Welcome to the Nanoform Audio Cast for Teleconference Q2 2022. For the first part of the call, all participants will be in listen-only mode, and afterwards, there'll be a Q&A session. I'll now hand the floor to Henri von Haartman. Please begin your meeting.
Thank you, Mark. Good afternoon all, and a warm welcome to Nanoform's second quarter 2022 report presentation. My name is Henri von Haartman, and I'm your Director of Investor Relations. Today, our CEO, Professor Edward Hæggström, CFO Albert Hæggström, and Chief Commercial Officer Christian Jones will present to you. This presentation is webcasted through Financial Hearings, and there is also the possibility to dial in and listen by phone. The slides are shown on the webcast, and they're also found on our webpage if needed. We will have a Q&A after the presentation, and it's possible to ask questions by calling in. You are welcome to ask several questions, but please do let us answer one question at a time. We will start today with a short introduction to Nanoform, then move on to CEO review, then commercial aspects, and then financial aspects.
Operator, if I may ask you to move to slide four, please. With these words, our CEO, Edward Hæggström, please go ahead.
Thank you, Henri, and welcome also on my behalf. Very briefly, Nanoform is a technology platform company. We're approximately 140 people, 30 nationalities. We are located in Helsinki, Finland, approximately 3,000 square meters, and our technology provides APIs that have either failed or are about to have problems a second chance. API stands for active pharmaceutical ingredient, and it's the core thing in medications. Now we move to slide number five. There is a big problem in the pharma industry. Problem is that too few new drugs comes to the market. We do address this problem. Slide number six. Here you can see that the pharma industry puts in a lot of money and still too few drugs comes out. Number seven tells about the reasons.
One of the biggest reasons is the poor bioavailability, which means that an otherwise potent API is not absorbed by the body and therefore cannot do what it's supposed to do. This problem is growing year by year, so we are addressing a big problem that is growing. Number 8. Here you can see that there is a lot of targets for us, both, unsuccessful candidates need a second chance. We can improve existing drugs, and we can enable new drugs. Slide number nine. What do we do? We take in coarse powder and make it fine. By doing that, we improve the solubility, and we address the problem that we were talking about 30 seconds ago. Slide number 10. We have a proprietary technology that basically does this trick. It has several parts, and we have during many years learned how to master them. Slide number 11.
When we can increase the solubility, a cascade of good stuff happens, which is depicted in this flower. You can see that it enables new drugs. It can potentially reduce the dose and the side effects. It also allows for patent expansion, reduced production costs, and also has a significant impact on the ESG dimension, which is something that many companies find increasingly important. Slide number 12. We work on small molecules. Basically these are the old drugs, but we also work on newer drugs called biologicals. We have been working the size range from 6- 150 kilodaltons, which is a commercially relevant range. Here you can see several things we can do for these new drugs. On slide number 13, you can see a simplified version of our business model. Basically, our clients own the API.
We take them in as bulk, and we make it nanoformed. By doing this, we can extract a fee for the work we do to show that we can nanoform it, and then we can get into a game where they, at the end of the game, can pay us royalty for drugs that are entering the market. On slide number 15, we're going into the CEO review, and here I want to highlight a few things. I start from the lower row, the left. AstraZeneca has concluded a very thorough evaluation of our report. They have basically found us to be good enough, and therefore, we are happy to announce that this technology evaluation has had positive outcome. I think this is very important, and it has shown that we provide a viable option that can then be used inside that company and also outside.
We have set a new half-year record when it comes to number of projects and also number of new clients. Nanoform has also partnered with Pharmanovia, which is a powerhouse for 505 assets. 505 assets are assets where we can make a generic or super generic-like asset and give it an opportunity in the marketplace. On the top row, you can see that we have made an announcement for U.S. GMP manufacturing. We have launched the STARMAP, which allows us to target assets that are amenable to nanoforming, and we have also scaled up our way of nanoforming hereby mentioned by a factor of 1000.
