised for a U.S. launch following the recent settlement agreement, we have established a trust-building track record. We believe we have all the ingredients for long-term success, the right strategy, scientific excellence and the agility to adapt and seize opportunities. And this enables us to expand patient access to critical biologics through our licensed partners and play an increasingly important role in this high-growth segment.

Biosimilars are still young, but here to stay. We operate in the fastest-growing segment of pharma, with more than 100 biologics losing exclusivity over the next decade. No single player can address them all. But with a streamlined development, we can deliver biosimilars faster and more cost effectively, capturing a greater share of these opportunities for the benefit of patients and health care systems worldwide. The stage is set for the next chapter of Formycon's growth story.

Thank you for your attention. With that, I conclude the presentation and hand over to the moderator for the Q&A session.

[Operator Instructions] And first up is Natalia Webster from RBC.

My first one is just around your full-year guidance. So it's implying obviously, Q4 quite a large step-up. Just curious if you're able to provide any more indication of how much you're factoring in, in terms of the pickup in FYB202 royalties versus the milestones for a potential deal for FYB206, appreciating some of those agreements may come in Q1 next year?

And then my second question, specifically on FYB202. If you're able to talk a bit more around the market penetration in the U.S. and Europe, are you still expecting it to take around 9 to 12 months in terms of reaching that inflection point, the market opening up more significantly? And then around your agreement with Fresenius Kabi in the U.S. I know they signed that exclusive agreement with Civica. Do you expect further contracts? And do you expect those to influence Q4? Or will that more likely be in 2026?

Thank you, Natalia. So let me maybe take the #2 and #3, and then I hand back to Enno for the guidance question. So on ustekinumab performance in general and in U.S. specifically, we anticipate, as mentioned in the call, in the presentation, incremental sales in Q4 following the Fresenius Kabi's exclusive distribution agreement with CivicaScript. And the general -- this is a very important milestone and following a set of deals that Fresenius Kabi is driving relentlessly to gain coverage.

Fresenius Kabi is going conventional, but also partly new types of ways with exclusive and non-exclusive agreements targeting direct health plans, direct distribution agreements and like the ones with CivicaScript. In general, we see a good movement there with Fresenius Kabi moving forward and signing one deal after the other. But on the other hand, the market penetration in general in the pharma benefit segment doesn't move that fast. And we always indicated that it's not a big splash, but an incremental increase. And it still takes time what we see.

I mean, we're 6 months in the market. And if you look at adalimumab comparable case, it took more than a year until we saw a significant inflection. And now we are talking worldwide of over 60% market share and also more than 26% market share in the U.S. of the biosimilars. So, it will come step by step. Still some time to remove Stelara from the lead position on many formularies. But we see it moving in the right direction, and we see Fresenius Kabi really doing a great job there and going several avenues to achieve more traction and achieve more market share in reasonable deals. And with that, as read, we feel confident to confirm the guidance with the Civica deal delivering results already in Q4, and we see more deals, of course, and signatures to come for the next deals, which make us confident.

And then back to the guidance, Enno?

Yes. Welcome, Natalia, also from my side on your question on the full-year guidance. Of course, I cannot disclose any detailed numbers here right now also due to ongoing negotiations with our potential partners. But clearly, if we succeed and also locking in one of the major regions, for instance, we certainly would assume that upfront and/or milestones in total would be clearly double-digit for FYB206 and then followed by FYB202 revenue generation in the last quarter. So, that would be the 2 leading part of our revenue generation. And as I said, certainly, 203 and 201 will also contribute, but that is certainly a couple of levels below the expectation for these 2 assets. That's as detailed as I can go right now. Sorry about that.

If I could just add one more question just around your costs. You mentioned around the Phase III waivers and lower development costs. Just curious to hear if that could benefit your P&L over the midterm or whether you'll look to reinvest that back into the pipeline?

I mean, in general, if you look at the costs, there's a lot of, of course, positive momentum by the streamlining regulatory framework motions that we see not only from the FDA but also from major regulators across the world, EMEA and U.K. And I mean, already depends on the Phase III waiver, it really depends on the clinical program costs and they might differ several magnitudes from oncology studies to other indications. But in principle, we see that we feel enabled to with the cost efficiency measures to develop a biosimilar for a cost investment in the range of EUR 80 million to EUR 100 million. And this is a significant reduction towards the past. And this, I think, puts us in a very competitive situation.

