Welcome to BioArctic Q1 Report 2026. For the first part of the conference call, the participants will be in listen-only mode. During the questions-and-answers 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 with colleagues. Please go ahead.
Good morning. Welcome to BioArctic's presentation for the first quarter of 2026. It has been a strong start of the year for BioArctic, following a transformative year of 2025 with record financial results. It shows that the growth year-round continues in a great way for BioArctic. It's reassuring to see that more and more patients are getting access to Leqembi, and we had more than EUR 500 million of sales during our partner Eisai fiscal year, and that resulted in a commercial milestone to BioArctic. Our projects and our BrainTransporter technology are also progressing really well, and we have increased focus on business development, which is based on great interest in BrainTransporter and in our projects. I'll talk more about that 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 Anna-Kaija Grönblad. Next slide, please. I will start our presentation by giving some key highlights. Next slide, please. BioArctic is focusing on two different platforms in precision neurology, and we are among the world-leading innovators in both areas. The first area is about creating highly selective antibodies, which is targeting aggregated misfolded forms of toxic proteins. The most advanced program here is Leqembi, and we also have projects targeting alpha-synuclein, TDP-43, and Huntington.
The second area is when we are utilizing our BrainTransporter platform in unique ways to deliver antibodies more efficiently into the brain. We have now also broadened our scope, we are also working on other modalities like enzymes and also genetic medicine and small molecules to enable more efficient transportation of them also into the brain with innovative approaches. The innovations at BioArctic continue to impress me deeply. They are unique and very competitive. Next slide, please. We are already delivering on our 2030 ambitions that we presented for our capital markets day last year. We have then stated that we have four areas of focus.
The first one is to establish Leqembi as a disease-modifying treatment for Alzheimer's disease. Here we see a steady growth across geographies with sales that was more than EUR 500 million the last 12 months. We expect that the subcutaneous autoinjector called IQLIK, together with increasing use of blood-based biomarkers, that together will contribute to continued strong growth. The second aspect here is that Eisai has also indicated in their guidance for 2026 that we are expecting sales of more than $900 million. I think that Leqembi is well on its way to become a blockbuster with yearly sales more than $1 billion in not too long. The second area is to have a broader pipeline and more advanced with projects in all stages of development. I'm happy to see that our pipeline has expanded last year and our projects are progressing really well.
I want to highlight our alpha-synuclein project, exidavnemab, where the phase IIa study is fully recruited with the results expected later this year, and also the follow-up compound BAN2238 with our BrainTransporter coupled to alpha-synuclein in an antibody, and there the IND activities are ongoing in order to take the compound into clinic next year. The third area is more partnerships. Last year we initiated partnerships with Bristol Myers Squibb and Novartis. We're very pleased with both of those partnerships and really impressed with how the collaborations are progressing and delivering. We also see continued strong interest that we have in both our projects and in our BrainTransporter platform. Partnership discussions are complex and take time. We are in a very strong position with our high-quality projects and innovative technologies.
The fourth aspect is strong financials. Our quarterly royalty revenues from Leqembi sales grew 68% compared to first quarter last year, and we have now more than GBP 2 billion in cash, which means that we can continue to invest in our projects and our innovations, and we have also the possibility to start to pay some dividends. Next slide, please. Our business model is built around partnerships. That is a key component behind our success. Eisai has been a long-term successful collaboration all the way back since 2005. Now we are getting 9% of royalties from global Leqembi sales. We have just then passed our second commercial milestone and got another EUR 20 million from Eisai. We have EUR 34 million still remaining in milestones.
For Bristol Myers Squibb, we have received EUR 100 million so far, and there is a substantial amount left, and Novartis, we have so far received EUR 30 million, and also here it's a substantial amount still to receive if it also continues well. We are grateful for AbbVie, who has made us receive EUR 30 million, which helped us build the company and also progressing the project further, and it's a project I strongly believe in and looking forward to more results. We expect more partnerships to come. That is our business model, and we're working on that, and we cannot say exactly when time is, but we will let you know when we can disclose. Next slide, please. By that, I hand over to our Chief R&D Officer, Johanna Fälting.