On slide number 16, you can see the GMP line number two that has basically arrived in beginning of August to Helsinki, and this here is a Category two, three line, which means that we can deal with potent stuff in addition to the cat three line that we had already in place a few years back. This is important for our expansion, and this here is a significant step in our journey forward. On slide number 17, you can see the four targets for this years. I think the important part is that we're on track with all of them. The number of new GMP lines, the biologics pilot plant, the number of new customer non-GMP projects, and also the number of new customer GMP projects.
On slide number 18, you can see the goals that we are working towards for 2025, and it's also already clear that we have achieved the gross margins. We are well on our way towards 70 new APIs. The lines are coming there, and we are also continuing our work to reach cash flow positivity. With this, I say thank you, and I hand over to Christian.
Thank you, Edward Häggström. On slide number 20, we can see the commercial market. The pharma market's rapidly growing, as we can see from the chart, with over 20,000 drugs now in development globally. This trend is only gonna continue as our global population increases and lives longer. It gives us a huge opportunity to really implement our technology across many, many different drugs. As we move to the next slide number 21, obviously, with the number of drugs increasing, so do the number of companies with active pipelines. Here we have over 5,000 currently operating globally. As this market increases, so do the number of companies that we can help and support to develop their medicines.
If we consider that 70%-90% of all drugs being developed have bioavailability issues, this means that most companies have a good reason to talk to Nanoform. If we move to the next slide, you can see here the now expanded global commercial team. I am delighted and very proud to show this slide. We've grown the commercial team now to 10 in total. In addition, we added in our latest Nanoformers, Dr. Huiyi He and Joana Moreira da Silva, who joined us just recently this year. But as you can see, all of our commercial team have a real vast and diverse background and experience that's really gonna help position Nanoform and our technology very well in the pharmaceutical market.
It's imperative to have such a strength to this commercial team if we want to grow at the rates that we have said we will grow to our investors and shareholders. If we go to the next slide. Slide 23. You can see the momentum that we have already established with customers, with client relationships, and with projects. Going from H1 2020, five new non-GMP to eight the following year to 13 in this half of the year. If we look at the number of customers going from five to six to 12 and really having a good split as well between Europe and U.S. This continued momentum is only going to continue as we go forward and we expand the team. We'll talk a little bit more about that later.
Go to slide number 24. You can see this really gives a snapshot of our commercial relationships. We have seven major pharma companies that we work with. AstraZeneca and BI, we have publicly named. We have one co-development, three collaborations, and we're working with a large proportion of mid-size specialty pharma and biotech companies as well. Those companies that we've named are companies, for example, like Pharmanovia, Herantis Pharma, TargTex, and others that we might have mentioned. Included in that 21 are five new in Q2 2022. The business development team have been very active developing new relationships with new clients and progressing relationships with existing clients. If we move to the next slide number 25.
This is, I think a fantastic recognition of the hard work that Nanoform have put in working with AstraZeneca, who are an incredibly diligent organization from a scientific perspective when they review technologies. As Edward mentioned, they concluded a very thorough technology evaluation of our CESS technology. The outcome was positive, and we're now moving forward with them to identify and implement the technology in current and future development projects. It was a very broad, deep technology review across many aspects of development and manufacturing. I think this is a real testimony to the hard work that the Nanoform team have put in. If we move to the next slide number 26. We have mentioned publicly that we've partnered with Pharmanovia, announced in July, on the 14th of July. This is a fantastic relationship.
I'm very pleased to talk a little bit about this. This is a recent strategic partnership with them. They're a fast-growing specialty pharma business with a portfolio of over 20 branded drugs in 140 markets. Their business model is to acquire branded medicines from major pharma companies at the tail end of their life cycle, and then continue to sell them as that brand in the marketplace. What they want to do over and above that is to take those medicines and make them better. They take the branded medicine, they have their captive audience of their patients, and they continue to sell that medicine to that patient population, but to improve them as they do so. That's why Nanoform are working with Pharmanovia.