It's still maybe the next question that might come, will that increase the competition heavily? But as I said, I mean, we're talking significant investments still. The entry barriers are pretty high with that. So, that does not mean cost reduction and investment reduction, does not mean that it opens up to multiple players that can now afford to develop biosimilars, just as an additional comment.

And next up is Yi Chen from H.C. Wainwright.

Congratulations on the quarter. This is Eduardo on for Yi. In regards to 203, I'm curious if you have any estimates or ideas about price at launch in Q4 '26?

Yes, that's a question I can really not comment and not answer. I mean we, of course, have now the settlement, are very happy that we are in this wave of additional biosimilars that first got first settlements. But there is a -- I mean, as soon as we start the marketing and preparation activities, we will know more about the pricing, but this is too early and of course, nothing we would be able to share officially. Sorry, I hope you can understand that.

That's okay. I guess in similar, maybe this one, you can have some idea as you prepare for the launches. You mentioned about -- you alluded to adalimumab as this 1-year time line and how you see this incremental growth over time. Do you anticipate that 206 would be a similar ramp after launch -- 203, I mean?

203 is different. It's not in the pharma benefit segment. So 203, we would more look into the Cimerli, ranibizumab, buy-and-bill segment of ophthalmology. So, we expect a much faster ramp-up in that segment. Also as -- I mean, ranibizumab, Cimerli, that was the first biosimilar in that VEGF space and now the way is paved and the retina specialists know how to deal with biosimilars, which are equally safe and efficacious. So, we expect a faster ramp-up for sure.

Got it. And I guess just a final one on the pre-filled syringe you guys mentioned you launched in Europe. And what insights you're gaining there for 201 and if you anticipate potentially bringing that to the U.S. and how that's contributing to your growth traction in Europe?

Yes. I mean, it's in the early starting, but what we get at least from the retina specialists is a very positive feedback because that syringe comes with a lot of very positive features, technologically safe application. We have a very low subvisible particle load, so all the -- and very good handling. And it's also very modern technology. So with that said, we get positive feedback, but sales-wise, we have to wait how that evolves. For sure, we expect that, let's say, markets like Germany and France, which didn't open up that much to the vial will definitely open up more fast, and that's what we see already in the forecast from our commercial partners.

The next question comes from Simon Scholes from First Berlin.

I've just got 2 questions. First of all, I was wondering if you could tell us what the figure for reimbursed development services was after 9 months? I couldn't see that in the presentation.

And secondly, I was just wondering if you could give any comment at all on the possible timing of the conclusion of 203 negotiations with Regeneron with respect to Europe? I mean, do you think the negotiations on Europe are likely to take more than a year longer than the U.S. negotiations did?

Yes. Simon, thanks for the very good question. Maybe I'll take the IP question on 203 first and then hand over to Enno for the development services. So the European question, as you rightly flagged, is different from the U.S. situation. So here, our litigation partner, let's say, in that is Bayer. The situation is still pretty complex involving multiple different national court procedures, which are partly public, and we'll continue to pursue litigation activities, has to be led country by country, and we'll see which potential launch dates will result from those proceedings. But there are some positive signals from some countries and some where we're going to appeal in other territories. So this is hard to predict, but how long it will take, but will, for sure, be a staggered approach country by country, depending on the court and litigation situation.

And Enno, reimbursement question?

Simon, you were referring to that to 203, correct?

No, just in general. I mean, I think in the H1 presentation, you had a line on the slides referring to reimbursed development services.

Yes. So what I can tell you is that basically recharges for Q3 standalone for FYB201 and FYB203, where we are receiving still some recharges were in the range of EUR 4.5 million.

Okay. That's helpful. And was that affected -- presumably that was affected by payments for development of the syringe.

Yes, that's the major part. I mean, as you know, the products have been approved already in both cases. So it's really the final work on pre-filled syringe mainly.

At the moment, there are no further questions. [Operator Instructions] There are no further questions.

