Welcome to BioArctic Q2 Report 2025. For the first part of the conference call, the participants will be in listen-only mode. During the questions- and- answers session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now, I will hand the conference over to CEO Gunilla Osswald and CFO Anders Martin-Löf. Please go ahead.
Thank you. Good morning and welcome to BioArctic's Presentation for the Second Quarter of 2025. BioArctic is now entering a new era. It's an era of profitable growth, and I think it's signified by yet another strong quarter and a lot of activities throughout the different parts of the business. We see increasing Leqembi royalties, and we are very pleased with the new partnership with Novartis. It's the third partnership utilizing our BrainTransporter technology, and it's the first of its kind. I'll talk more about that in today's presentation. Next slide, please. BioArctic is listed at Nasdaq Stockholm Large Cap, and this is our disclaimer. Next slide, please. I'm Gunilla Osswald, and I'm the CEO of BioArctic. Today, I will share the presentation with our CFO, Anders Martin-Löf, and also with our Chief R&D Officer, Johanna Fälting, and our Chief Commercial Officer, Anna-Kaija Grönblad. Next slide, please.
I will start our presentation, and I will be giving some key highlights. Next slide, please. Before I do that, I just want to do a high-level introduction to BioArctic if we have any new listeners today. BioArctic is among world-leading innovators in precision neurology. We have two different platforms. The first one is innovation and generation and development of highly selective antibodies that are targeting aggregated misfolded forms of toxic proteins like Leqembi and exidavnemab. The second part is utilizing our BrainTransporter platform in innovative ways in order to deliver antibodies and different modalities better into the brain. In today's presentation, we will talk more about both selective antibodies like Leqembi and exidavnemab, as well as the BrainTransporter technology, which we have utilized now for all our internal targets, and it's also now being used for external projects. An example of that is the just signed deal with Novartis.
Next slide, please. During the second quarter this year, we held our first Capital Markets Day, and there I presented our ambitions for 2030. We have already started to deliver on our ambitions. I'll just go through them briefly. The first one is Leqembi to be established as a treatment for Alzheimer's disease. The second one is a balanced and broader pipeline with projects in all stages of development. The third one is additional successful global partnerships. This is an area which I enjoy and engage heavily in. The fourth one is, of course, also very important to be profitable with recurring dividends. Anders will come back to this later during the presentation. Next slide, please. As I said, we have already started to deliver on our 2030 ambitions, and I will tell you how.
If we start with Leqembi, it's well on its way to be an established treatment for Alzheimer's disease. Thanks to our partner Eisai and their great work, Leqembi is now approved in close to 50 countries and also in Europe since April 15, 2024. The European launch has been initiated this week with Austria started this Monday, and Germany is preparing for initiation of launch on Monday next week, September 1. Our partner Eisai has submitted the HTA dossier in the four Nordic countries: Sweden, Finland, Denmark, and Norway. At the world's largest Alzheimer's Congress, which was held in Toronto in July, more very encouraging data was presented. It was a great congress with about 10,000 participants, with a lot of positivity in the field. There were many presentations on Leqembi, including long-term data over four years' treatment showing increased benefit over time.
Real-world data for Leqembi being used in clinical practice was also presented, both from the U.S. and from China. Here, data showed that the benefits and the safety profile were in line with the phase III results, which also is very encouraging. Eisai also presented data with the subcutaneous administration of Leqembi. This supports a great opportunity for patients to administer Leqembi in an easier way by getting the injection by an auto-injector at home, for example. I think it was a very positive meeting with a lot of hope for patients. There was also reporting on blood-based biomarkers and their great progress and the launching of guidelines for them. The second aspect I want to talk about is the pipeline and that we are growing with further projects in development and the projects are progressing well.
An example of that is exidavnemab, our alpha-synuclein antibody, which is currently in phase II-A. During the second quarter, it passed its safety evaluation and has now progressed into the next part of the study with higher doses. That is now both in Parkinson's patients and in multiple system atrophy patients. We are broadening indications for exidavnemab. We're also very happy that we got orphan designation in both the U.S. and in EU for exidavnemab with regard to the multiple system atrophy indication. We have also broadened our portfolio linked to the new deal with Novartis with a new neurodegeneration project with BrainTransporter, which, of course, is their project, but we are supporting. We come to partnership. Here, we said we should do additional successful global partnerships. I'm very happy with the new collaboration with Novartis regarding an undisclosed target for neurodegenerative diseases.
