Good morning, ladies and gentlemen. Welcome to our Full Year 2024 results. With me are Peter Janssen, our CEO, and Martin Möller, our former CFO. We would like to take a look now on our last year's number, and of course also at first on the ad hoc announcement that was just sent out this morning. With this, I'd like to hand over to Peter.
Yes, also from my side, good morning, everybody. Good morning, ladies and gentlemen. I am going to talk about the numbers in a minute, but first wanted to address the ad hoc release about the delisting. I want to give you a little bit of background behind the rationale. We are indeed considering delisting of ordinary and preference shares, and this is based on strategic priorities for us, also financing options we have, and also the regulatory obligations. I'll explain in a few words. Grifols, you know, holds most of the voting rights of Biotest, and it's not supporting us in any capital increases or bond issuances. We've tried last year, we've tried the year before, but also minority shareholders had difficulties with increasing our shares. As a result, capital markets are not a viable financing option for Biotest any longer.
On the other hand, the good news is that Grifols is and will support Biotest with financing, also in the future. The delisting would allow us to focus more on our growth, our operational effectiveness, and further innovation on R&D investments, while at the same time significantly reducing direct regulatory costs and continued indirect obligations. For those reasons, this also will represent an exit option for outstanding shareholders. There will be a possibility to accept the public offer that Grifols will make against cash consideration. If we then go into a little bit more detail about the offer. Under the terms of this delisting agreement that we've signed today, today Grifols and Biotest signed this delisting agreement.
Under these terms, there will be an unconditional public delisting tender offer for the shareholders of Biotest AG to acquire the outstanding shares of Biotest AG against payment of a cash consideration in the amount of EUR 43 per Biotest ordinary share and EUR 30 per Biotest preference share. According to the announcement of Grifols, it is expected that this offer price exceeds the statutory minimum price for a delisting tender offer pursuant to Section 39 of the German Stock Exchange Act. The final price will be published by Grifols in the offer document after confirmation by the German Federal Financial Supervisory Authority or the BaFin. The Management Board and the Supervisory Board of Biotest will carefully review the offer, the offer document regarding the public delisting, tender offer of Grifols and will issue a joint reasoned statement pursuant to Section 27 of the German Securities Acquisition and Takeover Act.
How would such a process look like? How much time would it take? Like I just said, Biotest and Grifols have signed the delisting agreement today. Grifols has published the offer announcement also today, and they will submit a draft of the offer announcement to BaFin, the regulatory authorities in Germany. This takes about 10 business days. However, we know also that we have the Easter period in the coming days. Grifols will publish an offer document, which we would count to be beginning of May. Beginning of May, we believe that Grifols will then publish the offer document once approved. This will then be the start of the acceptance period. This is the acceptance period where current shareholders can accept or not accept the offer. The acceptance period is approximately four weeks.
After this acceptance period, Biotest will publish the joint reasoned opinion statement of the Management Board and the Supervisory Board, including this fairness opinion. This will be approximately mid to end of May. We believe that the end of the acceptance period then could be beginning of June, followed then by the settlement or the settlement of the offer. This is as much as we can tell you today about the delisting. Let's jump into the highlights for the full year 2024. We will talk about our finest Biotest Next Level facility where we had the successful FDA inspection of our manufacturing plant.
We also have the FDA approval of Yimmugo®, the first product coming out of that plant for the U.S. market. We'll also talk about Fibrinogen where we had already successful GMP inspection by the German authorities, HLf GP. Then the Albumin in this facility, where we have commissioned the production line for Albumin, which gives us substantially more capacity for Albumin. We'll also talk about Yimmugo®, first product, and the FDA approval we got, the strategic partnership we signed with Kedrion Biopharma last year for the commercialization of Yimmugo® into the United States. Later on, we'll also talk about the second product, Fibrinogen, for which we've had a successful E.U. submission of the marketing authorization.
We've also successfully submitted the U.S. registration, or the BLA, end of 2024. We also had very good scientific results. We had positive results from both congenital and acquired fibrinogen deficiency phase III trials. Also, a summary of the financials, and Martin Möller will help me with explaining the financials, but the highlights is that we see a 6% or slightly above 6% sales growth to EUR 626 million versus EUR 684 million in the previous year. Knowing also that, let's say, below the surface, there's a significant increase in core sales. There's a decrease, of course, in technology transfer activities. The EBIT came in at the upper level of the guidance at EUR 94.5 million versus the EUR 143 million of last year, of, sorry, the year before, 2023.