So yes, with that, Beatrice, so I think we can conclude the call. And finally, I would like to thank you, the operator, our Investor Relations team and also my Board colleagues, especially everyone who joined today's earnings calls and asking great questions.

So, thank you for your interest and trust in Formycon. We remain deeply committed to driving sustainable growth and creating long-term value for our shareholders. So, thank you very much for joining in and looking forward to the next interactions we will have.

Good afternoon, ladies and gentlemen, and welcome to the Formycon AG Earnings Call regarding the half year 2025 results. [Operator Instructions]

Let me now turn the floor over to Dr. Stefan Glombitza, the CEO of Formycon.

Yes. Thank you for the introduction, Beatriz, and good afternoon, good morning, and warm welcome also from my side. We appreciate, of course, as always, your attendance and the interest into Formycon's H1 earnings call.

Earlier today, as you might have read, we issued a press release with detailed insights on our midyear performance. And in a nutshell, I'm very pleased to reconfirm the full year guidance for revenue and EBITDA, while working capital cash is boosted by our recent highly successful Eurobond placement. We are also looking back at a period with very strong operational achievements across many areas. And particularly, I want to mention our pembrolizumab Phase III waiver, which is putting us in a very strong competitive lead position and opens up manyfold opportunities for this attractive asset and beyond because this breakthrough will allow Formycon to develop biosimilars faster and at lower cost.

The financial numbers of the first half year are still indicating that we are at the starting point of the commercial ramp up. They are in line with our phasing assumptions for this transformational year. And we are expecting significant revenue-generating events, particularly in Q4, which make us very confident to confirm the 2025 full year guidance.

We want to use the next 30 minutes as an opportunity to provide additional context on both the operational achievements and of course, the financial performance, combined with an outlook into the period to come. Enno Spillner, our CFO, and me will guide you through the key facts in our joint presentation. And Andreas Seidl, our CSO, will chime in to answer any questions in the Q&A section.

As usual, in those settings, I'm starting with a legal disclaimer on forward-looking statements. Some of you might have seen this slide already quite often, but it's important to me to always refer to our strategic time plan, which we continue to execute stringently, which is unchanged, and we continue executing with laser focus step-by-step on our growth trajectory. 2024 was tremendously important for the company as we got 2 more biosimilar products approved, which prepares the ground for the next ignition stage, turning us into sustainable profitability after having those products established in key markets.

Our continued operational successes are driving the transformation of Formycon into a biopharmaceutical company. Increasing commercial revenues will fuel our pipeline and continuously drive more patient access to vital medicines through our products. The business is a key driver for many players in off-patent industry. You hear that across multiple earnings calls, supported by the overall positive momentum in biosimilars and thanks to the progress of our attractive pipeline, we are at an inflection point to profitable growth. And our target remains unchanged to turn Formycon into sustainable EBITDA profitability ideally as early as next year 2026.

Let me now focus on the operational achievements in more detail. The excellence and track record of our development platform remain the solid foundation for our growth path. And this is getting even more important in the light of a long-awaited Phase III waiver opportunity. In essence, this is driving higher throughput and value generation from our development platform.

Looking at the milestones and the programs in detail, we have been able to communicate a bundle of achievements, not only in the year '24 as well as in Q1 '25, but also in this strong operational quarter across all programs. And in this chart, you see depicted the major achievements of the first half and also an outlook for the months to come. Starting with 201, we gained approval in Brazil. That sounds like another country we add, but it's a gate opener to LatAm, underpinning our strategy of diversification and geographic expansion into emerging markets. Another deal for emerging markets could be signed with a company called Bio Usawa, serving patients in Sub-Saharan Africa, a clear testament that our biosimilars are the solution to address high unmet needs for affordable biological treatments, which are practically not existing in those regions by now.

201 had another highlight, the EMA approval of our prefilled syringe. That was another very important milestone, a high-end ophtha device with strong technological features that have been approved and will benefit doctors and patients. Launch quantities are being produced as we speak, and the preparations are on track for the introduction into key markets, and this will generate additional market traction in those countries.

