BioArctic AB (publ)

Good morning and welcome to Biotic's presentation for the fourth quarter and for the full year of 2023. I'm Gunilla Osvald and I'm the CEO of Biotic and I will share today's presentation with our CFO Anders Martin Löf. It's very exciting times for Biotic with Lekembe being the first and only disease modifying treatment with a full approval in the US and Japan and now also in China. It's the beginning of a new era, and BioRTIC is behind this true breakthrough in the treatment of Alzheimer's disease. I find it extremely gratifying that we now can help a large number of patients and their families. And I'll talk more about that here today. Next slide, please. BioRTIC is listed at Nasdaq Stockholm large cap, and this is our disclaimer. Next slide, please. At BioRTIC, we focus on disease-modifying treatments for neurodegenerative diseases. And we are now on the market for Alzheimer's disease patients. And we are preparing for phase two for Parkinson's disease patients. There is a huge unmet medical need and a very large patient population that we aim to help. We have a great organization with highly skilled scientists and drug developers with vast experience. And now we are also continuing to building our commercial organization to prepare for the commercialization together with our partner ASI. We have a broad portfolio. We're building on the success of Lecambi with very selective antibodies for both Alzheimer's disease and Parkinson's disease and ALS, together with a brain transporter technology that aims to get the antibodies better into the brain. We're well financed with more than 1.1 billion Swedish crowns on the bank. And finally, the fact that our science and company leadership throughout the years has given numerous awards I think that validates our innovation and global leadership position within the never-generative diseases. In this fourth quarter last year, that includes awards from Time, Scripps, Forska Sverige, and European Lifestars Awards. And all of that, of course, we are very proud of. Next slide, please. 2023 was a great year for Biotic, and so was the fourth quarter. At the Alzheimer's Congress CTAD, Biotic and Lars Lansfeld presented new data on leucanumab, further supporting the unique binding profile with lower CAA binding linked to lower incidence of the side effects called area E in comparison with competitors. ASI presented more data supporting leucandus disease modifying property and new data with the subcutaneous formulation after six months of dosing in Alzheimer patients, and that supports the subcutaneous autoinjector as a more convenient alternative for administration of Lecambi. The Lecambi launch started 20th of December in Japan, and now in January, Lecambi was also approved in China. In Europe, EMA has stated that they will convene a scientific advisory group to discuss Lecambi during this first quarter. Biotic and ASI have now also agreed how the commercialization and co-promotion of lecanumab will be done together in the Nordics. Next slide, please. Lecambi is the first disease-modifying treatment for Alzheimer's disease with a full approval in the US, Japan, and China. And it's on its way to establish a new standard of care for Alzheimer's patients. If we start with the US, It was approved and broadly reimbursed in July last year. ASI are now also preparing for a submission for less frequent maintenance dosing and for subcutaneous administration. And that submission is planned to go into FDA during this quarter. The launch is ongoing and more and more hospitals and physicians are ready to administer Lekembe. EISA just reported that approximately 2,000 patients are treated with Leukemia and approximately four times as many are waiting. If we then look at Japan, the launch started in December following the price and reimbursement decision and already about 100 patients are on treatment and approximately 300 are already confirmed for treatment. If we look at Europe, We're waiting for the Scientific Advisory Group meeting, and then we expect a CHMP opinion this quarter. Assuming a positive opinion from CHMP, that would then lead to a European Commission decision during the second quarter. If we look at China, the approval was granted in January and launched its plan during the third quarter this year. The Candidate has also a regulatory file being reviewed in many different parts of the world. And we look forward