BioArctic AB

STO:BIOA B

Earnings Call Analysis

BioArctic Reports Strong Growth and Advancements in Alzheimer's Treatment

In Q3 2024, BioArctic's progress was marked by a remarkable 64% increase in royalties from Leqembi sales, reaching approximately SEK 70 million as the U.S. market expands. The company is excited about its new BrainTransporter technology and the initiation of the Phase IIa study for Exidavnemab in Parkinson's disease. With SEK 800 million in cash and plans to increase R&D spending by 35%-40% in 2024, BioArctic is well-positioned financially. Regulatory developments are key, with upcoming FDA and European approvals expected that could enhance market access for Leqembi, further solidifying their role in Alzheimer's care【4:5†source】.

Advancements in Alzheimer's and Parkinson's Treatments

In the recent earnings call, the company reported significant progress in its development portfolio, particularly concerning treatments for neurological diseases such as Alzheimer's and Parkinson's. Notably, the drug Lecanemab, which is directed at treating Alzheimer's, has become the first disease-modifying treatment for this condition to gain full approval in pivotal markets, including the U.S., Japan, and China. The increased patient uptake is encouraging, with royalties from Lecanemab reaching approximately SEK 70 million this quarter, representing a more than 60% increase compared to the previous quarter. This reflects a solid demand trajectory for the treatment, signaling a positive commercial outlook.

Ongoing Trials and Regulatory Developments

The pipeline for treatments continues to expand, with the commencement of a Phase IIa study named EXIST, focusing on patients with mild conditions. The study's primary aim is to evaluate safety and tolerability, with secondary metrics including pharmacokinetics. Importantly, the results from these trials could influence future market strategies and patient treatment protocols. Additionally, approval processes for Lecanemab are underway in 17 different markets, with anticipation for a European Medicines Agency (EMA) recommendation expected shortly. Such regulatory movements are crucial for the eventual commercialization and broader accessibility of these therapies.

Strong Performance in Global Markets

The company's international expansion strategy is yielding results, particularly in countries like Japan and China, where the adoption of Lecanemab has exceeded expectations. This geographic diversification not only helps mitigate risks associated with reliance on a single market but also positions the company for robust revenue growth. In the U.S., while initial uptake had been slow, ongoing marketing efforts are expected to accelerate adoption, potentially enhancing future earnings.

Research and Innovation Driving the Pipeline

The success of the BrainTransporter project exemplifies the company's commitment to innovation in drug delivery systems. The ability to enhance the concentration of therapeutic antibodies in the brain is pivotal for treating Alzheimer’s and other neurodegenerative diseases. The evidence of a 70-fold increase in brain exposure of a specific antibody raises optimism about the efficacy of upcoming treatments. These innovations could lead to additional partnerships and collaborations, increasing the company's competitive standing in the biopharmaceutical industry.

Financial Outlook and Strategic Guidance

While the overall sentiment is optimistic, the earnings call did highlight some caution regarding the revenue guidance outlook due to earlier-than-expected market realities. Investors should monitor whether the company can sustain its recent revenue growth momentum. Continuous updates from ongoing trials are expected to provide clearer insights into future revenue streams, particularly as more data becomes available from the escalating patient enrollments and study results.

Earnings Call Transcript 2024-Q3

[Operator]

Welcome to BioArctic Q3 Report 2024. [Operator Instructions] Now I will hand the conference over to CEO, Gunilla Osswald; and CFO, Anders Martin-Lof. Please go ahead.

[Gunilla Osswald, executive]

Good morning, and welcome to BioArctic's presentation for the third quarter of 2024. I have 3 key messages for today. The first one is that [indiscernible] are progressing very well. And I'm really excited of our grain transporter technology where we now have been presenting data publicly, and I will show some of those data here today. Exidavnemab, our project for Parkinson's disease has initiated Phase IIa with screening of patients. My second message is that Leqembi sales are increasing, resulting in over 60% higher royalties for us compared to previous quarter. The market in the U.S. continues to grow, and Japan and China are above expectations. And the regulatory processes continues, and we are eagerly awaiting CHMP opinion tomorrow.

The third message is that we have a solid financial situation, so we can focus on progressing our projects in a good way. And then 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-Lof. We have also invited [indiscernible], our Vice President of Science and Technology, and he is also the leader of our Brainport program; and also [indiscernible], our Chief Commercial Officer, and they are here for the Q&A part of the presentation.

