BioArctic AB

STO:BIOA B

Earnings Call Analysis

BioArctic's Growth Hinges on Leqembi Rollout

Despite challenges, the uptick in patients treated with Leqembi post-Medicaid coverage in the U.S. has been promising, with close to 10,000 expected soon. Royalties have been tripling each quarter, and with $7.2 million in Q4 U.S sales and a spike to $1.5 million in weekly January sales, growth is anticipated to continue throughout 2024. The company forecasts significant contributions from Japan and China amidst shifting revenue streams towards royalties over milestones. Operating expenses are set to rise by 30%-50% in 2024, as R&D accelerates. With a strong cash balance of SEK 1.1 billion, and an operating profit of SEK 253 million in 2023, BioArctic expects profitability to follow the Leqembi rollout trajectory, with prospects of high profits from 2025 and beyond.

Robust Patient Growth and Revenue Potential

BioArctic's partnership with Eisai on an Alzheimer's disease treatment is gaining momentum despite initial challenges in reaching patient targets. While Eisai missed the short-term target of treating 10,000 patients by March, about 8,000 candidates are queued up, and Eisai estimates reaching 10,000 patients soon given the treatment-onboarding rate of 1-3 months. An exciting long-term prospect is Eisai's expectation to expand to approximately 100,000 U.S. patients by 2026, a significant figure considering it represents only 1% of U.S. Alzheimer's patients, highlighting a large untapped market.

Surging Royalties Indicate Positive Trajectory

BioArctic receives a 9% royalty rate on global sales and an extra 1% and 1.5% on U.S. and ex-U.S. sales, respectively, which is partially shared with their partner LifeArc. Royalty revenues have shown an impressive trend, tripling quarter-over-quarter and are expected to continue growing. With quarterly sales increasing, there's potential for substantial royalty income. Leqembi's Q4 2022 U.S. revenues were $7.2 million, and patient numbers could reach 10,000 soon, suggesting a significant revenue increase on the horizon.

Operational and Revenue Outlook

BioArctic's net revenues in Q4 were SEK 11 million, with an annual total of SEK 616 million, primarily from milestone payments totaling EUR 52 million, accompanied by new revenue streams from royalties and co-promotion. The anticipated revenue mix for the following year is expected to tilt more towards royalties than milestones. Operating expenses rose to SEK 90 million in Q4 and SEK 367 million for the year, primarily due to personnel costs. A continued increase of 30%-50% in costs is projected for 2024, mainly from advancing the company's pipeline and commercial preparations for the Nordic launch.

Financial Stability Supported by Milestone Payments

The company concluded 2023 with an operating profit of SEK 253 million and a robust cash balance of SEK 1.1 billion, sufficient to run operations for three years without further revenues. This financial cushion is buttressed by a positive cash flow, primarily from a milestone payment related to Japan's market. With an effective tax rate around 21%, BioArctic maintains a strong position to capitalize on Leqembi's success and anticipates potential profitability as early as 2024 if the rollout exceeds expectations.

Preparing for Nordic Expansion and Addressing MRI Bottlenecks

BioArctic is leveraging learnings from the U.S. launch, addressing diagnostic and infrastructural challenges unique to different regions. In the Nordics, less dependence on PET scans and radiologists' proactive role in education signal an encouraging start for Alzheimer's treatment introduction. Additionally, Eisai's Chinese market strategy focuses on out-of-pocket paying patients in the near term, with expectations of broadened market reach once reimbursement is in place.

Pipeline Progress and Markets Expansion

BioArctic is also advancing its pipeline beyond Alzheimer's, preparing for a Phase IIa Parkinson's disease study with primary endpoints centered on safety, tolerability, and pharmacokinetics. Moreover, the company looks forward to the potential launch of Leqembi in China, anticipating that reimbursement schemes will gradually raise patient numbers significantly. The upcoming BrainTransporter program is another exciting addition, setting up BioArctic for dynamic growth beyond 2024.