It was lower than 2023, but like I explained, also, partially due to the technology transfer, which is now reducing and stepwise being replaced by core business. We also had a very positive financial 2024 cash flow from operating activities of slightly above EUR 60 million. These are the highlights. Let me now look, dive into the first topic of our facility, Biotest Next Level. In June 2024, the FDA gave the approval for Yimmugo® after quite long, very extensive program in which they also inspected the facility, the clinical center. They looked at, yeah, a lot of the documentation, had also very extensive exchange, for almost one year, and then finally gave the approval slightly ahead of schedule. This was very good news. We also got approval for the facility, the facility in itself, its quality systems.
We had compliance of the production processes, and, in fact, the FDA gave approval for not only the product, but also the facilities. The start of the commercialization started soon after that. We started just after the summer with production for the U.S. markets that is now ongoing. We started at a, let's say, lower rate, two batches per week. We're now switching to three batches per week. By the end of the year, we hope to be at approximately five batches per week. You see a really steady ramp up of the production. Of course, the whole production process from, let's say, taking in plasma, fractionating, purification, etc., all the way down to packaging, packaging and shipment takes a lot of time. We still have also an FDA approval per batch, which we need, and after approval, products will be sent.
The good news is that the first packaged materials have been completed. Submission, let's say, release has been requested to the FDA, so we can expect the first batches to be released very soon. Fibrinogen, next product. Like I said, we already had our first inspection, positive inspection by the European authorities. They have qualified the, let's say, Fibrinogen production facilities in BNL. We also performed successful process performance qualification runs. That means also for the product, we have been able to demonstrate that we can produce the product successfully. This was then used also in the submission for the marketing authorization in Europe and the biological license application for the US market. Like I said, Albumin. Albumin is a very important product.
We will also extract this, and we need to extract this from every liter of plasma. It helps with the, the economics. For this, we have commissioned the Albumin drug substance line in BNL. That means that from this year, we will be able to also extract and purify Albumin out of every liter of plasma. The qualification runs were successful. In 2025, this year, the, let's say, production will start up. That is very important to have two, three. I think with Yimmugo®, Fibrinogen, and Albumin, we will have three products out of every liter, which still significantly helped with the, the economics. In summary, the BNL ramp- up is really on track, step by step. We're going in the right direction.
We hope to really reach a turning point once we are with above 50% of the capacity, and with three products out of every liter, we'll go from, let's say, cash consuming into cash generation. We expect this fully to be realized by end of 2026. What in terms of research and development? These are the timelines where we already talked about Yimmugo® U.S. It is approved. Production is going on and will be launching this year. For Fibrinogen, you see that the timelines are a little bit longer. We expect, for, let's say, market entry, probably in early 2026 or mid 2026 for the U.S. The last product we will talk about here in this remit is Trimodulin.
For Trimodulin, we will talk in more detail, but we had two studies going on for this. We will currently concentrate on one study, which is the ESsCAPE study. Recruitment is going on, so we have steady patients coming in. We have, let's say, confidence that this study will be successful, although the timeline is much longer than originally, let's say, expected. The treatment has changed after COVID. We've had some remediatory actions installed, but still with this, the current recruitment, we will end somewhere around the end of 2029. Jumping back to Fibrinogen, I just wanted to show this slide to demonstrate it's not just the last phase that was important.
The whole story started in 2010, with very, yeah, stepwise improvements, going through phase I, phase II, starting also with the manufacturing facility, the trials, for, for, let's say, congenital for Acquired Fibrinogen Deficiency. We included the U.S. scope, together with Grifols. We included the U.S. scope, which is, was also a very important milestone. Ultimately, last year, we were able to submit both dossiers and hope to get also positive results from those in 2025 and 2026. A little bit more detail again for those two fibrinogen studies. The congenital study is focusing on a very rare inherited bleeding disorder affecting either the quantity or the quality of circulating Fibrinogen in the body, in the veins. Then we have Acquired Fibrinogen Deficiency, which may be due to bleeding or be, let's say, caused by reduced synthesis.
In any effect, when somebody has Acquired Fibrinogen Deficiency, it can be life-threatening. It can only be corrected through administration of exogenous fibrinogen. By administrating Fibrinogen concentrate, it will allow for a rapid and convenient correction of Acquired Fibrinogen Deficiency. This is really the core of this product. This shows the same in the picture. If you bleed a lot, it might be that your fibrinogen levels are depleted to a low level, and as such, you do not get clotting and you continue bleeding, and you might bleed to death. By administering Fibrinogen, your fibrinogen levels are restored. Clotting does occur and you have a stable clot, and in fact, the healing process can start.
