Nanoform Finland Oyj

OMXH:NANOFH

Earnings Call Transcript 2023-Q2

[Henri Von Haartman, executive]

Good afternoon all, and a warm welcome to Nanoform's Second Quarter 2023 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 web page in the Investor section. After the presentation, we will hold a Q&A, and it's possible to ask questions by dialing in.

We will start today with a short introduction to Nanoform and then move on to CEO review, then commercial aspects and then financial aspects. With these words, our CEO, Edward Haeggstrom, please go ahead.

[Edward Haeggstrom, executive]

Thank you, Henri, and welcome also on my behalf. So next slide, please. Nanoform is a technology platform company. We're working in the pharma industry. And as you can see here, we are stationed in Helsinki, and the numbers are shown, 160 employees, 1/3, almost with PhD; a strong balance sheet, [ 2 ] patented technologies, and we will talk about how to use them now to get more drugs onto the market.

Next, please. The problem is that the industry spends a lot of money and gets out too few drugs. Next, please. The reason is poor bioavailability, which means that the body doesn't absorb otherwise potent medications. This problem is a growing one, and we are addressing it.

Next, please.The way we address it is nanoforming, which basically means that we make a very small granules out of the API. This is done by a bottom-up process. In order to have effect, you have to go clearly below 1,000 nanometers and even below 100 nanometers. On the right-hand side, you can see before and after.

Next, please. Here is a schematic of the process. Basically we use CO2, we dissolve into CO2, and we precipitate out of CO2. We have learned how to control this in a very efficient way. This technology is a green technology, and it uses clinical-grade CO2 as the medium to do these 2 processes that I just described.

Next, please. When we do this, we get increased bioavailability. This also allows us to get new drugs, potentially reduced dose, reduced side effects, and it allows to play a patent expansion [ game ]. When we don't have to make so much of the drug, we can produce less [ of the ] drug product, and this means smaller plants and less logistics. This, of course, has a green impact on the environment, too.

Next slide, please. Large molecules, small molecules, think ibuprofen, think insulin. On the large molecule side, there are several things that we can do. And the two bubbles in the center are the ones that have a lot of traction, basically how to enhance the drug loading capacity and how to tailor release profiles. We have worked in a clinically relevant size range.

And next slide, here is the schematics of the [ biologics ] process, this is also a green technology. And as you can see, there is an evaporation state, there is an electrostatic collection state, and then there is an ionizer state. This is patent protected, too.

Next, please. Here you can see that there are 3 pools that we can tap into: Unsuccessful drug candidates can get a second chance, we can improve existing drugs, and we can enable new drugs.

Next slide, please. Very simply, what we do, we work with clients and partners. They own the API. They are large pharma, midsized and specialty pharma and [ biotechs ]. We do nanoforming, and then they pay, they pay out every time. They pay to check whether we can nanoform their asset. Then when we show that we can do it and we optimize the process, then when we reproduce GMP-level material. And then finally, when we enter into a royalty-bearing agreement. Next, please. I'm now going to focus on the [ CEO ] review for Q2. Basically, you see 4 boxes this year. The first box up in the northwest corner tells that we had a record number of 11 new customer projects. The second box on the top row is big and very important. This is where our positions have moved forward. We're not only making proof of concepts, we are not only making GMP material, but we have started significant conversations about deal making.

And here, you can see a GMP manufacture for Project Blockbuster. This means that we have produced GMP material, which have -- will be shipped for clinical trials. The targeted timeline for one or several license supply agreements is, to our understanding, 2024.

We then move forward to the top-right box, you can see that we have submitted yet another application to FIMEA. This year is for nanoforming APIs to be used in products with marketing authorization. So this is one more level than we have had before. We expect this to trigger a FIMEA inspection, and this we expect to be in Q4.

Moving down to the lower level. Operating free cash flow continues to improve. This is part of what we need to do to get to cash flow positive by 2024. Lower-level center box, we have received allowance for our biologics patent order process. And then lower-level right box, basically in the biologics space, we have worked with big players. They have liked what we do, and our work has been on monoclonal antibodies. So this is clearly another part where we are moving forward on our trajectory.

Next, please. Here, you can see a graphical outlay of Project Blockbuster. This is important for us, and it's something which I call an [ orbital elevator ]. So we have completed clinical manufacture. This here is released and then is shipped to a manufacturer that has the right to then manufacture for product that goes into people.

The clinical trials are expected to commence Q4 this year, and the readouts are than expected in Q1. If this readout is positive, the targeted timeline for one or several license and commercial supply agreements is during 2024. And this is a new thing in our trajectory. I consider this to be maybe the most important bullet point in this report, together with the record number of 11 PoCs.

