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BioArctic AB (publ)
2/18/2026
Good morning and welcome to Biotic's presentation for the fourth quarter and for the full year of 2025. It has been a fantastic year for Biotic. 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 Lecambi. We are accelerating our innovations. Our portfolio is progressing really well and has been further expanded. And our brain transporter technology is further evolving with new innovations. We have increased focus on business development. We are broadening our collaborations and utilizing our brain transporter technology. And we'll talk more about all this in today's presentation. Next slide, please. Biotic is listed at Nasdaq Stockholm large cap, and this is our disclaimer. Next slide, please. I'm Gunilla Åsvall, and I'm the CEO of Biotic. And I will share today's presentation with our CFO, Anders Martin Lööf, and our chief R&D officer, Johanna Felting, and our chief commercial officer, Anna-Kaja Grönblad. Next slide, please. I'll start our presentation by giving some key highlights. Next slide, please. I'm proud to state that Biotic is among the world leading innovators in precision neurology. We have two key platforms, where the first one is innovation and generation and development of highly selective antibodies that are targeting aggregated, misfolded forms of toxic proteins like leucanumab. And we also have projects targeting alphasnuclein, TDP43 and Huntingtin. The second area is the brain transporter platform, where we have an innovative way to deliver antibodies. And 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, Lecambi, to be established treatment in Alzheimer's disease, Lecambi demand continues to grow to more and more patients, and we are now having global sales above 500 million US dollars. 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 related diseases as well as Huntington's disease. The third one is additional successful global partnerships, and we are very pleased with ASI 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. Our aim is to be profitable and have recurring dividends in the future. We were highly profitable in 2025. Our strong financial position allows us to continue to invest heavily in our business. At the same time, give something back to our shareholders. There is a proposal by the Board of Dividends of two Swedish crowns per share. Next slide, please. So I just want to comment on some of the latest highlights towards delivering on our ambitions. So we start with Lekembe. And I would like to start by thanking, thanks to our partner, ASI's great work. Lekembe is now approved in 53 countries around the world. The subcutaneous autoinjector that is called iClick in the US has been launched for maintenance dosing in the US. The next important step is approvals of subcutaneous initiation dosing. And it was great to see that both the authorities in the US and in China has granted priority review. And 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 Lecambi. 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 Exidabnema, which is our antibody which currently is in phase 2a, the second part of the study with both Parkinson's disease and the multiple systemic atrophy patients will be finalized this year. And we are actively preparing for phase 2b. 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. And as you know, I'm very excited about our brain transporter technology platform, where we have further innovations for different modalities, including our brain transporter technology, utilizing our brain transporter technology. And 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, ASI, Bristol Myers Squibb and Novartis. All three programs looks great. And it's also happy to notice that we were very busy during JP Morgan in January this year. And it's great to see that we have continued strong interest for our projects and for our brain transporter technology, both for antibodies as well as other modalities. The fourth aspect is about our financials. They are strong. We were highly profitable in 2025- with record full-year results of 1.2 billion Swedish crowns. The royalties for Lekemby are steadily increasing. And during 2025, we received several milestones also, both from ASI and upfront payments from Bristol-Myers Squibb and Novartis. And that led to that we have a strong cash position of 2.2 billion Swedish crowns. 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 Felting for an update from R&D.