Next slide, please. BioArctic is listed at Nasdaq Stock on large cap, and this is our disclaimer. Next slide, please. As you know, BioArctic, we focus on disease-modifying treatment for nebrogenerative disorders. And we are among the leaders in the world in 2 different areas. The first one is for highly selective antibodies targeting aggregated forms of misfolded proteins for Alzheimer's disease, Parkinson's disease and ALS. We also have a BrainTransporter technology which helps the biological treatments across the blood brain barrier to get higher concentrations in the brain where the target is for the treatment. Our business model focused on innovation of new treatments for nevrogenerative disorders. We are also becoming a platform company with a BrainTransporter technology.

An important part of our business model is partnering, and we see 3 types of partnering. The first one is for large indications like Alzheimer's disease and Parkinson's disease, where our aim is to partner before Phase IIb or at least before Phase III. For orphan drug indications, BioArctic can drive the programs longer ourselves and potentially all the way to the market. For our BrainTransporter technology platform, we can also partner with companies that want their biologics to have increased brain penetration.

Next slide, please. So today, I will start with the first message, which is about our pipeline and how well that is progressing. And there are 3 things I want to start to mention. First, about our BrainTransporter technology. Some of our patents are not public, and we have preclinical data validating our BrainTransporter technology intragenic mice and in nonhuman primates. The data demonstrates a rapid, broad and deep brain distribution of the [indiscernible]. Exidavnemab, which is our most advanced alphanuclein program has initiated the Phase IIa study in Parkinson's disease patients, and we plan to start dosing later this year. And we're also exploring to include MSA patients. Our founder, Professor [ Lars Lancet ], he received the Lifetime Award at the big CTAM Congress in Madrid a couple of weeks ago.

The Alzheimer's disease research community with experts, they emphasize and acknowledge his great efforts for Alzheimer's disease patients with new innovative treatments like lecanemab, which is based on his innovative research in Alzheimer's Disease.

Next slide, please. the brain has a natural barrier to protect the brain and that is called the blood brain barrier. And that is making it difficult for treatment to get into the brain and especially biologicals, which are a little bit larger like antibodies. At BioArctic, we focus on brain disorders and therefore, this kind of technology is critical for us. We are highly engaged in this area, and we invest in getting new treatments with improved vein penetration. We utilize the cancer in the sector to get active transport of our antibodies across the blood brain barrier. Our BrainTransporter approach is unique in several ways. For example, with where we bind to [indiscernible]. The binding site is the proteus like domain on the transfer perfector. And this is positioned near the cell membrane, which makes the safety profile for hematology parameters improved, especially with regard reticular sites for example.

The BT technology will increase brain exposure of the antibodies if we can give a broader distribution in the brain, making it possible to reach deeper brain structures. A fast blood-brain barrier transport results in rapid brain exposure and the potential for a fast effect. The increased exposure and broader distribution can potentially lead to a better effect as well. Lower doses can also result in better convenience for the patient, and we strive for subcutaneous administration. It could also lead to better safety due to lower doses and different distribution in the brain.

Next slide, please. We see a stronger and broader and deeper brain distribution with a BT approach. It has now been validated in [indiscernible] and in nonhuman primates. In the picture you see to the left, you see double transgenic mice with a human transfer receptor and the 5 tons FAD mice. And they are overexpressing amyloid deposits in the brain. To the left, you see a brain of where we have used a normal EBITDA antibody. And you see some green of the antibody, especially in the ventricle when we engineered the amyloid beta antibody and combine it with our brain transporter technology, then we get dramatically more antibody into the brain, as you can see in the green picture to the right. I think a picture says more than a thousand words.

To the far right of this slide, you see some data from our nonhuman primate study. And you can see that we substantially -- we get substantially higher brain exposure or amyloid beta antibody in different regions. And here, we show, for example, Cortex and [indiscernible], but it's also for [ Hypocampus ] and other places and we see up to 70-fold increase levels versus the next antibody. Importantly, when you work in this area and as we see with several other transfer in receptor technologies, they have shown issues with hematology and [indiscernible].

Our safety profile so far looks very good without affecting hematology, including reticulocytes that you can see down to the right left to the right. So in summary, I think we have very encouraging data, and we have now combined our technology with projects in all our disease areas with antibodies for Alzheimer's disease, Parkinson's disease, ALS. And we have also started to combine it with enzyme replacement therapies like with BTG case, where we are aiming to address CNS symptoms of [indiscernible] disease. This area is very much in focus, and this has been seen, for example, in recent deals in the industry, and we see an increased interest by potential partners.