Earnings Call Transcript 2023-Q4

[Operator]

Welcome to BioArctic Q4 Report 2023. [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 fourth quarter and for the full year of 2023. I'm Gunilla Osswald, and I'm the CEO of BioArctic. And I will share today's presentation with our CFO, Anders Martin-Lof.It's very exciting times for BioArctic with Leqembi being the first and only disease-modifying treatment with a full approval in the U.S. and Japan and now also in China. It's the beginning of a new era, and BioArctic 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. BioArctic is listed at Nasdaq Stockholm Large Cap, and this is our disclaimer.Next slide, please. At BioArctic, we focus on disease-modifying treatments for neurodegenerative diseases, and we are now on the market for Alzheimer's disease patients, and we're preparing for Phase II 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're also continuing to building our commercial organization to prepare for the commercialization together with our partner, Eisai. We have a broad portfolio. We're building on the success of Leqembi with very selective antibodies for both Alzheimer's disease and Parkinson's disease and ALS, together with a BrainTransporter technology that aims to get the antibodies better into the brain.We're well financed with more than SEK 1.1 billion 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 neurodegenerative diseases. In this fourth quarter last year, that includes awards from TIME, Scrip, Forska!Sverige, and European Lifestars Awards, and all of that, of course, we're very proud of.Next slide, please. 2023 was a great year for BioArctic and so was the fourth quarter. At the Alzheimer Congress, CTAD, BioArctic and Lars Lannfelt presented new data on lecanemab, further supporting the unique binding profile with lower CAA binding linked to lower incidence of the side effect called ARIA-E in comparison with competitors. Eisai presented more data supporting Leqembi's disease-modifying properties and new data with a subcutaneous formulation after 6 months of dosing in Alzheimer's patients, and that supports the subcutaneous autoinjector as a more convenient alternative for administration of Leqembi. The Leqembi launch started 20th of December in Japan, and now in January, Leqembi was also approved in China. In Europe, EMA has stated that they will convene a Scientific Advisory Group to discuss Leqembi during this first quarter. BioArctic and Eisai have now also agreed how the commercialization and co-promotion of lecanemab will be done together in the Nordics.Next slide, please. Leqembi is the first disease-modifying treatment for Alzheimer's disease with a full approval in the U.S., 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 U.S., it was approved and broadly reimbursed in July last year. Eisai 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 Leqembi. Eisai just reported that approximately 2,000 patients are treated with Leqembi and approximately 4x as many are waiting.If we then look at Japan, where the launch started in December following the price and reimbursement decisions. 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 launch is planned during the third quarter this year. Lecanemab has also regulatory files 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 BioArctic and for Leqembi.Next slide, please. The launch of Leqembi in the U.S. is steadily progressing, and we see that some different examples of that. For example, about 70% of the top IDNs in the U.S. have now approved Leqembi. And about 55% have now started to order Leqembi to treat patients. Approximately 4,000 neurologists or Alzheimer's disease specialists have established a diagnostic and infusion pathway and are ready to prescribe Leqembi. 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 sampling. Leqembi is now broadly reimbursed in the U.S. and approximately, 90% of people who are potentially eligible for Leqembi treatment are reimbursed. Biogen has also announced that they now will focus on Leqembi and supply resources for copromotion together with Eisai in the U.S. So I think we can conclude that there are several important and positive steps towards increased possibilities for access of Leqembi to patients with Alzheimer's -- early Alzheimer's disease in the U.S.Next slide, please. Leqembi 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 patient that had 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 Eisai 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 Eisai are exploring lecanemab 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 Leqembi treatment.Next slide, please. Leqembi is, of course, of interest -- of the main interest maybe, but BioArctic is more than Leqembi. 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 BrainTransporter technology progressed very well. And we've now nominated 2 candidate antibodies as potential disease-modifying treatment for Alzheimer's disease. And what we see for those antibodies is they have increased penetration into the brain. So by utilizing our BrainTransporter 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, exidavnemab, that's our selective alpha-synuclein antibody in a similar approach as lecanemab, but for alpha-synuclein. Here, we're preparing for a Phase IIa study that is called EXIST, and that is planned to start during the fall. The aim of that study will be safety and tolerability and pharmacokinetics with exploratory biomarkers.Next slide, please. To summarize our portfolio, we work in Alzheimer's disease, Parkinson's disease, ALS and utilize the BrainTransporter technology. And our most advanced program is, of course, Leqembi, which is now, as I said, on the market in the U.S. and Japan and approved in China and in regulatory review in many other countries. And the subcutaneous formulation is soon to be filed, and the pre-symptomatic Phase III study, AHEAD 3-45, is ongoing. On this slide, you can also note the progress of the 2 Alzheimer's projects combined with the BrainTransporter technology. And they have -- when they get the candidate drug nomination, they get BAN names. So I want you to see the names, BAN2802 and BAN2803. So we can conclude that our portfolio is progressing well.Next slide, please. So by that, I will hand over to Anders Martin-Lof for the financial summary.