Thank you so much Gunilla. Next slide, please. So this slide provides an overview of our R&D portfolio, featuring the two main platforms that Gunilla talked about, the antibodies and the brain transporter platform, and also the highlighted cross-program synergies. So the portfolio includes fully funded projects partnered with major global pharmaceutical companies, such as ACI, Bristol-Myers Squibb, and Novartis. And we also have several in-house projects and technology platforms with substantial market and licensing opportunities. All collaborations involving the Brain Transporter Platform are advancing well and as planned. And since the last quarterly update, we have also achieved important milestones within the portfolio, including the nomination of two candidate drugs, BAN 2238 for alpha-synuclein disease and BAN 3014 for TDP-related proteinopathies such as ALS. Additionally, you will notice a new project in the brain transporter portfolio, the PDBT2278, and this is targeting the alpha-synuclein disease. So next slide, please. So both BAN20-38 and BAN30-14 were recently nominated at Candidate Drugs and have now advanced from research into preclinical development. BAN20-38 is targeting toxic aggregated alpha-synuclein such as oligomers, protofibrils and aggregates. And this is combined with the brain transporter technology. It offers opportunities in several different nucleopaties, such as Parkinson's disease, MSA and dementia with Lewy body. And for BAM3014, this antibody targets toxic aggregated TDP43 proteins, such as oligomers, protofibrils and aggregates, and it offers opportunity for several of the TDP43 proteinopathies, such as ALS and frontal temporal lobe dementia. So both of these programmes, we have now initiated IND enabling activities and they are being prepared for clinical studies. So the next slide, please. So alpha-synuclein misfolding and aggregation is central to alpha-synuclein disease development. And our alpha-synuclein portfolio offers opportunity in several of these new synucleinopathies, such as Parkinson and dementia with Lewy body and multiple systemic atrophy. Exedamnibab is most advanced and is currently being tested in the EXIST study, a phase 2A study for safety and tolerability. And in parallel to this, we are preparing for the next stage of development into phase 2B. 2238, that I just talked about, is the newly nominated alpha-synuclein antibody combined with the brain transporter technology for better efficacy and better brain uptake. And BAN 2238 is an alpha-synuclein antibody combined with the brain transporter, also representing an additional advancement in the brain transporter portfolio, for which further details will not be disclosed at this time. Next slide, please. So I'm very excited to share some new data today on our brain transport platform. So we know that the blood brain barrier that represents a significant challenge for neuroscience. And 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. So we are investing very heavily in the brain transporter technology to deliver different types of biopharmaceuticals beyond antibodies and enzymes that we talked about in the past. So we have developed this technology further now to enable delivery of small drug modalities to the brain. So 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. So 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. And you can appreciate the hope that the great increase of the green fluorescent color, which represent the antibody present in the brain. And this is the same dose in the same time frame and the same antibodies just with and without the brain transporter technology. So antibodies we have worked with for quite some time, but we have also now shown you data with the distribution in the brain of an enzyme and also a small modality. So this BT coupled approach significantly improves the brain distribution of our 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 internal and external candidates at various stage of development. And then the BTE, the enzyme platform. We have our first internal program, the BTG case for Gaucher's disease, and this is progressing very well. It's an orphan indication that offers market potential for bioarchitecture and a project that we can drive longer into the clinic. And I think that this enzyme project, it really sets the foundation for future enzyme-based projects coming along in the portfolio. And then what's new and presented here today is the BT-S, the BT small modalities. And 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. And here some key data is now being generated showing the utility of the system and what is shown here is then the brain distribution. And I think that there's been a really strong interest in our brain transporter technology at the JP Morgan Health Conference in January in San Francisco. And 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. So next slide, please. So with this, I will hand over to our chief commercial officer, Anna-Kaja Granblad, for a commercial update.
Thank you, Johanna. I will go back to Lecambi for a while. I will start by just reminding everyone on the many recent and upcoming regulatory and development steps for Lecambi that really increases the treatment options for patients, but also drives the sales growth around the world. 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 EMA accepted ACI submission for the IV maintenance earlier this year. When it comes to the subcutaneous autoinjector, the weekly maintenance treatment was launched, as Gunilla mentioned, in the US in October last year. And the SPLA 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 ASA expects a launch later in 2026. And then finally, ASI also sent an application for the subcutaneous autoinjector also in China last month, where it was granted priority review and ASI expects a launch in 2027. So many advancements and this will drive the leukemia growth even further. The game changer being really the subcutaneous autoinjector, where the induction treatment is given as two injections of 250 milligram each, where each injection only takes 15 seconds. So next slide, please. So also with regards to the real world evidence, Lecambi 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 Lecambi. So real world evidence coming from US 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 Lekembe treatment may provide a benefit compared with stopping therapy. So finally, data also presented at CETER 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 Lakembi? Anders will soon show you the bioarctic royalty based on the Lakembi sales, but we can conclude that Lakembi sold for more than 500 million US dollars in the calendar year of 2025. That's a nice milestone. uh 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 confirmatory diagnosis is increasing china has been really in the forefront but also in the us it is steadily increasing and it is estimated that approximately 10 of confirmatory diagnosis in clinical practice in the US are done by blood-based biomarkers. Secondly, more physicians are prescribing Lekembe. In Japan, more than 800 facilities are now starting initial treatment, and 1,700 centers are focusing on the follow-up after six months onwards. And in the US, 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 EISA has been rolling out in the US and in Japan. And the second one is to address really the awareness of mild cognitive impairment. The fact that Lekembe was included in the commercial insurance innovative drug list in China in December will gradually give more physicians and patients access to Lekembe from the second half of the year, it is estimated. Thirdly, the subcutaneous water injector that I mentioned was launched in the US for maintenance in October, also drives growth. It is estimated that 80% of the patients on Lakembi 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 US. And finally, in Europe, the launches in Austria and Germany are ongoing since September last year, whereas the reimbursement discussions are ongoing in other countries. And finally, the first private clinic in the Nordics started treating patients in Finland in October last year. And 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 Lekembe 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 Lekembe. There is really a big interest and willingness to learn more and to make sure that all relevant staff at the clinics are educated. So 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 Lecambi reimbursement in the Nordics. And as you probably know, EISA 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 Lecambi in blue, which you can also find publicly available. It is the ambition for both ASI and us to secure patient access to Leukemia 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 ASI 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. The next step is to negotiate with the county council. And in Finland, the assessment report from Fimea has been recently published. And in Norway, the assessment is still ongoing, the Norwegian Medicines Agency. So there's no official set timelines on how long these processes are. But EISA 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 Barton Lööf.
