Good afternoon, ladies and gentlemen, and a warm welcome to the Formycon AG Earnings Call of Q1 2025. At this time, all participants have been placed on a listen-only mode. The floor will be open for questions following the presentation within the conference call, so please dial in. Let me now turn the floor over to your host, Dr. Stefan Glombitza.
Thank you for the introduction. Good afternoon, good morning, and also from our side, warm welcome to the international participants of today's earnings call. We appreciate, as always, your attendance and also your interest in Formycon. Earlier today, we issued a press release with detailed insights on our Q1 figures 2025. If I may summarize in a nutshell, another strong operational quarter and financial numbers, although at this early stage only indicative, in line with our Q1 expectation and thus confirming full-year guidance. We want to use this call today as an opportunity to provide additional context on both the operational achievements and the financial performance of the first quarter as well as giving you an outlook on the period to come.
Enno Spillner, our CFO, and me will guide you through the key facts in a comprehensive presentation, and Nicola Mikulcik, our CBO, and Andreas Seidl, CSO, will chime in to answer any questions that are on top of your mind in the Q&A section. As usual in those settings, I have to start, of course, with a legal disclaimer that today's presentation and discussion might contain forward-looking statements which are based on our current expectations and subject to risks and uncertainties that might lead to material differences to the estimates given here. Let me start with our growth path. After a strong 2024, we could tick all important boxes in a very reliable manner. Also, 2025 started operationally well advanced, but with headwinds from the US market, which affected the whole industry and specifically Formycon.
Those unexpected setbacks can never be excluded, but two at nearly the same time are kind of unique and triggered intense stock market reaction on the basis of an anyhow generally pretty volatile environment. That exactly happened at the start of our transformation period. Sometimes you have to take one step back to move two steps forward. Let me just say our R&D excellence and the track record of our development platform remain the solid foundation for our growth. This is getting even more important in the light of the opportunity that the long-awaited phase III waivers are opening up. With the laser focus on excellence and agility, we continue executing stringently on our strategic plan and maximize our assets step by step on our growth trajectory. 2024 was tremendously important for Formycon.
In pipeline execution and progress, we could tick all the boxes and prepare the ground for the next ignition stage. We shall then turn us into sustainable profitability after having two more products from our pipeline established in key markets. The recent commercial challenges and financial adjustments have an impact on this transformation period, but the overall positive outlook, the attractivity of our pipeline and of our business model remains. We target to turn into EBITDA profitability ideally as early as next year. Coming to the milestones and the strong operational performance, which has contained already a lot of highlights in first quarter, we have been able to communicate a series of achievements throughout the year 2024, and this strong team performance continued in the first quarter of this year at the same pace.
Going to the details of the highlights, FYB202/Otulfi will be able to enter additional markets in Canada and the U.K. after having received the approvals in the first quarter. This will complement the launches, which were already successfully performed by Fresenius Kabi nearly simultaneously end of February and start of March in the U.S. and in Europe. FYB203, our Eylea biosimilar, European Commission and U.K. approvals put even more markets into a launch prep position. To execute those launches, further commercial partnerships have been established with Teva, for instance, in Europe, and with Lotus for the Asia-Pacific region. For FYB206, the Keytruda biosimilar, our clinical and regulatory teams continued the intense communication with the U.S. agencies, provided data and arguments, which finally resulted in a written scientific advice that enables us to waive the phase III study completely.
This is another landmark and strengthens our position among the front runners in this attractive asset, on top, of course, of investment savings of more than EUR 75 million over the next couple of years. As of January this year, Formycon is part of the TecDAX, and the uplisting end of last year marks a significant milestone in the company's capital market strategy while strengthening, of course, the company's visibility. This is a perfect timing to switch to the financial part and happy to hand over to Enno Spillner, our CFO.
Thank you, Stefan. Also a very warm welcome from my side. Just upfront to reiterate on what Stefan just said, Q1 is as expected, and it is on track with our planning as we had it in our year-end planning anticipated. We can therefore confirm our guidance 2025, to just reiterate on that upfront. Q1 2025, however, is showing obviously less momentum than Q1 2024, and this is mainly due to a change of our revenue structure and therefore the continued transformation process into a commercial unit or in a commercially driven organization with strong focus on revenues going forward. Some parts of our revenues are fading out, while others need to ramp up or accelerate accordingly first, and that will take some time.
