Good afternoon, all, and a warm welcome to Nanoform's third quarter 2023 report presentation. My name is Henri von Haartman, and I'm your Director of Investor Relations. Today, our CEO, Edward Hæggström, CFO, Albert Hæggström, and Chief Commercial Officer, Christian Jones, will present to you. This presentation is webcasted through Financial Hearings, and there is also the possibility to call in and listen by phone. The slides are shown throughout the webcast, and they can also be found on our webpage in the investor section. After the presentation, we will hold a Q&A, and it's possible to ask questions by calling in. We will start today with a short introduction to the company, then move on to CEO review, then commercial aspects, then financial aspects. With these words, our CEO and founder, Edward Hæggström, please go ahead.
Good morning. Good afternoon, to all of you, also on my behalf. Let's get going, please. Nanoform is a platform technology company. We basically have several platforms that we work with. We are 165 employees all around, stationed in Helsinki. We work both with small molecules and large ones. Next, please. Here you can see the four legs. Small molecules, there we have CESS, which is a patented technology. Large molecules, we have a biologics technology that received U.S. patents just recently. The formulation is something which has become more and more into our focus. We will talk a lot about it today, and you will hear about two cases, both the TargTex case and the Project Blockbuster case, that were enabled by formulation.
We have many years worked on AI, and we are strong believers in the power of AI to help our case forward. Next, please. What do we do? We address the structural problem. A lot of money goes into getting new medicines on the market, and still very few come there. We try to make 37 become 2x. Next, please. The biggest problem on the small molecule side is that of poor bioavailability. This is a problem which is large and growing. Next, please. We address that problem by making very small particles that we formulate in a clever way. Small is a very powerful ingredient. Next, please. Here is the patented process on the small molecule side. Basically, we dissolve API into carbon dioxide, and we precipitate it out of the process. Carbon dioxide is green, and it works like a catalyst for us.
Next, please. There are many good stuff coming out, when we increase the bioavailability, we can enable new drugs, we can potentially reduce the dose. We can play a game where we ship around less material, ergo, we can also have smaller factories. This means that it's a green approach all in all. Next, please. On the biologic side, we have, together with our customers, identified at least two things that really have a market pool right now. To enhance the drug load, milligrams per milliliter, and to tailor release profiles, for instance, reducing the spike effects from depots. We work in the 1 kDa to 150 kDa range, which is commercially relevant. Next, please. On this side, we also have a patented process, for the biologics, where we can make these small particles. This is also green. Next, please.
There are basically three profit pools to tap into. One of unsuccessful drug candidates, one of improving existing drugs, and one of enabling new drugs. All of these are important. Next, please. Our value chain and business model are very, very standard and simple. We work with big pharma, mid-size and specialty pharma, and biotechs. We get bulk API, we nanoform it into very, very fine powder, and we have a model where we get paid for the service, for producing material, and also for enabling products onto the market. Next, please. Let's now dig into the CEO review for Q3. Next, please. This is a busy, busy slide, and I would like to highlight a few of the highlights. Project Blockbuster is something which takes a lot of our bandwidth now, both in what we do and what we think about.
Project Blockbuster is a project which by itself is really big, both in money and what it can do for a lot of patients. For Nanoform, it is not only a very big project, it is also a first project to break through the wall, to show that the technology can be the difference between having something and not having something. It is also the first project where we can open up a new class of opportunities. Both things are important, the fact that the project is big and the fact that it opens up a new class of opportunities. Amorphous solid dispersions. This is a class that was enabled by spray drying, the previous dominant technology, which captured on the order of one third of the U.S. market.
We have now an opportunity to play a game inside this class, a game which is IP-driven, a game which is technology-driven, a game which is formulation-driven. This is very, very important for Nanoform. The next thing I would like to highlight is the fact that our customer, TargTex, obtained FDA Orphan Drug Designation. This is important both for the patients suffering from a very debilitating disease, but it's also important for Nanoform because for the first time, Nanoform is now associated with FDA. So three things from this slide: the Blockbuster, the ASDs, and the Orphan Drug Designation. Monoclonal antibodies is something we work on, on the biologic side, and these are the first big pharma-driven projects that we do that have shown the traction and the market pull for our biologics offering. Next, please. This slide, focusing on the timeline, it really talks about Q3, Q4, Q1.