Thank you, Gunilla. Next slide, please. As Gunilla talked to, our R&D portfolio is built on two platforms: antibodies and BrainTransporter, providing both depth and scalability in neurodegenerative diseases. We combine fully funded partnerships with leading pharma such as Eisai, BMS, and Novartis with proprietary programs that offer further out-licenses in potential. Progress in the portfolio remains strong. All BrainTransporter collaborations are on track, and key milestones have been reached for our internal programs, including the start of IND-enabling activities for BAN2238 and BAN3014. Overall, we are advancing a diverse, partner-validated pipeline with growing scientific, strategic, and commercial options. Next slide, please. Our alpha-synuclein portfolio continues to advance and expand, offering multiple opportunities across alpha-synuclein properties. Our lead program, exidavnemab, is progressing well.
The phase IIa EXIST study in Parkinson's disease and Multiple System Atrophy is now fully recruited. We have held key regulatory and key opinion-leader interactions to prepare for the next stage of development. Next-generation assets in the portfolio are progressing as well, with BAN2238 in IND-enabling phase and PD-BT2238 in discovery. Together this builds a strong, expanding alpha-synuclein pipeline from clinical stage to future innovation. Next slide, please. Our BrainTransporter platform addresses one of the most fundamental challenges in neuroscience: efficient delivery across the blood-brain barrier of therapeutics. This is enabled by active transport of biopharmaceuticals into the brain via the transferrin receptor. This enhanced delivery can translate into higher, faster, and deeper brain exposure with improved clinical outcomes, improved patient convenience, safety, and lower cost for manufacturing. The BrainTransporter, therefore, plays a critical role in unlocking the full potential of CMS therapies.
Next slide, please. Our next-generation alpha-synuclein antibody, the BAN2238, demonstrates strong preclinical performance both with enhanced brain exposure and a favorable safety profile. By combining the alpha-synuclein targeting with our BrainTransporter technology, BAN2238 achieves significant increase in brain exposure in preclinical models, and that is what you see in the middle picture here, and importantly, this enhanced delivery is achieved without compromising safety. We observe no signs of anemia or reduction of reticulocytes while maintaining a full effective function of the protein, and that's the data shown to your right. Otherwise, reduction in reticulocytes is a commonly reported side effect targeting a transferrin receptor for brain delivery. Overall, the BAN2238 highlights how the BrainTransporter has the potential to both improve target engagement and reduce development risk, strengthening the value of our next-generation pipeline. Next slide, please.
As Gunilla also mentioned, we are also now broadening our BrainTransporter platform beyond antibodies and enzymes and also include additional modalities such as genetic medicines and small molecules, significantly increasing the scope of the platform. The data in the picture here clearly shows how the BrainTransporter-coupled modalities deliver superior brain distribution compared to a standard therapy. In the top picture, you see a standard therapy, and in the lower pictures, in green, you see an antibody; in yellow, you see an enzyme; and in red, you see a small modality, and all of them have very much higher brain exposure when coupled to the BrainTransporter platform. Across the platform, delivery of antibodies is preclinically validated and advancing. Enzymes are progressing with our first internal program, the GCase program for Gaucher's disease, and small modalities represent a new important growth area for us.
Overall, the BrainTransporter is evolving into a versatile platform with multiple future value drivers across CNS discovery disorders. Next slide, please. I will hand over to our Chief Commercial Officer, Anna-Kaija Grönblad.
Thank you, Johanna. I will continue with an update on Leqembi, and I will start with stating that the global sales of Leqembi amounted to around EUR 580 million in Eisai FY 2025, so that is almost a doubling versus the previous fiscal year, and we can see a good growth across the line, and Leqembi continues to be the global market leader of the anti-amyloid antibodies. A couple of the driving factors are that the market for blood biomarker continues to grow, and there has been approximately a 12-fold increase over the last two years, with the number actually doubling every six months since January 2024.
Last year, CNS also formally included the blood-based biomarkers as an A-beta confirmatory diagnosis. Today it is estimated that approximately 15% of the diagnoses were done by these blood-based biomarkers. These will continue to increase as more tests are expected to be approved this year. Another factor is that more and more patients receive continued treatment after the Leqembi maintenance dosing was approved, first for the IV and then for the subcutaneous formulation, the autoinjector IQLIK, which was approved in August last year. According to Eisai, IQLIK also seems to have led to an increase in new patients initiating treatment with Leqembi IV.