[Anders Martin-Lof, executive]

Thank you, Gunilla. If we look at the next slide, starting with the number of patients that are currently on Leqembi, 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 U.S. in October. And you also see there was a small plateauing around December, but after New Year, it seems like the trend is picking up quite well again. So Eisai stated last week, I think it was that there were 2,000 patients on treatment last week of January. They also stated that it will 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 4x 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? Eisai stated, well, generally they start treatment within 1 month to 3 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 online. So the number of patients that are in the waiting line are growing really fast.And as Gunilla stated, Eisai is now chipping into and they will help Eisai to further increase -- sorry, Biogen is helping Eisai 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 midterm, Eisai 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 U.S., that's roughly 1% of the Alzheimer's disease patients in the U.S. So the potential is much, much larger than that.If we then turn to the next page, you see the Leqembi royalties for us. And we should clarify that the royalty rates 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 U.S. sales and 1.5% on ex-U.S. sales that are then passed through to LifeArc. So net for BioArctic, we get 9%, but the numbers you see on the left-hand side are slightly higher, but some are passed on to LifeArc, 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 Leqembi in the U.S. 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 during 2024. So all in all, we're progressing well towards the 10,000 patients. And we've already stated earlier that if we would have 10,000 patients on average during the quarter, that would roughly equate to some SEK 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.Eisai 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 Eisai is expecting some 1,500 patients already at the end of the year without proper reimbursement. So the patient numbers will, of course, be higher when it's properly reimbursed. But before that, the price is probably higher than the U.S. 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, SEK 11 million, but for the full year, we [indiscernible] SEK 616 million. That's mostly due to the 4 milestone payments that we received totaling EUR 52 million. But also the 2 new revenue streams are starting to contribute. Royalty was SEK 7.3 million in Q4, SEK 10.2 million for the full year, co-promotion, SEK 1.9 million in the fourth quarter, and SEK 5.5 million 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 towards -- tilted towards royalty and then milestones for 2024. The operating expenses increased to SEK 90 million in the fourth quarter and to SEK 367 million for the full year. I think the largest contributor to the increase in the fourth quarter were personnel costs, mainly driven by a milestone related bonus. For 2024, the costs will increase. Gunilla mentioned that we have now selected 2 [ CDs ] and that we are approaching Phase II for exidavnemab. 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 Leqembi.I think it's also important to highlight on the right-hand side, we actually made an operating profit of SEK 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 SEK 1.1 billion, that's roughly 3x the cost of 2023. So if we kept going as we did in 2023, we could keep going for 3 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 SEK 229 million. We paid some SEK 47 million in tax. That gives us an effective tax rate of 17%. That's due to the fact that, that we had some tax losses carried forward that we used in the year. We don't have any left. So the effective tax rate if we're profitable going forward will 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 Leqembi 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 Leqembi.With that, I hand the word back to Gunilla for some closing remarks.

[Gunilla Osswald, executive]

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 you look at this first quarter, we are 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 lecanemab, both from BioArctic and from Eisai. Eisai are also planning to file the submission for subcutaneous administration with autoinjector and for maintenance dosing in the U.S. 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, then 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, Eisai plans for launching of Leqembi in China. And during the fall, BioArctic prepare to start the Phase IIa study in Parkinson's disease with exidavnemab. And we're looking forward to being able to present some data on our BrainTransporter program at the end of the year. So I think it's a lot of exciting times ahead for BioArctic.And next slide, please. So to summarize today's presentation, Leqembi is now approved in the U.S., Japan and China with huge patient populations with early Alzheimer's disease. If we just look at this patient numbers, I mean, they are enormous. 10 million patients in the U.S., 6 million in Japan, 17 million in China. Of course, all patients will not get Leqembi, 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 Leqembi.Our pipeline is progressing well with our next-generation Alzheimer's disease-modifying projects, together with the BrainTransporter technology, and also our Parkinson's disease program preparing for Phase IIa. Our finances are solid, as we heard Anders describe, with a profit of more than SEK 250 million last year. And now, we have more than SEK 1.1 billion in cash. And I think that's great, so we can focus on driving the project forward towards patients.Next slide, please. So just I 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're happy to take some questions.

