Formycon AG ($FYB)

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, along with 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 2 KEYTRUDA biosimilar as well as an agreement with Bayer clearing the path for the launch of our third biosimilar to 203. Over the next 30 minutes, Enno Spillner, our CFO, me, will walk you through our presentation Enno Spillner and Andreas Seidl 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., Pharmacon 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 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. only consent 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 other prefilled syringe to streamlined clinical development concept like our pioneering Phase III waiver in FYB206. 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 support and 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 disciplined and laser focus on a clear strategic growth math. 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 low 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. From 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 commonalization 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 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 context of our year-end process and the sum 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 on -- 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 1 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 FIM which makes about EUR 25 million in 2025, something we only recorded during Q4 in 2024. Would we adjust for these 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 F28 for the May course of the year 2025, Fit 29 and then F210 the most investment intense of these 3 assets is F28, which successfully achieved the POS, so technical proof of similarity with the end of Q3 and for Q4, respective investment to these assets was already capitalized. The remaining assets and especially FIM 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 outer balancing effect of significant reduced cost in the range of approximately EUR 18 million for example, development costs for FIM201 and FIM23 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 FG22 considered under our COGS here is neither EBITDA nor cash flow relevant and makes a very significant portion of our overall cost. 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 BioAg received in connection with the new sides partnership for FB21/o which came in very late in 2025. The earnings contribution from FIP201 via the joint venture BioAg 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 F206. The clear increase of this investment is due to the fact that F26 clinical trials were recorded for the full scope of 2025, whereas in '24, the activities were only started midyear. In Q4 2025, also F28 achieved TPS, 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 1 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 BioAg performance, especially within 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 F6, 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. Rig charges for development work on F21 and F23 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 F-22 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 FIP202 were a one-off effect in 2024 and thus not expected to repeat in such an amount in 2025. FP-20 royalties reduced May due to the pausing of the marketing for the product in the U.S. has just mentioned before. And therefore, total revenues in 2025 declined comparing against 2024, which was expected and also reflected in our guidance for '25. This effectively also means significant structural change of revenues for '25 and subsequent in the subsequent years. And in the regard, we recognized first strong signals of change in 2025. So F22 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 1 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 F26 partnering with Sines and me 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 FP206 as our next growing asset. So why did we come or while it will come out short of our guidance despite assuming 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, F206 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 1 of these examples, which we realized in the mean term. Furthermore, milestone payments originally expected in the fourth quarter of 2025, we have 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 FIP202 developed less dynamic 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 FIP202 going down by approximately EUR 15 million. And the reverse amortization for FIP202 saw the first full cycle in 2025 and thus, increased from approximately EUR 8 million in the fourth quarter of EUR 24 million 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 FIP 201 and F23 reduced by approximately 60% from roughly EUR 25 million to EUR 10 million. In total, our cost of sales reduced by approximately [indiscernible]. And on this slide, and you have seen a similar slide in the last year on our F22 valuation. It's just to make transparent to you with the change in our value assumptions here. And probably most important to use the upper line, the intangible asset of FIM202, 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 cash -- 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 and KPIs, which we summarized for you. Our balance sheet totals are at or do remain at a strong EUR 750 -- EUR 740 million, sorry, 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 1 hand side, we do have successfully raised our first bond, adding 70 billion to our liabilities. On the other hand, our earnout obligations have been reduced due to a payback and the adjustment of our valuation model for FIP21 and for FIM22, which also indicated a reduction in our 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 FIP206, especially our clinical activities showed approximately EUR 50 million of investment and also FP208 contributed to this aspect with approximately EUR 4 million in Q4 2025. At the same time, we were receiving EUR 15 million from BioAg repaying further parts of their shareholder loan to Formycon. On the working capital side, current receivables as well as current liabilities and revenue accrues where 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, 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 FB1 and 23 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 FIB202 will continue to grow significantly and should build 1 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 store. 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 FIP206. 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 F26 revenue performance. FIP201 is anticipated to show an upswing in royalties again with the Sandoz resuming sales for the U.S. already in January of this year, and ciders 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. FIP203 is expected to launch in Europe and in the U.S. in this year with the U.S. starting in Q4 2026, thus, no significant impact to be expected from the royalty part, but the major part of revenue is coming from our remaining development recharges as well as handling the supply for Fit202, sorry, for 523 product. So in essence, FIM202 and FIM26 will be the 2 strong main pillars of our revenue guidance pretty much on a comparable level. with P20 and 23, 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 BioAg should accelerate its performance once again against the relaunch of FIN 201 in the U.S. and actually adding the second quarter. 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 FP2 and partly F20. Based on this planning, going concern was also confirmed by our auditors, and it goes without saying that we had keep continuing with significant saving efforts and cost control efforts to manage the cost cycle in our organization, also securing EBITDA profitability. And 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 is 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 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 Stephen. Thank you very much.