This is the basics behind this, and it's really a product where there's a high patient need for these lifesaving drugs. Like I said, it's very fundamental to clot formation. When people bleed during surgery, during bleeding, during injury, it's also the first factor that will reach very critical levels, low levels, and needs to be replaced or substituted. Yeah. If you look at the markets for Fibrinogen, in the market, you see several kinds of markets. If we look at the markets, we have, let's say, very mature markets where people or, let's say, countries have really realized that using Fibrinogen is really the standard of the standard practices to use.
We also have less advanced markets where, let's say, the use of cryoprecipitate, which is one of the parts of the human plasma, non-purified, is being treated and being used, is used in the treatment, sorry. On the left side, the U.S. and U.K. are certainly the less developed markets, where we see a rapid entry now of, let's say, Fibrinogen as a good treatment option. On the very right side, you see countries like Germany where doctors are using this as a standard therapy or standard treatment. Both markets are very important. The U.S. market is extremely important since the huge potential, but also the German market, which is mature but still has very high usage for capital.
Also, good news is, of course, Fibrinogen is used out of the same production process, upstream. Meaning that, let's say, from the same production process, we also make our same, our other products like Yimmugo®, Albumin, I just talked about out of the same liter of plasma. To make more Fibrinogen, we don't have to, let's say, consume or collect more plasma. It's already one of the, let's say, side fractions of the same plasma that we can use for Fibrinogen. There is certainly efficiency, helps with the economics. If you look at the regulatory timeline in a little bit more detail, in 2024, like I just said, we had a very successful completion of the studies, also the acquired study. We had also the preparation to share the studies.
The both studies were publicized at medical conferences. We expect the approval, like I said, early 2026 for both the US, maybe mid 2026 for the E.U. Yeah, I think that's the most important I can communicate here. Trimodulin then, of course, we already spoke about Trimodulin as the fourth product coming out of BNL. First about the product itself, it's a, let's say, new polyvalent antibody preparation, meaning that it has several, let's say, yes, so it also has several, let's say, proteins. It has also a high content of IgM. So, and then also IgA next to the IgG, which is standard in immunoglobulins. If you look at the composition, it has a 5% protein solution for infusion, of which approximately 20% is IgM, 21% is IgA, and 56% is IgG.
There is a high medical need. We know this. We are, we're us, we're already, let's say, marketing a similar product, which is Pentaglobin®. We believe that with this product, Trimodulin, we have really a high commercial potential. I won't go into too much the technical details, but here you see also how the shapes of the three main classes of proteins that are combined in this cocktail. I also show you the study design for the ESsCAPE— ESsCAPE phase III study design. The objective is to demonstrate efficacy and safety of Trimodulin in adult hospitalized ESsCAPE patients on intensive mechanical ventilation, IMV. We use up to 25 countries worldwide, including, of course, Europe, Americas, Asia Pacific. In those 25 countries, we have 120 clinical trial sites. The study would include 590 subject patients.
We're currently at around 100, and so we're at one sixth of the total recruitment. We would already have also an interim analysis after approximately 295, so half of this population. The primary end point for the study is a 28-day mortality rate. This trial, like I said, is progressing well. I said we already have 100 patients, but I think we're really in a phase now where slowly we can start extrapolating the recruitment rate. If you look at this as extrapolation, we're close to 2029, like I said, which is a bit or is a few years later than we previously extrapolated or could predict, but that was based really on very limited data. Right now we have more data and the extrapolation becomes more reliable.
Of course, we see that the recruitment is challenging, because of the criteria. Yeah, you need hospitalized adult patients with signs of inflammation, inflammation. We need to have a diagnosis of community-acquired pneumonia, before or within 48 hours after hospital admission. That is also a strict criteria. You need also an acute respiratory failure requiring invasive mechanical ventilation. That is also a difficult inclusion situation. We are selecting centers with sufficient patients and staff, and we adapted the study design and some of the measures to facilitate recruitment. Nevertheless, despite the delay, we still believe Trimodulin is really relevant for us. There is a high unmet medical need. We also have, of course, already done a CIGMA study, which shows very relevant data for this subgroup.