for responses from, for example, Canada and Great Britain. So I think it's very exciting times for Biotic and for Lecambi. Next slide, please. The launch of Lecambi in the US is steadily progressing, and we see some different examples of that. For example, about 70% of the top IDNs in the US have now approved Lecambi. And about 55% have now started to order Lecambi to treat patients. Approximately 4,000 neurologists or Alzheimer's disease specialists have established a diagnostic and infusion pathway and are ready to prescribe Lecambi. The amyloid pet tracers are more broadly reimbursed by CMS since mid of October last year. More patients are now utilizing this opportunity to confirm amyloid instead of CSF something. Lecambi is now broadly reimbursed in the U.S., and approximately 90% of people who are potentially eligible for Lecambi treatment are reimbursed. Biogen has also announced that they will focus on Lecambi and supply resources for co-promotion together with ASI in the U.S. So I think we can conclude that there are several important and positive steps towards increased possibilities for access of Lecambi to patients with early Alzheimer's disease in the US. Next slide, please. Lecambi usage can further be supported by simplified diagnosis. And here I'm really happy to see the progress of the blood-based biomarkers. They already now started to be used in triage testing And that is a way to see which patients that have biomarker evidence for Alzheimer's disease. And then those could potentially then benefit from treatment. And I think in a couple of years time, it's expected that the blood-based biomarkers can be used as confirmatory tests for Alzheimer's pathology. Simplified treatment and more convenient administration is another really important part. And ASI preparing for maintenance dosing once a month with intravenous administration and for subcutaneous administration with an autoinjector and plans to file those submissions to the FDA later this quarter. Further progress can be done with indication expansion. And here we are thinking about, for example, preclinical Alzheimer's disease, where ASI are exploring leucanumab in individuals before they have any symptoms, so pre-symptomatic individuals. but they have increased levels of amyloid deposits in the brain. So I think it's very exciting times and great opportunities for many patients to benefit from Lecambi treatment. Next slide, please. Lecambi is, of course, of interest, of the main interest maybe, but biotic is more than Lecambi. So the fourth quarter highlights for the rest of the portfolio, there are a couple of things I really want to mention. And that is that our brain transporter technology progressed very well. And we have now nominated two candidate antibodies as potential disease modifying treatments for Alzheimer's disease. And what we see for those antibodies is they have increased penetration into the brain. So by utilizing our brain transporter technology, we get a rapid, broad and deep distribution of the antibodies into the brain. And this could potentially lead to even better efficacy and better tolerability with lower doses. So I think this part is very exciting. If we then look at our Parkinson's program, Exidavnibab, that's our selective alpha-synuclein antibody, in a similar approach as leucanumab, but for alpha-synuclein. Here we are preparing for a phase 2a study that is called EXIS, and that is planned to start during the fall. The aim of that study will be safety and tolerability in pharmacokinetics with exploratory biomarkers. Next slide, please. So to summarize our portfolio, we work in Alzheimer's disease, Parkinson's disease, ALS, and utilize the brain transporter technology. And our most advanced program is, of course, the CAMBI, which is now, as I said, on the market in the US and Japan and approved in China and in regulator review in many other countries. And the subcutaneous formulation is soon to be fine. And the pre-symptomatic phase three study ahead of Z45 is ongoing. On this slide, you can also note the progress of the two Alzheimer projects combined with the brain transporter technology. And when they get the candidate drug nomination, they get BAN names. So I want you to see the names BAN 2802 and BAN 2803. So we can conclude that our portfolio is progressing well. Next slide, please. So by that, I will hand over to Anders Martin Lööf for the financial summary.