Key highlight of the first half, of course, have been our FYB202/Otulfi launches in U.S. and key European markets via our commercial partner, Fresenius Kabi and the February start March that happened, followed by Canada in May. And the second half of this year started already with an exciting addition, the launch of Fymskina, the second brand of our FYB202 in Germany. The product is distributed by our commercial partner, Teva, Ratiopharm, and this shall add complementary customers and patients while maximizing our overall market penetration.

Coming to FYB203, several commercial partnerships have been installed in the last months. U.S. with a new biosimilar specialist Valorum, Europe with a very familiar partner, Teva, and we also struck the second product deal with Lotus for APAC. And you'll see more of those license deals for additional countries in the next months. All are lining up for a staggered launch as soon as the IP situation allows.

The year 2025 also started with a breaking news from a positive agency feedback, allowing us to wait the Phase III clinical study for FYB206, our Keytruda biosimilar. That puts the critical path on our Phase I study with a major time driver recruitment speed. And already in July, we could share the great news on last patient in. Combined with the Phase III waiver, this means that the patient recruitment for the total 206 study program is completed now. And this unique time advantage puts us into an extremely competitive situation -- strong competitive situation, sorry, around the attractive assets.

And we sense that very tangibly when it comes to this multiple licensing pages. Upfront payments are planned as an important contributor to our revenue target this year. We expect those to come in Q4. Of course, this is not the end. Our clinical team will dedicate full focus on accurate execution of the remaining treatment schedule until we have the final Phase I study results in hand, and this is expected for Q1 2026 already.

FYB208 has a very attractive cell line feature and is further progressing towards the so-called TPoS milestone, which is the entry gate to manufacturing scale-up and clinical phase and by the way, at a high probability of success. So in essence, you can expect that the strong operational momentum would generate continuous positive news flow in the second half of this year and beyond. And these operational achievements are creating the foundation of future revenues as a lifeblood of our growth path.

Allow me some thoughts on key strategic success drivers for the future because you always have to be agile and adapt to the needs, and there are clear success drivers that are important on the way forward, particularly the rather young segment of biosimilars is still evolving, and we are observing multiple dynamic changes. There are huge opportunities to embrace and the underlying momentum in that segment is definitely growth.

One key lever towards sustainable success in such a fast-moving business environment is geographic diversification. This helps to grasp as many opportunities as possible and boost the global leverage of our developments, including also a rapidly expanding network of international commercialization partners. We have intensified our efforts in this direction in the first half of the year. You saw some deals we struck for emerging markets and through expansion into the high-growth emerging markets and with a broad network of regional marketing specialists, we are today laying the foundation for tomorrow.

Pipeline selection excellence is and will always be of essence. Identifying where to play and how to win is super important. And then, of course, advancing with focus and conviction. Striking semi-exclusive deals, which we also have done partially already for certain territories provides the opportunity to even maximize revenues from this existing portfolio by complementary market strategies.

Our strong backbone is the excellence in biosimilar development. And this excellence is the basis for innovation as a key differentiator, top-notch novel technology and device development, like, for instance, our ophtha prefilled syringe is important to offer superior product features to patients and health care professionals. And innovation means for us also shaping the science. So challenging existing policies, shaping the regulatory landscape with novel, creative approaches in constant dialogue with the regulators. And this happened successfully, for instance, with our Phase III waiver in FYB206. And this is, by the way, not only saving investments of high-double digit millions in our program, same science applied to our younger pipeline enables us to develop biosimilar projects faster and more cost efficiently.

Building on our extensive biosimilar experience, we are thus streamlining our development processes through targeted AI deployment and a constant refinement of our approaches. Streamlined development time lines and advanced cost efficiencies will enable us to fully leverage our development platform and take even more advantage of the unprecedented number of LOE opportunities in the upcoming years.

So speaking about cost efficiencies is a perfect timing to switch over to the financial part. Happy to hand over to Enno, our CFO.

Thank you, Stefan, and also a very warm welcome from my side. Happy to introduce our H1 2025 numbers to you, plus, of course, providing an outlook/guidance for the remainder of the year.

Let's take a look first at our P&L, which is mainly on track. And starting with the revenues. Revenues are in range of what we expected for H1 based on our guidance, which we provided on end of March to you of this year. Due to transformation of our revenue structure, revenues are clearly reduced compared against H1 2024, and I will introduce some more details on the next slide.

