BioArctic AB (publ) ($BIOAB)
Earnings Call Transcript · May 20, 2026
Highlights from the call
In the first quarter of 2026, BioArctic AB reported revenues of SEK 438 million, reflecting a decline from the previous year primarily due to the absence of a significant upfront payment received in Q1 2025. However, the company's royalty revenue from Leqembi sales grew by 68% year-over-year, indicating strong market demand. Management reiterated their expectation for Leqembi to achieve blockbuster status with projected sales exceeding USD 900 million by 2030, and they maintained a robust cash position of over SEK 2 billion, allowing for continued investment in R&D and potential dividends.
Main topics
- Leqembi Sales Growth: Leqembi sales reached EUR 500 million over the last 12 months, with Q1 sales of approximately USD 180 million, nearly doubling from the previous fiscal year. CEO Gunilla Osswald stated, "Leqembi is well on its way to become a blockbuster with yearly sales more than USD 1 billion in not too long."
- R&D Expense Increase: R&D expenses rose significantly due to IND-enabling activities for key projects, particularly in the alpha-synuclein area. CFO Anders Martin-Lof noted, "We expect the cost for 2026 to be roughly 40% to 60% higher compared to 2025."
- Regulatory Challenges in Nordic Markets: Management expressed disappointment over a negative recommendation for Leqembi in Sweden, complicating access for patients. Anna-Kaija Gronblad mentioned, "We continue our dialogue with the different stakeholders and authorities... it takes time in Europe generally if you compare it to U.S. and Asia."
- Pipeline Progress: The alpha-synuclein project exidavnemab is fully recruited for its Phase IIIa study, with results expected later this year. Johanna Fälting highlighted that "the Phase II EXIST study in Parkinson's disease... is now fully recruited."
- Cash Position and Financial Stability: BioArctic reported a strong cash balance of over SEK 2 billion, providing a solid foundation for ongoing investments and potential dividends. Gunilla Osswald stated, "We are exceptionally well positioned for our continued growth journey."
Key metrics mentioned
- Revenue: SEK 438 million (vs SEK 538 million in Q1 2025, reflecting a decline due to the absence of upfront payments)
- Royalty Revenue: SEK 161 million (up 68% YoY, driven by Leqembi sales growth)
- Operating Profit: SEK 211 million (lower than last year but still solid; management expects profitability for the full year 2026)
- Cash Position: SEK 2 billion (providing a strong foundation for investments and dividends)
- Leqembi Sales Forecast: USD 900 million (expected by 2030, with potential for over USD 1 billion annually)
- Q1 R&D Spend: SEK 207 million (increased from SEK 203 million in Q1 2025; expected to rise 40%-60% in 2026)
BioArctic's strong sales growth for Leqembi and solid cash position are positive indicators for future performance. However, rising R&D costs and regulatory hurdles in key markets present risks. Investors should monitor upcoming trial results and regulatory developments as potential catalysts for stock performance.
Earnings Call Speaker Segments
Operator
OperatorWelcome to BioArctic Q1 Report 2026. [Operator Instructions] Now I will hand the conference over to CEO, Gunilla Osswald with colleagues. Please go ahead.
