Thank you very much, and welcome everybody to our full year results presentation. I'm not alone here today. In the left of me is Pascal Schmidt, our CFO, and right is Eva Prieschl-Grassauer, our CSO. So we'll dive right in. So we will talk today about the highlights of last year. Then Pascal will follow with the financials.
Then I will summarize the therapeutic areas, the recent development and next steps of our pipeline. Eva will show you some new, exciting new data on Carragelose, and then we'll, I will summarize at the end of the call, the update and the outlook, what's gonna be next. So in the last twelve months, our highlights were we report revenues of EUR 9.2 million today.
It's this revenue is clearly above pre-pandemic level, and when you compare it with just our recent IQVIA data on cough and cold in the European markets, it was a decline of more than 25% of the entire market. So the Carragelose is performing pretty well, and our partners are performing pretty well. Of course, it, it's not nice to report a decline in revenues, but gaining market share is not not bad at all.
We will report and show today also new products, the Carragelose eye drops, where we're currently preparing for launch and the Carragelose allergy blocker that has been recently launched in Austria. We're quite proud of that. It's a long-term program to make Carragelose a full year, not non-seasonal product.
So this is an important step for that. We reported our first long-term partnership with Chinese company SPH China, and there's more to follow on Solv4U. And of course, very important for the company, the agreement with the European Investment Bank to defer our repayments for 18 months, and Pascal will comment on that more or less now. And I'll hand over to Pascal to show us the results.
Yeah, thank you, Andreas. We jump right into the top line. As Andreas mentioned, it's an overall decline by nearly 20% from 11.3 to 9.2. This is mostly Carragelose based, and as mentioned, we can't complain compared to the market development overall in the post-pandemic world. This is still a good achievement. However, as we all know, the milestones from larger out licensing deals are missing. This is now on the agenda for this year and upcoming years. But overall, this is all right compared to the market development.
As you can also see in terms of the EBIT line, despite the declining revenue, we were able to mainly hold that level of around EUR 5 million in negative EBIT. This is A, because of the research grants that we received in the context of the research premium in Austria, as well as the COVID related studies, which were funded by the state of Austria.
And we were B, in the very much cash conscious in terms of expenses, especially on the consulting side and other operating expenses. So we reduced costs and therefore were able to hold the level despite the top line development. We still have some challenges in front of us.
The Carragelose business will still be in the post-pandemic world, and we still have customers with relatively high stock levels. Nevertheless, we look optimistic into the future because from most of our customers, we hear that the sellout levels from the pharmacies to end customers are still very robust. As Andreas mentioned, market shares can be gained.
So overall, this will lead to stocks going down at our customers and the reordering. We don't know when this will pick up again, but towards the next season, we believe that we'll see the right development. We have other initiatives, especially relating to our new products. Eva will refer to them in her part.
We have the allergy product, which just had the first launch in Austria, and we have the eye drops, which have generated good data. Business development is ongoing here, and we have good traction. We have also new partners. In the recent months, you've seen our press releases regarding DKSH in Asia, Vita Plus in Hungary, and with related Eastern European countries, and Gaia in the Gulf region. So, three new customers, expanding our network and reach into the countries with additional products, as well as business development process regarding the Carragelose franchise.
So here we are, actively working on the project, which we announced last year, to have an assessment on the Carragelose business, as a whole, as well as our top priorities, out licensing Budesolv and Tacrosolv, the two lead products from the Marinosolv platform. Also important, the Solv4U part, where we out license or where we provide technology partnerships to customers, here we are also gaining traction.
So overall, the Carragelose business will face another difficult quarters ahead, but with some view on how on positive development, and together with licensing and our M&A deals, we have the top targets of reaching profitability. Looking into the details of the profit and loss, mainly, on the top line, the margin has overall developed well.
As you can see, it reduced from 32%-29%, which is mainly due to write off of some products, which we needed to produce in order to comply with the MDR requirements. This is something where a lot of studies have to be done, and where you need to show stability and validation studies, and this has an impact on the margin. If you take that out, or adjust that element, we are also and still on the 30+ level, where we want to be.
Further down, the P&L, the R&D expenses mainly stayed at the same level, so from 6.9 to EUR 7 million. We took more in-house, so personal expenses increased. We did quite a lot. The service expenses increased a bit, but this is still related to remains of the COVID trials, and therefore, in the long run, service expenses are down as well. And, as you can see, other expenses which consist of to a large portion of the interest element, this is related to the loans that we have. So overall, as described on the operating result level, ending at nearly the previous year's level of EUR 5.1 million.
