BioArctic AB Aktie

Welcome to BioArctic Q2 Report 2026. [Operator Instructions]

Now I will hand the conference over to CEO, Gunilla Osswald, with colleagues. Please go ahead.

Thank you so much, and good morning, and welcome to BioArctic's presentation for the second quarter of 2026. Leqembi continues to progress really well with new approvals and launches. And BioArctic has signed additional strategic partnerships, and we will talk more about this in today's webcast. Next slide, please. BioArctic is listed at Nasdaq Stockholm Large Cap, and this is our disclaimer. Next slide, please. I'm Gunilla Osswald, 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 giving some key highlights. Next slide, please. BioArctic is among world leaders in 2 different areas. The first one is regarding highly selective antibodies where we are innovative and we are generating highly selective antibodies targeting aggregated misfolded forms of toxic proteins. And here, we have the frontrunner lecanemab, and we also have projects targeting alpha-synuclein and TDP-43, for example. The second area is when we are utilizing our BrainTransporter platform in an innovative and differentiated way to deliver antibodies. And I also want to highlight that we are broadening the platform to enable more efficient transportation into the brain of other modalities with innovative approaches, and this could be utilized for enzymes and genetic medicines like ASOs and siRNA. So a lot of new innovation is coming from BioArctic. Next slide, please.

We are already delivering on our 2030 ambitions, and they are in 4 different areas. The first one is regarding Leqembi to get it as an established treatment for Alzheimer's disease. And the Leqembi demand shows a steady growth to more and more patients on a global level. Sales are progressing in line with our partner Eisai's guidance. A true highlight during this summer was the FDA approval of Iqlik, the subcutaneous formulation with an autoinjector. And we got the approval from the FDA to 13th of July, and the U.S. launch was started this week. This means that there is an increased convenience for the patients to have the possibility to get their treatment at home instead of going to the infusion center. So I think it looks really bright also for further approvals and implementation of blood-based biomarkers, which also will simplify the diagnosis for patients. So these 2 aspects, the subcutaneous formulation together with the blood-based biomarkers for diagnosis are important for patients and for health care and is less costly for society and can lead to a broader uptake on the market.

The second area is with regard to a balanced and broader pipeline with projects in all stages of development. And here, I want to highlight Exidavnemab, our alpha-synuclein project, which is in Phase IIa in both Parkinson's disease and multiple systemic atrophy. And we had a planned safety review during this summer, and it was concluded that Exidavnemab showed a favorable safety profile, and it supports progression into Phase IIb, which is in planning. The other alpha-synuclein follow-up compound called BAN2238 is a follow-up compound to Exidavnemab with BrainTransporter. And here, we selected a candidate drug late last year, and the IND-enabling activities are progressing really well. And the pipeline overall continues to expand, and we have added new projects, for example, the ones due to new partnerships.

The third area is to have additional successful global partnerships. And we are very pleased with our new license agreement and collaboration with Eli Lilly as well as our previous collaborations together with Bristol-Myers Squibb and Novartis and of course, our partners since a long time ago, Eisai. And all these are working in neuro generation in different approaches. Our latest research collaboration with Mesenkia, a small Swedish biotech company, opens up utilization of our BrainTransporter in a new area, oncology, where better penetration into the brain is wanted. And here, we are focusing to start with on glioblastoma. I think it's great to see the continued strong interest in our BrainTransporter technology as well as in our proprietary programs. The fourth area is that our aim is to be profitable and have recurring dividends in the future.

We were highly profitable last year, and our strong financial position allows us to continue to invest heavily in our business as well as giving dividends to our shareholders. We have a strong financial position with about SEK 2 billion in cash at the end of the second quarter. And this is even without the upfront payment from Eli Lilly of USD 30 million, and we expect to be profitable this year. Next slide, please. Partnerships is a cornerstone in our business model and the key component behind our success. Our focus has been on big pharma and different business models. So we have 2 different business models here. The first category, we can see Eisai, AbbVie and Bristol-Myers Squibb, where they have done in-license agreements on innovative BioArctic developed programs.

The second category is Novartis and Eli Lilly, who are utilizing BioArctic as a platform company. So they bring their compounds to BioArctic. We reengineer the compounds and build in our BrainTransporter technology into new compounds. And we check then the transferrin receptor functionality and then hand it back to the partner who drives and finance the program further. Then I also want to add a new kind of addition to our business model is what we are doing with Mesenkia. I think this represents another category that we now are starting with a small research collaboration that could also lead to future business. Next slide, please.

Now I hand over to our Chief R&D Officer, Johanna Falting.

Thank you so much, Gunilla. Next slide, please. So our R&D portfolio continues to advance, as Gunilla has described. And this is really built on 2 complementary platforms, the antibodies and the BrainTransporter platform. A balanced mix of funded partnerships with Eisai, BMS, Novartis and Lilly, together with proprietary programs provide an -- both external validation and significant long-term value creation opportunities in the portfolio. All BrainTransporter collaborations are progressing well. And during the quarter, we have further strengthening the platform through 2 new collaborations, the Lilly partnership that represents a major validation by a leading neuroscience company and highlights also the platform's broad utility in -- or potential in CNS.

And then we have the Mesenkia collaboration that marks our first step into oncology, expanding the BrainTransporter platform beyond neurodegenerative diseases and broadening its future application potential. So overall, we continue to advance a diverse, increasingly partnered validated pipeline with expanding scientific and commercial potential, both for our antibody and our BrainTransporter platform.

Next slide, please. So taking a closer look at our alpha-synuclein portfolio, it is moving forward and expanding. So for Exidavnemab, during the quarter, we have evaluated the safety data from the Phase IIa EXIST study of Exidavnemab in both Parkinson's and multiple systemic atrophy and the results confirmed a favorable safety profile of the antibody, which is an important milestone for the program. So this data will provide a strong foundation for the next step of development, and we are currently planning for Phase IIb studies in both multiple systemic atrophy and Parkinson's disease-related dementia with the ambition to initiate these studies during next year. So Exidavnemab remains the most advanced alpha-synuclein targeting programs in our pipeline and addresses a significant unmet medical need in neurodegenerative diseases.

And for BAN2238, our BrainTransporter enabled alpha-synuclein antibody, we continue to make progress with the IND-enabling activities during the quarter. And BAN2238, it combines our disease expertise in alpha-synuclein biology with the BrainTransporter technology, which is then designed to enhance the antibody delivery across the blood-brain barrier. And this program is progressing according to plan, and we are currently expecting to initiate clinical development in next year. So together, Exidavnemab and BAN2238 represent a complementary strategy, combining the most advanced clinical stage asset with a next-generation BrainTransporter enabling program, targeting the same underlying disease biology. So next slide, please.

So one of the quarter's key highlights for us was really the new BrainTransporter collaboration with Lilly. Lilly selection of the BrainTransporter for next-generation CNS therapies provide a strong validation from a leading pharmaceutical company and reinforces the importance of efficient blood brain delivery for CNS drug development. And this collaboration expands, of course, the further potential on the application of the BrainTransporter beyond our internal programs, and it combines BioArctic neuroscience expertise with Lilly's global development capabilities, further strengthening the platform for long-term strategic and commercial value.

The Mesenkia collaboration in oncology marks BioArctic's entry into the oncology target space and expands the application of the BrainTransporter beyond neurodegenerative diseases. And the main focus here is glioblastoma, which is a highly aggressive brain cancer with significant unmet medical need. And together with Mesenkia, we are now evaluating a novel approach by combining the BrainTransporter with Mesenkia's HVEM targeting antibody, enhancing the drug delivery via this brain -- to the brain and also the capability to reach the tumor cells associated with reoccurrence and treatment resistance.

So this initial goal is to generate a drug candidate and establish a preclinical proof of concept in the program, further demonstrating the versatility of the BrainTransporter platform. So taken together, the Lilly and the Mesenkia collaboration highlights the broad potential of the BrainTransporter. Lilly validates the platform in neuro generation, while Mesenkia extends its application into oncology, demonstrating its versatility across multiple disease areas. So next slide, please.

And then I will hand over to our Chief Commercial Officer, Anna-Kaija Gronblad.

Thank you, Johanna. So let me go back to Leqembi and the global rollout of the subcutaneous initiation treatment. As Gunilla already mentioned, this is clearly an important step in really expanding the patient access and further strengthening our continued growth. So in the U.S., the FDA approved -- the approval came in July for the Leqembi, Iqlik initiation treatment, and it is available as of this week. So this will increase clearly the momentum as we now move into the second half of 2026. This will allow people the option to inject the drug themselves instead of going to the hospitals, so they can do this at home for the whole course of treatment. So without having to come to the clinic for the time consuming more invasive infusions. So this change is really expected to broaden uptake, especially for the people who live far from the clinics or travel frequently.

Looking at other benchmarks in the industry, we believe the uptake in the U.S. will happen gradually as the coverage will broaden at different time points with an expected shift potentially coming in the beginning of 2027. And we hope that the Medicare Part D coverage for both the initiation and maintenance can begin in January 2027. But we believe it will clearly be a commercial game changer and an advantage versus the competition. In Japan, we expect approval soon in this third quarter of 2026 and reimbursement a bit later expected to follow in the fourth quarter. And in China, the product is currently under priority review, and we expect the approval in the first half of 2027. So importantly also is that data presented in July this summer at the AAIC Congress in London, it showed really that the efficacy and the safety of the subcutaneous administration is comparable to the IV treatment. So it's clearly supporting the potential of this more convenient treatment option.

Eisai also continued to make progress across other international markets. So during the second quarter, Leqembi was launched in Australia, Belgium, Brazil and India. And at the same time, as market interest, unfortunately, is generally slower in Europe, the process continued to improve patient access across Europe. Here, the less frequent IV maintenance dosing is currently under EMA regulatory review. And if approved, this could not only enhance the convenience of continuous treatment, but also facilitate access discussions in some other countries in Europe. In the U.K., commercial discussions between Eisai and the NHS England are ongoing. And finally, we are seeing some encouraging interest from several private clinics in the Nordic countries and as we progress also the discussions for more broader public reimbursement.

So overall, we are very pleased with the progress. And together with the uptake of the usage of blood-based biomarkers, we see really significant opportunities to further expand patient access and growth. If you go to the next slide. So coming back to the AAI Congress in London this summer, several speakers showed data on how the drug is performing in the real world. Here, I'm highlighting a U.S. post-market study called LEADER, which now includes 16 clinical sites across the country.

In London, data were presented for a bit more than 400 patients from 13 sites. And after an average of 17 months of Leqembi use, approximately 83% had not progressed to more advanced disease as assessed by a clinician. So of these, 76% remained at the same disease stage and 6.5% improved. For a bit more than 200 people who have reached 2 years of treatment, the data are similar. 74% were stable and 9% improved. Among the a bit more than 200 patients that has been on treatment for more than 18 months, almost 80% transitioned to maintenance treatment either with Leqembi IV or subcutaneous Iqlik. So finally, safety observations in this real-world study were consistent with the FDA-approved label. So we are looking forward to the next data cut of approximately 600 patients that will probably be presented in November at the CTAD Congress.

So by that, I hand over to Anders, our CFO.

Thank you, Anna-Kaija. And if we then turn to the Leqembi numbers, we can see that the Leqembi growth continues. The global Q2 sales were JPY 29.3 billion or roughly $184 million, representing a healthy 12% increase from the first quarter or 27% increase from the second quarter of 2025. If we translate that into our royalties, you see that our royalties grew to -- by 12% to SEK 179.4 million in the second quarter. It doesn't look as fantastic if you compare with the second quarter 2025. But as you remember, there was a very low stockpiling effect in the second quarter of 2025. And if you remove that onetime effect, then the annual growth would have been roughly 43% in terms of royalties. So all in all, on a global scale, the growth looks really, really good.