Next slide, please. Our [ Alpha nuclear ] portfolio is also progressing very well. And I think there are many opportunities in several neuronal synucleinopathies, such as Parkinson's disease, Parkinson's disease dementia, [indiscernible] dementia and [indiscernible] stages and also orphan drug indications like multiple system atrophy. I think it's reassuring that biomarkers are available now to identify the right patients with pathological alpha-nuclene. And we will also use this in Phase III study with exidavnemab.

Next slide, please. The Phase IIa study with exidavnemab will be performed in patients with mild to [indiscernible], and we call the study EXIST. The design is a randomized carboline placebo-controlled trial with a low and a high dose compared to placebo. The primary endpoint is safety and tolerability. The key secondary endpoints are pharmacokinetics and [indiscernible]. And then we have exploratory endpoint several of them. So several biomarkers both biochemical biomarkers as well as digital motor and cognition markets, which are relevant for patients and an important preparation for the next proof-of-concept study. The study will be performed in Spain and in Poland, and the screening of patients have already started, and we plan to start treatment during this quarter. We are also exploring possibility to add a new cohort of patients with MSA.

Next slide, please. So in summary of this part of the presentation, our portfolio is progressing really well. And today, I've highlighted our BrainTransporter project and exidavnemab. And then next slide, please, and we come to my second part of my presentation, which is Leqembi. The number of patients treated with Leqembi continues to grow and I think it's very reassuring to hear that the clinical safety experience is on par or better than reported in the Phase III program. On the commercial side, royalties increased with more than 60% for this third quarter compared to the second quarter this year, resulting in royalties of about SEK 70 million to BioArctic.

With the continued growth in the U.S. market and an impressive growth in Japan and China, where it exceeds expectations. As has lowered that outlook due to the slower uptake in the beginning now in the U.S., and Anders will discuss this further. On the regulatory side, Leqembi's approved and also launched now also in Hong Kong, Israel, United Arab Emirates and also now in Great Britain. Regulatory authorities are reviewing [indiscernible] and that's ongoing in 17 different markets and regions, including EU. And as we know, we are waiting for the CHMP opinion tomorrow.

Eisai has finalized the rolling submission of the subcutaneous auto-injector for maintenance dosing at the end of October. On the development side, Eisai are continuing to do a lot of different things. For example, the AHEAD study 345, the Phase III study has completed recruitment by mid-October. The study is for preclinical Alzheimer's disease individuals. And this means individuals with elevated levels of amyloid deposits in the brain, but they do not yet have any symptoms and they will receive the treatment with either lecanemab or placebo for 4 years. During the related Alzheimer Congress, CTAD, AAIC presented new data from the Phase III CLAD study and those further support what both early and maintained treatment.

Next slide, please. Lecanemab is the first disease-modifying treatment for Alzheimer's disease with a full approval in the U.S., Japan and China. And it's only trying to be established as a standard of care treatment for Alzheimer patients. If we look at the U.S., IV administration every second week is approved and broadly reimbursed in July last year. A supplementary BLA is under review for less frequent maintenance dosing once a month with a PDUFA date in January next year. In October, a completed the rolling submission of the new BLA for subcutaneous admistration with an auto-injector for maintenance treatment. And is also preparing a submission for induction treatment with subcutaneous auto-injector to be submitted after the approval of the subcutaneous maintenance treatment. As I said, in Japan and China, the launch is exceeding expectations.

And in Europe, we are waiting for the CHMP opinion following the reexamination and we expect the information tomorrow. And of course, we hope it will be positive, so we also can leave [indiscernible] patients in Europe to access to Leqembi. Lecanemab, is also approved now in total in 8 countries and regions and under review in another 17 countries and regions.

Next slide, please. I would like to share with you some of the key highlights from the [indiscernible] for Alzheimer's disease, which is one of the largest [indiscernible], and it was held in Madrid at the end of October. As presented 3 years long-term data with Lecanemab, which showed increased patient benefit with maintained safety profile. We can see clear and meaningful long-term recent effect, and that was shown over 36 months when all patients now have got lecanemab. Either from the start, which means 3 years treatment, or if they had placebo in the core study, then they have been treated for 18 months. So if you look at the graph to the left, we see the benefit increase over time. The benefit was on the CDR [indiscernible] scale after 18 months and it doubled to 0.95 after 3 years.

Patients get benefit if they start treatment early, then they get more benefits. And that's what you see in the green top curve. But we also see that patients can benefit by starting later as we see with the middle cut where the green is when they -- the black is when they had placebo and the green is when they have started to get lecanemab. And we can compare that with the purple curve with is a matched historical control group from [indiscernible]. And also, I think it's very reassuring to hear the experience from key opinion leaders from clinical practice from both the U.S. and from Japan. They reported at CTAD, a wide patient acceptance and compliance. Very few patients want to stop treatment.

