Welcome to BioArctic Q1 Report 2025. For the first part of the conference call, the participants will be in listen-only mode. During the Q&A 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 so much. Good morning and welcome to BioArctic's presentation for the first quarter of 2025. BioArctic has now entered a new era, an era of profitable growth, which is signified by an extraordinarily strong first quarter and a lot of activities throughout the different parts of the business. I will talk more about that in today's presentation, and we take the next slide, please. I'm Gunilla Osswald, I'm the CEO of BioArctic, and I will share today's presentation with our CFO, Anders-Martin Löf. Next slide, please. BioArctic is listed at Nasdaq Stockholm Large Cap, and this is our disclaimer. Next slide, please. As I just said, BioArctic has now entered a new era, an era of profitable growth with continuous and increasing royalties, also supported by milestones, which is reflecting the benefit of our successful partnership business model.
This enables even further activities across the business as we develop new and better treatments for patients in an increasing number of severe brain disorders. Let's look at some of the highlights this year. First of all, Leqembi is now approved in all major markets, including the U.S., Japan, China, and Europe. We see continued growth across markets, and more and more patients are getting access to Leqembi. Continued development of more convenient dosing and more convenient diagnosis will continue to drive the growth going forward. We are very excited about the FDA recently approved the first blood test, which is used to diagnose Alzheimer's disease. That means that even more patients will be able to be treated with Leqembi. I continue to be very excited about our BrainT ransporter technology.
The significant deal with Bristol Myers Squibb for our paragluteal Beta antibodies for Alzheimer's disease, including BAM/2803, which is utilizing our BrainTransporter technology, that has now come into effect since February. This agreement also opens up for further partnerships utilizing our BrainTransporter technology. It's also great to see how Exidavnemab progresses. The phase 2A study started late last year and is progressing really well and according to plan. All patients have already completed dosing in the low-dose part of the study, and we have expanded the study to also include multiple system atrophy patients now. The quarter showed a record high profit due to several one-time events, including the upfront from BM S and milestone from Eisai`, as well as continuous royalties on Leqembi. Based on these achievements, BioArctic has now entered a new era, and I call that BioArctic Growth Area.
This is based on continuous and growing royalties quarter on quarter, which gives us revenues. We are not anymore dependent on irregular milestones. BioArctic will get even more stable finances, and we expect to be profitable from this year and onwards. Our BrainT ransporter platform is validated with strong partnering interest, and it could potentially lead to several partnerships in the future. Our alpha-synuclein portfolio with Exidavnemab and BT2238 is also receiving a lot of interest amongst external partners. Next slide, please. Before I go into details, just a short reminder of the two platforms that are forming our company. We are among the world leaders as innovators in these two areas. The first one is highly selective antibodies targeting aggregated forms of misfolded proteins in Alzheimer's disease, Parkinson's disease, and ALS.
The other area is our BrainT ransporter technology, which helps biological treatments to get better into the brain through the blood-brain barrier, and that makes it higher concentrations in the brain of the treatment close to the target. This means that it has potential for even better effect, better safety profile, and lower doses, which makes it more convenient for patients. Our business model focuses on innovation of new treatments for neurodegenerative disorders, but we are also now a platform company with the BrainT ransporter technology. Next slide, please. Now, I would like to start with Leqembi, where our partner Eisai is doing tremendous work on the regulatory side. The European Commission finally granted the market authorization for Leqembi in Europe on the 15th of April this year. This enables potential access to Leqembi in additional 30 countries.
It's indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer's disease. We call those together early AD. It is for patients who are ApoE4 non-carriers or heterozygotes with confirmed amyloid pathology. Homozygotes, which is about 10%-15% of the Alzheimer's population, are excluded in Europe. The next step now in Europe will be to work on the controlled access program and post-authorization safety study and education material for the introduction into the market, and then local price and reimbursement discussions in each country. In total, Leqembi is now approved in 44 countries, and we are awaiting decision in 12 additional countries. The European regulatory approval may serve as a reference for regulatory authorities in other countries where submissions are filed.
In order to make Leqembi administration even more convenient for patients, Eisai are progressing different lifecycle management activities. The first one is the IV maintenance dosing less frequently, and that will then be able to give it every fourth week. That has now been approved in the U.S. This means that after 18 months of dosing patients, they could consider transferring to dosing every four weeks instead. This supports long-term treatment, and this is important to continue the treatment, to continue to clear the toxic species of amyloid also after that the plaques are cleared. This is a clear benefit for Leqembi. Eisai are also preparing for a broader submission of IV maintenance across markets. Another benefit for Leqembi is the subcutaneous autoinjector, which is making treatment even more convenient for patients.
