After the presentation, we will hold a Q&A, and it's possible to ask questions by calling in. We will today start with an introduction to Nanoform, including key business highlights. Then we move on to financials, and we conclude with commercial. With these words, our CEO, founder, Professor Edward Hæggström, please go ahead.
Thank you very much, Henri, and welcome also on my behalf. Next slide, please. Our key strategy, which we have been executing for the last five years, is really that all APIs, the active pharmaceutical ingredients out there, should be STAR-mapped. This allows us to see where the technology platform works. We work together with customers and partners to enable novel and existing molecules to become new and improved medicines. You will hear about commercial partners and development partners today. In parallel, we show a conservative industry the power of nanoforming. We create up to a dozen of product kernels. Today, we will talk specifically about three of them: Nanoenzalutamide, Nanoapalutamide, and Nanoencorafenib. Next slide, please. Here you can see that we work on the product kernels. We do R&D to see how to make them better.
We then seek development partners, and together with them, we take this kernel forward. After that, we seek out commercial partners, and together with these partners, we take the kernel towards the market and maybe also onto the market. The first targeted drug on the market would be, according to our plans, in 2027. Our customers that we work with are global large pharma, mid-size and specialty pharma, and biotechs. We work with originators, and we work with value-added companies. Our mission is to take more drugs, more medicines to the market. Next slide, please. Here you can see a slide depicting four technology platforms of ours. On the small molecule side, the CESS; on the large molecules, the biotechnology; on the formulation side, the nanoformulation platforms; and then on the AI side, the STARmap. Next.
I'm going to spend a little bit of time on this slide, so please bear with me. This is really what we have gotten done last year. In the first box, you can see that we had a record number of new customer projects signed. This is the POC, the first cylinder in the Nanoform engine. We had a lot of deal-making discussions around our product kernels, and these intensified. We expect to sign deals on the first three product kernels in the coming weeks and months. These would be nanoenzalutamide, nanoapalutamide, and nanoencorafenib. This is cylinder number three in our Nanoform engine. Manufacturing of GMP material for pivotal studies and registration batches in project nanoenzalutamide continued in a three-shift pattern, and the pivotal studies start early Q2 2025. The first readout is expected in the same quarter.
This is cylinder two for manufacturing of GMP material, and I'm very, very happy that our three-shift pattern has gone both from a quality and production economics point of view as we planned. The fourth box talks about nanoenzalutamide. We expect nanoenzalutamide to be the first Nanoform medicine to reach the market. We have a planned launch in 2027 in the U.S. and 2028 in the EU. We expect this to be an income driver for Nanoform already in the upcoming years. Much of my time goes towards planning and preparing for this product launch. Number five, we expect some of our ongoing customer projects to enter the clinic in the upcoming quarters and years. This is, of course, cylinder number two and also partly cylinder number three in the Nanoform engine.
Six, growth will be fueled by a growing number of projects from development, exclusivity, and milestone payments, and later on from commercialization fees and royalties. During the last few months, we have been having a lot of negotiations on the mosaics that pertain to these various deals. Number seven, our company midterm business targets for 2030 are to be announced during 2025 in conjunction with the Capital Markets Day, and Albert will talk a little bit about that. Next slide. I like to be real, and this is real. Here you can see what we have manufactured and shipped to our partner. This is nanoenzalutamide, and you can see the size of it and the amount of it. With this, I hand over to CFO Albert.
Thank you, Edward. If we then go into the numbers a little bit, here you can see the number of projects signed to the left per quarter and to the right on a rolling 12 months. You can see that we had a very strong end to the last year. The early part of the year was very slow in signings, and then we had a very strong... We actually signed 20 new projects in only six months' time, which is clearly a new record. The positive thing was that that meant that we knew we hit a new high for the rolling 12 months, which is a good thing, of course.
If you then look at the same thing, but you do not look at it on a quarterly basis, but you look at it on a yearly basis, here you can see an interesting trend that both on proposals sent and on projects signed, we have every year had the same or a higher number. We have not had a down year in either proposal sent and project signed. I think this is a strong testament to the technologies and the people and organization of Nanoform. Despite the fact that in 2022 and 2023, the markets were shaken by the fact that interest rates rose a lot, all kinds of macro issues in Europe and other places, we still have had this positive trend every single year.
