Nanoform Finland Oyj

OMXH:NANOFH

Earnings Call Analysis

Earnings Call Transcript 2024-Q2

[Henri Von Haartman, executive]

Good afternoon all, and a warm welcome to Nanoform's second quarter 2024 report presentation. My name is Henri von Haartman, and I'm your Director of Investor Relations. Today, our CEO, Edward Haeggstrom; CFO, Albert Haeggstrom; 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 presentation 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, today, start with introduction to Nanoform, then financials and then we conclude with commercial. With these words, our CEO, Founder, Professor Edward Haeggstrom, please go ahead.

[Edward Haeggstrom, executive]

Thank you, Henri. And welcome, also, on my behalf. Next slide please. So we work in the pharma industry which has an issue with too few medicines coming every year, despite a lot of R&D money being put in.

Next please. The reason for this is something called poor bioavailability, which means that an otherwise potent drug is not taken up by the body where it can do some good. This problem is large and it's growing and this is the problem that we address.

Next, please. We address it by making coarse powder into fine powder. As you can see here, you need to go deep into the nanometer range in order to achieve the effect. That is what we can do.

Next. Nanoform has 4 platform technologies: one for small molecules; one for large molecules; one for nanoformulation; and one for AI. On the small molecule side, we improve the bioavailability, as outlined before. On the large molecule side, the strongest driver is that we can improve the drug load. We can make it higher.

This here means that we can either have smaller infusions or we can have smaller pills, for instance. In the nanoformulation part is really to put the size to work. There is a size effect that modulates the way the drug interacts with the body. And on the AI side, it's possible to use in-silica approaches to pick winners and to set the knobs right early on.

Next slide, please. From the bioavailability, improved bioavailability thing, a cascade of good stuff follows: so we can have new drugs come to the market; we can reduce the dose; we can reduce the side effects; we can have patent expansions and patent prolongations for our customers; we can reduce the production cost; and we can reduce the CapEx requirement by having to build smaller factories; and we can also increase the environmental sustainability.

Next, please. We can enable new drugs and we can improve existing drugs and we can give unsuccessful drug candidates a second chance. There are a lot of candidates that can be improved.

Next. If we take a look at this slide, we can see that we have achieved a lot of stuff already in 2024. The first bullet point is about preparing to put medicines on the market. We do this by generating something we call product kernels. And it's important to remember that Nanoform works with both new drugs with existing molecules and with molecules that, so far, have not been on the market. We do the work together with commercialization partners and with development partners. The first deals are expected to be signed in 2024.

We have also seen a clear increased biologics traction after the Takeda presentation earlier in May. We have signed several new customer projects and we have also seen that people buy multi-API projects where they test many project -- APIs at the same time. API stands for Active Pharmaceutical Ingredient and that's the stuff in the pill that makes you better.

We were awarded the GMP Quality Control lab certificate and this means that we can provide faster analysis and we can also provide a lower cost position for our customers. We have been doing GMP manufacturing now in a 2-shift pattern and we produce this for the registration batches on the enzalutamide program. This year, we're at 10x faster than we were last year.

We're on track for the 2024 business targets and it's clear that a lot of our work now is to make the nanoenzalutamide become the first Nanoformed medicine to reach the market. This is expected to happen in 2027 in the EU and 2028 in the USA.

In the coming 5 years, we are preparing to launch Nanoformed products together with our partners. First, we work with the development partners and then the commercialization partners.

Next slide, please. This is where I hand over to Albert.

[Albert Haeggstrom, executive]

Thank you, Edward. If we, then, first go through some financial numbers and then go to the product kernels. Here on the left-hand side, you can see that we have still added a few persons to our staff. These are mainly within the formulation and the biologics units. And -- but you can also see that the growth rate has come down in the personnel because we feel that we are already -- we have the critical mass. We have already 170 people. And with that, we can do a lot of things.

On the right-hand side, there are some lines both on the GMP and non-GMP side that we have not yet commissioned. And so the number will still go up without increased in investments. And here, the same thing is that we feel we have a strong fleet of nanoforming lines where we can do lots of projects annually.

If we then go to proposals sent and projects signed. You can see that the fluctuation between the quarters, if you look at the right-hand side is quite high. You have some quarters where we only sign 1 or 2 and then we have some quarters where we can sign 10. During this year, it's clear that the third quarter will be a very good quarter. And potentially, we will have a clear new record in a quarter when it comes to number of signings.