We then turn to the U.S. The growth there, 13% growing to $97 million in the quarter is now mainly driven by simplified diagnosis. And you should understand that there is a very tough competitive situation right now in the U.S. in period that ended. So the Iqlik launch that happened earlier this week is going to be really, really exciting to follow. This has the potential to drive the royalties from Leqembi in a number of ways. First of all, Anna-Kaija mentioned that the uptake of patients is likely going to increase due to the fact that it's so much easier for patients to access the therapy this way. On top of that, Leqembi should be able to generate a larger share of new patients as it will be the only drug that is available in the subcutaneous formulation.

And the third factor is that since this is a much more efficient way of delivering these therapeutics, a larger share will end up with the pharmaceutical part of the treatment cost. So the revenue per patient is likely to go up as well. So all in all, this will be a very important factor for the royalties in the future. and it would be very, very exciting to follow.

In China, we also saw a very healthy growth going up to $30 million. Here, we will also most likely see the introduction of the subcutaneous version in the beginning of 2027. We are also seeing broader insurance coverage. Eisai communicated that, that will start to come into place in the fourth quarter of this year, also a very intriguing development. Japan was tough this quarter. It was flat from the first quarter, roughly $38 million in sales. And it seems like based on presentations that we saw at the large conferences this summer that the issue of capacity for infusions in Japan has been tougher there than in other markets. So it will be very, very important now that we expect to see the subcutaneous version come out also in Japan.

We are expecting approval in the third quarter of this year and reimbursement and launch towards the end of this year. So all in all, I think things are going fairly well, but the subcutaneous introduction will really have an impact here, even though it may not come directly, but gradually, this will have a very large impact on the royalties. EU has been slow. We've talked about that in previous presentations, and it's still slow. So we'll not dwell on that too much. All in all, Eisai reiterated their forecast of JPY 143.5 billion in their fiscal year 2026. That is roughly $900 million of sales this year. And that corresponds to roughly SEK 880 million in royalties during the time period.

If we then turn to our numbers, starting from the left, you see our net revenues that amounted to SEK 248 million in the second quarter. That looks like we're shrinking from the second quarter of 2025, but this is all due to the fact that there was a milestone of SEK 223 million in 2025, and there were no milestones that were paid in the second quarter of this year. The underlying recurring revenues did continue to increase. The royalties were roughly SEK 179 million, and then we also had co-promotion revenues. So we're approaching SEK 200 million in recurring revenues every quarter, which is very healthy.

We also have some revenues from our collaborations. We entered into a collaboration with Novartis last year, where we recognized SEK 51 million from the upfront payment in the second quarter. And as Gunilla already mentioned, we also entered into a collaboration with Lilly in the second quarter of this year. None of that was recognized in the second quarter. We will start to recognize that from the third quarter, and we expect that roughly 40% of the $30 million will be recognized during the remainder of 2026.

Turning then to our costs. They continue to increase. They were SEK 232 million in the second quarter, up from SEK 193 million a year ago. And this is all due to the fact that we're investing more and more in our project portfolio in preparations for our exciting trials with Exidavnemab. And we reiterate here that for the full year 2026, the cost -- the operating costs, I should say, are expected to increase by 40% to 60% compared to the year before. So if anything, I would say, in the low range of that spend, but we reiterate roughly 40% to 60%.

And as you see in the right-hand graph, we were not making a profit in the second quarter. But all in all, in the first half of the year, we made a profit of SEK 179 million, and we still expect to be profitable for the full year. If we then turn to the net result, you see that was slightly negative due to an impact of financial net and tax. The cash flow was very positive, much stronger than the operating profit. That is due to the fact that the Eisai EUR 20 million sales milestone was paid in May. And then cash and cash equivalents was roughly SEK 2 billion at the end of the second quarter, and that's despite us paying a dividend of SEK 177 million in June. And this does not then include the Lilly $30 million upfront payment that was paid in July. So at the end of July, we had over SEK 2.3 billion in cash. So all in all, our position remains extremely solid with plenty of room to keep investing in our R&D portfolio.

With that, I hand over back to Gunilla.

Thank you so much, Anders. So we are coming towards the end of today's presentation with some upcoming news flow and some closing remarks. Next slide, please. So if we look at the second quarter, I think it was great to see more patients getting access to Leqembi around the globe, also in smaller scale in the Nordics so far through the private clinics in Finland and hopefully soon also in other Nordic countries. Eisai is driving continued regulatory processes on lecanemab in a great way. And the Iqlik is the subcutaneous version with an autoinjector was recently approved and launched now also for initiation in the U.S. And later this year, we expect response from authorities in Japan and in China next year.

We also heard about continued impressive results from real-world usage when we were at AAIC Congress in London in July. as Anna-Kaija i alluded to and also for subcutaneous data. We are looking forward to the next big Alzheimer's Congress called CTAD clinical trials in Alzheimer's disease, which is in Boston in November, where we also expect more presentations around lecanemab. Exidavnemab, the Phase IIa study, study results are expected later this year. We heard some really important safety data that was coming during the summer, but the full study is expected to read out late this year. And we are preparing for starting Phase IIb next year. We will communicate on further potential partnership milestones, et cetera, when that is relevant.

Next slide, please. So some key takeaways from today's presentation. I think BioArctic shows continued growth, and we have great progress both on Leqembi well as the rest of our portfolio and the BrainTransporter technology. As I said, we are delivering on our 2030 ambitions already in a great way. Leqembi is well on track to become an established treatment in Alzheimer's disease and sales continue to show increasingly demand globally. The subcutaneous autoinjector Iqlik has now been launched in the U.S. also for initiation treatment, which is a major milestone. Our business development efforts continue to deliver, and we have just concluded a landmark deal with Eli Lilly with our BrainTransporter technology. And we have expanded our product portfolio also into oncology by the new research collaboration with Mesenkia, also utilizing our BrainTransporter technology.

And last but not least, we have a very strong financial position with -- which was about SEK 2 billion in cash at the end of June. And this is after the dividend of SEK 2 per share and before receiving the upfront of USD 30 million from Lilly, and we expect a positive result this year. So all in all, I think BioArctic is exceptionally well positioned for continued growth. And the future looks very bright for BioArctic and that brings 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 Instructions]

The next question comes from Joseph Hedden from Rx Securities.

Congratulations on the collaboration with Mesenkia that certainly looks like an exciting application of BrainTransporter. Just wondering if you could give us your thoughts on the time line to the preclinical validation. And then any details you can give us on additional aspects of the deal who would be in controlled in clinical development? Or are you going to be looking for a partner? And secondly, if I could, just on Exidavnemab. So you stated that you passed safety analysis that facilitate Phase IIb. Do you still expect to be presenting results from the study?

I'm sorry, I had a little bit difficult to hear the first question.

It was on Mesenkia time lines.

Mesenkia. Okay. I thought it was Lilly. Okay. So Mesenkia. Okay. Maybe Johanna want to.

Yes. Thank you, Joseph, for that -- those questions. So I can start with a question on Mesenkia. This is a preclinical research collaboration that will validate preclinically the target together with our BrainTransporter. So after that, we will continue with discussions on how we should progress this. But I think it's a bit too early to talk about the time lines really and when this kind of program could go into clinic. But this is first research collaboration where we do some things and they do some things, and we will do sort of a preclinical evaluation in a disease model and see if the concept works, and then we will go on into further discussions on how to progress if positive.

And the second question was with regard to Exidavnemab. So maybe you want to take that also, Johanna?

Yes. So that was the Exidavnemab EXIST study. And yes, our plan is to conclude this study by the end of the year and then also report some data from that.

And just a follow-up on Mesenkia, if I could. Are there any other companies looking at that specific target in glioblastoma? Or is this a completely novel program?

As far as we know, I think this is a unique target, and that's why we think it's really, really interesting. And I think it's also unique combining one of these diseases together with the BrainTransporter platform. As far as we know, there are no other programs out there trying to treat glioblastoma with any target and in combination with the transferrin receptor BrainTransporter platform. So I think that it's a really interesting program, and we really think it's solid and really nice science behind Mesenkia's ideas entering what can be seen as a stem cell for these cancer drugs in an extremely difficult-to-treat patient population and disease.

The next question comes from Max Da from Goldman Sachs.

This is Max Da for Rajan Sharma. I have a few. The first question is about Exidavnemab. So in your Phase IIa study, did you see any efficacy signal? And when should we expect the results from the Phase IIb study? Second question, how will you prioritize between Exidavnemab and BAN2238? Also, if I can have another question. Could you talk about when Eli Lilly will make a decision to move the program forward to clinical development?

Do you want to take it?

Yes, absolutely. So if we start with the question on Exidavnemab efficacy from the EXIST study, I think that you should remember that this study that we are now concluding is a Phase IIa study. So it's a small study and the primary endpoint is safety and tolerability. We are also looking at biomarkers exploratory, but I don't think we should get our hopes up too high on that one because the study is not powered to look for a clinical efficacy and it's not long enough. It's 3 months. And I think that you need much longer time for that. But we are definitely looking into that. But the primary endpoint is safety and tolerability. And in terms of the Phase IIb results, I think that we haven't communicated externally on those time lines. We are still looking at the design and planning this study.

And in terms of the prioritization between Exidavnemab and BAN2238, I mean, I think a real strength with this portfolio is that there are so many diseases here to treat. Alpha-synuclein is a key component in Parkinson's, in MSA and in DLB and potentially also some other diseases. I mean, we see a lot of co-pathology also with Alzheimer's. So my hope would be that we don't need to prioritize between these 2 that we can actually maybe position them for different diseases depending on how they span out. So I think that there is a real strength in having 2 different options that might be able to be positioned to different diseases.

And the third question was with regard to Lilly and the collaboration there, and we do not disclose details on that.

[Operator Instructions]

The next question comes from Mattias Haggblom from Nordea.

I have 2, please. So firstly, on Exidavnemab, now with a confirmed favorable safety profile from the ongoing Phase IIa testing in Parkinson's MSA patients. Sometimes the pushback around this asset is coming back to the fact that it's now roughly 4 years or somewhat more than 4 years that the asset was handed back to you. So I guess the question is, was there any point in time where there was a chance to use maybe Bayesian clinical trial design to possibly speed up clinical development and explore the optimal dose? And if not, why?

And then secondly, with draft guidance from FDA on Bayesian trial design in January, how is the company thinking about this as a tool across the rest of the portfolio in general terms?

So should I -- or do you want to -- you can.

Yes. No. So I think I agree with you that, I mean, we got the Exidavnemab program back from AbbVie 2022. And when they had done 2 Phase I studies and both of those studies showed excellent data with regard to safety, tolerability and pharmacokinetics. So the next thing that needed to be done was, of course, to look at multiple dosing. And we did that then in Parkinson's patients, and we also add the MSA patients. So we have expanded this into -- and we see more opportunities for further indications as well. So of course, you are right that there is a lot of interest in different kind of innovative clinical design models and with the Bayesian statistics, and we did utilize that for lecanemab. So far for Exidavnemab, we have done more traditional design and are taking it a bit more stepwise here. So I think that I really think Bayesian design is really interesting when it is the right thing. But so far, for Exidavnemab, we have utilized traditional design.

And any general thoughts around Bayesian trial design for the rest of the portfolio or what this draft guidance updated in January may possibly mean?

Yes. No, I think -- I mean, it's definitely something which is important and will continue to be important. And I think that how it was utilized for lecanemab is really also seen as a role model. That Phase IIb study with this adaptive design and with Bayesian design, I think, was really innovative and also came with really good results, understanding the dose that could be used in Phase III with a more traditional design was used. So I think I really think that it's important sometimes with the traditional design, but also in the future, of course, to look at adaptive designs and Bayesian design.

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

Thank you so much. We have a couple of written questions here. We'll start with one from [indiscernible]. He's asking about the research collaboration that we have ongoing for BAN2802 with Eisai and if there are any updates we can give there.