Looking at the asset side of the balance sheet, I think the important part here is certainly inventory levels. We strive to get them down. Mainly, it consists of raw materials, which is the glass bottle, which is still a strong bottleneck in our supply chain. We still have lead times of more than 12 months for this part.
So one thing is that we stock this, but the other same thing is, and that is something that you can see, is that we try to reduce the glass portion in our supply and move more to HDPE, which also from a sustainability viewpoint has a benefit because bottle and pump are both then from HDPE, and from a recycling perspective, that's made easier.
Moving ahead to the equities and liability side, I think most important element here is certainly the borrowings. As you can see, this reflects the status as of end of year, where we didn't have the EIB agreement in place. Here, borrowings moved to short term, which increased the short-term portion to EUR 7 million.
By the agreement that we reached, we now are able to classify that back to long term, and this certainly very much appreciated that this was possible to come to a conclusion here with EIB. Other significant development is current contract liabilities and other current liabilities, where we reduced this element through the use of the subsidized COVID-19 trials.
So we were able to finalize the calculation with the authorities and were able to take in all the proceeds that we received in that context. Taking a view on the cash position, this is certainly a reflection of in the beginning, repayments of loan as well as spendings on trials.
Towards the end of the year, especially the fourth quarter, we significantly reduced cash burn. So, our initiatives that we started in the beginning of the year now take effect, and we tried obviously to get a good view into this year's cash flow and make use of the cash position as best as we can. Overall, the cash position of EUR 2.6 is that does not take into account or that does not reflect last year's drawdown of the last EIB tranche. This is why the EUR 8.2 obviously was significantly higher. We didn't have significant cash proceeds this year from funding.
The important element, certainly this year, beginning of this year, was the agreement with EIB. And the real estate lenders, we were able to get a deferral of repayments on the tranches by 18 months, roundabout. So, the most important tranche one element here from October this year, moving to April 2026, that certainly was an important part of this agreement.
It in total means that we won't have repayments on the loans before December 2025, which gives us the time that we need to maximize the proceeds from our business development activities relating to Carragelose as well as Marinosolv assets. That said, I will hand back to Andreas for the next part.
Yeah, thank you, thank you very much, Pascal. The Marinomed has two big therapeutic areas, the immunology and the virology, and that's based on two platforms, the Carragelose and Marinosolv platform. We discussed about the cough and cold portfolio. We just saw that we, after that first product launch, to expand that portfolio into the immunology field, with the mild allergic rhinitis treatment of the nasal spray. That should help to bring that portfolio to a full year portfolio, and adding the eye drops contribute significantly to that as well. We'll hear something on the eye drops later on from Eva.
With Budesolv on the immunology side, the progress there is, as reported in previous conferences or conference calls, is that we were able to solve the technical problem that led to a stability issue with the Budesolv product. And technically, actually, we are very proud that we were able to solve that, now have a much better stability. Even we were able to file another patent for that product, that this patent will last until 2044. So, really protecting Budesolv for quite some time.
That new technical data helps to progress the business development process for Budesolv, that is gaining traction, and we hope to be able to report new deals on Budesolv in the near future. With Tacrosolv, it's a similar development here also, technical issues and also development issues have been resolved.
So this product is early in stage, it's a phase two product that we successfully completed a phase two proof of concept trial. And we're currently planning, or we are in partnering discussions with potential partners to out license or partner that program with a bigger company. Also, an ongoing process, so you'll see that there is a significant commercialization activities ongoing.
With Solv4U, we reported the technology partnership, the first long-term partnership here, and a series of projects are ongoing. Leading to a streamlined pipeline, where you see Budesolv ahead with phase three completed and working. We're now working to get the work done to bring that product to the market with commercial partners in different regions.
So it's an effort that is ongoing in China, an effort where we're working on partnerships in Europe and the US, as well. And our plans includes that year that we make significant progress on this program. I will jump on to the Carragelose. Those in the call, I don't need to probably explain what Carragelose is. It's a blocker.
We can block more or less anything, and if it will show us that this is even surprisingly effective with new data. So we added the portfolio expanded the portfolio with an allergen blocker and also with the eye drops. We added the new distribution partners in the Gulf region, in Eastern Europe, but also not mentioned here, but in Asia.
And launched a product, and we are initiated the clinical study for the moisturizing eye drops, filed a new patent on the eye drops. And currently, and probably interesting for the investors, is we are evaluating the strategic options for the entire Carragelose business... Here we're making some progress.
