BioArctic AB Class B

BioArctic AB Class B

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Q1 FY2026 · Earnings Call TranscriptMay 20, 2026

Operator

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 5 on their telephone keypad. Now, I will hand the conference over to CEO Gunilla Osswald with colleagues.

Please go ahead.

Gunilla Osswald

Good morning and 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 era continues in a great way for BioArctic. It's reassuring to see that more and more patients are getting access to Leqembi.

We had more than €500 million of sales during our partner Eisai's fiscal year. 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.

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 lecanemab, Leqembi, and we also have projects targeting alpha-synuclein, TDP-43, and huntingtin. The second area is where we are utilizing our BrainTransporter platform in unique ways to deliver antibodies more efficiently into the brain, but we have now also broadened our scope, and 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, and 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 €500 million the last 12 months.

We expect the subcutaneous autoinjector called Iclick, together with increasing use of blood-based biomarker, 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 2a study is fully recruited with results expected later this year.

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, and last year we initiated partnerships with Bristol Myers Squibb and Novartis.

We are 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 takes time. We are in a very strong position with our high-quality projects and innovative technologies.

The fourth aspect is strong financials, and our quarterly royalty revenues from Leqembi sales grew 68% compared to first quarter last year. We have now more than 2 billion Swedish kronor 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, and now we are getting 9% royalties from global Leqembi sales, and we have just then passed our second commercial milestone and got another €20 million from Eisai.

We have €34 million still remaining in milestones. For Bristol Myers Squibb, we have received $100 million so far, and there is a substantial amount left.

Novartis, we have so far received $30 million, and also here is a substantial amount still to receive if it also continues well. We are grateful for AbbVie, who has made us receive $30 million, which helped us build the company and also progressing the project further.

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. We cannot say exactly when timing 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.

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-licensing 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-synucleinopathies. Our lead program, exidavnemab, is progressing well.

The Phase 2 EXIST study in Parkinson's disease and multiple system atrophy is now fully recruited, and 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 PDBT2278 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 of manufacturing. The BrainTransporter therefore plays a critical role in unlocking the full potential of CNS therapies.

Next slide, please. Our next-generation alpha-synuclein antibody, the BAN2238, demonstrates strong preclinical performance, both with enhanced brain exposure and favorable safety profile.

By combining the alpha-synuclein targeting with our BrainTransporter technology, BAN2238 achieved significant increase in brain exposure in preclinical models. That is what you see in the middle picture here.

Importantly, this enhanced delivery is achieved without compromising safety, we observed no signs of anemia or reduction of reticulocytes while maintaining a full effector function of the protein. That's the data shown to your right.

Otherwise, reduction in reticulocytes is a commonly reported side effect targeting the 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 to 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 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.

All of them have very, very much higher brain exposure when coupled to the BrainTransporter platform. Across the platform, delivery of antibodies are 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. Then I will hand over to our Chief Commercial Officer, Anna-Kaija Grönblad.

Anna-Kaija Grönblad

Thank you, Johanna. I will continue with an update on Leqembi, and I'll start with stating that the global sales of Leqembi amounted to around $580 million in Eisai's fiscal year 2025.

That is almost a doubling versus the previous fiscal year. 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 over six months every six months since January 2024. Last year, CMS also formally included the blood-based biomarkers as a confirmatory diagnosis.

Today, it is estimated that approximately 15% of the diagnoses were done by these blood-based biomarkers. This 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 Iclick, which was approved in August last year. According to Eisai, Iclick 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 US with a set PDUFA date in in August, 24th of August, and with an expected approval also in Japan in quarter three this year and in China in quarter one 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 reimbursement are ongoing in the EU. Today, it's available in Germany and Austria, as well as out-of-pocket in UK, 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 NT 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 Nordics, and 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 ways of securing a structured introduction.

We are also evaluating a resubmission in Denmark, and 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, and 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 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 AD/PD 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 show that long-term continuation of treatment is essential, and that four years treatment with Leqembi saves between 10 to 14 months of time in the mildest stage of the disease, if you compare to matched controls in two large databases, the prespecified 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.

Also, as usage increases across the world, more and more hospitals present real-world data from clinical practice in these congresses, at AD/PD specifically from countries such as the US, Japan, China, and South Korea. To the right, you can see, for example, a graph showing that there is also a high treatments persistent in initially 371 patients at a US clinic starting in 2023.

It was 78% at 18 months, and after two years, it was a 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 CFO, Anders Martin-Löf.

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 €500 million, as that triggered a sales milestone to us to €20 million.

If we look at the quarter, the global Q1 sales were 26.2 billion yen, roughly $168 million. That's a 27% increase from the last quarter of 2025.