There's no competitive product identified except for our own, which is Pentaglobin®, but of course, Trimodulin is a much enhanced version, and it's an additional plasma protein per liter. The same holds true for, like I explained, for Fibrinogen. Also here, it's out of the same liter of plasma, which, you know, it's a rare, expensive resource. This would really improve our financial value creation. Looking at, let's say, the total product portfolio and looking at more lifecycle initiatives for Intratect®, which is our primary IgG or immune globulin right now, we have positive sales growth for, let's say, in 30 countries outside of Germany. In Germany, of course, we already launched Yimmugo®, but in most other countries in Europe and the rest of the world, Intratect® is really still the sales driver.
Cytotect® is also a product where we see increased sales in France, Spain, Italy, Lithuania, U.K., and we also have a new marketing authorization for Thailand. Pentaglobin®, already talked about a few times, we see also very positive sales growth in various European, but also international markets, such as Germany, France, Colombia, Turkey, and India. Zutectra®, we also launched in Turkey and Taiwan. Albumin demand remains very high. We have new sales in Oman, Vietnam, and China. You see also for our existing products, there is good demand worldwide. A few words about sustainability. I probably forgot to mention, but also when we designed BNL, it had sustainability in mind to use, let's say, less resources per liter of plasma to produce more proteins with less energy and waste.
We also installed, let's say, a photovoltaic system on our parking lot, but right now we also are planning to install, yeah, photovoltaic installation on our new facility BNL, which would give us an additional 400 megawatt-hour renewable energy per year. We also have a heat recovery system for all biosystems in planning. We have a pilot which is running well, but we want to, yeah, use more production waste heat, and use this to reduce costs, heating costs, and others. We are also in the planning phase of an ethanol recuperation facility. You know that, besides plasma, we use a lot of water, but also a lot of ethanol. These are, let's say, the three main components of our production: it's water, ethanol, and of course, plasma.
We are currently, let's say, of course, reusing the ethanol, but it is done at an external facility. We want to see if we can do ethanol purification on site. Yeah. We also have sustainable supply chain as a goal. That is very important. We also established a transformation concept for emission reduction and efficient use of resources. Yeah. I think in next iteration, we will talk more about that. We dive into the financials of full year 2024, and I would ask Martin to assist me in this.
Yeah. Okay. Yeah. Thanks, Peter Janssen. Also from my side, a warm welcome for today's meeting. I will give you a brief overview about the financials of the year 2024. Starting with the sales, as Peter already mentioned, we had a sales increase of 6% compared to last year. Especially the Q4 was again a very successful quarter. The December sales have been the largest in the history of Biotest in one month, taking only the product sales together. With regard to the EBIT, we have reached a very successful EBIT figure with almost EUR 95 million, which is in our guidance on the upper level. The guidance was between EUR 80 million and EUR 100 million. The EBITDA impact shows a similar development as compared to the EBIT. On the income statement, in the 2025 financial year, we generated sales, as we said, of EUR 726 million.
The growth is mainly due to the sales of our new intravenous immunoglobulin Yimmugo®. The sales increased from EUR 27 million in 2023 to EUR 62 million in the year 2024. Our sales in Intratect® increased by EUR 41 million compared to the year before. Our specialty sales have been increased in addition by EUR 13 million. In addition, we made plasma sales of EUR 13 million compared to the year before, where we had almost zero sales in this region. The revenue from technology disclosure and the development services for Grifols declined to EUR 123 million compared to EUR 190 million the year before, due to the fact that we have disclosed in the year 2023 four out of the six technologies and the remaining two then in the year 2024. The cost of sales in the year 2024 rose faster compared to the revenue increase.
We have increased our cost of sales from EUR 404 million to 502 million, especially due to the fact that we have higher sales and also that the BNL facility ramp- up, as Peter just explained. The cost of sales ratio deteriorated from 59% to 69%. The operating profit amounted to almost EUR 95 million. This is mainly due to lower earnings effect from the TTLA impact. They decreased from EUR 158 million to EUR 98 million in the year 2024. The financial result and taxes are mainly impacted by a change in the taxes. In 2024, we recognized EUR 22 million in taxes, compared to the last year, where we had a negative, positive impact of EUR 20.7 million.
This development, this change in the numbers, is due to the deferred tax income on net carry forwards, capitalized in the previous year and utilized now and in the future. Therefore, we had a deferred tax income in the previous year and tax loss in this for table tax in this year. At the end, the earnings after tax decreased from EUR 127 million to EUR 26 million in the year 2024. This results in an earnings per share, ordinary share, of EUR 0.66 after EUR 3 million in the previous year. Looking to our split in the therapy sales, you can see that our main sales are coming from IgG products, our Intratect® and Yimmugo®. Compared with the previous year, we had here an increase from 55% to 60% in the year 2024.