I'll come back on the next slide for more details on the breakdown on the revenues, but let's stay on this slide for a couple of seconds. Overall, we do see a reduction of our revenues from EUR 17.7 million to EUR 5.3 million. Again, this was anticipated and is mainly due to some changes also in the milestone structure that I will show you on the next slide. Also, for the cost of sales, we have a separate slide prepared for you. However, overall on the cost side, also across R&D and other expenses, we remain fairly stable compared to Q1 2024, but also here observing some structural changes that I will comment on. With regard to EBITDA, we obviously see the consequences of the reduced revenue performance.
Also with regard to the adjusted EBITDA, we notice the weaker contribution from the EBITDA on the one hand side, while also having less impact on the equity result from Bioeq AG, which is also being reduced and therefore showing an adjusted EBITDA of EUR 11.8 million. Capitalized costs are increasing significantly, and this is due to the fact that in Q1 2025, we were still on full swing for phase I and also partially for phase III of 206 clinical trial activities. In essence, Q1 is affected by our changing revenue structure. Some revenues reduced while costs remain similar simply to maintain our development of our broad product pipeline. New revenues just started in Q1 and still need some ramp-up period. Therefore, the cost-revenue ratio will change as we move forward into 2025, especially in the second half of the year going forward.
Now, let's take a look at the breakdown of our revenues and the respective structure. For FYB202's milestones, which were deferred, we can see that these are fading out as planned because all relevant milestones have been achieved in Q3 2024, and therefore we cannot recognize any further milestone increase from there. That is a significant portion that we still reported in Q1 2024. For FYB201 and FYB203, cost reimbursement is reducing to maturing products. Also, this was as anticipated, and during the year of 2025, this will become even more obvious with less chargeable costs that we can pass on to our partners. For FYB201 royalties, as already indicated, we see reduced performance in the first quarter of this year simply due to the eroding prices in the U.S., also for the reason why Sandoz took the product off the market after Q1 2025.
For FYB202 royalties, this is new, and after just one month of marketing or sales and marketing in the US and also starting in Europe, we see a first slight impact here. Again, please bear in mind this is just one month of performance by our partner Fresenius Kabi. During the course of 2025, the revenue positions will change in structure and hopefully will also become more diverse as we move on.
I said or I mentioned that also with regard to the cost of sales, we do see a change in the structure, and here I would like to draw your attention in particular to the change of the cost for FYB202 because what we have basically since the last quarter of 2025 is from now onwards or from there onwards a regular amortization of the product since it is marketable, which means we do recognize roughly EUR 6.2 million amortization per quarter, which is of course not cash relevant and which is also not EBITDA relevant. However, it has to be recognized in the cost, more cost of sales. The rest basically is fairly stable, but therefore we also have in return less development cost, which we still showed in Q1 2024.
However, we do remain with roughly EUR 5 million of cost for 202, which is in context of the auto injector of commercial efforts and also aiming for further approvals that we are working on. Just briefly on some KPIs on our balance sheet. Most of them basically have already been explained indirectly on the previous slides. The change in the total balance sheet volume by roughly EUR 19 million is mainly due to the net result and working capital, and the net result again also includes obviously the amortization of EUR 6.2 million for FYB202. The same is then true with regard to the net result for the equity, which is also reducing accordingly, and liabilities slightly increasing, which is mainly due to earnout obligations that have been approved and some working capital activities.
The Equity Ratio remains fairly stable and on a high level at 58%, and on the very bottom on the right showing a cash position of roughly EUR 33 million at the end of the quarter. What does this mean for our cash flow and for our working capital? First of all, it is important to mention that we have a positive EUR 9.1 million from operating activities, very different to last year, and this is mainly due to trade receivables from our partner Fresenius Kabi, plus some prepayments that we have received. That's clearly positive. I already mentioned the investing activities, which is the capitalized cost after TPoS in context of the development of our FYB206, mainly phase I and phase III clinical trials.