That meant that our royalties grew by 27% to 160.8 million Swedish. That was quite a steep increase, as you can see in the graph, up from 127 million in the fourth quarter.

This really big boost is due to the fact that the China sales are now back on the normal levels after very low sales in Q3 and Q4 due to big stockpiling during the second quarter of 2025. China sales were now 4.1 billion yen or $27 million, and that's almost a tenfold increase from the fourth quarter.

Our largest market is the US market, and there the growth is largely driven by the simplified diagnosis with blood-based biomarkers and the introduction of Iclick that talked about. That was a very healthy growth, going up to 13.4 billion yen, i.e., $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 Iclick 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.

There we saw solid growth, but 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, but that's still a very low share of our royalties.

If we then 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 76.5 billion yen for 2025.

They beat that by 15%, reaching 88 billion yen or roughly $580 million. They roughly doubled from '24 to '25.

Last week, they also issued a new forecast for 2026 of 143.5 billion yen. That's roughly $910 million.

As Gunilla said, they're 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 US market.

As you can see here, the Americas sector is expected to grow from 44.6 billion yen to 77.5. That's 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 US with the Iclick 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 880 million royalties during the same period, i.e., from April '26 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 438 million Swedish.

That's quite a big decline from the first quarter last year, but you should remember that we reported a $100 million upfront from Bristol Myers Squibb in the first quarter last year, and can't repeat that every first quarter. We're still really happy about the revenues that we generated, and that includes then the 219 million Swedish 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 161 million, and the co-promotion revenues 7 million.

We also recorded 51 million Swedish from the Novartis collaboration, where we received a $30 million upfront payment last year that is recognized over the entire collaboration. Turning then to our expenses, it seems like they're fairly flat.

Our operating expenses in the quarter were 207 million compared to 203 million in the first quarter 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're actually increasing quite a lot to 203 this year versus 131 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 cost for 2026 to be roughly 50 to 70% higher than 2025. We don't expect that high growth in the cost currently.

We would like to revise that to be roughly 40 to 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 211 million Swedish, still lower than last year, but that's still very, very solid. We expect to be profitable for the full year in 2026.

Finally, 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 12 million that counteracted that.

All in all, very much in line with our operating profit. Cash flow, then, 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 2 billion Swedish, again, very, very solid position, and we can continue to invest for the long term in our portfolio.

We look forward to continued investments and continued growth of the company. With that, I hand back to Gunilla.

Gunilla Osswald

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. 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. Iclick, the subcutaneous autoinjector, is approved for maintenance dose in the US, and we are 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.

We're also looking forward to exidavnemab Phase 2a readout that Johanna talked about in both Parkinson's disease and MSA patients later this year. We're 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 era 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, and sales continue to show increasing demand globally, and 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, and that next week is our AGM, where there will be a decision around a dividend of 2 Swedish kronor per share.

We have a strong financial solid position with more than 2 billion Swedish kronor in cash. All in all, I think we are exceptionally well positioned for our continued growth journey.

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 are happy to take some questions.

Operator

If you wish to ask a question, please dial pound key 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key 6 on your telephone keypad.

The next question comes from Joseph Hedden from RX Securities. Please go ahead.

Joseph Hedden

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 could give any color as to which individual projects are seeing the greatest increase in cost, and then if you could give us any idea of the phasing of R&D costs that you expect going through this year. Second question, just on the exidavnemab Phase 2 EXIST study, could you confirm what the final number of Parkinson's disease and MSA patients were after the study was fully recruited?

Thank you.

Anders Martin-Löf

Right, if we start with R&D costs, basically what happens is when we start IND-enabling activities in a 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.

Then for the year, we expect the costs to be a little bit lumpy, going up and down, it's to give you a really good estimate for the facing of the costs during the year. Maybe it was a little bit higher than it will be in the next quarter, but 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.

Johanna Fälting

Thank you, Joseph, for those questions. In terms of the portfolio and the costs for R&D, of course, programs that are closer to an IND is 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 3014, are, of course, more costly in our R&D portfolio in the early pipeline. Then, of course, exidavnemab, which is our clinical asset, is also a more costly program.

In terms of the number of patients in the study, EXIST study for exidavnemab, for Parkinson's, we had two cohorts with two different doses, a low dose and a high dose, with 12 patients per arm. Actually it was 13 patients per arm, we have dosed 26 patients for PD.

For MSA, we have only dosed the higher dose, so that is 12 patients that has been dosed in the MSA cohort.

Joseph Hedden

That's great. Thank you very much.

Operator

The next question comes from Suzanne van Voorthuizen from Kempen. Please go ahead.

Suzanne van Voorthuizen

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 to at this moment? Is it in one of your existing programs, or more only use of the technology for on a pharma program, or is it more tech-based like the use for different modalities?