Our second largest product range is our Intensive Care products with Cytotect®, Pentaglobin®, Zutectra®, and the Hepatect® products. With the hyper IgG, we have 11%, and the haemophilia business is currently with 7%, the smallest area in the year 2024. We are also reporting an adjusted EBIT. The adjusted EBIT describes the operating performance of the Biotest group, excluding the special effects. We have calculated the adjusted EBIT to ensure a continuity and comparability between the different EBIT figures between the year 2023 and 2024. Major topic is Biotest Next Level, with an increase from EUR 47 million to 59 million. These are including the ramp-up costs in the new facility. In the year 2023, we had a disposal gain from the sale of the five subsidiaries towards Grifols of EUR 23 million.
We have not sold any subsidiaries in the year 2024, and therefore we have no impact in this year. The earnings from the development service when we are recharging development costs towards Grifols are almost on the same level compared to the year 2023. As we just mentioned, the earnings from the technology disclosure has a sharp decrease in the year 2024 compared to the year 2023, by 45, by almost EUR 70 million. At the end, our adjusted EBIT has a very strong increase from EUR 10 million in the year 2023 to about EUR 64 million in the year 2024. Our balance sheet has almost the same value as the year before, only a very small increase overall. Our current assets stood at EUR 810 million by the end of the year. This is EUR 53 million higher compared to the year before.
Among other factors, we have a significant increase in inventories by almost EUR 60 million in the year 2024. The higher level of inventories will serve then, these higher sales in the year 2025 and also in the coming, coming months when we will enter the American market with Yimmugo®. In addition, our trade receivables increased slightly by EUR 12.7 million, so it's lower than the Q3, but still higher, as the year 2023. Contract assets decreased, on the other hand, by EUR 15.6 million compared to the previous year, which is attributable to the quantitative decline in inventories from our manufacturing business. Total liabilities fell slightly by EUR 9.6 million, and non-current liabilities amount to EUR 743 million by end of the year 2024.
The main reason for this very strong increase compared to the year before, there is a change in the non-current financial liabilities, by EUR 206 million. This change is due to the reclassification of the loan, received from, from Grifols. We have reclassified this loan that we have received partly in, or with, with increase in the year 2024, into non-current because, it has been prolongated and therefore, or prolongated at the end of 2026, and therefore it was reclassified. Our cash flow, as Peter explained, has increased from a negative figure in the year 2023 towards, over EUR 60 million in the year 2024. This has been very successful in the Q4, with several actions that have been taking place so that we have been much favorable compared to our guidance.
We had a lot of projects started that have been successfully completed until end of the year to improve our cash situation and cash flow situation by the end of this year. I would hand over again to Peter to talk about the guidance for the next year. Yeah. 2025, of course, will again be an interesting but also challenging year. We, in terms of revenue, expect mid-single- digit percentage decline in sales. First 2024, sales in 2024 were positively influenced by technology disclosure and development services, about EUR 123 million. The latter will be significantly lower as the technology disclosure has already been completed in full. What that, of course, means is, like I said, below the surface, operational revenue will grow significantly, but will not be able to fully compensate for the technology transfer.
For the EBIT, we still expect, like I said, this transition years, 2025 and 2026. For EBIT also here, we expect a result in the range of EUR -55 million to -75 million for 2025. For cash flow, cash flow from operating activities expected to be in the low negative triple- digit millions range. Also here, mainly because we're ramping up the facility and loading the facility with working capital. Expected ROCE will be in the range of 3% to 7%. This is our guidance for 2025. If you go in, in summary, very brief summary, we've spoken today about continuous focus on innovation and lifecycle management. Some of this has been also already converted successfully into operations. Part of it is still ongoing.
We've spoken about the US mar ket introduction, for which Yimmugo® will be first, in, yeah, in a few weeks' time, most likely, and then Fibrinogen, most likely, early next year. The production capacity ramp-up is also very important. I told you about the plasma economics. We need to be above 50% of capacity utilization, and we need to be at three products per liter for this turnaround to happen. We are really focusing on this. Of course, it means a lot of hard work from many, many people, a lot of, let's say, acceleration in the whole supply chain, but also, of course, financially, working capital required to feed this. We, of course, will, with this, be able to generate significantly increases in product sales. This is the summary for today's, let's say, meeting.