[Operator]

[Operator Instructions] The next question comes from Rajan Sharma from Goldman Sachs.

[Rajan Sharma, analyst]

So just in terms of kind of the investment required for the Leqembi 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 has already been made in 2023? And also to what extent does the slower launch than expected of Leqembi in the U.S. influence 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 Lundbeck's alpha-synuclein data in multiple system atrophy and just wondering if that influences your decision-making on BAN0805.

[Gunilla Osswald, executive]

Thank you so much for great questions. So I just want to say with the Nordics that we also today have Anna-Kaija Gronblad, who is the Head of the Commercial Operations organization with us here in the room today. I'll just -- 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 positions that we already have and to be collaborating with Eisai to prepare for that. So please, Anna-Kaija, and then I'll come back and take the Parkinson's question.

[Anna-Kaija Gronblad, executive]

Well, thank you, Gunilla for the question. No -- so this is Anna-Kaija Gronblad, Chief Commercial Officer, and my main focus is, of course, on the Nordic launch. And we're, of course, looking at the ramp-up in the U.S., which we find very encouraging. And as Gunilla mentioned, we have been gradually building up our organization in the Nordics. And we started also our collaboration with Eisai early last year, and 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 Eisai team, I think that is kind of a very conscious buildup of the organization and the resourcing for the Nordic launch. We're, of course, waiting for the CHMP opinion, and then after that, Eisai 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 Leqembi going forward and how the buildup of the infrastructure would happen. So I think we have a very kind of conscious but ambitious buildup based on -- also on the experiences from the U.S.

[Gunilla Osswald, executive]

Okay. And then I will continue with the question on BAN0805 or exidavnemab, that is now being called. And our approach there is our next step will be to do a Phase IIa study in Parkinson's disease. And after that, then we -- our thought is to go into, for example, PDD and DLB. But of course, we're also looking into our competitors' MSA studies, that's Lundbeck, 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 Lundbeck alpha-synuclein 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 II 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 that could -- 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 that we also can apply in the alpha-synuclein antibodies or alpha-synucleinopathies like Parkinson's disease, MSA, and Lewy body disease and so forth. I hope that answered your question.

[Rajan Sharma, analyst]

Yes, perfect.

[Operator]

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

[Alistair Campbell, analyst]

Just a couple of questions. The first one, obviously, fingers crossed, the approvals are approaching in Europe and U.K. 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 able to publish a bit more information around that? And then secondly, just on the 2 BrainTransporter projects. Just a sense, are they basically going to run potentially in parallel or are you looking maybe a combination of the 2, or kind of just see which one is best? Get a sense of that, please.

[Gunilla Osswald, executive]

Excellent questions. Thank you so much. The first question about NICE, I have to refer completely to Eisai for that one. They are really driving the pricing and reimbursement discussions. So I will refrain from commenting on that. But I'm happy to talk about our projects like the BrainTransporter Alzheimer's programs. 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 2 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.

[Operator]

The next question comes from Patrik Ling from DNB Markets.

[Patrik Ling, analyst]

Maybe just a few short ones first. Could you please remind us how much milestones you are still to receive from Eisai in total?

[Anders Martin-Lof, executive]

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

[Patrik Ling, analyst]

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

[Gunilla Osswald, executive]

No, that's the last one.

[Anders Martin-Lof, executive]

That's the last one.

[Patrik Ling, analyst]

That's the last one. Okay, great. And then just Anders, since you're on the line here, just so I heard you correctly talked about your operating expenses increasing now in fiscal year '24. Did you say 30% to 50% or 30% to 40% potentially?