The FDA has accepted the filing for maintenance dosing with a PDUFA date of August 31st this year, so end of August. Eisai is also preparing for a supplementary BLA submission to the FDA for the subcutaneous autoinjector for induction treatment after the approval of the maintenance treatment. Next slide, please. Leqembi data were presented at the latest key Alzheimer's Congress, the ADPD Congress. I think it was very reassuring to hear that real-world use confirms FDA prescribing recommendations with similar rates of side effects as in the Clarity AD study when it's now being used in the real world. Data from the U.K. and the E.U. indicated population, which is excluding ApoE four homozygotes, which I said is about 10%-15% of the population.
Data from that population were also presented confirming that the effects of Leqembi were similar to the overall population in the Clarity AD study and with lower risk of ARIA events. We are now looking forward to coming congresses, the next one is AAIC in July in Canada, where Eisai will present data from Clarity AD open label extension study supporting early treatment and maintenance dosing. We expect four-year data to be presented and more real-world evidence data. On the commercial side, Eisai are progressing commercialization of Leqembi across markets, and this is then adjusted to each market depending on the time point for market entry. The first phase Eisai call. That is now where E.U. and Asia is, and that is the areas where Leqembi just recently has been approved.
When marketing continues, they come into the demand creation phase, and this is like what China is now, which was launched last year. The third phase is demand expansion phase, and here we see Japan having had the best launch, and now the U.S. is also entering into the demand expansion phase. In E.U., Eisai aims to start launch later this year. As for most launches, the first countries tend to be Germany and Austria. At BioArctic, we are preparing for a Nordic launch together with Eisai pending local reimbursement discussions, and the launch is estimated to start first half of next year. Next slide, please. I want to point out three major things that could broaden the use of Leqembi and accelerate the uptake.
The first one is more convenient dosing, so less frequent IV dosing is now approved in the U.S., and the next step is subcutaneous autoinjector. That will make it even more convenient for the patients. The first BLA has been submitted for maintenance dosing. After the approval that we're hoping for end of August, Eisai plan to submit a supplementary BLA for subcutaneous autoinjector for the induction phase. The subcutaneous autoinjector will make the treatment much more convenient for the patients and for caregivers, so it's more possible to give this as home administrations with less requirements and lower costs for administration compared to IV infusions. The second part is the simplified diagnosis based on blood-based biomarkers.
It's very exciting with the first approval by the FDA last week of the first blood-based biomarkers, which has been accepted as confirmational for the diagnosis, making the diagnosis considerably simplified and increasing opportunities for primary care to make the diagnosis. This could also shorten in queues and free up time for specialists to focus on eligible patients. Eisai are also increasing focus on primary care in different approaches and also working on direct-to-consumer advertisement in order to increase access to early patients that could benefit from Leqembi. The third aspect is broadened indication to even earlier stages of Alzheimer's disease. Now we talk about pre-symptomatic individuals, so even before symptoms, but the individuals have elevated levels of A Beta in the brain. The ongoing AHEAD 3-45 study will evaluate the effect when starting treatment of Leqembi very early.
I think this is a great opportunity, especially based on all the data that has been presented at congresses on early patients, alluding towards even better effect when you start treatment early in the disease. Next slide, please. Let us turn to our BrainT ransporter technology. The license agreement with Bristol Myers Squibb is a key event for BioArctic. It is a global license for our amyloid beta antibody programs, and it includes both BAM1503, the naked antibody, and BAM2803, which is utilizing our BrainT ransporter technology. This partnership was effective from the 20th of February this year. I think BM S is a great partner for our amyloid beta program with patients in focus. We are now preparing for BM S to take over the projects and drive it towards patients.
This is our largest agreement, which has been signed so far, and one of the largest globally for such an early project. It includes $100 million upfront and another $1.25 billion in milestones, plus tiered low double-digit royalties on global sales. Importantly, BioArctic retains all other rights to the BrainT ransporter technology outside of the amyloid beta field, and we have several interested partners and good discussions ongoing. At BioArctic, we also continue to develop the BrainT ransporter technology further, and we are also working on broadening it into other modalities like enzymes and antisense oligos. Next slide, please. Now let's turn to Exidavnemab, which is targeting toxic aggregated forms of alpha-synuclein, and it's a potential disease-modifying treatment for several different neuronal synucleinopathies.
There are no existing disease-modifying treatments and a huge medical need with opportunities to help patients with Parkinson's disease, Lewy body dementia, Parkinson's disease with dementia, and multiple system atrophy. Exidavnemab is the most selective alpha-synuclein antibody that I'm aware of, with more than a hundred thousand-fold selectivity for the pathological forms of alpha-synuclein while sparing the physiological monomers. We have very strong preclinical data showing reduction of the toxic forms of alpha-synuclein and delaying disease progression and increasing lifespan in very tough Parkinson's disease mice models. The two phase one studies performed showed excellent PK profile, and Exidavnemab was well tolerated, supporting progression into phase two. Last week, the patent for Exidavnemab was also granted in Europe, and it has previously also been granted in the U.S. and in Japan, and we have a long patent life up to 2046, including extensions. Next slide, please.
