Welcome to the conference call. For the first part of the conference call, the participants will be in listen-only mode. During the questions- and- answer session, participants are able to ask questions by dialing star five on their telephone keypad. Now, I will hand the conference over to the speakers. Please go ahead.
Thank you, operator. Good day all, and a warm welcome to Nanoform's second quarter 2026 report presentation. My name is Henri von Haartman, and I am your Director of Investor Relations. Today, our CEO, Edward Hæggström; CFO, Albert Hæggström; Chief Commercial Officer, Christian Jones; and Chief Development Officer, Peter Hänninen, will present to you. This presentation is webcasted through Investor Caller, and there is also the possibility to call in and listen by phone. The presentation slides are shown throughout the webcast, and they can be found on our webpage in the Investors section. After the presentation, we will hold a Q&A, and it is possible to ask questions by calling in. We will today start with a short introduction, then key business highlights, then financials, then commercial, and we conclude with our product kernels and the biologics market. With these words, our CEO and founder, Edward Hæggström, please go ahead.
Thank you, Henri, and welcome also on my behalf. Today, we are going to talk about the U.K. response, we are going to talk about our reduced cash burn, and we are going to talk about the bio GMP CDMO negotiations. Next slide, please. First of all, I think it is important to say that we are executing the strategy that was presented in the Capital Markets Day in December 2025. That is really the framework. And we offer both services and development on small molecules, biologics formulation, and we have a strong AI platform to support us. Our customers are from global pharma, from mid-size and specialty pharma, as well as biotechs. We have two technologies, and right now they are in small molecules and biologics. The revenues come to Nanoform from service fees, from developmental and commercial milestones, from commercial GMP supply, and then from exclusivity fees, royalties, and profit shares.
The midterm targets were presented for 2030 on the Capital Markets Day. Three Nanoform medicines launched by 2030, an income growth larger than 50% CAGR, and the EBIT margin above 30% by 2030. Next, please. Here we have four business highlights. First of all, we now got positive feedback from the scientific advice meeting in the U.K. This means that we are on track to submit our first market authorization application for nanoenzalutamide. We expect this to happen during 2026. We have shown a significantly improved cash flow, and this means that our target to have a cash burn below EUR 10 million is on track. Then, we have been working diligently to increase our status on the biologics side to GMP. And this means that we have now been negotiating with reputable CDMOs how to do exactly just this. Peter will talk more about the details.
Then the coming years now is really about preparing to launch Nanoform products, first on the small molecule sides and then on the large molecule sides. This we will do together with our partners, and this will have a global impact. Next, please. Here I hand over to Albert.
Thank you, Edward. If we then go to a little bit numbers, here you can see the number of projects signed. In the second quarter, we signed three GMPs and three non-GMPs, so first time we had equal amounts of both. On the right-hand side, you can see that according to our strategy, we have been able to increase the proportion of GMP projects, and the signed ones are related to our kernels on the small molecule side. If we then go on the following page to income, you can see that in the first half, income grew. Here it's important to remember that the deal we made with the biopharmaceutical company listed on Nasdaq, only a small proportion of that is booked in P&L in the second quarter, while the whole amount we received, $1 million, got into the cash flow.
That's why cash flow is even a little bit better than the P&L. We can also see on the right-hand side that the gross margin exceeded 90% again, which is, of course, our target level. If we then go to operating expenses, they came down by 33% in first half, and that is of course the reason from our focus on decreasing the cost structure. You can also see that the fact that we were able to build the factory, and after the factory has been built, we need less people and less costs. It's quite expensive to build a factory with all the systems and the different functions. Now, you can start to see the impact from the fact that we now have built basically the factory ready on the small molecule side. So the trend has been very good so far this year.
