Yes, thank you for the intro, and warm welcome from my side as well. Good afternoon, good morning, wherever you are and dialing in from. No worries, we won't bombard you with earnings calls every week, but as the recent 2023 full year results have been presented already intensely by us, we can focus this time now on the Q1 results, financial results in this quarter, but also operational highlights in that period. And we'll also give you an outlook on the important news flows to come in the upcoming months. So let me start also with reminding you that we, our presentations may contain forward-looking statements that are always based on our current expectations and assumptions, which will always be subject to risks and unforeseen changes.
Q1 2024, this is kicking off a year which is setting the ground for the next ignition stage of Formycon. We, as one of the few pure-play biosimilar companies, are executing along a clear growth plan. Starting in 2023, with a very intense year, rich of milestones, which we all could tick off financially and operationally. The year 2024 will be the preparation of the ground for the next ignition phase, will be equally intense, equally important, and lead us and turn the business into sustainable profitability after having two more products on top of our existing biosimilar, two more products in key markets introduced. So let's have a closer look to the operational and financial achievements in the first quarter. The highlights are manifold across the whole program. Let me start with FYB201.
We had already a very nice start with 2 further launches in 2 more countries, Canada and Switzerland. Commercialization performed by our partner, Teva. Our partner, MS Pharma, is happy to have 1 more country, with Saudi Arabia in the launch plans. We got an approval there and also won the NUPCO tender already, which is very important for a launch that is planned as we speak in the second quarter. In the U.S. market, which is very important, of course, for that product as well, we warmly welcome Sandoz as a new commercialization partner, replacing Coherus, which successfully set the ground for a very good performance. We are now launching and marketing in 18 countries worldwide, and we won't stop there. So there are new approvals and launches in the pipeline, and we will soon break the 20.
For Stelara biosimilar, our FYB202, on top of the settlement that could be achieved together with our commercialization partner, Fresenius, and us with J&J, on a U.S. launch date, no later than April 15, 2025, which puts us in the first launch wave of biosimilars. We could also settle for additional regions, Europe and Canada, with J&J this year in 2024, and the date is not disclosed. The regulatory procedures are mandatory, of course, for launches to come. That's why we are intensely running and pushing forward the regulatory procedures at the two major agencies, FDA and EMA. This is nicely progressing, and we're expecting approvals from FDA end of September, and EC approval a bit further down in the fourth quarter this year. Similar activities apply to FYB203 in parallel, our Eylea biosimilar candidate.
The regulatory procedures are running at full steam, also at both key agencies, and FDA approval is targeted for end June this year, even already, and the EC approval for early next year. As this is attractive asset for all commercial regions, we of course, intensely, part in partnering activities and closing out the deal in the next month. The second wave of our portfolio, the earlier ones, are in the lead or led by our Keytruda biosimilar. A very important asset, and we after intense- we are in intense preparation of a clinical trial after having aligned the clinical concept with the major agencies last year already, and having supply, secured of the clinical study. We are in full steam, last steps of preparation, all to pave the way for a clinical start and have the first patient in still this year.
For FYB208 and FYB209, we have very promising clones in hand. Promising always means good yield, but also good stability and high similarity profile. And we are in the selection process and doing the final deals with our commercial manufacturing partners, which we, we always tend to, actively work very early in the process. In parallel, we're still driving the technical development forward, always, always towards the target technical proof of similarity, to really prove the high similarity in, in across 50-60 different analytical methods against reference in our products. And also, FYB210 to the portfolio, is in the selection process. This is intense process around a comprehensive set of selection criteria, and we want to take the selection decision and also kick off the first development activities still second half of this year. With that, that's the operational part. I will hand over to Enno. Happy to learn more about the financial performance.
Yes, and great pleasure to present the respective numbers. Thank you, Stefan, and warm welcome everybody else from my end. We are looking at a solid and positive financial performance for the Q1 2024, fulfilling our guidance and being underway according to our plans. On the next slides, I will provide some insights on the details or the respective backgrounds on these numbers. So let's start with the P&L, where we are fully on track. And as a reminder, revenues are consisting of three major pillars, revenues from services and cost reimbursement, like for instance, in the case of FYB201 and FYB203. Revenues from milestones, like for instance, receiving the success payments from Fresenius Kabi in context of our FYB202 collaboration.
