Formycon AG (FYB) Earnings Call Transcript & Summary

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?