You can also see that we have reached a level where we send some 70 new proposals per year. This is mainly on the small molecule side. But now, as Edward said, we are seeing more and more traction on the biologics side and that should help that number going up. And then on the signing, we also know that we have reached a level of some 20 on annualized. We have every annual year, have an increased number and we also believe that this year, we will have a bigger number than last year when it comes to signing during the year.

On the revenue per quarter or revenue rolling 12 months, there has not been big changes during the last quarter. If we then go to revenue, we saw a small sequential increase in the second quarter, while the 12-month rolling still was down a little bit. Now with the comps getting easier in the second half and we also see more traction when it comes to signings. And of course, when we sign deals around nanoenzalutamide, that will have an impact later on in the year. So we expect the numbers to start to go up during the second half of the year.

When it comes to the cost of goods and on the gross margin, we got the license from Fimea. And that means that we don't have to spend money on the GMP QC. With outside partners we can now start to in-source it. And that means that already in the fourth quarter, we will see whether we can reach -- go back to the levels we saw before we started the nanoenzalutamide campaign, but we feel positive about this, that in the coming months, we will be able to in-source the GMP QC and therefore, the gross margin should go back to the good level we have seen previously. This is very good for us. And it saves money and it also saves time and it gives us more control over the process when it comes to GMP manufacturing and quality control within it.

On the operating free cash flow, we saw a small improvement again. You can see that every quarter, we have improved. You can also, on the right-hand side, see that the rolling 12 months have improved. Of course, this is despite the fact that we have created lots of kernels. We have done lots of work and we have not seen yet the top line impact. So when the top line impact comes from signing deals and getting more GMP projects, then of course, the improvement will be faster. We have a strong balance sheet with more than EUR 50 million in cash and short-term government bonds and we have no debt.

Here on the short-term and near-term business targets for '24, as Edward said, we are on track to meet them all: increased number of projects signed on the non-GMP and GMP side; improved operating free cash flow versus last year; and potentially the most important one, to sign one or several licensed commercial supply agreements during the year and this is around enzalutamide together with our partners in the ONConcept Consortium.

Before we go to the product kernels, I want to shortly emphasize our -- a few key strategy points. So remember, even though we will now start to talk about product kernels, there are 3 parts or 2 parts to Nanoform's strategy. The first one is that all APIs should be starmapped. STARMAP is our AI engine where we can look whether the molecule is amenable to nanoforming. It's a very cost-efficient and time-efficient way to do and it's also a green way because you don't have to test it in the real world.

Once you have starmapped it, the molecules, you can pick the ones that are amenable to nanoforming. And here, Nanoform work with partners or their customers, both on novel and existing molecules. And here, the idea is that, just like most of our projects, our customers owning the API having problems with bioavailability or wanting to have better bioavailability, different delivery route or something, we work with them on their asset fee for service in non-GMP and GMP and then we get a royalty for when the product is launched.

However, as this is a very conservative industry, and as we -- as a result of the very good results in nanoenzalutamide and apalutamide, we have decided to produce more of these kernels within the -- mostly at the ASD area, but also in biologics, inhaled and in long-acting. And here, the idea is that we do these product kernels, we early on partnered with a development partner and then we do the up-to-a pilot study and then we find a commercialization partner that then together with us take it to the market in the coming years.

We think this is both financially smart because the return on investment can be significant, but it's also a very important step because this is a way to prove to the industry that nanoforming is a very versatile and very broad technology.

So let's now go to the product kernels. As a fast reminder, we talk about alternatives to ASDs, amorphous solid dispersion medicines. There's roughly 50 on the market, they sell for roughly $50 billion a year. The reason why they are amorphous is that amorphous has better solubility and bioavailability than the crystalline form. By doing -- by using nanoforming, we could potentially have a substantially higher drug load. We've seen it with XTANDI, for example, or the nanoenzalutamide XTANDI 4 pills. We have been able to do a one tablet of 160 milligrams. You can reduce the pill burden. You also have the IP angle and you have the opportunity for an earlier market entry.

We have starmapped all the ASDs on the market. There's roughly 50 of them, some 80% of them are amenable to nanoforming. We have looked at these, here is a list of more than 30 of them. We have looked at them from a commercial and a technical and a IP angle and we have decided that we want to have 7 product kernels from this ASD group. Here, the 2 first ones we announced was nanoenzalutamide and nanoapalutamide. And now in this quarterly report, we also showed further projects -- progress on some other product kernels.

So if we here look at the product kernels we have developed so far, we have already 2 where we have a development partner. That's nanoenzalutamide together with ONConcept Consortium and then we have another one where we have not yet disclosed the development partner. Then we have 4 where we have not yet a development partner, but where we are having discussions already now. For example, in nanoapalutamide, we have had several discussions already and we have come quite some way already.