Gunilla Osswald
ExecutivesGood 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 around 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 sites fiscal year. And that resulted in a commercial milestone to BioArctic. Our projects and our range of technology are also progressing really well, and we had 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 Nasdaq Stockholm LargeCap, this is our disclaimer. Next slide, please. So I'm Gunilla Osswald, and I'm the CEO of BioArctic, and I will share today's presentation with our CFO, Anders Martin-Lof, and our Chief R&D Officer, Johanna Falting; and our Chief Commercial Officer, Anna-Kaija Gronblad. Next slide, please. I will start our presentation by given some key highlights. Next slide, please. BioArctic is focusing on 2 different platforms in precision neurology, and we are among the world's 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 Huntington. The second area is where we are utilizing our BrainTransporter platform in unique ways, deliver antibodies more efficient 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 stated that we have 4 areas of focus. The first one is to establish Leqembi after disease-modifying treatment for Alzheimer's disease. And here, we see a steady growth across geographies with sales that was more than EUR 500 million in the last 12 months. And we expect the subcutaneous auto vector called Iqlik, together with increasing use of blood-based timer, that together will contribute to continued strong growth. The second aspect here is that has also indicated in the guidance for 2030 that we are expecting sales of more than USD 900 million. So I think that Leqembi is well on its way to become blockbuster with yearly sales more than USD 1 billion in not too long. The second area is to have a broader time line and more advanced with projects in all stages of development. And 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 IIIa study is fully recruited with the results expected later this year. And also, the follow-up compound BAN2802 with our BrainTransporter alpha-synuclein in an antibody. And there, the ING activities are ongoing in order to take the compound into next year. The third area is more partnerships. And last year, we initiated partnerships with Bristol Myers Squibb and normalities. And 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 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 revenue from the Leqembi sales grew 68% compared to first quarter last year. And we have now more than SEK 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, but is a key component behind. has been a long-term successful collaboration all the way back since 2005. And now we are getting 9% of royalties from global Leqembi sales, and we have just then passed our second commercial milestone and got another EUR 20 million from. And we have EUR 34 million still remaining in milestones. For Bristol Myers Squibb, we have received USD 100 million so far, and there is a substantial amount left. And Novartis, we have so far received USD 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 receiving USD 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. And we expect more partners to come. That is our business model, and we are working on that, and we cannot say exactly when time is, but we will let you know when we Leqembi disclose. Next slide, please. So by that, I hand over to our Chief R&D Officer, Johanna Falting.
Johanna Fälting
ExecutivesThank you, Gunilla. Next slide, please. So as Gunilla talked to, our R&D portfolio is built on 2 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 Leqembi programs, including the start of IND-enabling activities for BAN2238 and BAN3014. Overall, we are advancing a diverse partner validated pipeline and growing scientific, strategic and commercial options. Next slide, please. So our alpha-synuclein portfolio continues to advance and expand the offering will take opportunities across alpha-synuclein. Our lead program, exidavnemab, is progressing well. The Phase II EXIST study in Parkinson's disease and multiple systemic 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 in discovery. And together, this builds a strong expanding of alpha-synuclein pipeline from clinical stage to future innovation. Next slide, please. So our BrainTransporter platform addresses one of the most fundamental challenges in neuroscience, efficient delivery across the blood-brain barrier of therapeutics. And this is enabled by active transport of biopharmaceuticals into the brain via the transpiring receptor. And this enhanced delivery can translate into higher foster and deep brain exposure with improved clinical outcomes, improved patient convenience, safety and lower cost for manufacturing. So the BrainTransporter therefore plays a critical role in unlocking the full potential of CNS therapies. Next slide, please. So our next-generation alpha-synuclein antibody, the BAN2238 demonstrates strong preclinical performance, both with enhanced brain exposure and favorable safety profile. So by combining the alpha-synuclein targeting with our BrainTransporter technology, BAN2238 achieved 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. So we observed no signs of anemia or reduction of radicular sites while maintaining a full effector function of the protein, and that's the data shown you right. So otherwise, reduction in reticulocyte is a commonly reported side effect targeting a transparent receptor for brain delivery. So overall, the BAN2238 highlights how the brain transporter has the potential to both improve club engagement and reduce development risk, strengthening the value of our next-generation pipeline. Next slide, please. So as Gunilla also mentioned, we are also now broadening our BrainTransporter platform beyond antibodies and enzymes can also include additional modalities such as genetic medicines and small molecules, significantly increasing the growth of the platform. So the data in the picture here clearly shows how the BrainTransporter copper modalities deliver superior brain resolution so compared to a standard therapy. So 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, and you see a small modality and all of them have a very, very much higher brain exposure when coupled to the BrainTransporter platform. So across the platform, delivery of antibodies are preclinically validated advancing. Enzymes are progressing with our first internal program, the GTS program for disease and small modalities represent a new important growth area for us. So overall, the BrainTransporter is evolving in diversity platform with particular future and value drivers across CNS discovery disorders. Next slide, please. So then I will hand over to our Chief Commercial Officer, Anna-Kaija Gronblad.