This, of course, impacts the EBITDA directly, which you can see on the right-hand side. As I said, the cash flow was even better than the P&L, and we actually burned only EUR 1.5 million in the second quarter, meaning that the half-year cash burn in this year was EUR 5 million, and that means that we are on track to meet our cash burn target for the full year, which is below EUR 10 million . The EUR 1.5 million cash burn in the second quarter also meant that our cash was EUR 19 million at the end of the quarter, compared to EUR 20.5 million at the end of the first quarter. So I think we have done a really good job on reducing the cash burn, and we believe that the cash pile is enough until we are cash flow positive. Here you have the near-term business targets for this year.
Cash burn below EUR 10 million, we are on track on that. First marketing authorization application for a Nanoform medicine submitted, and now after the positive feedback from the scientific advice in the U.K., we are on track on that also. Increased number of non-GMP and GMP projects signed in 2026. We are on track there also, and we are working hard to also achieve the fourth near-term business target, meaning to sign development and license commercial supply agreements on several product kernels still during this year. Just as a reminder, here are our business targets for 2030. Three Nanoform medicines on the market, income growth more than 50% on average during the five- years period, and the EBITDA margin above 30% by 2030. With that, I give over to Christian. Please, Christian.
Thank you, Albert. As you can see on this slide, we are going to talk about the recent positive feedback from the MHRA, the U.K.'s regulatory agency. This was around our nanoenzalutamide product, and it is very, very positive for many different reasons. First is the product and its regulatory approval status. This means we are moving in the right direction. It does not mean that we will have an approval, but it means that scientifically, the FDA believes that our rationale for taking the product forward makes sense. It is on this that we will be filing an application with the U.K. regulatory authorities this year. It is positive for other applications that we may want to put forward because the U.K. authorities are viewed very positively by other authorities, certainly in Europe and around the globe.
Also, both for our customers in the generic space, but also in the innovator space, it is very positive to see that our technology has been received positively by the regulatory authorities. There has been no questions around the technology itself, and we are very pleased to see this feedback. All in all, a very positive situation. Can we move to the next slide? When we look at the performance in H2, we have had obviously the feedback from the MHRA, which was, I would say, key and quite a milestone. Then we had very positive news earlier this year with regards to our bio deal that we did with a U.S. Nasdaq-listed company, and that is around our biologics technology. This has been really, I guess, a key milestone for us as a company.
As we progress the biologics technology forward, it has really helped to raise the profile of Nanoform in this space for ultra-high concentration subcutaneous injections. We have seen great momentum from this and also further endorsement of the technology and an approach to be active in this space and to create value for patients. The third point is we have had six new customer projects signed in Q2, three non-GMP and three GMP projects, which is great, and of course, that helps us be on track to deliver more projects this year than last year. As I mentioned, the momentum has really accelerated around the biologics technology. So we have multiple major pharma and biotech feasibility projects underway at this point in time.
And of course, the key thing is to be able to give all of our partners confidence that our technology is not just a laboratory-based approach, but we actually have a viable GMP manufacturing process to deliver clinical material to start generating value in clinical development and then ultimately into commercial manufacturing. We will talk more about that in the next couple of slides when Peter talks. But we have advanced negotiations underway now to secure a strategic GMP partnership for our biologics technology with multiple different CDMOs. We will make an announcement on that when we feel it is appropriate. And I will hand over now to Peter to take us through our product development strategy.
Thank you, Christian. My colleagues already commented on the recent positive MHRA feedback that when our partners received, and this was, of course, also what we were hoping for as well. Without now repeating everything that was already said, I would just want to maybe highlight from my side also the shared legislative background of Europe and the U.K. in this, and that this shows really that different regulators may have different views on the interpretation of t hese regulatory pathways, but that there is really a good support for the view that we have adopted together with our partners since the start.
And of course, importantly, that there is a clear pathway forward to meet a first marketing application for a Nanoform medicine this year. We have, of course, also continued the focused execution on the rest of the kernel pipeline as well, and in particular, the most advanced programs. You can see that we have also added a line here as we now have received a 9% ownership share in PlusVitech. This is a customer that we mentioned before as well, that is repurposing an anti-nausea medication for oncology indications. This new use that PlusVitech is pioneering for this medication requires a substantially higher dose, and they are looking to, therefore, an enabling nanoformulation for the product with our particles.