And last but certainly not least, revenues from licensing payments derived from our approved and already revenue generating asset FYB201. What is different to Q1 2023 is that we don't have a EUR 10 million one-off effect like we had from the Fresenius Kabi upfront payment in Q1 2023. Also, reimbursement for FYB201 and FYB203 is reduced as these projects nicely mature and only require little development work, which is reimbursed at this point in time, so in Q1 2024. Success share from FYB201 is increasing significantly from EUR 0.3 million in Q1 2023 to EUR 1.9 million in the reporting quarter.
But of course, this cannot yet compensate for the upfront payments and reimbursements that we received in Q1 2023. The cost of sales, here we see the same effect. Cost of sales reduce due to reduced development costs for FYB201 and FYB203. R&D expenses, here we have two opposing effects, actually. FYB207 fading out for 2024, while FYB208 and FYB209 are further accelerating and also expanding in context of our maturing pipeline, as Stefan just nicely mentioned and described. The EBITDA reflects the same effects as just described in the other P&L lines above.
Important to point out is the Adjusted EBITDA, and this Adjusted EBITDA, which now stays at -EUR 0.4 million for the first, sorry, -EUR 1.2 million for the first quarter of 2024, versus -EUR 0.4 million in Q1 2023. Still, the effect from the at equity result from FYB201 is contributing EUR 4.3 million in Q1 2024, versus the -EUR 6.4 million in Q1 2023. So showing a significant upswing in this regard. Let's take a look at some KPIs from our balance sheet structure. And here, the basis for comparison, obviously, is the 2023 December or year-end numbers.
The main KPIs are all stable or increasing, but in particular, the increase in share capital obviously has a major role here for Q1 of 2024. The balance sheet total is very strong and is up by 6% to almost EUR 950 million. The major driver here is the increase in our equity. Here, the major point is, again, the capital increase with gross proceeds of above EUR 82 million. On the other side, we have a reduction in liabilities, and here we repaid or paid back EUR 20 million in our shareholder loan facility, so that this is being reduced to zero at this point in time. Consequently, the equity ratio is up due to the increase in equity, as well as the reduction of the liabilities.
Cash and cash equivalents are also up from EUR 27 million at the end of 2023 to EUR 57 million at the end of Q1 2024. Again, main drivers here, capital increase on the plus side and repayment of the shareholder loan on the minus side. If we move to the cash flow and the working capital flow and capital, then we can say that cash flows from operating as well as from investing activities show continued investment into our product pipeline, like for instance, FYB202 and FYB206, helping to build and to broaden our sustainable pipeline. On the other side, cash flow from the financing activities contributed net approximately EUR 6 million via the EUR 80+ million capital increase, as just described, deducted by EUR 20 million repayment of the shareholder loan.
This leaves us with approximately an EUR 80 million uptick of cash and cash equivalents at the end of Q1 2024, while maintaining the 48 million credit line, which is currently untapped due to our repayment. Working capital stays even higher at EUR 84 million, obviously, strongly influenced by the capital increase in February of this year.... Let's switch gears and take a brief outlook, and also take a look at our guidance on the next slide. So first of all, let me confirm our guidance for 2024. We have achieved all numbers as anticipated for Q1 2024, and currently, we assume guidance to be firm for the full year 2024 as well, therefore, no adjustment.
Again, revenues, here our expectation includes license income from FYB201, FYB202-correlated success payments, and the remainder then coming from development recharges, where approximately one-third is associated to FYB201, and two-thirds probably to FYB203. Looking at the EBITDA, our increased development activities for FYB208 and FYB209, plus newly adding FYB210 in the second half of the year, will lead to a higher EBITDA loss in the range of EUR -25 million-EUR -15 million. Obviously, also, the reduced revenues, compared to last year do play a role in this regard. Again, importantly, adjusted EBITDA, which considers the at equity, where we expect this to contribute about +EUR 10 million for 2024 in total.
That's also why you see here the delta in these two guidance, showing a range of -15 to -25 for, quote, unquote, “normal EBITDA,” versus -5 to -15 for the adjusted EBITDA. Overall, we continue to strive to achieve midterm EBITDA profitability, turning Formycon into a sustainable and profitable company. Therefore, it is paramount, as Stefan already just indicated, to add FYB202 and FYB203 to our revenue generation over time, where we are on a very good track, today, and 2024 is certainly meant to build the platform in this regard with receiving respective market approvals by the authorities.
My last slide is very briefly a reminder on our shareholder structure, where we once again welcome our new anchor investor, Gedeon Richter, which I already did in the year-end call 2023. But I'm very happy to repeat this, as they have a great understanding of the industry and are very committed, and are also a strong operational partner to us. So that is very exciting. And in total, this means that we now have five major anchor investors holding clearly more than 50% of the company, while we remain with a free float which is above 35%.