Of course, at the moment, we cannot report, besides that, that the project is making progress, and we expect some news on that project in the upcoming quarter. So, what are the next steps in Carragelose? Of course, we want to maximize the value of our Carragelose business. On the one hand, the clinical studies running in Austria, and as far as I know, the study is going well.
We'll launch afterwards the moisturizing eye drops in Austria, which drives the BD process for the allergy blocker and the eye drops. Progress the partnership, and of course, important for us is the Procter & Gamble progress. Here we're working on the approval.
It's a process that is ongoing for quite some time, and I know that investors are waiting for that. And the long work is gonna be good. We hope to be able to post some news here as well, and I already commented on the evaluation of the strategic options. For Marinosolv, the recent developments, of course, the improved stability, helped to drive the BD process that we get momentum here. The partnership with Luoxin, we are progressing towards the next milestone. It's quite some work, and altogether on to the result, it took us longer than we expected.
We know that we had hopes that it's going faster, but we can assure you the project is going on. It's going well. The data are still good, and we maintain our positive outlook. That's gonna be a very, very important product for the allergy patients out there. And that's true for Tacrosolv as well. Also here, it took us longer, but the year 2024 is gonna be a decisive and interesting year for those assets and for the entire company.
And what we are doing, what is ongoing, we're working on adding further partnerships. This year, we're completing the development towards the marketing authorization with partners. Here's a lot of activity ongoing. Already talked about China. We are working on enabling a near-term partnership for Tacrosolv as well. So quite some activities and adding new partnerships on the Solv4U business is ongoing. We hope to be able, or we are almost sure that we're gonna be able to post some news here as well. And having said that, I am gonna hand over to Eva to give you a look into the new data on Carragelose.
Thank you, Andreas. So basically, what we have done is to support the development of the moisturizing eye drops that are based on Carragelose. We have developed an in vitro test system to assess the hydrating potential of Carragelose on human cornea cells. And this assay is a pretty suitable assay to assess different products on the market, different polymers in parallel.
And what you do is you incubate the cells with the different products for 2 hours, then you take off the medium and leave the cells without liquid on top of it, and for several minutes, and then you determine the viability of the cells after such a procedure. If you look at this graph on the right-hand side, this is a comparison of Carragelose eye drops with different marketed products after 10 minutes of dehydration.
So this shows that approximately 80% of the cells are still surviving if they were in contact with carrageenan for 2 hours, whereas, the hyaluronic acid competitors are almost down to 30%-40%. So we see a superior hydrating potential of carrageenan on corneal eye cells. Well, you can say this is in vitro data. What does it mean? First of all, if you look at the cells in such a treatment, you can compare the positive controls, control.
These are cells that are only treated medium, no product. Then you have a negative control, where cells are dehydrated for 10 minutes, and on the right-hand side in this picture, you can see carrageenan-treated cells. And if you compare the middle to the right picture, you can see that cells go back to normal.
They look like in the positive control, so it really makes a difference in the cellular appearance. We then went further on to try to see if we can translate the in vitro data to ex vivo data. So we receive porcine eyes from freshly slaughtered pigs. We incubate them in a laminar flow, meaning that they are dehydrating for approximately six hours.
This ex vivo study has been developed internally. We have the eyes blinked every 15 minutes with either sodium chloride or different products. And after six hours, we determine the corneal damage by fluorescein staining. As you all probably know, it's also done at ophthalmologists, fluorescein staining to determine the damage of the cornea. So what you can see here, fresh eyes without any exposure to laminar airflow.
This is the baseline, this is undamaged eyes. If we treat them with sodium chloride, this is the negative control, so to say. These are the maximally damaged eyes, they are set to 100%. If you treat the eyes every 15 minutes with carrageenan, you can reduce the damage to 40% compared to the negative control, to the sodium chloride.
And we took as a comparator, a marketed hyaluronic acid product, and this is not active in this particular assay after six hours. So this supports the in vitro data, where we see a superiority of carrageenan compared to hyaluronic acid products. As Andreas already mentioned, carrageenan is regarded as a blocking polymer. What we have developed is an assay, where we can determine the blocking potential of different product polymers.
It's based on a system where you have agar at the bottom in a well, then it's covered by the barrier, which is either carrageenan or something else, and on top of it, you can put allergens or particles. And these particles then are incubated for 2 hours to migrate through the barrier. We always compare that with a sodium chloride solution, which is the matrix of the carrageenan, and the migrated particles then can be determined in a photometric reader.