This slide here talks about the potential readout, where we can potentially have a good result from the Blockbuster Project. So what did we do? We manufactured GMP material, we shipped it for GMP formulation and for GMP dosing. They made pills, and now these are going into a clinical trial. As far as we know, the readout should be during Q1. If this readout is positive, of course, it's a very, very big thing. If this readout is neutral, it's still a big thing. And even if this readout would be slightly too little, we still have the opportunity to do other formulations here. So upcoming, very important, both as a project and as an opening for a new class of opportunities. Next, please. So let's talk a little bit about these ASDs and this Project Blockbuster . Basically, what can we do?
In the Project Blockbuster, we have been able to show a substantially higher drug load for the final drug product. What does that mean? The pills can be smaller. If the pills are smaller, it means that the patient can have fewer pills to take, smaller pills to take. This is important for people who are elderly and have difficulty of swallowing. Maybe more important is the fact that this allows us to come in with a new IP game, a game where we can prolong the IP protection for the originator. This is also an IP game that can be played with generics and super generics. This formulation work we have done, the breakthrough we have achieved, allows us also to vie for an earlier market entry. So far, we have had clear interest from both the originator and from a lot of value-added medicine companies.
Our preference is, of course, to work with the originator. Next, please. So let's talk a little bit about what we do with Fimea. Fimea is the national authority who grants the right to work under GMP. We have interacted well with them, and we had hoped that they would be coming and visited us for inspection during Q4. We, however, got message that they are very, very overbooked, and therefore, they said that they probably won't have time to come during Q4, but rather in Q1. This has nothing to do with Nanoform, and it is only a reason because of work related to COVID. So what have we filed for? We have filed for getting our GMP 2 and 3 lines online. Technically, they are already online. To get our GMP QC laboratory online, technically, it's already online.
Maybe most importantly, we have filed to get the right to put out products with marketing authorization. This is more than products for clinical trial use only. Next, please. This slide here tells about the targets for this year. Basically, the number of customer projects and the work to reduce our operating free cash flow. Both of these are on track. Next, please. This is our targets for 2025. My focus has already for a few years been fairly closely on this 2025 target. Out of these, the first question is, is it realistic to reach 70 new APIs per year? I find it still to be realistic. Will we need 35 lines? I don't think we will need 35 lines. I think we will land on something which is clearly lower than that. Will we reach the 90% gross margin? Yes, we will.
You will see in the financial numbers that we are now clearly below that, and the reason is very simple. When we were producing for Project Blockbuster, we had to take costs, which had to do with synchronization of getting the Fimea stamps for the GMP QC lab.
Will we become cash flow positive? This is what we will be working towards, and as Albert will show you, we'll see that we have already taken the first steps clearly towards delivering on that target. Next, please. Here, I'm happy to hand over to Christian. Christian, please.
We are experiencing some technical difficulties, so please hang on.
I think we will recover. Albert will help out with commercial.
Okay, let's go to the next.
Albert, one idea, it's Henri. Do you wanna do financials first, and then we see what happens with Christian?
Yes. Okay. We can do that like that.
Let's go to financials, and then we take Christian after that. Here we go.
Thank you. If we start with the business model, so we chose already early on to the business model of the pharma industry, where you get a fixed fee for the preclinical work. You get a fixed fee, which is roughly 10x bigger for clinical work, and then if you are able to let your clients enable drugs to the market, you get a royalty. Nothing has changed here. Just to remind you that all the projects, both on non-GMP and GMP, they are booked as potential, meaning that, for example, if a project takes 12 months, you divide the value of the project with 12 months, and then you according to the budget.
Then if you do more hours or less hours during that month or that quarter, then that will have an impact on the top line compared to the sort of projection. Let's go to next slide, please. During the quarter, we added seven more people, so we are now, we're 165 by the end of the quarter, and as you can see, and what it already indicated is that we are focusing now on productivity, and it means that we see that we can get more out of the existing, quite impressive of nanoforming lines. So rather than building new lines, we are getting more out of them. Next, please. Here on the left-hand side, you can see the number of opportunity and the non-GMP opportunities that our team has seen during the quarter.