Next, please. So here, we can see the near-term business targets. Customer projects and operating free cash flow, these are, as far as I understand, on track. Next, please. Then we have reiterated the near-term business targets for 2025 here. Here, the most important one is the cash flow positivity and also the ability to keep the PoC machine running, bringing in a lot of them, and keeping our gross margin high and of course, elevating our game according to our business strategy.

Next, please. With this, I would like to thank you and hand over to Christian.

[Christian Jones, executive]

Thank you, Edward, and I'm pleased to discuss the commercial update to our listeners. If we go to the slide for revenue drivers and industry attrition rates, we operate in an industry which has a huge amount of clinical attrition.

So when we're building up our pipeline and our customer relationships, we need to bring in as many projects as we can and we need to keep the funnel broad, which is why the record number of client intakes in the last quarter is very positive to see, and we're very pleased with the momentum that we're starting to experience with our technology in the industry.

And clearly, we're also operating at different time points within a molecule development phase. So majority of our projects are in the preclinical space, helping those molecules to overcome solubility by availability issues and move into Phase I successfully, but also optimizing molecules in Phase II and Phase III and helping project molecules or products that are on the market.

And I think this is the phase change that we're seeing, from an organizational perspective, with Nanoform, is that we're moving from a clinical-stage development company with our technology into a commercial-marketed-product-stage company in terms of the types of products that we're trying to work on and support our customers with.

And this is no mean feat and testimony to all of the work involved by the teams inside our company and supporting our clients. And it also recognizes the interest that our clients have in the marketplace for our technology, they see significant value to also improve products that are on the market to make them better.

So if we move to the next slide, we look at our attractive revenue model. We operate in a fee-for-service type model, proof of concept, proof of process. These projects are typically non-GMP. And then when we move into clinical development, we charge again on a fixed fee project basis throughout the various phases of clinical development, Phase I, II, III, moving into registration and then on to drugs on the market.

And when we get to marketed products, we're looking at a commercial supply agreements for that product with a recognition of the value that the technology has contributed to the product over and above that commercial supply agreement, and that would be in the form of a royalty, typically, somewhere in the region of 1% to 20%.

But we need to be flexible in the organization as well and listen to our partners and try and find the best model that works for them and for us.

If we move forward to the next slide, you can see that we're operating in an industry that has a significant amount of molecules. The latest record show 21,000 drugs in development or on the market, so a huge amount of drugs. And if we remember what Edward said, 70% to 90% of those have solubility and bioavailability issues. But also we have found, as we've grown as a company, that it's not just solubility and bioavailability that Nanoform is trying to solve.

Our partners actually see the value in our technology for drug delivery applications, for improving solubility of drugs in certain types of dosage forms or maybe even making long-acting drugs in some sort of polymer-based systems or hydrogels. So some very novel applications that we found where our technology can really have a significant value for our partners. I'm going to talk about that later.

So we look at the number of molecules here, significant molecules, 70% to 90% of them we can probably help from a solubility, bioavailability aspect, but we can also help molecules as well over and above that from drug delivery application as well.

And if we go to the next slide, you'll see here that we have a lot of companies that we can talk to. There are over 5,500 globally. Our focus as an organization has really been in Europe first, and then we moved and started to build a presence in the U.S. And I would say that we, between U.S. and Europe, are pretty equal in terms of the client engagement we have now.

If we move to the next slide, we can see that in the last quarter or last -- or in fact, the last half year, we started 17 new projects with both new and repeat customers. And that was actually across U.S., Europe and Japan. So we started to broaden our customer interaction and engagement also into Asia as well. And that's more than the number of projects we did in the whole of last year. So a real significant momentum you're starting to see come out in our results with our engagement, which is great.

And if we go to the next slide, we can see how those relationships have been established since 2019. We're working with 10 major pharma companies, 1 co-development, 3 collaborations and 26 midsized specialty and biotech pharma companies.

If we can move to the next slide, you see here that not only can we say we're working with 10 of the top 20 pharma companies, but some of them actually allow us to use their logo. And I think that is also a testimony to the relationships that we have established with those companies and the value they potentially see in our technology. And we've got here some fantastic names. We're delighted to be able to say publicly that we work with these companies.

If we move to the next slide, please. Monoclonal antibodies. So Edward touched on this in his CEO review. We have 2 technologies. We have our CESS technology for small molecules, and we have our biotechnology for peptides and proteins and monoclonal antibodies.