Some color would be nice. Then I have a follow-up on Leqembi after that.

Gunilla Osswald

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.

Suzanne van Voorthuizen

Got it. Then on Leqembi, as for the Eisai guidance, how comfortable are you with the number that they put out?

Can you also elaborate a bit more on the status and next steps in a launch in the Nordic countries where you have co-commercialization rights? Thank you.

Anders Martin-Löf

As for the full-year forecast, we can't really comment on that. This is Eisai's 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 the word to Anna-Kaija.

Anna-Kaija Grönblad

As I already alluded to in the presentation, we were obviously disappointed with the Swedish negative recommendation, as our ambition is really to help patient access to these innovative treatments. Our Nordic launch strategy is really long term and evidence driven, and as we know, the reimbursement decisions differs across countries and system all across Europe actually, and we know that it takes time in Europe generally if you compare to US and Asia when it comes to speedy access and new innovations.

We continue our dialogue with the different stakeholders and authorities, and as mentioned, there might be some other pathways going forward with discussing broader reimbursement in the different countries. We continue to engage and prepare for a broader reimbursement.

As we know, neither Europe nor Sweden is kind of a bigger chunk of our financial expectations of revenue, we have time and we continue.

Operator

As a reminder, if you wish to ask a question, please dial pound key 5 on your telephone keypad. The next question comes from Rajan Sharma from Goldman Sachs.

Please go ahead.

Rajan Sharma

Hi, 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, asked 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. Johanna?

Gunilla Osswald

Okay. With regard to exidavnemab, what we're 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 2b. We also have included some biomarkers, but they are more there in order to learn for and prepare for the next Phase 2b 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, and I think we will have an interim analysis for safety at an earlier stage, and then at the end of the year, we will have the full results from the study.

Johanna Fälting

If I may add to that in terms of recent attritions, there's also been recent progress with two alpha-synuclein antibodies now in Phase 3 studies: prasinezumab in PD from Roche and Lu AF82422 from Lundbeck in MSA. I think that every antibody needs to stand on their own merits, and we have a very, 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 human of 30 days.

A 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 design are also very, very different, I would say.

Anna-Kaija Grönblad

Yes, and 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 differs from one country to another, and you have to remember also that, of course, the different authorities has 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.

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 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.

Of course, we are looking forward to a broader reimbursement.

Rajan Sharma

Thank you.

Operator

The next question comes from Joseph Hedden from RX Securities. Please go ahead.

Joseph Hedden

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? Then 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.

Gunilla Osswald

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, 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.

Joseph Hedden

Thank you.

Operator

There are no more phone questions at this time, I hand the conference back to the speakers for any written questions and closing comments.

Anders Martin-Löf

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.

Anders Martin-Löf

That's the short answer.

Gunilla Osswald

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.

Anders Martin-Löf

Operator, I see that there's somebody waiting in the speaker queue.

Operator

The next question comes from Natalia Webster from RBC. Please go ahead.

Anders Martin-Löf

We can't hear you, Natalia.

Natalia Webster

Apologies for that. Can you hear me okay now?

Anders Martin-Löf

Yes, perfectly.

Natalia Webster

Thank you. Firstly, just a follow-up on Leqembi regarding the subcu induction PDUFA delay.

Appreciate we have Eisai's guidance for the full year, but how does a three-month delay affect your assumptions around the ramp through the year, and are there any read-throughs for the Japanese subcu initiation timeline as well? Then second question is just on the BrainTransporter BAN2803.

You previously had plans to go into Phase 1 in 2026. Appreciate it's up to BMS, but are you able to share any details around timelines there?

Thank you.

Gunilla Osswald

If we start with the Leqembi subcutaneous autoinjector, where the FDA has a new PDUFA date of 24th of August, and they have asked for some more data on switching between IV and subcutaneous administration, and our partner Eisai are very confident that this will run through in a good way. We have a priority review, and even if it is a three-month delay, it's 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's the PDUFA date. I don't 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 it all looks very good.

I think that subcu autoinjector, which in the US is called Iclick, 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 on exactly when that will go into man.

It's progressing well, according to all news we have.

Natalia Webster

Thank you.

Anders Martin-Löf

We see there's another written question here from Erik Hultgård at Carnegie, and that's regarding the recent data that came out from Biogen in their tau project, and what the implications are, if any, for the field with that.

Gunilla Osswald

I think what we have seen in the Alzheimer's field so far is that we have two treatments that has shown positive clinical data and also got through full registration process, Leqembi and one more. Then 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 2 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 there will be good with combination treatments as well.

I really look forward to seeing more data.

Anders Martin-Löf

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 again.