Yes. Thank you very much, Anna, 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 Anna 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 initiatives. 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 F21 launch in Brazil with Bain and also the mentioned deal with LOTUS across multiple APAC markets for FIT26. Further license agreements, of course, will follow along those lines. Looking at our commercial portfolio, as Anna mentioned, similarly has been introduced to the U.S. market in January by Sandoz. and TIMCO, our second F21 brand with a partner sides shall be added in the second half of this year. P23 reached a key inflection point with the settlement enabling a European launch in May, so close today 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 waiver project 26 continues to progress as planned, and we could confirm in February the PK equivalence data, which are 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 Westar from RBC.

I have a couple, please. The first, on your 2026 revenue guidance for EUR 70 million. Are you able to provide a bit more of an idea of how much of this depends on Feb QoQ royalties specifically? And then how much of this you're expecting from the U.S. versus other regions? Then just touching on the impairment for FIP202, 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 FB206, 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 6. Maybe we start with -- in the different order with the 206 partnership question. Let me hand over to Nicola, our CEO. 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 dosing and please understand that we cannot share a detailed timing of the submission that 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 shortly deal with Lotus on APAC, and there are more regions that we can expect. Nicolas, 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 question was possible, I think, about milestone projections, right? Was that NOL?

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, 1 of the key pillars for our overall revenue recognition. We cannot portal also for confidentiality reasons, not guide on the details, but the milestones are probably -- typical milestones that you would expect along further development and filing strategy towards market approval then later years. And in that regard, these milestones will probably be in total can be 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 Q2, 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 is 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 thrid of our total revenues of our organization for next year in that range as a rough orientation. Thus 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 valuation 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 the 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 Nicolas 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.

I comment a bit on the U.S. So 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 original -- 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 -- or 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 in as Kainos our partner there to gain share out of this more and more opening space to practice the long-term success and cash contributor and it's revenue contributor to our company.

And the next question comes from Katherine Deganfromi from.

Good morning. This is Katie. I'm on for you. Chen at H.C. Winright. 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.

Maybe -- I mean, Andreas to comment on the PA results 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 -- barriers are already recognizing double digits 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 the major deal triggering these revenues for -- 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, 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, any future yields to what we have already.

And the next question now is Nicolas Pak from Kepler.

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 will 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 see our 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 insight into the strategy of this kind of stable product commercialization that you are kind of building. What's the idea behind 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 primarily moving forward. So that would be the free.

Yes. Thank you, Nicolas. Very interesting questions. Of course, maybe I get to start and then Nicolas to chime in. Additionally, so 2, I mean, Nicolas outlined already, what's the situation there in the PBM market. I mean, we have seen significant sales in Q4 following Fresenius Kabi's, excuse me, the U.S. distribution deal with Civica script. 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 [indiscernible] around 70% are still with the originator, 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 positive focus in the U.S. increasingly moving beyond this streamlining regulatory framework toward improving market access. And we saw some announcement also on -- 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. properly 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 -- it moved towards a realistic reflection based on 1 -- more than 1-year market reflection -- while seeing the positive momentum in the market. Fresenius Cabin is focusing relentlessly on coverage gains with a direct contracting like the -- with the commercial plants like the Silica deal. And in the European market, there is 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 FYB202. On the FYB201 U.S. strategy, I mean, the -- at least we are happy that it's been really introduced Similarly, it's back to the market since January. and we also complemented that by a second brand, Notino with partnered with Side 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 2 or 3, I mean, yes, there is -- each partner has a different strategic approach to the buy-and-bill market and with a partner Valora, it's not expected that they go the same path as we did for similarly, so I would not expect similar dynamics or a similar action coming from Valor on FYB203.

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

Yes, I can confirm that. So our current assumption, triggering the going concern or resulting into a positive growing concerns 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 today in our pipeline and being covered from a development perspective. So FYB208, 210, and so on and also the remainder by the way, for FYB206 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.

Yes, I've just got a couple of questions. First of all, on the FYB206 milestones. I mean you did 17.2 million last year. I mean 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, in this year, Asia Pacific. So are you expecting Europe and Asia Pacific to 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?

Thanks, Simon, for the questions. Maybe I'll take the first one. 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 in particular higher this year, last year, sorry, 2025, due to the significant investment into the clinical stage of FYB206 or for 2026 operational year, we have expectation of less CapEx as 2010, for instance, not yet clinical, FYB208 is getting ready or get it being prepared, but yet not fully exposed despite the respective costs being capitalized. And we have some remaining activities under FYB206 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] And 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, 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 team for all the preparations, my Board colleagues for joining in for the answers and especially everyone on the call who joined is 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.