The other comment that I would like to make is that in 2023, we have already added two analysts, namely, MM Warburg and Berenberg, but we will engage hard to further add additional analysts during the course of 2024. So, I hope we can also show some updates during the year in that regard. With that said, I'm done with my introduction of the Q1 2024 numbers, and hand over back to Stefan. Thank you very much.
Yeah, thank you, Enno, for illustrating the numbers and explaining where the effects come from and confirming the guidance, which is always good. Let me continue with one of my favorite slides, because it shows at one glance, our attractive portfolio and pipeline. There's a lot of information on that, but let me draw your attention to mainly four things. One, is really adding up an attractive pipeline with market reference sales of more than $50 billion. Number two, we have three late-stage assets, one already in 18 markets, soon in 20, and 2 more to follow, and are, as explained, also in the regulatory procedures and getting closer and closer to approval, and then the upcoming launches.
So with all those according to our plans, within the next 18-24 months later, we will have three products of our pipeline in the market, in key market introduced. And this is really a big achievement we are looking forward to. And in the younger pipeline, of course, Keytruda is standing out, and also there, it's nice to see that Keytruda is approaching the next important milestone, which is the first patient in which starts the clinical phase of this very attractive asset. And fourth, attention to the gray one. This is the new kid on the block, FYB210, which we're going to start, and it's just the start of a series of new additions, which we want to add constantly to our pipeline.
So in all portfolio selection processes, it's always the same amazing effect that you look at a huge number of potential assets and potential targets for biosimilar development. Many of them will remain untapped in the next years to come. But if you only look at the 45 blockbusters of the next year until 2032, that's adding up to target reference sales of more than $200 billion. So no wonder that biosimilars is the fastest growing segment in the pharma business. As explained operationally and financially, we are preparing the ground and preparing Formycon for the next ignition stage. This is also reflected in the plans for additions to our supervisory board, which we published in a press release yesterday.
Let me use the opportunity also to provide you a bit more color and a bit more context to that.... So the target markets in biosimilars, to put it on the general note, are very international. The business operations are international, and maneuvering successfully through that demanding and growing space requires a lot of broad expertise and global network. And that's why we feel very privileged that two top-notch industry experts are joining us as candidates for election at the AGM. Nick Haggar and Colin Bond, and we know them for quite some years, are heavyweight pharma veterans with decades of experience in C-level positions across many reputed companies.
With Bodo Coldewey, as financial caliber, with strong entrepreneurial expertise as a managing director of the family office, we also ensure continuity in representing the major shareholders, together with Wolfgang Essler, representing Athos, and Klaus Röhring representing Active Ownership. Olaf Stiller and Peter Wendeln. Olaf, as co-founder and chairman of the current board, and Peter Wendeln as the first early anchor investor into Formycon and co-chair, significantly shaped Formycon for more than 10 years. Without them, Formycon would look completely different than it looks today. We are very, very grateful for their engagement and passion and entrepreneurial guidance over many years. They supported us also in the new design of the future supervisory board, and now are really proudly handing over to the successors, to the baton, to the new giants.
So in a nutshell, there's a lot of positive momentum in the biosimilar market, and there's a lot of positive dynamics in our company on its way to a leading position in the attractive biosimilar space. So 2024, and we gave you a first glance of the Q1, will be another year of bold proof for our pure-play R&D platform. We have all ingredients in place for a success story. We have a clear plan to maximize our assets, and we prepare the ground in this year for entering the next ignition stage, step by step on our growth trajectory in a highly attractive market. So with that summary, in a nutshell, I want to conclude our presentation on our encouraging Q1 results, and would like to open the audience for questions and hand back to our operator. Thank you so much for your attention.
Thank you very much, also from my side. So dear ladies and gentlemen, if you are dialed in the conference call and have a question for our speakers, please press nine, followed by the star key on your telephone keypad now. Once your name has been announced, you can ask a question. If you find your question is answered before it is your turn to speak, you may press nine, followed by the star key a second time to cancel your question again. So please press nine star now to state your question. One moment for the first question, please. The first question comes from Nicolas Pauillac of Kepler Cheuvreux, and I'm very sorry if I mispronounced your name in advance. Please go ahead.