And we've had some really interesting engagement with 2 major pharma companies looking at monoclonals and the value that we can add to develop improved patient-centric commercial products in the biologics field. So a very exciting developments there. If we move forward into the next slide, as I mentioned earlier, small can be powerful as for bioavailability, but it can also be an ingredient in formulation. And we've got 2 case studies here. One is Celanese and one is TargTex.

So Celanese was a collaboration with Nanoform. And Celanese are a Fortune 500 specialty chemicals company in the U.S., and they have a technology that could EVA copolymer. They use this for long-acting injectables, for implants and for vaginal rings and different delivery mechanisms for drugs. And they work with the pharma industry who used to sell in their polymers.

We've worked with them to say, well, if we were to use nanoparticles of a drug in their polymer system, could we actually improve that drug-eluting mechanism? Could we reduce the initial burst effect that is often seen in high drug load concentrations in these long 3-month, 6-month implants? And indeed, we showed we could.

We worked with 2 molecules, fingolimod and risperidone. And we showed that we could actually not only reduce the initial burst effect, but we could also delay the release of the drug. And this is significant because many, many drugs nowadays are being developed to have a long-acting impact in terms of injectables, implantables. And we feel that there's a real value that our technology can also play in this space. So very, very exciting.

Now we move to TargTex. Equally interesting is that both Celanese and TargTex are taking nanoparticles and putting them into a drug-delivery mechanism. So in Celanese case, it's a polymer. In TargTex case, it's actually a hydrogel. And I would say, of all the projects we do, TargTex is the one that sort of, I guess, I feel most passionate about because here, we actually are trying to help patients with glioblastoma.

And when patients present themselves to their doctor with a tumor, glioblastoma, then that tumor has to be surgically removed. The life expectancy is very, very short. It's a matter of months. And what TargTex has developed is a hydrogel with an API that can actually extend life.

And -- but they came to Nanoform because their drug wasn't working as effectively in animal models via standard means, they tried nanomilling, it helped slightly. They came to us, and we were actually able to improve the drug load in the hydrogel by 200-fold.

And we've even done animal models with them that were very, very positive, with 40% of all of the mice, rats surviving long term. So that was with a subtherapeutic dose. And we're looking forward as TargTex is one of our clinical customers to supporting them, going forward.

So they have received some important milestones in July. TargTex had a pre-IND meeting with the FDA. And they got very positive feedback about the incorporation of nanoformed API in their formulation. It clarified the regulatory path taking the treatment to clinic, and you can see more in the links that are provided in this slide.

We move now to final slide on commercial and perhaps end with one of -- perhaps the most significant achievements in the last quarter, is the development of Project Blockbuster and the progress we've shown there.

So as Edward mentioned, clinical manufacture is expected to be completed in August. And the produced nano material will be released and shipped to final drug product, clinical trials are expected to commence in Q4 2023. Readout is expected in Q1 2024. Now if this readout is positive, then we expect next year to have in place one or several license or commercial supply agreements.

So it's a very, very exciting time. It's a project where we really can show significant benefit to patients. And one that we're all eagerly awaiting the next steps. So that's it from commercial, and I'll hand over to Albert on the financials.

[Albert Haeggstrom, executive]

Thank you, Christian. If we then go to financials, so here, you can see on the left-hand side that -- we said in the beginning of the year that we would have roughly the same number of employees by the end of the year as we are focusing now on improving efficiency and productivity. We have found some great people, so we have hired them naturally.

But the idea is that at the moment, we have enough lines and employees for the coming quarters to just focus on efficiency and the productivity. Meaning, of course, that the operating expenses should be quite flat also. So any impact from top line should be seen.

If you look at the number of lines on the right-hand side, you can see that we now have 20 lines, 5 on the Biologics side, 15 on the CESS side, and #2 and #3 on the GMP side for small molecules will be calculated in this picture after receiving positive inspection from FIMEA, expected by the end of the year or roughly by the end of the year.

If we then go to customer momentum, and if you remember what we said a couple of quarters ago that there was a dip in the beginning of 2022, meaning last year, after the Ukrainian War started, after the COVID was still hanging on, and you had the interest rates started to go up very dramatically, which impacted the financial markets, that was a situation that lasted until the fourth quarter of last year. But then we really said that the momentum return issued lots of proposals, and this has continued.

So here, you can see that, on the left-hand side, first half of this year, we issued almost 50% more proposals than in the last 2 years. And also when you look at it on the right-hand side, you can see that the rolling 12 months number, now 74, is back on the sort of growth trajectory after being slow after the Ukrainian war and the interest rate started in the rise in -- before summer last year.