Cost of goods also reduced against H1 2024. However, at first site production takes place in a smaller scope. This is mainly due to the fact that we are now recording the regular amortization of FYB202, which makes about EUR 6.2 million per quarter, something we didn't have during the first half of 2024. Would we adjust for this accounting measure, we would be looking at operational cost of sales of approximately EUR 10 million for H1 2025 versus EUR 25 million in H1 2024.

R&D expenses remain in a similar ballpark with the main spending for FYB208 and FYB210. EBITDA is about the same range. This is a -- is in the same range, sorry. This is a, due to savings and phasings along the previous positions I just mentioned to you; and b, due to the fact that the beforementioned amortization is neither EBITDA nor cash flow relevant. The adjusted EBITDA declined due to the reduced equity result coming from our joint venture, Bioeq, which is running our FYB201 performance.

With Sandoz pausing its U.S. activities for similarly and the Q1 sales being under some price pressure, there's lower contribution from this joint venture in H1 2025. The capitalized development costs in 2025 are fully contributed to the clinical development activities of FYB206 and the clear increase of this investment is due to the fact that FYB206 clinical trials started in June '24, extending the investment at that point in time.

Let's take a closer look at the breakdown of our sales, which are consisting of 3 pillars: a, service/development recharges; b, upfront and milestone payments; and c, royalties. In the future, we will recognize a kind of a fourth category, namely sales as manufacturer of FYB202 for retained countries and FYB203 supply chain management. However, both haven't recognized revenues in H1 2025 yet. Current development is clearly reflecting our change in our revenue structure, while recharges for development work on FYB201 and FYB203 continue to reduce as products mature successfully, deferred milestones from FYB202 have now completely faded out due to the successful approval of the product in fall 2024, and FYB201 royalties reduced mainly due to pausing marketing of the project -- product in the U.S. by our partner, Sandoz, as mentioned before.

However, the last position we assume to resume in H1 2026. In return, FYB202 royalties generated EUR 1.7 million of revenues, a relatively moderate start year-to-date, assuming to pick up in the second half, especially Q4 of this year. These incoming royalties are not yet in a range to compensate for the other effects, which I mentioned to you. Upfront payments and on milestone payments from, for example, FYB206 partnering are yet to come and are anticipated to contribute to our overall performance in the future. Therefore, in total, revenues in H1 2025 declined compared against H1 2024, which was expected due to the backloaded 2025 revenue structure.

Also with regards to our cost of sales, we are recognizing similar structural changes as just described in context of our revenues. Operational cost of sales reduced significantly for FYB202, going down by almost EUR 10 million, plus cutting more than 50% of cost of sales for FYB201 and FYB203, respectively, due to reduced and fading out development work. On the other side, we do record a new position of FYB202's regular amortization. And this EUR 12.5 million amount is neither EBITDA nor cash relevant, but significantly influences our cost of sales. In total, our cost of sales reduced by approximately 10%.

Let's review some group asset KPIs. Our balance sheet totals at a strong EUR 743 million. The light reduction mainly results from reduced trade receivables as well as a reduced cash position at the end of the reporting period. Equity is reduced by EUR 54 million due to the net result. And at the same time, our liabilities increased by EUR 24 million or 8%, which mainly is a technical effect from our noncurrent liabilities resulting from a change of WACC or weighted average cost of capital from 10% down to 8.7% being used to discount the earn-out obligations. In consequence, our equity ratio slightly drops, but remains with a strong 55%.

Cash and cash equivalents adjusted to EUR 27.3 million at the end of H1 2025. Also, while we continue to invest a lot into our FYB206 Phase I study, we saw significant cash savings due to the fact that we didn't have to continue to invest into prior Phase III activities. The recent concluded bond is not yet considered in these numbers as it was only settled in July or July 9 to be more precise.

Cash flow and working capital were determined by multiple factors. So net cash from operating activities was quite balanced between our negative EBITDA on the one hand side and a strong positive impact from more than EUR 20 million trade receivables, mainly from a Fresenius payment. Net cash from investing activities reflects our strong engagement into FYB206, showing a EUR 25 million investment, while at the same time, receiving almost EUR 8 million from Bioeq, our joint venture, repaying further parts of their shareholder loan to Formycon.