We will re-engineer their antibody to include our BrainTransporter technology, enabling better penetration into the brain. Our BrainTransporter collaboration that we had previously and which is ongoing with Eisai on BAN2802 is progressing according to plan. The tech transfer of BAN2803 to Bristol Myers Squibb is on track. It's also great to see that we have continued strong interest for our BrainTransporter technology. Our financials are strong, and we are highly profitable with record royalties as well as the European regulatory milestone from Eisai during the second quarter. The new agreement with Novartis will bring further on an upfront of $30 million to BioArctic. Next slide, please. I'll just talk a little bit also about the agreement with Novartis, which is our third agreement to include our BrainTransporter technology.
It is the first one where another company brings their cargo antibody for us to re-engineer into a new antibody to introduce our BrainTransporter technology. I think this agreement shows that BioArctic now is also a platform company. Importantly, the BrainTransporter platform is BioArctic's proprietary technology. In our business model, we are making deals linked to different targets while keeping the platform to ourselves. Novartis' agreement encompasses one undisclosed target for neurodegenerative disorders. It is distinctly different from our other collaborations and targets. The Novartis agreement starts with a generation and evaluation phase, after which Novartis has the option for a full license. BioArctic is entitled to $30 million upfront. The total deal value of this agreement is up to $802 million plus mid-single-digit royalties if the project reaches the market. The three agreements we have so far with the BrainTransporter technology platform are all with antibodies.
I also want to mention that we are investing and expanding our efforts into other modalities as well, where we also would like to see better brain penetration in order to have better efficacy. We have further business development discussions ongoing, and we aim to establish more collaborations in the future. We had to realize that these kinds of discussions take time. Next slide, please. By that, I will now hand over to our Chief R&D Officer, Johanna Fälting, for an update on the R&D.
Thank you so much, Gunilla. Next slide, please. Starting with an overview of our R&D portfolio, we have two world-leading platforms, as Gunilla described, in precision neurology with cross-program synergies. First, we have our antibody projects with highly selective antibodies targeting aggregated forms of toxic proteins intended for the treatment of severe neurodegenerative diseases with high unmet medical need.
We also have projects based on our BrainTransporter platform that delivers biopharmaceuticals better into the brain. For those of you familiar with our portfolio, you will now note a new project in the portfolio, the ND-BT8825. That is the Novartis collaboration on an undisclosed target in neurodegeneration, combining the Novartis antibody with the BioArctic BrainTransporter technology. We are very happy now to have three BrainTransporter collaborations in the portfolio with distinct and different targets. Importantly, like Gunilla said, the BrainTransporter technology is BioArctic's proprietary, and it will have the possibility to generate more collaborations in the future. To summarize the portfolio, our R&D portfolio is the combination of fully-funded projects run in partnership with global pharmaceutical companies and innovative in-house projects and technology platforms with significant market and out-licensing opportunity. Next slide, please.
A major challenge working with brain disorders is that only a small fraction of the antibody or the biopharmaceutical administered via the blood enters into the brain. The aim with our BrainTransporter technology is to improve the brain exposure, allowing for lower doses, improved dosing convenience, reduced manufacturing and cost of goods, and potentially also improved efficacy and better brain distribution. We have a unique approach targeting active brain transport via the transferrin receptor. This platform has been preclinically validated in non-human primates, showing an improved brain exposure up to 70-fold without affecting reticulocytes, which is a safety concern with this approach. What we now are doing is that we are currently working with different modalities, as Gunilla described, such as antibodies and enzymes, but we are evolving the technology also to other modalities, such as proteins, peptides, or even antisense.
This will also bring new modes of actions and expand the target space in the brain. The BrainTransporter technology platform unlocks an enormous potential not only for internal projects but external opportunities. As Gunilla mentioned, we see a high external interest in our platform. Next slide, please. Exidavnemab is an antibody that selectively targets pathological alpha-synuclein aggregates while sparing the physiological monomers. Exidavnemab is in phase II-A in the Axis study. This is a study with a primary endpoint, safety and tolerability of exidavnemab. We are, of course, also exploring a wide range of biomarkers, both biochemical, digital, and imaging biomarkers. This is a very innovative study, I would say, and unique in its approach of including the right patients into the study.
We do this by a smell test and also a CSF seeding amplification assay to ensure that the patients included in the study have the correct diagnosis and have the alpha-synuclein pathology that we are targeting. In June, we had a safety review of the cohort one with Parkinson's patients supporting progression into the higher dose. Cohort two is now intended to be initiated both in Parkinson's and multiple system atrophy. Exidavnemab is progressing well in phase II-A, and study results are expected mid-2026. As Gunilla mentioned, exidavnemab has reached orphan designation for multiple system atrophy, which is a rare progressive neurodegenerative disorder both in the U.S. and in the EU. Following the Axis study, we see several possibilities for further development in different synucleinopathies, such as Parkinson's, multiple system atrophy, or DLB. We are currently evaluating and preparing for the next phase of development. Next slide, please.