[Anders Martin-Lof, executive]

I said 30% to 50%.

[Patrik Ling, analyst]

Yes, 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's trial?

[Gunilla Osswald, executive]

Yes.

[Patrik Ling, analyst]

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?

[Gunilla Osswald, executive]

Yes. No, thank you so much for that. Very good question, Patrik. And I think it's really important to set the expectations here. I mean, that is a Phase IIa 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 IIb study and in which indication should that be. So that's really the aim of the study. We will 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 IIb 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.

[Patrik Ling, analyst]

Okay. But -- yes. So is it reasonable to assume that it will be sort of a similar size to the Lundbeck trial?

[Gunilla Osswald, executive]

Yes, it will be a small study. It's not at all a large Phase IIb study. That's the next step.

[Operator]

The next question comes from Joseph Hedden from Rx Securities.

[Joseph Hedden, analyst]

I've got a few. So if I just go one at a time. First on the operating expenses, 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 that the kind of SEK 50 million as the new base for further increases this year as those programs ramp?

[Anders Martin-Lof, executive]

It's hard to guide you on the R&D expenses. I think you can assume that we will spend something like SEK 50 million to SEK 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.

[Joseph Hedden, analyst]

Okay, okay, fair enough. And then next, Eisai obviously giving out some fairly detailed metrics about their launch of Leqembi in the U.S. 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?

[Gunilla Osswald, executive]

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 at all as depending on the PET scans as they are in the U.S., for example. But I will hand over the questions more to the expert in the room, Anna-Kaija.

[Anna-Kaija Gronblad, executive]

Yes, in a way, it's kind of -- I'm not kind of surprised to see the learnings from the U.S. 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 health care is even more challenging. And then if you look at the Alzheimer's, there's -- 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 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 HCPs 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 discussing with them, and that's what we're doing now as well.

[Joseph Hedden, analyst]

Okay. That's helpful. And then a final one perhaps. I know your comments on dividend policy today. 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 there'll be some M&A activity you're increasing your efforts there?

[Anders Martin-Lof, executive]

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

[Joseph Hedden, analyst]

Okay. Fair enough.

[Operator]

The next question comes from Viktor Sundberg from Nordea.

[Viktor Sundberg, analyst]

Yes. So just want to get maybe one thought here on some things that Biogen said just 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 seem to create some scheduling issue for patients. Anything you were heard on that in the U.S. and potential impact of that here in the start of the 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 imposed for commercialization in that country from what you are hearing? And what is a reasonable maybe expectation of that market overall? Just higher level would be helpful. As I understand, you don't want to guide on specifics as that is more on Eisai. But any thoughts on China would be appreciated.

[Gunilla Osswald, executive]

Yes. So we start with the MRI. I think, I mean, what we understand there are some scheduling that needs to be sorted. And I think that it's an important learning that everyone can learn from. And I think it's every of those bottlenecks that we learn from and understand that 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 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-Kaija, if you want to...

[Anna-Kaija Gronblad, executive]

No, but I can mention that also in the Nordics, I mean, the radiologists are already, I mean, starting to discuss how -- what's their role in the future introduction of [ DMCs ]. So that's already ongoing, which is encouraging, I think, because they see that there is a need for education always there.

[Gunilla Osswald, executive]

And now, do you want to comment on China, Anders?

[Anders Martin-Lof, executive]

So this year, Eisai is planning to launch in the third quarter, mainly to patients that can pay out of pocket. That's why you see the low patient 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 U.S. So -- 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 a 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 [ talk to you right now ].

[Gunilla Osswald, executive]

It's a good start.

[Anders Martin-Lof, executive]

It's a good start.

[Gunilla Osswald, executive]

Yes.

[Viktor Sundberg, analyst]

And also maybe your thoughts here on Europe as Eisai will get hopefully approval here soon. Any thoughts on the uptake here in Europe versus the U.S.? 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 U.S. 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?

[Gunilla Osswald, executive]

So I think it's -- [ I think it's roughly fair ]. I think it's important to understand that Europe 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 they are -- 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. But -- and then other countries that needs 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're much more used to doing CSF sampling. That's almost part of routine.So -- but I think 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 Eisai is working on it, and I know that BioArctic is working hard on it together with Eisai. I don't know Anna-Kaija, if you want to comment anymore.

