Welcome to BioArctic Q4 Report 2025. 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 pound key five on their telephone keypad. Now, I will hand the conference over to CEO Gunilla Osswald and CFO Anders Martin-Löf. Please go ahead.
Good morning, and welcome to BioArctic's presentation for the fourth quarter and for the full year of 2025. It has been a fantastic year for BioArctic. In 2025, we entered into a new era that we call the growth era, and we can conclude that we have a transformative year behind us with record financial results. We are making our science accessible to more and more patients than ever before, and I think it's great and reassuring to see that more and more patients are getting access to Leqembi. We are accelerating our innovations. Our portfolio is progressing really well and has been further expanded, and our BrainTransporter technology is further evolving with new innovations. We have increased focus on business development. We are broadening our collaborations and utilizing our BrainTransporter technology, and we'll talk more about all this in today's presentation. Next slide, please.
BioArctic is listed at Nasdaq Stockholm Large Cap, and this is our disclaimer. Next slide, please. I'm Gunilla Osswald, and I'm the CEO of BioArctic, and I will share today's presentation with our CFO, Anders Martin-Löf, and our Chief R&D Officer, Johanna Fälting, and our Chief Commercial Officer, Ann-Kaija Grönblad. Next slide, please. I'll start our presentation by giving some key highlights. Next slide, please. I'm proud to state that BioArctic is among the world-leading innovators in precision neurology. We have two key platforms, where the first one is innovation and generation development of highly selective antibodies that are targeting aggregated misfolded forms of toxic proteins, like lecanemab. We also have them projects targeting alpha-synuclein, TDP-43, and huntingtin. The second area is the BrainTransporter platform, which where we have an innovative way to deliver antibodies.
I want to highlight that we are broadening the platform to enable more efficient transportation of other modalities into the brain with new innovative approaches. I'll talk more about that in today's presentation. Next slide, please. Last year, we held our first Capital Markets Day, where we presented our ambitions for 2030, and I'm so happy to see that we are already clearly delivering on our ambitions. If we start with the first one, Leqembi, to be established, treatment in Alzheimer's disease, Leqembi demand continues to grow to more and more patients, and we are now having global sales above $500 million. I think it looks bright with the blood-based biomarkers and the subcutaneous administration coming.
The second aspect is balanced and broader pipeline, with projects in all stages of development, and the pipeline is already broader, with new projects added last year for both Parkinson's related diseases as well as Huntington's disease. The third one is additional successful global partnerships, and we are very pleased with Eisai and our two new collaborations since last year, Bristol Myers Squibb and Novartis. We are also really happy with the further discussions that are ongoing. The fourth one is about our finances, and our aim is to be profitable and have recurring dividends in the future. We were highly profitable 2025, and our strong financial position allows us to continue to invest heavily in our business and, at the same time, give something back to our shareholders.
There is a proposal by the board of dividends of SEK 2 per share. Next slide, please. I just want to comment on some of the latest highlights towards delivering on our ambitions. We start with Leqembi, and I would like to start by thanks to our partner, Eisai's great work, Leqembi is now approved in 53 countries around the world. The subcutaneous auto- injector, that is called Iqlik in the U.S., has been launched for maintenance dosing in the U.S. The next important step is approvals of subcutaneous initiation dosing, and it was great to see that both the authorities in the U.S. and in China has granted priority review.
I think this points to how important the subcutaneous opportunity is for the patients, and we are very much looking forward to the PDUFA date that FDA has set by the 24th of May this year. It's also reassuring to notice that all data being presented at congresses, including long-term data and real world evidence data, are very encouraging for Leqembi. If we then turn to the pipeline, it's progressing really well, and we are growing the pipeline, and they are advancing. If we look at our alpha-synuclein portfolio and start with exidavnemab, which is our antibody, which currently is in phase II-A, the second part of the study with both Parkinson's disease and the multiple system atrophy patients will be finalized this year, and we are actively preparing for phase II-B.
We can also communicate that we have nominated two new candidate drugs, and we are preparing for INDs, and we have also further expanded our portfolio. As you know, I'm very excited about our BrainTransporter technology platform, where we have further innovations for different modalities, including our BrainTransporter technology. Johanna will talk more about this and show some nice new data. The third one is about our partnerships, and as I said, I'm really happy with all three partners, Eisai, Bristol Myers Squibb, and Novartis. All three programs look great. It's also happy to notice that we were very busy during J.P. Morgan in January this year, and it's great to see that we have continued strong interest for our projects and for our BrainTransporter technology, both for antibodies as well as other modalities.