Thank you, Gunilla. If we look at the next slide, starting with the number of patients that are currently on Lycambi, you see that in the graph on the left hand side. As you can see, the trend started to pick up a little bit after PET was broader covered by Medicaid in the US in October. And you also see there was a small plateau in around December. But after New Year's, it seems like the trend is picking up quite well again. So as I stated last week, I think it was that there were 2000 patients on treatment last week of January. They also stated that it would be somewhat challenging to reach their target, the stated target of 10,000 patients towards the end of March. However, they also stated that there are around four times as many patients waiting to begin treatment. So 7,000-8,000 patients that are currently in the waiting line to start treatment. And when asked how long does it take to get them on treatment, ASI stated, well, generally, they start treatment within one to three months. So I think it's fair to assume that fairly soon there could be 10,000 patients on treatment. It's very hard to predict in which month, but everything is going according to plan in terms of underlying factors. And as Gunilla stated, more and more hospitals are coming online. And the largest hospitals that have the most patients are already up to some 300 patients. And there are only a handful of those. And now more and more hospitals are coming in line. So the number of patients that are in the waiting line are growing really fast. And as Gunilla stated, ASI is now chipping in too, and they will help ASI to further increase. Sorry, Biogen is helping ASI now to further increase the pace. I think it's also important to remember, it's exciting to talk about what month will we reach 10,000 patients, but in the long term, It's really not that important. The important thing is when we look at the long-term potential and mid-term, ASA is expecting some 100,000 patients in 2026. And that's a really big number. But longer term, you should also remember that 100,000 patients in the US, that's roughly 1% of the Alzheimer's disease patients in the US. So the potential is much, much larger than that. If we then turn to the next page, you see the Lecambi royalties for us, and we should clarify that the royalty rate that BioArctic gets is 9% on global sales, but the recorded number that you see on the left-hand side also includes an additional 1% on US sales and 1.5% on ex-US sales that are then passed through to LifeArts. So net for biotic, we get 9%, but the numbers you see on the left-hand side are slightly higher, but some of it passed on to Life Park, which is a partner that helped us humanize the antibody back in the days. And as you can see then in the graph on the left-hand side, basically royalties are tripling quarter by quarter. And I do believe that that is a trend that could continue. As you saw, the Q4 sales of Lecambi in the US were $7.2 million. But already in the last week of January, the weekly sales were $1.5 million. So that's roughly 150% higher than the Q4 average already in January. And as you understand, if that trend continues, you will see very high growth rates continuing into 2024. So all in all, we are progressing well towards the 10,000 patients. And we have already stated earlier that if we would have 10,000 patients on average during a quarter, that would roughly equate to some 50 million in royalties. So that could give you some hint on where our revenues are trending, because we cannot give you a proper forecast, unfortunately. You should also see some sort of positive impact from Japan and China towards the end of 2024. believe that they would have some 400 patients at the end of Q1, 5,000 patients at the end of Q4, and 7,000 patients at the end of Q1 next year. And the list price in Japan is fairly high. It's around $20,000. So that should give us a significant contribution. And in terms of China that Gunilla mentioned, the launch will happen in Q3. And ASA is expecting some 1,500 patients already at the end of the year without proper reimbursement. The patient numbers will, of course, be higher when it's properly reimbursed. But before that, the price is probably higher than the US price. So that should give us a significant contribution in 2024 as well. If we then turn to the next slide, looking at the net revenues on the left, the revenues were fairly low in Q4, 11 million. But for the full year, we grew to 616 million. That's mostly due to the four milestone payments that we received totaling 52 million euros. But also the two new revenue streams are starting to contribute. Royalty was 7.3 million Q4, 10.2 million for the full year, co-promotion 1.9 in the fourth quarter and 5.5 for the full year. We do expect to see a shifting mix for the next year. We are expecting a milestone if we get approval in the European Union, but the milestone revenues will be lower 2024 than they were 2023. And royalties, well, that's the thing that is really hard to predict. But as you can understand, the mix will be more tilted towards royalty and then milestones for 2024. The operating expenses increased to 90 million in the fourth quarter and to 367 million for the full year. I think the largest contributor to the increase in the fourth quarter were the personnel costs, mainly driven by a milestone-related bonus. For 2024, the costs will increase. Gunilla mentioned that we have now selected two CDs and that we are approaching phase two for Exedavnemab. So it's fair to assume that the R&D cost will increase substantially. And I think that's really, really positive that we're now accelerating our pipeline. And we will also have further cost increases for our commercial organization that is preparing for the Nordic launch. So I think it's fair to assume that we will have a cost increase of something like 30 to 50% in 2024. But we will not give you a proper forecast at this point because everything is sort of dependent on how fast things develop and the royalties for the camping i think it's also important to highlight on the right hand side we actually made an operating profit of 253 million in 2023 which is very very positive for us and that helps us if you look at the next slide if you look at the cash balance we ended the year with the cash balance of 1.1 billion swedish that's roughly three times the the cost of 2023. So if we kept going as we did in 2023, we could keep going for three years without any revenues. The cash flow was very positive in Q4, even though the result was not that strong. That's mainly due to a payment that we received for the milestone related to Japan. And on the right hand side, you see the net result. The net profit was 229 million. We paid some 47 million in tax that gives us an effective tax rate of 17%. That's due to the fact that we had some tax losses carry forward that we used in the year. We don't have any less. So the effective tax rate, if you are profitable going forward, would be more like in the 21% range. So, all in all, we are in a very strong position. If we're profitable or not in 2024, that will largely depend on the Lecambia rollout. If things go great, we will be profitable. If it's somewhat slower, we may make a small loss, but we can handle that as well. However, from 2025 and onwards, we really see that things will start to improve and we expect to see a lot of profits in the coming years from Lecambia. With that, I hand the word back to Gunilla for some closing remarks.