I think it's a really great, very niche angle where we can place our technology to further improve branded medicines to the marketplace, and maintain the value to our patient population. If we move forward to slide number 27, this is our revenue model. You know, it hasn't changed at all since we started, since we announced at our IPO. We effectively work with clients from early stages of proving the technology, prove it works, make the nanoparticles on a fixed fee per project basis for a proof of concept study. Then we look at a bit more detail around the process, make sure it's robust, before we move into GMP manufacture, and that's a proof of process. Again, a fixed fee pricing for that.
When we move into clinical phase supply, we would have a EUR per kilo price for the material that we supply. When the product gets to commercial supply, we would have a commercial supply agreement with our partner, and we would also share in the value that the technology delivers to that product. That revenue share or that royalty share, shall we say, could be anywhere between 1%-20%. It could be royalty or it could be based on supply price per kilo. Clearly the technology, the value the technology delivers has to be recognized by our partners for us to work with them. If we move to the next slide, final slide on the commercial revenue drivers and industry attrition rates.
As I'm sure we're all aware on this call, industry attrition is very high in the pharmaceutical marketplace, which is why as a commercial organization within Nanoform, we need to build a large and broad sales funnel of proof of concept projects to ensure that we have our technology enabling marketed products. We want to do that as quickly as possible. The sales funnel has to be as broad and as deep as possible on the front end in those early phase development projects to make sure that with this high attrition rate, that our technology does get to market very quickly. To that point as well, we don't only work with preclinical and early phase clinical programs. As I mentioned, Pharmanovia is a good example.
We also work at the later end of the drug development life cycle in life cycle management and 505(b)(2) drugs. That concludes the commercial presentation. I'll now hand over to Albert.
Thank you, Christian. If we go to the financials and go to page 30, here you can see on the left-hand side that we added 13 employees in the quarter. A few of them are summer interns that we plan to from time to time keep and when we have peaks in demand and so forth. We added 13 people. We are well on track to the 2025 target of 200-250. However, it's also clear that even if the absolute number has grown very stably during the quarters, as a percentage the growth is coming down in the number of employees.
That is of course good from a P&L point of view that when the top line grows clearly faster than the costs, at some point we will become cash flow positive. If you look at the number of lines, you can also see that we added one non-GMP line in the quarter, so now we have 16. As said, we are planning to get the number two and number three of the GMP lines ready by year-end. That is the target. If you go to the next slide, as Christian already mentioned, we have had a good momentum in projects signed.
Here you can see that in the second quarter alone, we signed one in 2020, two in 2021, and now we actually signed five already in the second quarter of 2022. If you look at the half year, it has been five, eight, and 13, as Christian said. More importantly even than the single quarter or single half year is the cumulative amount of projects signed. Because we sign more and more, this is the number that when we have done hundreds of projects, the likelihood of us hitting successful projects that will take us all the way to market will be much higher. Here you can see that two years ago in the second quarter of 2020, we had signed seven projects. Last year it was 20.
Actually now we are already more than 40 projects that we have signed. The target for by the end of this year, we should have signed more than 50 projects. There it says 48+ 5 GMP. It's of course clear that you need to sign lots of POCs, and then with the lag you will start to get more and more GMPs as well. If we then go to page 32, you can see the same numbers but a little bit differently as a rolling 12 months number. This is of course related to our target for this year. The target for this year, 12 months this year, is to have 20+ 3. Actually, if you look at it from a rolling 12 months number, we are already at 21+ 2.
During the last 12 months, we have signed 21 non-GMP projects and 2 GMP projects. Again, if you look at the cumulative, the same number as last slide, but this is on a quarterly, you can see that the trend has been very nice and steadily growing. This of course shows that the interest in the technology is good and our BD team is doing a fantastic job. If we go to page 33 and we start to think about revenues, here you can see the number of projects that are generating revenue on a rolling 12 months basis. You can see that we have gone from six to seven in early 2020.