The fourth aspect is about our financials, and they are strong, and we were highly profitable 2025, with record full year results of SEK 1.2 billion. The royalties for Leqembi are steadily increasing, and during 2025, we received several milestones also, both from Eisai and upfront payments from Bristol Myers Squibb and Novartis. And that led to that we have a strong cash position of SEK 2.2 billion, and Anders will talk more about this. Next slide, please. So by that, I will now hand over to our Chief R&D Officer, Johanna Fälting, for an update from R&D.
Thank you so much, Gunilla. Next slide, please. This slide provides an overview of our R&D portfolio, featuring the two main platforms that Gunilla talked about, the antibodies and the BrainTransporter platform, and also the highlighted cross-program synergies. The portfolio includes fully funded projects, partnered with major global pharmaceutical companies such as Eisai, Bristol Myers Squibb, and Novartis. We also have several in-house projects and technology platforms with substantial market and out-licensing opportunities. All collaborations involving the BrainTransporter platform are advancing well and as planned. Since the last quarterly update, we have also achieved important milestones within the portfolio, including the nomination of two candidate drugs, BAN2238 for alpha-synuclein disease and BAN3014 for TDP-related proteinopathies, such as ALS. Additionally, you will notice a new project in the BrainTransporter portfolio, the PD-BT2278, and this is targeting the alpha-synuclein disease.
So next slide, please. So both BAN2238 and BAN3014 were recently nominated as candidate drugs and have now advanced from research into preclinical development. BAN2238 is targeting toxic aggregated alpha-synuclein, such as oligomers, protofibrils, and aggregates, and this is combined with the BrainTransporter technology. It offers opportunities in several different synucleinopathies, such as Parkinson's disease, MSA, and dementia with Lewy bodies. And for BAN3014, this antibody targets toxic aggregated TDP-43 proteins, such as oligomers, protofibrils, and aggregates, and it offers opportunity for several of the TDP-43 proteinopathies, such as ALS and frontotemporal dementia. So both of these programs, we have now initiated IND enabling activities, and they are being prepared for clinical studies. So the next slide, please.
Alpha-synuclein misfolding and aggregation is central to alpha-synuclein disease development, and our alpha-synuclein portfolio offers opportunity in several of these synucleinopathies, such as Parkinson and dementia with Lewy body and multiple system atrophy. Exidavnemab is most advanced and is currently being tested in the EXIST study, a phase II-A study for safety and tolerability. In parallel to this, we are preparing for the next stage of development into phase II-B. BAN2238, that I just talked about, is the newly nominated alpha-synuclein antibody combined with the BrainTransporter technology for better efficacy and better brain uptake. BAN2238 is an alpha-synuclein antibody combined with the BrainTransporter, also representing an additional advancement in the BrainTransporter portfolio, for which further details will not be disclosed at this time. Next slide, please.
I'm very excited to share some new data today on our BrainTransporter platform. We know that the blood-brain barrier, that represents a significant challenge for neuroscience. If we can improve the delivery to the brain of our drugs, that represents an enormous opportunity for increased, of course, exposure in the brain, enhanced clinical efficacy, greater patient convenience by lowering the dose and offering other routes of administration, potentially better safety and lower manufacturing costs. We are investing very heavily in the BrainTransporter technology to deliver different types of biopharmaceuticals beyond antibodies and enzymes that we talked about in the past. We have developed this technology further now to enable delivery of small drug modalities to the brain.
This is a very innovative and flexible system that aims to transport various types of drugs, such as genetic medicines and small molecules, into the central nervous system. Next slide, please. Here, I'm very happy to show you some new data, and this image here compares the brain distribution of a standard antibody up to your upper left corner in green, with a BT- coupled antibody in green below. You can appreciate, I hope, the great increase of the green fluorescent color, which represents the antibody present in the brain. This is the same dose and the same time frame and the same antibodies, just with and without the BrainTransporter technology.