Overall, we have consummated that as a net effect of that of roughly EUR 9 million, which again brings us to the EUR 33 million at the end of the quarter. These EUR 33 million do not contain any drawdown of the still fully available shareholder loan of up to EUR 48 million, which we have not made use of at this point in time. Looking at the right-hand side, the translation from the cash and cash equivalents into the working capital is mainly current receivables that have been reduced, and on the revenue accruals, this is mainly in context with 202 and 203 going forward. Let's summarize on the guidance and on the financial part.
The numbers basically remain unchanged, as mentioned before, and again, the structure of our cost and revenue ratio is expected to change during the course of 2025, especially during the second half of the year with increasing revenues that we anticipate from a ramp-up of FYB202, showing more quarters and hopefully also growing in Europe and in the U.S., plus some potential licensing activities that we are working on and aiming for. Therefore, consequently, the EBITDA, as well as the adjusted EBITDA in Q1, look already quite close to our full year guidance at this point in time. However, this is going to change during the course of the year, so that's why we confirm the guidance as is. That said, revenue was or is expected in Q1 as we planned. The EBITDA is also on guidance here on track.
Same is true for the adjusted EBITDA, and I think we are looking at a solid cash position and liquid reserves based on our current cash position plus the potential shareholders. Briefly looking at our shareholders and our share as such, there have been no major changes in our shareholder structure being reported to us. This means more than 52% of our shareholder structure remains with our top four shareholders. Our liquidity increased significantly compared to Q1 2024. Just as an example, in the first quarter of 2024, we saw 775 shares trading in the first quarter. In the same period, 2025, we saw more than EUR 5 million shares trading, which is an increase of more than 500%. The average trading volume across all floors in 2024 Q1 was at 12,000 versus 82,000 or 83,000 per day in the first quarter of 2025.
Most analysts remain with a buy year to date, so also not a lot of change here yet. Therefore, we continue to be very present at future conferences, and our CEO, Stefan, has the great pleasure of traveling to the Spring Forum already tonight or tomorrow morning and will be available for you in Frankfurt. With that said, I hand over to Stefan.
Thank you, Enno, for giving us a lot of more details on the Q1 numbers. Maybe just a bit back to the operational outlook. As said in my introductory part, the teams really executed in full steam and delivered reliable across multiple areas in Q1. The next important milestones, combined with attractive news flow, are on schedule for 2025. Just to give you a glance on what you can expect next to come.
First of all, Q1, we expect approvals in LATAM, Latin America, and with that, we're tackling a new geography with a high unmet need for affordable biologics. With the launch of a specifically designed high-end technology of thermologic pre-filled syringe, we expect the push in FYB201 adoption for markets in important European countries. Based on the FYB202/Otulfi approvals we received recently, the launches in Canada and U.K. are in the starting blocks to add revenue. Two or three activities are focusing on closing important spots in the global map of commercialization partnerships across the main geographies, and we are going to lift the secret around the molecule behind 208. The latest very good news on the phase III waiver supports our strong competitive positioning among the Keytruda biosimilar developers.
Combined with the advantage of a very well-advanced recruitment in our phase I PK case study, this creates an attractive licensing package and builds a good basis for partnerships and starting those and implementing those already partly this year. Multiple interactions are being pursued as we speak. In essence, you can expect that the operational momentum will continue generating further positive news flow as a lifeblood on our growth path. In summary, with three pipeline assets approved, two of which being marketed and a strong and progressing pipeline, we were able to create a trust-building track record. At the same time, a robust platform for commercial partners that are seeking for an increasing number of assets in their biosimilar sales pipelines, which are key in their strategy.
This is enabling us to increase access to biologics to our partners and to play a leading role in this attractive growth space. We believe that we have all ingredients in place, a clear plan to adjust to any headwinds while taking the necessary actions to maximize our assets and to be fit for future. Biosimilars have come to stay. There is a gigantic number of biologics out there, and we are acting in the fastest growing segment of pharma, and we are diligently preparing the ground for the next stage of the Formycon growth story. With that, I want to conclude the presentation part. Thank you for your attention and hand over back to the moderator for the Q&A section.