Actually now, the rolling twelve months meaning third quarter 2021 to second quarter 2022, it's 32 projects already that has been part helping us with creating revenue. These are, of course, most of them are basically all but one is non-GMP projects. On the right-hand side, we see a very important KPI. How many projects can we do on a line per year? Again, we are using rolling twelve months numbers. Here you can see we have been able to double our efficiency. Two years ago, we did one project per line. Now we have already come, so we are roughly doing two projects per line. This is about efficiency and productivity.
Here we have earlier said that our target, long-term target is to get to five projects per line per year. That, of course, means that if we today have slightly less than 20 lines on the non-GMP side, and we are gonna have by 2025, slightly less than or let's say, 25 or so, that means that for us to be able to do the 70 projects plus per year, we need to get this number up. We don't need to get it up to five, but five is our target. The trend is very clear there, and we are very happy with this trend because it shows that we are becoming better at doing projects.
If we then move from number of projects to revenues, in EUR million of euros, first half of 2020 to first half of 2022, you have seen a factor of five. We had EUR 1.65 million in the first half, and these came from 28 projects, of which one was a GMP project. Of the signed GMP projects, we have recognized revenue from one, and the impact has been quite small on the revenue. We are very conservative, and we want to stay conservative on recognizing revenues. We don't want to be sort of overly optimistic around that. The same goes for the cost. We want to be conservative on that, booking more costs and not activating them.
Here you can see that the number of projects contributing to revenue has grown by a factor of 4x from 7 to 28, and on the left-hand side by a factor of 5x from EUR 0.34- EUR 1.65. That, of course, means that the average revenue per project has been increasing. This is also a testimony that the client see value in our technology. As our brand becomes more recognized, we will be able to get higher price. If we then go to the next slide, you can see the quarterly revenue. We had a new record quarter again, so EUR 0.89 million in the second quarter. On the right-hand side, you can see the rolling 12 months, meaning third quarter of 2021 until second quarter of 2022.
There we were already at EUR 2.78 million. This came, as I said on previous slide, from 28 projects. If we then go to page 36 and look at the revenue gross profit and gross margin, you can see that we have been seeing the gross margin grow very fast, but now the last three quarters, we have basically plateaued at least temporary on the 92% level, which is actually a very good level because it means that we have already reached our 2025 target of being above 90%. However, in these numbers, we'd have still not seen the synergies from the big CO2 tank. So these 92% has been done without the big CO2 tank. So there might be still some upside in the margin.
If you look at the quarterly EBITDA, you can see that we had a somewhat bigger negative EBITDA in the second quarter than in the first. The main reason for that is the quite big jump in the IT costs, where we are now in a very hectic phase with implementing the SAP. I will come back to that. As we see it going forward, we believe that we are at the moment in a very sort of intense phase when it comes to investments. As we book, for example, the SAP or the ERP system in implementation over the P&L, we don't activate it in the balance sheet. The same goes for our R&D costs. We don't activate them.
That means that we are in a very active, intense phase now. Going forward, when the revenue grows much faster than the costs, we hope and we expect that this trend will start to turn north, and we will see an improvement in the operating cash flow going forward in the coming quarters and the coming years. Of course, the target is to be cash flow positive in 2025. If we go a little bit into the details around what impacted the last quarter on the EBITDA or on the EBITDA level, here you can see the IT expenses. To the left, you have the quarterly IT expenses, and here you can see that we had a very intense quarter in the second quarter.
The third quarter will still be intense, but then we should go live with the SAP in the fourth quarter. The underlying IT expenses from laptops, from stuff like that, other systems have been roughly EUR 150,000- EUR 200, 000 per quarter, and we don't see any reason why this would be much higher, going forward. We should see the IT costs actually already next year come down from this year's level. If we look at the rolling twelve months, you see that we were already up at EUR 1.74 million. Roughly EUR 1 million of that was related to the ERP implementation, where we take all the costs in the P&L.
Then another one which we have seen a somewhat absolute term, not so big, but this is actually a cost line that I like in a sense, because this clearly shows that the COVID has at least in our core markets, Europe and U.S., is behind us, and we are now at travel expenses at the same level as we were before COVID. However, I also see efficiency and economies of scale here, and potentially also that humanity has learned that video calls is quite efficient because in first quarter of 2020 we had two persons in the BD team, and now we have 10 and we are roughly at the same level.