This also had an impact in this quarter, meaning that there is usually a lag of 4 to 6 months, 3 to 5 months, 4 to 6 months before -- between the issuance of proposals and then when they are signed. And this is what we can see now. So already in the last quarter, first quarter, we signed 6, but now we signed already 11 agreements in the second quarter, which was a new high, clearly.

This, of course, on the right-hand side, you can see that had an impact immediately on the rolling 12 months. And as the sort of the second half of last year was quite slow in signings, this means, of course, that the year-on-year comparison in the second half will be much easier, which will take the rolling 12 months further up.

If you look at the signings, the signed non-GMP projects because we have looked a lot of this and thought about it at market dynamics. And here, I want to show you that if you look to the left and in the middle, you can see that both in 2020 and 2021, we had an equal amount of signings in the first and the second half of the year.

But then, second half of 2022 was really sort of off, in a sense. The first half was really strong, still, with 13, but then we only had 4. But now we are back on track. And let's see how the second half of the year goes, but we feel comfortable that the momentum has returned and we are in a very good growth trajectory. And this year, we have already signed almost the same amount as in the full year last year.

And on the right-hand side, you can also see the rolling 6 months numbers. And here, you can see that during the last 3 years, we have had 2 periods with external shocks. First, it was COVID, and then it was Ukraine and the interest rates. And despite these big shocks, we have continued to see Nanoform getting more and more projects.

And this, we believe, is a clear statement towards the fact that we have a very interesting technology. We have built a lot of capacity, and the clients really like what they see, and they do that -- when they do that, they signed contracts with us. And of course, this is on the non-GMP side, but we expect some of them to move to GMP, and we believe that we are on our growth trajectory.

The following slides shows the cumulative number of projects signed since we started. And actually, when you think about all the slides, this is potentially the most important one because this shows the cumulative knowledge, experience, expertise we have gathered over the years. This is something you cannot build fast. If you were a 100-year-old company or a 20-year-old company, you would have been able to accumulate more experience and expertise in our niche. But we believe already now with having more than 10,000 hours of experience running nanoforming lines that we have a lot of experience. We have come a far way already, and we are very proud of our achievement. And this is also something that the client feels when they visited us -- visits us, is that we really know what we are talking about when it comes to nanoparticles and how to formulate them and how to potentially put them into drug delivery and so forth.

So we are very excited about the coming years. And of course, in Nanoform, we usually think about logarithmic scales. So the next step would, of course, be when we will have 100,000 hours of experience.

If we then go to the P&L, here, you can see the quarterly revenue on the left-hand side and the rolling 12 months. Due to the slow signings in the second half of last year, that had somewhat of an impact on the last 2 quarters. However, when you look at the right-hand side, you can see that on the rolling 12 months, the impact has been quite small.

And we expect that when we move more and more projects to GMP and when the number of projects we sign go up, we should be coming back to a growth trajectory also on this side. And the most important thing is, of course, that higher growth in the top line means that our operating free cash flow will improve faster.

If you look at specifics on how many projects have been generating revenue, you can see that in the second quarter, it was 22. And in the rolling 12 months, it's been 37, which was a new high. This fluctuates from quarter-to-quarter and the impact on the P&L can also fluctuate. In some quarters, we have more projects that have just started with little revenue, where we are just finishing writing the report, meaning also quite little impact.

In some projects, we do much more work than originally expected. And there might even be a negative impact on the revenue, from an IFRS point of view, if we do much more work than expected, so you can have a negative impact. But we like to look at the rolling 12 months and sort of a little bit longer term. And we clearly see that the customer momentum has returned after last year. And we look with -- we have a very positive outlook.

Another thing which has happened on the P&L in the last couple of quarters is that in the Project Blockbuster because we have not yet received our stamp from FIMEA related to our quality control, QC, lab when it comes to GMP, that means that we need to use outside help. And so we have used outside companies to -- for the QC GMP in Project Blockbuster. And that has had an impact on the materials and services costs above the gross margin.

This is expected to become smaller. And when we get the clearance from FIMEA on our QC lab, GMP QC lab, we expect this to go back to normal, and normal has so far been EUR 30,000 to EUR 60,000 per quarter. We also calculated this gross margin number for the first half, and it was roughly 95% without this one project impact.

On a positive note, last year, we talked quite a lot about the SAP project, and you saw it in the IT expenses. And this is a graph that we are very proud of. This is an example of an SAP implementation project where things have gone really well. We went live in the beginning of January. And you can also see it from the costs.