All right. This was the overview of the year 2024. We could now go and take your questions. If you could also please name your name and your company.
Okay. There should be some questions in the chat. With regard to the annual general meeting, the correct date is the 2nd of July. The dividend for the preference shares, I know everybody can read the question. There was a question with regard to the dividend for the year 2024. We will have a preference dividend for the preference shares of EUR 0.04 per share and no dividend for the ordinary shares. I think the next question has been already explained by Peter. I have said lower EBIT. I know that for 2024, I think we have explained.
I think these sales are higher. Part of the EBIT was, thanks to the technology transfer, which is, of course, being reduced and being, let's say, replaced by, by operating, sales or, or core sales. Of course, we are continuously working also on efficiency. You can only have the efficiency once, like I said, you're above a certain limit of occupation of the facility and also above a certain number of products. We're certainly working on that. The main effect was due to the technology transfer, which is reducing. Operationally, we're still improving. We can't see the other questions. Not sure how to do this. Just a second.
Some people have raised their hand, so you can just allow the people raising their hands in the chat to ask questions.
Okay. Maybe we'll start.
This is Abhishek from Westbourne River.
Yeah. Oh, Abhishek. Hello.
Hi there. To the question about, let me start with the question about sales and EBIT first, because I don't think the explanation provided helps with the guidance. You said that sales will decline by mid-single- digits, but EBIT will go down to EUR 55 million to 75 million of loss. Now, technology transfer was about EUR 85 million, as you disclosed. Even if I subtract that from your EUR 95 million, you get to EUR 10 million EBIT. On an underlying basis, you are actually calling for a sales improvement. Why should that EUR 10 million positive EBIT become a EUR 55 million or more of losses?
I would like to say that there are several impacts in the year 2025. As you just mentioned, if you want to compare 2024 with the 2025 guidance, you can say, yeah, there's a huge impact by the TTLA Agreement. We are facing higher R&D expenses in the year 2025 in addition. We are expecting a general decline in the prices. We have seen already in the Q4 that prices are going down overall. We are expecting also a further decrease in the year 2025. This has an additional impact, and we have a slight technical impact.
We have changed the plasma allocation towards the products, and this plasma allocation has also a further impact in the year 2025, just related to the expected costs and the inventory level. Of course, we are increasing. Peter mentioned the BNL. We have now started with the Fibrinogen, and there is more expenses and more, yeah, costs related with the BNL.
Given all the stuff you're mentioning, I think it is very important for the company to disclose a proper bridge between 2024 and 2025, because the swing you're talking about is a plus EUR 10 million to a minus EUR 55 million swing with improving underlying sales. Especially in light of the fact that the management is supporting a delisting offer, which I'll come to in a second, the management is supporting that delisting offer, it is imperative for the management to provide clear transparency on why you are having such a negative guidance with underlying sales improvement. Please help us with giving that transparency so we can make an informed decision about what to do here.
Okay. Questions, note or questions, note.
On the delisting offer, could you help us? Four years ago, Grifols made EUR 43 offer for the ords and EUR 37 offer for the, for the prefs. Now, four years later, how is the management justifying support for, like, EUR 43 for the ords, but EUR 30 for the prefs? What is the justification for that huge price difference given the prior offer?
Yeah. Like I said, we will be doing, let's say, a fairness evaluation. I'm not ready to talk about it now. We will do this once we have the final offer, and then we can talk about this more and more detail.
When you say you will do a fairness opinion, does that mean that you are not, you're not supporting this yet?
We are, let's say, what we are supporting is the agreement. We have an agreement where we will go through this process. Once we have the fairness opinion, we will make our joint recent opinion.
Aren't you effectively saying whatever is the fairness opinion, you are going to support a delisting because the press release says you will make the best efforts to get it delisted from the different exchanges? Help us understand how does a delisting help all your shareholders, not just Grifols?
Like I said, we will go through the process to make a fairness opinion. If, let's say, the offer meets the fairness criteria, we will support.
Okay. I will wait for that, and hopefully we will get an opportunity to engage in more detail with you. I would request you again to provide the transparency on the bridge on EBIT.
Yeah. Let's see more questions. I think Maria Danimis, you have a question? You're still on mute.