You can clearly see that we have been keeping track on this since beginning of 2021. At the end of 2021, which was basically when the market exuberance in the market and in both on the fixed income side, but also on the XBI Index, was in the first quarter, second quarter of the year, but still there were lots of opportunities, mainly by X in the market. What we have seen now is that the level of opportunities have plateaued out at roughly 70 active possible projects. What we have seen is that the proportion of big pharma within that has clearly gone up. So, two, three years ago, it was much more biotech relative to big pharma.
Now, it's clearly that big pharma's proportion of the opportunities has gone up. The thing is that what we have also is the number of projects that we sign has been increasing every year from big pharma, while we lately have seen sort of a somewhat of a stagnation among biotechs. The projects are still there, but they are not necessarily moving forward until they have got the funding. If you see, look at the right-hand side on the proposals issued, we hit a new 12-month rolling record. So during the last 12 months, we have issued 76 proposals, and this is good. This is what we want to see. We want to engage with more clients, have more projects per client, issuing more proposals.
We believe we are doing very good, high-quality proposals. So every proposal we send, we send with the idea that we'll win it. Next, please. Third quarter, during the summer months, we signed only one non-GMP deal. That is not a direct reflection on anything in the market. Christian will tell you about that, the fact that there is clearly good momentum going on. Potentially, there was something around. We signed quite a lot in the previous quarter, and then the summer months were a little bit lower, but we see good momentum in the fourth quarter, and we expect the second half of this year to be better than last year.
We expect the sort of positive trend after plateauing, if you look at the 12-month rolling, to start to tick up again in the coming year. Next, please. Here you can see the cumulative number of projects signed so far, and this is very important because this is where we really learn about nanoforming, about formulation, about how to formulate, how to nanoform different clusters of projects or APIs. And it's so much, you know so much more when you have worked on 60 client projects compared to have worked only on six.
So this is really important, and related to this is that we have now more than 10,000 line hours on our CESS lines, which is very important from a sort of manufacturability and productivity point of view. Next, please. The revenues was slightly lower than we had or lower than we anticipated in the quarter, but this is also fluctuations. When you look at the right-hand side, the impact is smaller when you look at rolling 12 months. Also, remember in the third quarter, there is summer vacation, so basically, when people are one month on vacation, we don't book any revenue because we book all the revenue according to hours worked.
If we go to the next slide, here you can see actually what I was meaning, that there is fluctuation in the revenue booked under IFRS. However, we looked at the number of projects during the last quarter. Quarters, they have been quite stable on a quarterly quarter-to-quarter level, and also when you look at the rolling 12 months. So the last half year, we have been having a rolling 12 months of number of projects at 37. Next, please. If we go to the gross margin and the materials cost, because we have not yet received the Fimea stamp for the QC GMP lab, we have been able, we have been forced to use outside help, and that has cost us quite a lot.
So you can see here that we are closing in on EUR 1 million in materials and services costs, and this is, of course, directly related to the Project Blockbuster case. This will now start to diminish, and when we get the QC GMP lab audited and stamped by Fimea, which should happen first quarter next year, we expect these costs to go down to sort of closer to the levels they were one year ago. And as we write here, underlying excluding the Project Blockbuster, the gross margin of the company was in the first nine months above 90%, like we have had historically. Next, please. And here you can see the same, that if you exclude the Project Blockbuster, the gross margin was about 90%.
But of course, the impact has been felt quite significantly during the last quarter from the extensive QC work that has gone into the Project Blockbuster. Next, please. Here is an example of how you can... when we forecast that it will come back, it's the same what we have seen already on the IT expense side. So, last year, we started to do the SAP implementation, and then the peak of the intensity was somewhat before we went live in January.