As Gunilla mentioned, everything that we have seen coming out from the AAIC meeting in Toronto this summer has been very positive, especially when looking at the Leqembi data. Eisai presented new data from the phase III open-label extension study, and new data from patients treated with Leqembi for up to 48 months are shown on this slide. To start with the efficacy, treatment effects continue to expand compared to the natural course of disease shown by ADNI or BioFinder data. Another way of describing the efficacy is to talk about time saved or time that you stay in an earlier stage of disease. In this analysis, time saved is up to 13 months after 48 months of treatment. Also, in terms of safety, the long-term safety profile continues to be in line with previous data. Next slide, please.
In addition to the full Clarity AD study results, subgroup analysis has also been done. I would like to highlight this one in patients treated with Leqembi and patients that have a low tau. This subgroup is likely to have an earlier stage of the disease. They seem to benefit even more from treatment, looking at the CDR-SB boxes, and a large percentage of patients being stable or even improving after 48 months. This is, of course, very, very exciting data, but it's also a smaller study. We have to be mindful that this is a small population. It shows the importance of starting treatment early on. We are really looking forward to the AHEAD study results testing Leqembi in earlier AD patients. Next slide, please.
In addition to the presented long-term efficacy and safety data of lecanemab, important presentations during the congress covered real-world evidence data from Leqembi being used in clinical practice. These data confirm the Clarity AD phase III data. It's very reassuring that the real-world evidence data is in line with the clinical study, both with regard to safety and efficacy. Also, Eisai presented encouraging data on the subcutaneous auto-injector maintenance treatment. A more convenient subcutaneous dosing will allow patients to easily be treated at home, enabling continued treatment without visiting infusion centers. Anna-Kaija will talk more about this. In addition to the Eisai presentations at the AAIC, new guidelines for blood-based biomarkers were presented. Anna-Kaija will talk more about this as well. Taken together, all of the data presented would help to expand Leqembi usage. Next slide, please.
I now will hand over to our Chief Commercial Officer, Anna-Kaija Grönblad, for a commercial update.
Thank you, Johanna. As Gunilla mentioned earlier, Leqembi, as you can see, has now been approved by 17 health authorities globally, covering 49 countries, of which the latest approvals since the last quarterly report were in Thailand, Saudi Arabia, Qatar, Kuwait, and Bahrain. Meanwhile, in the U.S., we are eagerly awaiting the FDA decision any day now on the subcutaneous auto-injector for the maintenance dosing. Eisai is also planning to shortly thereafter submit the application also for the initiation treatment for the same auto-injector. Anders will soon comment more on the actual sales. In short, Leqembi is growing steadily in the different regions and markets.
In the U.S., we can see that the usage of both blood-based biomarker tests and PET and CSF testing is increasing, indicating that more patients are being investigated for Alzheimer's disease. As for the EU, after the European Commission approval in mid-April, it's really exciting news now that Austria launched earlier this week on Monday and that Germany is planning to launch next week, Monday. These are usually the early launch countries where there will be a gradual rollout of the expected launches in the EU throughout 2026 and into 2027, following the regulatory requirements and their national pricing and reimbursement processes. In France and Spain, on the other hand, there is an opportunity to provide Leqembi sooner through an early access program. This will probably be in place in the last quarter of this year.
As Gunilla mentioned, in the Nordics, Eisai has submitted the dossiers to the authorities in four of the Nordic countries for the health technology assessment, which is the start of the whole pricing and reimbursement process. There are no fixed timelines for these processes, but we are aiming to launch in the Nordics next year in 2026. Next slide, please. I would like to come back to what Johanna referred to earlier regarding the developments in this field presented at AAIC in July, both in regards to blood-based biomarkers and also Leqembi's competitive edge and growth opportunities thanks to the subcutaneous auto-injector. Firstly, I think that the fact that we now have both clinical practice guidance from the Alzheimer's Association in place in the U.S.
and the first blood test approved by the FDA in May, which was the Fujirebio test, and there are probably more to come soon, this clearly offers a simplified diagnosis pathway. In the future, the usage of PET and CSF will probably decrease, which also means less cost and infrastructure needs for the health care. As an example, also here in Sweden, the Sahlgrenska University Hospital also offers clinics the possibility to analyze blood samples with the phosphatide 217 since July this year. This will clearly simplify, as I said, the diagnostic flow since it will be easier to evaluate which patients need to be investigated further, while other patients can have the results much quicker if their cognitive issues are not due to Alzheimer's disease.