The phase 2A study is called Exist, and it's progressing really well. The low-dose part in patients with Parkinson's disease has been fully recruited and dosed, and we are now preparing for a safety readout this summer. We're excited also about that we now will include MSA patients into this trial, and the approval has been granted in both countries, both in Spain and in Poland. We're also pleased that the FDA has granted Exidavnemab orphan drug designation for MSA. I think Exidavnemab offers opportunities to support several different neuronal synucleinopathies like Parkinson's disease, Lewy body dementia, and multiple system atrophy. Next slide, please. A couple of words on MSA. There are no disease-modifying treatments available and a huge unmet medical need. It's a tough disease. It's fatal and rapidly progressing with a lifespan from diagnosis of about six to eight years. Patients suffer from motor symptoms and autonomic dysfunction.
It is an orphan drug indication, and we have received orphan drug designation in the U.S. for Exidavnemab, which is beneficial for continued drug development. Now new biomarkers are being developed both for diagnosis and to follow disease progression, and this is also improving the possibilities for drug development. MSA alone as indication is of blockbuster level, and Exidavnemab has also other opportunities with other even larger indications. Next slide, please. In summary, our portfolio is progressing really well from innovative discovery and all the way to market, helping patients with devastating diseases. Today in the presentation, I have highlighted Leqembi, Exidavnemab, paragluteal beta programs, and our BrainT ransporter platform. I am pleased to see that BioArctic's innovation and research with high quality is also being recognized externally. Next slide, please. By that, I hand over to Anders Martin-Löf for the financial summary.
Thank you.
If we then turn to the next slide, starting with the Leqembi sales, the global Q1 sales were JPY 14.7 billion. That's roughly $96 million. That's roughly an 11% increase from the fourth quarter last year or a 380% increase for the first quarter of 2024. You see the royalty numbers in the graph to the left of the box, and they look a little bit weird. The recorded royalty for the quarter was SEK 96 million, but that includes a currency effect from the Q4 royalty of SEK 5.7 million. So the accrued real royalty for Q1 was SEK 101.7 million. We saw solid growth in the underlying royalties in line with the sales, basically. If you then look at the different markets globally, I would really want to highlight Japan that has been incredibly successful.
There is a 9% increase from the fourth quarter last year up to JPY 4.4 billion or $29 million. We also saw solid growth in the U.S., 4% growth up to $52 million, and it looks like we have stellar growth in China going up 46% from the fourth quarter, but that's really choppy, so it's hard to draw that many conclusions from that. It is really reassuring to see good growth in all the markets. All in all, Eisai beat their full year forecast by roughly 4%, reaching JPY 44.3 billion or roughly $290 million in full year sales in their fiscal year 2024. Looking forward a little bit, as Gunilla mentioned, the U.S. market is now following Japan into the demand expansion phase, as Eisai calls it.
What that really is about is that they try to focus on leveraging the core data that emphasizes the benefit of early treatment of the patients. The patients that are in the earlier stages in mild cognitive impairment, almost all of them are treated in primary care, and the vast majority of them have not even been diagnosed. It is a big imperative to really focus on increasing engagement with the primary care practitioners to encourage coordination with specialty care so you can get more of those patients into treatment. Eisai is now targeting roughly 2,000 primary care practitioners during the year with their sales force. Learning from Japan, they are also now starting direct-to-consumer campaigns to increase brand awareness and disease awareness to really create more of a pull from the patients.
Of course, this is facilitated by the streamlining pathway that Gunilla also talked about. First of all, we'll see the start of the use of blood-based biomarkers for diagnosis starting already this year in 2025 with the first approval early this year and probably the inclusion in treatment guidelines during the summer. As a second step, the subcutaneous administration will be approved for maintenance in the third quarter of this year and hopefully also then for induction in the first half of next year. I think we will see some effect of this increased focus on primary care practitioners in the U.S. already this year, but I expect the full effect of this basically in 2026. It will be very interesting to follow this going forward.
Based on that, if we turn to the next slide, Eisai has updated a forecast for their fiscal year 2025 where they believe the Leqembi sales will grow by 73% globally to JPY 76.5 billion. As you can see in the chart, they expect 53% growth in the U.S., but stellar 88% growth in Japan and then even higher growth in China and in other markets. If this happens, this would correspond to roughly SEK 510 million in royalties during the same time period. Over time, Eisai has issued a revenue simulation in March of roughly JPY 250-JPY 280 billion in 2027. If you look at the growth rates in the coming years that are necessary to reach that, they are basically expecting similar or even higher growth in the coming years. One question we always get is how likely is Eisai to reaching this forecast?