Here you can see already now that, there was a, a clearly intense period where the costs were higher, but now with the successful implementation and the SAP is now humming nicely, you can see that the, quarterly cost from IT has gone down significantly, and that has also turned the rolling twelve months, cost for IT down significantly. This is what we expect also on the materials side in the coming quarters. Next, please. Now we come to the really important, slides on the financial side. This is what we mostly look at when we look at the financials. This is what we talk a lot about internally also, and that is the cash flow.
This, of course, where we have the official target for 2020, for this year, to improve the operating free cash flow, and, I'm very happy with what we have been able to achieve. I think the Nanoformers have done a great job when they have turned their attention away from build, build, build, more to become more effective, become more cost-effective, get more productivity out of the fleet, and so forth. Here you can see that during the first nine months of the year, we have improved the operating free cash flow by 19%, and that means that actually during the last quarter, in the third quarter, the operating free cash flow was less than EUR 5 million negative.
That means that annualized, it was less than EUR 20 million, compared to where we were only five quarters ago when annualized it was up 30, EUR 30 million. So we have taken a big step already, in the right direction. And then if you take the following slide, there you can see that, we feel that we are on track towards, our target in 2025 of becoming cash flow positive. And here you can see that if we were almost at EUR 30 million negative last year, now we are at, annualized at less than EUR 20 million. Now, in the coming years, of course, we need the top line to help us.
We still can become more effective on the cost side, for example, on the material side and so forth, but of course, a chunk of the improvement in operating free cash flow should come from improved top line in order to get to positive cash flow. Compared to the balance sheet, where we have EUR 52 million in cash and no debt, we are of course in a very strong position. Next, please. And then we have the tables that you can have a closer look at. And then I think it's time for us to, here you have a calendar, but then it's time for us to go to the commercial. Christian, have you been able to recover? To-
I am, I am here, Albert.
Perfect.
Super. So, apologies for the technical issue, but I'm here to present the commercial today, and thank you very much for your attention. So the first thing I'd like to comment on is the recent announcement with AstraZeneca and what this entails. Nanoform have been working with AstraZeneca for some time, one of our longest-standing relationships, in amongst the 10 top pharma out of the top 20 that we work with. AZ are one of our, perhaps longest-serving partners, and we have enabled them to be able to screen their molecules, confidentially, within the AZ business, to see which molecules are a good fit for our technology.
They can put hundreds or thousands of molecules through the STARMAP system to quickly identify the opportunities to take forward to improve those products from a patient benefit and also from a planet benefit, and that's obviously aligned very much with their ambitious sustainability goals. Can we go to the next slide? With TargTex, we have again had a relatively long-standing relationship with them. Just to recap, for those that are not aware, TargTex is a Portuguese biotech company that have developed a product for the treatment of glioblastoma. And they came to Nanoform because they had challenges associated with this product in the development of a hydrogel formulation for delivery into the brain. We were able to nanoform the API.
We were also able to develop a novel formulation hydrogel that worked in rodents, and we are now moving forward into a clinical development program with TargTex, where our technology will hopefully allow that product to move forward into clinic, into a phase I, phase II-B study. And this has only been possible by the use of our nanoparticles, where we've been able to get over a 200-fold increase in drug load. And the fantastic news is that they've received Orphan Drug Designation from the FDA for this drug candidate to be used in patients with malignant gliomas, so not just for glioblastoma, but more broadly than that.
The other aspect of this is that obviously, to fund this development, they have had to raise money, and they have recently received EUR 14 million from the EIC, and they are currently looking to raise the remainder of the Series A fundraising that they're taking forward. But very, very encouraging, and hopefully will provide hope for patients with this terrible, debilitating disease. I'd like now just to showcase really our pipeline of projects that we're working on and to give a flavor of some of the disease areas and therapy areas that we're working in.
As you can see, more of these compounds fall in the preclinical space, which is to be expected, given that our technology is primarily used for bioavailability enhancement, so trying to enable these products to move forward into a successful phase I study. But you'll also notice we have a number in phase I, phase II and III as well, and here we're looking at optimizing the formulation, making a more patient-centric product. And the same can be true in the marketed and 505(b)(2) section, where here we're really looking to either extend the life cycle of an existing product to make a better product for patients, but also potentially to make a greener product for our partners. I've highlighted here three therapy areas where STARMAP has identified as hotspots for our technology.