In the future, it can also be used in the primary care as a triaging tool, detecting patients earlier, improving the referrals, i.e., making sure that the right patients are referred to the specialist clinics. Secondly, I already mentioned the subcutaneous auto-injector. This also offers a choice for both the patient and the health care professional to choose which treatment option is best suited for that specific patient. Not only could it be a freedom for the individual to self-inject at home, but the usage of the auto-injector will also free up infusion capacity at the hospital and mean less cost for payers. Eisai expects that the potential approval of the subcutaneous initiation treatment could come in the first half of 2026.
Finally, the four-year study mentioned ahead 345 with more than 1,400 people with pre-symptomatic Alzheimer's disease was fully recruited in October last year and offers new opportunities both for the science to evolve but also for the potential growth for Leqembi. It's really exciting times ahead. Next slide. Just a few words on the Nordics, where we have been gradually building a team of very experienced and knowledgeable, and I would say very motivated pharma professionals. We're about 20 people in the commercial operations team at BioArctic and working very closely with our colleagues at Eisai. Since the European Commission approval, we have onboarded some additional field-based people that can help prepare the health care for the coming launch. We have supported Eisai in the HTA submissions and will continue to do so in the upcoming price negotiations.
Our objective is to help optimize the early AD patient journey and the infrastructure and educate on the value that Leqembi brings. We have engaged in several collaborations with health care, mentioning only a couple here, such as the EU Prominent Project and the Real AD study in Sweden. We can now also promote Leqembi proactively in three of the four Nordic countries. We experience a big interest from the health care professionals in learning more about the field and Leqembi. Next slide. Just in my final slide, I have just selected a couple of additional examples of initiatives that we have prepared to roll out in the Nordics to support our launch. On the left-hand side, you can see the HCP web portal called Campus Alzheimer, which will be launched in Sweden in the coming week and in the coming months in the rest of the Nordics.
The education need is big, and we have strived to create a hub where Nordic health care professionals can find all the relevant and updated information about the diagnosis and treatment of Alzheimer's, new research findings, training opportunities, upcoming events, etc. Also, on the right-hand side, you can see the invitation to what is expected to be an annual high-quality Nordic educational event in Stockholm, happening only in one week's time. This has been organized together with an external scientific steering committee who has put together an excellent program. All in all, we are very excited to enter this new chapter in Alzheimer's disease with the expansion of Leqembi globally and with the launch of Leqembi in the Nordics. With that, I hand over to Anders for our final.
Thank you, Anna-Kaija. If I start with the Leqembi development, we see very strong growth during the second quarter. The global sales increased to JPY 23.1 billion or $160 million, which represents a 57% increase quarter- over- quarter, or roughly a quarter of the increase from the same quarter last year. This is partly due to a stocking effect in China, where sales were JPY 7.7 billion or $52 million, which is a 300% increase from the first quarter. This is due to the threat of tariffs, which meant that large inventories were being built up in China during the quarter. BioArctic has calculated that if you remove this stocking effect, the growth in China would still have been 24%, or global growth would have been 20% if you remove that one-time effect.
All in all, the underlying growth is still very strong, and it was further boosted by this one-time effect in China. If you look at the different markets, Japan, I would say, is still the strongest market that has come farthest along in the implementation of Leqembi treatment. They're now well into the demand expansion phase with sales of JPY 5.5 billion or $38 million. That's a 23% increase from the first quarter. Here, they're already starting the second disease awareness campaign for mild cognitive impairment, which is the earliest phase where you can use Leqembi and this largest area where we believe growth can be seen in the future.
They have also been very successful in setting up a big network of 1,500 follow-up facilities that are collaborating with the sites where the patients get their initial treatment so they can be moved over to these follow-up facilities after roughly six months of treatment. This is a pattern that BioArctic is now replicating in the U.S., where we're also seeing solid growth, even though there is more competition in the U.S., where in the Middle East, it's very active. Sales of Leqembi in the U.S. were JPY 9.1 billion or $63 million in the quarter. That's a 14% increase from the first quarter. There were some currency headwinds. At constant currency rates, the increase would have been 20%. Here, the market is growing fast. There is competition from Lilly, but Lilly is also helping to build the market.
The market growth is now expected to continue, and it will be further boosted by the initiation of usage for blood-based biomarkers for diagnosis and not just for triaging. We do expect to see a continued market growth boosted by this. Here, Eisai has now launched a targeted direct-to-consumer campaign. They will spend more efforts on involving primary care in the second half of this year, roughly what they have been doing in Japan quite successfully. This will, of course, be supported by the approval of the subcutaneous version, which makes it much easier for the patients to take the treatment at home. All in all, this means that the primary care segment will be much more active in the whole treatment chain.