Okay. Sorry, I didn't realize I had to introduce myself. Thank you very much. Yes, thank you. I have a few questions, please. First of all, on the actual business. Also a clarification on the delisting. Could you please help us understand what sorts of underlying product sales growth you actually expect for next year? Given that it's a bit difficult to tease out exactly how much of the mid-single- digit revenue decline is actually due to the technology agreement, given that your R&D expenses are going up and you're getting a reimbursement for that. Maybe if you actually could clarify the R&D expenses you're expecting as well, please. Specifically on product sales, how much Yimmugo® do you expect to produce for the U.S. in 2025, 2026, 2027 in kilograms, please?
Also on the profitability, when would you actually expect to achieve break even, you know, just assuming a going concern basis? Because everything you've said about the negative factors affecting EBIT next year, I think is actually going to, is probably going to carry forward into 2026, 2027, and Trimodulin, which is obviously a big profit driver, is delayed to pretty much the end of the decade. Would you actually expect to break even in 2026 or 2027, or would you expect to continue to make significant losses? Finally, on the delisting, I was just wondering if you could help us clarify the process some more. When would you expect to be the last trading day? What would you expect to be your last publication? Would that be Q2 or Q3?
Can you remind us of the squeeze-out procedures, in particular for any preference shareholders who do not tender? I mean, as has been alluded to before, the offer does not actually include any sort of premium over the unaffected share price. How many of the preference shareholders would really need to tender in order for the delisting to go through? What would happen if participation in the tender were quite low? Thank you.
A lot of questions.
I think the first one is the sales, just a second. What is the sales increase in terms of the budget you mentioned of the normal product, is an increase of approximately EUR 40 million.
Four zero.
Yeah. Four zero. Yeah.
Thank you.
With regard to the R&D increase, we are expecting roughly EUR 14.14 million additional R&D expenses in the year 2025 compared to 2024. Yeah. I think you moved over the question. What do you expect of sales? This year is around 700 kilos for the U.S. market. I think, I believe next year is, 2026 is around 2,000 kilos and then growing, yeah, up to the maximum. For the further years, I think we, we do not have a precise view yet. Yeah.
Thank you. And on the break even?
The break even, it is, so we are currently making our, our, let's say, longer or, or let's say we are revising our long range planning. Our expectation is that it would be as from 2027 that we would be break even. Yeah. Not in 2025 and not in 2026, only as from 2027.
Thank you.
Last publication date—
2022.
Yeah. Second quarter. Yeah.
Yeah. 2022, Q2.
Yeah. There was a question with the, with regards to the squeeze-out. This is a separate. This is, this, let's say, delisting is independent from the squeeze-out, as far as I know. Monika, you can maybe explain the status of the squeeze-out.
The squeeze-out of the ordinary shares is still with the federal court. We have no update, for our latest update, by Grifols.
Yeah.
No change at this point in time.
Thank you. Just, I mean, if the delisting date for the preference shares, do you have that? What actually happens, you know, I'm not talking about the ordinaries, but for the preference shareholders, if very few people end up tendering, what would then happen?
As far as I know, both preference shares and ordinary shares, let's say delisting, would be in parallel. The same dates. I think there's not a requirement that there is a certain quorum. There's no quorum for preference shares. The delisting would go through, anyhow. What would happen to the people who don't tender? The people that don't tender can remain shareholders. Of course, I think they would miss the trading platform, so they have to do private sales or, yeah, purchase.
Thank you. I do have a final question. Do you have a delisting date in mind? I mean, would that actually happen in June or July or more likely, like, August or September?
June. June. June. June. Yeah.
It also depends on the start of the period, the acceptance, the offer period. Depending on at this point in time, assuming that Grifols will hand in the offer in two weeks' time, it would be approximately beginning of June. That depends on the procedures that are to follow now.
Okay.
It's on the third slide, you can see a rough timeline.
That is also the reason why we have organized our general shareholders meeting after that date.
Okay. Thank you.
You're welcome.
Hi, Abhishek again from Westbourne .
Yeah. Hi, Abhishek.
Hi , one follow-up. You talked about price reduction in the industry, responsible for some of the EBIT decline. That price reduction, is that impacting everyone in the industry, including Grifols, or is that something particular to Biotest?
It's affecting to a certain extent everybody in the industry. There is maybe one, one, let's say, element is also how much you, let's say, where you make the sales, I think, where your network exactly is. I think we had some extremely good prices during COVID, in some Middle East tenders, which, which fell away. Of course, if you're less impacted by such events, this will impact your price also differently. Geographical spread is one element that could give a difference. Then also, let's say, what companies focus on, let's say, for Biotest, really, the focus currently with the ramp-up is also to minimize, working or, let's say, to finance our working capital. There is a lot of finance, focus on cash. If you focus on cash, sometimes you give in on margins. This is temporary, of course, as long as you do this. This also is an effect you see for Biotest.