Going forward, we see even more expansion possibilities with the potential approval of the subcutaneous initiation treatment both in the U.S. with a set PDUFA date in August 24, and with an expected approval also in Japan in Q3 this year and in China in Q1 next year. This is a huge advantage for patients, the caregivers, and less of a bottleneck for hospitals, and obviously also a competitive edge for Leqembi. In Europe, the IV maintenance dosing is under regulatory review at EMA since February, and in parallel, the negotiations for pricing and reimbursements are ongoing in the EU, and so today it's available in Germany and Austria as well as out-of-pocket in the U.K., Finland, and Portugal. Next slide, please.
As the Nordic countries are BioArctic's home market, I thought I would also comment on the recent negative recommendation for Leqembi by the New Therapies Council in Sweden. As we have seen in other European countries, it is a challenge to get immediate access, and we knew that the dialogue would be challenging also in Sweden based on the assessment report issued in December last year by the TLV, the Dental and Pharmaceutical Benefits Agency, in which some of the assumptions in the health economic modeling were extremely conservative in our opinion. Although Eisai was very solution-oriented in the negotiations, the expectations from the NT Council were impossible to meet at this point.
Both Eisai and BioArctic, we are very committed to securing patient access in Sweden and across the Nordics. The NT Council has stated that there is a possibility to reopen the dialogue, for example, if and when we have the IV maintenance dosing approved by EMA. We could also try to find another innovative way of securing a structured introduction. We are also evaluating a resubmission in Denmark. In the coming months, we are expecting to see assessment reports coming out in Norway and Finland. In the meantime, though, we see that there is a private market in Finland. Four clinics have now started Leqembi treatment. We are approached by other private clinics across the Nordics who are looking into this possibility as well.
In parallel, our neuroscience account managers as well as our medical affairs team are working every day with educational and site readiness activities in preparations for a broader reimbursement across the Nordics. Next slide, please. Finally, I would like to conclude by showing a few highlights from the ADPD Congress in March in Copenhagen, where four-year follow-up data were presented for the EU-approved population, meaning the APOE4 non-carriers or heterozygotes. This data showed that long-term continuation of treatment is essential and that four-year treatment with Leqembi saves between 10-14 months of time in the milder stage of the disease if you compare to matched controls in two large databases, the pre-specified ADNI cohort and the matched cohort of the Swedish BioFinder.
At the conference, it was also highlighted that starting treatment as early as possible, as it seems to result in even better results. As usage increases across the world, more and more hospitals present real-world data from clinical practice in these congresses at ADPD, specifically from countries such as the U.S., Japan, China, and South Korea. To the right, you can see, for example, a graph showing that there is also a high treatment persistence in initially 371 patients at a U.S. clinic starting in 2023. It was 78% at 18 months, and after two years, it was 67% persistence of the treatment. More and more data further strengthen Leqembi's efficacy and safety profile, and we are already looking forward to attending next congress coming up, the AAIC in London, in July.
Next slide, and I will thereby hand over to our Chief CFO, Anders Martin-Löf.
Thank you, Anna-Kaija. I'll start by commenting a little bit on the Leqembi sales, and as Gunilla already mentioned, we were really happy to see that the full-year Leqembi sales exceeded EUR 500 million as that triggered the sales milestones to us to EUR 20 million. If we look at the quarter, the global Q1 sales were JPY 26.2 billion, roughly $168 million. That's a 27% increase from the last quarter of 2025, and that meant that our royalties grew by 27% to SEK 160.8 million Swedish. That was quite a steep increase, as you can see in the graph, up from JPY 127 million in the fourth quarter, and this really big boost is due to the fact that the China sales are now back on normal levels after very low sales in Q3 and Q4 due to big stockpiling during the second quarter of 2025.