They also concluded that the treatment is safe and no new safety findings reported and the side effects are manageable. The side effects in focus are especially IRE and age, and they are similar to the clinical studies, even though it's now being used in clinical practice. They are mainly asymptomatic and transient and comes during the first 6 months. Very few areas are reported after 6 months. The patient journey is improving in several ways, for example, with blood-based biomarkers. Safety matters, of course, and approximately 18,000 patients have now been treated with Leqembi. And I think it's reassuring that no new safety findings have been reported and that there is a low frequency of area after the first 6 months. And that the key opinion leaders concluded that these side effects are manageable with lower or similar frequency than was seen in the clinical trials.

Next slide, please. More data were presented at detail supporting starting treatment earlier and that could benefit patients more and also to continue to dose it. After the Alzheimer Congress called AAIC in July, then presented the graph to the left, which I think is very encouraging data from a small sub-study in patients with no or very low tower which means that they are early in their disease. 60% of these patients had improved after 18 months and more than 50%, were still doing better after 36 months. We should, of course, be a bit careful since only 40 patients are part of this study, but I think it's encouraging and further emphasize the importance of starting treatment early. Now at CTAD, at this congress, [indiscernible] presented the graph to the right. And now there are more patients that are in early stages, and they are then measured by amyloid pet and had baseline levels below 60 [indiscernible]. What we see here is that after 18 months of Lecanemab treatment, there were 51% less decline versus placebo. And this is in contrast to the first population of the study, which was 27% less decline versus placebo.

We see similar results also when we look at other scales measuring cognition and activities of daily living. I think also it's very exciting, and we hear more and more patient stories with patients benefiting from Leqembi treatment.

Next slide, please. Lecanemab development continues with subcutaneous auto-injector, which could make administration much more convenient and possible to give at home in an easier way. And I think this is of great support for the patients and for society. The blood-based biomarkers for diagnosis will also simplify the patient journey and help to identify patients in a much easier way than to do it with pet scans and CSF sampling, which sometimes could be challenging. And this development is going really well. Professor [ Susan Schindler ] from [indiscernible] at CTAD on blood-based biomarkers and stating that prime time is now. And it's already use now for screening. And I think the usage for confirmation is not far away, could be expected next year and onwards. And there again, treatment earlier has shown more benefits, which is encouraging for the Phase III study [indiscernible] in subjects who do not yet have symptoms, but they have elevated amyloid deposits in the brain. This study is already using blood-based biomarkers to identify the right patients. and recruitment have now been completed.

Next slide, please. So by that, I hand over to the third key message about our solid finances, and I will hand over to Anders Martin.

[Anders Martin-Lof, executive]

Thank you, Gunilla. I'll start to talk a little bit about the Leqembi revenues on this slide. It's been known for a while that the global sales of Leqembi in the third quarter were roughly JPY 10 billion or $67 million. That means that our royalties that you see on the left-hand side, increased to SEK 69.8 million. That's a 64% increase over the second quarter of 2024 or if you like, 3,200% over the third quarter of 2023. So we're seeing very, very rapid growth in our [indiscernible] revenues. If you look a little bit on the different geographies, the sales in the U.S. were JPY 5.9 billion in the third quarter or $39 million and that's roughly 30% higher than in the second quarter. And it seems that there is a very good demand initially, it was start that diagnosis with PET and CSF would be a bottleneck.

That's what the market expected. That does not seem to be the case. And that has actually been facilitated by the start of the implementation of using blood-based biomarkers for prescreening patients in the U.S. So even though test capacity is fairly scarce, when you use blood-based biomarker, you can prequalify the patients and you have a lot of patients that are actually positive on the [indiscernible]. So that has helped the diagnostic process. And the inflow of patients is not fairly big, and it is feasible to get reimbursement. However, what ESA has seen now lately is that there has been a bottleneck in infusion capacity. So they stated that they have roughly 6,000 patients lined up that could not be treated due to the lack of future capacity.

They are working really hard on that program and have contracted more facilities and the capacity is expected to increase by 90% in the following 2 quarters. So they're expecting to treat the 6,000 patients that are lined up for treatment. But that has held back the sales in the U.S. during the last few quarters. I think this also underlines the importance of the subcutaneous administration if Leqembi is going to grow to hundreds of thousands of patients, infusion capacity could become a really big problem in the world. But we are in a fortunate position that the subcutaneous version is evolving really, really well, [indiscernible] expecting approval for maintenance therapy used in the subcutaneous version by mid next year and with induction therapy towards the beginning of 2026.