Anna-Kaija Gronblad
ExecutivesThank you, Johanna. So I will continue with an update on Leqembi and I'll start with stating that the cool sales of Leqembi amounted to around USD 180 million in Eisai fiscal year 2025. So that is almost 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 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 twelvefold increase over the last 2 years with a number actually doubling over 6 months -- every 6 months since January 2024. Last year, CMS also formally included the blood-based biomarkers as confirmatory diagnosis. And today, it is estimated that approximately 15% of the diagnoses were done by these blood-based biomarkers. And 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 auto-injector Iqlik, which was approved in August last year. So according to Eisai, Iqlik also seems to have led to an increase in new patients initiating treatment with Leqembi IV. So going forward, we see even more expansion possibilities with the potential approval of the subcutaneous initiation treatment, both in the U.S. with the PDUFA in August 24th of August and with an expected approval also in plan in quarter 3 this year and in China in quarter 1 next year. So this is a huge advantage for patients, the caregivers and less of a bottleneck for hospitals and obviously also a competitive edge for Leqembi. So in Europe, the IV maintenance dosing is under regulatory view at IRMA since February. And in parallel, the negotiations for pricing and reimbursement are ongoing in the EU. And so today, it's available in Germany and Austria as well as out-of-pocket in U.K., Finland and Portugal. So next slide, please. So as the no countries are BioArctic's home market, I thought I would also comment on the recent negative recommendation for Leqembi 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 DLB, the Dental and Pharmaceutical Benefits Agency. So in some of the assumptions in the health economic modeling, we're extremely conservative in our opinion. Although Eisai was very solution-oriented in the negotiations, the expectations from the anticancer were impossible to meet at this point. But both Eisai and BioArctic we are very committed to securing patient acts in Sweden and across Nordics and the 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. And we could also try to find another innovative ways of securing structured introduction. We are also evaluating a resubmission in Denmark. And in the coming months, we are expecting to see assessment reports coming out of -- in Norway and Finland. But in the meantime, though, we see that there is a private market in Finland. For 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. So in parallel, our neuroscience account managers as well as our medical affairs team are working every day with education on that site readiness activities in preparation for a broader reimbursement across the Nordics. So next slide, please. So finally, I would like to conclude by showing a few highlights from the Congress in March in Copenhagen, where a 4-year follow-up data we have presented for the EU approved population, meaning the APOE4 noncarriers or. This data show that long-term continuation of treatment is essential and that 4 years treatment with Leqembi sails between 10 to 14 months of time in the mid stage of this -- of the disease if you compared to matched controls in 2 large data betas, the prespecified admecohort and the match cohort of the Swedish fire finder. At the conference, it was also highlighted that starting treatment as early as possible as it seems. It is -- 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 ADPD specifically from countries such as the U.S., Japan, China and South Korea. And to the right, you can see, for example, the graph showing that there is also a high treatment persistent in initially 371 patients at a U.S. clinic starting in 2023. It was 78% at 18 months. And after 2 years, it was 67% persistence of the treatment. So more and more data further strengthen the Leqembi efficacy safety profile, and we are already looking forward to be attending attending next congress coming up the AAIC in London in July. So next slide, and I will there by hand over to our CFO, Anders Martin-Lof.