It will also be interesting to see what will happen in the EU, as Anna-Kaija mentioned, where Leqembi is now launched in the EU for the first time. However, it will take some time before we see a significant impact of this in the world, as it takes a couple of quarters to establish the treatment. That's what we've seen in the U.S. and Japan. It is, of course, very encouraging that we're now finally on the way in the EU as well. If we now turn to the forecast, we think that this very positive development that we've seen now means that Leqembi is fully on track to reach the forecast of JPY 76.5 billion in the fiscal year of 2025. This is Eisai's forecast that they have issued, and it covers the second quarter of 2025 until the first quarter of 2026.
What we can see now is that they are above plan in several markets. For example, if we look at China, as you can see here, Eisai expects to sell JPY 9.5 billion in total in that fiscal year. The sales in the first quarter of the fiscal year were JPY 1.7 billion, so they just need an additional JPY 1.8 billion in the coming three quarters to reach the forecast. The same, if you look at Japan and the U.S. and calculate what growth they need to reach the forecast, it's roughly 6% in both markets. They're currently growing at roughly 20% in both markets, and there's really nothing that says that growth is going down significantly. Eisai even stated that July, which is the month of this quarter that we are in right now, was the strongest month that they have ever seen.
All in all, we think there's a very high likelihood that Leqembi will beat the forecast when we close the year. If we then turn to our own numbers, our second quarter revenues were SEK 392 million, which is quite a big increase from SEK 50 million the same quarter last year. This is then, of course, due to the milestone payment that we received of EUR 20 million. The recurring revenues are increasing and will continue to increase. As you see now, the royalty was SEK 162 million in the second quarter. Co-promotion is still not that big. As Anna-Kaija gets going during next year, we expect to see increasing co-promotion revenues as well. The Novartis upfront payment that we talked about earlier of $30 million will not be reported fully this year. It will be reported over the whole research collaboration phase on that project.
I would estimate that roughly 20% of the upfront payment will be reported during this year. If we then turn to our expenses, you see that our operating expenses increased to SEK 193 million from SEK 121 million a year ago. Roughly SEK 32 million of that is currency effect. The underlying operating costs were roughly SEK 161 million compared to SEK 120 million one year ago. We spend heavily on R&D, and 70% of our operating expenses are spent on R&D. For the remainder of the year, we do expect to see an increase compared to last year. I have previously stated that we expect operating costs of 2025 to be roughly 60%- 80% higher than 2024. We now see that it's going to be lower than that. We estimate that it's going to be roughly 50% - 70% higher than the cost of last year.
If we then turn to the operating profit on the right-hand side, you see there was SEK 179 million for the second quarter. It's a steep decline from the first quarter, but that was then heavily impacted by the $100 million upfront payment that was fully reported in the first quarter. I should remind you that the second half of the year will most likely be less profitable than the first half of the year. We do expect that the operating profit will be above SEK 1 billion for the year. On the next slide, you see our net profit on the left-hand side. The net profit was SEK 97 million, which is roughly SEK 82 million less than the operating profit. That's then explained by negative financial net due to currency effects and accrued tax of SEK 75 million.
In the mid-graph, you see our whopping cash flow, more than +SEK 1.1 billion in one quarter. That would be hard to beat for the coming quarter. That's, of course, explained by the $100 million received from Bristol Myers Squibb and the $20 million received from Eisai during the quarter. A very, very strong cash position, SEK 1.9 billion at the end of the second quarter. That's the equivalent of roughly three years of underlying costs currently. We have a very, very strong financial position. It will continue to strengthen during the last quarters of the year since we will receive the $30 million from Novartis during the fourth quarter. I expect to end the quarter with more than SEK 2 billion in cash equivalents. With that, I hand back to Gunilla for some closing remarks.
Thank you so much, Anders. We're coming towards the end of today's presentation. I'll just do some look at the news flow and some closing remarks. Next slide, please. We just informed about the initiation of Leqembi launch in Europe. We've started in Austria this week and are planning for Germany beginning of next week. We are eagerly waiting for the response from the FDA regarding the subcutaneous auto-injector for maintenance dosing in the U.S., where the PDUFA date is August 31. Our partner Eisai is preparing for a U.S. filing for induction dosing with the subcutaneous auto-injector soon thereafter. We are hoping for an approval first half of next year. I think the subcutaneous auto-injector will be an important further treatment option, making the administrations much more convenient for patients and with less cost for society. We are also expecting further regulatory responses on Leqembi.
The next countries for commercialization with early access in the EU are expected to be France and Spain. We are looking forward to further European launches next year, including the Nordics, which, of course, is very exciting for us at BioArctic. During the first half of next year, we also expect the exidavnemab phase II-A study to be concluded and a decision on next steps for development. There we see several different opportunities, as Johanna described. In summary, we have a lot of exciting things ahead of us. Next slide, please. Some key takeaways from today's presentation are that BioArctic has now entered a new era, an era of profitable growth. That is signified by yet another strong quarter. We see increasing Leqembi royalties, and we are very pleased with the new partnership with Novartis.