So I'm so sorry to disappoint you when it comes to different collaborations and discussions with partners, we cannot disclose. We can just say that everything looks really, really great that we have with 8 2802 and that we are in discussions with Eisai, but we cannot disclose anything more at this moment.

Thank you. And then another presentation from [ Mr. Balder, ] and he's asking about the Bristol-Myers Squibb collaboration, if it's still in preclinical phase and when it can be expected to enter patients.

So I can say, I think we have a really great collaboration also with Bristol-Myers Squibb. And again, we cannot disclose details of the program. Sorry.

Great. Thank you, Gunilla. I think there are no more people in the queue presenting, and there are no more written questions either. If you have any follow-up questions, you're obviously always welcome to give us a call or send us an e-mail. But I think that concludes today's call. See you again in 3 months.

Thank you so much. Have a great day.

Welcome to BioArctic Q1 Report 2026. [Operator Instructions]

Now I will hand the conference over to CEO, Gunilla Osswald with colleagues. Please go ahead.

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 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.

Thank 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.

Thank 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.

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 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.

Thank 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 Instructions]

The next question comes from Joseph Hedden from Rx Securities.

Your 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?

Right. 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.

Yes. 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. .

The next question comes from Suzanne van Voorthuizen from Kempen.

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 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.

Yes. 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.

-- 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?

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 and forecasting, and we can't really comment any more than that. As for the Nordics, I hand word to Anna-Kaija.

Yes. 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 Instructions]

The next question comes from Rajan Sharma from Goldman Sachs.

So 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.

So 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.

And 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.

Yes. 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

The next question comes from Joseph Hedden from Rx Securities..

Sorry 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?

Yes. 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. .

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

Thank 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?

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. .

The next question comes from the Natalia Webster from RBC.

Apologies for that. Can you hear me okay now?

Yes, perfectly.

So 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?

So 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.

Okay. 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.

So 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.

There 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.

Welcome to BioArctic Q4 Report 2025. [Operator Instructions]

Now I will hand the conference over to CEO, Gunilla Osswald; and CFO, Anders Martin-Lof. Please go ahead.

Good morning, and welcome to BioArctic's presentation for the fourth quarter and for the full year of 2025. It has been a fantastic year for BioArctic. In 2025, we entered into a new era that we call the growth era. And we can conclude that we have a transformative year behind us with record financial results. We are making our science accessible to more and more patients than ever before. And I think it's great and reassuring to see that more and more patients are getting access to Leqembi.

We are accelerating our innovations. Our portfolio is progressing really well and has been further expanded, and our BrainTransporter technology is further evolving with new innovations. We have increased focus on business development. We are broadening our collaborations and utilizing our BrainTransporter technology, and we'll talk more about all this in today's presentation.

Next slide, please. BioArctic is listed at Nasdaq Stockholm Large Cap, and this is our disclaimer.

Next slide, please. I'm Gunilla Osswald, and I'm the CEO of BioArctic, and I will share today's presentation with our CFO, Anders Martin-Lof; and our Chief R&D Officer, Johanna Falting; and our Chief Commercial Officer, Anna-Kaija Gronblad.

Next slide, please. I'll start our presentation by giving some key highlights. Next slide, please. I'm proud to state that BioArctic is among the world's leading innovators in precision neurology. We have 2 key platforms, where the first one is innovation and generation development of highly selective antibodies that are targeting aggregated misfolded forms of toxic proteins like lecanemab. And we also have then projects targeting alpha-synuclein, TDP-43 and Huntingtin.

The second area is the BrainTransporter platform, where we have an innovative way to deliver antibodies. And I want to highlight that we are broadening the platform to enable more efficient transportation of other modalities into the brain with new innovative approaches. We'll talk more about that in today's presentation.

Next slide, please. Last year, we held our first Capital Markets Day, where we presented our ambitions for 2030. And I'm so happy to see that we are already clearly delivering on our ambitions. If we start with the first one, LEQEMBI to be established treatment in Alzheimer's disease. LEQEMBI demand continues to grow to more and more patients, and we are now having global sales above USD 500 million. I think it looks bright with the blood-based biomarkers and the subcutaneous administration coming.

The second aspect is balanced and broader pipeline with projects in all stages of development. And the pipeline is already broader with new projects added last year for both Parkinson-related diseases as well as Huntington's disease.

The third one is additional successful global partnerships, and we are very pleased with Eisai and our 2 new collaborations since last year, Bristol Myers Squibb and Novartis. We are also really happy with the further discussions that are ongoing.

The fourth one is about our finances and our aim is to be profitable and have recurring dividends in the future. And we were highly profitable 2025, and our strong financial position allows us to continue to invest heavily in our business and at the same time, give something back to our shareholders. And there is a proposal by the Board of dividends of SEK 2 per share.

Next slide, please. So I just want to comment on some of the latest highlights towards delivering on our ambitions. So we start with Leqembi, and I would like to start by thanking -- thanks to our partner, Eisai's great work, Leqembi is now approved in 53 countries around the world. The subcutaneous auto-injector that is called Iqlik in the U.S. has been launched for maintenance dosing in the U.S.

The next important step is approvals of subcutaneous initiation dosing. And it was great to see that both the authorities in the U.S. and in China has granted priority review. And I think this points to how important the subcutaneous opportunity is for the patients. And we are very much looking forward to the PDUFA date that FDA has set by the 24th of May this year.

It's also reassuring to notice that all data being presented at congresses, including long-term data and real-world evidence data are very encouraging for Leqembi.

If we then turn to the pipeline, it's progressing really well, and we are growing the pipeline and they are advancing. If we look at our alpha-synuclein portfolio and start with exidavnemab, which is our antibody, which currently is in Phase IIa. The second part of the study with both Parkinson's disease and multiple systemic atrophy patients will be finalized this year, and we are actively preparing for Phase IIb.

We can also communicate that we have nominated 2 new candidate drugs, and we are preparing for INDs. And we have also further expanded our portfolio. And as you know, I'm very excited about our BrainTransporter technology platform, where we have further innovations for different modalities, including our BrainTransporter -- utilizing our BrainTransporter technology, and Johanna will talk more about this and show some nice new data.

The third one is about our partnerships. And as I've said, I'm really happy with all 3 partners: Eisai, Bristol Myers Squibb and Novartis. All 3 programs looks great. And it's also happy to notice that we were very busy during JPMorgan in January this year. And it's great to see that we have continued strong interest for our projects and for our BrainTransporter technology, both for antibodies as well as other modalities.

The fourth aspect is about our financials, and they are strong, and we were highly profitable in 2025 with record full year results of SEK 1.2 billion. The royalties for Leqembi are steadily increasing. And during 2025, we received several milestones also, both from Eisai and upfront payments from Bristol Myers Squibb and Novartis, and that led to that we have a strong cash position of SEK 2.2 billion, and Anders will talk more about this.

Next slide, please. So by that, I will now hand over to our Chief R&D Officer, Johanna Falting, for an update on R&D.

Thank you so much, Gunilla. Next slide, please. So this slide provides an overview of our R&D portfolio, featuring the 2 main platforms that Gunilla talked about, the antibodies and the BrainTransporter platform and also the highlighted cross-program synergies. So the portfolio includes fully funded projects, partnered with major global pharmaceutical companies such as Eisai, Bristol Myers Squibb and Novartis. And we also have several in-house projects and technology platforms with substantial market and out-licensing opportunities.

All collaborations involving the BrainTransporter platform are advancing well and as planned. And since the last quarterly update, we have also achieved important milestones within the portfolio, including the nomination of 2 candidate drugs, BAN2238 for alpha-synuclein disease and BAN3014 for TDP-related proteinopathies such as ALS. Additionally, you will notice a new project in the BrainTransporter portfolio, the PD-BT2278, and this is targeting the alpha-synuclein disease.

So next slide, please. So both BAN2238 and BAN3014 were recently nominated as candidate drugs and have now advanced from research into preclinical development. BAN2238 is targeting toxic aggregated alpha-synuclein such as oligomers, protofibrils and aggregates, and this is combined with the BrainTransporter technology. And it offers opportunities in several different synucleinopathies such as Parkinson's disease, MSA and dementia with Lewy body.

And for BAN3014, this antibody targets toxic aggregated TDP-43 proteins, such as oligomers, protofibrils and aggregates, and it offers opportunity for several of the TDP-43 proteinopathies such as ALS and frontotemporal dementia. So both of these programs, we have now initiated IND-enabling activities, and they are being prepared for clinical studies.

So the next slide, please. So alpha-synuclein misfolding and aggregation is central to alpha-synuclein disease development. And our alpha-synuclein portfolio offers opportunity in several of these synucleinopathies such as Parkinson's dementia with Lewy body and multiple systemic atrophy. Exidavnemab is most advanced and is currently being tested in the EXIST study, a Phase IIa study for safety and tolerability. And in parallel to this, we are preparing for the next stage of development into Phase IIb.

2238, that I just talked about, is the newly nominated alpha-synuclein antibody combined with the BrainTransporter technology for better efficacy and better brain uptake. And BAN2238 is an alpha-synuclein antibody combined with the BrainTransporter, also representing an additional advancement in the BrainTransporter portfolio, for which further details will not be disclosed at this time.

Next slide, please. I'm very excited to share some new data today on our BrainTransporter platform. So we know that the blood-brain barrier that represents a significant challenge for neuroscience. And if we can improve the delivery to the brain of our drugs, that represents an enormous opportunity for increased, of course, exposure in the brain, enhanced clinical efficacy, greater patient convenience by lowering the dose and offering other routes of administration, potentially better safety and lower manufacturing costs.

So we are investing very heavily in the BrainTransporter technology to deliver different types of biopharmaceuticals beyond antibodies and enzymes that we talked about in the past. So we have developed this technology further now to enable delivery of small drug modalities to the brain. So this is a very innovative and flexible system that aims to transport various type of drugs such as genetic medicines and small molecules into the central nervous system.

Next slide, please. So here, I'm very happy to show you some new data. And this image here compares the brain distribution of a standard antibody up to your upper left corner in green with a BT-coupled antibody in green below. And you can appreciate, I hope, the great increase of the green, fluorescent color, which represent the antibody present in the brain. And this is the same dose and the same time frame and the same antibodies just with and without the BrainTransporter technology.

So antibodies we have worked with for quite some time, but we have also now here shown you data with the distribution in the brain of an enzyme and also a small modality. So this BT-coupled approach significantly improves the brain distribution of our -- of drug modalities. And for the BTA, the antibodies, this is a technology now that is fully implemented and validated both in mice and in nonhuman primates. And here, we have both internal and external candidates at various stage of development.

And then the BTE, the enzyme platform, we have our first internal program, the BTG case for Gaucher's disease, and this is progressing very well. It's an orphan indication that offers potential -- offered market potential for BioArctic and a project that we can drive longer into the clinic. And I think that this enzyme project, it really sets the foundation for future enzyme-based projects coming along in the portfolio.

And then what's new and presented here today is the BTS, the BT small modalities. And this is a novel and very flexible system that enables efficient brain delivery of genetic medicines such as ASOs or siRNA. It could be degraders. It could be small molecule approaches or anything that you want to deliver into the brain basically.

And here, some key data is now being generating, showing the utility of the system. And what is shown here is then the brain distribution. And I think that there's been a really strong interest in our BrainTransporter technology at the JPMorgan Health Conference in September -- or in January in San Francisco. And we are very excited about the future further development of this platform and hope that we will be able to show you some more data in the coming year.

So next slide, please. So with this, I will hand over to our Chief Commercial Officer, Anna-Kaija Gronblad, for a commercial update.

Thank you, Johanna, and I will go back to Leqembi for a while, and I will start by just reminding everyone on the many recent and upcoming regulatory and development steps for Leqembi that really increases the treatment options for patients, but also drives the sales growth around the world.