I'm glad to see that we don't have a five times higher travel expense, but I'm also glad to see that the travel expenses have come back after the very depressed levels during the COVID. After that there are 3 slides with tables. I won't go through them now. Basically, they include what I've said. One number I want to mention is on page 40, you can see the bottom line. Our cash position was EUR 83 million in cash at the end of the quarter. We have a very strong balance sheet, and we have no debt. The only accounting that we have is the rental leases, but otherwise we have no debt and EUR 83 million in cash. With that, I say thank you and let's go to Q&A.
Thank you. If you wish to ask a question, please dial zero one on your telephone keypads now to enter the queue. Once your name has been announced, you can ask your question. If you find it's answered before it's your turn to speak, you can dial zero two to cancel. Our first question comes from the line of Max Herrmann at Stifel. Please go ahead. Your line is open.
Great. Thanks for taking my questions and congratulations on an impressive group of new partnerships in the last six months. Four questions, if I may. Firstly, just wanted to get an update on the U.S. facility and plans there, how they're progressing. Secondly, on the biologics GMP line and where you are with that. You've spoken quite a bit about the obviously small molecule lines. Then a little bit more detail. In terms of your partnerships, I wondered, are you able to disclose kind of number of top ten pharma companies that you now have relationships with? Then maybe a little bit more detail on the number of programs with the Pharmanovia.
I'm assuming that since it was announced in July, that's outside the first half numbers. Just wonder how many potential candidates or projects there are within that. Thank you.
Edward, are you on mute or?
Yeah, I'm on mute. Thanks, Max, for the questions. I will try to provide you with top-level answers, and then if Christian, Albert want to chip in, then please do so. Related to the U.S. facility, we are working diligently on that, basically narrowing down the number of states. We have been evaluating 8-10 states and then looking into the counties and looking into the plots and looking into the facilities there. Americans are very effective, and they are also very helpful, and they are very, very interested in helping us out with the scouting. This is absolutely progressing according to plan. I will be happy to talk more about that later on. This is the status now.
On the biologics line, that one, the pilot line, that is also progressing according to plan. We are getting parts done and parts in as we speak. On the partnerships, maybe Albert can take a stab at that, and then the Pharmanovia, the molecules, maybe Christian can take a stab at that.
Thanks, Edward. Yes. As you know, we have mentioned two big pharmas, AstraZeneca and Boehringer. If your question was how many of the big guys within the big ten or big fifteen global pharma we are working with? When we use the word big pharma, we mean the big, really big guys. We are working with seven of the real big guys.
Right. Thank you.
Christian, if you then can comment a little bit about around Pharmanovia.
Yes. What we've said in the press release is that we are starting with one iconic brand medicine. The intention is for this to develop further and broader into multiple products. As you can imagine with any relationship, you want to start
Start first with one product, prove it's successful, and then expand it quickly. I think both sides see great promise in this particular relationship. We're looking forward to seeing how that develops, and I'm sure we'll have more news to tell you in the coming announcements and reports.
Great. Thanks, guys.
Thank you. Our next question comes from the line of Lars Hevreng of Danske. Please go ahead. Your line is open.
Yes, thank you. Can you just tell a bit about the GMP projects that you talked about towards the end of last year? You mentioned in the report that they're not significant revenue generators so far. Can you just tell a bit about the status of all these projects?
Sure. If I start by again giving a general overview, both these projects are progressing according to plan. Albert will tell you more about the financials. I think that there is always a lag the way we sort of recognize and do. My answer to you is that they are progressing according to both our internal plans and those of the partners.
Yes, if I comment. When you have a GMP project, first you do planning and the POP and the technology transfer, and you do the planning in. The big work comes when you produce the material or the batches. That is, of course, when you have a project and, for example, expect the project to be X thousand hours or so, then you make a plan. When you start to have hours, you book the revenue based on sort of the total cost where the hours is the most important one. Of course you have material as well. There, of course, if you have a too optimistic guesstimate or estimate for how many.