Thank you so much, Anders. So we're coming to the final part of the presentation with some closing remarks and upcoming news flow. Next slide, please. So our upcoming news flow, if we look at this first quarter, we're looking forward to the next big congress for Alzheimer's disease and Parkinson's disease, which is in Lisbon in March. And there will be more presentations on L-acanema, both from Bioartic and from ACI. ACI are also planning to file the submission for subcutaneous administration of the water injector and for maintenance dosing in the US. In Europe, we are looking forward to the Scientific Advisory Group meeting, which is planned later this quarter. And then, of course, we hope for a positive CHMP opinion, and if so, we could expect the European Commission decision and EU approval next quarter. Other potential approvals could come in Great Britain and Canada, and later on in other countries as well. After summer, during the third quarter, ASI plans for launching of LeCambi in China. And during the fall, Biotic prepared to start the phase 2A study in Parkinson's disease with Exidamnema. And we're looking forward to being able to present some data on our brain transporter program at the end of the year. So I think it's a lot of exciting times ahead for Biotic. The next slide, please. So to summarize today's presentation, Lekembe is now approved in the US, Japan, and China. with huge patient populations with early Alzheimer's disease. We just look at this patient numbers. I mean, they are enormous. 10 million patients in the US, 6 million in Japan, 17 million in China. Of course, all patients will not get Lecambi, but even a small part of the population will be huge. And I think it's very gratifying that we will be able to help many patients. The launch is steadily progressing and sales are starting to pick up. and it will be exciting to see more and more patients being able to get access to Lecambi. Our pipeline is progressing well with our next generation Alzheimer's disease modifying projects together with the brain transporter technology and also our Parkinson's disease program preparing for phase 2a. Our finances are solid as we heard Anders describe with a profit of more than 250 million Swedish crowns last year And now we have more than 1.1 billion Swedish crowns in cash. And I think that's great. So we can focus on driving the project forward towards patients. Next slide, please. So just to end by saying that our aim is to improve the lives of patients with neurodegenerative disorders. And I think that we are very well on our way. Thank you so much for your attention. And we are happy to take some questions.