We are starting to deliver on our 2030 ambitions, both with regard to Leqembi, which is well on track to become an established treatment in Alzheimer's disease, where we also have seen now further regulatory approvals, further launches, reassuring data both from long-term treatment and real-world data, and continuously increasing revenues and number of patients that we're helping on a global level. The second part is exidavnemab, which is progressing very well with a high-dose part of the phase II-A study being initiated in both Parkinson's disease and multiple system atrophy patients. Our business development efforts continue to deliver with a third BrainTransporter partnership agreement signed. This is, as I said, the first of its kind, which is expanding BioArctic also to being a platform company now. The fourth part is that we have strong financials with yet another highly profitable quarter with record royalties and cash flow.
I think that the future looks very bright for BioArctic with great hopes for many patients. Next slide, please. By that, I say thank you so much for your attention. We are happy to take some questions.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad.
Viktor from Nordea, go ahead. Your line is open.
Yes, thank you for taking my questions. I have three from my side, please. First, on the Novartis deal, I just wanted to see if you could elaborate how long you expect the evaluation of your BrainTransporter technology together with the antibody from Novartis to take before we could reach a stage where Novartis could exercise its option and perhaps what kind of data they would be looking at, if it's preclinical or if they need some kind of more advanced data. Secondly, also with this one-time stocking in China that was announced for Leqembi in Q2, I just wonder if you heard from your partners if this could lead to lower sales in China in Q3 or Q4 or any other information on this. Finally, I just noticed on your pipeline slide that I didn't see BAN2802 in Down syndrome.
I just wanted to understand if this has been dropped from your development program or if it was due to any kind of commercial evaluation or if it was driven by any data you generated. Thank you.
Thank you so much, Viktor. Three very quick questions. We start with the first one with the Novartis collaboration. The first part is that we should generate the new asset and then do some evaluation work together with Novartis. I think that period is preclinical and it's about two years. Your second question with regard to Leqembi in China, I think Anders wants to comment on that one.
No, we don't have any specific details. I think it is to be expected that sales will be significantly lower in the coming two quarters than it would have been without this stocking effect. At least that's a fair assumption, even though I don't have any full details to share.
Your third question with regard to Leqembi or BAN2401 lecanemab in Down syndrome. It's definitely not dropped. It's just not on the slide anymore because we don't do so much work right now. Of course, Down syndrome is an important patient population that potentially also could benefit from Leqembi. It's definitely still on the radar.
OK, thank you. Just a quick follow-up on Novartis. When they do exercise or if they would exercise the option when data has been generated, could that trigger an additional upfront payment, or would it just enable Novartis to take over the rights of the program and then pay you milestones further out?
We're not disclosing details about the rest of the milestones. I can say that there is a next milestone linked to if they exercise the full license deal. That is also a milestone at that stage. I'm not disclosing how big that one is. Of course, it's a normal approach to the rest of the milestones, development and commercial.
OK, thank you very much.
Thank you, Viktor.
For me.
The next question comes from Joseph Hedden from Rx Securities. Please go ahead.
Good morning. Thanks for taking my questions and congratulations on the Novartis deal. I just wanted to dig a little deeper into the deal. Is the target that Novartis is pursuing, is that a target that's related to one indication or is it perhaps something that could span several neurodegeneration indications? Could you say whether these are rare diseases or broader indications like Alzheimer's disease?
Yes, I really can't disclose much about that program. I can say I think it's a very interesting target that can help many patients potentially. These can be several different indications. I'm not going to reveal any details.
Thank you. Just on the research collaboration agreement with Novartis, where they have an option on a BrainTransporter candidate, is that still progressing well and on track for a decision from them in 2026? I think that was the initial target.
Our collaboration with Eisai is progressing really well according to plan. That is with regard to BAN2802 that you're talking about. I cannot comment exactly on the timelines there, but it's progressing according to the plan and it all looks good.
OK, thanks. Perhaps a question on the rare diseases portfolio where you're using BrainTransporter technology to look at candidates in ALS and Gaucher preclinically. Just a question on the overarching strategy when considering these rare diseases. Will you take these candidates into the clinic yourself to kind of progress them a bit further down the line before looking for a licensing deal? Or are these available for licensing straight away as kind of been your historical model apart from exidavnemab at the moment? Thank you.
Thank you so much. Another good question, Joseph. I think based on that, we now have a strong financial situation. We have all possibilities. I mean, we could drive programs much longer, potentially all the way to the market when we talk about rare diseases. We still have an open-door policy. If we get a good deal proposal, we might partner. I think it's a great strength for BioArctic that we could partner. We don't have to partner. We can do what we think is the best for the projects. Both of those, I think, are very, very exciting and rare disease indications with huge opportunities for us to potentially drive them ourselves longer.