Remember that here the idea is that, first, you find a development partner and then after doing the -- for example, the pivot -- the pilot study, you get the commercialization partner. And you can see here in the green column that around nanoenzalutamide, we expect to sign the commercialization partner this year and then for the rest in the coming 2 years. And this is a very good way for us to get the technology, show the broadness of it and the power of it, but also to get decent and good returns on the investments we have made in this product kernels.

With this, I turn over to Christian. Please, Christian, go ahead.

[Christian Jones, executive]

Thank you, Albert, and good day to all of you on the call. I'm happy to take you through the commercial highlights of the Q2 report. And we go to this slide. I'd like to just recap on where the value proposition is from our technology and some of the great examples where we've shown value with our partners. And we've really shown both in vitro, in vivo and also now a clinical study value using our technology.

So first of all, in oncology, we've replaced amorphous solid dispersion formulations with nanocrystalline high drug load formulations. Perhaps that's best represented by the nanoenzalutamide case study that we've discussed. We've also been doing something very similar with nanoapalutamide. And of course, we also announced publicly this year the relationship with PlusVitech and this is around a molecule called aprepitant and there so many tablets would be required for patients in lung cancer. So we're there looking to reduce that tablet volume and improve the patient-centricity.

Then we go to inhalation. And in inhalation, we've been looking at engineering nanoformulations, both small and large molecules, to give superior performance in the lungs with high fine-particle fraction and fine-particle dose. And we've been able to show performances of more than 95% versus 50% with spray drying, again, representing high drug load delivery to the lungs. And you'll see a common theme in all of these points and it's around high drug load.

So in the oncology space, in the oral tablets, we're really focusing on increasing bioavailability, but getting a very high drug load. In inhalation, we're looking about getting a high drug load to the right part of the lungs. In the biologics space, demonstrated in partnership with Takeda and other companies as well, ultra-high concentrations for subcutaneous drug delivery with acceptable viscosity for injection.

Now that's -- we have been able to demonstrate drug loads of greater than 400, 500 milligrams per mil on some of our projects. And that's, again, representing a very high drug load that's possible with nanoparticles, but in the biologics space.

In ophthalmics, we've been looking at multiple projects where nanoparticles have shown improved delivery. Again, high drug load to the eye, enabling smaller implants with no requirement for mesh membranes. This is something that we demonstrated with Celanese collaborator last year and the ability to make ophthalmic inserts or eye drop suspensions that can have superior delivery profiles.

And then in hydrogels, fantastic example is with TargTex, we were able to get 200-fold improvement in drug load over the bulk drug substance. And this was only possible with our nanoforming and this was 5x more than the nanomilling alternative, so again, high drug load. And when we sort of think about all of this, that's the common theme. But what actually backs up all of this is that we're able to do it with a proprietary technology in a proprietary formulation.

And these novel technologies, processes and formulations can really help our partners, our innovator partners to further protect their products, to add value to their products, to enable market opportunities, to life cycle management and very strong launch strategies.

A great example of that would be; if, for example, an innovative pharma was to actually launch their product with a nanoformed oral tablet and they were able to make a tablet that's 1/3 of the size of anything possible in amorphous dispersion, that technology and that product could be on the market exceeding its patent exploration with no generics able to copy that product and we see significant value in those types of discussions as well.

So as we go to the next slide, let's just talk about some of the products that we're working on. And here is a very nice overview, an updated one since the last report on our pipeline. And I'd like to spend a few moments here just to discuss again where the value is and the types of projects that we're working on.

Majority of our work is in the preclinical space, and that really hasn't changed. And the reason for that is because we're trying to address one of the biggest problems in the industry, as Edward mentioned at the beginning, which is that of poor bioavailability. And poor bioavailability has to be overcome before you move into first-in-man Phase 1 studies. Therefore, many clients come to us with projects where all other technologies have failed and they still can't get the molecule to be soluble enough. So we work on a lot of projects in that preclinical space and that's still a core focus for Nanoform.

But increasingly, as we've demonstrated value in making products more patient-centric, once the product has been successful in Phase 1 studies, maybe it's not optimal, but it's proven that there is efficacy and they've got good enough bioavailability, many companies are now coming to Nanoform to say, could you help us make our patient -- our product more patient-centric? Could you help us take 6 tablets down to a single tablet? And those types of discussions. So we're seeing an increasing amount of projects now in the Phase 1 to Phase 2 area where that's still an option to optimize the formulation.