If you wish to ask a question, please dial pound key 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Rajan Sharma from Goldman Sachs. Please go ahead.

Hi. Thanks for taking my question. So just in terms of kind of the investment required for the Lakembi launch in the Nordic regions, could you maybe just provide your latest thoughts there in terms of kind of how many additional employees you may expect to add, how much of this investment's already been made in 2023, and also to what extent does the slower launch than expected of Lakembi in the U.S. how you're thinking about the investment and the rollout in the Nordic regions. And then secondly, just on the pipeline, I'd be curious to hear your perspectives on Lumbeck's alpha sign nucleon data in multiple system atrophy and just wondering if that influences your decision making on BAN 0805. Thank you.

Thank you so much for great questions. So I just want to say with the Nordics that we also today have Anna-Kaja Granblad, who is the head of the Commercial Operations Organization with us here in the room today. So we'll hand over to her. But I think that it's a lot of work that needs to be done building up the infrastructure. And we have started for a couple of years now to build up with the strategic position that we already have and to be collaborating with ASI to prepare for that. So please, Anna-Kaja. And then I'll come back and take the Parkinson question. Thank you, Gunilla, for the question. This is Anna Kagry. I'm the chief commercial officer. My main focus is on the Nordic launch. We're looking at the ramp-up in the US, which we find very encouraging. As Gunilla mentioned, we have been gradually building up our organization in the Nordics. We started our collaboration with ASI early last year. we are doing this together. And when it comes to the resourcing, at Bioarctic, we aim to be at around 20 people at the end of this year. And combined with the ASI team, I think that is a kind of a very conscious build up of the organization and the resourcing for the Nordic launch. We're of course waiting for the CHMP opinion. And then after that, ASI will lead the market access process with pricing and reimbursement. So I see that we have a focus on the key clinics in the Nordic countries to really inform and educate and discuss who would be eligible patients for Lecambi going forward and how the build-up of the infrastructure would happen. So I think we have a very kind of conscious but ambitious build-up based on also on the experiences from the US. Okay, and then I will continue with the question on Bano805 or Excedavnema, as it's now being called. And our approach there is, our next step will be to do a phase II-A study in Parkinson's disease. And after that, then our thought is to go into, for example, PGD and DLB. But of course, we're also looking into our competitors' MSA studies at Lundbäck, and there will be another one coming in a year's time or so. And then we're also looking at another competitor and their Parkinson's program. So I think we have a very clear path for ourselves, but we're also, of course, looking opportunistic to the other parts. So if we look at the Lundbäck-Alpha-Smuklin MSA study that just had the top-line data presented, I think we should see what kind of study that was. It was a very small phase two study with about 60 patients. So it's like a signal searching study. So I'm really looking forward to seeing those data to see what learnings we could take from that. And I think that's an interesting opportunity for all the alpha-synuclein antibodies. So I think it's a really important part. We have the amyloid beta antibodies for Alzheimer's disease. That is coming first, and we're learning a lot from those. But we also can apply in the alpha-synuclein antibodies for alpha-synucleinopathies like Parkinson's disease, MSA, and Lewy body disease and so forth. I hope that answered your question.

Yeah, perfect. Thank you very much.

The next question comes from Alistair Campbell from Royal Bank of Canada. Please go ahead.

Just a couple of questions. The first one, obviously, fingers crossed the approvals are approaching in Europe and the UK. I just wonder, I mean, it's early days. I wonder if you can maybe talk through how you're approaching things like technology assessments with NICE and how well prepared you feel for that right now, maybe when you expect to maybe be able to publish a bit more information around that. And then secondly, just on the two brain transporter projects, just a sense of Are they basically going to run potentially in parallel? Or are you looking at maybe a combination of the two? Or kind of just see which one is best? Get a sense of that, please. Thanks.

Excellent question. Thank you so much. The first question about NICE, I have to refer completely to ASI for that one. They are really driving the pricing and reimbursement discussion. So I will refrain from commenting on that. But I am happy to talk about our projects like the brain transporter Alzheimer's program. And I think that we are in a really good situation here that we can build on previous learnings from the Alzheimer's field. And we have two very interesting programs that we plan to drive in parallel. So I think it's really exciting times and we really build on previous great data that we can then drive both programs forward. Because if you think about how huge this patient population is and the enormous need, there will be place for many different treatments in the future. So we're definitely driving both forward.

Okay, thank you.

The next question comes from Patrick Ling from DNB Markets. Please go ahead.

Hi, good morning. Thank you for taking some questions. Maybe just a few short ones first. Could you please remind us how much milestones you are still to receive from EISA in total?

Yes, it's in total 84 million euros. The most significant part of that is commercially related milestones.