And this by no means is exclusive. We work across all therapy areas, and the technology is widely applicable for most molecules. However, within neurodegenerative disorders, prostate cancer and HIV, we see molecule structures that lend themselves very well to being nanoformed, and these are clearly very high-value areas as well. So let's move forward to the next slide. So taking that one step further ahead, not only have we identified therapy areas that are very, very interesting, we have also identified particular types of formulations that Nanoform can improve upon. And Edward mentioned earlier about amorphous solid dispersions, one of the standard technologies now that's used for overcoming bioavailability issues, or trying to overcome them with pharma products.
Actually, nearly 50 products that use amorphous solid dispersions are on the market today, selling for over $15 billion in the U.S. alone. There's an incredible number that are being developed in that are disclosed in the clinical pipeline, and there's even more that are being developed in the preclinical pipeline that are not disclosed. But Project Blockbuster is our first example of what nanoforming potentially can do to or for ASDs, and we plan to replicate this with other products as well. 78% of all the marketed products are very lend themselves very well to our technology, and would be ideal to use to overcome some of the limitations that are present with amorphous solid dispersions. Now I'm gonna take you through something which is highly innovative.
It's an innovation that Nanoform has created ourselves, and this is about the formulation. So making particles is one thing, but actually getting them to behave in the way that you want them to is another, and that's where formulation comes into play. But not all particles behave in the way that we want them to. And we're gonna talk about nanocrystallization of amorphous nanoparticles. Now, with an amorphous dispersion, these typically increase the dissolution rate. They have a very high polymer loading. Polymer is used to stabilize the amorphous material, and it uses high volumes of organic solvents as well. They have low levels of crystallinity, because they're amorphous. So a crystalline material, however, has a lower solubility, but it's stable and has a rigid structure.
So the best situation would be to make something that's amorphous, nano, and stable. Some particles below 100 nm, when we make them via the CESS process, they actually want to be amorphous nanoparticles, but they might not be stable. So we want to try and find ways to stabilize them, to retain the power of the very, very small nanoparticle that we can create, but be able to take them forward in a product. So we have developed a new platform that can crystallize these amorphous nanoparticles to make smaller nanoparticles that are crystalline by controlling the particle size, by retaining their size, by retaining their polymorphic form, their stability, and by enabling a lower polymer drug loading and increasing the stability.
And this proprietary process has enabled us to take forward, in the case of Project Blockbuster and in the case of other products as well, crystalline material that we receive as a bulk drug substance, convert it into amorphous nanoparticles, and then translate those to stable crystalline drug product intermediates. So, with a standard process, direct crystallization via CESS, you have no polymers or excipients, they're stable to changes, no organic solvent waste, tight PSD, particle size control. With this process, we get a very high API loading compared to the amorphous solid dispersions. We don't have any organic solvent waste, very tight particle size control, and we increase the stability. But what does it actually mean?
This is the, shall we say, the killer slide, where you can see that actually we can match the performance of an amorphous solid dispersion in an animal study with an optimized formulation. So effectively, we're able to take a multi-tablet ASD product, reduce it to a single tablet, the same size as one of the original tablets, so the same combined dose with a novel nanocrystalline formulation. And this can help to reduce the pill burden, enable fixed dose combination possibilities, but very importantly, this also creates a unique IP position, and can enable life cycle extension for our originator partner. I think that's the end of my presentation.
Thank you, Christian. Operator, we are ready for questions.
If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from Sami Sarkamies, from Danske Bank. Please go ahead.
Okay, hi. I want to ask about the topic of conversion. So if I look at your commercial activities, you're currently sending about 60-70 proposals per annum, and it seems that this is sort of the level you're able to do at the moment. Out of these, about one third get converted into deals, mostly non-GMP deals. And then if you look at the number of GMP deals, they are about 10% of the number of non-GMP deals. So what will improve conversion from here?