So antibodies we have worked with for quite some time, but we have also now here shown you data with the distribution in the brain of a, of an enzyme and also a small modality. So this BT- coupled approach significantly improves the brain distribution of our, of drug modalities. And for the BTA, the antibodies, this is a technology now that is fully implemented and validated, both in mice and in non-human primates. And here we have both the internal and external candidates at various stage of development. And then the BTE, the enzyme platform. We have our first internal program, the BT-G Case for Gaucher's disease, and this is progressing very well. It's an orphan indication that offers potential offered market potential for BioArctic, and a project that we can drive longer into the clinic.
I think that this enzyme project really sets the foundation for future enzyme-based projects coming along in the portfolio. What's new and presented here today is the BT small modalities. This is a novel and very flexible system that enables efficient brain delivery of genetic medicines such as ASOs or siRNA. It could be degraders, it could be small molecule approaches, or anything that you want to deliver into the brain, basically. Here some key data is now being generated, showing the utility of the system, and what is shown here is the brain distribution. I think that there's been a really strong interest in our BrainTransporter technology at the J.P. Morgan Healthcare Conference in January in San Francisco.
We are very excited about the future further development of this platform, and hope that we will be able to show you some more data in the coming year. Next slide, please. With this, I will hand over to our Chief Commercial Officer, Ann-Kaija Grönblad, for a commercial update.
Thank you, Johanna, and I will go back to Leqembi for a while, and I will start by just reminding everyone on the many recent and upcoming regulatory and development steps for Leqembi. That really increases the treatment options for patients, but also drives the sales growth around the world. So as Gunilla mentioned, the IV formulation is now approved in 53 countries, of which the latest ones were Canada, Brazil, and Malaysia. And the IV maintenance treatment, once every four weeks, is approved in seven countries. And in the EU, the EMEA accepted the submission for the IV maintenance earlier this year.
When it comes to the subcutaneous auto-injector, the weekly maintenance treatment was launched, as Gunilla mentioned, in the U.S. in October last year, and the sBLA for the weekly induction treatment was granted priority review by the FDA, and we're looking forward to the PDUFA date set for May the 24th. In Japan, the application for the subcutaneous induction treatment was submitted in November last year, and Eisai expects a launch later in 2026. And then finally, Eisai also sent an application for the subcutaneous auto-injector also in China last month, where it was granted priority review, and Eisai expects a launch in 2027. So many advancements, and this will drive the Leqembi growth even further.
The game changer being really the subcutaneous auto-injector, where the induction treatment is given as two injections of 250 mg each, where each injection only takes 15 seconds. So next slide, please. So, also with regards to the real-world evidence, Leqembi continues really to deliver more data. At the most recent Alzheimer's Congress, CTAD, in December last year in San Diego, there was a lot of presentations on Leqembi. So real-world evidence coming from U.S. and Japan shows really consistent results in terms of efficacy and safety, with findings from the clinical trials. Additional data presented indicated that earlier initiation may be associated with greater benefit, and that continued Leqembi treatment may provide a benefit compared with stopping therapy. So finally, data also presented at CTAD verified that the subcutaneous formulation offers a convenient option with comparable exposure and safety to IV.
And this can really reduce treatment burden for patients, and their care partners and healthcare, of course. So this was really, really encouraging to see all this data, in December last year. So next slide, please. So what are the trends on the key markets for Leqembi? Anders will soon show you the BioArctic royalty based on the Leqembi sales, but we can conclude that Leqembi sold for more than $500 million in the calendar year of 2025. That's a nice milestone. The global anti-amyloid market has more than doubled in 2025, and this is driven by mainly three things, I would say. First, the use of blood-based biomarkers, both for triaging and for confirmatory diagnosis, is increasing.
China has been really in the forefront, but also in the U.S., it is steadily increasing, and it is estimated that approximately 10% of confirmatory diagnosis in clinical practice in the U.S. are done by blood-based biomarkers. Secondly, more physicians are prescribing Leqembi. In Japan, more than 800 facilities are now starting initial treatment, and 1,700 centers are focusing on the follow-up after six months and onwards. And in the U.S., there is an enhanced coordination between the primary care physicians and neurologists. On the slide, you can see the targeted direct-to-consumer information campaigns that Eisai has been rolling out in the U.S. and in Japan. And the second one is to address really the awareness of mild cognitive impairment.