China sales were now JPY 4.1 billion or USD 27 million, and that's almost a tenfold increase from the fourth quarter. Our largest market is the U.S. market, and there the growth is largely driven by the simplified diagnosis with blood-based biomarkers and the introduction of iClick that I talked about, and there was a very healthy growth going up to JPY 13.4 billion, i.e., USD 86 million, and that's a 13% increase from the fourth quarter. As Anna-Kaija also alluded to, Eisai is expecting this growth to continue as the blood-based biomarkers are really starting to make an impact on the market, and of course, when IQLIK comes out later this year for induction therapy, that should mean a further boost. Japan is the second largest market, and there they have really built a strong network between the primary and specialty care sectors.
We saw solid growth, it's still affected by a price reduction that was introduced in November of last year, it's still chugging along really well, and we're also expecting the subcutaneous version to be approved there later this year in the third quarter. We also touched on the EU launch already. It's good to see that it's starting to happen, that's still a very low share of our royalties. We turn to the full-year figures, I think the highlight here is that it was good to see that Eisai beat their forecast. They had a forecast of JPY76.5 billion for 2025. They beat that by 15%, reaching JPY88 billion or roughly $580 million, they roughly doubled from 2024 to 2025. Last week, they also issued a new forecast for 2026 of JPY 143.5 billion. That's roughly $910 million.
As Gunilla said, they are now approaching blockbuster status with Leqembi, which is really reassuring for us. Most of that growth, or I would say a big part of that growth, is expected to come from the U.S. market. As you can see here, the America's sector is expected to grow from JPY 44.6 billion to JPY 77.5 billion, that is roughly a 74% increase, which is significantly higher than they are expecting for the global market. A lot of growth is expected to come from the U.S. with the IQLIK and the blood-based biomarkers really making a splash from the second half of this year. If this forecast holds true, we will receive roughly JPY 880 million royalties during the same period, i.e., from April 26th to March 2027, which is, of course, a significant amount for us.
Turning to the next slide, we see on the left-hand side our net revenues. Our Q1 revenues were SEK 438 million. That's quite a big decline from the first quarter of last year, you should remember that we reported a $100 million upfront from Bristol Myers Squibb in the first quarter last year, it can't repeat that every first quarter. We're still really happy about the revenues that we generated, that includes then the SEK 290 million that was a milestone payment from Eisai. We're also really happy to see that the recurring revenue continues to increase. You saw the royalty was SEK 161 million and the co-promotion revenues SEK 7 million. We also recorded SEK 51 million from the Novartis collaboration where we received a $30 million upfront payment last year that is recognized over the entire collaboration.
Turning to our expenses, it seems like they're fairly flat. Our operating expenses in the quarter were JPY 207 million compared to JPY 203 million in the first quarter of last year. However, last year, we had quite a big currency effect that was recorded as a cost. If you look at the underlying operating costs, they are actually increasing quite a lot to JPY 203 million this year versus JPY 131 million last year. We do expect to see a continued increase in the costs for this year compared to 2025. I have previously guided that we expect the costs for 2026 to be roughly 50%-70% higher than 2025. We don't expect that high growth in the costs currently, we would like to revise that to be roughly 40%-60% higher in 2026 compared to 2025. On the right-hand side, you see our operating profit.
We're really happy to make a profit of SEK 211 million, still lower than last year, but still very, very solid, and we expect to be profitable for the full year in 2026. On the last slide, you see our net result. This was very much in line with our operating profit where the financial net that was positive and then a tax of SEK 12 million that counteracted that. All in all, very much in line with operating profit. Cash flow, of course, significantly lower than our operating profit. That's due to the fact that the sales milestone from Eisai was not paid in the quarter. It will be received during the second quarter.
Our cash balance was over SEK 2 billion, so again, very, very solid position, and we can continue to invest for the long term in our portfolios, so we look forward to continued investments and continued growth of the company. With that, I hand 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. If we look at the second quarter coming forward, we see that more and more patients are getting access to Leqembi around the globe, which is really reassuring, and we also see that in the Nordics so far through several private clinics in Finland, and we expect to see further progress in the Nordics initially on the private market. Eisai is driving continued regulatory processes on Leqembi in a great way, and IQLIK, the subcutaneous autoinjector, is approved for maintenance dose in the U.S., and we're now awaiting the response at the latest by 24th of August for induction treatment as well.