Will you be sort of more focused with, with the new proposals, and then we can assume that there's going to be better conversion, or is there, for example, a time factor that it just takes time for potential customers to digest the new information and sort of plan for commercial-
Yeah
... stage project?
So, Edward, if I may take that question.
Mm-hmm.
So, the typical industry standard for conversion rates of proposals sent to one business for new business with new clients is between 20%-25%. So we're already at sort of 33%, which is quite high within what is expected in the industry. And then of course, with repeat business, you would expect those numbers to go up. And we do see that with repeat clients and when we win, we win continuation of business with existing clients. And what would actually improve the conversion from non-GMP to GMP is, and I think we touched on this, is the importance of formulation. And it's the importance of being able to demonstrate value, not just from the particles that we create, but how they actually behave in the human body.
That's why we're spending a lot of time now on the formulation aspects of our business and growing the knowledge and understanding required to ensure that when we give material to our partners, that it behaves in the right way, and we get the maximum value out of them. So that's what will convert and increase the proportion of non-GMP to GMP projects ultimately.
Okay, thanks.
I can continue it, Albert. I can continue a little bit. So if you look at the total industry number, roughly 25% go from non-GMP to GMP. And remember, this includes all molecules, also the easy ones. It includes all the technologies. And what we have said all the time is that if we become good, we might end up in a situation where we have matches that number or slightly above it. But when you look at our numbers so far, remember, in the beginning, we were very novel to the technology. Let's say the first 10 projects, you have only worked on 10 projects. The other thing is that we are still, to a big extent, the last resort, so we don't get any easy molecules. They use other technologies for that, but we get the toughest one.
And in many cases, we have not yet have a situation where clients use STARMAP to pick the right ones to use nanoforming for. And also, of course, what Christian said, formulation is very important. So actually, both the cases where that has moved and that we have talked about that have moved to GMP so far is both the TargTex and the Blockbuster are cases where we have come up with the formulation because no other company has experience in formulating nanoparticles. And what we have seen is that they behave very differently from nano micronized particles. But remember this, the difference when we have a situation. Let's paint a very bullish picture. All big pharma and many other companies use STARMAP .
They screen for 1,000 molecules, and they put one or two or three to us to nanoform that are amenable to nanoforming. The hit ratio will be very different from that, and especially if they also consider nanoforming as one of the first choices like they do now with spray drying, because then you might even get easy molecules also, that are not the toughest ones. So we still believe that it's just a matter of time. We just have to work hard, get more projects, learn more, and get the clients to use STARMAP and get the clients to use nanoforming more widely. Then we will be able to reach the industry numbers. I would say like this, for a young technology to have this one, this kind of conversion rate, is still already good.
Many technologies don't get a conversion rate this high, at this stage.
Okay, thanks. And then I would have a second question regarding Blockbuster. Just wanted to verify if I understood correctly. In the presentation, I think you alluded that the plan was to include the originator in the project, and you were kind of, like, hopeful on that front. Just taking... I mean, you're having this consortium with already, I think, four players, but not the originator. So, I mean, it's a pretty sizable group of actors already. So, I mean, any thoughts on how this could kind of, like, play out? Or, I mean, is there a possibility for you to just work directly with the originator instead of this consortium that you're a part of?
This is a very intricate question, and let me briefly sort of say something. In the consortia, we're the ones who make the nanoparticles. There are people who are very good at marketing in the consortia, and there are people who have the necessary stamps to make the GMP material in the consortium. Of course, in a scenario where we end up working with the originator, the originator will have a say in how they want to proceed.
But remember also that we. The reason why we do this is also that this is a joint effort. The consortium members, they have a lot of experience in, they have in IP, they have in producing, putting drugs on the market, value-added medicines. They have the knowledge of doing clinical trials in many, many of clinical trials on many continents. So they have. And they also have the knowledge to make the final product that go into the clinical trials.
T hat is, this is the reason why we have hooked up with them. And of course, also from the fact that if you are doing it yourself, the cost will be 100%. If you do it with two, three others, then your cost will be only 25%. So we are very happy with the consortium, and remember also that this is only one opportunity. This consortium works on many products, and this is the first one we are talking about. But of course, as you say, originators are then really big entities, and they have the final mile all the way to the patients, and the patient via all the doctors.