So I think these problems will be alleviated of time. If we then turn to Japan, we saw very rapid growth, 80% from the second quarter up to JPY 2.7 billion or $80 million. They're now treating some 5,000 patients to over 800 facilities, and that's almost half of what they're treating in the U.S. where they've been going for a long, much longer time. So I think the Japanese market is to [ move well ]. Here, I think it's interesting to note that they're now starting a direct-to-consumer campaign to raise awareness about mild cognitive impairment and to promote early diagnosis but you may have showed early diagnosis is going to be really, really important. And I think the largest growth area in the coming years will be mild cognitive impairment, especially since that's probably the period of the disease when we can have the largest impact. So I think what you see in Japan will be followed in other regions that you start to focus on these [indiscernible] patients.

Turning then to China, where the product was launched in late June, they sold for about JPY 1.2 billion in the first quarter where it was actually on the market, so $8 million so already after 3,000 patients in China in the first quarter of sales, which is really, really strong. Here, Eisai is using a self-pay model. There is no reimbursement from the larger health care system and they're relying solely on blood-based biomarkers and using a digital platform. And this is also a model that I think could be copied and used in different parts of the world over time. We will not see that short term. But in the longer term, I think blood-based biomarkers and focusing on MCI and using subcutaneous version is where we are heading in the years to come. All in all, due to the slightly slower development in the U.S. Eisai reduced their fiscal year forecast. It was JPY 56.5 billion or $370 million, and they reduced that down to [indiscernible]. That means that they are expecting sales of roughly $170 million in the 2 quarters to come.

However, longer term, the mid- and long-term forecast have not been changed. And we still have the same belief in the potential of the product. It is a number of things that we have to sort out. It is a complicated product to administer in the beginning. And that is now being sorted out. But longer term, those problems will diminish since we have a number of developments that will help the implementation of Leqembi treatment going forward.

If we then turn to the next slide, I will comment on our financials. On the left-hand side, you see our net revenues that decreased from the third quarter of 2023 from SEK 29 million to SEK 77 million. Of course, in 2023, we received a big milestone for the Japanese approval. So it's not really comparable. I should also mention that we're not expecting any new milestone payments in the coming quarter. We didn't get anything in Q3 this year, and we will not get any milestones in the fourth quarter even if we see a positive CHMP opinion, that will then happen during next year, you forget the positive opinion and approval.

But I think you can also see the trend that from -- during the year, our revenues are growing, and that is what we expect to continue. So those are the royalty revenues that are growing over time and that trend will, of course, continue. We also have some co-promotion revenues in the area of SEK 3 million that will grow if we get the proven in Europe. We don't know that yet. But hopefully, that will happen shortly if we get this positive in opinion.

Looking at the cost on the mid-graph, you see that the operating expenses increased to SEK 95 million from SEK 78 million, 1 year ago. R&D is now 72% of our total operating expenses, it was SEK 68 million in the third quarter of this year. That's roughly 100% higher from a year ago when it was SEK 33 million. However, it's down from the second quarter when our R&D expenses were SEK 84 million. And this is fairly lumpy. It goes up and down a little bit when we have larger payments for clinical trials and [indiscernible] work but the long-term trend is that the cost will continue to increase on the R&D side as we are progressing our project portfolio. We are now, as Gunilla mentioned, starting our Phase II trial with exidavnemab, we're also investing heavily in our other programs that are falling behind that are making really good progress. And then we will invest significantly in CMC, et cetera. So you should expect growing R&D costs in the coming year.

We were planning to increase our spending in marketing and sales, but we have held back some recruitment until we get the [indiscernible] opinion is that positive, you'll see an increase in the next year, if not probably not. We have previously guided that the full year cost will be roughly 30% to 50% higher in 2024 over 2023. We're still in that range and now expect that the cost will be roughly 35% to 40% higher in 2024 versus 2023.

If we then turn to the right-hand side, you see that the operating loss was SEK 26 million, and that's when we made the profit in the third quarter of 2023, of course, that was driven by a milestone received in 2023 that we need not to get now. But you also see, I think, again, it's interesting to see the trend that without any milestones, we're also decreasing our losses really starting to see the impact of growing royalties starting to finance more and more of our R&D spending.