Anders Martin-Lof
ExecutivesThank 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 26.2 billion, roughly $168 million. That's a 27% increase from the last quarter of 2025. And it meant that our royalties grew by 27% to SEK 160.8 million. There was quite a steep increase, as you can see in the graph, up from SEK 127 million in the fourth quarter. And this is -- 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. So China sales were now 4.1 billion or $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 Iqlik that I talked about. And there was a very healthy growth going up to 13.4 billion, i.e., $86 million, and that's a 13% increase from the fourth quarter. And as Anna-Kaija also alluded to, the 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. There we saw solid growth, but it's still affected by a price reduction that was introduced in November of last year, but it's still chugging along really well, and we're also expecting the subcutaneous version to approved there later this year in the third quarter. We also touched on the 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. The -- I think the highlight here is that it was good to see that Eisai did their forecast, they had a forecast of 76.5 billion for 2025. And the EBITDA by 15%, reaching 88 billion or roughly $580 million. So they roughly doubled from '24 to '25. Last week, we also issued a new forecast for 2026 of JPY 143.5 billion. That's roughly $910 million. So 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 down from the U.S. market. As you can see here, the Americas sector is expected to grow from 44.6 billion to 77.5 billion. So that's roughly a 74% increase, which is significantly higher than they are expecting for the global market. So a lot of growth is expected to come from U.S. with with Iqlik and the blood-based biomarker really making its flash from the second half of this year. If this forecast holds true, we will receive roughly SEK 880 million royalties during the same period, i.e., from April '26 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 last year. But you should remember that we recorded a $100 million upfront from Bristol Myers Squibb in the first quarter last year and that can repeat that every first quarter. But so we're still really happy about the revenues that we generated and that includes 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. So the royalty was SEK 161 million, and the core promotional 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 then to our expenses. It seems like they're fairly flat. Our operating expenses in the quarter were SEK 207 million compared to SEK 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. So if you look at underlying operating costs, they are actually increasing quite a lot to SEK 203 million this year versus SEK 131 million last year. And we do expect to see a continued increase in the cost for this year compared to 2025. I have previously guided that we expect the cost for 2026 to be roughly 50% to 70% here than in 2025. We don't expect that high growth in the cost currently. So 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 SEK 211 million is still lower than last year, but that's still very, very solid, and 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 by the financial net that was positive and then tax of SEK 1 million that contracted that. So all in all, very much in line with the 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 not paid in what it will be received during the second quarter. But 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 portfolio. So we look forward to continued investment and continued growth of the company. With that, I hand back to Gunilla.
Gunilla Osswald
ExecutivesThank you so much, Anders. So we are coming towards the end of today's presentation with some upcoming news flow and some closing remarks. So if we look at second quarter coming forward, we see more and more patients are getting access to the 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 I click the subcutaneous sector is approved for maintenance dose in the U.S., and we're now awaiting the response at the latest by 24th August for induction treatment as well. And later this year, in the third quarter, we expect response from the Novartis in Japan for both initiation and maintenance dosing of the subcutaneous auto-injector 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 Congress in July, in London at AAIC, and we are also looking forward to EXIST Phase III readout that talked about in both Parkinson's disease and patients later this year. And we're also looking forward to when we can disclose additional partnerships. Next slide, please. So 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. So 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 insect from potential partners and the fourth one that we have a strong financial position. And that next week is our AGM, where there it will be a decision around a dividend of Swedish crowns share. And we have a strong financial solid position with more than SEK 2 billion in cash. So 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. So by that, we say thank you so much for your attention, and we are happy to take some questions.
Operator
Operator[Operator Instructions] The next question comes from Joseph Hedden from Rx Securities.
Joseph Hedden
AnalystsYour Q1 R&D spend was substantially above any quarter that we saw last year and the pressure of the portfolio. Just wondering if you can 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? And the second question, just on the exidavnemab Phase III EXIST study, can you confirm what the final number of Parkinson's disease and MSA patients were after the was set recruited?
Anders Martin-Lof
ExecutivesRight. So if we start with R&D costs, basically, what happens is when we start IND-enabling activities in the program, we see -- invest a lot more in CMC. So there are a couple of programs where we're really happy to do that right now in the Parkinson program. We are spending more on both exidavnemab and the follow-up compound that is coupled with the BrainTransporter. So I would say the alpha-synuclein areas where we have without going into specifics regarding what program. Then for the year, we expect the cost to be a little bit lumpy going up and down. So it's really good for the phasing of the costs during the year. So maybe it was a little bit higher than it will be in the next quarter, but it's really, really hard to tell. So I would just stick to the full year guidance of 40% to 60% increase over last year in our total cost. That's sort of the only guidance I can give you that is more accurate. And then for the other question, I think it's up to Johanna to answer to the EXIST trial.