So here is the total IT expenses, and we were already below 300,000 in the second quarter, despite the fact that we are now also implementing other new systems. And on the right-hand side, you see that the rolling 12 months have been coming down fast. So this is a little bit like an example of what will hopefully look also on the gross margin side and on the materials cost side when we get our QC GMP lab up and running.

And finally, when we look at the operating free cash flow, you can see that the improvement -- the rate of improvement increased in the second half -- second quarter versus the first quarter. So it's now improved by 22% to EUR 6.1 million minus in the second quarter compared to last year.

And on the right-hand side, you can see that rolling 12 months, we have come down from above EUR 30 million to less than EUR 25 million. And we expect this trend to continue. And as you know, by the end 2025. Our target is to become cash flow positive. And this is after investments.

And then you have all the detailed numbers, which you can find in the report as well that I commented on. So I think we can go to Q&A after that. Thank you.

[Operator]

[Operator Instructions] The next question comes from Christopher Uhde from SEB.

[Christopher Uhde, analyst]

Christopher Uhde, SEB. So I guess the first one is maybe the most hard ball one. You've now completed 60 non-GMP projects. You're now on your fourth GMP project order. You said your success rate is in the upper end of the 10% to 90% range. So that's at least 30 successes. So your record on converting successful nanoforming tests to recurring revenue is then, at best, 13% or so, so far.

So what additional detail, for example, around the number of proof-of-process project orders can you give us to increase our comfort that this is a healthy rate or that it will increase in a reasonable time frame? That's my first question.

[Edward Haeggstrom, executive]

Okay. Albert, this is probably a question for you first and me second.

[Albert Haeggstrom, executive]

Okay. Thanks. First of all, remember that what we -- when we say above 60, it means signed contracts. So there is usually when you have a non-GMP project, and it takes up to 12 months, and then you have a period after that when the client sort of -- before we signed the following GMP contract. So don't -- it should more look like the 4 quarters ago, so by second quarter last year. So what is the sort of success rate related to that number? And then you have a quite much higher number. . Another thing which impact that is that in the beginning, when we got lots of test molecules from -- especially from big pharma, so these are molecules where they just wanted to test our technology, and they were not live molecules. And this, of course, means that the intention was never to go to clinic with these test molecules.

So first, they give us test molecules, and then they start to give us live molecules, and those have been coming now. And that, of course, means that there is also a lag when you can calculate the probability of success.

So we still say that we see no reason why we could not have the same success rate as the industry numbers mid to long term. And finally, I would say that naturally also when we are getting better at nanoforming and learning more about the process, about client APIs, about these different clusters of APIs, we become better. So I would say that in a sort of positive way that these three factors are the reason why we still believe that we should have the industry numbers or even better in the future.

[Edward Haeggstrom, executive]

I don't have much to add to that except for the fact that in the beginning, we knew less about how to process them. This is a clustering, and now we know more. And I think a very strong indicator is also the fact that clients are coming back to us also after we have had assets that have not progressed. That means that they believe in the technology.

[Albert Haeggstrom, executive]

And I could potentially also add that -- remember also that we -- the clients are starting more and more to realize the power of STARMAP. And so if the client has -- gives us their portfolio, and we pick the ones where we have good results on STARMAP, then the probability of going to GMP will also increase. And this has not, of course, been the case when you look at the first project before we had the potential of utilizing STARMAP.

Now STARMAP already have tens of thousands of molecules, and we are increasing them by the week, and we get better at them. And the clients have also learned to appreciate STARMAP when they start to think about which molecules to give us.

[Christopher Uhde, analyst]

That's a very helpful answer. I don't suppose, as a follow-up, you could give us any idea of what sort of proportion of the projects have been test molecules? And then my next question is in terms of the 2 monoclonal antibody studies. To what extent, have they been successful? And what detail can you give around that?

And then also, what's the status on the time to a bio GMP line? And what would you need from a regulatory perspective to get GMP approval for that?

[Edward Haeggstrom, executive]

So I can take on the maps, it's clear that they are clinically relevant to the customer. My understanding is that they have been happy with the work we have done, they have come back and asked for more, and they are prepared to pay for it. We still don't know exactly about how they only the game, moving forward. From our point of view, we try to deliver what they ask. So the approach is the same as on the CESS side early on.

Then when it comes to the bio GMP, there are really two parts to bio GMP: One, you need to have the quality management system in place, and that we have. And secondly, you need to have the cleanliness around the system. I think that since part #1, [ de facto ] is already there, and the sort of solution for how to put the cleanliness around the system is a standard one. I think we could move fairly fast on that.