If we turn to the next slide, you see that the net results were -- net result was SEK 20 million, so that's roughly SEK 6 million better than the operating result, and that's explained by financial net. On the middle graph, you see that the cash flow from operating activities was a negative SEK 80 million. That's roughly SEK 60 million lower than the net loss and this is basically due to the delay of royalties that we get paid for the royalties roughly 2 quarters after the sales have occurred so we have a growing accounts receivables. So our current assets containing these numbers were roughly SEK 110 million related to royalties.

On the right-hand side, this year, cash balance still very strong. We have over SEK 800 million, including short-term investments at the end of the third quarter. We think that we will end the year with more than SEK 700 million in cash and short-term investments. And going forward, we have mentioned this before, we will become profitable based on Leqembi royalties. So we will maintain a very, very strong financial situation going forward in the coming years. However, we will not talk today about exactly when we become profitable there a number of moving parts. But long term, this will lead to profitability.

With that, I hand the word back to Gunilla for some closing remarks.

[Gunilla Osswald, executive]

Thank you so much, Anders. So we are coming towards upcoming news flow and some closing remarks. So next slide, please. The upcoming news flow. So this fourth quarter, we plan to start the exedavnimab Phase IIa study in Parkinson's patients with the dosing. So we hope to be able to communicate that and then we're also awaiting, of course, the CHMP opinion of Lecanemab in EU tomorrow. We do not yet know the outcome. I think it's not decided yet. But of course, we're hoping for a positive outcome and then a potential approval in the European Commission within 67 days. In January next year, we also expect response from the FDA regarding less frequent monthly IV maintenance dosing of Leqembi in the U.S. And regarding the subcutaneous auto-injector, we expect responses next year regarding maintenance dosing and 2026 also for the induction treatment. And of course, we're also hoping for further regulatory approvals and launches in several other countries and regions.

Next slide, please. So to summarize today's presentation, our pipeline is progressing very well, and we are very encouraged by the BrainTransporter data that has been presented and generating a lot of interest. We're looking forward to the exidavnemab Phase III start, and Leqembi is approved in 8 geographies and now launched in 7 of them, including Japan and China, where there are very large patient populations with early Alzheimer's disease. And even a small part of the population will be huge and is gratifying that we can help many patients. Leqembi Royalties revenues continue to grow as the sales continue to increase. And we heard Anders explain that our finances remain solid. We have about SEK 800 million in cash, which I think is great, so we can focus on driving the project forward towards patients.

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

[Operator]

[Operator Instructions] The next question comes from Luisa Morgado from Van Lanschot Kempen.

[Luisa Morgado, analyst]

First of all, congrats on the BrainTransporter data. And on that, my first question, could you please elaborate a bit on the results that you shared in terms of how should I look at benchmarks that should be used here but also to understand a bit better how or if this technology would produce a similar increase in terms of brain exposure with any other antibody or does that depend per antibody. So if you could elaborate a bit here, please.

[Gunilla Osswald, executive]

I think we hand over to [indiscernible]

[Unknown Executive]

Yes. Thanks for the question. It's quite an important question, obviously. And I mean we're also using the [indiscernible] for crossing the blood and barrier. And we think based on our nonhuman primate and the boasting we see in this study that we get at least as much as other competitors see [indiscernible] with the transfer sectors. We're using quite normal value side on the [indiscernible]. As Gunilla mentioned, we're buying to a protein like domain, which is very close to [indiscernible]. And that sort of hide the molecule when it binds to the transfer receptor when it's on the blood side making sure that it doesn't engage with the immune system which are sort of also linked to the potential safety issue that maybe other companies have -- they are using a different binding site, which is more exposed to the blood side. So we expect at least the same potency and delivery of our antibody and also due to this normal buying side on the [indiscernible] as we have engineered from the start, we also expect to have maybe a more improved safety profile.

[Gunilla Osswald, executive]

So I think in short, we stand very well in the competition. And also, I think that what we have seen now exemplified with this antibody linked to the BrainTransporter, I think we expect that to be a similar situation for other brands and portline antibodies. .

[Luisa Morgado, analyst]

Okay. That's quite helpful. And...

[Gunilla Osswald, executive]

Does that answer your question,Luisa?

[Luisa Morgado, analyst]

Yes, yes, yes, definitely. And please correct me if I'm wrong, but so you will likely share further data on the BrainTransporter technology at PD next year. If so, what kind of data update can we expect here?

[Unknown Executive]

Yes. So we plan to show more data around our most advanced program where we're using the Brain Transporting technology. So it's based on the [ BAN203 ] program that we're running, which are in [indiscernible] now. So further sort of additional data when it comes to CMC and development time lines for that.