It hasn't felt like that all the time, especially when you look at the revenues that can fluctuate much more depending on IFRS and depending on whether we work a lot on early stages of a project or later stage or how many hours. When you look at it annually, you can see that every single year since we went public has been a higher year or flat, same or higher year. I'm very happy about that. If we then go to revenue, last quarter was, of course, year on year very positive because we had a low number last year. Also on an annual level, you see that we grew the revenue by 8% in 2024.
We didn't hit a new high, but the reason for that is roughly that many of the projects we signed, as I said, were in the latter part of the year, and of course, the revenues from that will come later. One other way of looking at how many projects do we do and what is the activity we are doing, and that is by looking here to the left on number of projects generating revenue. Here we significantly took a new level. We had actually 43 projects last year that contributed to revenue. However, again, many of them were signed late in the latter part of the year, and therefore the impact on the revenue was not that much, but it shows the underlying amount of projects.
We have been able to attract more clients, more projects, and we expect growth in top line to follow from that also. If we then look at operating free cash flow, or actually we look at the real cash flow a lot internally, but operating free cash flow is a good measure of that. We saw a small improvement last year. It was not as large as we hoped for, but this year we will work a lot on improving the cash flow and the cash burn. We will be able to do that on basically three fronts. The cost should not go up. Potentially, they can even go down a little bit. Let's see, but we are targeting or planning for not increasing the costs.
We plan to increase the revenue, but we also plan to start to get other operating income milestones or signing fees or so. All these three should mean that in the coming year, we should see an improved free cash flow, and the improvement should be clearly bigger than what we saw this year. On the right-hand side, you can see the quarterly free cash flows. How did we do compared to our targets? We hit two of the targets, even though it was with a small margin. The third one, to sign one or several licensed commercial supply deals. We now say that we expect to sign deals on our first three product kernels in the coming weeks and months. In the previous report, we talked about coming months and quarters. Now we say coming weeks and months.
The reason for that is that some of the discussion has gone very far, and so a few ones should be coming in the weeks and then rest in the coming months for the three products that are mentioned in the report. If we then go to business target, near-term business target 2025, we have four. First one, the potentially most important one, is to sign several licensed commercial supply agreements on several product kernels during 2025. That should start to happen already in the coming weeks. We plan to do the first pivotal bioequivalence clinical study with a Nanoform medicine. That is, of course, nanoenzalutamide, and that should both start, and we should get the first readouts in the second quarter of this year.
We plan to sign an increased number of non-GMP and GMP projects this year versus last year, and we target to improve the free cash flow in 2025 versus 2024. Of course, in order for us to become self-sustainable, the improvement should be bigger than it was last year, but this is the official target. Finally, previously in the IPO, we had the 2025 midterm target. Now we decided not to have both a midterm target and a near-term 2025 target. Now we will come out with a new midterm business target 2030, and that is to be announced during this year in conjunction with the Capital Markets Day. Our early indications are that we will try to have it roughly around our five-year anniversary at the stock exchange, meaning in June before midsummer. We will come back with the exact date.
By that time, we should also be able to disclose more on the deal side, meaning that we can have a meaningful discussion around the coming five years and what they would look like with product launches, with milestones and payments, and how that impacts the P&L and the cash flow in the coming years. With that, I give over to Christian and Peter. Please.
Thank you, Albert, and welcome to the commercial slides for this presentation. I would like to look back at 2024 and cover the highlights first. As Albert and Edward mentioned, we had a new annual record in customer project intake. We had 10 new customers, including one new major pharma. We are now at 11 of the top 20 pharma companies that we work with. We had a record number of customers returning with new projects, and we had significant traction with originators on Nanoform's product kernels. There was also a strong interest in the biologics technology seen by a significant market demand around the value that this technology can deliver for high concentration biologics and inhaled delivery. We have several exclusivity discussions that have been initiated around this technology. Last year saw us enter Japan.
We expanded our market presence from Europe and the U.S. into the Japanese markets, and we established a strong momentum through a sales partnership with CBC Japan as a distributor for Nanoform. We made significant investment in our commercial organization, and we also included many C-level approaches to major pharma and to other organizations. Two new members joined our team, one in the US and one in Germany, in Europe, and we added several C-level consultants as well. Last year, we saw many customers and partners visit our manufacturing facility in Helsinki. The ones that we can mention are AstraZeneca. We had also the ex-chairman of Janssen and an ex-senior executive of Pfizer visit, as well as Polpharma and CBC Japan. We are building momentum in our pipeline as seen with a new record in CPhI meetings.