We think it looks really good. They indicated during their quarterly update with analysts that already in April, the sales in Japan, for example, were JPY 2 billion. They are already at the level that would indicate an annual level of JPY 24 billion. If they keep growing in Japan, it looks possible to actually beat the forecast in Japan, and hopefully we will have a similar situation in the other countries. We remain very confident that they can reach this global forecast. Turning then to our financials on the next slide. On the left-hand side, you see that our revenues have increased from SEK 30 million last year to SEK 1,290 million this year, fairly large increase.
This is, of course, driven by the upfront payment from BM S of $100 million, but we also received the milestone payments from Eisai of EUR 10 million, which was a sales milestone. The EU-approved milestone of EUR 20 million was not recorded in the first quarter, but it will be recorded in the second quarter. This is also then supported by the royalty revenues. I've already mentioned that they were SEK 96 million. We also had some co-promotion revenues, so SEK 3 million. Over time, as we have said in the past, these recurring revenues will become more and more important, but in this quarter, they are really dwarfed by the enormous upfront payments and milestone payments. Looking a little bit at the costs in the middle, the operating expenses increased to SEK 203 million in the quarter.
The big increase is mainly explained by an increase in other operating costs, which was SEK 72 million, and this is basically a currency effect on the upfront payment from BMS. If you deduct that and just look at the underlying operating costs, they were SEK 131 million, which is roughly 30% higher than the year before. Out of that, R&D makes up 65%. The vast majority of our costs are spent on R&D and really accelerating our portfolio. The costs are expected, the underlying costs, I should say, are expected to increase during 2025 as our project portfolio progresses, and we will also increase our commercial expenses when we intensify the preparations for the launch of Leqembi in the Nordics. I previously said that I expect the costs to increase by roughly 50%-80% in this year.
I should probably revise the lower limit there to roughly 60% because we will have this, I did not anticipate this currency effect. If I would guess today, I would say that our costs will increase by roughly 60%-80% this year compared to last year. On the right-hand side, you see our operating profit, which was almost SEK 1.1 billion in the first quarter. I'm sad to say, but the remaining quarters of the year will be slightly less profitable than that. We expect the full year profit roughly in line with the first quarter. As Gunilla already mentioned, we expect to remain profitable for the coming year. It is really a big shift for us becoming more of a profitable company going forward. On the last slide that I will show on the next slide, you see the net result.
It's roughly SEK 55 million below the operating profit, and that's explained by a financial net of a -SEK 9 million, and we have also recorded a tax of SEK 44 million in the quarter. The cash flow is much weaker than the result, and that is then also explained by the upfront payment from BMS. It was recorded in the first quarter, but we received the money in April. We did not see the cash effect of that. We did get the money for the sales milestone of EUR 10 million. At the end of the first quarter, our cash balance was roughly SEK 800 million, but already a couple of weeks after the closing of the quarter, we received SEK 1 billion more.
Following us in the remainder of the year, you will see that our financial position will strengthen in the coming quarters from a cash perspective. All in all, we are in really good shape and are really looking forward to investing more and working hard to accelerate our portfolio and focus on the launch of Leqembi in the Nordics. With that, I turn back to Gunilla for some final remarks.
Thank you so much, Anders. We are coming to the final part of the presentation with upcoming news flow and some closing remarks. Next slide, please. Before that, I want to welcome you all to our first Capital Market Day, which is planned for 2nd of June. It will be live in Stockholm, and it will also be live streamed.
We are looking forward to giving our shareholders an in-depth look at our business and our ongoing research. It will be presented by some of my colleagues in the management team, and there will also be an opportunity to listen to a distinguished scientist and clinician who has treated several hundred patients with Leqembi in the U.S. If you're interested, then please register at www.bioarctic.com. The last day of registration is 28th of May. Next slide, please. Our upcoming news flow, I think that this second quarter has started really well with several regulatory approvals for Leqembi in, for example, E.U., and we're looking forward to more regulatory responses. The next important congress is AAIC, where we look forward to several presentations on Leqembi. During the third quarter, then that's actually where AAIC is, the third quarter.
That's, of course, the regulatory response on subcutaneous autoinjector as maintenance treatment in the U.S. and Eisai's subsequent filing for induction treatment with the subcutaneous autoinjector. We also look forward then to the Exidavnemab safety review and progression into the high-dose part in Parkinson's disease and also in MSA in the Exist phase 2A study. Next slide, please. In summary, this quarter was an amazing quarter with a record high profit. Leqembi is now approved in all major markets, and more and more patients are getting access to treatment. We concluded our first license agreement utilizing our BrainTransporter technology, and it continues to generate great external interest. The Exidavnemab indications are now expanded, and we are preparing for several different opportunities for phase 2B. The profits so far this year are great, and it will make BioArctic highly profitable for this year. Next slide, please.