In the world of, of pharma, the ones who sort of have this final mile, last mile, and have all that connect, con, data about the, the patient population and product on the market, of course, they can then decide. But, and the consortium's idea is never to put the alone, the drug on the market or the drugs on the market. The consortium's idea is to jointly come up with new ideas, prove them in early clinical phases, and then out-license it or the products to partners, be it or originators or value-added medicine, companies. The consortium's idea is to do just what we are doing now.
We are very happy with the consortium, and combined, we are so much stronger, both from a knowledge point of view, experience point of view, but also from a financial point of view, when we then talk with originators.
Okay. Thank you. I don't have any further questions.
The next question comes from Christian Glennie from Stifel. Please go ahead.
Hi. Good afternoon, guys. Thanks for taking the questions. There's a couple on the project, Blockbuster, then, if we can. I guess thinking about the, you know, what you can say around the design of the clinical trial, what are the objectives here? And when you say, if positive, you know, what, what does success look like for this trial? Obviously, if you've had some, you know, some initial engagement with the originator, perhaps, you know, what, what are they- have they given a steer in terms of what, what positive looks like from their side?
So Christian, thanks for the question. And on the first part, the exact design, this is to verify in a 505(b)(2) sense that we can reach equivalence. That is so much we can say. Right now, we're not prepared to disseminate more technical details around the trial. There is nothing spectacular about it. It's a standard trial to show bioequivalence.
Okay. Thank you. And then in terms of thinking about the, you know, the expectation management around the potential deal, obviously, not to give numbers, but the sort of structure of a deal that might ensue, either from an originator or from maybe another partner.
So this deal thing, I think it's very early to speculate in sort of very detailed way. I will ask Albert to give you a little bit sort of financial perspective on it. What is important is, regardless of the exact outcome of the readout, there is a way forward. So my expectation is either we will have something which is bioequivalent, something which is slightly better than bioequivalent, or something which is a little bit less than the bioequivalency. The progress forward doesn't stop there because this is one of the formulations we would go in with, and we already know what other kinds of formulation we can do should we need to do that. Albert, please.
Yes. So from... I think of it like this, that there is a mathematical probability that we will succeed with a positive readout in the study, and nobody knows it, but we feel that there is a positive probability of us achieving it. Of course, not 100%, but what the exact percentage is, there is industry numbers for that, but I will not give our estimate. Then the follow-on is, of course, after that, whether we achieve it in the first or second try, and then what happens after that? Then you have another probability of what is the probability if we have a positive readout, that we make a deal with big pharma, meaning the originator or with one or several value-added medicines companies.
And then the third point is, of course, with the positive outcome in both, what is the monetary value of that deal? And that is again, in all these cases, I would say that there is lots of industry examples of where they can be, but it's of course, at this moment, it's speculation. But what is really important is that this is just the first ASD we are working on, and that means that 50% of the market, we have STARMAP at 46, and we have identified already clearly that there is potential for other similar cases which can be really interesting. And, of course, if we succeed already in the first one, we would sort of break the wall and really show the global industry what nanoforming can do, and it would be fantastic.
But, of course, we can't give you any probabilities at this moment or what the size of the-- But naturally, the size of the deals in the pharma industry, when you have something truly unique, can be significant, can be significant. And this is also a little bit earlier than when we thought when we did the IPO. So in the IPO, when we set the 2025 targets, our idea was not to include any potential signing fees or milestone payments that we would receive them before 2025. So now we are actually in a positive situation that we believe that there is a probability that we could have one of these already next year, which would be clearly earlier than expected.
And that is, of course, something we are working towards, showing the power of nanoforming and the power of our formulation with Nanoform material to both originators and value-added medicines companies.
Thanks. That's helpful. And then finally, maybe just a thought on revenues, both as it relates to Q4, anything particularly to note that might be an acceleration in Q4? And then looking into 2024, obviously not to give guidance, but thinking about, you know, outside of any potential license, or deal milestones, you know, particularly those for GMP runs. I'm thinking about TargTex, whether that could be a... You know, is that schedule that could go in the clinic next year in terms of a GMP project?