I'm going to hand over now to Peter to talk a little bit about our product kernels and the exciting work we're doing there from a commercial development perspective.
Thank you, Christian, and welcome to all on the call also on my behalf. To start on the strategy around our product kernels, in order for us to further accelerate the adoption of our technology offering by the industry, as we've told before, we have initiated internal development of a number of nanoparticle-enabled reformulations of marketed products. This is to show in practice to the industry what our technology can enable for the products across a range of delivery routes and for both small and large molecules. Each of these has also the possibility to become a commercially attractive partnering opportunity for us, and this is, of course, what we are already seeing. For each of these opportunities, after the initial preclinical development stage to establish the concept, we aim to partner these for both the development stage and ultimately for commercialization of the product, of course.
These deals, which were referenced earlier as well for the more further progressed products, may take many forms depending on the product development stage, our chosen partnering strategy for that opportunity, and so forth. For the development stage, in the typical case, we expect revenues from the services and access to the technology we provide, as well as development milestones. Later in the commercialization stage, in addition to payment for supply of material, we would also expect royalties or a profit share, as well as potential commercialization milestones. The most advanced of our projects to date are nanoenzalutamide and nanoapalutamide. To this group of nanocrystalline alternatives to ASDs, we have today also added nanoencorafenib, which we have not named before.
For nanoenzalutamide, as told before, we look forward to the pivotal trial that is now planned to start early second quarter, with the first preliminary readout still in Q2 as well. We are currently finalizing the manufacturing of the registration batches for this. We have also progressed well with our nanoapalutamide project and are both proceeding towards the GMP manufacturing and first human PK study, as well as in parallel with the number of the partnering discussions. Based on our earlier experience with nanoenzalutamide and nanoapalutamide, we are excited with the work we are undertaking and the results to date on nanoencorafenib, including the first in vivo study results we have received. Encorafenib is a great medicine that unfortunately is currently a daily dose of up to six very big capsules, and we target to reduce this to one single tablet, which we believe will provide patients a clear benefit.
As a reminder, amorphous solid dispersions, or ASDs as they are commonly known, is really the technology that has enabled a past generation of poorly soluble drugs. ASD-based m edicines is a group of approximately 50 products on the market, selling for an estimated $50 billion annually, and with hundreds estimated to be in development as well. Our nanocrystalline formulation platform, as evidenced by our nanoenzalutamide, nanoapalutamide, and nanoencorafenib programs, enables significantly higher drug loads in the product as compared to the ASD-based formulation. For the patient, this means smaller pills and a reduced pill burden. We believe our technology can here provide an attractive alternative for both the originators and value-added medicine companies. This is also what we are seeing in practice, of course, in the interest to partner on these assets. I will now turn it back over, Christian, to you. Thank you.
Thank you, Peter. I'd just like to highlight the commercial team that we have here and all of the territory in which we cover. We are very widely spread. We have good coverage in both the US, also in Europe, and now increasingly into Asia with partners in Japan. This slide also highlights the experience within the commercial team with some of the companies that our team have worked in previously. A very strong team, one that I am incredibly proud of, and we're having some excellent conversations with customers at all parts of the value chain, from early stage, preclinical, through to clinical, and even into life cycle management with small biotechs and major pharma companies too. The next slide just highlights what we achieved last year.
This was covered briefly by Albert earlier, but we have now 52 customers that we have worked with, and we've worked with 96 projects, eight new in Q4 last year. A growing number of customers and projects. That customer mix, as I mentioned earlier, is 11 major pharma. We've got two co-developments. We have three collaborations, and we've got 39 mid-sized and specialty pharma and biotech companies that we work with. You can see some of the logos for the selection of partners that we're able to publicly disclose. Just looking back, last year, we had many customer visits. You can see here several of those. We have Dr. Ajit Shetty, former chairman of Janssen, and Dr. Mak Jawadekar, former Pfizer Global R&D executive visiting Nanoform in Helsinki on the bottom left.
To the right, you have AstraZeneca visiting Nanoform, and to the top right, you have Polpharma, who visited us recently. Also, two conferences where we were recently presented at, PODD in Boston. This is one of the premier global conferences around drug delivery. We were privileged to take such a center stage within this conference and to really be at the forefront of the discussions around high concentration monoclonal antibodies. I was there chairing a session with Takeda and GSK and other companies. Nanoform really is in the conversation around how we can make better medicines for patients. I mean, it's helping to steer some of that conversation with our pharma partners.