By that, I say thank you for your attention, and we're happy to take some questions.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Viktor Sundberg from Nordea. Please go ahead.
Yes, hi, and thanks for taking my questions. I have three questions, and I can take them one by one. Now with Leqembi approved in Europe, how do you see the Nordic launch of Leqembi? Are any costs here increasing ahead of the launch? Also, for your internal planning, is it expected that the Dental and Pharmaceutical Benefits Agency in Sweden and other neighboring countries will be done with its health economic analysis of Leqembi and subsidize the drug? I can start there.
Thanks.
Do you want to take that, Anders?
If we start on the cost side, yes, we will see some increase in cost, not by a really large number, but yes, the cost will increase during the year. I should have a look at what they were in the quarter. Maybe I will have a look at what they were in the quarter and give you some guidance on how much they will grow during the remainder of the year while Gunilla responds a little bit on what happens on the reimbursement side, for example.
Yeah, I can also say, I mean, we have, as you know, started to build our commercial organization a couple of years ago with the strategic positions. Now, since we got the approval in Europe, we also now are hiring a small number of customer-facing resources.
It will be a fairly small organization because we are also sharing the marketing and the commercialization with Eisai. Eisai are in the lead, and they are driving the price and reimbursement discussions. We are supporting, and it is really their call, and they are driving it. I think that we can expect that the price and reimbursement discussions will continue this year and hopefully will have a good outcome next year.
The marketing and sales costs in the quarter were roughly SEK 19 million. I would estimate that they will increase by roughly 10%-15% per quarter in the coming quarters.
Okay, thank you. I also wanted to get a feel for the timeline in MSA. I noticed that Lundbeck's master trial in MSA will read out in 2028, their phase three.
If you continue running the program in MSA yourself, is this an opportunity more for 2030 and beyond, or how do you see that program going forward? Thanks.
Yeah, first of all, we are really happy that we now can include MSA patients in the ongoing phase 2A study. That will, we think, have the same readout as for Parkinson's disease, which I think is a tremendous piece of work from our organization and for the sites and for the patients. We are looking into different approaches going forward for MSA, for Parkinson's disease, for PDD and DLB. We are looking into different alternatives to drive some of the indications either ourselves or with a partner. We are looking into several different opportunities. There are opportunities to drive it very aggressive for MSA, for example, or a little bit more conservative.
That is the kind of discussions that we are preparing for, going up to the board later on to have those discussions. We are also looking at other important readouts, which are coming later this year also in MSA by another competitor. I think we are learning a lot from different competitors in this area. Sometimes it is good not to be first. Sometimes it is good to be first. Sometimes it is good to learn from others. As we have done in Leqembi, we have learned a lot from others. We are in the same situation right now for Exidavnemab, learning a lot. There is no clear easy answer, Viktor, to your question. We are working on different approaches, but I think most likely it is not before 2030.
Okay, and also, just going back again to this program, what kind of efficacy signals could we get from the phase 2A? I guess you won't be evaluating any scales in Parkinson or MSA, but in terms of the biomarkers you're talking about, what could potentially give the most information about efficacy here in your opinion or how you should maybe plan your future trials in Parkinson and MSA? Thank you.
Yeah, very good question. Again, Viktor. I just want to manage expectations that the phase 2A study is really mainly a safety, tolerability, and pharmacokinetic study in order to see what dosage should be used in the next study. We are also casting a wide net of different biomarkers more for exploratory purposes and to prepare for the next study where we really would expect to see clinical effect. We are looking into several blood-based biomarkers.
We are looking into digital biomarkers and so forth. We will see if we get any signal, but it will be at the most on the signal level. The study is really safety, tolerability, and PK, preparing for the next important study.
Okay, yep. Thank you very much for giving me these answers. Really helpful. Thank you.
Thank you, Viktor.
The next question comes from Joseph Hedden from RX Securities. Please go ahead.
Good morning and thanks for taking my questions. Congrats on the strong quarter. My question is about the expectation to be sustainably profitable. I know this is something that you've restated since the full year results. Since then, we've had high-sized revenue simulation, which was modestly reduced from its previous one.
I'm just wondering, is there any expectation of, is there a milestone component of your expectation for 2026, or are you expecting to be profitable purely from the royalties you receive? Thanks.
It will probably be a combination with some royalties and some sales milestones going forward. We haven't really specified exactly if it's only royalties or only milestones, but if we get the expected combination of royalties and milestones, we expect to be profitable. I can't be more specific than that.
Thank you. I was just wondering from the Exist trial of MSA, just to understand what we'll be getting. We have a safety review in Q3, and that's going to primarily be PD patients.
The top line results in the first half of 2026, is that going to be the Parkinson's disease cohort, or is that also going to include the MSA patients, or do they come at a later date because it started later for them?