All right. I look forward to receiving the transparency. I'm guessing you would make that public to everybody, the transparency on EBIT Bridge?
Yeah. I think we can do that. Yeah. Yeah.
Thank you.
There is also a question from Klaus Schroeder?
Yes. Thank you. As far as I know, the preference shares are listed on the free market at the Hamburg Exchange. In future, people who are not handing in their preference shares during the offer period, they still can trade in Hamburg. Do you have thoughts on that?
I believe also that will be delisted then.
It's listed there now. Typically afterwards, it will still be listed in Hamburg. That's the experience with other shares.
Yeah.
That's why I asked whether you can share that impression of.
Yeah. I mean, I cannot. We will get back to you. Yeah.
Yeah. Okay.
That's a good point. Yeah.
Yeah. And the Trimodulin, why is it pushed back by, I would say, approximately three years? That sounds a little bit, sounds a little bit, surprising to me.
Yes, of course.
I think there are two reasons. I think one, we, I see now we did not explain in detail. I said we concentrate on study ESsCAPE, which h as the number 996. We also stopped the other study 1001, which is called, which was called CAP. This CAP study was recruiting faster. But, let's say the recruitment, the patients that were recruited were not really the target profile. In the end, we decided, and for other reasons, we decided to really focus on the other study, the 996. This was already, let's say, delayed because you stopped the faster study, which you believe is not the best study. Secondly, also, let's say when you start a study, you make a kind of an assumption based on theoretical parameters.
Based on those theoretical parameters, you forecast an end date. Right now we have, like I said, 100 patients out of the 600 recruited. We can now make a much more reliable extrapolation of the total recruitment phase. This is longer. I think when we did the theoretical forecast, it was too optimistic. I think it is due to those two effects.
What are the costs regarding the recruitment of 600 people? 100 are already recruited and 500 will be recruited in the future? Can you tell us the cost involved, please?
Do you have an idea?
Just—
We can get back to you.
Yeah.
It is okay.
For the several millions, that is, it is a high, high recruitment cost.
You mentioned you will increase R&D expense by EUR 14 million in 2025. This is not reimbursed by Grifols, or is it?
It is. A lot of it is partly reimbursed by Grifols, but these expenses are not reimbursed by Grifols as well.
That is just right now. Because it was five million about. It was about EUR 5 million in 2024. It goes up now to EUR 14 million or I do not know exact number. It will be higher than in 2024 what Grifols is reimbursing in terms of, for, for R&D expenses.
We have different, I mean, not all of the R&D expenses are reimbursed by Grifols. It is always depending on where, what kind of R&D projects we are talking about here. These are the expenses that are remaining by Biotest.
Okay.
This is the reason why they are increasing by EUR 14 million.
Thank you.
Yeah. You're welcome.
Do we have any other questions?
Hi, I wish. Hi, I wish. I wish you again one last follow-up from me. On the Trimodulin recruitment, could you guys tell us in Q4 and Q3 how much did your recruitment go up by? It is 100 now, but in the last one and two quarters, what was the ramp-up in that recruitment?
I think, science. We've recruited since the beginning of the year about, yeah, 40, 40 patients. About 40 in three months' time, two and a half, yeah, three months' time. It's about 20 per month. This is what we count with. You also have in this recruitment basis, let's say, the flu period. We have the flu season in the northern hemisphere around the end of the year, and in the southern hemisphere, it's right now. You also have to take that into account. If you do an extrapolation, I think you can also account back, so being completed in 2029. For the period between now and 2029 for the remaining 500 patients, that's the linear recruitment rate.
Did you, you said 20 per month. That would be 240 a year. Another 500 in roughly two years. That would mean you complete recruitment in 2027? Yeah. The protocol is—,
The recruitment of 20 per month is only during the two flu seasons. In between, it is much lower. It is like five a month. If you add up this in the curve, then you end up in 2029. Yeah.
Okay.
All right.
Do we have any other questions? No. All right.
Thanks. Thanks a lot. Yeah. Thanks. Thanks a lot for your questions and also your interest. We will, let's say, look to the follow-ups. I think your remarks were all very valuable. We will look at that and we will share it then for all others. Yeah. Yeah. Okay. Okay. Thank you.
Thank you.