[Anna-Kaija Gronblad, executive]

No, I think you said it all. I think what's encouraging here, specifically in the Nordics is also that we have very good international key opinion that is also already now testing the blood-based biomarkers, which is -- so we're more advanced, I would say, especially in Sweden when it comes to this point which is encouraging overall.

[Viktor Sundberg, analyst]

Okay.

[Gunilla Osswald, executive]

And I think there's one more comment on that. Thank you, Anna-Kaija. And that's, I mean, 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. So -- and I think it's really encouraging that the triaging is happening in the U.S. 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 patient.

[Viktor Sundberg, analyst]

Okay. 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 Eisai paying you on LifeArc 10% on [ U.S. sales ] and then LifeArc gets 1% and you 9% or did I get that right? Sorry.

[Anders Martin-Lof, executive]

So, first of all, no, they don't have any other rights. And yes, Eisai pays us 10% or 10.5% if it's outside the U.S., and then we pass on 1% to 1.5% then to LifeArc. So net, we get -- we keep 9%.

[Operator]

[Operator Instructions]

[Oskar Bosson, executive]

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 Fredrik Thor at Redeye. The report mentioned the new dividend policy. Could you elaborate on your view on how the company will balance dividends, in-house projects, and potentially M&A going forward?

[Gunilla Osswald, executive]

Question for you, Anders.

[Anders Martin-Lof, executive]

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 dividend. 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 2 years' time, 3 years' time, but everything is on the table. We're not paying a dividend right now. We 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. But we are investing more heavily into our own R&D portfolio. That's something we expect to continue. So that's pretty much the only thing that I can say, yes, that will continue. I hope that sort of answers Fredrik's question.

[Oskar Bosson, executive]

Thank you, Anders. Second question here from [ Peter ]. Eisai has applied for approval of Leqembi in several countries, but so far not in India. Can you provide any additional information regarding the status of the Indian market?

[Gunilla Osswald, executive]

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

[Oskar Bosson, executive]

Okay, thank you. And then moving on to another question. I think you already answered that last question from Fredrik, that was about the royalty rate and how much we receive versus LifeArc, et cetera, but I think you clarified that.

[Anders Martin-Lof, executive]

That's been clarified.

[Oskar Bosson, executive]

Super. Those are all the questions that have been asked via online. If -- are there any more questions operator on the line?

[Operator]

The next question comes from Patrik Ling from DNB Markets.

[Patrik Ling, analyst]

Just one short follow-up maybe to -- regarding your [ sales ] organization in the Nordics. You mentioned that by the end of this year, you probably have around 20 persons in your organization. How many of those 20 are already in place now by the end of Q4 '23?

[Anna-Kaija Gronblad, executive]

Yes. We -- of course, we are around 14 today, but also -- it depends on also what you refer as 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.

[Gunilla Osswald, executive]

And we're now having staff in all the Nordic countries.

[Anna-Kaija Gronblad, executive]

Yes.

[Gunilla Osswald, executive]

So I mean the majority of people are in our Stockholm office, and we have then 2 people -- 2 persons in Denmark, 2 in Finland and 1 in Norway.

[Anna-Kaija Gronblad, executive]

Yes.

[Gunilla Osswald, executive]

And we are continuing to building the more customer-facing staff later on.

[Anders Martin-Lof, executive]

Yes. Together with Eisai.

[Gunilla Osswald, executive]

Together with Eisai. Yes.

[Patrik Ling, analyst]

So how should I interpret that? Is that meaning that you're going to increase with like 6 sales reps more or is the total organization that is sort of the commercial organization is going to be larger than 20 persons?

[Anna-Kaija Gronblad, executive]

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.

[Patrik Ling, analyst]

Okay, great. Then I understand.

[Operator]

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

[Anders Martin-Lof, executive]

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 5 today, you also read in our report or you read in Eisai'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 Eisai going forward for Leqembi. With that, I hand over to Gunilla to close the call.

[Gunilla Osswald, executive]

Yes. So 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 BioArctic, Leqembi, and for Alzheimer's patients. Thank you so much for today.