The fact that Leqembi was included in the commercial insurance innovative drug list in China in December will gradually give more physicians and patients access to Leqembi from the second half of the year, it is estimated. Thirdly, the subcutaneous auto-injector that I mentioned was launched in the U.S. for maintenance in October, also drives growth. It is estimated that 80% of the patients on Leqembi want to continue treatment after 18 months. The insurance coverage through the medical exception process is increasing, and the pay approval rate is estimated to be over 80% in the U.S. Finally, in Europe, the launches in Austria and Germany are ongoing since September last year, whereas the reimbursement discussions are ongoing in other countries.
Finally, the first private clinic in the Nordics started treating patients in Finland in October last year. What we hear from the market is that there are several other private clinics that are about to start, and we also hear that there are private patients traveling to Finland, also from Sweden, for example. Also, since April, our team in the Nordics has gradually been out visiting memory clinics every day, educating on the Leqembi data, and on the infrastructure that needs to be in place. We are active at national and regional specialist meetings, visiting regional healthcare decision makers, and we're increasing our digital communication on Leqembi. There is really a big interest and willingness to learn more and to make sure that all relevant staff at the clinics are educated. Next slide.
So finally, this is my last slide, and I know it's a busy one, but there was a question sent to us before, Harald, on the progress with governments regarding Leqembi reimbursement in the Nordics. And as you probably know, Eisai is responsible for reimbursement and pricing. But this slide shows an overall picture of the different steps and the parties involved in the process, and what the completed steps are for Leqembi in blue, which you can also find publicly available. It is the ambition for both Eisai and us to secure patient access to Leqembi in all Nordic countries. And as you might know, in red there, you see that in Denmark, the Danish Medicines Council came out with a negative recommendation in December.
So here, Eisai is considering the next steps and will be in dialogue with the authorities regarding potential next steps. In Sweden, the TLV published their health economic evaluation in December, and the next step is to negotiate with the NT Council. In Finland, the assessment report from Fimea has been recently published, and in Norway, the assessment is still ongoing, the Norwegian Medical Products Agency. So there is no official set timelines on how long these processes are, but Eisai is working very closely in dialogue with the authorities to answer any potential questions or other requests. And clearly, the ambition is to finalize these different steps during the year. So you can go to the next slide, and by that, I leave the word to our CFO, Anders Martin-Löf.
Thank you, Ann-Kaija. I will now start with the Leqembi numbers, where we saw solid growth globally. In Q4, the sales were JPY 20.7 billion, or $134 million. That was a 15% increase from the last quarter, or a 55% increase year-over-year. And as Ann-Kaija mentioned, this now means that we are well above $500 million in annual sales, which is a significant milestone for a product like this. Looking at the royalties, they grew by 31% year-over-year to SEK 127 million, and this is despite the Swedish krona getting significantly stronger during the periods. So, with constant exchange rates from last year, we would have seen more than 50% royalty growth.
Looking at the different markets, starting with China, the sales there are still a little bit distorted by the Q2 stockpiling effect. Sales came in at JPY 0.4 billion, or roughly $3 million. That is a 100% increase from the third quarter. However, that's still on a very low level, and this is due to the fact that there was a big inventory build-up in the second quarter, with sales of $53 million in the second quarter. And we have estimated roughly what our royalty would have been like if the sales in China would have been roughly in line with demand.
You see that in the pink bars in the graph, that our royalty would have been roughly SEK 125 million, SEK 135 million, and SEK 145 million during the second to the fourth quarters. Right now, we believe there is no more inventory to sell off, so we expect sales to return to more normal numbers for the first quarter of 2026. If you then turn to the U.S., their sales were roughly $78 million or JPY 11.9 billion. That's a 17% increase from the third quarter. As Ann-Kaija mentioned, here, the solid growth is expected to continue, mainly driven by the introduction of Iqlik for induction, and also by the introduction of blood-based biomarkers during the year. In Japan, the volumes are growing steadily. However, there was a price reduction.
The sales were JPY 6.2 billion, or $40 million. That means no change from the third quarter. The volume increase was roughly 15%, so healthy growth, but there was a one-off 15% price reduction from the Japanese reimbursement system, which is expected when volumes grow per product. Furthermore, the launch has been initiated, we're well on the way in Austria and Germany, but still, the royalty from the European market is very, very limited and has a very small impact on our royalties. That should grow, but even in 2026, we expect the impact from Europe to be fairly small to our royalties.