Thank you for that question, Joseph. You're absolutely right that we are looking forward to the safety review of the low dose in Parkinson's disease patients around summer. Both the Parkinson's disease and the MSA patients can be treated simultaneously in two different cohorts during the autumn and going forward. We expect, we'll see how quickly both of those indications can recruit, but there is a possibility, of course, that both of them can be ready because they will be done in parallel for readout next year. Okay, great. Thanks, Gunilla. Thanks, Anders. Thank you.
The next question comes from Suzanne van Voorthuizen from Van Lanschot Kempen. Please go ahead.
Hello, thanks for taking my question and congratulations with the strong quarter. This is Chiara Montironi on behalf of Suzanne van Voorthuizen. I was wondering, could you please elaborate on your intentions for further partnership or collaboration for the BrainT ransporter platform?
Yeah, I wish I could tell you more, but I will not. I mean, I can just say that the B rainT ransporter is progressing really well. We are driving the platform forward ourselves. We are expanding it also with enzymes and oligos and ASOs internally as well. We are in discussions with external companies in order to see how they could potentially utilize our BrainT ransporter technology.
That means that we would then take in another project, re-engineer that asset, and then hand it back to the company who would drive it forward. That is the kind of business model that we are opening up for now. I will not tell you any more details about ongoing discussions or so. I think that we have really, I mean, opened up since the plan was all the time since November last year to go out and talk about the BrainTransporter technology, show what we have done with our internal programs, add it into all our internal programs, and then open it up for possibilities for other companies to utilize our technology platform by us helping to re-engineer their assets. That makes it new chemical entities that could be going forward.
I think the exciting thing here is that by doing this, we see that there is an opportunity for a better effect, a better safety profile because you enter the brain in another way. You can give lower doses. That helps cost of goods, but also is more convenient for patients. I think this is very, very exciting, and it is great to see that we have a lot of interest from several external parties.
That is already very helpful. Thank you very much.
Thank you, Suzanne.
The next question comes from Rajan Sharma from Goldman Sachs. Please go ahead.
Hello, thanks for taking my question. One on Leqembi in the Nordic regions.
Just wanted to kind of get a sense of your confidence that there's sufficient infusion capacity in the region and just wondered if you have any visibility on potential blood-based tests both in the Nordic region and Europe more broadly. I had another one which I can follow up on.
Okay, thank you. The first question with Leqembi in the Nordics and our team together with Eisai have been preparing and are preparing the market via a lot of discussions and interactions with different sites to see and look into site readiness. I think there is a clear interest from many different sides that they would like to initiate and start with. We will see the infusion capacity, how it could be built up step by step.
We really hope that all of this will be worked out in a good way with the price and reimbursement part, and then preparation for the Nordics. The blood-based biomarkers in the Nordics and in Europe. I think it's really good for the Nordics that Sweden is one of the areas where I have been part of leading the whole development part of the blood-based biomarkers, both from the Gothenburg region and from the Skåne region. There are really, really good opportunities, and they are utilizing it already on a smaller pilot scale, but it can be utilized step by step. It's not yet fully approved in Europe, but it's being used on a smaller scale to start with.
You know that you could start by a way of triage screening, which means that if you then have a high level showing that you with high likelihood have amyloid deposits in the brain, then you know with high likelihood if you have some clinical signs that it is Alzheimer's disease. If you have very low levels, then you know that it is not Alzheimer's disease. If you are intermediate, that is when you really need them to verify with amyloid PET or with CSF samples. I think what we really look forward to is when we can utilize the blood-based biomarkers also as confirmational, which now has happened in the U.S. I think that it is also on its way in Europe, but it is already being used to some extent.
Of course, when you can replace PET and CSF, that makes it much, much better for especially primary care and so forth and broader use. I hope that answered your question.
It did. The follow-up was just a couple, actually. Maybe slightly related to that, just, and I'm sorry if you've kind of addressed this on previous conference calls, but how feasible do you think it is to develop a subcut formulation of the BrainT ransporter?
I mean, that's definitely our ambition. That's definitely in our plans that by utilizing our BrainT ransporter, those assets also could utilize subcutaneous administration. That's definitely our ambition. I think that's likely.
Okay, thank you.
Thank you.
The next question comes from Alastair Campbell from RBC. Please go ahead.
Morning, everyone. Thanks so much for taking your questions. I've got three, please, just on Exidavnemab.
First of all, can you just remind me of the differentiation versus other molecules in the field? You've touched on the specificity for toxic form, but maybe just remind us how Exidavnemab stacks up against some of the other competing antibodies. Secondly, with amyloid beta antibodies, obviously, ARIA emerges as kind of a hallmark safety signal. From the data you've seen so far with alpha-synuclein antibodies, has anything emerged as kind of a hallmark safety signal? Is there anything specific you're going to be looking for that could be related to alpha-synuclein depletion? Maybe finally, just get a sense of your relative confidence of the mechanism. I mean, is there any reason to believe that MSA might lean itself more favorably versus Parkinson's disease the other way around, or do you think it's broadly applicable across both? Thank you.