What the total cost will be, then there is a risk that you might book the revenues too aggressively. We don't want to be in a situation like that, especially when we are doing our first commercial order for a client, the GMP. We rather do it like that. We know that we don't book them too aggressively. That of course means that when we make the GMP material and we ship it to the client and we have the stamps from Fimea, at that time, we will feel very comfortable to book the revenues as well.
On a general level, I can say that among all the projects we have done, we are still in a situation where we have clearly, when you look at the rolling 12 months numbers, for example, we have got paid more from our clients than what we have booked revenues. This is a situation where I, as a CFO, would rather err on being a little bit too cautious than being too optimistic on booking revenues. When the situation today is, of course, that we only have one GMP line, the second GMP project will of course be, as they have also publicly announced, is that it will be sort of, after this first one, and that will, the shipments will happen next year.
Okay. Thank you. What can you say about the order book in the company today? I mean, you mentioned that in the fourth quarter results saying that it exceeded EUR 5 million at that time, and you also had a comment of an order intake in the first quarter of over around EUR 1 million. What's the situation for the second quarter?
Yes. We have a good situation for the second quarter also, and we are seeing clear growth in the order book. But we decided not to sort of every quarter. We would rather do it on an annual basis than on a quarterly basis. Because if you have a GMP project, for example, there can be big sort of swings between the quarters, if you talk about the order book. If you sign a GMP contract today, and the plan is that, let's say that we do most of the work in the second or third quarter or fourth quarter next year, and then something happened to that, you don't exactly know how that will impact the revenue from a short-term timing point of view.
That's why we decided not to do quarterly numbers on the order book at this moment yet. When we have more projects and bigger revenues, then we will be like, more like a capital goods company that give you both the order intake and the order book and the revenue, but we are not there yet.
And the-
The order intake has been good.
Lars, if I may add to this, I have told Christian that continue to sell, even though we are a little bit strapped for capacity on the GMP side, we will make sure that we can deliver. I rather have a little bit constraint in capacity than having idle capacity. Also from that point of view, the order book is growing with the projects that he and his team is working.
Mm-hmm. Okay. Great. Thanks for that.
Thank you. We've had one further person join the queue. That's Christopher Uhde at SEB. Please go ahead. Your line is open.
Hi there. I've got two questions. The first is would you please talk a little bit about the impact of inflation and FX and yeah how you're trying to deal with that and the extent to which you know need to. And then I'll come back with my second question in a moment.
Okay. This is a question clearly for Albert.
Okay. Thanks. This is a question I really like because this is a very strategic question. You can of course look at the situation today, but it will have a very big impact on the if you have a higher inflation for several years or and so forth. The way we see it as two years ago we had the foresight in a sense that we felt very strongly that there is gonna be a sort of a shortage of capacity in the supply chain in the pharma industry just like it was in so many other places. We saw it that when because of corona situation that that's where was why we were very eager to order the GMP lines as fast as possible and sort of do decent deals.
What we are now seeing is that the difference in inflation when it comes especially to commercial manufacturing, where you have a very good-
Yeah.
Have a big sort of inflation in the U.S. The inflation on the R&D side has been smaller than on the commercial side, but you have seen a big jump in costs on the commercial side, especially in the U.S. On a general level, you can say that the last two years you have been having big salary increases and inflation in the U.S. That situation has been much more calm in especially Finland, but in Europe generally. We feel that our cost competitiveness has clearly improved during the last two compared to two years ago when it comes to salary costs and costs in general in Europe and in Finland compared to the U.S.
Of course, we have also seen that the U.S. dollar has gone 20% basically during the last two years, 1.20 to parity. This is something I believe. If we stay on this level and if this trend continues with higher inflation in the U.S. than in Europe, which might be very likely because of certain if you exclude the direct gas or direct energy costs in Europe, I think this will have a position where U.S. companies will feel that it might be good to have some more capacity in Europe, and they will be looking at Europe as a place where the sort of the manufacturing costs are potentially lower than in the U.S.