If we then turn to the forecast for Leqembi, Eisai has a JPY 76.5 billion forecast for their fiscal year 2025, that ends on March 31st. Right now, after nine months of that full year period, they have already reached more than 80% of the target. You see the numbers to the right of the graph, that in the U.S., they reached 78%, Japan 75%, and China 87%. What this means is that Eisai will reach the forecast, even if there would be no growth in any of the larger markets, and that is not what we're seeing. We believe they have a very good shot at reaching their forecast for the full year.
If we then turn to our numbers, I think it is worth to emphasize how big a transformation 2025 was for us, when we saw an eightfold increase in revenues. I won't be able to say that often, but this time around, it that actually happened. You see our revenues on the left-hand side, you see they're very lumpy, with the highest revenues in the first and second quarters, mainly driven by the agreement that we entered into with the BMS in the first quarter. But even so, if you look at the fourth quarter, our net revenues were SEK 184 million, and I think it's very reassuring to see that our recurring revenue base is continuing to increase.
So we had royalty of SEK 127 million and co-promotion revenue of SEK 6 million. So all in all, SEK 133 million in the fourth quarter, and that means that we had recurring revenue of roughly SEK 520 million in 2025. And that's really starting to become a solid base for us to fund our future R&D investments. We also get some questions on the Novartis upfront. It's recognized over the initial collaboration, and we recognize SEK 51 million out of $30 million during the fourth quarter. If we turn to our operating expenses, they actually decreased to SEK 136 million from SEK 143 million a year earlier.
If we take away currency effects that are recorded as other operating costs, the underlying operating costs were SEK 134 million. I think it's worth to highlight that that's very, very close to the recurring revenue that was SEK 133 million. We're actually more or less at a break even, with our recurring revenues funding our full operations in the fourth quarter. Looking forward a little bit, our underlying costs are expected to increase in 2026, upfront from SEK 680-SEK 681 million in 2025. This is, of course, then due to the progression of our project portfolio that Johanna mentioned.
We're investing heavily into exidavnemab, where we're currently in phase II, but we're also starting big CMC programs for our new candidate drugs, BAN2238 and BAN3014, which is really, really positive. So the higher R&D costs we have, the better it is, 'cause that means we're making progress in our portfolio. So it's hard to make a proper forecast for the cost, but if I can give, I would like to give you some guidance, and I guess, or estimate that the growth will be roughly 50%-70% in 2026. That is, the cost should increase by 50%-70% in 2026, compared to 2025.
Then finally, if we turn to our operating profit on the right-hand side, it was 33 million for the fourth quarter, and the full-year operating profit was roughly 1-26 billion. More, here, here you saw a really big effect, of course, of the BMS deal that we entered into and recognized in the first quarter. If we turn to the next slide, we're looking at the net result. It was then a loss for the period. That is explained by a significant accrued tax of 48 million due to the big profit for the first year. The operating cash flow was significantly stronger than the result, and that is explained by the fact that the 30 million upfront payment from Novartis was received during the quarter.
Three hundred thirty-three million SEK in positive cash flow during the fourth quarter. We ended the year with a cash balance of SEK 2.2 billion, a very solid position, and the board decided, based on that very, very solid position and our growing recurring revenues, that we should pay a dividend of SEK 2 per share, which is, of course, a significant milestone for a biotech company like ours. With that, I hand the word back to Gunilla.
Thank you so much, Anders. So we're coming towards the end of today's presentation with some upcoming news flow and some closing remarks. Next slide, please. I think it's great to see that more and more patients are getting access to Leqembi around the globe, and also that in the Nordics, that we have a private clinic in Finland so far, and we hope to get more and more patients in the Nordics, too. Eisai is driving continued regulatory processes on Leqembi in a very good way, and we hope to get more approvals in the future now. The Iqlik subcutaneous administration with auto-injector recently was approved for maintenance dosing in the U.S., and we are now awaiting the response for the induction treatment with the PDUFA date, 24th of May.