No worry, madam. So thanks a lot and thanks for the presentation. So maybe the first question, I think you already answered that during the presentation, but I had some pros. Could you come back on how do you use a revenue breakdown for the year? And maybe also, I don't know if there is new guidance from the sale of FYB201 from Sandoz or Coherus beforehand. So that will be my first question. And then the second question, I think it has been the real hot topic of these days with Sandoz, Novartis and Teva today. There was a lot of momentum going around the biosimilar that Sandoz commercialize on the back of the deal that they did with one of the PBM with CVS, sorry. How do you use that going into your Stelara drug? Do you think that you will need to get a similar deal in order to get some traction in the market, or do you think that it's very too early to tell on that? So thank you.
Yeah, thank you for your questions. So let us start with the two oh one details. If I may ask Enno to respond to that.
Yeah, I mean, we are not really guiding on all the details of the respective sub-segments of our revenue breakdown. But certainly, we do a significant portion of the revenues coming from the two deferred revenue recognition, where we have received major payments already early last year in context of the Fresenius Kabi collaboration. We will see another important and significant block, which is the reimbursement of costs for FYB202, sorry, for FYB201 and FYB203. That said, this is shrinking compared to last year, as the project reduce efforts heading towards market approval of FYB201. Actually, being at the market already here, we are working on topics like prefilled syringe going forward. and the minor part yet will be on the success share on net sales participation in 201 , which comes then directly into our top line. The major part, again, here will go through the equity result. But I'm, I'm sorry if I cannot break it down in, in details and depth numbers. This is not what we guide in.
Okay.
And then, the next question on the PBMs.
Yeah.
Yeah, yeah, thank you. Of course, that's, that's, on everybody's mind, looking at the PBM market and which levers will break that up. I mean, first positive thing is, and that will also pave the way for our Ustekinumab Stelara biosimilar, is that the PBM market obviously is breaking up. So we see now, even in the recent weeks, we saw a boost from 5%, which was double the total rate of biosimilars share last year, to now, I think it's 60% currently. I mean, it's changing every week, with the CVS Caremark deal with Sandoz. So it's, and we will see further those deals.
I would expect further deals in that shape coming up, which will definitely open up the market for Humira, which was also very much looked at because the channel was so much so far closed, but it's now opening up. So the last break is taking off, and I think that's a very good sign. Of course, that's one of the reasons why Fresenius is our commercial partner. It's always helpful that if you build that network already, and Fresenius is having with Ustekinumab, our product, it's the third product in that channel in the same therapeutic area in line. That means they have Adalimumab, they have Tocilizumab, and Ustekinumab will be the third one. And for sure, those connections that will have been built on formularies, on PBMs, will help there definitely to pave the way. So all in all, positive trends, I would expect, that the market opens up further and that those kind of network collaborations with healthcare providers will be essential for success in the future.
Okay, great. Thanks a lot.
You're welcome.
Thanks a lot. The next question comes from Benjamin Thielmann of Berenberg. Please go ahead.
Yeah. Hey, guys, this is Ben from Berenberg. Maybe two questions from my side. First question would be, sorry, on Lucentis. You mentioned already, Stefan, that we're going to see more countries you're going to get into. In terms of regions, what can we expect there? Is it going to be predominantly in developed nations, or are you trying to get a little bit more in the MENA region? So a little bit of color on that would be very nice. That's the first question. Second question is on your at equity result. I mean, Q1 was quite solid on at equity. Is there a similar development we should expect in Q2, three and four as well? Thank you.
Yeah, thank you, Ben, for the good question. So let me take the first one. MENA region, yes, that's one of the focus areas. We will have further launches in Saudi Arabia for sure, is the biggest one there and the most important market there. But together with our regional specialist, MS Pharma, of course, we want to enter into as many markets as possible, but that's not the only focus. So we will expand also our launches in Europe, further. Also Latam is on the plate, so we want to go as global as possible and add market by market. And also not only adding markets, but also growing the existing markets, because some have boosted already, like U.S. and U.K., up to 38% and up to 70% last year. But there are other markets that more slowly develop, not as a big splash, but continuously step by step, adoption by adoption, and education by education. So it's a mix of new additions. We have the big ones already, but we will add more, plus growing the existing markets. And the second part goes to Enno.
Yes, I take it. The question on at-equity performance expectation. So for Q2, you probably can expect numbers in the same range like Q1, as we have reported today. Second half of the year is probably a little bit down. Why is that? Because we will see more impact from the development cost for the pre-filled syringe, which we are pushing. And that's where we will see a bit of an impact here on the at-equity performance.
Okay, perfect. Thank you, Stefan. Thank you, Enno. I'm going back into the line.