And as we look towards the latter part of this table, you see the marketed and 505(b)(2) products. As Albert alluded to, we started to develop these product kernels. We want to demonstrate value in that space, value that is clear, that can be clearly commercialized with our pharmaceutical partners. And very often, going to a major pharma company with a concept, with data, is a lot more credible. And so I think we're going to see a lot more traction in that space by developing these product concepts and taking them to major pharma and to other partners to see how we can commercialize them going forward.

So life cycle extension, 505(b)(2)/generic opportunities here and this is where we're going to see more deals. So the earlier work in the preclinical space moving into Phase 1, it's more around fee-for-service and trying to develop a relationship, prove that the technology works. Once we've already established there is value by doing these product kernels, we will be able to do deals in a much faster way with our pharma companies that we're talking to.

So if we go to the next slide, I want to just talk about the highlights from this year. We've had a very positive 7 to 8 months. And Q3 has exceeded expectations. We've certainly seen a huge momentum and driving in commercial traction and we see that only continuing as we go through the latter part of this year.

August has been a very positive month. We have the announcement with Takeda that we had initiated a collaboration on that plasma-derived therapy development. This is a continuation of the existing relationship that we have with them and that's in the biologics space.

In July, we had a new U.S. major pharma who signed a multi-API contract, really exciting there. Our relationships with global top 20 pharma has now gone from 10 of the top 20 to 11 of the top 20 companies that work with Nanoform.

In May, we were able to be present at the DDF exhibition where Takeda presented on Nanoform's technology and talked about the great data there in the high-concentration biologics space for subcu delivery. And since then, we've seen a significant traction and interest in our technology. And it's the first time that a major pharma has stood up and talk about Nanoform externally. And we're delighted that they were pleased to do that with us and for us.

Celanese, also at the same conference without Nanoform asking, they were also showcasing work we've done with them previously on the long-acting space, at the same conference. So we're really starting to see an increase in Nanoform's brand, its visibility and its credibility in the industry.

In April, we signed a contract with a global top 5 animal health company for a new multi-API contract. And we also entered into partnership with a trading company in Japan called CBC. And that's really to expand our market access into Japan as we want to bring our technology to all corners of the earth. As we have demonstrated good traction in both Europe and U.S., we see it natural, as a natural progression to start to look towards Asia as well. We've also mentioned the Nanoform and PlusVitech partnership in April.

And in February and in January, we had the fantastic announcements around nanoapalutamide preclinical promising studies results and also the clinical data, the promising data around nanoenzalutamide that was announced in January. So a very busy 7 to 8 months, but a great start to the year and we are very much looking forward to continuing this success as we move forward.

If we look at the number of customers that have signed, we've increased that by 5 so far this year. But we've actually increased the number of molecules significantly more than that, so by 13 since last year. And that's because we're starting to develop broader and deeper relationships with our major pharma partners who have deep pipelines. And both from an economic perspective, the markets haven't been particularly buoyant for the biotech companies, but also because of the strategic intent, we want to develop deeper and broader relationships with major pharma companies. This has really paid off. So we're starting to see some of these major pharma companies giving us more than one molecule to work on at a given time.

And as we review the selection of partners, we have those on the right-hand side that have allowed us to talk publicly about our relationship. And as you can see, we're now working, as I said before, with 11 major pharma, 35 midsized specialty pharma and biotech. We've got 2 co-developments, that's the nanoenzalutamide and the one that's undisclosed on our product kernels and 3 collaborations in the mix.

If you would like to meet with us at any of our upcoming events, you can see them here. They're also on our website. Both commercial and financial events are listed here and we very much look forward to discussing more about our technology with you, should there be an interest.

And with that, I think we close for a Q&A session.

[Operator]

[Operator Instructions] The next question comes from Sami Sarkamies from Danske Bank.

[Sami Sarkamies, analyst]

I have 2 questions still. Firstly, on Takeda cooperation, I think you sent out a release a couple of weeks ago regarding a deal you have done on biologics. Can you provide some color on what this cooperation is about and how it will be moving forward?

[Christian Jones, executive]

Thanks Sami, for that question. Happy to take it. What we can say is what's in the press release. And what's in the press release states that we have continued our relationship with Takeda that post promising in vitro results from a proof-of-concept study. And we move forward into further formulation development of a novel formulation for subsequent testing in vivo by the end of this year. That's all we can say, I'm afraid.

[Sami Sarkamies, analyst]

So is it safe to assume that we're talking about preclinical activities at this point? And if those are successful, you would then start like new drug development process, beginning with Phase 1?