We have chosen deviate from what we did with CESS. In CESS, we built first and -- in order to entice the people to come and to understand that we are for real. Now in bio GMP, we want to synchronize the evolution of the GMP on the buyer side to what the customer wants to pay for.

[Albert Haeggstrom, executive]

And if I follow on related to the question about proportion of test molecules, so as I said, 1 year ago, our cumulative number of projects signed was 41. And now we have already signed 4 GMPs. So that gives you something.

But of those 41s, if you think about it, we are now working with 10 of the largest -- 20 largest major pharmas. And if they give us a couple of molecules in the beginning, on average, as molecules, then you can give an indication of what kind of proportion that would be. So that's usually the way. It's not in every case that way, but it's usually that it's 1 or 2 test molecules before they then start to work on real live assets.

[Edward Haeggstrom, executive]

Christian, do you have something to add to this customer dimension?

[Christian Jones, executive]

No, I think you've covered it well. I think the only aspect I would say is something that we iterated earlier, which was around initially Nanoform was set up to sort of improve bioavailability. So we're thinking there about faster solution and enhanced delivery. But in perhaps areas like the biologics space and also with small molecules, we're also able to see long-acting benefits delivered from the nanoparticles as well.

[Christopher Uhde, analyst]

If I could just ask one more question before getting back in the queue, what can you say about the quality of material produced so far from the GMP-grade campaign in Project Blockbuster?

[Edward Haeggstrom, executive]

So without going into too much details in this first delivery, we are on quality related to our quality agreement.

[Operator]

The next question comes from Christian Glennie from Stifel.

[Christian Glennie, analyst]

To start with, I guess, just drilling in, if we can a little bit in terms of the new -- the 11 contracts or 10 plus 1 contracts in the second quarter and overall 17 in the first half, any sense for the mix in terms of 505(b)(2)s versus NMEs? Is that potentially shifting a bit more to 505(b)(2), given the progress or profile maybe of Project Blockbuster?

And then related to that, you seem to be talking a bit more around the drug delivery benefits of Nanoform versus the pure sort of solubility conundrum. Is that sort of starting to get a bit more traction now maybe in terms of that commercial offering or partnership or...

[Edward Haeggstrom, executive]

Yes. So I'm happy to take this on the ratio, maybe Christian can help me a little bit. First, when it comes to the 17 in H1 and 10 plus 1 in Q2, I think it's clear that in the interaction with the customers, they treat us more as a known entity, and that means that I feel the process for selecting, onboarding and sort of interacting has become more effective. . Then when it comes to the 505(b)(2)/NME ratio, my gut feeling is that there are no big changes, but I would like to invite Christian to sort of take a stab at that, too.

And then when it comes to the drug delivery part, you're absolutely right. There is a clear shift, both in our interaction with our clients and partners, but also internally, that as we now mature, our job is to get drug products on the market. And in order to get them there, we need to make sure that the delivery is good.

And in the beginning, it was sufficient to have the particles. And now we have seen together with our customers that it's really, really beneficial that we develop our ability to formulate in an effective way. And this is something that we are building up the capacity during the last 3, 4 years from scratch. And now we start to be very relevant there. And Project Blockbuster is a result of that. We were able to do a formulation that others couldn't do. The glioblastoma case is a similar one.

So the short answer to your question on the drug deliveries, absolutely, it's becoming more important. And we are using it as a lynchpin for moving forward on our strategic trajectory. But Christian and Albert, if you want to add, chip-in?

[Christian Jones, executive]

Sure. So maybe talk a little bit to the ratio question first. When we first started out, it was -- 99% of the discussions we had were all around preclinical candidates and trying to help them improve their bioavailability. I would say there is a fair mix of 505(b)(2) discussions in our everyday life now.

And I think that's partly driven by the maturity of the technology, now that we are operating at -- getting ready to be a commercial company to be able to support products on the market, that certainly attracted more of those discussions.

It's also linked to the fact that with our STARMAP, we're actually able to screen large volumes of data out there on existing marketed products and identify opportunities. And then we're able to have those discussions more easily with interested parties. So I think that's also led to an increased number of interactions in that space. There's certainly not more 505(b)(2) than there are of the NCE development candidates. We certainly have -- we still have the larger proportion of our discussions around the early development stage candidates, but there is a positive rise in the number of 505(b)(2) discussions we're having now as well.

I think to the drug delivery aspect, as with any technology, the more you work on -- the more different molecules you work on, you realize the value it can have in different types of formulations. And I think that's certainly true for Nanoform. We started to see inklings of where value is being created in certain projects. And we're investing time and resources to investigate areas like that as well ourselves.