Later this year, we also expect response from Japan, and there it is both regarding initiation and maintenance dosing with the subcutaneous auto-injector. We are very much looking forward to the next big Alzheimer Congress and Parkinson Congress, which is in Copenhagen in March, where we will see several presentations. Then we see more things happening with the exidavnemab, for example, where we expect to have the phase II-A study readout later this year, and we are preparing for phase II-B. So, a lot of exciting times ahead of us. Next slide, please. So some key takeaways from today's presentation. I think that it's great to see that how BioArctic has entered into the new era, the growth era, and we see great progress, both of Leqembi as well as the rest of the portfolio, including the BrainTransporter technology.
We have started really well to deliver on our 2030 ambitions, where Leqembi is well on track to become an established treatment in Alzheimer's disease. Sales continue to show increasing demand globally, and we have now had global sales of more than $500 million, and we are then halfway to becoming a blockbuster. Our portfolio has increased and progressed well, and our BrainTransporter technology, as well as our two CD nominations that Johanna spoke about, have taken exciting development steps. Our business development efforts continue to deliver, and we see continued strong interest. We have a strong financial position, and we can then both invest in our programs and projects, and we can also pay some dividends that the board has recommended, two crowns per share.
All in all, I think we are exceptionally well positioned for the next phase of our growth journey. The future looks very bright for BioArctic, and we are bringing hope for many patients. Next slide, please. So by that, we say thank you for your attention, and we're happy to take some questions.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Viktor Sundberg from Nordea. Please go ahead.
Yes, hi. Thanks, thanks for taking my questions. So, one first here, maybe on your effort to launch lecanemab in the Nordics. I just wanted to get a feel for how much of your operating expenses are allocated to building up an organization around this launch, in- and, and what could potentially happen to those costs in 2026 if the rest of the Nordic countries follow Denmark and deem lecanemab, not cost-effective, at least for the IV administration in the Nordics. Yeah, I think I'll start with that question. Thanks.
If you look at the costs, most of our organization is already there. We're not seeing any significant increases in cost, or even if there wouldn't be any change in Denmark and that decision would stand, I don't think we'll see any significant decreases either. We expect to fight with Denmark, and we're not planning any layoffs anytime soon, despite the initial response there. A small increase, I would say, on the cost side for marketing sales.
Okay, thanks. And maybe if you could speak a bit about what kind of indications outside of neurology that have sparked some interest, at, for example, J.P. Morgan, around your BrainTransporter technology. Is that mainly oncology indications? If you could elaborate on where - yeah, where is the interest outside of neurology for this platform? Thanks.
Now, I think, as you know, we are not commenting about details when we talk about business development. We can just notice that there is great interest, and we see it on a broad level, and we see it on antibodies, but we also see it on other modalities, which we also know Johanna showed some really nice data on today. So, I think that there is a lot of different utilizations, but I think I also want to say with regard to business development, these things take time. It's not that it's quick things that you should expect from day- to- day. This is long processes. It takes time. It's really important for selecting a partner because it's a long-term commitment. So, it looks really good. We are having a lot of fun, but it will take some time.
Okay. Yeah, thanks. I jump back into the queue. Thank you.
The next question comes from Suzanne van Voorthuizen from Kempen. Please go ahead.
Hi, team. This is Suzanne. Thanks for taking my question. One on the BrainTransporter. Could you elaborate a bit more on the ALS and next gen exidavnemab programs in particular, what preclinical activities are undertaken at this moment, and, how does the road look and timeline, for these programs to be ready for the clinic? And, perhaps still, you mentioned the interest in the platform is broad. Could you speak a bit to the relative focus of these, this interest between, your existing programs versus interest to apply the technique to a pharma program? Just some extra color would be nice. Thank you.
Would you like to start, Johanna?
Absolutely. So thank you for that question. So, we have now nominated, as I said, our alpha-synuclein antibody coupled to the PD program. Coupled to the BT platform. The activities that we are now embarking on, in terms of moving the project from a research arena to the preclinical arena is the CMC activities that it takes a lot of time to manufacture a drug to be able to do toxicology studies. So this is the IND enabling activities. It's mainly CMC toxicology to prepare for the clinic.