Yes. So of course, our we don't give guidance on the revenue. It fluctuates also due to IFRS rules and so forth. But when you look at the number of projects that we have been booking revenue on in the quarters and on a rolling twelve months, we believe that we should continue to see good growth in the number of projects we get in, helped by all the factors we've been talking about. People use more STARMAP, we become more known. If we would get a big success like Blockbuster, of course, that will be a huge benefit to us. And also the fact that when we do more project, the probability and the number of GMP projects should go up.
And the fact that we also now, in the first quarter, will have the visit by audit by Fimea, which means that we, instead of having only one GMP line, we will have three GMP lines up and running. That will, of course, enable us to do more GMP projects from a pure, sort of real-life mechanical manufacturing point of view. And then finally, when we did the IPO, we set the target of getting 50 new APIs in per year. That was around only the small molecule side. And now we have, during the last quarter, seen a significant increase in interest in the biologics technology also. And that is, of course, the reason why we, summer of 2021, we raised the target to 70, because that included the biologics.
On the biologics, we see that, especially the drug load is something that the industry is really, really interested in. And we have early sort of data that looks very promising. And if we start to get more traction also on the biologics side, that will be sort of a additional force that could help us to get more projects. And of course, we have already the pipeline for GMP for biologics, and if client interest is there, we can quite easily turn it into a GMP line.
Thank you. So, sorry, was there any comment you can make on TargTex timeline?
The TargTex is expected that they should go, next year. Yes.
Next year. Okay. Thank you.
The next question comes from Max Herrmann from Stifel. Please go ahead.
Hey, thanks so very much for taking my question. It's just one really. Just in terms of your comments on GMP and non-GMP lines and not needing as many as you've most recently set, I wondered what additional lines you do think you need in the, I guess, in the next two years, and what the implications for that are on your CapEx spend over that period as well?
Albert... Yes, Albert will talk to the euros, but generally speaking, we have a fleet now. We don't intend to increase the line count on our own dime. If there is a customer coming in who really wants us to upgrade the biologics line to GMP, then we will do that. But basically, up till 2025, we intend to keep the fleet, take out more from it, and it will happen by having higher production and have a faster switchover times, which we see that we will be able to deliver on. Albert?
But this is, of course, what—based on what we are seeing now, if, for example, if we have a positive outcome and make a significant deal on the Blockbuster, or if we have something other that really drives demand, let's say STARMAP takes off among big pharma and so forth, then we can easily add more lines, both on the non-GMP. And you guys who have visited us have actually seen that... that we have a line that we could—a very big line that we can transform into a GMP line on the CESS site also quite easily, because we have already the big line there. We just haven't built the clean room around it. So, I would put it like this, if needed, we can increase the number of lines also without significant CapEx.
Then, of course, we have also the other thing is that, related to the U.S. and footprint in the U.S., if we do that together with a partner, together with an originator or a large pharma, then, of course, we would quickly put up lines also in the U.S. So what Edward was referring to was more of like the way it is right now, but we are ready to increase the capacity more if clients wants us to do it, or if client wants sort of their own sort of special lines where nobody else can APIs in it, so they are proprietary only in our facility, and that is also possible.
So if I understand that correctly, minimal kind of base case, minimal kind of investment now in CapEx over the next couple of years? But that's obviously could be flexed if a partner or a deal necessitates further investment?
Yes, sir. Yes, and the reason is that we see lots of potential of improving the productivity of the lines. We have made significant improvements in the lines, and we see lots of potential still to do more projects and more efficient projects on the lines.
Great. Thank you.
Thank you.
As a reminder, if you wish to ask a question, please dial star 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 someone has more questions, then you're welcome to contact us after this. We will be out on a roadshow starting tomorrow at SEB in Stockholm, followed by Carnegie in Helsinki next week, and then at DNB in Oslo in mid-December, and then early next year in Copenhagen at the SEB Nordic Seminar. We wish everybody a great Wednesday evening, and thank you for today, and goodbye.