Good afternoon, ladies and gentlemen, and welcome to the Formycon AG earnings call, full year 2025. At this time, all participants have been placed on a listen-only mode. The floor will be open for questions following the presentation. Let me now turn the floor over to Dr. Stefan Glombitza.
Yeah. 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. It required additional diligence and 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 three key messages up front. 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 four pillars of our Fit for Growth strategy, which I will explain later in a bit more detail. 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 two 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 four 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 four pillars. Pillar one, 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 two, 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 three, excellence and innovation are core to how we operate. Formycon since years consistently delivers high development and regulatory quality, accelerated approval timelines. 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 for FYB206. Excellence in execution and innovation creates first-mover opportunities and positions Formycon as a trusted high-performance partner in biosimilars. Pillar number four, lean development is a core enabler of our platform. By optimizing our clinical and regulatory concepts and leveraging more and more digital and AI support and processes, we materially reduce development timelines 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 growth method.
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. 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 timeline, which was stretched beyond the usual timeframe. 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 context of our year-end process, and the sum of the parts that made it very challenging to maintain the timeline as initially anticipated.
Let's take a look at the financial outcome and at the first slide on a high-level summary. Revenues are below what we had targeted for 2025. 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.
If we adjust for these accounting measures, you 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 costs of the year 2025, FYB209, and then FYB210. The most investment intense of these three assets is FYB208, which successfully achieved the TPOS, so Technical Proof of Similarity, with the end of Q3. For Q4, respective investment into these assets was already capitalized. The remaining assets, FYB209 and especially FYB210, 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 revenue is reduced by approximately EUR 25 million, as just indicated, we do recognize a direct out-of-balancing effect of significant reduced cost in the range of approximately EUR 18 million.
For example, development costs for FYB201 and FYB203 and R&D cost. 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 - 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 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 2024, the activities were only started mid-year.
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. A nd here the main reasons for the EBITDA are effects from sales on the one side, but very intense cost management, high capitalized development cost and development cost to be incurred to a later point in time as the major building blocks. The adjusted EBITDA, as I just mentioned, that mainly benefits the profits from the positive development of the Bioeq performance, especially with the latest deals.
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 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. For 2025, this is consisting of three 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 2024 moving into 2025. Recharges for development work on FYB201 and FYB203 continued 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 in 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. Therefore, total revenues in 2025 declined comparing against 2024, which was expected and also reflected in our guidance for 2025. This effectively also means significant structural change of revenues for 2025 and in subsequent years. In that regard, we recognized first strong signals of change in 2025.
FYB202 royalties generated for the first time revenue in the amount of EUR 9.7 million in 2025. This 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. 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, 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. In 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 2024 to EUR 25 million in 2025. Again, not EBITDA relevant, not cash relevant, just as a reminder. Cost of sales for our research 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 a quarter. On this slide, you have seen a similar slide in the last year on our FYB202 valuation, is just to make transparent to you the change in our value assumptions here.
Probably most important to you is the upper line, the intangible asset of FYB202, which we tested in an impairment test, reducing the respective value 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 -EUR 46 million. 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.
The slight reduction mainly results from reduced non-current assets, while, for example, our cash position increased. Equity is reduced by EUR 63 million, mainly due to the net result. At the same time, our liabilities increased net by roughly EUR 30 million or 10%, which is driven by two main effects. On the one hand side, we do have successfully raised our first bond, adding EUR 17 million 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 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 respect with approximately EUR 4 million in Q4 2025.
At the same time, we were receiving EUR 15 million from Bioeq AG, 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-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.
This 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. The trend should be positive and clear. 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 we 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. The major part of revenue is coming from our remaining development recharges, as well as handling the supply for FYB203 product. In essence, FYB202 and FYB206 will be the two 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-EUR 15 million as Bioeq should accelerate its performance once again against the relaunch of FYB201 in the U.S. and actually adding the second partner. Our working capital is expected to come out in the range of EUR 20 million-EUR 30 million, considering no financing activity for 2026, 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 keep continuing with significant saving efforts and cost control efforts to manage the cost side within our organization, also securing EBITDA profitability. 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, also our goals and our anticipated and planned initiatives for ESG across all different contexts that go along with that, and it also summarized 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. 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. With that, I conclude my part of the presentation and would like to hand back to Stefan.