This graph on the right-hand side shows the barrier function of carrageenan against different agents. On the one hand, we tested different particles sized between 0.3-2.5 micrometers. They are blocked very efficiently between 60%-100%. But we also have included in such an assay, the house dust mite allergen, Der p 1. And also this particular allergen can be blocked by approximately 70%.
So carrageenan is not only acting against viruses, we can extend its function to particulate matter and also to allergens. We have also tested other allergens, such as, ragweed or Timothy grass, and for all of those different allergens, we could show the blocking potential of carrageenan. I hand back to Andreas.
Yeah, thank you, Eva. Just one comment from my side. This helped, this data and some data more helped to file for another patent for the Carragelose blocking these barriers and additional data. So we'll have an additional carrageenan patent running for quite some time. Typical patent lifetime is 20 years. So that helps a lot, of course, and increases the value of the entire platform.
And we got some significant very good feedback from especially ophthalmic companies interested in adding something of value to their portfolio. So here I summarized the project status of the most important ongoing projects. Mainly, what you see is mainly registration work, business development, enabling partnerships.
That's true for the Tacrosolv for Budesolv, also for the already launched Carragelose nasal spray in Austria and also for the eye drops. So we are in a stage where we're pushing for commercialization of our already developed projects, and we're pushing also for getting the entire value out of our Carragelose platform. Of course, the submission for approval with Procter & Gamble is something medium.
We still, even if it's already April, we still according to the processes that regulatory processes that are behind, we still plan, and also Procter still plans, as far as we know, for the upcoming season, the 2024-2025 season. That's gonna be really important for us, and it's quite some effort on the team to work on the specialties and the special parts of the US regulatory environment that get that product re-registered.
Yeah, and with Solv4U, we are progressing. We already had the first-term partnership, but we're really working on several new partnerships, and we believe it's gonna be a very interesting and important forward revenue stream for our company from the Solv4U business. So maximizing the value of the Carragelose business, as already mentioned, we concluding to license the further license agreement for Budesolv, working on this partnership, hopefully being able to announce that.
Of course, we're talking for some time on that. Yes, but we are more optimistic than ever to show something here. And support, of course, our partner, get the partnership for Tacrosolv in place and expand the technology partnership for partnerships for Solv4U. So with this conclusion and the numbers that Pascal reported in the new data from that Eva reported, we conclude this call, and we're now ready for your questions.
Ladies and gentlemen, at this time, we will begin the question and answer session. Anyone who wishes to ask a question may click the Q&A button on the left side of your screen, and then click the Raise Your Hand button. If you are connected via phone, please press star followed by one on your telephone keypad. You may also submit your questions in written form. Anyone with a question, click the Q&A button and raise your hand. One moment for the first question. So far, there are no questions. Okay, we have the first question from Dr. Norbert Kalliwoda from Kalliwoda Research. Please, go ahead.
So can you hear me?
Yes, now we can hear you. Thank you.
Ah, that's great. Yeah, thank you. Yeah, thank you so much, Frau Dr. Eva Prieschl-Grassauer and Herr Dr. Grassauer and Herr Schmidt. I have, thanks for this detailed presentation. I have a question in regards of Budesolv. You mentioned a partnership or one of your partnerships with Luoxin in China. So this market in China seems to be relevant for you.
Have you maybe an idea of market potential and penetration rate? This would be one question, and the other is also a similar question. You have a part or you have a activity, or you have, you seem to have a launch in Spain with iTrap product. There is a clinical study in Spain, and you will have a launch in this year. Can you give us some more insight how big the market is there, and can we expect this in second quarter, third quarter, or end of the year, please?
Probably, I can start. Sorry, I see.
Is there... Sorry, Mr. Kalliwoda, just two quest- or you have a further question?
No, no, so far, these are my two questions.
Then I will start concerning the eye drops. You're right, there is an ongoing clinical study in Spain, in Valladolid. It is a specialized clinical center for dry eye disease. But the clinic is currently ongoing, and we have positive feedback with respect to tolerability, so patients don't complain if they use the eye drops. We can recommend them more. The launch is not planned in Spain, but in Austria, and it's pretty likely that the launch will take place this year.
Mm-hmm.
Concerning the market, the eye drop market or the market for Carragelose or for eye drops is a, if you look on the global scale, it's $8 billion market for eye drops. And what is important here that this data that we generate, like, create some differentiating, some differentiating data, and with Carragelose, you not only have the ability to compete with these other products that are on the market, but also to have the perspective to treat viral infections or to
Mm-hmm
... treat viral, early viral infections of the eye, with an OTC medical device. So that has a certain value. We most likely won't see it in the sales numbers for this year, but it could happen that we strike the one or the other deal, and help to increase the value of the entire Carragelose portfolio.