So as Gunilla mentioned, the IV formulation is now approved in 53 countries, of which the latest ones were Canada, Brazil and Malaysia. And the IV maintenance treatment once every 4 weeks is approved in 7 countries. And in the EU, the EMA accepted Eisai submission for the IV maintenance earlier this year.

When it comes to the subcutaneous auto-injector, the weekly maintenance treatment was launched, as Gunilla mentioned, in the U.S. in October last year and the sBLA for the weekly induction treatment was granted priority review by the FDA, and we're looking forward to the PDUFA date set for May 24.

In Japan, the application for the subcutaneous induction treatment was submitted in November last year, and Eisai expects to launch later in 2026. And then finally, Eisai also sent an application for the subcutaneous auto-injector also in China last month, where it was granted priority review and Eisai expects a launch in 2027.

So many advancements, and this will drive the Leqembi growth even further, the game-changer being really the subcutaneous auto-injector, where the induction treatment is given as 2 injections of 250 milligram each, where each injection only takes 15 seconds.

So next slide, please. So also with regards to the real-world evidence, Leqembi continues really to deliver more data. At the most recent Alzheimer's Congress, CTAD in December last year in San Diego, there was a lot of presentations on Leqembi. So real-world evidence coming from U.S. and Japan shows really consistent results in terms of efficacy and safety with findings from the clinical trials.

Additional data presented indicated that earlier initiation may be associated with greater benefit and that continued Leqembi treatment may provide a benefit compared with stopping therapy. So finally, data also presented at CTAD verified that the subcutaneous formulation offers a convenient option with comparable exposure and safety to IV. And this can really reduce treatment burden for patients and their care partners and health care, of course. So this was really, really encouraging to see all these data in December last year.

So next slide, please. So what are the trends on the key markets for Leqembi? Anders will soon show you the BioArctic royalty based on the Leqembi sales, but we can conclude that Leqembi sold for more than USD 500 million in the calendar year of 2025. That's a nice milestone. The global anti-amyloid market has more than doubled in 2025, and this is driven by mainly 3 things, I would say. First, the use of blood-based biomarkers, both for triaging and for confirmatory diagnosis is increasing. China has been really in the forefront. But also in the U.S., it is steadily increasing, and it is estimated that approximately 10% of confirmatory diagnosis in clinical practice in the U.S. are done by blood-based biomarkers.

Secondly, more physicians are prescribing Leqembi. In Japan, more than 800 facilities are now starting initial treatment and 1,700 centers are focusing on the follow-up after 6 months and onwards. And in the U.S., there is an enhanced coordination between the primary care physicians and neurologists.

On the slide, you can see the targeted direct-to-consumer information campaigns that Eisai has been rolling out in the U.S. and in Japan. And the second one is to address really the awareness of mild cognitive impairment. The fact that Leqembi was included in the commercial insurance innovative drug list in China in December will gradually give more physicians and patients access to Leqembi from the second half of the year, it is estimated.

Thirdly, the subcutaneous auto-injector that I mentioned was launched in the U.S. for maintenance in October also drives growth. It is estimated that 80% of the patients on Leqembi want to continue treatment after 18 months. The insurance coverage through the medical exception process is increasing, and the payer approval rate is estimated to be over 80% in the U.S.

And finally, in Europe, the launches in Austria and Germany are ongoing since September last year, whereas the reimbursement discussions are ongoing in other countries. And finally, the first private clinic in the Nordics started treating patients in Finland in October last year. And what we hear from the market is that there are several other private clinics that are about to start. And we also hear that there are private patients traveling to Finland also from Sweden, for example.

Also since April, our team in the Nordics has gradually been out visiting memory clinics every day, educating on the Leqembi data and on the infrastructure that needs to be in place. We are active at national and regional specialist meetings, visiting regional health care decision makers, and we're increasing our digital communication on Leqembi. There is really a big interest and willingness to learn more and to make sure that all relevant staff at the clinics are educated.

So next slide. So finally, this is my last slide, and I know it's a busy one, but there was a question sent to us before [ Harald ], on the progress with governments regarding Leqembi reimbursement in the Nordics. And as you probably know, Eisai is responsible for reimbursement and pricing. But this slide shows an overall picture of the different steps and the parties involved in the process and what the completed steps are for Leqembi in blue, which you can also find publicly available.

It is the ambition for both Eisai and us to secure patient access to Leqembi in all Nordic countries. And as you might know, in red there, you see that in Denmark, the Danish Medicines Council came out with a negative recommendation in December. So here, Eisai is considering the next steps and will be in dialogue with the authorities regarding potential next steps.

In Sweden, the TLV published their health economic evaluation in December, and the next step is to negotiate with the NT-council. And in Finland, the assessment report from Fimea has been recently published. And in Norway, the assessment is still ongoing in the Norwegian Medicines Agency. So it is -- there's no official set time lines on how long these processes are, but Eisai is working very closely in dialogue with the authorities to answer any potential questions or other requests. And clearly, the ambition is to finalize these different steps during the year.

So you can go to the next slide. And by that, I leave the word to our CFO, Anders Martin-Lof.

Thank you, Anna-Kaija. I will then start with the Leqembi numbers where we saw solid growth globally.

In Q4, the sales were JPY 20.7 billion or $134 million. That was a 15% increase from the last quarter or 55% increase year-over-year. And as Anna-Kaija mentioned, this now means that we are well above $500 million in annual sales, which is a significant milestone for a product like this.

Looking at our royalties, they grew by 31% year-over-year to SEK 127 million, and this is despite the Swedish krona getting significantly stronger during the period. So if with constant exchange rates from last year, we would have seen more than 50% royalty growth.

Looking then at the different markets, starting with China, the sales there are still a little bit distorted by the Q2 stockpiling effect. Sales came in at JPY 0.4 billion or roughly $3 million. That is a 100% increase from the third quarter. However, that's still on a very low level, and this is due to the fact that there was a big inventory buildup in the second quarter with sales of $53 million in the second quarter.

And we have estimated roughly what our royalty would have been like if the sales in China would have been roughly in line with demand. And you see that in the pink bars in the graph that our royalty would have been roughly SEK 125 million, SEK 135 million and SEK 145 million during the second to the fourth quarters. Right now, we believe there is no more inventory to sell off, so we expect sales to return to more normal numbers for the first quarter of 2026.

If we then turn to the U.S., their sales were roughly $78 million or JPY 11.9 billion. That's a 17% increase from the third quarter. And as Anna-Kaija mentioned, here, the solid growth is expected to continue, mainly driven by the introduction of Iqlik for induction and also by the introduction of blood-based biomarkers during the year.

In Japan, the volumes are growing steadily. However, there was a price reduction. So the sales were JPY 6.2 billion or $40 million. That means no change from the third quarter. So the volume increase was roughly 15%, so healthy growth, but there was a one-off 15% price reduction from the Japanese reimbursement system, which is expected when volumes grow for a product.

Furthermore, the EU launch has been initiated. We're well underway in Austria and Germany, but still the royalty from the European market is very, very limited and has a very small impact on our royalties. That should grow, but even in 2026, we expect the impact from Europe to be fairly small to our royalties.

If we then turn to the forecast for Leqembi, Eisai has a JPY 76.5 billion forecast for their fiscal year 2025 that ends on March 31. And right now, after 9 months of that full year period, we have already reached more than 80% of the target. And you see the numbers to the right of the graph that in the U.S., they reached 78%, Japan 75% and China 87%. So what this means is that Eisai will reach the forecast even if there will be no growth in any of the larger markets, and that is not what we're seeing. So we believe they have a very good shot at reaching their forecast for the full year.

If we then turn to our numbers, I think it's worth to emphasize how big of a transformation 2025 was for us when we saw an eightfold increase in revenues. I won't be able to say that often, but this time around, that actually happened. And you see our revenues on the left-hand side, you see they're very lumpy with the highest revenues in the first and second quarters, mainly driven by the agreement that we entered into with BMS in the first quarter.

But even so, if you look at the fourth quarter, our net revenues were SEK 184 million. And I think it's very reassuring to see that our recurring revenue base is continuing to increase. So we had a royalty of SEK 127 million and co-promotion revenue of SEK 6 million. So all in all, SEK 133 million in the fourth quarter. And that means that we had recurring revenue of roughly SEK 520 million in 2025, and that's really starting to become a solid base for us to fund our future R&D investments.

We also get some questions on the Novartis upfront. It's recognized over the initial collaboration, and we recognized SEK 51 million out of the $30 million during the fourth quarter.

If we turn to our operating expenses, they actually decreased to SEK 136 million from SEK 143 million a year earlier. And if we take away currency effects that are recorded as other operating costs, the underlying operating costs were SEK 134 million. And I think it's worth to highlight that that's very, very close to the recurring revenue that was SEK 133 million. So we are actually more or less at the breakeven with our recurring revenues funding our full operations in the fourth quarter.

Looking forward a little bit, our underlying costs are expected to increase in 2026, up from SEK 681 million in 2025. And this is, of course, then due to the progression of our project portfolio that Johanna mentioned. We're investing heavily into exidavnemab, where we're currently in Phase II, but we're also starting big CMC programs for our new candidate drugs, BAN2238 and BAN3014, which is really, really positive. So the higher R&D costs we have, the better it is because that means we're making progress in our portfolio.

So it's hard to make a proper forecast for the cost. But if I can give, I would like to give you some guidance, and I guess or estimate that the growth will be roughly 50% to 70% in 2026. That is the cost should increase by 50% to 70% in 2026 compared to 2025.

And then finally, if we turn to our operating profit on the right-hand side, it was SEK 33 million for the fourth quarter and the full year operating profit was roughly SEK 1.26 billion, more -- here, you saw a really big effect, of course, of the BMS deal that we entered into and recognized in the first quarter.

If we turn to the next slide, we're looking at the net result. It was then a loss for the period that is explained by a significant accrued tax of SEK 48 million due to the big profit for the full year. The operating cash flow was significantly stronger than the result, and that is explained by the fact that the SEK 30 million upfront payment from Novartis was received during the quarter. So SEK 313 million in positive cash flow during the fourth quarter.

And we ended the year with a cash balance of SEK 2.2 billion, a very solid position. And the Board decided based on that very, very solid position and our growing recurring revenues that we should pay a dividend of SEK 2 per share, which is, of course, a significant milestone for a biotech company like ours.

With that, I hand the word back to Gunilla.

Thank you so much, Anders. So we are coming towards the end of today's presentation with some upcoming news flow and some closing remarks.

Next slide, please. I think it's great to see that more and more patients are getting access to Leqembi around the globe and also that in the Nordics that we have a private clinic in Finland so far, and we hope to get more and more patients in the Nordics, too. Eisai is driving continued regulatory processes on Leqembi in a very good way, and we hope to get more approvals in the future now.

The Iqlik subcutaneous administration with auto-injector recently was approved for maintenance dosing in the U.S., and we are now awaiting the response for the induction treatment with a PDUFA date 24th of May. Later this year, we also expect response from Japan, and there it is both regarding initiation and maintenance dosing with the subcutaneous auto-injector.

We are very much looking forward to the next big Alzheimer's Congress and Parkinson's Congress, which is in Copenhagen in March, where we will see several presentations. And then we see more things happening with exidavnemab, for example, where we expect to have the Phase IIa study readout later this year, and we are preparing for Phase IIb. So a lot of exciting times ahead of us.

Next slide, please. So some key takeaways from today's presentation. I think that it's great to see how BioArctic has entered into the new era, the growth era, and we see great progress both of Leqembi as well as the rest of the portfolio, including the BrainTransporter technology.

We have started really well to deliver on our 2030 ambitions, where Leqembi is well on track to become an established treatment in Alzheimer's disease. Sales continue to show increasing demand globally. And we have now had global sales of more than USD 500 million, and we are then halfway to becoming a blockbuster.