Thank you very much. Dear ladies and gentlemen, if you are dialed in the conference call, please press nine and then the star key now to state your question. I repeat, the combination is nine and then the star key. If your name has been announced, you can ask a question. If you wish to cancel your question again, please press nine and then the star key again. One moment for the first question, please. The first question is from Christian Ehrmann of Warburg Research. Over to you.
Hello everyone, and thanks for taking my question. Just one at the moment. In order to reconcile the Q1 result with the full year guidance, could you give us or could you walk us through the quarterly sales and cost expectations a little bit more detailed as you see them at the moment? Thank you.
Thank you, Christian, for that question, which I immediately pass on to Enno.
Welcome, Christian. Hello there. First of all, as I said, to our total guidance, which is roughly for the top line in the range of EUR 60 million, if you take the midpoint of our guidance range, then certainly the major part of the revenues are expected for the second half of the year. We will see hopefully a further ramp-up of the 202/Otulfi product from Fresenius Kabi in Europe as well as in the US, then showing full quarters, while at the same time the volume or sold units should increase over time. That probably here during the last quarter, we see the most significant impact from that.
Also from our overall expectations with regard to potential licensing, we anticipate that most realistically this will be Q4 if things go well, Q3, but in our internal planning, we have most of that in Q4 2025. This will certainly be our major product here, so to say, our major revenue drivers that we will see across the line. Over time, we hopefully will see some further impact from 201 and 203 from reimbursement, but that part will reduce. However, as you could see already now, this is on a fairly low level, so it should not show a dramatic impact. The main key events are here to performance and potential partnering for our earlier stage products.
On the cost side, you will certainly notice from a cash perspective, to put that maybe upfront, that we will have less invest into 206, so our Keytruda biosimilar, which is focusing only "on phase I". However, this also comes with a significant commitment to push this clinical trial forward so that you can basically assume kind of a flat or parallel or ongoing cost structure compared to where we are right now going forward in the future quarters. This is exactly also the reason why I said our performance will turn around a little bit here, having kind of a slow start in Q1, however, then accelerating into the next quarters. That is at least the plan. I'm sorry for the a little bit extended answer, trying to give you a little bit of context here, but I hope that helps.
Sure, very much appreciated. Could you break down the split between licensing revenues and sales revenues a little bit more?
No, Christian, I'm very sorry. We will not, also for our partnering efforts, we will not go into more detailed guidance here. I think we said during [unclear] year-end process or presentation that we anticipate 202 to be above the 30% revenue performance of the total expected revenues, and then closely followed by potential licensing, but clearly being below that, and then the remainder being performance from 201 and 203 contribution. That's as far as I can go, but everything else would be too detailed at this stage.
Of course. Thank you very much.
Thank you, Enno. In summary, really backloaded the second half of the year.
All right, thank you very much. Also from my side, moving on to the next question then. The next question is from Ben Thielmann of Berenberg. So over to you, Ben.
Hi guys. This is Ben from Berenberg. Hi from Frankfurt. A few questions from my side, if I may. First question is, can you remind us, Enno, how large was the milestone payment you guys received in Q1 last year? I could not access the presentation, so sorry if that was written down there.
So the milestones that we received last year, actually in Q4, we received payments of two milestones, namely, so I am referring now to 202 Fresenius Kabi relationship, namely approval of the FDA and approval of the EMA. There were two major milestones that were kind of locked in or based on completing the successful part. And in Q1 2024, we had deferred revenues of EUR 11.2 million out of these milestones being recognized.
Because in total, you may recall, it was total payments that we received from Fresenius Kabi success-based EUR 60 million, which broke down at EUR 10 million when we signed the contract in early 2023. Another EUR 50 million, so to say, deferred over three milestones, approval or achievement of phase I, which also took place in the second quarter of 2023. Then the two later ones that I just mentioned in Q3 2024, cash coming in in Q4 of 2024.
Okay. Okay, perfect. Maybe two more questions, if I may, regarding the phase III waiver. Is that something, if I now think about your very early stage assets, is that something we could see more often in the future, or do you think that was now just very specifically to your biosimilar to Keytruda?
I mean, there was quite a free cash flow positive impact from waiving that phase III. Any color on that, whether it's likely that we could see that for your other biosimilars?