Johanna Fälting
ExecutivesYes. Thank you, Joseph, for those questions. And in terms of the portfolio and the cost for R&D, of course, programs that are closer to an IND is more positive because then we initiate CMC activities and manufacturing and also toxicology studies to enable the clinical trials. So the 2 programs that I talked about where we have initiated IND-enabling activities, the BAN2238 and 2014 are, of course, were costly in our R&D portfolio in the early pipeline. And then of course, exidavnemab, which is our clinical asset, is also a more positive program. And in terms of the number of patients in the study, EXIST study for exidavnemab. I mean for Parkinson, we had 2 cohorts with 2 different doses, a low dose and a high dose with 12 patients per arm, and it actually it was 13 patients per arm. So we have dosed 26 patients for PD. And for MSA, we have only dosed higher dose. So that is 12 patients that have been dosed in the MSA. .
Operator
OperatorThe next question comes from Suzanne van Voorthuizen from Kempen.
Suzanne van Voorthuizen
AnalystsMaybe 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 technology for a pharma program? Or is it more tech-based like the use for different modalities? Some color will be nice. And then I have a follow-up on the Leqembi.
Gunilla Osswald
ExecutivesYes. So 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 new stuffs that we're working on. So I would say a broad interest.
Suzanne van Voorthuizen
Analysts-- got it. And then on Leqembi, as for the Eisai guidance, how comfortable are you with the number that they would out? And can you also elaborate a bit more on the status and next steps in the launch in the Nordic countries where you have co-commercialization rights?
Anders Martin-Lof
ExecutivesAs for the full year forecast, we can't really comment on that. This is Eisai's forecast, and we believe that they are good and forecasting, and we can't really comment any more than that. As for the Nordics, I hand word to Anna-Kaija.
Anna-Kaija Gronblad
ExecutivesYes. As I already alluded to in the presentation, we were obviously disappointed with them. Swedish negative recommendation as our ambition is really to help Alexis to these innovative treatments. But our Nordic launch strategy is really long term and evidence driven. So -- and as we know, I mean, the reimbursement decisions differs across countries and systems across Europe, actually, and we know that it takes time in Europe generally if you compare it to U.S. and Asia when it comes to speedy access and new innovation. So we continue our dialogue with the different stakeholders and authorities and as mentioned, I mean, there might be some other pathways going forward with discussing broader reimbursement in the different countries. So we continue to engage and prepare for broader reimbursement. And as we know, I mean, neither Europe nor Sweden is kind of bigger chunk of our financial expectations of revenue. So we have time and will continue.
Operator
Operator[Operator Instructions] The next question comes from Rajan Sharma from Goldman Sachs.
Unknown Analyst
AnalystsSo 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? And then one on the commercial, I realize it's small, but could you just help us understand the size of the commercial opportunity for like in the private markets and 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.
Gunilla Osswald
ExecutivesSo with regard to exidavnemab, what we're looking for here, 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 dose is in Phase IIb. And we also have included some biomarkers, but they had more that in order to learn for and prepare for the next Phase IIb studies. So I think a positive readout would be that it's well tolerated and looks safe and we can see what dose to use in the next study and that we have learned how to use the biomarkers. So that is what I would expect. And I think we will have like an interim analysis for safety at the other states. And then at the end of the year, we will have a full results from the study.
Johanna Fälting
ExecutivesAnd if I may add to that in terms of recent attritions, there's also been recent progress with alpha-synuclein antibodies now in Phase III studies, the in PD corrosion and Ilmenite from MSA. So -- and 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, they aggregated alpha-synuclein. So we have a differentiated profile -- we also have an excellent human PK profile within half-life in human of 30 days. So 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 in excellent indexed. So 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.