[Christian Jones, executive]

I think you probably read into what is written pretty well, but I can neither confirm nor deny that. I can only comment that what is written in the press release is what we're allowed to disclose.

[Sami Sarkamies, analyst]

Okay. And then a bit of a detailed question. This is related to the grant you received earlier this year, I think it was like EUR 3.7 million. I think you were planning to use the grant during this year and next year, it will cover part of the R&D costs. I think it's reported under other operating income line. But I was just curious that the book in the second quarter [Technical Difficulty] some color on when you will be booking those -- that grant as an income?

[Albert Haeggstrom, executive]

Yes. So we will be booking it over the coming years in the other operating income. And we book basically as we do work according to the plan. And there is -- so basically, if you think 8 quarters or 10 quarters and you divide the number, then you could get a estimate for how it would be. Mostly, it's work-related, internal work-related.

Some of it can be also, for example, if we do some animal studies or so or if we use some outside consultants or outside help, then that can also have an impact. But think of it as 8 or 10 quarters and we have been ramping it up now and now the numbers are getting -- but slightly higher per quarter, but that's the best way to think about it.

[Sami Sarkamies, analyst]

Okay. And then maybe third question regarding the planned commercial deals. These are probably related to nanoenzalutamide project. Can you provide any color on what kind of deal structure you would like to see in place that -- I mean, is there a preference over upfront payments? Or would you sort of rather go after maximum royalties?

[Albert Haeggstrom, executive]

I think that what we have said before is that there are different kinds of deals, very many different kinds of deals to be made. And we do it together with our partners in the ONConcept Consortium and we try to, sort of, do it the smart way. And of course, for us, at this point, it might be smarter to have a broader scale.

So let's not try to do everything in the royalty line, but also get something upfront and some of the milestones. But in the end, I think these will be deals that are quite similar to what you see in the industry. So you get something upfront and then you have milestones and then you have the part where the products are launched. That's the way they're probably going to be.

And what we have said is that we can do one or several. So think of it like we can do -- for one country, we can do with one partner. If it's -- for example, if it's an oncology or a prostate cancer specialist in one big market, think of a big European market, then we can have one partner for that market. And then we can have other partners for other markets. We could also do a deal with a larger player that covers an entire area like, let's say, North America or Europe.

But we are now getting and talking with them about the term sheets and what kind of deals could be made and what the interest is and then we'll see. So as a former finance guy, I would put it like this order, a little bit like when you do the IPO that you talk to a lot of people and then you start to get the indications of the interest and then everything is priced and you see with whom you do the deal. But they should happen this year.

[Operator]

The next question comes from Christopher Uhde from SEB.

[Christopher Uhde, analyst]

Christopher Uhde from SEB. So perhaps you could help us understand why proposals issued has been going up, but the proposal success rate has been pretty clearly trending down? And also I don't -- perhaps not related, but why has days of sales spiked in H1 '24? So that's my first question.

[Edward Haeggstrom, executive]

Christian, would you like to take that?

[Christian Jones, executive]

Yes. I think you have to look at everything within a certain time period. So it's easy to look at proposals issued and proposals won in a month-by-month basis or on a quarterly basis. But what we have seen is that we've had quite a lot of discussions with biotech companies that perhaps have struggled with financing. And therefore, they've been holding off on awarding a proposal.

But it doesn't mean that those proposals are lost. Those proposals could still be active. And once they get financing or once they get funding, then they may well be awarded. So it could look like, we haven't been as successful in winning proposals. But I think the important thing is that there are a lot of proposals out there that are active and are waiting for certain triggers and the funding one is an obvious one. But there are also other reasons why companies might stall or wait before actioning something and that could be due to their own strategic internal decisions.

[Albert Haeggstrom, executive]

If I add something, so think about it like this, in '20 and '21, the biotechs were swimming with money, everybody was in a hurry and the signings biotechs were very fast. Then hit -- then the money went -- became much tougher to get. And then on the biotech side, people started to become much slower. And in many cases, they were not able to sign even if they wanted to because of a slow funding situation and slow funding deals.

In the beginning, we had a higher proportion of biotechs compared to big pharma. When you look at the big pharma signings, they are much more the same. So the speed at the big pharma in the beginning were quite slow because this was the first deal and we had to sign in some cases, the master service agreement and sign up to their systems and get all the checklists and so forth. And then once you have got the first API and everything is structured, the following can be a little bit faster.