Maybe I start with that, Ben, and then Andreas might chime in with more details. In principle, we will see that more often. That's my personal opinion. You see that also with announcements. Number one, following our pembrolizumab strategy, waiving the phase III, which has been initiated. Of course, we were the first ones to announce and to drive that forward, but we will see others to follow. As I always indicated, it's depending on the molecule specifically and on the data packages that are in, but in principle, there's much more openness if the molecule fits that the FDA will grant a waiver.
We also see that supported by the EMA paper that has been published 1st of April, if I remember correctly, exactly stating the same., o bvious that it seems to be it's more an exception to have a phase III study than the routine. In a nutshell, the trend, yes. Of course, you have to prove specifically that your data package is solid.
Okay, that makes sense.
Maybe one addition from my side to that, because I think I have an idea where you're aiming at. For Q8, for instance, the phase three is not considered in our current planning, purely financially speaking.
Okay.
Which is also justified. We received from FDA also here positive feedback that we don't need a phase III study for this molecule.
Okay. How is it for the other assets that you have in the pipeline? When you say that phase III, you did not factor in for that asset, did you factor in for the other ones, let's say 209 plus?
That is too early to say. Of course, I mean, you approach the agencies when you have a solid data package being close to the TPoS, the famous one. As soon as you have a data package, you are convincing them, then you go to the FDA and they ask for the scientific advice. As said, it is more the default scenario than the exception to plan without a phase III. Of course, we will not select molecules in the portfolio selection only based on the assumption if we need a phase III or not. There might be exceptions to that, but the future planning for sure has to happen without phase III.
Okay, perfect. Now I got it. That is very clear. Last question, and then I go back into the queue, would be a follow-up on Christian's question, basically. I understand that you can't give a lot of granularity for the remainder of the year in terms of quarter-over-quarter growth. If I just look at your guidance, the lower the floors at EUR 55 million on the top line, now we have five and a bit in Q1. Can you at least tell us if you are planning with a milestone payment in the second half of the year or even in Q2? You don't need to give a size, but is that currently part of the guidance?
Yeah, I mean, what we currently have in there, and again, that comes back to what I refer to as licensing efforts that we are working on.
Just referencing back here to the Fresenius Kabi deal from where we inked the deal in early 2023, where we, aside from the revenues, which have been, by the way, deferred, just as a reminder, the upfront payment of EUR 10 million at that point in time was immediately recognized due to the fact that this was kind of taking notice of the work that had been done so far for the product at that point in time. Obviously, typically, and it always depends in the end also on the partner, but typically you would structure a deal in a similar way that you try to achieve an upfront payment, which you can recognize immediately, plus agreement of future milestones, plus later royalties, which is the traditional three pillars of a licensing deal. In the end, you always need a partner on the other side.
That's important to remind ourselves on, but that's the structure that you could imagine, for instance.
Perfect. That's it from my side. Thank you, Stefan. Thank you, Enno. Thank you to the team.
Thank you, Ben.
Thanks a lot also from my side. All right, the next question is from Yi Chen of HC Wainwright & Co. Over to you.
Hi there, this is Eduardo on for Yi. I was hoping to get a little color if you had a specific percentage of market share you expect 202 to acquire relative to other competing Stelara biosimilars.
Thanks for the question. I mean, of course, we have some assumptions, but we are not sharing those, and also Fresenius Kabi is not sharing those. You can expect that Fresenius Kabi, as they are doing successfully with Tyenne at the moment, that they are contracting, are in intense contract negotiations.
As also communicated, it will be a mix of PBM contracts and commercial payer contracts, also with a clever mix of exclusive deals of considering volume and price. The overall market share is not something we would state. I don't know, Nicola, if we want to add something on that.
Just one point. I mean, that was what you said, Stefan, is relating to the U.S., yeah, where the market only started really very recently, except for one front runner who launched in January, but everyone else launched around the same time as we did. It is really early. In Europe, it is a bit different. You know that we were with our partner, Fresenius Kabi, became a bit later than competition. What we can say is that in Europe, especially in very attractive markets like Germany, there is still a significant share with the originator.