Gunilla Osswald
ExecutivesYes. So 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. So you shouldn't have any major expectations on the sales. But I think it's -- and it's different 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 4 major Nordic countries have different ways of adjusting that. So it takes a little bit of time to to set the clinics up and see if they kind of meet the criteria to offer treatment of Leqembi to private patients. But 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 health care 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. So 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
Operator
OperatorThe next question comes from Joseph Hedden from Rx Securities..
Joseph Hedden
AnalystsSorry about that. Just a couple of follow-ups. So BAN2238, is that the same antibody as exidavnemab just quantitated to the BrainTransporter technology or is a sick antibody? And then secondly, you talked about expanding use of the BrainTransporter platform. So when you're 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 sort tweaks or is it something larger?
Gunilla Osswald
ExecutivesYes. If I start with the first question on BAN2238, it's not the same antibody as exidavnemab. It's a slightly modified antibody. And that's all I can say. And it's, of course, coupled to our BrainTransporter technology as well, but it's not exidavnemab. And 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. So depending on what you want to achieve, if it's a large Cmax or an AUC in the brain, if you need a rapid uptick or what kind of pharmacokinetic profile you need, you might need different affinities for the transferrin receptor. So this is a family of different options that we have, and it's a very versatile platform that we can tailor made 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. So it is very versatile, and we have modified it in several ways in order to play it with different targets. .
Operator
OperatorThere are no more phone questions at this time. So I hand the conference back to the speakers for any written questions and closing comments.
Anders Martin-Lof
ExecutivesThank you so much. So we have one written question from Frederic at Red Eye 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?
Unknown Executive
ExecutivesNo.
Anders Martin-Lof
ExecutivesThat's the short answer.
Gunilla Osswald
ExecutivesWe 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
OperatorThe next question comes from the Natalia Webster from RBC.
Natalia Webster
AnalystsApologies for that. Can you hear me okay now?
Anders Martin-Lof
ExecutivesYes, perfectly.
Natalia Webster
AnalystsSo firstly, just a follow-up on Leqembi regarding the subcu induction producer delay. I appreciate we have Eisai's guidance for the full year, but how does a 3-month delay actual assumptions around the ramp through the year? And are there any read-throughs for the Japanese initiation time line as well? Then second question is just on the BrainTransporter BAN2803. You previously had plans to go into Phase I in 2026. I appreciate it's up to BMS, but are you able to share any detail around time lines there?
Gunilla Osswald
ExecutivesSo if we start with the Leqembi subcutaneous auto-injector, where the FDA has a new PDUFA date of 24th of August. And they are as 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. And we have a priority review. And even if it is a 3-month delay, it's still shorter review time than if we had had a standard review of time. . So -- and I would not be surprised if it comes before 24th of August, but that's the PDUFA date. And I don't think that we should see any read-through in this delay to Japan. On the other side, we see that Eisai Q3 is when they expect that response. So I think that's -- it looks very good. And I think that's, 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 on exactly when that were going to, but it's progressing well according to ones we have.
Anders Martin-Lof
ExecutivesOkay. We see there is another question -- written question here from Erik Hultgard at Carnegie. And that's regarding the recent data that came out from Biogen on their tau in their tau project and what the implications are, if any, for the field with that.
Gunilla Osswald
ExecutivesSo I think what we have seen in the field so far is that we have 2 treatments and has shown positive clinical data and also got 2 full registration process. Leqembi can be 1 more. And then it is, of course, important to see if there can be other treatments coming through as well. And we saw that there are some interesting data coming out from the Phase II study from and I really look forward to seeing the results that I see. And 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 mean we -- but I think maybe in the future, that will be good with combination treatments as well. So I really look forward to seeing more data.
Anders Martin-Lof
ExecutivesThere doesn't seem to be any more questions lined up for us. So with that, I think we thank everybody for listening in today. And looking forward to seeing you soon again.
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