But generally speaking, the big pharmas' behavior has not changed from when it was low interest rate environment as today, they behave very similarly. However, their proportion of the total deals signed have gone up compared to biotechs. And that means, of course, that relatively speaking, it might look like it takes longer. But I don't think there is a big difference when we look at the success rate. But it's too early to say.

And also remember that the biologics is also having an impact on it. So it's -- we don't see any clear trends in that sense. We still believe we have a high success rate. We do really good proposals. We put a lot of effort into them, we talk a lot with the clients. And we have a high hit ratio when you look at it from a new technology in a conservative industry point of view.

[Christopher Uhde, analyst]

And the days of sales outstanding?

[Albert Haeggstrom, executive]

That's -- I -- that's not -- we haven't seen any -- we have -- over the 5 years, we have one situation where there was a small problem with the payment, but basically no. And this is not an issue. This is very much fluctuation between one month to the next and this is not an issue.

[Christopher Uhde, analyst]

Right. So then in terms of the 3 multi-API deals you've done and I guess, from your past comments, it sounded like more might be on the table. I guess my first question would be, are more on the table? And then perhaps you could comment on the nature of the deals. Obviously, I realize you won't get too specific, but what can you say about how similar the deal structures are? Are we talking about a set number of APIs? How variable is that? Are they non-GMP deals only? Or -- yes.

[Edward Haeggstrom, executive]

Christian, please.

[Christian Jones, executive]

Yes. So I would say we have everything that you just described and more besides. So a real variety of different types of discussions ongoing. So we have some that are more POC-related, on individual POCs, project-by-project basis. Then if they're successful, they then progress to the next stage. We have some that are more like stage-gated contracts. So we've already agreed effectively the terms for moving forward into the next stage and on to GMP, providing we reached the successful milestones within the project.

Then we have some that are more broader in terms of strategic nature and the company might want to fast-track, for example, 3 or 4 molecules or even more at one time in parallel with Nanoform, some of the big pharma companies and then based on the success of that move forward into taking forward some of those molecules into the next stages.

We have some discussions where companies are already wanting to discuss commercial terms upfront before they've done any work with us, before they've even done a project with us. And those are very interesting discussions. So it really, really depends. And yes, you would be right to assume that there are more multi-API projects coming forward, but we can't probably disclose in that.

[Albert Haeggstrom, executive]

And one additional thing, which is a very -- potentially a big change versus last year is that before we have never thought about exclusivity on certain receptors or certain diseases or so, but now it's coming more and more into the discussion also that Nanoform might be -- there are several companies that are now reaching out and talking about if they can get the exclusivity. And this is both to the small and to the large molecule side on receptors or disease areas or something like that.

And this is, of course, something that is not uncommon in the pharma industry. We see these kinds of deals on a regular basis. But of course, for us, it's a positive development also because we know that our technology can give a lot of upside and a lot of interesting opportunities for drug developers.

[Edward Haeggstrom, executive]

May I, Christopher, here also inject that this exclusivity [ MOSAIQ ], it's something that we spend a lot of time on with Peter and our IP lawyer Winfried. Basically, in the end of the day, there is no reason to be able to play 10,000 different games. It's more important to map out the 50 or 100 games that we in practice are going to play. And this means that there is a balance between molecule receptor and indication. And we are starting to learn this.

And of course, again, the clients, they have their viewpoint, we have our viewpoint. But I have seen that these discussions are clearly much more mature than the similar kind of discussions that we had with more technical people earlier on. So this is an interesting thing, the exclusivity MOSAIQ and how that is developing.

[Christopher Uhde, analyst]

Okay. And then in terms of the GMP project signing that you reported, is this a customer project or an own project kernel?

[Edward Haeggstrom, executive]

This is a customer project.

[Christopher Uhde, analyst]

And the -- so, all right, obviously, you have this deal with Takeda, the intent is to go all the way, how I interpret the press release if everything works out. What are your plans for a bio GMP line? Because obviously, you have 3 that are built, right, and finished now on the SaaS side, should we assume that you're going to likely be doing some CapEx for the bio side?

[Edward Haeggstrom, executive]

So maybe if I start and Albert then patch in. So our strategy for the SaaS side was built and they will come on the GMP side. For the biologics, we have stated that our strategy is that we will together with a partner invest in the GMP on the biologics side. What we have done already is to do extensive planning work for what a bio GMP facility could look like here using our tech platform.

And I think we are moving in the right direction. What we also do, which is relevant to that is we do active industrialization on the biologics side, which means that we will have a very good understanding of what the scale-up means and then what the scale-up and the GMP aspect will mean. Over to you, you want to add something.

