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.

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 four pillars of our Fit for Growth strategy, with a key highlight, of course, of positive results from our FYB206 PK study in February. Third, on 15th of May, just recently, we successfully launched our third pipeline product, FYB203, 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. 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 four pillars that directly translate into competitiveness, capital efficiency, and sustainable long-term growth when executed in a disciplined and agile way. Let me briefly explain what is behind each of the four pillars.

Number one, geographic diversification. Europe and United States are still remaining the core target markets, but 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 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 the 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.

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 on 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 autoinjector for FYB202, and further to streamlined clinical development approaches, including the pioneering Phase 3 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 attractiveness also generates fierce competition. 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. 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. 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 roadmap. 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 months 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 four pillars of Fit for Growth. Several value-creating milestones have been already achieved in the first months of 2026 in all four 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 Biomm 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, FYB201 has been reintroduced to the US market in January, and FYB201, our second FYB201 product with partner Sandoz, 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 a settlement enabling a European launch in May and a clear path forward in the US in Q4. On May 15th, we finally brought the third product from our development pipeline to the 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. Building on the last year's ophthalmic prefilled syringe launch in FYB201, we will soon enhance our partner's FYB202 offering with an autoinjector, following EMA approval which we received in April.

Driven by the pioneering Phase 3 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 steam.

Phase 3 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%. 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.

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, you probably still recall some in-depth details.

Therefore, we will only focus really on Q1 2026 performance. That said, let's take a look at the overside of our P&L, where we have good operational momentum translating into a significant revenue growth and significant revenue increase.

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. Now, I'll come back to the details later on one of our next slides.

Looking at the cost of sales, these cost of sales in total are relatively stable compared to Q1 2025. We continue recording the regular amortization of FYB202, which makes about €5.2 million in Q1 2026 versus €6.2 million in Q1 2025.

Would we adjust for this accounting measure, we would be looking at operational cost of sales of approximately €10.7 million in Q1 2026 versus €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 two remaining assets are still less cost-intense due to their 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 €11 million compared to Q1 2025. This, of course, is consisting of different effects: revenues increased significantly, as just mentioned, while cost of sales stood fairly stable or 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 amount to -€3.6 million versus -€11.8 million in Q1 2025.

This, again, is a significant €8.2 million uplift against the comparable quarter in 2025, trailing our EBITDA, 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 US, 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 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 US part is being covered under cost of sales in context of our Sandoz 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 2026, 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 €2 million.

Royalties for FYB201 now need to reaccelerate after pausing marketing in the US until end of 2025. Our US partner now has to re-engage into the US market and rebuild respective market share, which may take some time.

We are optimistic seeing an acceleration here during the course of the year. Royalties for FYB202 almost doubled, and while these sales revenues from FYB202 are currently still developing modestly, we see positive trends from our partner's activities in the US, leaving us optimistic 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 autoinjector, which we do recognize in Q1 2026 as a one-off. The new kid on the block are 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 Sandoz, 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 recharged 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 cost for the US development and targeted market approval.

Looking at our group assets and respective structure, our balance sheet total stands at a strong €717 million, and the reduction mainly results from the net cash outflow and some prepayments that we had. Equity is reduced by €15 million—1-5 million—mainly due to the net result, and at the same time, our liabilities decrease slightly by net €9 million, which is driven by two 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 €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.

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 will 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 €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 €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 US. 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 partnerings like the already aforementioned 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 joining for the US sales and marketing during the course of H2. FYB203 is launching in Europe and in the US, with US 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. In essence, FYB202 and FYB206 being the two 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 a 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 report in previous quarters. With that, I'm 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 the strong communication voice in our team here at Formycon, and Sabrina Müller, unfortunately, has decided to leave Formycon after many exciting years at the company.

We would just say a big thank you to Sabrina for her engagement, for her commitment, and also for a great contact to you out there at conferences, at roadshows, and with the analysts. Thank you, Sabrina, for your support over the time.

Was a great pleasure. 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. Thank you.

Okay. Hi, guys.

Hopefully, you can hear me. Congrats on the result, and all the best to Sabrina.

That was really nice working with you. Just some 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-promoted cost? That would be the first question.

Then just on 206, 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 would be the, let's say, commercial milestone or development milestone that we should expect over the next maybe three years? Also on that, what would be your assumption on when you think that you will be able to launch the drug, whether it's in the US or in Europe?

Lastly, the final is on the 208. We've seen 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're offering that they think they could get up to two-year of extra commercial opportunity in the US.

How do you think about that, and was that kind of your initial assumption that it was going to go that way? I will stop there.

Thanks, Nicolas. That was three questions.

I would like to start with the probably most easiest part. On 206, the next milestones are, of course, compiling all the different parts you need for a complete dossier for an FDA filing.

Of course, 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 3 waiver, where we need good results, which we have in hand. We are compiling that.

I will not comment on a timing, but we are fast-track on our way to the next milestone, which is the submission. Then typically 60 days after submission, you will receive, if the FDA is okay with the data you submitted, the so-called file acceptance.

That would be then the latest point in time where we would announce this milestone. 208, maybe I hand over to Nicola, who is also overseeing the IP.

We found that 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 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.

At this stage, we do not see a reason why we should become nervous about that. The other question was on

the joint venture Q1 performance for Bioeq, to say. 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.

Super helpful. Sounds great.

It's a kind of regular not always matching inventory building and sales, so that's typical behavior you see in some products. Nothing concerning.

With that, Nicolas, are you fine with the responses?

Perfect. Thanks a lot.

Thank you.

Good morning, 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 and licensing for this year?

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?

Hi. I'll start that, and the others might chime in.