Okay, and apart from the European Union. Are there any more regulatory milestones or is that the last one?

No, that's the last one.

That's the last one. Okay, great. And then just since you're on the line here, just so I heard you correctly, you talked about your operating expenses increasing now in fiscal year 2024. Did you say 30 to 50 percent or 30 to 40 percent potentially?

I said 30 to 50.

Okay, good. Good. Not going to hold you to it. I know it's difficult. But then the more important question, maybe you can share a little bit more light about how you're planning to conduct the first Parkinson trial. Anything about size and endpoints or, I mean, is it going to be larger than the Lundbeck signal searching trial? Anything that you can provide us with, please?

Yeah, no, thank you so much for that. Very good question, Patrik. And I think it's really important to to set the expectations here. I mean, that is the phase two A study where the primary endpoint will be safety and tolerability and then with pharmacokinetics to really see how can we then after that do a large phase two B study and in which indication should that be? So that's really the aim of the study. We'll do several exploratory biomarker endpoints. in the study, also in order to prepare for the most important study after that, which is the proof of concept study, the phase two study. So I think it's important to understand what kind of study our next study is. Safety, tolerability, pharmacokinetics, and exploratory biomarkers. And we will come back with a design when we're closer to starting the study.

Okay. Yeah. So, is it reasonable to assume that it will be sort of similar size to the Lundbeck trial?

Yeah, it will be a small study. It's not at all a large-paced-to-be study. That's the next step.

Good. That was all from me right now. Thank you.

Thank you, Patek.

The next question comes from Joseph Hedden from RX Securities. Please go ahead.

Good morning. Thanks for taking my questions. I've got a few, so if I just go one at a time. First on the operating expenses, I appreciate you've already guided to kind of 30%, 50% cost increase this year, but Q4 project expenses were quite a lot higher than they were in Q3. So can we see the kind of $50 million set as the new base for further increases this year as those programs ramp up?

It's hard to guide you on the R&D expenses. I think you can assume that we will spend something like 50 to 100 million on the clinical trials and something similar on the new CDs. Some of those costs started to increase already in Q4, but we will see much larger increases in 2024. I'm not sure if that answers your question, but it's very hard to give you proper guidance here.

Okay, okay, fair enough, thanks. And then next, ICI are obviously giving out some fairly detailed metrics about their launch of Lakembi in the US at the moment. So is there anything that you're seeing that you think you can, are there any lessons to be learned from what they're showing in terms of what you can apply to the Nordic launch, potential Nordic launch next year?

I think there is a lot of learnings that you can do from every region, even though I think every region has some parts which is specific and some parts which is more general. I mean, in the Nordics, we are much more used to taking lumbar puncture, for example, not that they are less dependent on the PET scans as they are in the US, for example. But I will hand over the questions more. to the expert in the room. Yes, in a way, I'm not kind of surprised to see the learnings from the US launch. We all know that when you have to launch this kind of new drug in a field where nothing has happened for 20 years, that requires change. And change in healthcare is even more challenging and then if you look at the Alzheimer's, there's, you know, they have been used to diagnosing and maybe sending back the patients to primary care and nothing more. And now all of a sudden they have to maybe learn new ways of diagnosing and they have to prepare for biweekly infusions and the follow-up with MRI. So I think I'm not kind of surprised. It also, it only stresses the need that you are in close dialogue with the HEPs in the care to make them aware, inform, educate and answer questions of what they need to be doing in order to be prepared once we have a positive opinion and later on reimbursement. So I think it's more being close to the physicians and the different memory clinics. Some university clinics are very advanced and some maybe smaller memory clinics are not as advanced. So you have to be out there and and discussing with them. And that's what we're doing now as well.

Okay, thanks. That's helpful. And then a final one, perhaps. I know your comments on dividend policy today. I'm just wondering, can we read anything into this in terms of your appetite for M&A this year and going forward? I mean, you've got a very strong cash balance, and I appreciate costs are going to increase as you build a commercial business and ramp your R&D, but you have milestones to come and royalties ramping. So does the fact that you're not looking to pay a dividend this year, perhaps next year, can we read into that that there'll be some M&A activity, you're increasing your efforts there?