There's still a lot of share to be grabbed, even for Fresenius, which came a bit later. Therefore, we are quite positive there. The same is true for a country like France, for example. The big markets in Europe, there is still quite some work to be done to intensify the shares of biosimilars, and hopefully, Fresenius will be a strong player there.
Thanks, Nicola. Maybe just, as you mentioned, US and Europe, the difference, I mean, volume share is not always the most important stuff here. I mean, you have profitable and less profitable deals. The majority or the main driver here is profitability and revenues to generate based on the net sales. That's the most important part here.
Got it. Thanks. That's really helpful. Do you have an estimated timeline for 203's commercial launch at this point in time?
Also that one, but yeah.
So, still nothing concrete. Sorry. Within the next couple of months, few months, there will be in the U.S., there's a lot of litigation ongoing still, not only for us, but also for other competitors. It's really in the very next few months where there will be some outcomes of these litigation activities. Therefore, I believe we will get clarity on this within the next three, maximum six months when the launch in the U.S. can really happen. So far, there was one competitor announcing a launch date in 2026, but that's, yeah, we will have to see. It's not completely the same situation as we have. Not a lot we can say more at this stage, but I hope that next quarterly results, we can tell you more. In Europe, it's a bit clearer.
Also there, still country by country, there is litigation ongoing, but there the situation is much more, let's say, predictable. We are quite optimistic that we can launch in Europe earlier than in the U.S. Again, we cannot say because it's really country by country different, and it's not yet absolutely clear. We are preparing everything. We have our approvals ready. We do whatever is possible in supply chain, but the exact launch dates, I cannot tell you. The SPC expiry, though, in Europe is in November. There are these other patents which are built around, which we are still struggling or fighting with in certain court cases. Soon we will have clarity.
Thanks so much. The final one regarding the U.S. markets and possible disruptions. I'm curious how exposed you are with tariff policies. Just this morning or last night, I think there was an announcement. President Trump had expected to reduce drug prices to equalize global prices. I do not know if you would be as exposed in the scenario with the biosimilars, but kind of to get a perspective on your take on tariffs and possible price adjustments from the federal government and the U.S. markets.
Maybe I start with that one. Very good question. Very recent announcement. As you rightly say, I mean, it is mainly addressing the originator prices that are double, triple as high as in Europe. For instance, for biosimilars, that is not the case. If you look at the U.S. biosimilar pricing, that is pretty on a similar level to Europe average. Still, there will be an impact, we expect.
Of course, it's hard to predict how and to which extent those announced measures will in the end be implemented. From our point of view, first assessment, there are risks as well as opportunities in those plans. Number one, opportunities, of course, biosimilars are already an established tool to drive prices down. Trump, as well as all the Republicans, support market dynamics driven by competition, less by regulation. Fully supportive for biosimilars. That's what they stated in the first governance periods, but also repeatedly. There are, I think, two dozen Republican bills against the PBMs and to change the structure there and to support biosimilars. If implemented efficiently and supported by the corresponding measures and government savings from biosimilars, this can be very powerful and address exactly the problem he wants to address. This is the high healthcare spend.
How should that happen? So far, a lot of indications went in that direction, also from the Biden administration, but it did not change a lot because the U.S. administration has to make sure that those price reductions that are happening already in the market do benefit the healthcare budget and the patients. This is only possible by massively changing the PBM structure, which is, according to the latest report, consuming more than 50% of the cost reductions already. A change there will definitely then help the biosimilars to really be very effective and achieve what the Trump administration wants to achieve. On the downside, of course, the risk is always, as it is already existing, that the price pressure might even increase. Again, I mean, we are not talking percentage-wise reduction. We are talking net sales prices.
If the price pressure on the originator products goes even further, this is underlining the importance of our initiatives for cost leadership. That does not change by whatever announcement. That would be my five cents, i f there is any, or ten cents. Is there anything to add, Nicola? Maybe.
Just to emphasize again, I think the real problem of the real high drug prices is mainly for branded products before expiry of the patent. There are really massive three-fold, four-fold higher prices. On the generics or biosimilars, this is not the case. Of course, you have not every product everywhere the same, but to a far lesser extent, our price is higher for generics and biosimilars in the US, sometimes even significantly lower. Therefore, I think this is more something which affects the innovator industry.