Thank you Anna-Kaja. I will then start with the Lecambi numbers where we saw solid growth globally. In Q4, the sales were 20.7 billion yen, or $134 million. That was a 15% increase from the last quarter, or a 55% increase year over year. 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 127 million. This is despite the Swedish krona getting significantly stronger during the periods. 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 0.4 billion yen 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. And you see that in the pink bars in the graph, that our royalty would have been roughly 125, 135 and 145 million Swedish 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 US, their sales were roughly 78 million dollars, or 11.9 billion yen. That's a 17% increase from the third quarter. And as Anna-Kan mentioned, here the solid growth is expected to continue, mainly driven by the introduction of iClick 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. So the sales were 6.2 billion yen or 40 million dollars. That means no change from the third quarter. So 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 for a product. Furthermore, the EU launch has been initiated. We're well underway 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 Lecambi, ASI has a 76.5 billion yen forecast for their fiscal year 2025 that ends on March 31st. And right now, after nine months of that full year period, they have already reached more than 80% of the target. And you see the numbers to the right of the graph, that in the US they reached 78%, Japan 75% and China 87%. So what this means is that ASI 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. So 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's worth to emphasize how big 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 that actually happened. And 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 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 127 million and co-promotion revenue of 6 million. So all in all, 133 million in the fourth quarter. And that means that we had recurring revenue of roughly 520 million 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 51 million Swedish out of the 30 million dollars during the fourth quarter. If we turn to our operating expenses, they actually decreased to 136 million from 143 million a year earlier. And if we take away currency effects that are recorded as other operating costs, the underlying operating costs were 134 million. And I think it's worth the highlight that that's very, very close to the recurring revenue that was 133. So we're actually more or less at the 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, up from 681 million in 2025. And this is, of course, due to the progression of our project portfolio that Johanna mentioned. We're investing heavily into Exit Amnema, where we're currently in phase two. But we're also starting big CNC programs for a new candidate drugs bound 2038 and bound 3014, which is really, really positive. So the higher R&D costs we have, the better it is, because that means we're making progress in our portfolio. So it's hard to make a proper forecast for the costs. 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 to 70 percent in 2026, that is the cost should increase by 50 to 70 percent in 2026 compared to 2025. And then finally if we turn to our operating profit on the right hand side it was 33 million for the fourth quarter and the fully operating profit was roughly 1.26 billion. Here you saw a really big effect of course of the BMS 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 full 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. So 313 million Swedish in positive cash flow during the fourth quarter. We ended the year with a cash balance of 2.2 billion Swedish, a very solid position. The board decided, based on that very solid position and our growing recurring revenues, that we should pay a dividend of 2 kronor 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. We're coming towards the end of today's presentation with some upcoming news flow and some closing remarks. I think it's great to see that more and more patients are getting access to Lecambi 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. ASI is driving continued regulatory processes on Lecambi in a very good way and we hope to get more approvals in the future now. The ICLIC subcutaneous administration with autoinjector recently was approved for maintenance dosing in the US 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 autoinjector. We are very much looking forward to the next big Alzheimer's Congress and Parkinson's Congress, which is in Copenhagen in March, where we will see several presentations. And then we see more things happening with Exidavnumab, for example, where we expect to have the phase 2a study readout later this year. And we are preparing for phase 2b. So a lot of exciting times ahead of us. Next slide, please. Some key takeaways from today's presentation. I think that it's great to see how Biotic has entered into the new era, the growth era. We see great progress, both of Lekembe as well as the rest of the portfolio, including the brain transporter technology. We have started really well to deliver on our 2030 ambitions. While Lekembe 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 US dollars. And we are then halfway to becoming a blockbuster. Our portfolio has increased and progressed well, and our brain-transported 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 to Crowns Per Share. So all in all, I think we are exceptionally well positioned for the next phase of our growth journey. The future looks very bright for Biotic 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 Victor Sundberg from Nordia. Please go ahead.