So thanks for the question. No, you can't read anything like that into the dividend policy statement.

Okay, fair enough, thank you.

The next question comes from Victor Sundberg from Nordea. Please go ahead.

Yes, hi, thanks for taking my questions. So I just want to get maybe one thought here on some things that Biogen said yesterday in their call, seeing that they had some bottlenecks with MRI scans in the U.S. needed to be booked at a specific time, interval after infusion, which seemed to create some scheduling issues for patients. Anything you heard on that in the U.S. and potential impact of that here in the start of their launch? And also looking at China, I mean, the guide here is for quite few patients in relation to its gigantic population. So what are some of the barriers or pushes and pulls for commercialization in that country from what you are hearing? And what is a reasonable maybe expectation of that market overall? Just high level would be helpful. I understand you don't want to guide on specifics as that is more on ASI. But any thoughts on China would be would be appreciated. Thanks.

Yeah, so we start with the MRI. I think I mean, what we understand that there are some scheduling that needs to be sorted. And I think that is an important learning that everyone can learn from. And I think it's every of those bottlenecks that we learn from and understand those can we be facilitated for the future. So I don't think that's too much of an issue for the future, but it's important to understand that when now it's being, the infrastructure is being built up at the different parts, what kind of challenges that we should work through. I don't know if Anna-Kaja, if you want to. No, I can mention that also in the Nordics, I mean, the radiologists already, I mean, starting to discuss what's their role in the future introduction of DMTs. So that's already ongoing, which is encouraging, I think, because they see that there's a need for education over there. Do you want to comment on China, Anders?

So this year, ASA is planning to launch in the third quarter mainly to patients that can pay out of pocket. That's why you see the low patients number forecast for this year. Over time, we think that the reimbursement will come in place. We don't know at what level yet, but it's typically somewhat lower than the US. And at that point, I think the patient numbers will, of course, grow significantly in the long term. But as of this time, when we don't have a price in China, it's very, very hard to give you proper guidance. But the near term forecast is then based on sort of out of pocket spending rather than reimbursement. That's why the numbers are low. That's pretty much what we can offer right now.

It's a good start.

Thanks. And also maybe your thoughts here on Europe, as Asa will get hopefully approval here soon. Any thoughts on the uptake here in Europe versus the US, what you're hearing? in terms of maybe the biggest countries here, are they as well prepared or how should you think about maybe PET scans that seem to be more common in the US and here you can also do CSF tests instead and so on. What are your kind of expectations here for Europe maybe for the start here?

Thanks. I think it's important to understand that Europe is is very different from other parts of the world. And Europe is not one Europe. I mean, you really need them to think about country to country. So if we assume that we have a positive opinion and we get an approval, then there are some countries that can start to launch very early. And then other countries that need to have the price and negotiation discussion that takes a bit longer time. So you really need to think about country by country here. And also, I think, In Europe, and especially in the Nordic region, we are much more used to doing CSF sampling. That's almost part of routine. But I think that there is a lot of work also we need to understand that needs to happen also in Europe to prepare for this new kind of treatment with an earlier patient population that previously had been diagnosed and with the infrastructure that's required. So I think there is a lot of work that is also needed. And I know that ASI is working on it. And I know that Bioartic is working hard on it together with ACI. I don't know, Anna, if you want to comment anymore. No, I think you said it all. I think what's encouraging here, specifically in the Nordics, is also that they have very good international key opinion. It is also already now testing the blood-based biomarkers, which is... So we are more advanced, I would say, especially in Sweden, when it comes to this point, which is encouraging overall. Okay, thanks for that. One more comment on that, thank you, Anna-Kaja. I think that different parts of the world, when the blood tests are coming through, and here I also think China, when the blood tests are coming through, that can really help to find the right patients for the future. I think it's really encouraging that the triaging is happening in the US and it's happening in Sweden and so forth and in many different places. But I think when it's being used more in the clinical setting, routinely, that's when we'll see the larger possibilities to find the right patients.