[Luisa Morgado, analyst]

Okay. Perfect. And maybe one final question regarding the blood-based diagnostics. Could you expand a bit on -- so what do you foresee over the coming years? How do you see playing out in terms of using the blood-based biomarkers with other kinds of markets, of course, imaging when should we expect that they are starting to be used alone and overall impact on adoption of Leqembi?

[Gunilla Osswald, executive]

Very good question. Thank you for that. So I think right now, it's mainly being used for screening, which helps to see which of the patients that then should be confirmed by CSF or [indiscernible]. But as was presented at CTAD, the time is very soon here for when you also can use the blood-based biomarkers directly for confirmation. So I don't think that's far away. I think we'll start that -- to see that happen next year and onwards. So I think, I mean, it's really -- I think it's time now, and that will really help to find patients in an easier way. I think the first step with screening is really good, but it's really the confirmatory that will be really, really helpful.

[Operator]

The next question comes from Viktor Sundberg from Nordea.

[Viktor Sundberg, analyst]

So just one also here on the BrainTransporter technology. I think your previous experiments has shown quite a different profile than comparing therapeutic doses of BrainTransporter antibodies versus trade dosing targeting the [ transferring ] receptor where some of your competitors have shown 40x higher exposure at trace dosing but only 1.5x at the therapeutic doses, which was explained in your patent documents. So I just wondered how you compare at therapeutic doses versus trace dosing in your more recent experiments that you showed here. I think your patent document stopped about 10x higher therapeutic doses and higher trace dosing versus naked antibody, if I read it correctly. So I just wanted to get a clarification on that.

[Gunilla Osswald, executive]

I think [indiscernible] will answer the question.

[Unknown Executive]

Yes. Yes. Thanks for the question. I think it's important to understand. So the holding program that we disclosed now is based on the nonhuman primate study. And then it's down quite differently compared to when you do the study in rodents. And in the non-barrier study, we use therapeutic dosing, which is relevant for clinical use and then we compare that, obviously, with an antibody, the same antibody without a BrainTransporter linked to the antibody. So the figure we disclosed now is the more relevant one for clinical application and also it's also based on sort of a more translatable animal model, if you like. So that figure is yes, the most recent figure that we have disclosed with is the most relevant one, I would say.

[Viktor Sundberg, analyst]

Okay. And just curious, if you heard any rumors why Biogen handed back the rights to [ Denali ] for a similar brain transporting technology, was that maybe safety related, as you talked about or hinted to in your previous comments?

[Unknown Executive]

I don't think I can comment on that actually. What I mentioned was that it was not related to safety or efficacy in the press release. But obviously, you hear some rumors.

[Gunilla Osswald, executive]

Yes, we don't comment on that [indiscernible]

[Unknown Executive]

So I pass on that.

[Operator]

The next question comes from Joseph Hedden from Rx Securities.

[Joseph Hedden, analyst]

Congrats on [indiscernible] BrainTransporter data. Just a question on a potential EU milestone if you do get a positive CHMP tomorrow, can you confirm if that would be around the same level as you would have expected for a first-time approval? And can you just remind us of what kind of [indiscernible] and then the second question is, again, if you do get a book to CHMP opinion, when would you expect that you could make the first launches in the Nordic and our co-promotion agreement with [indiscernible]

[Gunilla Osswald, executive]

So will you take the first one?

[Unknown Executive]

I could take the first question. Yes. So it's known that we were paid $25 million when we got approval in the U.S. and $17 million when it was in Japan and EU will be somewhere in between, and it doesn't matter if it has been reexamined or not, that has no impact on the size of the milestone. As for the second question, [indiscernible]. .

[Gunilla Osswald, executive]

Yes. And just to mention it, of course, the market access process is led by Eisai. And when it comes to hospital products, there are no exact time lines. So they're kind of estimates. So if we get a European Commission approval later -- beginning of next year, it might take everything from 6 to 18 months. So -- but I'm hoping that we could launch early 2026 and like that. In one of the countries, which is -- and then yes.

[Unknown Analyst]

I just have a follow-up around the time frame for your brain transport technology. I appreciate all the data and differentiators that you've mentioned that we've heard from [indiscernible] to select a Phase III dose next year and they're suggesting a 2028 potential filing date. I wanted to understand broadly how far behind rush you think your Alzheimer's project is?