Three excellent questions. Thank you, Alastair.
The first one with the differentiation of Exidavnemab, I would point to two different things. The first one is that it is more selective than the others that we are aware of. The selectivity here, I think, is quite important because you have so much Alpha-synuclein in the blood. It is really important that you target the aggregated forms, the toxic forms, while you spare the monomers, which has physiological meaning. I think that is an important part. There we are definitely the most selective among those that we are aware of. The other aspect that also helps is that we have also a superior pharmacokinetic profile with a longer elimination half-life than the others. We have a 30-day elimination half-life. This means that you get higher exposure. You could then lower the dose a bit.
I think the combination of the high selectivity and the pharmacokinetic profile makes Exidavnemab a differentiated and very attractive asset. Your second question was with regard to safety of alpha-synuclein. I'm really reassured by the data we have seen so far by all competitors that we are aware of that it has so far been quite good safety profiles. I think that also is really helpful for us when we're going forward and increases my expectations, of course, for the safety review that we have in front of us. Your third question was with the mechanism of action. I think this is an excellent question, thinking about which indication could be the best indications for Exidavnemab going forward. I think there are different pros and cons for several of the different indications.
That is why we have such an interesting work in front of us to really see which indications should we start with and which ones could come later. There are opportunities both in MSA, which is a more aggressive disease variant than Parkinson's disease. On the other hand, it is possible it is an orphan drug indication. You can then do shorter studies and so forth. It is a more aggressive disease. There is a scientific debate if it targets different parts in the cells and so forth with alpha-synuclein. Parkinson's disease with motor symptoms or Lewy body dementia or Parkinson's disease dementia or going very early in Parkinson's disease are also being considered. We are looking into several different opportunities and seeing which would be the preferred approach going forward after this.
This phase 2A study opens up opportunities for several different other indications for the next step, which is phase 2B. I hope that answered your question, Alastair.
Yeah, that's great. If you don't mind, can I come back with just a follow-up on that? If there's a lot of alpha-synuclein in the blood itself, does that potentially create issues around designing a BTT, a BrainT ransporter technology adaptation? I mean, does it run the risk of sort of the product being sequestered in the blood if it binds too heavily to the blood form of alpha-synuclein? Or could it even end up dragging alpha-synuclein into the brain as a result of that technology? Just wondering if that creates kind of quirks in terms of how the BTT could work.
Yeah.
I think, I mean, if you compare alpha-synuclein with amyloid beta, Alpha-synuclein, there we can have different mechanisms of actions. We can reduce the spreading between cells, but we can also have an effect in the cells because Alpha-synuclein also exists in the cells. We need to come into the brain and also then lower the spreading in the brain, but also ideally come into the cells. We have data showing that with our antibodies, we are also entering and can come into the cell and have the effect even there. I think it is important to have a lower binding in the blood and then also especially to have it in the brain where you can do.
I mean, there's a lot of work ongoing, and we are really putting a lot of effort into driving this forward also with our BT2238 program, which can continue to progress well.
Brilliant. Thank you.
Thank you, Alastair.
The next question comes fromErik Hultgard from Carnegie. Please go ahead.
Yes, hi. Thanks for taking my questions. I have a few, mainly on or starting with Leqembi future launch in Europe. Can you talk a bit? I recognize that there are many different countries and healthcare systems, but can you talk about potential bottlenecks in the uptake in Europe compared to, for example, the U.S. relating to sort of specific bottlenecks like PET/CSF diagnosis, infusion capacity, MRI capacity, etc.? Where do you see is there a difference in which will be the most important bottlenecks in Europe for Leqembi uptake compared to the U.S.?
Following up to that and related to that, maybe if you can talk a bit about how we should think about the uptake once you have price and reimbursement in the individual countries. Do you expect it to be similar to the U.S. or more like in Japan, other single-payer countries? I have a follow-up. Thank you.
Thank you so much, Erik. Really good questions. If I start, and I am sure Anders wants to add also. If we think about Europe, I mean, Europe is several different countries, and every country is working in their own approach. It is a quite complex market from that perspective and different healthcare systems. In Sweden, we also have the MT rådet in different regions. I think you need to look at each country by itself.
I would say that it's a lot of learnings that we can utilize from both the U.S. and Japan and to some extent China with regard to what and how we can do a really good launch. We're committed to doing a really, really good launch in the Nordics in order to make the right patients get access to Leqembi. For example, there are different bottlenecks, I think. Today, you should then, I mean, confirm the amyloid pathology either through PET or CSF. Sweden is really good at doing CSF. It's not much of an issue. There are some sites who also can do PET. Some other countries are less used to CSF. It also depends on where you have your PET scans.