Bottom right, that's actually taken from this week when I was in India at the beginning of this week at the BioAsia conference, again, talking on how we can deliver promising and new innovations to patients together with other panelists from Novartis and J&J and other organizations hosted by Deloitte. If we move forward, we have a very active year ahead of us. Many events on the calendar, both a mixture of finance events and also the industry, pharmaceutical industry events that we will be attending. I encourage you to meet with us at these events and also encourage you to reach out if you have any questions. As we move to questions, that's the next slide. Thank you very much for your time, and look forward to answering your questions. Thank you.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Christian Glennie from Stifel. Please go ahead.
Hi, guys. Thanks for taking the questions. I guess three, please, and probably all around the kernels and the strategy there. I guess, firstly, as you've now got three, you've listed, obviously, the brander there, the originator. What's been the reception generally? Presumably, there's been sort of follow-up discussions and/or interest from on the originator side. What's been the sort of reception generally to ultimately what you're doing, what you're seeking to achieve with the drug load and the dosing benefits here? How has that been taken on the other side of the table, as it were?
Thanks, Christian. Briefly, I would say that the original group are closely following what we do. They are in control of the timing, of course, and relative to our strategy, we always give them the opportunity to work with us. Christian, would you like to add something to this discussion?
I would say that when we came out with nanoenzalutamide, this was the first product where we could show the value of our technology in the marketplace. When people looked at that, well, maybe it was just luck. Then we came out with a second product, nanoapalutamide. I think the industry and our pharma partners started to get more interested. Now we've come out with a third product showing the utility of our technology as a platform to add value for life cycle management, but not only life cycle management, but also to enable pharma companies to launch their products as single tablets from day one. The industry is getting quite excited about that. You can imagine we're having quite a positive reception from innovative pharma companies right now.
Thanks. Maybe thinking, obviously, it was just over a year ago. I think, obviously, we knew about Project Blaster, and then it was disclosed as nanoenzalutamide sort of early January of last year. You're sort of approaching partnerships for that now. On the more recent ones, whether it's APO or Encoraf, it seems like there's potentially an acceleration of the timelines, at least in terms of moving forward in terms of development partners and/or other partners around those assets. I guess, is there a learning that you're from the original process with nanoenzalutamide that you are able to then accelerate things on the development side and partnership side for the other kernels in the pipeline?
I think the short answer is yes, and I think the reasons are several. First of all, we are getting more known in the industry. Secondly, the fact that we have put out all these blockbusters makes it easier for people to feel safe and secure to talk to us and also to engage in meaningful conversations. Thirdly, of course, as we mature, all our abilities are stronger, which again makes it easier to engage in meaningful conversation with us. Taking this together means that we foresee that probably we will be able to increase the pace. Christian.
I would agree. I think we started off with enzalutamide as a partnership. I think that's something important to remember that we've developed this product in a partnership with the OnConcept Consortium. We have development timelines associated with hitting certain goals before we reach out and strike commercial deals around the product. The other products are products that we are developing ourselves and taking them to a certain point. We have, shall we say, more flexibility in how we maybe could reach out earlier and try to strike deals around these products.
Okay. Fine. Thanks. Then on the, I guess, maybe just thinking about the cost of development on the kernels, has anything changed there, particularly that's maybe related to the previous question about acceleration? Thinking about this, obviously, typically, the potential that if you can take it a little bit further, maybe yourselves through the initial sort of early stage preclinic or, sorry, early stage clinical proof of concept that you can retain, obviously, comes with a greater cost, but then you potentially retain a bit more of the value when it comes to those partnership deals. Yeah, just how are you thinking about that in terms of absolute cost of these projects, but then maybe taking them a little bit further to retain a bit more of the value?
Albert, would you like to take this?
Yes. Christian, can you please mute? It's quite strong, the background noise.
I'll go on mute now. Yeah.
I think it's like this that we are getting a lot of bang for the buck. When you compare us developing these kernels and you compare it to biotechs or other people, there's an enormous difference because we have the organization, we have the skill, we have the technology, and we are doing this on the side of what we are serving the other clients on the POC and non-GMP projects. This is a very cost-efficient way of developing these kernels. It's true that you can take them further and potentially get more value. As we own the tech, we don't need to do that because it's enough for us to get, let's say, a single-digit mid royalty. In the long run, we are not a product company per se.