[Gunilla Osswald, executive]

Thank you so much for the question. So our most advanced BrainTransporter program is in Alzheimer's disease. And there, we are about 2 years from going into the clinical setting. 2026 is what we expect to go into the clinical setting. And then I think we can learn so much both from lecanemab, endonanimab, enfrantinumab and others. So I think there is an opportunity to do a really good clinical development program but I will not say any more days than we expect to go into 2026 with the first one.

[Operator]

The next question comes from Fredrik Thor from Redeye.

[Fredrik Thor, analyst]

My first question was about if Leqembi would not be approved in the reexamination, do you have any expectations on what kind of new [indiscernible] you would have to send in, for example, could real world, is it enough for every submission? Or would you probably need to do a new or is kind of a new clinical trial?

[Gunilla Osswald, executive]

Thank you so much for the question, Fredrik. I think I mean, it depends very much on what happens. We will know by tomorrow what the outcome is. And then we'll have to digest and understand. If it's not a positive outcome, we need to understand why it's not a positive one and then we will have to take it from there. .

[Fredrik Thor, analyst]

Got it. And my final question was about the bottom neck here was the infusion capacity and as I mentioned that they will increase in Q4 and in Q1. Do you have any expectations on your own about how fast that will be? And for example, when it comes to the remaining sales in the forward process given -- should expect it to be kind of even between Q4 and Q1 or more towards that will increase more for -- in Q1 for example, is the bottleneck is very much here now.

[Unknown Executive]

Thanks for the question. So yes, we are expecting, of course, continued growth. So we see a little less sales in Q4 of this year and a little bit more in the first quarter of next year. in terms of how fast the bottlenecks will be resolved. We can't comment more than [indiscernible] did. They expect that we're waiting now for treatment to be treated in the coming 2 quarters. But -- and that they had contracted capacity that will come online in the following 2 quarters. Exactly when in the 2 quarters has not been communicated and we don't have any opportunity to comment more on that.

[Gunilla Osswald, executive]

But we have seen press releases about companies who have been contracted. So I think it's happening. .

[Unknown Executive]

It doesn't seem like there are any more people in queue right now, so I'll just go and look through the written questions, and we have one in and I'm not sure you're able to comment. But the question is from Goldman Sachs, [ Max ] Goldman Sachs and he's asking, what's your level of confidence in Leqembi's European approval? Is there a potential for the CHMP and other local regulators to take similar strategy as the U.K. with the approval that is with a smaller without the [indiscernible]

[Gunilla Osswald, executive]

I don't think anyone knows yet. I mean, we just have to wait until tomorrow when we will have the information from CHMP. And I don't want to speculate or comment anything more. I mean we just have to wait until tomorrow.

[Unknown Executive]

Okay. And then there's another question from -- again from Max at Goldman Sachs. It's about [indiscernible] presymptomatic patients. So specifically in the ahead 345 study. And he wants to know if we know if there's any correlation between a severity of the disease and ARIA. And how confident we are if regulatory agencies would be concerned about [indiscernible] in the very early patients?

[Gunilla Osswald, executive]

So to my knowledge, there has not been any correlation between stage and severity like that. And I think that what we hear and heard at CTAD was that the key opinion leaders who have been using Leqembi in clinical practice, I think this is manageable. So I think we need to continue to follow this closely. .

[Unknown Executive]

There was an additional question too from Max and that was about the differentiation of our technology relative to competitors when it comes to the BrainTransporder, but I believe that [ PO ] already answered that question previously.

[Gunilla Osswald, executive]

Yes. We have a unique [indiscernible] technology to my knowledge. So really exciting data. So we really look forward to that part. .

[Unknown Executive]

And then another question that just popped up, and maybe that's for Anders or Anna-Kaija and that's what's our expectation on the market for Leqembi in Europe if there would be a positive opinion and an approval.

[Anders Martin-Lof, executive]

Thank you. Well, we can just revert to Eisai's forecast. They do that once every year, and they did that in the beginning of this year where they basically said that roughly 6% of Leqembi sales in 2026 were expected to come from Europe, and that number would grow to 14% in 2032, I think. So it is, of course, an important market, but out of the whole, Leqembi market, it has limited the potential especially in the near term. But of course, that does not mean that it's unimportant to us. We certainly hope that Leqembi will get approval in Europe and that we will be able to help the patients in Europe. I hope that answers the question.

[Unknown Executive]

Thank you. I don't see anybody more in the queue on the phone and I also do not see any more questions in the written question section. So I think that sort of concludes. Gunilla, do you want to say anything, any final words?

[Gunilla Osswald, executive]

Thank you so much for your attention and for all great questions. And I wish you a great rest of the day and cross our fingers for tomorrow. Thank you so much.