[Albert Haeggstrom, executive]

Yes. I mean for us, it's -- I mean, we have built the clean rooms and everything on the small molecule side, we have SAP install, we have the [indiscernible], the QMS systems and the likes. So for us, it's more -- remember also that on the biologics side, it's a little bit more customized depending on what kind of products you do than on the small molecule side. But for us, it's very clear that we have done it already on the small molecule side.

And then when the customers say that what -- more exactly what they want on the biologics side, depending on whether it's a subcu or inhaled or potentially even oral product, it will be a little bit different or if it's a sterile product or IV. So -- but we will do it with the partner and we feel that that step is sort of much smaller compared to what we have already done because we've taken the first step on the small molecule side. So we also see that the CapEx will not be that big.

And Chris, you have seen the lines. So you know that the biologics lines are not that big. So it's -- we are not talking about really big footprint here. We are talking about very clever technology that fits into a room. So that also helps when it comes to the GMP scale-up and these are clever technologies with a small footprint and low CapEx.

[Christopher Uhde, analyst]

And then could you remind us or is it just me, have you fully finalized the formulation work for nanoenzalutamide?

[Edward Haeggstrom, executive]

So I need to answer a little bit carefully now. We have done formulation work on the nanoenzalutamide and that takes us into the response domain where we need to be. We have not finalized the formulation, nanoformulation work on enzalutamide in the way that it is the one that's going to go into a marketed nanoenzalutamide product.

[Christopher Uhde, analyst]

Got it. Okay. That's -- and so how far -- how much time will that likely take? And what are the -- are you waiting until you sign to do that or -- yes.

[Edward Haeggstrom, executive]

So I think that's a very, very good question, and I would like to answer it in the following way. We have already now sufficient formulation results that we can continue to do the 2 tracks. One is the originator track and the other is the non-originator track.

I also think it is smart to continue to improve the formulation for 2 reasons. One, I believe that the formulation will give strategic options, both for the originators and for the others. So the better you make it, the more valuable it is. I also believe that all the work we do on enzalutamide will partly be relevant to the apalutamide work. And I also think that in the ASD class, there will be other classmates, if you like, that will benefit from what we do on this sort of first in this nanocrystalline modified class. So a long answer, but your question is good and it's an important one.

[Albert Haeggstrom, executive]

And remember, so you remember, you know that enzalutamide, apalutamide and darolutamide, they are all in the same basically stemming from the same original molecule in a sense. So you get learnings and -- but related to the time line, so what we have said that we expect to get the readouts from the studies early next year.

[Christopher Uhde, analyst]

And so then the...

[Albert Haeggstrom, executive]

Sorry to interrupt, but -- and also that the deals can be done before you have the results. So the deals are done already earlier. And there are -- this is, again, some clients want to do them really early and some clients want to wait more, but the deal should be done this year.

[Christopher Uhde, analyst]

And then the 31 out of 39 ASDs that you've predicted or would be nanoformable, what's the problem with the other 8?

[Edward Haeggstrom, executive]

I think it's a matter of bandwidth. So I always think of this as least rank, prioritize, focus and park. So in order to maximize the probability of driving Nanoform as a company forward, I think it's smart to do what I just said. So that's the reason.

[Albert Haeggstrom, executive]

And remember also that some of them are -- if they are really, really poorly soluble in supercritical CO2, they are not good candidates, so that's one reason.

[Christian Jones, executive]

Absolutely. You remember that slide, Chris, where it said that 80% of ASDs were amenable to nanoforming. That's why 31 out of 39.

[Christopher Uhde, analyst]

Yes. And then lastly, is there any indication that you can give of the R&D cost per project kernel?

[Edward Haeggstrom, executive]

It's low and Albert will give you sort of a little bit more financial flair to it. But the way we have structured it, it's a very interesting way where we can create a lot of value at a very low-cost position because of what we have in-house and because of how we structure the deals. But Albert, maybe from a financial point of view.

[Albert Haeggstrom, executive]

Yes. I mean if you look at it from a cost point of view, you see that when we do the work, we get 75% of it from the partners. When they do the work, we pay our 1/4 of it. And you can see that the external R&D expenses line has not moved very much even though we have done this product kernels.

So they have been changing between 200,000 and 500,000 per quarter. And the idea here is, of course, that when we do the clinical trials, that is a little more expensive because that we do externally. But otherwise, a lot of the work can be within Nanoform and within our partners. So for example, Bluepharma are doing the -- when they are doing the final drug product, the tablets formulating it to the final tablet and that's also a very cost-efficient way of doing it.