Thank you very much.
Yeah. 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 two key aspects for Formycon. First, in Q4, we passed the inflection point towards sustainably positive EBITDA, which Enno alluded to as well. Secondly, we made major progress in the operational transformation across our four strategic levers, as outlined 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 already been achieved in the first months of 2026.
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 today, and a clear path forward to the U.S. in quarter four. 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.
Driven by the pioneering phase III waiver approach, FYB206 continues to progress as planned, and we could confirm in February the PK equivalence data, which are key elements to the regulatory dossier which we are preparing. For our Dupixent bio similar 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 timelines and costs for new programs by around 30%. 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.
Thank you very much. Ladies and gentlemen, asking questions is only possible via telephone. If you would like to ask a question, please press nine and star on your telephone. If you would like to withdraw your question, please press three and star. You can now press nine and star to register your question. The first question comes from Natalia Webster from RBC. Please go ahead.
Hi there. Thanks for taking my questions. I have a couple, please. The first on your 2026 revenue guidance for EUR 670 million. Are you able to provide a bit more of an idea of how much of this depends on the FYB202 royalties specifically, and then how much of this you're expecting from the U.S. versus other regions? 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? 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.
Thank you.
Yeah. Thank you, Natalia. There are two finance questions and one partnership question, 206. Maybe we start in the different order with the 206 partnership question. Let me hand over to Nicola, our CBO. We can give you to that. On the timing, maybe I answer that first. As 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. The partnerships, we started already with the U.S. partnership last year.
We have also just signed a deal with Lotus on APAC, and there are more regions that we can expect. Nicola, maybe you can comment on how the interest looks like and what our position is there.
Yeah. Happy to do 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. These are the two big regions which we are tackling this year. Question was also, I think, about milestone projections, right? Was that, Enno, should I?
I can comment on that. First of all, welcome, Natalia, to the call once again. 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 upfront 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. This will be, as I said, one of the key pillars for our overall revenue recognition. We can unfortunately, also for confidentiality reasons, not guide on the details. The milestones are probably typical milestones that you would expect along a further development and filing strategy towards market approval then in later years.
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 a third of our total revenues, just as a rough indicator. 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. Don't expect that necessarily to go on a linear line moving forward. We have seen that last year, also in 2024, with Q4 being exceptionally high compared against the other quarters.
Here we are in total are also expecting a double-digit number which could make another third 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 the 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 disclosed this here. This fully includes a long-term planning for the next couple of years in separate markets. Certainly what I can say, U.S. remains the major revenue driver in our anticipation.
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.? Yeah. Just for the U.S., 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. There is still a significant market on the brand and/or on the originator, and the biosimilar competitors are now fighting to open up this space. In that space, we expect more and more volume becoming available. As explained already in the past, this goes slower than what was originally projected in the industry and therefore, yeah, it's a marathon and not a sprint.
We have to continue using this 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.
Great. Thank you very much.
Thank you. The next question comes from Katherine Degen from H.C. Wainwright. You have the floor.
Good morning. This is Katie. I'm on for Yi Chen at H.C. Wainwright. I apologize if this has already been answered. My connection's 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 Q1 2026 or if you had to trade some of that upfront cash for higher long-term royalties?
Yeah. 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 three pillars, namely upfront, which we received in Q4 2025, and also then respective development milestones/commercial milestones, and then obviously royalties. We tried to negotiate a very balanced deal here, which still has very significant upside on the long end, which we consider highly attractive.
Various already recognizing double-digit millions in Q4 of 2025 for
upfront and milestones. Again, as I just indicated already for 2026, also having significant potential for further development milestones. We think all three parts are well covered and do reflect the true upside of this asset as this is 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. In particular, Europe is not yet partnered as well. Ideally, there's more to come during 2026 and 2027 also from that perspective, adding future deals to what we have already.