Even there, not so clear how this can really be changed because it has not changed. Many, many administrations before tried to change it, and it has not happened. It seems to be something very difficult. I am not an expert on politics in the U.S., but that remains to be seen. Will Trump really be able to tackle this topic, which is around since a long time?
Got it. That is really helpful. Thanks for all your answers to the questions.
You are welcome.
Thank you very much. The next question is from Alexander Galitza of HAIB. The floor is yours. Over to you, Alexander.
Good afternoon. Thank you for taking the question. I have just two. One is on 202. Just wonder how you think, how reliable you think is the EUR 700,000 revenue for 202 you have generated in kind of in one month of Q1.
Is this sort of a reasonable run rate, you think, that could be extrapolated for the full quarter in Q2, meaning that the revenue would fall at least at around EUR 2 million, or whether there are some preloading effects, etc.? That is the first one. The second, the last one is for Cimerli. Just wondering to what degree Cimerli still played a role in your Q1 sales numbers for 201. Thank you.
I can take it right away. Thanks for having me on the call, Alexander. On your first call with regard to Q2, honestly, I hope that the EUR 700,000 is not a good guidance here because we want and we need to be significantly above as numbers continue to grow. That is at least our expectation.
In the end, Fresenius is in the driver's seat here, but probably also based on what Nicola said, we see good headroom in Europe to further take shares from the innovator or originator. The U.S. obviously has to accelerate by further contracting with partners here. We have higher expectations than just EUR 2 million for the next quarters as an average number. That is quite clear. On 201, on Cimerli, in our presentation, we have a little breakdown of the revenues. You can see that we had a change here, basically overall coming down from EUR 1.9 million from last year, now a contribution from 201 Cimerli now to EUR 600,000. That is a significant reduction. That is mainly, or actually absolutely driven from the reduction in the pricing. Obviously, that is the challenging part coming from the U.S., not from Europe.
This was, in the end, also the reason why Sandoz stopped marketing and sales activities after Q1.
Sorry, just to clarify, you said EUR 1.9 million was Cimerli revenue Q1 2024 versus EUR 0.6 million in 2025?
Yes.
Or did I hear?
Yeah, but yeah, that's so Cimerli is just US, to be clear. That's the branding for the US that I just used here, sorry. Speaking of total 201, that was EUR 1.9 million and EUR 600,000 for Q1 of.
Understood. Thank you.
I could just briefly add to your question regarding 202. We do not expect this to be the run rate. What is behind that number is in the first quarter, we had now effective contribution to the revenues of Fresenius and subsequently to our royalties of only six countries. Not all of them started on the 1st of March. Really, staggered launch.
Meanwhile, there are 11 countries have launched. There are also, of course, more countries coming in. Plus, it's pretty normal that you have, it's not something like shadow loading or whatever. It's really that we will see the increase of market share and with that increase of sales and increase of royalties for us over the course of the year.
Also, maybe just to add, it's depending on the contract. Some kick in only later in the year, although it's signed or close to signature, it doesn't add to revenues immediately. All we say is we don't believe that this is the run rate. It would not be the right maths to just take that times 12. That's not our expectation, as you're right, clearly.
Sorry, just one quick follow-up back to 201. Out of EUR 0.6 million revenue in Q1, basically the largest chunk or the vast majority is just revenue outside of the U.S. Is that correct? Maybe if it's—
So the EUR 0.6 million total revenues for Q1 of this year is mainly coming from Europe and the rest of the world, and maybe around about one-third from the U.S.
Thank you.
Thank you very much. Dear ladies and gentlemen, there are no more questions in the queue currently. Last reminder, please press nine and then the star key now if you wish to state a question. I repeat, the combination is nine star. Couple more moments, but I see no more questions to be incoming. With that, I'm closing the Q&A and handing the floor back over to the hosts.
Last task on our side is finally, of course, to thank the operator, our Investor Relations team for the preparation, my board colleagues for supporting the Q&A and the presentation. Especially everyone who was joining our Earnings Call, thanks for your good questions and for your lively interest in Formycon. Looking forward to speaking with you soon.
The recording has been.