May even happen that it's gonna be a separate asset, because companies in the cough and cold field are not all of them have an eye drop or eye care business, so it might be a separate deal. Concerning Budesolv and Luoxin, the Chinese market is a fast-growing market, and it's a market where especially Budesonide is a market leader.
Mm-hmm.
It has seen significant growth, Budesolv in China, and it recently became an OTC in China. And that's why it's a very interesting market since typically in China the OTC system is only in development, and that's why it's fast growing. And those companies who are involved early when this OTC segment is developing will have a huge benefit afterwards. Given the amount, it's a multi-hundred-million-dollar potential.
Mm-hmm. Okay. Maybe a further short question. You have the trade payables stood similar in 2022 and 2023, so there was no change in trade payables? This is one question, and maybe the last question is, I tried to learn a lot in this biology things, and Frau Dr. Brigitte Grassauer, you mentioned about this nice chart with Carragelose blocking properties, and you have there incubation.
So you put allergens and particles, and you have then a wash step, and via a buffer overnight, then you put the results in a readout photometric. This photometric, how can I think about it? What is happening then in this photometric, please?
Basically, the particles that we use are fluorescent particles, so they emit light. In a photometer, you can determine the amount of light that is emitted-
Mm-hmm.
This is a direct correlation to the number of particles that have migrated through the barrier. In case of allergens, it's a little bit different. There we use a technique that is called ELISA. It's an immune technique, where we use antibodies to detect the allergens.
Mm-hmm.
These antibodies, again, are marked with a dye, and this dye can then be determined in the reader.
Okay. Thank you so much.
Relating to the trade payables, so yes, they typically at year-end are at the highest level throughout the year because this is the season and this is year-end business. So it's a normal level, and we can expect that generally for the end of the year.
Mm-hmm. Thank you, Andreas. Thank you so much.
As a reminder, if you wish to register for a question, please press star followed by one. The next question comes from Bosco Ojeda from Hauck Aufhäuser Lampe. Please go ahead.
Hello, can you hear me?
Yes.
Okay, fine. Just a short question. It's just a sentiment question related to your general situation in relation towards Carragelose business with Procter & Gamble. We already heard since the last meetings that P&G is quite interested, and they are doing a substantial effort to bring this through the FDA process.
What I'm wondering is, or what I can imagine, is that they do not like to have some kind of public messages running around that process. But you as a professional partner in that, can you give us some kind of insight about your feeling in what stage of development that process currently is? Is it already brought to the FDA, or are they about to bring it, and just to turn the clock?
So basically, probably I can answer that question because I'm in close contact with P&G-
Mm-hmm
... nearly every week. So the process is not at the FDA yet. However, we expect that in very soon future. We are currently discussing, for example, the text on the packaging. We are discussing which claims the product should make. The Procter & Gamble has engaged a consultant, a very experienced consultant, with respect to medical devices in the U.S. market. So we are making good progress here, and we expect that the product will be presented to the FDA within the next weeks.
Okay. The trouble with consultants is always they are paid by time. As long as it takes, the more they get.
I'm also here in this respect, so I think she's really doing a very good job. I like her very much. She's very experienced, and she really speeds up the process because Procter internally, the regulatory team is not so big as one would assume.
Mm-hmm.
So they need that consultant, and I'm not sure if she's paid by time or if she's paid for her success.
Okay. Okay.
But it's outside of our control.
Okay. Yeah, yeah, it is out of your control. But, last part of the question, please. Do you expect to be informed when the process is started?
Yes.
Okay, and
As mentioned, we have a meeting every week-
Mm-hmm
... on Wednesday, and we are in very close
Okay
... in intense contact.
Yes.
So basically, we also give Procter every support that we can give with respect to claims and.
Mm-hmm
... all the data that they require. So we have spent quite some time on generating additional data to facilitate this, this application-
Mm-hmm
... and, we are in very close contact.
I suppose that you will inform the market when that process is started as well?
This is the plan.
Okay, thank you very much.
There are no further questions at this time. I hand back to Andreas Grassauer for closing comments.
Yeah, thank you very much, everybody, for joining the call and being interested in what on the progress in Marinomed. We'll have pretty soon, in about a month, the publication of our Q1 results, and in the meantime, look on our press releases. This could be very interesting quarter ahead. Thank you very much, and thank you, Bosco and Eva.
Bye-bye.
Bye-bye. Bye-bye, thank you.