Great. Thank you.
Sure.
Thank you very much. The next question is Nicolas Pauillac from Kepler Cheuvreux. The stage is yours.
Hi, guys. Thanks for taking my question and congrats on the result and this very interesting guidance. Maybe if I can just come back on 202, and kind of play around your answer, but would 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. Three players are kind of taking it over with the private label deal. When you do your forecast, what do you assume? That this is something that kind of get blown up and so you can take your market share? That will be the first question.
Also, still on the U.S. market, but on FYB201 this time, could you give us some insights into the strategy of this kind of double product commercialization that you are building? What's the idea beyond that, and how should we think about it when we look into the future? Lastly, on FYB203, also on the U.S. for the focus, but how confident are you that we are not going to run into a similar situation to what happened with CIMERLI moving forward? That will be the three.
Yeah. Thank you, Nicolas. Very interesting questions, of course. Maybe I get a start and then Nicola to chime in additionally. FYB201, Nicola outlined already what's the situation there in the PBM market. We have seen significant sales in Q4 following Fresenius Kabi's exclusive U.S. distribution deal with CivicaScript. That shows that single deals can make a difference in both directions. There's a lot of momentum or potential in there as well. Also, given the fact that around 70% are still with the originator, so still accessible to biosimilars. It remains a stepwise approach to remove Stelara from the formularies. 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.
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 believe that the assumptions we took in our second impairment now, after more than one year in the market, appropriately reflect what is visible and controllable today rather than what might become possible under more favorable structural conditions. That's kind of the pendulum we have. It moved towards a realistic reflection based on more than one year market reflection, while 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.
In the European market, there's also gaining traction in France and Germany, for instance. Also there, 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. Especially with our two partners there, well-known two brands being strong in the space of the pharmacy substitution, we expect additional momentum for both brands. Given that situation, I think we have a realistic view with some potential for future growth of FYB202. On the FYB201 U.S. strategy, 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, partnered with Zydus.
We can also have two complementary market strategies, which will also stabilize and grow that market accordingly. I cannot share more details, of course, on the different strategic approaches. Coming back to 203, each partner has a different strategic approach to the buy-and-build market. With a partner, Valorum, it's not expected that they go the same path as we did for CIMERLI, so I would not expect similar dynamics or similar action coming from Valorum on 203.
Okay. Super. Yeah. Maybe if I can just squeeze a final one. On the going concerns, does that include the new investment that you will have to put into 208 when it moved into clinical study and the rest of the pipeline?
Yeah, I can confirm that. Our current assumption triggering the going concern or residing into positive going concern is the current cash reserves that we had at the end of the year, EUR 68.8 million+ 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. 208, 210, and so on. 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.
Okay. Super. Yeah. Thanks a lot for the answer.
Thank you very much. The next question comes from Simon Scholes from First Berlin. The stage is yours.
Yes, good afternoon. I've just got a couple of questions. First of all, on the 206 milestones, 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. Last year you had the marketing agreements in the U.S. and MENA, I think, and this year, Asia-Pacific. Are you expecting Europe and Asia-Pacific together to exceed the milestone from the U.S. and MENA? On CapEx, I was wondering if you could provide. 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? Thanks very much.
Yeah. Thanks, Simon, for the questions. Maybe I'll take the first ones. The 206 milestones are not only down payments for deal signature. 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. 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. CapEx was in particular high this year, 2025, due to the significant investment into the clinical stage of 206. For 2026, operational year, we have 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 cost being capitalized. 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 clearly reduced compared to what we had last year.
Okay. Thanks very much.
Welcome, Simon.
Thank you very much. Currently, there are no further questions. Once again, if you would like to state a question, please press nine and star on your telephone. We are waiting another moment to see if there is another question coming in. That is not the case, and that concludes the Q&A session. I will hand back to Dr. Stefan Glombitza for some closing words.
Yeah. Thank you. Finally, I would like to thank the operator, of course, our investor relations team 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. 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.
The recording has been stopped.