Yeah. Thanks, Ben.
Thanks a lot. Dear participants, if you wish to state a question, just a reminder, please press nine star on your telephone keypad. And we have a new question incoming. It's of Christian Ehmann of Baader Research. Please go ahead, Christian.
Hello, everyone, and thanks for taking my questions. So I have one for the cash reach for your companies. And looking at the nice cash position you have right now and conscious of the fact that you have a EUR 48 million shareholder loan, my question would be: How far can this take you along your growth path? I mean, probably you want to expand, keep expanding in the next year again, to actually accelerate pipeline, product or pipeline expansion. So how far can you take this, and what kind of funds inflow can we expect in the future for you?
Well, currently, the indication that I will give is based on no further- ... additional financing rather than having or utilizing potentially the credit line that we have on standby with EUR 48 million, as I mentioned during the presentation. That should bring us on that basis into probably late Q2, early second half of 2025 going forward. So right now, we feel very comfortable with this position and no urgent needs to take any measures, but really monitoring the markets and also seeing what happens on our product development and licensing opportunities.
Thank you very much. Dear ladies and gentlemen, last call. Thank you very much, Christian. If you wish to state a question, please press nine star. At the moment, there are no questions in the queue, so just a couple of more seconds. Ah, I see new questions are incoming, so the next one is from Alexander Galitsa of HAIB. Please go ahead.
Yes, thank you so much for taking the question. Just one on the syringe for 201. By when do you expect to finalize the development of the syringe?
In the current plans, target to launch in the first half of next year.
Understood. Thank you. And then, does that mean that the Bioeq joint venture then will have basically lower running operating costs? Or, should one expect some additional operating costs emerging on the entity level?
Let me start with that. I mean, the main costs are still the development costs are still with the prefilled syringe, which is a highly complex system, but we are progressing nicely there. And other than that, I would, I'm looking at my financial colleagues, I would not see bigger, bigger-
No, I mean, and as I mentioned earlier, the PA or the development cost that we still see today for 201 as well as 203, is mainly dedicated to this particular field, developing and getting ready with the PFS. And once this is established, we will see no additional cost, in that regard, and this would basically then fade out the major part of the development cost.
Understood. Thank you.
Thank you, Alex.
Thank you also from my side. We have a follow-up question from Benjamin Theilmann of Berenberg.
Yeah. Hey, one follow-up question, if I may. Again, for you, Stefan, in terms of competitive landscape in the regions, I mean, we have seen you public or you, you're now going into Switzerland and Canada with your biosimilar to Lucentis, and you're all already covering the big ones. But is there any country that is still very attractive in terms of the share of population, being treated by, or people that have NAMD or something? What countries should we look out for? Do you have, like, a map and you can tell us, "Okay, these countries are most attractive in Europe, these countries attractive for most, are most attractive in MENA." Is there something like this? Just to get a little bit more colors. Also, how maybe the competitive landscape looks in these regions.
Yeah, for sure. Not in detail, I'm sorry. But, I mean, we put our priorities to, of course, the most attractive markets first. And, as said, I mean, launching is one thing, but also driving the adoption there is another thing. So we started with high impact of U.S. and U.K., but France, for instance, is growing nicely, much more slowly because of the local policies and situation, but nicely. And this, Europe in as such, will grow constantly and take over, and especially when we are able to add the series, some other markets will also grow much on a higher path, growth rate as we see them now.
So it's kind of the major markets are covered from population, from attractiveness, for sure, but there is still room for growth in some of the major markets because the adoption takes just longer. And we have to remember still, we are in the second full year after launch. So ramping up a product like this in all the countries takes a bit longer, especially as we have the first biosimilar in the space of AMD and retina specialists. That always takes its time. I hope that-
Okay.
- answers a bit your question,
Yeah, it was perfect. Perfect.
Yeah.
Thank you very much, Stefan. Have a nice, nice holiday tomorrow, everybody.
Thank you.
Thank you so much. That's a different topic, which thank you. Thank you.
Thank you, Benjamin. Have a nice holiday tomorrow, everybody, also from my side. With that, I would like to switch off the Q&A for now, since there are no more questions, and I hand it back over to the host.
Yes, thank you, not only for the nice wishes, but for the, for the perfect technical performance today. So that was really great. Thank you for that. Also, thank you for the investor relations team that prepared all that and content, and of course, to Enno, and also to every participant, watching and having, showing interest in the performance of Formycon. And stay tuned, there are a lot of good news ahead of us, and thank you for your interest, and also have a nice holiday.