Later this year, the third quarter, we expect response from the authorities in Japan for both initiation and maintenance dosing of the subcutaneous autoinjector and in China early next year. We are, as Anna-Kaija said, also looking forward to more presentations on Leqembi at the next big Alzheimer's Congress in July in London at AAIC, and we are also looking forward to exidavnemab phase IIa readout that Johanna talked about in both Parkinson's disease and MSA patients later this year. We are also looking forward to when we can disclose additional partnerships. Next slide, please. Some key takeaways from today's presentation. I think BioArctic continues in the growth area in an excellent way, and we see great progress both on Leqembi as well as the rest of our portfolio and the BrainTransporter technology.
We are already delivering on our 2030 ambitions. I think Leqembi is well on track to become an established treatment for Alzheimer's disease. Sales continue to show increasing demand globally. It's well on its way to become a blockbuster. Our second part is project portfolio, which is progressing really well together with our BrainTransporter technology with new innovations. The third area, strong interest from potential partners. The fourth one, with that, we have a strong financial position. Next week is our AGM where there will be a decision around a dividend of SEK 2 million per share, and we have a strong financial solid position with more than SEK 2 billion in cash.
All in all, I think we are exceptionally well positioned for our continued growth journey, and I think the future looks very bright for BioArctic, and we are bringing hope for many patients. Next slide, please. By that, we say thank you so much 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 Joseph Hedden from Rx Securities. Please go ahead.
Good morning. Thanks for taking my questions. Your Q1 R&D spend was substantially above any quarter that we saw last year, and you've highlighted the progression of the portfolio. Just wondering if you can give any color as to which individual projects are seeing the greatest increase in costs. If you could give us any idea of the phasing of R&D costs that you expect going through this year. Second question on the exidavnemab phase II EXIST study, can you confirm what the final number of Parkinson's disease and MSA patients were after the study was fully recruited? Thank you.
Right. If we start with R&D costs, basically what happens is when we start IND-enabling activities in the program, we invest a lot more in CMC. There are a couple of programs where we're really happy to do that right now in the Parkinson's program. We are spending more on both exidavnemab and the follow-up compound that is coupled with our BrainTransporter. I would say the alpha-synuclein area is where we have increased the most without going into specifics regarding what program. For the year, we expect the costs to be a little bit lumpy going up and down, it's going to give you a really good estimate for the phasing of the costs during the year. Maybe it was a little bit higher than it will be in the next quarter, it's really, really hard to tell.
I would just stick to the full-year guidance of a 40% to 60% increase over last year in our total costs. That's sort of the only guidance I can give you that is more accurate. Then for the other question, I think it's up to Johanna to answer to the EXIST trial.
Thank you, Joseph, for those questions. In terms of the portfolio and the cost for R&D, of course, programs that are closer to an IND are more costly because then we initiate CMC activities and manufacturing and also toxicology studies to enable the clinical trials. The two programs that I talked about where we have initiated IND-enabling activities, the BAN2238 and BAN3014, are, of course, more costly in our R&D portfolio in the early pipeline, and then, of course, exidavnemab, which is our clinical asset, is also a more costly program.
In terms of the number of patients in the EXIST study for exidavnemab, I mean, for Parkinson's, we had two cohorts with two different doses, a low dose and a high dose, with 12 patients per arm, and it was 13 patients per arm, so we have dosed 26 patients for PD, and for MSA, we have only dosed the higher dose, so that is 12 patients that have been dosed in the MSA cohort.
That's great. Thank you very much.
The next question comes from Suzanne van Voorthuizen from Kempen. Please go ahead.
Hi there. Thanks for taking my questions. Maybe first, on the BrainTransporter, can you elaborate how your strategic discussions have been progressing over the recent few months and where the interest is geared more towards you at this moment? Is it in one of your existing programs or more on the use of the technology on a pharma program, or is it more tech-based like the use for different modalities? Some color would be nice, and then I have a follow-up on Leqembi after that.