On the working capital side, current receivables as well as current liabilities and accruals were the most influential factors leading to H1 2025 working capital of EUR 17 million. What you need to know about our debut bond offering, in June, we announced the offering of our first-time Nordic bond as a debut offer to institutional and to retail investors, opening the network to a new group of investors joining Formycon. The offer was well taken by investors from DACH, from Scandic, but also from the U.S. And while initially targeting for EUR 50 million, we finally have more than EUR 100 million on the table and decided to lock in for EUR 70 million. The transaction was concluded on July 9, 2025.

And this is why, as I mentioned, the reason why the successful chapter was not yet accounted for in the H1 reporting. The bond is publicly traded. The proceeds will be utilized for further developing our existing product pipeline, pushing our assets further down the value chain towards [indiscernible]. The loan is unsecured and contains very moderate covenants and maintenance only. Interest is floating at 3-month Euribor plus 700 basis points, turning out at the lower end of the spread, payable quarterly with first payments due on October 9, 2025. The term is 4 years. Our so far existing shareholder loan was, by the way, waived in this context while also seeing a commitment into this new loan from some of our major shareholders, which, of course, is highly appreciated.

But let's get back to our financial performance and our respective guidance for second half of 2025. It is obvious that with revenues of EUR 9 million recognized for H1 2025, aiming for a range of EUR 55 million to EUR 65 million of revenues for the full year looks a bit like a stretch. That said, we remain positive to achieve this revenue guidance for the full year 2025 based on 2 main revenue drivers. Formycon expects a strong and very dynamic second half of the year due to the targeted conclusion of first licensing partnerships for FYB206 and further establishment of FYB202. This is especially true for the fourth quarter of 2025 and therefore, and backloaded or a backloaded expectation.

Regarding FYB206, we are progressing in positive discussions with various industry players, which may become our future licensing and commercialization partners for FYB206. Not yet a done deal, but we consider it realistic to conclude accordingly still in this year. Regarding FYB202, we are receiving encouraging signs from our commercialization partners for further accelerating increase in revenues and thus royalties for Formycon. Recently announced deals, for example, in the U.S. between Fresenius Kabi and CivicaScript confirm this trend. However, it takes a while until these agreements materialize into revenues with benefits for Formycon.

So overall, we confirm our guidance for 2025. Revenues in H1 2025 came in below '24. And as just described, '25 will be backloaded due to the market grip of FYB202 and expected licensing deals for FYB206. Full year EBITDA will benefit from the expected positive revenue performance during the second half of the year. Adjusted EBITDA should even reverse slightly. And working capital is the position we change, namely uplift, mainly due to the successful bond financing contributing to the working capital. Liquidity with the additional EUR 17 million gross on our accounts will get us through the developing of the current pipeline and achieving EBITDA profitability.

Just 3 very brief points on this particular slide. Engagement of existing anchor investors remains stable or unchanged. Comparing our trading volume for H1 2024 versus H1 2025 shows a more than 4x increase of our average share liquidity. And now with a publicly listed bond in place, we do have the second publicly listed vehicle in the capital markets.

And with that, I'm at the end of my part of the presentation and would like to hand back to Stefan for a final summary. Looking very much forward to your questions, and thank you very much.

Yes. Thank you, Enno, for providing us with all the necessary details to understand the numbers.

Let me just conclude in a summary regarding our company and the way forward. So with 3 pipeline assets approved, 2 being marketed and the third one in the waits was a very strong and steadily progressing pipeline, we were able to create a trust-building track record. And at the same time, also a robust platform for commercial partners that are seeking to license in our attractive assets for their portfolio.

And we believe we have all the ingredients in place, the right strategy, the right science and excellence, combined with passion and agility to adapt and grasp the multiple opportunities. And this is enabling us to increase access of patients with severe diseases to our biologics through our partners and play an increasingly leading role in this attractive growth space.

Biosimilars have come to stay. And we are acting in the fastest-growing segment of pharma with more than 100 biologics losing exclusivity in the next decade. So the ground is prepared for the next chapter of Formycon's growth story.

With that, I want to conclude the presentation. Thank you for your attention and hand over to the moderator for the Q&A section.