And we're really starting to see some very interesting product attributes associated with nanoparticles in different types of formulations that perhaps are not obvious. And I think that's the really exciting thing as well. So with some of those product developments, there's also potentially IP that we can develop with those formulations as well.

So we started off very much focused on oral drugs because of the large proportion that were solubility and bioavailability limited. We're now doing a lot of work in many different drug-delivery platforms, where nanoparticles can have a role as well.

[Christian Glennie, analyst]

That's helpful. And then maybe as a follow-up on the commercial the pipeline side. I guess, I think previously, you [ granted ] some numbers on the pipeline proposal to sort of contract rate conversion ratio and the time to conversion.

Is there anything noticeable changing there maybe or improvement there, based on the second quarter numbers at least? Or is that just a factor of a bit of a time lag for those proposals landing in now?

[Edward Haeggstrom, executive]

So I think I can take that, maybe Christian can then help. No big changes in conversion, no big changes in times. The big change is in the depth of the conversations that we are starting early on, by which I mean we start early on to talk about, "Okay, how could the improved product? What could it look like?"

[Christian Jones, executive]

Yes. I would completely agree with that, Edward. There's -- I think we certainly reduced our time to execution of contracts quite significantly since we started, but we haven't really come down any further since perhaps we last spoke about that. We've got to a very, I think, efficient and effective way of starting discussions with partners and executing on contracts.

With respect to the types of conversations, we're starting to have more mature grown-up conversations earlier with parties, again, due to the maturity of our company as we're growing.

[Albert Haeggstrom, executive]

And then if I also comment on the other question, I would say like this that it's clear that we are signing more clients. We are signing more deals, and the size of the deals and the value of the products and the value of the projects are increasing as we become more mature and as the partners see us more and more as sort of equal partners, even the big ones. So we are definitely going in the right direction.

[Christian Glennie, analyst]

Okay. Maybe one final one on -- maybe on the modeling side, the gross margin, obviously, you explained why that's a bit lower than the norm on -- based on [ the ] part of it. But what should we be modeling or thinking about for the second half once you talked about that improving maybe with FIMEA approval towards the end of the year? But how does the second half compared to the first half in terms of...

[Albert Haeggstrom, executive]

If you think about it, the -- excluding the Project Blockbuster impact, the gross margin was 95% in the first half. And you could think of it that we don't expect the impact -- we expect the impact to be clearly smaller in the second half than compared to the first half. And by next year, it should be sort of negligible, very, very small. So if we get it in December or January or something, then, of course, next year will be business as usual.

[Operator]

The next question comes from Lars Hevreng from Danske Bank.

[Lars Hevreng, analyst]

Can I ask about the -- your current view on the plan to have 7 to 14 GMP lines up and running by 2025? And then given the timelines for construction and approval, et cetera, what's the current view there?

[Edward Haeggstrom, executive]

Yes, I can take that. So right now, we are -- we have 1 line, we have 2 lines that are technically ready, and they are waiting for the FIMEA, so that's 3. Going up to 2025, for me, it's very clear that we are going to synchronize our build-out with our customer payments. And this means basically that we move away from this build and they will come. . What we do need to do anyway is to make sure that we stay on the growth trajectory that they need in order for us to put the products on the market. And the way to look at that is really to increase the ability to produce GMP material, 1,000 kilo, a few thousand kilos per year. And we're monitoring this closely.

I don't want to change the numbers yet, but it's one of those where if the customers drive it up to the higher part of that range, then fine. If the customer drive it to the lower part of that range, then fine. No reason to change them yet, in my opinion.

[Albert Haeggstrom, executive]

And I would add that remember also that we have already built the pilot line -- GMP pilot line for the biologics side. And actually on the sales side, for those of you who have visited us, you have seen that we have a new very big non-GMP line that is basically -- can be turned into a GMP line as well. So we have a little bit extra capacity from that point as well also.

And of course, this is somewhat linked to the question about the second site, together with potentially with a client in the U.S., and that, of course, would be at lines. All in all, what we are still saying is that the CapEx will be clearly lower this year compared to last year. And as Edward said, before we start to make lots of new lines, we expect that to be sort of in agreement with clients.

[Lars Hevreng, analyst]

Okay. And the filing you did with FIMEA back in -- now in June, that is -- what's the difference between that and earlier filings? Is that for a commercial-scale production? Is that what it [ entails ] before when this Blockbuster product is due for sale?