Our portfolio has increased and progressed well and our BrainTransporter technology as well as our 2 CD nominations that Johanna spoke about have taken exciting development steps. Our brain -- our business development efforts continue to deliver, and we see continued strong interest. We have a strong financial position, and we can then both invest in our programs and projects, and we can also pay some dividends that the Board has recommended, SEK 2 per share.

So all in all, I think we are exceptionally well positioned for the next phase of our growth journey. The future looks very bright for BioArctic, and we are bringing hope for many patients.

Next slide, please. So by that, we say thank you for your attention, and we're happy to take some questions.

[Operator Instructions] The next question comes from Viktor Sundberg from Nordea.

So one first here, maybe on your effort to launch lecanemab in the Nordics. I just wanted to get a feel for how much of your operating expenses are allocated to building up an organization around this launch? And what could potentially happen to those costs in 2026 if the rest of the Nordic countries follow Denmark and deem lecanemab not cost effective, at least for the IV administration in the Nordics? Yes, I think I'll start with that question.

So if you look at the cost, most of our organization is already there. So we're not seeing any significant increases or in costs or even if there wouldn't be any change in Denmark and that decision would stand. I don't think we'll see any significant decreases either. We expect to fight with Denmark, and we're not planning any layoffs anytime soon despite the initial response there. So a small increase, I would say, on the cost side for marketing and sales.

Okay. And maybe if you could speak a bit about what kind of indications outside of neurology that have sparked some interest at, for example, JPMorgan around your BrainTransporter technology? Is that mainly oncology indications? If you could elaborate on, yes, where you see interest outside of neurology for this platform?

No, I think we -- as you know, we are not commenting about details when we talk about business development. We can just notice that there is great interest. And we see it on a broad level, and we see it on antibodies, but we also see it on other modalities, which we also know, Johanna showed some really nice data on today. So I think that there is a lot of different utilizations.

But I think I also want to say with regard to business development, these things take time. It's not that it's quick things that you should expect from day to day. This is long processes. It takes time. It's really important for selecting a partner because it's a long-term commitment. So it looks really good. We are having a lot of fun, but it will take some time.

The next question comes from Suzanne van Voorthuizen from Kempen.

This is Suzanne. One on the BrainTransporter. Could you elaborate a bit more on the ALS and next-gen exidavnemab programs in particular? What preclinical activities are undertaken at this moment? And how does the road look and time line for these programs to be ready for the clinic? And perhaps still, you mentioned the interest in the platform is broad. Could you speak a bit to the relative focus of this interest between your existing programs versus interest to apply the technique to a pharma program? Just some extra color would be nice.

So would you like to start, Johanna?

Absolutely. So thank you for that question. So we have now nominated, as I said, our alpha-synuclein antibody coupled to the PD program, coupled to the BT platform. And the activities that we are now embarking on in terms of moving the project from a research arena to the preclinical arena is the CMC activities that takes a lot of time to manufacture drug to be able to do toxicology studies. So this is the IND-enabling activities. It's mainly CMC toxicology to prepare for the clinic.

And with regard to the BT-coupled ALS program, I mean, the one that we have nominated now is the standard antibody against TDP-43, but we, of course, also have a BT-coupled program going along, and there is no difference in the priority of these 2 antibodies. It's just that the BT-coupled antibody is a bit behind. So therefore, we have nominated now the antibody, the standard antibody. But we are definitely progressing both of these programs and have a lot of belief in them. And in terms of the time lines, I mean, depending on how everything is going, it takes approximately 2 years for us from a decision to first time in man.

And I will continue with your second question about business development. I think that it's great to see that we have interest in both our internal programs and the BrainTransporter technology like a platform company that I've said previously that we also are. So I think that we see both interest also in the BrainTransporter together with antibodies, but we also see interest in BrainTransporter together with, for example, the new things that Johanna showed with small modalities.

So I think it's -- that's what I mean with broad interest. But we are coming from a position of strength. As I've said before, we have fantastic, exciting own programs, and we have the luxury situation that we can invest in them. So we can drive things forward ourselves or we could partner if we find the right partner. So I think it's a really position of strength, and we have a great organization that are driving the programs further.

And then I think that it's also good to see that we can utilize the company as a platform company and do things like the Novartis deal, where they come with their antibody, we reengineer the antibody. We check it and to see that it works as it should with regard to the transferrin receptor and so forth and then hand it back. So I think you will see more deals like that in the future. But if we find the right partner also for internal programs, that could also happen. But we don't have to partner, but we will partner if we find the right proposal and collaborator.

The next question comes from the Natalia Webster from RBC.

First one is just on Leqembi in Europe. I appreciate that you expect a small contribution here. But are you able to talk a bit more about what you expect is required to improve the slow adoption and how important you see both the longer-term data and the less frequent maintenance dosing in Europe? And then if you see potential for subcutaneous treatment here in the future?

My second question is on the BrainTransporter platform. Just in terms of time lines around BAN2803. You previously had plans to go into Phase I in 2026. Appreciate this is now up to BMS, but are you able to share any details around expected time lines there?

Then just finally, on overall OpEx. It looks like Q4 OpEx was lower than consensus is expecting, both on R&D and SG&A. I see that you're expecting an increase in cost in 2026. But are you able to touch on any key considerations for the cost phasing there next year?

So Anna-Kaija, would you like to take the question about Europe?

Yes. I heard the question was on the IV maintenance and the subcutaneous formulation. Is that correct? Yes. So I mean, as we just said, I mean, Eisai had submitted the application for the IV maintenance, and hopefully, this will be an approval on this during the year. And obviously, this will help, I mean, also in the different reimbursement processes across Europe. I mean, each country has their own reimbursement processes, and they usually, unfortunately, take a little bit more time than in the U.S. and the rest of the world. So I mean, globally, it's proceeding very well, but Europe is a bit slower. And hopefully, we will also see subcutaneous also coming to Europe in the future.

And then continue with your next question, 2803. I mean it's now up to our partner, Bristol Myers Squibb, to comment about when and how that is progressing with more details. I can just say that I think Bristol Myers Squibb is a fantastic partner who are driving the program forward in a great way. But I will not comment about when it will go into man. And then the OpEx is an Anders' question.

Yes. So yes, you should not draw any trend conclusions based on the Q4 costs coming in lower than expected. It is a little bit lumpy in our R&D programs. As for the phasing in 2026, I think we will grow steadily as the year goes by. But then again, it's really hard to give you any sort of hard forecast for how much it will grow quarter-by-quarter. You should expect that it will be a growing trend. It will probably not be a huge impact in the first quarter and then will be larger and larger as the quarters go by. I think that's the right way to model it for 2026.

The next question comes from Max Da from Goldman Sachs. [Operator Instructions] There are no more phone questions at this time. So I hand the conference back to the speakers for any written questions or closing comments.

Thank you so much. So we have a couple of written questions that we'll address now, I guess. The first one comes from Erik Hultgard, Carnegie. And he's wondering when the 2 drug candidates that we just nominated when we can expect those to be in the clinic? Maybe a question for Johanna.

Yes. As I mentioned on the question earlier is that we expect it to take approximately 2 years from our nomination to entering into clinic if everything goes according to plan, of course. That is the guidance I can give you.

Yes. Super. Thank you. Then we have a couple of questions from Joseph Hedden, Rx Securities. I guess the first one, Gunilla, is for you. Anything that you can say on the BAN2802 project that we are running with Eisai and the progression of that program?

I'm happy to see that BAN2802 program is progressing well and really nice data. Everything with the data looks really, really good. And we are now discussing with Eisai regarding potential next steps.

Great. I see that we have Max Da back online. We'll take the written question first, Max, and then we'll come back to you. So then second question for Anders maybe is a question on, is there a commercial milestone, can we expect that during the course of this year for Leqembi?

Yes, I think it's fair to assume that we will reach a commercial milestone during the year. I cannot really comment on the timing of that. The last one we received was EUR 10 million. And as sales grow, it's normal that milestones grow, too. So I think it's fair to assume that it would be bigger than the EUR 10 million. But as for more details, I cannot really provide that at this point.

We can remind everybody that we still have outstanding milestones from Eisai of EUR 54 million, I believe.

In total.

In total, yes. Okay. And I think the last one here from Joseph is, R&D costs in Q4 '25 were lower than model, that we already discussed. Considering the Phase IIa, what do you think is a phasing? That question we already had, sorry about that. It's the same question that Natalia had at the end, right...

Yes. So yes, we already commented on the R&D cost phasing, so I hope that answer was enough for Joseph as well.

Okay. And then I think we can go back to Max's question online in the telephone queue.

[Operator Instructions] The next question comes from Max Da from Goldman Sachs.

So this is Max Da for Rajan Sharma. A couple of questions. What is your progress on finding a partner for exidavnemab? And do you require Parkinson's disease to be included in the deal or the partner has the option to license only the MSA indication? That's the first one. And could you speak to the difference between PD-BT2278 and 2238 because I couldn't tell the difference? Yes, I'll start with these 2.

Okay. So the first question was with regard to exidavnemab and partnering. And as I said before, I mean, exidavnemab continues to progress really, really well. We are expecting the Phase IIa results later this year, and we are preparing for Phase IIb. We have interest for potential partners, and we might partner or we might not partner right now. It depends on if we get the right kind of proposal from the right kind of partner. Otherwise, we are very strong and can drive programs like this ourselves. We have the competence and so forth.

And I will not comment upon details on this at all at this stage. I mean we're open. We have the open door philosophy like we do all the time. And if the right partner comes, then we will make a partnering. But we are coming from a position of strength, and we can drive things forward ourselves also a bit longer.

And then there are different opportunities. I mean we have opportunities for Parkinson's disease with dementia, for example, or Lewy body dementia or other parts of Parkinson's disease or multiple systemic atrophy. And we have now 3 different programs in our portfolio, where exidavnemab is the most advanced, and we have 2238, which was just nominated and got the BAN number. So BAN2238 is the one with BrainTransporter. It's not exidavnemab, it's a slightly different antibody and it's combined with our BrainTransporter.

And then as Johanna said, I will make it easy for you now, Johanna, I'll just answer that question, too. And that is 2278, which is slightly different from 2238, but we will not, at this stage, talk about what difference we have. But we have one further new invention that has been added to this program, but we are not revealing any more details at the moment.

Got it. Sorry, one more question, if you have time?

Yes.

Could you talk about the dividend payout going forward and how we should model that?

So yes, this is Anders here. So yes, the Board has now proposed a dividend for SEK 2 per year. We cannot give you a forecast for what it will be in the future. However, I think it's fair to assume that the Board is expecting us to be able to pay a dividend going forward for the foreseeable future. The size of that or how certain I am of that, I cannot really comment. But I think it's fair to assume that they are hoping to pay -- hoping to be able to pay a dividend in the forthcoming years.

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

And we have no additional written questions. So I'll hand it over to Gunilla to end the call.

So I'll just say, thank you very much for your attention and a lot of great questions, and I wish you all a great rest of the day. Thank you so much.

Welcome to BioArctic Q3 Report 2025. [Operator Instructions]

Now I will hand the conference over to CEO, Gunilla Osswald; CFO, Anders Martin-Lof; and colleagues. Please go ahead.

Thank you. Good morning, and welcome to BioArctic's presentation for the third quarter of 2025. BioArctic is continuing a great way in our new era. With yet another quarter where we see more and more patients are getting access to Leqembi. And we are broadening our collaborations, utilizing our BrainTransporter technology and we are also broadening our portfolio with new projects and new modalities, and we will talk more about that in today's presentation.

Next slide, please. BioArctic is listed at nasdaq.com large cap, and 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 Fälting; and our Chief Commercial Officer, Anna-Kaija Gronblad.