Okay, thanks. And just a final financial question also here with LifeArc. Do they have any other rights apart from this pass through of the royalty? And just to clarify, is ASI paying you and LifeWorks 10% on US sales and LifeWorks gets 1% and you 9%? Or did I get that right? Sorry.

So first of all, no, they don't have any other rights. And yes, ASI pays us 10% or 10.5% if it's outside the US. And then we pass on 1% to 1.5% to LifeWorks. So net, we keep 9%. Okay.

Thank you.

As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad.

We have some questions, written questions that have been sent in. So maybe I'll then read them. And Gunilla, you can decide who takes the questions. So first of all, from Frederick Thor at Red Eye. The report mentions the new dividend policy. Could you elaborate on your view on how the company will balance dividends in health projects and potentially M&A going forward?

Question for you, Anders.

Yes. So this all depends on how things will evolve in the future. Right now, we want to invest all the capital we have available into our exciting pipeline. So right now, we're not giving up the dividends. Over time, if we amass a lot of cash and we cannot properly invest it in our R&D pipeline, of course, then dividends could become paid to the shareholders over time. M&A, of course, that could also be something that we do over time. It's very, very hard to say exactly where we're going to be in two or three years' time, but everything is on the table. We're not paying a dividend right now, could over time we're not sort of engaged in any m&a activity at this moment but over time we could of course do that as well uh but we are investing more heavily into our own r d portfolio that's something we we expect to continue so so that's pretty much the only thing that i can say yes that will continue but i hope that sort of answers frederick's question thank you anders

Second question here from Peter. ASI has applied for approval of the campaign in several countries, but so far not in India. Can you provide any additional information regarding the status of the Indian markets?

And the short answer is no. We have to refer to ASI and when they announce things, then we will also announce things.

OK, thank you. And then moving on to another question. And I think you already answered that last question from Frederick. That was about the royalty rate and how much we receive versus Life Park, et cetera. I think you clarified that. It's been clarified. Super. Those are all the questions that have been asked via online. Are there any more questions, operator, on the line?

The next question comes from Patrick Ling from DNB Markets. Please go ahead.

Just one short follow-up, maybe regarding your Saints organization in the Nordics. You mentioned that by the end of this year, we'll probably have around 20 persons in your organization. How many of those 20 are already in place now by the end of 2024-2023?

Yes, of course, we are around 14 today. But it depends on also what you refer us to commercial operations. Of course, we have other support functions supporting our commercial launch. But I mean, in the organogram, we're 14 people, plus some consultants. And we are now having staff in Northern Nordic countries. Yes. So, I mean, the majority of people are in our Stockholm office. And we have then two people, two persons in Denmark, two in Finland, and one in Norway. And we are continuing to building the more customer-facing stuff later on. Together with ASIC. Together with ASIC, yes.

So what... Oh, sorry. How should I interpret that? Is that meaning that you're going to increase with like 6 eighths reps more or... Is the total organization that is sort of the commercial organization is going to be larger than 20 persons?

No, I mean, the aim is that we will be around 20 people at the end of the year. So that's including functions like marketing, sales, medical affairs mainly, but also market access, public affairs people.

Okay, great. Then I understand. Thank you very much. Thank you.

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

Thank you. Firstly, I just wanted to refer back to Peter's question regarding the Indian market. I know Gunilla said we couldn't comment on it, but if you look at the slide five today, you also read in our report or you read in ASI's report from last week, you will note that they have filed for market approval in India. So the Indian market is definitely also included in the strategy of ASI going forward for Lecambi. With that, I hand over to Vinilla to close the call.

Yeah, I just want to say thank you so much for many great questions and for your attendance of the meeting today. I think we just can conclude that it's really exciting times for Bioartic, Lecambi and for Alzheimer patients. Thank you so much for today.