OK, thanks very much. Congratulations again.
Thank you so much, Joseph.
The next question comes from Mirt Bainvoort from Van Lanschot Kempen . Please go ahead.
Hello. I'm calling in for Luisa from Van Lanschot Kempen . First, congrats on the Novartis deal. I had a few questions. Considering the Novartis deal, do you expect from here onwards to establish more deals using the BrainTransporter technology also as an option deal or more similar to the deal with Bristol Myers Squibb? Secondly, could you remind me what are the next steps for exidavnemab? Could you provide more color on what differentiates BioArctic's BrainTransporter from other shuttle technologies using the same transporter? Thank you so much.
Thank you for three great questions. The first one with regard to the BrainTransporter, this is our proprietary technology. I think that we can foresee several different opportunities in the future. We could foresee more deals like the one we did with Novartis, whether or not the company comes with their assets and wants them to be re-engineered into a new asset which has better brain penetration. I think that's one possibility in our business model. We are also working on other modalities. We're open to discussions for collaborating with others on other modalities as well. We have then combined the BrainTransporter with all our internal targets. That could potentially be deals more like the one with Bristol Myers Squibb, where it was combined with one of our internal programs.
The beauty with BioArctic's portfolio and the approach that we're working is that we can drive ourselves or partner with our own assets. We can also now, since we are a platform company, work with other companies' assets and improve them. We can do our own further development of the BrainTransporter technology ourselves or together with others. We have a lot of opportunities and great possibilities, I think, for the future, both with our own therapeutic targets and with our BrainTransporter technology. Maybe, Johanna, you want to allude a little bit to what's different with our technology versus others?
Yeah, absolutely. Thank you, Gunilla. I think that, yes, we are working with the transferrin receptor. Many companies are pursuing the same target for active transport into the brain. I think that's great because this target actually has clinical validation from the Trontinemab-Roche brain shuttle program.
What is unique with our approach is that we have done extensive screening. We have a lot of structural data that has made us identify a unique epitope on the transferrin receptor that is different from the other companies as far as we understand it. This epitope and the binding site then enable us not to interfere with the normal function and the normal transport function of the transferrin receptor. Also, it's positioning our therapeutic antibody close to the cell membrane. That is something that is very important, we believe, from a safety perspective and not interacting with reticulocytes. That has been a reported potential side effect with these kinds of approaches. I think that we have a unique way of interacting with the transferrin receptor, enabling us to have a better safety profile.
We have seen great data in the non-human primate study with an almost 70-fold increase in brain exposure. We think that we have a really unique approach in that sense.
Thank you, Johanna. Maybe you want to talk also about the exidavnemab question?
Yes, where we are heading? Yes, the exidavnemab, of course, I mean, we are now eager to think about what's going to be the next step for exidavnemab. There are several different opportunities there in terms of multiple system atrophy, Parkinson, or DLB. We are, of course, looking into how the competitive world is evolving. We know we're, of course, encouraged also for the target that Roche has now pursued prasinuzumab into phase III. Lundbeck has pursued their almanitogib compound into phase III in multiple system atrophy, whereas Roche is going for Parkinson. We see many opportunities there for further development.
I hope that answered your question.
Thank you so much. Yes, thank you.
The next question comes from Natalia Webster from RBC. Please go ahead.
Hi, thanks for taking my questions. I have three, please. The first two just on Leqembi. The first one's fairly broad. Just curious to hear a bit more color on the progress you're seeing in infusion capacity in the U.S. and the impact you've seen from recently approved blood-based biomarkers, and also how quickly you expect the subcutaneous maintenance and initiation potential approvals to have an impact on adoption going forward. Secondly, if you're just able to comment a bit more about your expectations for the European launch, I appreciate it's early days and you said it'll take a couple of quarters to see impact. I'm curious if you're expecting to account for some of the challenges that you saw in the U.S. around capacity and if there's anything you're doing at the moment that can help mitigate that.
Thirdly, just on profitability, you've maintained your long-term ambition for sustainable profitability and recurring dividends. This year should be helped by milestone payments, but just wanted to check that you're still confident on reaching sustainable profitability from 2026 onwards. Also, if you're able to comment on what point you may expect to start paying dividends. Thank you.
Yeah, thank you so much. I think we start with Anna-Kaija and Leqembi questions, please.
Yes, if I remember your questions right, it was about the U.S. and the kind of development of the growth and related also to the subcutaneous. What Eisai has communicated is that we can expect maybe a kind of increase of Leqembi starting the beginning of next year, thanks to a potential approval of the subcutaneous auto-injector for the maintenance treatment. It will take some time, I guess, through the system before we can see that growth coming. I think also mentioning the different data we see from lab companies, it's encouraging to see that, as I mentioned, the usage of different blood-based biomarkers, but also PET and CSF testing increasing, which would indicate that the growth is really starting to expand for the usage of Leqembi.