What we are doing is we are creating lots of kernels in order for the major pharma and the whole pharma industry to realize that nanoforming is a platform technology that should be widely used. I don't think you should expect us to put lots of money into going deeper and longer into development. We want to partner up early on with many companies on many products. As these projects don't cost a lot, it's the smart way to do. You will always find bigger pockets and bigger pharma or bigger generic companies who are interested in coming in later to help launch it in a commercial deal. Don't expect the costs to go up just because we are doing more kernels. We can be very efficient on that.
Great. Thanks, guys.
Thank you, Christian.
The next question comes from Sami Sarkamies from Danske Bank. Please go ahead.
Okay. Hi. I have several questions. Starting from the pivotal study, can you share a bit more details on how many patients will be enrolled relative to the previous study, what the study length will be, and how much it will cost, and what will be your share of the cost?
The question was on the pivotal study, and the share is according to what we have stated about the consortium where everyone takes their part both in cost and in revenues. Peter, do you have the numbers for the enrollments?
Sure. Thanks. Our share of the cost is 25%, as said before, as it's an equal share in the consortium of four partners. This will be a quite standard bioequivalence, pivotal bioequivalence study with both fed and fasted in healthy volunteers and for both the EU and the US to start with. I don't have the exact number of healthy volunteers to provide, but this probably answered most of your questions.
Yeah. What about the total study length? You mentioned some interim readout in the second quarter, but when will the study be finalized?
Towards the second half of the year.
Okay. What about the total cost for the study?
I think we have not sort of shared that unless we're working with the consortium. As Albert said, I think the expectation is that this should not add sort of a substantial cost. I know, Albert, do you want to comment on that more in detail?
Yes. This is not very expensive. If the total cost is maximum a few million, then that means that our share is clearly below $1 million.
Yeah.
Okay. Thanks. Moving on to deal-making, there was already an earlier question related to kind of the originator reception, but just wondering, you're seeing potential for the first deals in the coming months. Could this include originator deals, or are we talking about other players?
As we have said, we are always first talking to originators because of our IP and tech background. We think they have earned the right to the first call. We are also well aware that they know much more than we both about the assets and the markets. It is hard to have a crystal ball to say who signs first. I would presume that as we come out in the capital markets day, everybody will get the answer to that question.
Okay. And then thinking about the nanoenzalutamide kernel, would you say that you're still on track for US launch in 2027, assuming that the partnering deals get done over the next couple of months?
Yes.
Okay. I have a couple of questions related to manufacturing. Could you update us with the situation related to GMP lines two and three, please?
Yes. If we start with GMP one, that's where we have now done the material for the pivotal study. That's the line that would hold the clinical license. This year, we will apply for a commercial license. This will probably be for GMP one. We will apply for a clinical license for GMP two and three. This is basically the GMP status for the lines.
Okay. You said that you've been working three shifts to produce the registration batch for the pivotal study. When do you expect to have finalized manufacturing of the registration batch?
As we said, the clinical study starts in Q2. Within the next three, four weeks, it should be done with.
The whole 100 kilos?
Yes.
Okay. In the second quarter, you will not anymore be manufacturing for the registration batch?
No. They need to have the materials to make pills for it. When all the pills are done, some of them will be dosed to patients, and some will be put on the shelves because of the requirements to show that we can produce approximately 10% of what is first presumed to go onto the market.
Okay. Just wondering on what the investment needs will be on the biologics side. You probably need also a GMP line for that as well. When do you see that need, and what's your estimate on the investment cost?
Albert, would you like to take the investment question?
Yes. Here we have said that we are discussing with partners, potential partners, and the idea there is that we will do the investments with a partner. The idea there is that we can bring the technology, but the partner, of course, can bring the cash. That is the idea.
Okay. So that's probably not something for the near term then.
It can be in the near term, but the idea here is that it will not be a big cost or cash outlay for us.
Yeah. Okay. Thank you. I don't have any further questions.
Thank you, Sami.
As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. There are no more questions at this time, so I hand the conference back to the speakers for any closing comments.
Thank you, operator. On behalf of Nanoform, I would like to thank all participants for today. If you have any more questions, just reach out to us. We wish everybody a great Thursday afternoon and evening. Thank you and goodbye.