Next slide, please. So I will start our presentation today by giving some key highlights. We go to next slide, please. So before I come into this quarter and the presentation, I just want to give a high-level introduction to BioArctic, if we have any new listeners today. BioArctic is among the world's leading innovators in precision neurology, and we have 2 key platforms: the first one is about innovation and generation and development of highly selective antibodies targeting aggregated misfolded forms of toxic proteins. And examples here are -- for example, lecanemab, Leqembi and exidavnemab. The second one is when we are utilizing our BrainTransporter platform in innovative ways to deliver antibodies and different modalities to come better into the brain.

In today's presentation, we will talk about both selective antibodies like Leqembi, exidavnemab and our new project for Huntington's disease with Huntington as well as our BrainTransporter Technology, which we have utilized now for all our internal targets, and we have also started to use it for external projects. And we now have 3 different partnerships utilizing the BrainTransporter technology, including the recently signed deal with Novartis.

Next slide, please. During the second quarter this year, we held our first Capital Markets Day, and then we presented our ambitions for 2030. And I'm really pleased to say that we are already delivering on our ambitions.

So if we start with the first one, Leqembi, to be an established treatment in Alzheimer's disease, I'm really happy to see how Leqembi's demand continues to grow. The second one is to have a balanced and broader pipeline with projects in all stages of development. And our pipeline is already broader and continue to increase and develop. The third one is additional successful global partnerships. And of course, we are very happy with the new collaboration with Novartis, and we have more positive discussions ongoing. The fourth one is our aim to be profitable and to have recurring dividends in the future. And we expect to be highly profitable this year, and these will come back to this.

Next slide, please. As I said, we are already delivering on our ambitions. And now I will go through a bit about how. We start with Leqembi. And I think now we are really well on our way to get Leqembi established as a treatment for Alzheimer's disease, a disease-modifying treatment affecting the underlying disease. Thanks to our partner Eisai. They're great work with Leqembi. It's now approved in 51 countries around the world, with Canada being the latest one. The Iqlik, the subcutaneous auto-injector, like a subcutaneous pen was called Iqlik was approved for maintenance dosing in the U.S. during the quarter. And Eisai has already initiated a rolling submission for initiation dosing as well and launch has already started for maintenance dosing in the U.S. after the quarter.

Next thing I want to say is about Europe, and there, the launch has been initiated in Germany and Austria. And we're really happy to see that Finland has got the first patients that have been treated in a private clinic. Of course, this is great news from us from a Nordic perspective since we are preparing for launch together with Eisai in the Nordic countries. And Anna-Kaija will come back and talk more about this.

Then there has been several presentations on Leqembi during the period and after the period. And those have shown that long-term data over 4 years treatment show continued increasing benefits over time. And these are really reassuring to follow the real data coming for Leqembi when it's being used in clinical practice. And we have heard presentations, both from the U.S., Japan and China. And the data have shown that the benefit and the safety profile are at least in line with the Phase III results, which I think is great and encouraging.

Subcutaneous administration data has also been started represented, and that supports this great further opportunity for patients, to, in a more easily way, get the injection, buy an auto injector and possible to do that at home in an easier way.

Then I also want to mention that we -- of course, we follow with great interest the fantastic progress with the blood-based biomarkers. And the guidance was launched earlier -- or during the quarter about how to utilize the blood-based biomarkers and they can now be used both for confirmation and for charging, and we'll come back to that.

If we then look at the second part of the pipeline, which is progressing really well and growing with new projects, I want to mention exidavnemab, our alpha-synuclein antibody currently in Phase IIa, with the second part of the study ongoing in both Parkinson's disease patients and in multiple systemic atrophy patients. And also really happy to be able to communicate that we are also now working on another misfolded protein target called Huntingtin for Huntington's disease. And here, we are working with antibodies, but we are also broadening it into other modalities, utilizing our BrainTransporter technology, and Johanna will talk more about this in today's call.

The third one is to have additional successful global partnerships. And as I said, we are very happy about the new collaboration with Novartis regarding an undisclosed target for neurodegenerative diseases. And we will reengineer their antibody to include our BrainTransporter technology and enabling them a better penetration into the brain.

I also want to mention the other BrainTransporter collaborations that we have so far is one with Eisai on BAN2802, where we're generating great data and BAN2803, which we are completing now the tech transfer to Bristol Myers Squibb.

It's also great to see that we have continued strong interest for our projects and for our BrainTransporter technology for antibodies as well as for other modalities.

The fourth part about the financials. We have strong financials, and we are highly profitable this year with increasing royalties as well as several milestones from Eisai and upfront payments from Bristol Myers Squibb and Novartis.

Next slide, please. If we think about the Alzheimer's field, it's evolving in a very nice way, and I want to highlight 5 different areas. The first one is that we see that we are getting easier and easier diagnosis by blood-based biomarkers. And I think this is important in helping to build the market in an easier way and to help to get the right patients to come to specialists to get a treatment initiated. The first tests are now available as confirmatory for specialists as well as for triaging for primary care.

If we then look at the second one, we see more and more data that shows that earlier initiation of treatment of Leqembi shows better effect. So when we are looking at the earlier patients in the Phase III Clarity AD open-label extension study, where now 48 months data are available. We see that the majority of aducanumab-related patients were stable or even improved after 48 months treatment. I think this is very encouraging. And I think it's also further supports the ongoing AHEAD 3-45 study in presymptomatic individuals with amyloid pathology, but yet without symptoms.

The third one is also really important, and that is the data that are being presented show the importance with maintenance treatment to maintain the treatment and the benefit of continued treatment with Leqembi, even after the plaques are cleared in order to continue to clear the toxic protofibrils and that's possible due to the mechanism of action and the low immunogenicity that we see with Leqembi.

The fourth one is about more convenient dosing with Leqembi Iqlik, the subcutaneous auto-injector. And I think this is a really important next step for Leqembi. And it's making dosing so much easier for the patients and care partners to handle the dosing at home. And we are also pleased to note that it was awarded as one of the top innovations for 2025 by Time Magazine.

And the fifth one is that in the future, we expect to see more combination treatments for even better outcomes. And there is currently an ongoing study with lecanemab, and Eisai's tower antibody. And I think in the future, we will see more and more combination treatments.

So to summarize, the key is to identify patients at an early stage. And here, we can use the blood-based biomarkers, and we can start Leqembi treatment early and continue treatment with convenient dosing with Leqembi Iqlik. So great progress in this field for Leqembi.

Next slide, please. So now we come to the R&D update, and I hand over to our Chief R&D Officer, Johanna Fälting.

Thank you so much, Gunilla. Next slide, please. So as Gunilla mentioned, BioArctic is among the world's leading innovators in precision neurology, where we have 2 key platforms: the antibody platform with highly selective antibodies targeting aggregated forms of toxic proteins. And these are intended to treat severe neurodegenerative diseases with high unmet medical need, such as Leqembi in Alzheimer's disease, exidavnemab in synucleinopathies, Parkinson or MSA and also the TDP-43 project for ALS.

BioArtic is also developing a BrainTransporter technology that facilitates the passage of antibodies and other drugs across the blood-brain barrier. And the aim with this platform is to improve the brain exposure and distribution of the drug and thereby allow for lower dosing, improved convenience, reduced manufacturing costs and potentially also better efficacy. And in addition now, we are also further developing our BrainTransporter technology and expanding this into new modalities other than antibodies, such as enzyme proteins and even genetic medicines. And the development of the platform that will enable us to address different diseases by tailoring the modality target combination with the highest potential clinical benefit.

Next slide, please. So this is an overview of our R&D portfolio with the 2 platform antibodies and brain transporters and the cross program synergies. The portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies, innovative in-house projects and technology platforms with significant market and out-licensing potential.

So far, our BrainTransporter platform has generated 3 collaborations with Eisai, BMS and Novartis and all of these collaborations are progressing really well. They are all with different targets. But importantly, the BrainTransporter technology is BioArctic's own proprietary and has the potential to generate more collaborations in the future. You will also note a new BrainTransporter project in the portfolio, the [HD-BT 4801] for Huntington's disease, and I will come back to this specific project later in the presentations.

So to summarize, we are both advancing and broadening our R&D portfolio with new projects into new disease areas and with new collaborations.

Next slide, please. So exidavnemab is an antibody that selectively targets the pathological alpha-synuclein aggregates while sparing the physiological monomers and exist is a Phase IIa study, testing the safety and tolerability of exidavnemab. In this study, we are also exploring a wide range of biomarkers, both biochemical and digital and we have a quite unique approach in including the right patients in the study with a smell test that is an early sign of Parkinson if you have an impaired smell and also a CSF seeding amplification test to really make sure that we have the correctly diagnosed patients with the alpha-synuclein pathology in the study.

The high dose cohort is currently ongoing, both in Parkinson and multiple systemic atrophy and the results are expected mid-2026. So following this EXIST study, there are several potential possibilities for future development in different synucleinopathies such as Parkinson MSA and DLB, and we are currently preparing for the next stage of development.

Next slide, please. So this is very exciting to me that we are now expanding our portfolio into a new neurodegenerative disease, the Huntington's disease. And this is an inherited progressive neurological neuropsychiatric disorder that is caused by impaired function and degradation of nerve cells in specific areas of the brain. Huntington's disease is caused by a toxic mutant Huntingtin protein in the brain and the mutation in this gene results in a buildup of toxic aggregated Huntingtin protein causing Huntington's disease. The disease onset is between 30 and 50 years old of age, and it's fatal within 10 to 30 years. Current treatments are only symptomatic and there is a large unmet medical need for better treatments.

So next slide, please. Targeting the Huntingtin protein in the Huntington's disease is an excellent strategic fit into our portfolio at BioArctic and with our capabilities. So this project is built on BioArctic's extensive experience in developing antibodies against misfolded aggregated toxic proteins and also our BrainTransporter platform that will enable us to increase the brain delivery of the drug. In this project, several modalities is being explored in parallel, antibodies as well as genetic medicine approaches. And since this is a brain target we have, of course, also combined it with our BrainTransport technology. So we are excited that we now expand our portfolio with yet another neurodegenerative disease in addition to Alzheimer alpha-synucleinopathies ALS and Gaucher with the potential to bring hope for even more patients.

Next slide, please. So with that, I will hand over to our Chief Commercial Officer, Anna-Kaija Gronblad for a commercial update.

Thank you, Johanna, and you can go to the next slide, please. And I will go back to Leqembi again. And I'll start with the regulatory update for all of you. So since the last quarterly report, Leqembi IV has now been approved in 3 additional countries. That is in India, Australia and in end October also in Canada. So in total, Leqembi it can is approved in 51 countries and territories. And as of October, in addition to the U.S., the IV maintenance treatment, meaning once every 4 weeks is also approved in China, in Qatar, United Arab Emirates and India.

So Anders will soon present the sales numbers. But in short, I would say that the Leqembi growth really continues steadily. So in Q3 versus Q2, when you adjust to the China's actual demand, the growth was 14%. And we have seen recent launches in Mexico and Saudi Arabia. And as of August and September, as Gunilla mentioned, Leqembi was launched also in the EU, in Austria and Germany, where patients have started treatment. So -- and what we hear is that within the first 2 months, it's around 350 centers were registered in the system for the controlled access program. And as educational activities is being rolled out in the 2 countries, registrations and prescriptions continue to increase at major specialist clinics.

And finally, in the Nordics, of course, as Gunilla mentioned, there is a private clinic in Finland offering Leqembi treatment to patients willing to pay out of pocket and we know that a few patients have received treatment in October. So this is an important milestone for us in our ambition to also becoming a fully-fledged pharmaceutical company. So in the meantime, the price and reimbursement and the dialogue continues with all the Nordic countries, and we aim to launch gradually across -- throughout 2026.