[Edward Haeggstrom, executive]

Yes. So let me clarify that. We filed in May for GMP 2, 3 and GMP QC, that was end of May, beginning of June. And then we filed a few weeks later for the upgraded permit that really took us or will take us from ability to produce for clinical studies to ability to produce for products on the market. The reason why there were 2 filings in a short window was the fact that it had to do with synchronization of the Blockbuster negotiations that we were having.

From a FIMEA point of view, in practice, when they come here, they will look at both those filings together. So they will look at first, the hardware, as I mentioned, and then they will look at the ability produce for using products. And the difference between that and the clinical is the number of people it can affect, which affects the risk calculation and therefore, sets the bar higher.

[Operator]

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

[Edward Haeggstrom, executive]

Operator, do we have some more questions?

[Operator]

The next question comes from Christian Glennie from Stifel.

[Christian Glennie, analyst]

Just a follow-up in terms of Project Blockbuster, just clarify or explain how scenario -- I can get the scenario where you might find some sort of license or agreement, commercial agreement with the originator of the product. But how do you end up with potentially multiple license agreements?

[Edward Haeggstrom, executive]

Sure. So basically, as you can understand on the strategic level, there are 2 branches, one where you end up with the originator, as you said, that's going to be one or a few products probably close to each other. Then there is another branch of that strategic game, which is decoupled. It's unclear to us whether it's totally sort of either/or or whether there is a game which is and/or. And that is with super generics.

And of course, there are many companies that are interested in that kind of play because everybody knows that there is a patent cliff and there is a blockbuster in the market. So the short answer to your question is there are these 2 branches, and it's a little bit unclear whether it's or, or and/or.

[Albert Haeggstrom, executive]

And if I add to that, there is also the aspect of different regions in the world. So you have Europe, you have U.S., you have Asia, you have the globe. So there might be different regions also where there might be sort of different interest, depending on the region and the local legislation.

[Edward Haeggstrom, executive]

Christian, anything you want to add to this?

[Christian Jones, executive]

No, I would just say that due to the commercial sensitivities of the discussions we're having right now, we really can't speak further on this.

[Operator]

The next question comes from Christopher Uhde from SEB.

[Christopher Uhde, analyst]

So just one quick question would be, can you quantify the proportion of your small and midsized clients, that's from each of the U.S. and EU? And then also, would you be willing to quantify the negative revenue component of the Q2 results? And then -- and of course, you have a lot of revenue coming from GMP projects in H2 '23. So is the gross margin at the floor? Or should we prepare for it to be [ lower ]?

[Edward Haeggstrom, executive]

I take the first one, Albert take the second one. The SME across the EU and the U.S., a fair way to look at it is 50-50 or very close to that. And Albert, if you want to talk about the revenue components.

[Albert Haeggstrom, executive]

Yes. So I would just say that we split up the revenue from Europe and U.S. in the report. So you can see it from there, but we don't give the sort of the slicing of the clients per region. And frankly, they also -- they can change from quarter-to-quarter.

So if you look at it annually, we started with clients in Europe a few years back. And then a couple of years back, we started to get traction in the U.S., and at some point, U.S. will be bigger, most likely, but we are -- and U.S. has been growing very nicely, and they are quite close to each other already. . And then when it comes to the gross margin, as I said, the second half gross margin impact should be smaller than the first one from the Project Blockbuster and the underlying gross margin was 95% in the first half. And during next year, after we received the FIMEA stamps, there should be no impact on the gross margin anymore.

[Christian Jones, executive]

I think just to add to that, given the markets and given the challenges that biotechs are seeing in terms of raising finance to support early-stage biotechs, we're very cautious about who we work with.

We like to have a balanced and mixed portfolio of clients from those large clients that are more financially mature, also have larger groups of molecules that they can work with us on; to the smaller clients, we do still work with smaller clients, but we want to make sure that they're financially secured so that we mitigate any risk from our business perspective as well. So if that [ was a ] question as well.

[Albert Haeggstrom, executive]

But I could add to that also that we are very happy to see that there seems to be some positive momentum and traction starting also in the U.S., now -- so the trends have been down for a couple of years, probably peaked in the first or second quarter in 2021.

But now we are seeing more and more deals being done in the biotech space, and funding seem to be coming back, of course not to the same level as it used to be in '21 or in the boom, but it's clearly starting to -- we are starting to see green shoots, as you all know. So hopefully, that will also come to Europe, and it will be a global phenomenon. .

[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]

Thank you, operator. On behalf of Nanoform, I would like to thank all participants for today. And if someone has more questions, then you are most welcome to contact us again. And we wish everybody a great Thursday afternoon and evening. Thank you, and goodbye.