[Operator Instructions] And first up is Nicolas Pauillac from Kepler Cheuvreux.

Hopefully you can hear me. Maybe a few annoying questions from my side. But just to come back on this good slide that you showcased for the ramp-up of the revenues over H2. I was wondering, first, if you could maybe give us some color on how much of the, let's say, total sales will be exposed to the licensing deal? And so how much will be tied to FYB? I think broad idea on that would be clear.

And then maybe a second question tied to that. We saw like this increase in trade receivable and you are saying that this is tied to Fresenius. So are we to expect that maybe there is like potentially a private label deal or something like that, that can happen around the end of the year for 202? And then on 203, if you have any update on the time line, that would be really helpful, too.

Yes. Thanks, Nicolas for questions, and I'll start with the 203 first in the different order. So although I cannot tell a lot more than last time, I think you're probably aware that FYB203 or aflibercept biosimilars are currently multiple litigation and court proceedings in several countries, and each country is handled differently on different courts and different grounds. And we will learn more about the timing depending on the outcome of those proceedings in the next couple of months. There is still a lot going on there. We feel well positioned, but the outcome is never 100% to predict. And for those reasons, we are currently unable to make a valid statement here. I mean we have also announced that we have approvals and commercial partners. So we are in the waits for the launches to come. But besides that, we have to wait for the outcomes country by country and then be ready for launch, which we are.

Then 202, the statement of the Civica deal. So we are happy to confirm that Fresenius Kabi has signed an agreement with CivicaScript and CivicaScript will act as exclusive distributor of unbranded ustekinumab product as Fresenius customers. So that's a very positive announcement and deal, and this is in the series of deals we expect. So we -- the market penetration, of course, goes step by step. So it doesn't move fast in the PBM segment, but Stelara is still dominating the formularies, but Fresenius Kabi is well positioned based on the established customer relationship and also on an integrated commercial infrastructure. This team is -- the U.S. team is not only launching this molecule, but also other molecules with the same payer structure. So the U.S. team is relentlessly driving coverage gains step by step with a growing number of deals and totally different types of settings, direct, indirect, exclusive, nonexclusive and the CivicaScript is a nice and a good example for that.

And the first question, was that around 206...

It was basically about the revenue ramp-up and breakdown. And we can -- at this stage, we cannot guide on detailed numbers with regard to each single asset. Clearly, we can confirm that 202 from royalty performance and 206 hopefully from upfront payments/milestones will be the 2 major revenue contributors. Of course, we will also see some revenues from 203 from preparation work and services. The same is true for 201. But clearly, 206 and 202 met to be the major revenue drivers, but no details. Both of them, however, will probably show their most significant impact in Q4 of this year.

Next up is Simon Scholes from First Berlin.

I've got 2. So I think it's likely you'll be disclosing the originator product for 208 in the course of the remaining months of this year. I was just wondering if you could remind us or tell us for the first time roughly how large or how the market for the 208 originator product compared to the size of the originator of the market for some of your other assets?

And then just on the working capital position, I was just looking at your balance sheet, your H1 balance sheet, it looks if you generated about EUR 13 million from receivables in the first half and EUR 8 million from payables. I mean that makes it roughly comes to the EUR 20 million you mentioned in the slides. I was just wondering what might happen to those positions in the second half of this year?

Yes. Thanks, Simon. Happy to hear you, and thanks for your questions. I mean first -- on the first one, I have to ask for your patience. So we will disclose, I can confirm, we will disclose around the TPoS, which is expected in the next few months. And in that moment, we will disclose, and that will come then, of course, with the size and the description and the molecule. So we have to ask for a bit more patient and for the work patients.

And for the working capital, handing over to my neighbor.

Yes. And welcome, Simon, from my end as well. With regard to the receivables that you were mentioning, this is basically the repayment of the shareholder loan that we received from Bioeq which is a larger position still remaining. And we had an extended slide on that, I think, 2 quarters ago, how the structure works. So whenever Bioeq is in a liquidity position to repay positions of this loan, they will transfer. So it's hard to guide on regular numbers here. And the EUR 13 million payables that you were referring to is based on receivables from Fresenius royalties, right?

The next question comes from Yi Chen from H.C. Wainwright.