So next slide, please. So additionally, I would like to spend a few minutes again on the Leqembi Iqlik, the subcutaneous auto-injector, which was approved in the U.S. in August and launched as of early October. And as Alzheimer's disease is a progressive disease where neurodegeneration and cognitive decline continues even after plaque removal, it is important to offer both health care professionals and patients the possibility to choose between continuing on once-monthly infusions in the hospitals or to switch to once weekly at home injections after the 18-month treatment. So this obviously could be a benefit for the patient who might want to travel and feel less bound to the hospital but also to health care providers in reducing the resources related to the infusions.

Reimbursement for the Iqlik is expected to be included on formulary in the beginning of 2027 but individuals can seek insurance coverage via the medical exception process, which is something that is quite common in the U.S. And Eisai staff is providing information on this process and nurse educators provide support on dosing and demonstration kits, et cetera. So this is truly a major step in the treatment of Alzheimer's disease patients. And recently, Leqembi Iqlik was selected by Time as one of the best inventions in the medical and health care category.

In addition, Eisai has also rolling SBLA ongoing also for the weekly initiation treatment in the U.S. since September, which is planned to be completed in the last quarter of this year. So potential approval maybe in Q2 or Q3 next year. And finally, submissions for the subcutaneous weekly initiation treatment is also planned for Japan before the end of this year.

Next slide, please. So moving on to my final slide. This is to highlight again the true advancements we are seeing with the Leqembi Iqlik and with the parallel development in the usage of diagnostic blood test. If you remember, U.S. clinical guidelines were presented at the AD/PD congress in July this summer, saying that blood-based biomarker test showing more than 90% sensitivity and specificity can be used for confirmatory diagnosis in patients with cognitive impairment. And the first blood-based confirmatory tests are available in several countries in U.S. and China, for instance. And Fujirebio's test, Lumipulse, for instance, has been granted IVD clearance and C2N is another company has submitted for regulatory filing in the U.S. for their confirmatory test.

And meanwhile, Roche phospho-tau 181 blood test was granted IVD clearance from the FDA for use in the primary care test as a triage test. So more tests will be done. 350,000 tests are expected to be used in 2025. And the new CMS payment rate is coming up from January next year. And of course, as more patients are being tested, more patients will receive a diagnosis. So as we see it, these advancements will contribute significantly to the Leqembi growth going forward, especially in the U.S., China and Japan.

So that's all for me. And with that, I will now hand over to our CFO, Anders Martin-Lof.

Thank you, Anna-Kaija. If you start to look at the Leqembi numbers, the global Q3 sales work came in at JPY 18 billion or roughly $121 million. And at first glance that looks quite negative since there was a 22% decrease from the second quarter of 2025, but that is all due to a large stockpiling effect in China in the second quarter. So Eisai calculated what the growth would have been from the second to the third quarter without the stockpiling effect and then the growth would have been 14%.

We recorded a royalty of SEK 117.2 million. That's also then down from SEK 162.5 million in the second quarter. But we have also estimated what the royalty would have been without the stockpiling effect. And then we would have been around SEK 125 million in the second quarter and SEK 135 million in this quarter. So I think that's a better reflection of the actual development of the Leqembi sales in the world.

Turning then to China. So actual recorded sales for JPY 0.2 billion or $0.6 million. So a 97% decrease from the second quarter. Basically, the clinics in China are receiving Leqembi from inventory right now in the third quarter. The actual demand was roughly $18 million, and that's a 10% increase from $16 million in the second quarter. But all in all, this means that there is still quite a significant inventory left in China. So we expect very low sales in China also during the fourth quarter, and that was reported by Eisai.

Turning to the U.S. There, the sales are increasing well. They were up to JPY 10.2 billion or roughly $69 million, representing a 12% increase from the second quarter. And here, Eisai is really trying to leverage the developments that Anna-Kaija was talking about with the blood-based biomarkers that are now being used more and more and acceptance of Iqlik for maintenance therapy this year and for induction next year.

But to really get the full effect of this, you have to target the primary care practitioners. So that is what they say it's doing now. They're targeting roughly 2,500 primary care practitioners. They're running very big educational programs and running large awareness campaigns straight to the patients. So they're really building momentum now to start to see an impact from Iqlik and blood-based biomarkers starting probably more from next year, but they're really starting to do the groundwork now.

And here, you can say that they're mimicking Japan a little bit. Japan is the market that has come the furthest along in the demand expansion phase. Sales here were $42 million, representing a 13% increase from the second quarter. And here, they have really succeeded in setting up a good treatment chain where roughly 4,200 doctors are referring to 800 initial treatment centers, and there the patients stay for a while, and then they are moved over to follow-up facilities. So that's a system that has worked incredibly well, and that is what they're trying to achieve now in the U.S. as well.

I think it's also really interesting to see that the disease awareness campaigns that they are running for mild cognitive impairment in Japan are significantly increasing the recognition rates because we all know that mild cognitive impairment, which is the earliest phase of the disease is really where you want to treat the patients with the disease-modifying therapy, you can have the most effect if you start as early as possible. But today, those patients aren't really diagnosed to a large extent. So these awareness campaigns can really start to build momentum for more patients getting the drug when they really should have it.

And then as Anna-Kaija mentioned, the EU launch has been initiated in Austria and Germany. It's really exciting to see that, that is starting well. However, it will take some time before you see any significant impact in our royalties from EU, which is slightly slower market than the U.S. and Japan.

If we then turn to the Leqembi Global sales forecast. They have a forecast of JPY 76.5 billion for their fiscal year 2025 for Leqembi. And if you look on the right-hand side of the graph, you see that they have already in the first 2 quarters of that fiscal year, achieved 48% of the forecast in the U.S. and 49% in Japan and already 83% in China. So all in all, if you also include the other countries, they have achieved roughly 52% of the overall annual forecast in the first 2 quarters of that period. And since they are growing, we have a very high confidence that they would reach the forecast for the year. So everything is looking really, really good for Leqembi, and it seems to reach their forecast with some margin.

If we then turn to our own numbers, you see that the Q3 net revenues were SEK 133 million. And this quarter, that was mainly based on the recurring revenues with royalties of SEK 117 million and co-promotion revenues of SEK 5 million. So it's exciting to see that we're becoming more and more like a normal company with recurring revenues that make up a larger share of our revenue base.

We also recorded some revenues from the new Novartis agreement. As you know, we got in a $30 million upfront when we started that collaboration. And now we recorded SEK 9 million out of that in the third quarter, and we will record the rest during the remainder of that collaboration.

Looking at our operating expenses, they increased to SEK 150 million this quarter compared to SEK 95 million a year ago. And this time around, that was basically just normal cost. We have had large currency effects in the previous 2 quarters, but not this quarter. So the underlying operating costs were SEK 146 million. And that's slightly over than our recurring revenues. So we have operating costs that are SEK 24 million higher than our recurring revenues, but we are approaching a point where we will have recurring revenues that are larger than our operating expenses. So we are getting closer and closer to long-term profitability.

If we then look at our cost for the remainder of the year, we expect them to keep increasing since we have a more mature project portfolio, and we have built up our commercial organization. I have previously stated that I expect our full year cost to be roughly 50% to 70% higher than the cost of last year. Now we think we will be in the lower range of that interval. So I would say roughly 50% to 60% higher than the cost of last year.

And then on the right-hand side, you see that operating loss was SEK 29 million for the third quarter. We expect something similar in the fourth quarter. So the operating profit for the year should be well above SEK 1 billion.

On the next slide, you see our net result on the left. It's then, of course, a lower loss or a bigger loss the operating loss, but -- and that's mainly explained by the accrued taxes of SEK 65 million that we also -- we have a positive financial net of SEK 8 million, so that ameliorate a little bit. And then the operating cash flow, you typically see one very big bar, and that's the payment of the $100 million upfront payment that we received from Bristol Mayer Squibb in the second quarter. The $30 million upfront payment, $30 million, I should say, from Novartis had not been received in the third quarter. It was received in October. So the bar you see on the left-hand side with our cash balance right now of SEK 1.9 billion does not include the Novartis payments. So our financial position will continue to be strengthened in the fourth quarter. So we are going to end the year with a very, very solid position.

I think that was all for me. And now I hand back to Gunilla for some closing remarks.

Thank 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 next slide, please. So we are now in the fourth quarter of 2025. And I think it's great to see that more and more patients are getting access to Leqembi around the globe. And also really pleased to see that we're also starting even if it's small. So we are starting in the Nordics. We see continued regulatory processes on lecanemab, with the Canada approval. And I think it's great to see the Iqlik being approved for maintenance dosing in the U.S. and our partner, Eisai are working hard to conclude the supplementary BLA filing for Leqembi Iqlik in the U.S. for initiation dose. And also to file in Japan for both initiation and maintenance dosing with Iqlik.

We are, of course, looking forward to the next Alzheimer Congress its CTAD in San Diego in the beginning of December. And there, we note several presentations on lecanemab, including subcutaneous data and more real-world evidence data from, for example, U.S. registered. So this is something I'm really looking forward to.

So I'll come to next slide. So the key takeaways from today's presentation is that BioArtic is now in our new era, and we see great progress both on Leqembi as well as the rest of our portfolio and the BrainTransporter technology. We have already started to deliver on our 2030 ambitions. Leqembi is well on track to become an established treatment for Alzheimer's disease. Sales continue to show increasing demand on a global level, further regulatory approvals, launches reassuring data from long-term treatment and real-world evidence.

Our portfolio has increased, and we have initiated program for Huntington's disease with different modalities. Our brain -- or our business development efforts continue to deliver with a third BrainTransporter collaboration now having been initiated during the third quarter. And this was the first of its kind, and it shows that we are also expanding to becoming also a platform company.

And the last point is that we have strong financials, as Anders described, with great cash flow with milestones and record royalties during this year, growing more than 180% year-on-year. So I think the future looks very bright for BioArtic and is bringing hope for many patients.

Next slide, please. So by that, we say thank you so much for your attention, and we're happy to take some questions.

[Operator Instructions] The next question comes from Joseph Hedden from Rx Securities.

Firstly, on the Leqembi Iqlik, do you have any visibility on when regulatory filings might be made in Europe or China or the strategy there is? And then secondly, it's great to see a Huntington project. Just on the BrainTransporter technology. I know that first program is an antibody and you've mentioned genetic medicines. Is BrainTransporter are capable of, for instance, using an AAV vector like, I mean, Huntington's, the uniQure therapy made a lot of noise recently. Does any significant modification need to happen with your current platform to be able to carry a vector such as AAV?

Thank you so much, Joseph. Excellent questions. So I think the first question on Leqembi Iqlik in Europe and China, we cannot comment on that. I mean right now, we are really happy about the progress in the U.S. and Japan. And then we know our partner is doing everything they can to help as many patients as possible around the world. So we'll come back to that. Then your question with regard to Huntington's disease and where we are also really happy to see the BrainTransporter. So I didn't understand any specific question.

I think I can take the question.

But if I just -- then I hand over to you, Johanna. And then for the BrainTransporter, I think it's really, really good to see that we can utilize that for several different modalities and definitely help to get different modalities better into the brain. And I think it's important to point out that BrainTransporter is not one thing, it's the platform with many different tailor-made ways to handle depending on if it's what kind of target and what kind of modality. So we have several different approaches that we utilize depending on if it's an extracellular target, intracellular target or what kind of modality we have. And then I hand over to Johanna, who understand the question I missed.

Thank you so much, Joseph, for that excellent question. And we are, of course, following the competitive landscape very well, and we understand and we have seen the uniQure data. I think it's excellent data. But that's a treatment that is not for everyone. It's a quite invasive treatment, and you actually need maybe a 15-hour surgery for one patient to administer that drug and you do it with intrathecal administration and injections in different sites in the brain right now. So our approach is a bit different, and I can't speak too much of it today before we have the patents in place and so -- but we have another approach, and we are not primarily targeting AAV with our BrainTransporter technology.