And with regard to the BT-coupled ALS program, I mean, the one that we have nominated now is the standard antibody against TDP-43, but we of course also have a BT-coupled program going along, and there is no difference in the priority of these two antibodies. It's just that the BT-coupled antibody is a bit behind, so therefore, we have nominated now the antibody, the standard antibody. But we are definitely progressing both of these programs and have a lot of belief in them. And in terms of the timelines, I mean, depending on how everything is going, it takes approximately two years for us from a decision to first time in man.
I will continue with your second question about business development. I think that it's great to see that we have interest in both our internal programs and our BrainTransporter technology, like a platform company that I've said previously, that we also are. So I think that we see both interest also in the BrainTransporter together with antibodies, but we also see interest in BrainTransporter together with, for example, the new things that Johanna showed with small modalities. So, I think that's what I mean with broad interest. But we're coming from a position of strength, as I've said before. We have fantastic exciting own programs, and we have the luxury situation that we can invest in them.
So we can drive things forward ourselves, or we could partner if we find the right partner. So I think it's a really position of strength, and, we have a great organization that are driving the programs further. And then I think, that it's also good to see that we can utilize the company as a platform company and do things like the Novartis deal, where they come with their antibody, we re-engineer the antibody, we check it, and, to see that it works as it should with regard to the, transferrin receptor and so forth, and then hand it back. So I think you will see, more, deals like that in the future, but, if we find the right partner also for internal programs, that could also happen.
We don't have to partner, but we will partner if we find the right proposal and the collaborator.
Got it. Thanks.
The next question comes from Natalia Webster from RBC. Please go ahead.
Hi there. Thanks for taking my questions. First one is just on Leqembi in Europe. I appreciate that you expect a small contribution here, but are you able to talk a bit more about what you expect is required to improve the slow adoption, and how important you see both the longer-term data and the less frequent maintenance dosing in Europe? If you see potential for subcutaneous treatment here in the future. My second question is on the BrainTransporter platform, just in terms of timelines around BAN2803. You previously had plans to go into phase I in 2026. I appreciate this is now up to BMS, but are you able to share any details around expected timelines there?
Then just finally on overall, OpEx, it looks like Q4 OpEx was lower than consensus was expecting, both on R&D and SG&A. See that you're expecting an increase in costs in 2026, but are you able to touch on any key considerations for the cost phasing there next year? Thank you.
So Ann-Kaija Grönblad, would you like to take the question about Europe?
Yes. I heard the question was on the IV maintenance and the subcutaneous formulation. Is that correct? Yeah. So, I mean, as we just said, I mean, Eisai had submitted the application for the IV maintenance, and hopefully, this will be an approval on this during the year. And obviously, this will help, I mean, also in the different reimbursement processes across Europe. I mean, each country has their own reimbursement processes, and they usually, unfortunately, they take a little bit more time than in the U.S. and the rest of the world. So I mean, globally, it's proceeding very well, but Europe is a bit slower. And hopefully, we will also see subcutaneous also coming to Europe in the future.
And then continue with your next question, 2803. I mean, it's now up to our partner, Bristol Myers Squibb, to comment about when and how that is progressing with more details. I can just say that I think Bristol Myers Squibb is a fantastic partner. We're driving the program forward in a great way. But I will not comment about when it will go into man. And then the OpEx is an Anders question.
Yeah. So yeah, you should not draw any trend conclusions based on the Q4 costs coming in lower than expected. It is a little bit lumpy in our R&D programs. As for the phasing in 2026, I think we will grow steadily as the year goes by. But then again, it's really hard to give you any sort of hard forecast for how much it will grow quarter by quarter. You should expect that it will be a growing trend. It will probably not be a huge impact in the first quarter, and then will be larger and larger as the quarters go by. I think that's the right way to model it for 2026.
Great. Thank you.
The next question comes from Max Da from Goldman Sachs. Please go ahead. As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. There are no more phone questions at this time, so I hand the conference back to the speakers for any written questions or closing comments.
Thank you so much. So we have a couple of written questions that we'll address now, I guess. The first one comes from Erik Hultgård at Carnegie, and he's wondering when the two drug candidates that we just nominated, when we can expect those to be in the clinic? Maybe a question for Johanna.
Yeah. As I mentioned on the, on the question earlier, is that we expect it to take approximately two years from our nomination to entering into clinic, if everything goes according to plan, of course.
Thank you.
That's the guidance I can give you. Yeah.