Especially if you have a situation now in, for example, in China where the Chinese yuan has been quite strong. It has almost been keeping up with the U.S. dollar. You have had the question marks around the COVID restrictions and so forth. I would say like this, as a European manufacturer, we feel good today about our competitive situation. It has improved compared to two years ago.
Great. Thanks. Just to follow on from that, since we're on the subject of what do you expect. I mean, how should we think about how to model pricing going forward?
Albert Häggström, if you
I think at this moment it's a little bit too early to start to tweak the models. We are still in early days, but I think as a general level, I feel that as a former you know public market guy, I think that the valuations are lower in Europe. The cost pressures are lower in Europe if you exclude the energy sector. Here, of course, Nanoforming is in a relatively good advantage situation because we use much less energy than many of the other technologies because we produce less material and so forth. I would be sort of quite optimistic on a European pharma manufacturing in the coming years.
I'm not saying that it will fare better than the U.S., but I think that the European situation has improved as long as you have the right technology and you have the electricity things in order and the energy things in order. Here I think that the Nordic region is a good region when it comes to the energy situation. I think it's a little bit too early to potentially start to talk about tweaking the models long term because of the situation. At the moment we feel good.
Great. Thanks. My next question is, so drug pricing reform impact, and I guess in particular 505(b)(2)s, would you please expound on how you think about the impact of the legislation in the U.S. on your strategy, where you want to place whether it changes how the sort of where you place the emphasis on what's important. Thanks.
Okay.
As you file-
Yeah. This is a big question, and let me give you a first answer, and then maybe Albert can give a finance answer, and Christian can give a sort of tactical commercial answer. I think that in the end of the day, Americans want the best drugs available. I think that tomorrow America will prevail and will be strong. If you draw from these two sort of presumptions, what comes out from that is as long as we can make drugs that are better, the policies that are now sort of being put in place will help us rather than hurt us. I think that in the very big picture, Americans have the means and they want to pay for quality. Quality here means something that makes their lives better.
Maybe Albert and Christian can give a different view.
Yeah, I would say, of course, this is a very difficult, it's difficult to guess exactly how everything will play out. Generally speaking, there is the saying that if you can make it in the U.S., you can make it anywhere or if you can make it in New York. I think on the pharma side it's a little bit different that the sort of the European fragmented, quite low price market is much tougher than the U.S. market. Again, if you can do well in Europe, I'm sure that even if you have changes in the legislation in the U.S., you will still be profitable and do well in the U.S.
If we have a technology that is strong competitively and we have strong partners, they will know what to do and they will know how to utilize the technology. We don't need to take the drugs ourselves to the market and think about all the details around pricing and launches and so forth. If we work with, for example, big pharma, they will know what to do.
Christian-
Yeah. Maybe if I could just add, I think as with all drugs that we're involved in developing, we ultimately want to try and show value to the patients. That value can be different depending on whether we are reformulating a drug to make it more convenient for a patient or we are changing a drug to make it more, shall we say, more efficacious for the patient. Clearly, you know, our technology can do both. It can have, shall we say, more incremental advantages for patients in terms of convenience, but it can have a big impact in terms of lowering healthcare costs.
If we change something from an IV to an oral, and it means that the patient doesn't have to go into the healthcare system to have their drug delivered to them, I think there's strong arguments to show the value that that type of approach can create. Also if we can potentially lower the dosages of drugs or make them faster acting or have less side effects, clearly that can be beneficial for patients. I think the regulatory bodies will agree that that value is something that patients are willing to pay for and something that the payers are willing to also pay for. We're quite acutely aware of the, shall we say, the challenging regulatory environment.
As we do with all of our partners, we have detailed discussions about what the value is commercially for our technology when we're applying it to their products. Again, we want to make sure that that value is shared appropriately between us and our partners. We won't be involved in products where we don't see that value being transferred to the patient. Otherwise, our technology is not being used on products that are really gonna enhance patients' lives.