I think what we can say is that we have a broad interest. We have interest both for our drug programs. We have also interest from our BrainTransporter with things that we have done before, and we also have interest in the new stuff that we're working on. I would say a broad interest.
Got it. On Leqembi, as for the Eisai guidance, how comfortable are you with the number that they put out, and can you elaborate a bit more on the status and next steps in the launch in the Nordic countries where you have co-commercialization rights? Thank you.
As for the full-year forecast, we can't really comment on that. This is Eisai forecast, and we believe that they are good at forecasting, and we can't really comment any more than that. As for the Nordics, I hand over to Anna-Kaija.
Yeah. As I already alluded to in the presentation, we were obviously disappointed with the Swedish negative recommendation, as our ambition is really to help patients access to these innovative treatments. Our Nordic launch strategy is really long-term and evidence-driven, and as we know, I mean, the reimbursement decisions differ across countries and systems all across Europe, actually, and we know that it takes time in Europe generally if you compare to the U.S. and Asia when it comes to speedy access and new innovations. We continue our dialogue with the different stakeholders and authorities, and as I mentioned, I mean, there might be some other pathways going forward with discussing a broader reimbursement in the different countries. We continue to engage and prepare for a broader reimbursement.
As we know, I mean, neither Europe nor Sweden is kind of a bigger chunk of our financial expectations of revenue, so we have time, and we continue.
As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. The next question comes from Rajan Sharma from Goldman Sachs. Please go ahead.
Hey. Morning. Thanks for taking my questions. Firstly, on exidavnemab, could you just help us understand what your internal bar is for a positive readout? I guess that's another way. What would you need to see to justify further development given that we've seen a reasonable amount of attrition with the mechanism previously? Then one on the commercials, realize it's small, but could you just help us understand the size of the commercial opportunity for Leqembi in the private markets in the Nordic regions? Are there any sort of comps that you could point to where there have been some successful rollouts in that segment of the market? Thank you.
Okay. With regard to exidavnemab, what we are looking for here, and we should remind ourselves what kind of study this is, it's a study where the primary endpoint is safety and tolerability and where we also will be looking at pharmacokinetics to see which doses should we use in phase IIb. We also have included some biomarkers, but they are more there in order to learn for and prepare for the next phase IIb studies. I think a positive readout would be that it's well tolerated and looks safe and that we can see what dose to use in the next study and that we have learned how to use the biomarkers.
That is what I would expect, I think we will have an interim analysis for safety at the U.S., then at the end of the year, we will have the full results from the study.
If I may add to that, in terms of recent attritions, there has also been recent progress with two alpha-synuclein antibodies now in phase III studies, the prasinezumab in PD from Roche and the amlenetug from Lundbeck in MSA. I think that every antibody needs to stand on their own merits, we have a very selective and the most selective antibody for what we believe are the toxic species, the aggregated alpha-synuclein. We have a differentiated profile. We also have an excellent human PK profile with a half-life in humans of 30 days.
The combination of this high selectivity and the very attractive pharmacokinetic profile, I think, makes us really being able to test the concept of alpha-synuclein lowering in an excellent way with exidavnemab. I think it's very important to not mix the antibodies with each other, and the study designs are also very, very different, I would say.
Yes. On the question on the size of the private market in the Nordics, I would say it's not a huge private market for the Nordics, you shouldn't have any major expectations on the sales. I think it's and it differs from one country to another, and you have to remember also that, of course, the different authorities have set up some requirements when it comes to the risk minimization measures required by EMA, and all the four major Nordic countries have different ways of adjusting that. It takes a little bit of time to set the clinics up and see if they kind of meet the criteria to offer treatment of Leqembi to private patients.
We think it's a good experience, and of course, it's very reassuring to know that some patients do have the opportunity at least to get treatment, and it's also much appreciated by the healthcare professionals in the other Nordic countries to hear the experience that the Finnish clinics are now having now when they are treating more and more patients in Finland. I think it's reassuring to see that there is an interest to provide this treatment to patients, but of course, we are looking forward to a broader reimbursement.
Thank you.
The next question comes from Joseph Hedden from Rx Securities. Please go ahead.