Yep. Super. Thank you. Then we have a couple of questions from Joseph Hedden at Rx Securities. I guess the first one, Gunilla, is for you. Anything that you can say on the 2802 project that we have running with Eisai and the progression of that program?
Mm-hmm. I'm happy to see that BAN2802 program is progressing well and really nice data. Everything with the data looks really, really good, and we are now discussing with Eisai regarding potential next steps.
Great. I see that we have Max Da back online. We'll take the written question first, Max, and then we'll come back to you. So then second question for Anders maybe is a question on: Is there a commercial milestone? Can we expect that during the course of this year for Leqembi?
Yes, I think it's fair to assume that we will reach a commercial milestone during the year. I cannot really comment on the timing of that. The last one we received was EUR 10 million, and as sales grow, it's normal that milestones grow too. So I think it's fair to assume that it will be bigger than the EUR 10 million. But as for more details, I cannot really provide that at this point.
We can remind everybody that we still have outstanding milestones from Eisai of EUR 54 million, I believe.
In total.
In total, yes. Okay, and the, and the, I think the last one here from Joseph is R&D costs in Q4 2025 were lower than modeled that we already discussed. Considering the phase II-A, what do you think is the phasing? That question we already had. Sorry about that. It's the same question that Natalia had at the end, right?
Yes. So yeah, we already commented on the R&D cost phasing, so I hope that answer was enough for Joseph as well.
Okay. And then I think we can go back to Max's question online in the telephone queue.
Sorry, it's the operator here. Max, you should press pound key five, so then I can take your question if you're able to do that.
The next question comes from Max Da from Goldman Sachs. Please go ahead.
Hello, can you hear me?
Yes, we can hear you, Max.
Thank you so much. Yeah, thank you for taking my question. So this is Max Da for Goldman Sachs. A couple of questions. What is your progress on finding a partner for exidavnemab? And do you require Parkinson's disease to be included in the deal, or the partner has the option to license only the MSA indication? That's the first one. And could you speak to the difference between PD, PD-BT2238 and BAN2238? Because I couldn't tell the difference. Yeah, I'll start with these two.
I don't know. I don't know how.
Okay. So the first question was with regard to exidavnemab and partnering. As I said before, I mean, exidavnemab continues to progress really, really well. We are expecting the phase II-A results later this year, and we are preparing for phase II-B. We have interest for potential partners, and we might partner or we might not partner right now. It depends on if we get the right kind of proposal from the right kind of partner. Otherwise, we are very strong and can drive programs like this ourselves. We have the competence and so forth. I will not comment upon details on this at all at this stage. I mean, we're open.
We have the open door philosophy like we do all the time, and if the right partner comes, then we will make a, a partnering. We are coming from a position of strength, and we can drive things forward ourselves also a bit longer. I mean, we have opportunities for Parkinson's disease, with dementia, for example, or Lewy body dementia, or other parts of Parkinson's disease, or multiple system atrophy. We have now three different programs in our portfolio, where exidavnemab is the most advanced, and we have 2238, which was just nominated and got the BAN number. So BAN2238 is the one with BrainTransporter. It's not exidavnemab. It's a slightly different antibody. It's combined with a BrainTransporter. As Johanna said, I will make it easy for you now, Johanna.
I'll just answer that question, too. And that is 2278, which is slightly different from 2238, but we will not, at this stage, talk about what difference we have. But we have one further new invention that has been added to this program, but we are not revealing any more details at the moment.
Got it. Thank you. Sorry, one more question, if you have time.
Yes.
Could you talk about the dividend payout going forward and how we should model that?
So yeah, this is Anders here. So yeah, the board has now proposed a dividend for SEK 2 per year. We cannot give you a forecast for what it will be in the future. However, I think it's fair to assume that the board is expecting us to be able to pay a dividend going forward for the foreseeable future. The size of that or how certain I am of that, I cannot really comment, but I think it's fair to assume that they are hoping to be able to pay a dividend in the forthcoming years.
Got it. Thank you.
There are no more phone questions at this time, so I hand the conference back to the speakers for any written questions or closing comments.
We have no additional written questions, so I'll hand it over to Gunilla to end the call.
I'll just say thank you very much for your attention and a lot of great questions, and I wish you all a great rest of the day. Thank you so much.