I think also then the blood-based biomarkers, which has already started to be used, and we heard, I mean, a really strong advocate for the blood-based biomarkers from Holland at the latest congresses that I think, and we know that it's being used in Sweden. I think that we will see that being progressed more and more, at least as a first screening method in the triage system that I described. I think this will then help the patients to get the right patients more to the memory clinics and the specialists. Infusion capacity, I think there is a lot of learnings there from the U.S. and from Japan. With the MRI capacity, I think there is a lot of work ongoing also with utilizing AI and other things to see how we can improve the approach with regard to MRI.
There is a lot of work to do in all the building up of the infrastructure, which we can utilize a lot. I think China, I think, is quite interesting to look at because they have started with blood-based biomarkers and digital assessments. That was their approach. It is a very different approach from the others. I think the area to really look at a lot is Japan because they have done a tremendous introduction and launch, which continues really well. It is also good to look at all learnings from everywhere.
Yeah, maybe Gunilla, follow-up to that regarding pricing in Europe.
Considering President Trump's plan to leverage lower ex-U.S. prices in negotiations with pharma companies and given a relatively high price point in Japan, do you see a risk that Eisai and Biogen will not launch in certain European countries if the price is too low to protect the U.S. market?
I would just refrain from commenting. I think it is Eisai who is the lead in the price and reimbursement discussions, and it is really their call.
Okay. Sounds fair. Thank you.
Thank you, Erik.
As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. 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.
We have received some questions on the chat, and I will start with the question if we plan to continue with the Exidavnemab project alone or if we are looking to make partnering agreements at some point. I think that, as you heard, I'm very excited about the Exidavnemab project and the follow-on project, BT2238 with the BrainT ransporter for the alpha-synuclein. Here we are driving both programs ourselves, and we are open for discussions with partners, and we have discussions with partners. The strength of BioArctic where we are now is with our good financial position. We can drive the projects longer ourselves and increase the value more, or we can partner if we get the right partner, just as it was with Bristol Myers Squibb. We did not have to partner that program, but we found the right partner, and we did the partnering then.
I see a very similar approach to Exidavnemab. We believe strongly in this project. We will drive it forward, and we have discussions. If we find the right partner, we will partner. Otherwise, we will continue ourselves. I think we have a great asset with a lot of opportunities. Thank you. The next question is, how does the BrainT ransporter platform compare to other similar platforms? I think the BrainT ransporter technology and the blood-brain barrier technology, there are a lot of different companies working on this, and Roche is one of those who are in the lead. Their technology, they call it Brain Shuttle. There are a lot of similarities with our BrainT ransporter technology, like that we both utilize transferrin receptor.
There are some really important differences in how we bind to the BrainT ransporter, which makes it, for example, a possibility to have less risk for some of the side effects because the approach, how we bind to the transferrin receptor and how we kind of turn the antibodies towards the membrane. Also, we have data that we have presented externally showing that we have a very low interaction with the blood, like reticulocytes and so forth, where several of the competitors have issues. I think that we have a very, very good approach in our own technology with the BrainT ransporter, which I think can be utilized for many different projects in the future. I think we have taken the best and then done some tweaks, which makes it differentiated. Thank you. We on to some questions on Leqembi.
There's a question if we can discuss the patent strategy for Leqembi, such as possibilities for extensions and lifecycle management. Yeah. So BioArctic, I mean, we work a lot with patent strategies, and we have patent strategies, of course, for all our different targets. In the Alzheimer part, we have several different patents, both with regard to the protofibrils and Leqembi. There are other opportunities that I cannot go into. Of course, we are very active in the patent strategy for Leqembi and for Exidavnemab and for all our different assets. For the BrainT ransporter, definitely, we have several different patents, and we're working on more patents. This is one of the really important parts for an innovative company like BioArctic.
We also have a question on the latest status of the research evaluation agreement with Eisai regarding BAN2802, if we can comment on that. Yeah. That's also a very exciting collaboration with Eisai where we are utilizing our BrainTransporter technology. I'm not allowed to talk much about that program, so I can just say that it's an Alzheimer program, disease-modifying treatment utilizing our BrainTransporter technology. It's progressing really, really well. We are driving it up to some more data, and then Eisai will review the program to see if they would be interested in further partnering there. One last question is, when we can expect that BioArctic will start to pay dividends?
Maybe that's a question for me.
We do have a dividend policy that we should start to pay dividends when we have proper financing that will not risk the development of our programs, etc. It's a little bit early to tell exactly when that will happen, but if we are as profitable during this year and the coming years, I think it's a fair expectation to expect that we will start to pay dividend maybe next year or the year after that.
Thank you. We have no further questions in the chat, so I hand back to you.
I say thank you so much for your attention and for a lot of great questions. I wish you a great rest of the day. Thank you so much.