Moving then forward towards biologics, and as has been mentioned, just before summer, we shared this news that we have signed the first exclusivity deal for our biologics technology, and that we are progressing or looking to progress towards clinic without delay. We have identified that the fastest and most efficient way to do this is to partner with a CDMO that has a long experience from aseptic manufacturing, something that our small molecule technology doesn't require. These discussions have progressed fast over the summer, and we are, of course, pleased to have received concrete, feasible options from potential partners. We believe that combining, on one hand, Nanoform's leading particle engineering capability with a leader in aseptic biologics manufacturing will be a competitive offering for customers considering clinical trials and help accelerate the commercialization of this technology.
This is a slide we've now been showing for a few quarters. What we want to highlight with it is that there is an established market and business model for drug delivery technologies that can enable subcutaneous delivery for biologics. The slide really highlights why many biologics developers are actively looking for alternatives as the business model that has been adopted is based on signing these exclusive deals on a target-by-target basis. During the second quarter, the current market leader, as well as ourselves, have been signing deals. We believe that the biologics subcutaneous delivery market will only continue to grow from here, potentially in an accelerated pace. With that, I will turn it back over to Henri.
If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from Christopher from SEB. Please go ahead.
Hi there. Christopher Uhde from SEB. Thanks for taking my questions. I guess what I'm wondering about is the revenue implications of the bioprocess outsourcing to a CDMO. If we, let's say for instance, take a 5% royalty as a midpoint on an average royalty, and you're using a CDMO. I appreciate it's a discussion ongoing, but how should we think about the impact to that royalty level? Thank you.
Albert, would you like to take that?
Yes. As you know, the business model in the CDMO world is very much about fee for service and potentially less around royalties, a nd that is the sort of the norm. Our thinking is different. Our thinking is more like the proprietary technology provider that has something unique, and therefore you can enable a situation where the clients are actually prepared to pay milestones and royalties for that. We are, of course, negotiating with several now, and this is a discussion, but if I put it like this, that it seems that this is not a hot topic in that sense that we have clearly different strategic and tactical thinking around this in the sense that they are fine with thinking about the fee for service part, and we can think about the sort of the milestones and royalties.
I would say that at this point, I do not think of it like there would be changes to our strategy. However, of course, this is negotiation still ongoing, but that is what I would like to say.
Maybe I could ask a clarifying question. From a cash flow perspective, is there any kind of guidance at all you can give to what kind of impact it would have proportionally? Thank you. That is all for me.
I think that this would have an absolute positive impact on the cash flow and the revenue for Nanoform, and exactly how the share goes when it comes to the— Think about it like this. We do nanoforming, they have other services in their facilities, and then the exact share of those are, of course, different. But on an absolute level, we believe this will be very positive for our cash flow and top line. As I said, that we are unique in that sense that we have a unique technology, and they recognize that.
Thank you very much.
The next question comes from Christian Glennie from Stifel. Please go ahead.
Hi. Good morning, guys. Maybe just on the U.K. process. Obviously, you've had different outcomes here now from going to EMA, and then the U.K. What do you think has been the reasons for the acceptance on the U.K. part and versus the EMA? Is there any prospect that this may have an influence back on the EMA process or that's probably a bit of a stretch at this point? Thanks.
Thank you. First of all, if I may speculate a little bit, I think that the objective thing that differed between our first interaction that we reported in the previous call and this one is that there is something called ICH M15, which is a document that was in existence but was not ratified during our first interaction, and it was now ratified. So one proposed explanation could be just this. Of course, every single authority has a prerogative, their ability to interpret the situation the way they see fit. Then, your final part of the question, which is there a feedback loop? Which means that if there are positive outcomes in country one, two, three, can it affect other countries that we either have or have not interacted with? Of course, speculative again, but I would presume that this is the case.
Thank you. In terms of potential partnerships for the U.K. market at least, what is the status of any discussions that may be ongoing or the interest level that this has sparked? What do you think is the optimum timing around a commercial deal as you are thinking about regulatory filings as well? Thank you.