Sorry about that. Just a couple of follow-ups. BAN2238, is that the same antibody as exidavnemab just conjugated to the BrainTransporter technology, or is it a distinct antibody? Secondly, you talk about expanding use of the BrainTransporter platform. When thinking about incorporating different modalities, how much do you need to modify the technology itself? Is it all still based on the transferrin receptor? Are we talking about subtle tweaks, or is it something larger? Thank you.
If I start with the first question on BAN2238, it's not the same antibody as exidavnemab. It's a slightly modified antibody. That's all I can say. It's, of course, coupled to our BrainTransporter technology as well, but it's not exidavnemab. For the second question, in terms of modifying the BrainTransporter platform, I mean, this is a very versatile platform, and we have different transferrin receptor binders with different affinity. Depending on what you want to achieve, if it's a large CMAX or an AUC in the brain, if you need a rapid uptake or what kind of pharmacokinetic profile you need, you might need different affinities for the transferrin receptor.
This is a family of different options that we have, and it's a very versatile platform that we can tailor-make based on the target and the indication and the pharmacokinetic profile that you want to achieve with your specific modality and target of interest, I would say. It is very versatile, and we have modified it in several ways in order to play with it with different targets.
Okay. Thank you.
There are no more phone questions at this time. I hand the conference back to the speakers for any written questions and closing comments.
Thank you so much. We have one written question from Fredrik at Redeye, and it reads, "Any near-term effect on investments or costs in Sweden to be compensated for in the Leqembi co-promotion in the coming quarter due to the recent recommendation by the NT Council?" Anything we can comment there?
No.
That's the short answer.
We continue to prepare, and we really hope that we will be able also to help Swedish patients. Even though it's not a financial impact, which is large, we still want to help also Swedish patients.
Operator, I see that there's somebody waiting in the speaker queue.
The next question comes from Natalia Webster from RBC. Please go ahead.
We can't hear you, Natalia.
Apologies for that. Can you hear me okay now?
Yes. Perfectly.
Thank you. Firstly, just a follow-up on Leqembi regarding the sub-Q induction procedure delay. I appreciate we have Eisai guidance for the full year, how does a three-month delay affect your assumptions around the ramp through the year? Are there any read-throughs for the Japanese sub-Q initiation timeline as well? Second question is just on the BrainTransporter BAN2803. You previously had plans to go into phase I in 2026. Appreciate it's up to BMS, are you able to share any details around timelines there? Thank you.
If we start with the Leqembi subcutaneous autoinjector where the FDA has a new PDUFA date of 24th of August, they have asked for some more data on switching between IV and subcutaneous administration. Our partner, Eisai, are very confident that this will run through in a good way. We have a priority review, even if it is a 3-month delay, it is still shorter review time than if we had had a standard review time. I would not be surprised if it comes before 24th of August, but that is the PDUFA date. I do not think that we should see any read-through in this delay to Japan. On the other side, we see that Eisai mentioned that Q3 is when they expect that response. I think that it all looks very good.
I think that sub-Q autoinjector, which in the U.S. is called IQLIK, is a really important next step, which I think that will help patients a lot in making it more convenient. Your other question, I think, was I didn't hear really, but I thought you asked about BAN2803, which is partnered with Bristol Myers Squibb, and it's really in their hands, and we're not commenting upon exactly when that will go into man, but it's progressing well according to all news we have.
Thank you.
Okay. We see there's another written question here from Erik Hultgård at Carnegie. That's regarding the recent data that came out from Biogen on their Tau project and what the implications are, if any, for the field with that.
I think what we have seen in the Alzheimer field so far is that we have two treatments that have shown positive clinical data and also got through full registration process, Leqembi and one more. It is, of course, important to see if there can be other treatments coming through as well. We saw that there are some interesting data coming out from the phase II study from Biogen, and I really look forward to seeing the results at AAIC. I think it's good that we can have combination treatments in the future. We should remember that Leqembi, even though the target is amyloid, we also affect Tau and Phospho-Tau and so forth. I think maybe in the future, that will be good with combination treatments as well. I really look forward to seeing more data.
There doesn't seem to be any more questions lined up for us. With that, I think we thank everybody for listening in today and looking forward to seeing you soon.