I hope that responded to your question. Thank you, Johanna.

Yes.

The next question comes from Suzanna Queckbörner from Handelsbanken.

I'd like to ask a question regarding the Leqembi subcu. So listening to the Eisai conference call, there was talk about the Iqlik being listed in formularies only by 2027. There seems to be a medical exemption program, which would address something like 80% of patients. To me, it sounds like there's likely to be more paperwork associated with that, which sounded like it was going to be limited or access was going to be limited at least until 2027. Maybe you can just sort of explain that to me? And then also, how does that impact your competitive advantage versus Elli Lilly's remternetug, which is also expected to read out data in 2026 and they have the subcu formulation as well.

Yes. So we start with your question on Iqlik and the process in the U.S. with the reimbursement agency or CMS is that it's certain times of the year that you need to submit in order to come into the next year. So that's the reason for why we expect Leqembi Iqlik to be on the formulary from January 2027. Right now, just as you said, Suzanna, there is a possibility to utilize the medical exemption program, where -- which I think many of these physicians are used to do for other treatments. And what we have understood from Eisai is that it's not overwhelming paperwork. It's a fairly easy process that can help the patients -- most patients to already be reimbursed right now.

And I'll also go on the differentiation part a little bit and then hand over to Anna-Kaija. So I think, I mean, we see then the Iqlik has a really good differentiator versus competitors. And then we will follow with great interest when also remternetug comes with some efficacy data. We haven't seen much yet. So I think each compound has to show itself before we can comment too much. And we haven't seen much of it yet. So -- but I think meanwhile, we're really happy for Leqembi Iqlik, which all the data we have seen so far looks really, really promising. And more data is expected to be shown at CTAD. I don't know, Anna-Kaija, if you want to add something.

No, not really. I think -- again, I think it's -- we haven't seen that much data on remternetug yet. So I think it's too early to say anything about it. But we, of course, understand that they also see the need of subcutaneous auto-injector because we think that this will be a key driver and for patients also being having an easier treatment. So we see -- so the need from the Elli Lilly as well. They see this as a competitive advantage.

If I can have a follow-up question. Also, I saw that Takeda discontinued their alpha-synuclein antibody, which they reported to had Phase II results on. Maybe you can talk about the differentiation to your alpha-synuclein antibody.

Yes. I think it's really important to understand that every antibody is different from each other. And we think that we have a clearly superior antibody, much more selective. The most selective antibody that we know for alpha-synuclein between the pathological forms and the physiological forms. So we have more than 100,000 fault electivity, which is a huge difference from competitors. And also, I think it's important to see the design of the clinical studies that we also think that we are designing better studies for the future. But I will hand over to Johanna.

Thank you, Gunilla. I totally agree, and thank you for the question. Of course, it's always sad when a clinical study that being sold to patient does not read out. But I think that we have a differentiated profile, both in terms of the selectivity for what we believe is the toxic species, the aggregated species and a very high affinity for those species. And we also have a superior human PK profile as compared to the AstraZeneca Takeda that recently read out. It was also fairly small, I would say, a Phase II clinical trial. And I think that we can have a clear differentiation versus both in terms of human PK study design and selectivity for the toxic species.

So not much read over, I would say.

Absolutely not.

The next question comes from Natalia Webster from RBC.

Firstly, I was wondering on Eisai's full year Leqembi guidance to March. This is implying a slowdown in growth for Leqembi sales for calendar Q4 into Q1 '26. So just curious to hear if you think this is conservative, appreciating that there may be some further impact from the China inventory adjustment in Q4.

And then my second question is on the European launch. I appreciate it's early days and it could take some time to see a more meaningful contribution here, but are you able to provide a bit more feedback on how this is progressing? And if you're counting any of the initial challenges that you saw in the U.S. around capacity or otherwise?

And then finally, just on profit. You've maintained your long-term ambition for sustainable profitability. I was wondering if you're able to touch on any key considerations for cost phasing in 2026? And if you're able to confirm that you still expect to reach sustainable profitability from 2026 as well?

So I think it's Anders, who should start this questions.

Right. So if you look at the Eisai's forecast, I think you're specifically asking whether they will reach for China. Well, all in all, they are already at 52% of the full year forecast after 2 quarters, 87% in China. I think it's correct that the Chinese sales will be very low in the next quarter as well. But then I think more or less the inventory should be used up, so they should have a strong first quarter of next year. So we remain very confident that they will reach their forecast for the full year, and so are they. That's what they communicated on their call. As for the profit for next year, we will not comment on our cost for next year until we finish the year. So you'll hear more about that in February when we communicate our year-end results.

And then there was a question for Anna-Kaija.

Yes, regarding the EU launches and what I can say is that, of course, I mean EU consists of 27 countries and all of these countries have their national market access processes on price and reimbursement. So I would say that after Germany and Austria, typically being the early launch countries, it takes quite some more time before each country has gone through this process. So I would say that we can be cautious when it comes to the sales coming from Europe next year.

I think we are, let's say, infrastructural wise in a better situation than in the U.S.A. But still, I mean, this is a new treatment paradigm also that is being implemented. So each clinic has to really go through and have a checklist on what to have in place in order to start treatments on patients. So I think we should be kind of cautious and understanding of the changes that needs to be in place in the clinic. So it will be rolled out gradually throughout Europe next year.

And I just want to remind also that we have said all the time that Europe is a small, small proportion out of the global sales especially, I mean, the coming 2 years, but also long term. It's really U.S., Japan, China and other parts of Asia and other parts of the world, that also contributes. Yes, a lot.

The next question comes from Viktor Sundberg from Nordea.

So yes, one first on the financials. So I just wondered how we should think about the Novartis upfront payment being recognized over 21 months. Will this be in a linear fashion? Or how should we think about the revenue contribution of that part going forward?

The short answer is, yes.

Linear.

So yes, linear. It's very hard to -- we are delivering as we have communicated, we are working on the Novartis compound that we are modifying and we will deliver back to them. And that will take some time, and it's really hard to estimate how large share of that work has been done. So you typically do that in a linear fashion over the expected time course of the collaboration, so linear.

Okay. And also I had a question on your competitive position or Eisai's competitive position versus Kisunla. Looking at the curve, it seems that they are accelerating sales, I guess, Eisai has done a lot of the groundwork already to prepare for that. But I just wonder on your discussions with Eisai, like why are some patients choosing Kisunla over Leqembi, or why some patients choosing Leqembi over Kisunla. What's your feedback here so far in the launch?

Would you like to take it, Anna-Kaija?

Yes. I mean, of course, we're still -- Leqembi still the #1 disease modifying treatment Alzheimer's in the U.S. as well. But as you say, I mean, of course, Kisunla is having some advantage to us being a front runner in establishing these kind of treatments on the market. So it's -- but what we can see is that at Eisai reports is that it's not kind of reducing the Leqembi market, but it's growing the kind of total market as such.

Of course, I mean, there is a difference in the -- they have once monthly today, and we have twice monthly in the 18-month treatment phase, and then you can choose to go to once monthly or Iqlik. So of course, every patient is an individual and has to kind of decide what is -- what works best for that patient. So -- but otherwise, I think Leqembi is still showing a strong growth, so -- and driving, and so in total, it's growing the total market.

The next question comes from Sebastiaan van der Schoot from Kempen.

Congrats on the progress. Just one from our side. Could you maybe give some color on what would be your goal or non-go discussion decision for further development of the Parkinson's program. What type of signals do you want to see against placebo to push the development forward? And what could next steps for the program look like?

Yes. So I will start and just say that exidavnemab, which is currently in a Phase IIa study. And the main task for this study is to look at safety tolerability and we have 2 doses. We have had first a lower dose where we have had a safety review that supported us to go into the higher dose part in exactly the way that we had planned and wanted. And then we have also broadened it not only for Parkinson's disease, but also for multiple systemic atrophy where we also have called orphan drug destination.

So I think -- I mean, we are doing a lot of biomarkers, but that's really in order to prepare also for the next step for Phase IIb. So I think it's really important to see that the expectation here is really to look at safety tolerability for this program. And so far, what we have seen, it looks really good. So I think that's -- but the readout there will be just after summer next year is what we expect. The study is ongoing and still recruiting. So it's a little hard to say exactly when it happened, but the best estimate is a little bit after summer next year.

And then there is a lot of opportunities for this asset. And as we have described before, it can be Parkinson's disease dementia, it can be Lewy body dementia. It can be different parts of Parkinson's disease. It can be MSA. So there's a lot of opportunities. And at the moment, we are evaluating different of those kind of indications and preparing for the next step. So I think this is a very interesting asset, very exciting with a lot of opportunities.

I don't know if you want to add something, Johanna?

No, I have nothing to add to that. Just to say -- to echo what Gunilla said, this is a quite small study and a short study. So not too much should be expected in terms of biomarker readouts. It's a safety and tolerability study, it's 3 months, and that's a bit too short to see efficacy on biomarkers related to disease modification.

That should be the next...

[Operator Instructions]

So there doesn't seem to be any people in the phone queue right now, but we have some written questions that have been posted during the call, so I'll read them out loud. And then Gunilla can direct who should take the question, although I think the first one is maybe Anders one. But it's from Peter, who wonders looking forward when we start to record sales in -- for Leqembi in the Nordic countries, how are we going to report that going forward?

So in our profit and loss statement, you have our total revenues. And then in the notes, we will have our different revenue split up by line, and we already do actually. So the revenues from the Nordics won't be seen straight away. They are part of what is called co-promotion revenue, which is the reimbursement we get from Eisai for profit sharing. But over time, yes, I think we will comment on how things are going in the Nordics. I hope that answers the question.

And then a follow-up question from Peter as well regarding OpEx and the difference in OpEx if you compare Q1 and Q2, it's down in Q3, and he wonders what were the reasons for this and then going forward also what is the level that we can expect? Anything you can say there?

Right. No. So our costs are quite lumpy. So if you deduct the other operating expenses, which is mostly currencies. Yes, our costs were down a little bit in the third quarter, but we expect them to go up again in the fourth quarter, and then we'll see what happens next year. Especially what happens with -- after the EXIST trial, if we enter into significant clinical trials with exidavnemab, you should expect increasing R&D spending next year. But it's too early to tell exactly what that will look like. But of course, with the maturing R&D portfolio, you incur larger costs, which is a great thing for a company like ours.

Then we had a question from Frederic, but I think we answered that because it came from somebody else as well. And then Eric from Carnegie has a question regarding the EVOKE trials that are coming up soon in just the next couple of weeks. Expectations on results for the EVOKE trial where semaglutide is tested in early AD in EVOKE and EVOKE+. What's our thoughts on that if that study is positive and how that could potentially impact or not impact Leqembi. Gunilla?

Yes. So I think I'm really looking forward to seeing the results, and it's quite imminent now. I think it's 2 well-designed clinical trials in Phase III. They did not have a proper Phase II. So it's very hard to say anything about what to expect here, I think. But if positive, then I think that it's a complement to Leqembi. I don't see this as a competitive treatment. I see it's a complementing treatment because it has a completely different mechanism of action and potentially then could help patients together with Leqembi.

Okay. Thank you. And I think the last one about the risk regarding China. You touched upon it, Anders, but maybe you want to clarify once again what we think about the stocking effect in China and how long that's going to last and when we can expect more new sales coming in, in China.

Yes. So the stockpile that was built up in Q2, I expect it to run out during the fourth quarter. So you should see an effect of that on the sales in the fourth quarter, but not beyond that, but that would be my estimate.

Yes. Thank you. Those were all questions in the queue. I don't believe, operator, that we have any more questions waiting in line either. And if so, I think that concludes today's call. Thank you so much for listening, and we'll see you back in a quarter from now. Thank you so much.

Thank you. Have a good day.