Of course guidance, and Enno alluded to that also in the year-end 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. Basically most of the milestone amounts that are planned in our guidance are deferred revenues from achievements, not additional deals.

Additional deals would come on top. There's existing deals where we have continued milestones, 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 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. Really, what we basically doing, we are bundling all relevant milestones up to market approval in the US, putting them into one bucket, if you will, and then deferring over the whole period until we achieve that goal.

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 costs. 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 at the end of the year or so, other milestones in context of filing, for instance.

It's not that volatile or digital, but it's deferred over time.

Perfect. Thank you, guys.

Thank you. Good afternoon.

I've got three questions. I was wondering if you expect any further non-206 milestones during the rest of this year.

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. Can you give me an idea what total capitalized development expenditure for '26 might be?

Presumably I'm right in assuming that nearly all of the capitalized development expenditure relates to 206, and that's it?

Happy to start with the first one. Any further non-206 milestones not foreseen for now.

Of course, that gives us also the flexibility for an upside opportunity, if we strike deals, but we need the flexibility not to be forced into signatures because we need that to deliver our guidance. We are clear, from today's point of view, guidance is not having any non-206-related milestones in.

Then with regard to the breakdown, currently the assumption is that, again, as you indicated, roughly 2/3 of the investment will be in context of the US engagement and roughly 1/3 then for Europe. Total COGS, to say, that we are anticipating here under this partnership is in the range of, yeah, 15 to 20, let's keep it that way, million that we are kind of anticipating here for 2026.

Okay.

That 15 is

Are you expecting 2/3 of that 15, 20 to be in COGS?

Yes.

The other third in Okay, and the other third in capitalized?

Yes. Roughly.

Just as an over the thumb. We will not guide

That would suggest that you're hardly going to capitalize anything for the rest of this year because you've already done 6.

Say again?

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

No. When I said 15 to 20, this was only COGS.

Oh, okay. Got it.

Bear in mind 208 also being capitalized.

Thanks very much.

You're welcome.

Yes. Sorry for the follow-up question.

I was just looking at your slides, and one of the four pillar that you flagged for the next stage is going to be the geographic expansion. How should we think about what would be the ideal mix in terms of geographic split going forward between the US, Europe, and international?

Is there reason to think that maybe the US is not where is the largest opportunity for biosimilar today? Just trying to figure out how you are building the, let's say, development stage in the future.

That's a question that is hard to answer, Nicolas. Of course the strategic pillar means that we have to do all of that, stay focused on EU and US, and they will remain for the next years, of course, the key markets in size and healthcare budgets that needs to be reduced by biosimilars.

We should not overlook, and we put a lot of emphasis on the additional markets so that we reduce the dependency from EU and US. You see already let's say that in some of the product, and that's really also product-specific and very partner-specific, for 201, for instance, we have very strong, among the top three countries, is one of the countries of the MENA region.

We see that already tangibly in some of the markets. For sure, it will take another 5 years plus until we see those regions kick in significantly and replacing Europe and US.

For sure that's the journey that the trend is significant, and I would say it's an add-on opportunity to fully leverage our value of the assets because the developments can be used unilaterally for all regions. It's very capital-efficient way to leverage those with commercial partners everywhere.

As we do not have to build commercial workforce and sales force in those countries, our partnership model is the right thing to do to increase the global reach.

There's probably one thing we can add, and this is that some of those smaller markets are, from a patent perspective, easier to tackle, and therefore this helps us to get started earlier and get our supply chain in full swing in preparation for the larger markets. That's also a strategic element in this whole discussion.

It very much depends really on the product and on also patent situation in each and every market. So

That's, yeah, thanks, Nicola, for the addition. Especially for 206, that will be relevant because we have the first-mover advantage and we can leverage those opportunities.

Thanks a lot.

Thanks for the question.

Alexander, we cannot hear you in case you are speaking.

I'm unmuted. I hope you can hear me.

Now it's clear.

Oh, perfect. Good afternoon.

On FYB202, could you provide more color on the positive signals that make you optimistic, and is this directed at the US specifically, and could you elaborate on international performance, perhaps? Thanks.

There was, let's say, a recent announcement that makes us happy, of course, and that was that the Fresenius Kabi's strong US team recently secured a contractual agreement for Otulfi with a large federal buyer, so that adds to our positive mood there. Similar to the CivicaScript exclusive distribution deal, which was entered into last year and which will continue, of course, and which was the main driver for strong performance in Q4 last year, this new federal agreement just is also very positive trend because it opens up new channels and customer segments and is expected to strengthen Otulfi's US performance already in the second half of this year.

That's the one positive momentum, and in Europe, of course in general, we are seeing a fierce competition, especially in tender-driven markets and countries. Also there was a recent announcement.

In France, we see encouraging momentum our partner Fresenius Kabi for further growth, and that's not only the introduction of auto-substitution, which in general is supposed to drive the biosimilar adoption, but also contract wins, recent ones including the country's largest retail pharmacy, which was also stated in the Fresenius Kabi earnings call, Fresenius earnings call, where Otulfi is positioned as number one product. Those two elements are driving our optimism that we will see growth in FYB202 and already tangible increase this year, so that we are confident with our guidance.

Many thanks.

Yeah. Welcome.

Thank you, and finally, I would like to thank you, the operator, our investor relations team with a special big thanks to Sabrina, my board colleagues, and especially everyone who joined today's earnings call. Thank you for your continued interest and your trust in Formycon.

We remain fully committed, as you know us, to delivering sustainable growth and creating long-term value for our shareholders, and ultimately also, let's not forget, to the benefit of the patients worldwide. Thank you for joining us today.