So if I start first, then maybe Christian can follow up on that. My mental picture is always that it is better to be fast and it is better to talk early, and everything positive that comes out drives actually both the conversations that are ongoing and the conversations that are about to start. Maybe Christian can give some more flavor.
Yes. Obviously, we are in talks with many different companies in different regions. I think when we have something more to say about that, we will. Needless to say, this will be received very positively by our partners, not just those that may be interested in the U.K., but also in other regions as well.
Thanks. Maybe one final one . I know it has not been a huge amount of time, obviously, since you signed that biologics deal with a U.S. biopharma company. O bviously, you are now talking about this potential for accelerating into CDMO for GMP, but anything to note, particularly on the progress of the development work on your side, at least on that asset? Thank you.
No, I don't think we have anything specific to report on that at this moment. To me, it's clear that the customer is very interested in what we do on getting this biologics GMP status. We are working on getting it as soon as we can. That is in everybody's interest.
Great. Thank you very much.
The next question comes from Sami Sarkamies from Danske Bank Markets. Please go ahead.
Hi. I have three questions. I will be taking this one by one. Firstly, regarding the first exclusivity deal within biologics, have you already booked any revenues from this deal? When do you think that will happen, and will this be under revenue or other operating income?
Albert, please.
Yes. We will book it over the 12-month period, and that means that we signed it in May, so the impact is very small on the P&L, as I said, but we received the amount of money, the full amount already in Q2. That is why you see that the Q2 cash flow is better than the EBITDA, for example. The small proportion went into the top line, the revenue line.
Then secondly, regarding the GMP manufacturing for biologicals, you have initiated discussions. How long do you think these discussions will take, and what has been the initial response or feedback from the parties that you have been contacting?
Maybe I can start, and Peter can then provide some detail. To me, it is hard to judge into the future. I think it is in everybody's interest to execute the negotiations effectively, and that means also as fast as possible. However, there are many details that needs to be put in place, so expect it to take a little bit of time. When it comes to how people see this, I think it has been seen very positively by all the different parties that we have been talking to. The positivity comes from the fact that this is not us pushing a technology. This is us making sure that we serve a need which has been explicitly stated by a customer. Peter, please.
Thanks, Edward. I do not really have much to add to that other than that this has been over the summer and vacation period, and even with that in mind, the discussions have progressed very nicely to a point where, as we say, we have concrete and feasible proposals that we have received. So we are optimistic, and that the good momentum will continue, but of course, cannot provide any guidance on it.
Then finally, regarding nanoenzalutamide, you will be filing in the U.K. by the year-end. But can you summarize the other actions you have ongoing regarding other European markets and the U.S. market?
Albert, since this is a financial call, maybe you want to take it this time. I only say that this is the program I spend a lot of time on, both on the originator, on the generic, and on the technical side. Albert, please.
As you know, we are having a multi-track strategy as we write in the report. As you know, we have signed agreements and negotiations going on for a long time already on very many markets. We are, of course, keeping a close contact with all the parties involved. As we also say that in the coming months, we now received the feedback from the— First we received the feedback from one authority in Europe. Now, we received the feedback from U.K. that was positive after potentially the change in the guide or the ratification of the guidelines. We will, in the coming months before year-end, have feedback from other countries and also from the U.S., for example. So we will keep you updated, and this is, of course, something that we do together with both signed commercial partners, but also partners that we are talking to.
In some case, it is the consortium together with us who are more in the driver's seat, and in some cases, it's the sort of the partners on the commercialization side. But we will keep you informed when we have more to tell.
Thank you. I don't have any further questions.
But fair to say is that we think that this will be a very intriguing end of the year during the coming four, five months. We will get lots of more info.
There are no more questions at this time, so I hand the conference back to the speakers for any closing comments.
Thank you, operator. On behalf of Nanoform, I would like to thank all participants for today. If you have any more questions, then just please reach out to us. We wish everybody a great Thursday afternoon and evening. Thank you and goodbye.