Yes, hi. Thanks for taking my questions. So one first here, maybe on your effort to launch Lacanumab 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 and what could potentially happen to those costs in 2026 if the rest of the Nordic countries follow Denmark and deem the Canemab not cost effective, at least for the IV administration in the Nordics. Yeah, I think I'll start with that question. Thanks.
So if you look at the costs, most of our organization is already there. So we're not seeing any significant increases in costs or even if there wouldn't be any change in Denmark. 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. So a small increase, I would say, on the cost side for marketing and 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 JP Morgan around your brain transporter technology. Is that mainly oncology indications? If you could elaborate on where you see interest outside of neurology for this platform. Thanks.
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 jumped back into the queue. Thank you.
The next question comes from Suzanne van Forthuizen from Kempen. Please go ahead.
Hi, team. This is Suzanne. Thanks for taking my question. One on the brain transport there. Could you elaborate a bit more on the ALS and next-gen exudapnema 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 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.
So 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 PT program, coupled to the BT platform. And the activities that we are now embarking on in terms of moving the project from a research arena to a preclinical arena is the CMC activities that takes a lot of time to manufacture. 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 TDP43, 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 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.
And 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 the brain transporter 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 brain transporter together with antibodies, but we also see interest in brain transporter 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 programmes. 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 organisation that are driving the programmes 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 to see that it works as it should with regard to the transferring 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. But 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. The first one is just on Lecambia 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? And then if you see potential for subcutaneous treatment here in the future. My second question is on the Brain Transporter platform, just in terms of timelines around BAN 2803. You previously had plans to go into phase one in 2026. Appreciate this is now up to BMS, but are you able to share any details around expected timelines there? Then just finally on overall OPEC, It looks like Q4 OPEX was lower than consensus was expecting, both on R&D, MS, G&A. I 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.
Anna-Kaja, 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? Yes, so I mean, as we just said, I mean, ASI 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, take a little bit more time than in the US 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 who are driving the programme forward in a great way. But I will not comment about when it will go into man.
then the opex is another question yeah so yeah you should not draw any any trend conclusions based on on the q4 costs coming in lower than than expected it is a little bit lumpy in our r d programs as as for the facing in in 2026 i think we will grow steadily as the years 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 that 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 Dahl 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 Yair Kurtgård 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 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. That's the guidance I can give you.
Super, thank you. Then we have a couple of questions from Josef 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 ASI and the progression of that program?
I'm happy to see that BAN 2802 program is progressing well and really nice data. Everything with the data looks really, really good. And we are now discussing with ASI regarding potential next steps.
Great. I see that we have Max 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 Lecambi?
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 10 million euros. And as sales grow, it's normal that milestones grow too. So I think it's fair to assume that it would be bigger than the 10 million euros. But as for... More details, I cannot really provide at this point.
We can remind everybody that we still have outstanding milestones from ASI of €54 million, I believe. In total? In total, yes. I think the last one here from Josef is R&D costs in Q4-25 were lower than the model that we already discussed. considering the phase 2a, 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 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 Rajan Sharma. A couple of questions. What is your progress on finding a partner for X, sorry, X.NAMP? 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 PT2278 and 2238, because I couldn't tell the difference. Yeah, I'll start with these two.
The first question was with regard to Exedavnamab and partnering. As I said before, Exedavnamab continues to progress really well. We are expecting the Phase 2a results later this year and we are preparing for Phase 2b. 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. And 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 partnering. But we are coming from a position of strength and we can drive things forward ourselves also a bit longer. And then there are different opportunities. 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 systemic atrophy. And we have now three different programs in our portfolio, where Exdabnumab is the most advanced, and we have 2238, which was just nominated and got the band number. So BAN2238 is the one with brain transporter. It's not Exidavnimab, it's a slightly different antibody. And it's combined with our brain transporter. And then, 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. 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 two kronors per year we cannot give you a forecast for what it would 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 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.
And we have no additional written questions. So I'll hand it over to Gunilla to end the call.
So 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.