This is Eduardo on for Yi. I guess a question around FYB202 and kind of the progress in the U.S. market. If you have any -- just an update on early uptake and the distributor dynamics there and what the time line is for kind of seeing the revenue reflect the revenue ramp in the U.S. market?

Yes. Thanks, and thanks for the question. I mean partially answered already to the first question. So what we see is that you can compare a bit with adalimumab where it took 9 to 12 months until there was an inflection point until the market opens up more significantly, and it does and it did. So we expect the same for ustekinumab. What we see here is still that in the first year, what we also announced that Stelara is still very dominant on the formularies.

So overall, I don't know the very recent percentages because IQVIA is not always correct on that one, but it's above the 90% still percentage points. But it's slowly eroding to the favor of biosimilars and to the favor of the deals that are being struck. And I mentioned just one example, the Civica deal. This is for sure, a major one, but there are others as well ongoing. And as I said, the U.S. team in Fresenius is doing a very good job and striking one deal after the other. As I said, the major impact for this year is very backloaded in Q4. But the deals are, of course, something that will then generate revenues in the future years to come. So 2025 will be just the starting point, but in Q4, significant numbers compared to the first half.

Got it. That's really helpful. And then maybe switching over to 206 and clinical data there. Do you have any visibility into interim safety and PK comparison for the 206 trial? And any early signs or reports that we should watch for in the coming months?

I mean, of course, this is something where Andreas jumps in, please, Andreas.

This is Andreas Seidl. The clinical study for 206, so the PK study is progressing very well. We have finalized the recruitment of this study in July. The first patients have passed the 12-month treatment period also successfully, and we expect the top line results of this study. So this means the results of the primary endpoint in the first quarter of 2026. The study is progressing extremely well. We have no issues there. And therefore, we expect also a good outcome in next year.

The next question comes from Alexander Galitsa from Hauck Aufhäuser Investment Banking.

Just have 2. One sort of a clarification. I think you kind of touched upon that in your presentation. I'm not sure if I caught it correctly. The increase in the contingent purchase price payment from EUR 173 million to EUR 192 million in the second quarter. Why was that? And how does this liability, which is essentially earn-out split between 201 and 202?

Yes. Thanks, Alex. It goes right away to Enno.

Yes. And the factor is the way that the -- indeed, we have to, on a regular basis, review and calculate the earn-out model. And obviously, underlying there's the WACC, the weighted average cost of capital is a key calculating parameter. And this change as it changes once in a while as an external factor, which we do not totally have on our own control. And in this case, it went down from 10% to 8.7%. So that means we have less deduction here or depreciation here, so to say. And then that means that for technical reasons, the amount increases, which is obviously something that can go up and down by a while.

And with regard to the earn-out question, it's roughly a split 75% on 201 and 25% on 203 -- 202, right, sorry. Yes.

Understood. And my second question is related to 202 revenue. I guess I wonder what kind of step-up would you require to see in the third quarter for you to still be confident in the guide?

I mean there will be, of course, increase in the third quarter we expect, but it's incrementally increasing. I mean we see with the additional launch in Germany, we see markets evolving step-by-step in Europe. The big drivers will be U.S. And this is kind of one-point assignment of a deal and one-point assignment of delivery and supply to that deal. That's why we don't expect a huge increase in Q3, we will see a heavy loaded increase in Q4. And that's all the signals we see there confirm that. So that will be a kind of hockey stick event or evolve that, which will then be more stabilized in the way to go, but we are just establishing that market and its early launch phase still. I mean the Q code and interchangeability was assigned in May. So it takes some time to evolve that. So again, Q4 will be much stronger than Q3. That's our expectation.

At the moment, there are no further questions. [Operator Instructions] There are no further questions.

Okay. So with that, thank you very much.

Finally, everybody has deserved to enjoy the sun outside, obviously. So we, of course, close earlier. I would like to thank the operator, Beatriz, and also our Investor Relations team, my Board colleagues and especially everyone who is joining this today's earnings call, and thank you for your lively interest and trust in Formycon. We remain highly committed to building solid growth of Formycon and thus creating value for our shareholders.

So thank you very much for joining and looking forward to the next interaction.