So when Nanoform is developing this drug kernels, it's very different compared if you are a biotech with no internal resources and you need to buy everything from outside. And we can also, of course, when we have -- so if we have 20-plus projects running in parallel in a year and then at the same time, we are doing these. So then some of the projects we are doing are internal and most of them are customer projects. So it's also about timing the work that if you have a slower month, then you can do more work on the internal projects. But we always -- the customer projects always come sort of with a high priority, of course.

[Operator]

The next question comes from [ James Osborne ] from Stifel.

[Unknown Analyst]

Just on the Takeda collaboration, if I may. I think, Christian, you mentioned it had a pretty immediate impact in terms of the incoming on potential projects. I wondered if you would be able to kind of maybe quantify or give a little more color around that, how much impact that Takeda presentation and that collaboration has had thus far? I appreciate it's early. But also I guess, how it's going to gain exposure to the Japanese market and how you perhaps see that in the mid- to long-term working with Takeda?

[Edward Haeggstrom, executive]

Christian, please?

[Christian Jones, executive]

I think this space is a very interesting one in terms of the high concentration per unit volume drug load delivery of subcu for biologics. There are other players in the market that try to enable larger delivery of monoclonal antibodies, for example and other proteins to patients by partnering, such as Halozyme. And we're starting to get engaged with pharma companies now around what could the commercial terms look like for using our technology and starting to get into some really interesting discussions.

And I think -- when we think about perhaps looking back at the SES technology and where we would have been in a parallel track a few years ago on that, we certainly didn't have that level of commercial interaction that we are seeing on the biologics now back then, albeit we are having some very exciting commercial conversations around the small molecule platform now.

It's taken a lot longer to get to that position than it has with the biologics platform. And I think the data is really exciting. There is a clear need for these types of product innovations. And I think that's what's driving that level of traction. So we're seeing a lot of interest from major pharma through to smaller clients around higher concentration of delivery for subcu administration for bio.

But equally, I think that has also made those companies in that space who have products, but may be looking for different routes of administration, they're also coming to us to say, "Well, okay, this sounds great. It looks like you can make stable dry powder biologic nanoparticles, maybe we could use them for different routes of administration." This provides other novelty and value addition that isn't possible with other technologies. So that's perhaps what I can say, James.

[Edward Haeggstrom, executive]

James, can I answer a little bit tangential to that question? I think one thing which has been clear is that the results we have gotten now, they have allowed us to communicate on a higher level, sort of, in the other prospect companies and also in our client companies. And these discussions can be sort of stated in one, what kind of new strategies and strategic tweaks can we enable for them that they did not have in their strategic pallet before.

And this is something which we have never been able to do in the previous years. And the sort of time line for when this will matter [indiscernible] on this is hard to estimate. But from my perspective, it's absolutely clear that this is a significant step. And I just heard rumor-wise that one of our clients, they have had questions in their calls about what Nanoform is doing and what they are doing with Nanoform.

[Unknown Analyst]

Okay. That's great. Very interesting. And I guess following on from that, you're looking at the cadence of signing new agreements, you see that you've got signed already in Q3 with a bit of time to go, which I think kind of close to a new record for you guys. Are you -- following on from what you're saying about a shift in terms of your profile, is that fair to say that's indicative of you being seen more by clients or potential clients or maybe pushing back on the funding environment as well? Are you kind of rising with the release of funding and can rates really move in the right direction and those kinds of things?

[Christian Jones, executive]

I think -- sorry, it's Christian. I think funding is clearly one factor that's supporting and driving the commercial discussions that we're having. But I think the other factor is that these are starting to be Nanoform maturing as an organization and starting to be really [Technical Difficulty], the more we come out [Technical Difficulty].

[Unknown Analyst]

And just one for Albert, in terms of the gross margin [Technical Difficulty]?

[Albert Haeggstrom, executive]

I had -- it was a little bit difficult to hear what you asked, but you asked about the gross margin and I would answer here that when we -- now we have started already to plan for the in-source of the GMP QC work and that should start to have an effect already in Q4. And as you know, our target is to go above [Technical Difficulty] gross margin.

[Operator]

There are no more questions at this time. So I hand the conference back to the speakers for any closing comments.

[Henri Von Haartman, executive]

James, we had a fairly poor line from you during the end, but thank you for the questions. So thank you, operator. On behalf of Nanoform, I would like to thank all participants for today. If you have more questions, then please do reach out to us and we wish everybody a great Thursday afternoon and evening. Thank you and goodbye.