We haven't seen any, let's say, signs of decreasing growth also after Sunla launching. It seems to be good that we have two companies driving this need of changing the infrastructure and the patient journey in a smoother way. I think it's encouraging to see that growth to continue. We expect it to continue even more at the beginning of next year. The blood-based biomarkers, yes, and of course, the blood-based biomarkers mentioned many times during the call already today. I mean, it's been talked about many years, but now it's really happening. This is really encouraging. It will take, if I then go to the European launches, as I mentioned, there is this regulatory requirement to implement this CAP, Controlled Access Program, which needs to be done by a national level. Also, the different pricing and reimbursement processes are different in the European countries.
I think you will see the launches roll out gradually during next year mainly. We know that there are quite a few centers already in France, for instance, ready to initiate Leqembi usage through this early access program. It will take some time. We will probably see the same kind of infrastructure challenges as in the U.S. We've heard from our Eisai colleagues in Austria how they have worked on this. What is a key takeaway is that you really have to be close to each hospital clinic because the challenges might be different from one hospital to another. That's what we're doing also in the Nordics now, really visiting the main hospitals that we think will start to see what kind of challenges they have and how we can support that.
We continue to the profitability, Anders, those questions.
Sure, yeah. We have mentioned earlier that we expect to be profitable from this year and onwards based on the royalty revenues, especially that comes from next year. No, we haven't changed anything there. We still expect to be profitable from 2026 and onwards. As for dividends, I can't really answer to that. It's a board call. I said at the capital markets day that I think is likely to happen within one or two years. It really depends on what happens with Leqembi. I do expect that our board would like to see that we are profitable on a sustainable level based on Leqembi royalty before that happens.
Great, thank you.
The next question comes from Rajan Sharma from Goldman Sachs. Please go ahead.
Hi, thanks for taking my questions. I also had one on the Novartis deal. Novartis are also collaborating with Cyrenax on a brain delivery platform. I just wanted to understand how your technology compares to Cyrenax and whether the target that you're working on is different to that being explored by Novartis with Cyrenax. I have just a couple on Leqembi. Firstly, just on the Nordic launch, could you provide just a little bit more color on timing there? Is that likely to be in the first quarter of next year or is it more likely at some point during the first half? The other one was just on subcutaneous Leqembi. What's your expectation for approval in Europe? Do you expect that to move the needle on some of the reimbursement decisions and discussions that you're having? Thank you.
Great questions. The first one, we'll have a very short answer. I will not comment anything on Novartis. That's for them to comment on their other collaborations. Then we turn to Leqembi and the Nordics, Anna-Kaija.
Yes, I mean, as I mentioned, there are no fixed timelines for these kind of processes. We are expecting launches throughout 2026. I can't kind of, it would be guessing from my side exactly when this will happen. 2026, throughout 2026. Subcutaneous in Europe, yes, so I mean, we're hoping that this will be a decision from Eisai to also launch subcutaneous in Europe. We haven't heard anything yet on that, and for the authorities to review, of course.
Not much more we can say there. Next question, please.
If Rajan didn't have any more questions, we have a few that have been written, sent in. I'll read them and maybe we'll help direct who should take them. A couple of ones from Frederick at RedEye. He's asking in relation to the deal with Novartis, I guess, should we expect more option or valuation agreements for the BrainTransporter platform when it comes to using external drug candidates? I think you touched on that already, Gunilla.
Yes, the answer is yes. We cannot say anything about timing. You should be aware these kind of discussions take time. We definitely have a lot of possibilities for the BrainTransporter in the future in different ways.
Yeah. Maybe a couple for Anders. The stockpiling effect that we saw in China, have we had any indications of anything similar happening again or is it likely just a Q2 thing? If you can talk a bit about the tax post in more detail.
If nothing extreme happens, I don't expect any similar effects in the future. However, there may be new initiatives coming from the U.S. government that will have an impact like this. If that happens, of course, I can't promise that it won't have an effect on this. As for the tax recorded, it's based on an estimate of the profit per year, not a very exact estimate. We have to do that according to the tax regulations in Sweden, and we're just following what we have to do.
Good. Thank you. There was a question here from Peter, but I think we've already answered that.
That was about the timeline for the evaluation of BAN2802. I think you already made a statement there, Gunilla. Those were the questions we had online. I don't think there are any more questions in the telephone queue either. With that, I guess we can conclude today's call. Thank you, everybody, for joining. See you next quarter.
Thank you so much.