Okay, thanks. Sort of, as a follow-up to that, obviously the legislation, in particular, addresses reformulations from the same manufacturer that, you know, that basically would count, you know, as the same molecule. At the same time you guys have therefore it would be, you know, sorry, up for negotiation, just the same as the parenteral API formulation. At the same time, obviously this is what you have is a nanotechnology, so there's challenges in duplicating that. As you say, as you highlight, Christian, there are benefits to patients that come with that, and those would be things that would be taken into consideration. But perhaps, I mean, could you just expound a little bit more around those areas?
Does it make you feel more bullish or less bullish about pursuing 505(b)(2)s compared to, you know, other types of APIs?
If I can start with this and then again give to Albert and then Christian.
I think that what the legislator really wants to achieve in America, and of course, I may be a little bit speculative here, is they want to try to achieve a situation where people actually get more value when they pay more. They want to kind of cut down on a situation where you just extend the patent term, but without giving more value to the patient. I think that what we do in our 505(b)(2) efforts is to try to give more value to the patients. Therefore, I think that from a legislator's perspective, we are not a target to sort of try to exterminate.
We are rather a company who wants to make the life of Americans better, and therefore we could be agreeable also to these legislative efforts that you were talking about. Maybe Albert and Christian have something to add to this too.
I think it's also good to take a little bit of a step back and think about when I look at the 505(b)(2) and I think about the last three years. I would say that three years ago only a few financial guys were talking about it, but it was not a discussion that was broadly held in the pharma industry. It was not that at every seminar somebody was talking about 505(b)(2). I think it's a little bit. That means that the trend has sort of got stronger and has started, but we are certainly not yet at the situation where 505(b)(2) is sort of really, really mainstream and everybody is doing it and so forth.
Potentially a little bit like, you know, EVs, electric vehicles, that it's not like everybody is driving an electric vehicle. Of course, just like on that side, there will be changes to regulation. There will be changes on smaller areas in the regulation. There might be different regulation changes in different areas of the Europe and/or U.S. I still believe that this is a trend that's gonna grow stronger, not weaker, regardless of what happens. Companies in the sector hopefully will create more value by utilizing, for example, new technologies that are to give to the patient and to give them a more fair return on investment than potentially previously. I think that believing that one decision today might be the only thing that matters, I don't think so.
I think that the trend has started, and it's gonna get stronger. Exactly how it plays out, we will see.
I think that.
I would say that I'm not less or more or less bullish than I was a year ago or so. I think we still see a great opportunity in 505(b)(2)s, just like previously.
If I may just add to that, I see this in a very positive light because in actual fact, it drives the discussion right from the outset with our pharma partners. If they want to use the technology, we can have a more in-depth, in detail discussion because of this news that's come out recently, to really understand what the future landscape could be for the product and whether the technology is appropriate for the product in terms of driving the value, to deliver a certain patient outcome. I think it's very positive because it puts us on the front foot for the commercial discussions around the technology with our pharma partners, rather than potentially waiting till we've evaluated the technology and further down the stream, having those discussions.
I think I see it from that perspective in a very positive way. Ultimately, we don't want to expend our efforts on molecules where we're not gonna get that reimbursement back for the value the technology delivers. Just as we as a company target specifically molecules where we think we can have the most impact, both from a patient perspective, where it's a good technology fit from a STARMAP® perspective, on our nanotargeting initiative, when we go in to speak to pharma companies, we also can put this lens now into products to really ultimately drive technology towards products where that value can be reimbursed as well and can also help patients. Thanks very much.
You're welcome.
Thank you. Once again, if there are any further questions, please dial zero one on your telephone keypads now. Okay, it seems there are no further questions from the phones at this time, so I'll hand the floor back to our speakers.
Thank you, Mark. On behalf of Nanoform, I would like to thank all participants today. If someone has additional question, then you are most welcome to contact us after this event. We wish everybody a great Thursday afternoon and evening. Thank you and goodbye.
Thank you.