BioArctic AB (publ)

Welcome to BioArctic Q3 Report 2025. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing pound key 5 on their telephone keypad. Now I will hand the conference over to CEO Gunala Oswald, CFO Anders Martin Loft, and colleagues. Please go ahead.

Thank you. Good morning and welcome to Bioartic's presentation for the third quarter of 2025. Bioartic is continuing in a great way in our new era. with yet another quarter where we see more and more patients are getting access to Lekembe. And we are broadening our collaborations, utilizing our brain transporter technology. And we are also broadening our portfolio with new projects and new modalities. And we will talk more about that in today's presentation. Next slide, please. Biotic is listed at nasdaq.com large cap, and this is our disclaimer. Next slide, please. So I'm Gunilla Osvald and I'm the CEO of Bioartic and I will share today's presentation with our CFO Anders Martin Lööf and our Chief R&D Officer Johanna Felting and our Chief Commercial Officer Anna-Kaja Grönblad. Next slide please. So I will start our presentation today by giving some key highlights. We go to next slide please. So before I come into this quarter and the presentation, I just want to give a high level introduction to Biotic, if we have any new listeners today. Bioartic is among the world's leading innovators in precision neurology. And we have two key platforms. The first one is about innovation and generation and development of highly selective antibodies targeting aggregated misfolded forms of toxic proteins. And examples here are, for example, leucanumab, leucanbin and exodanumab. The second one is when we are utilizing our brain transporter platform in innovative ways to deliver antibodies and different modalities to come better into the brain. In today's presentation, we will talk about both selective antibodies like Lekembe, Exedabnimab, and our new project for Huntington's disease with Huntingtin. as well as our brain transporter technology, which we have utilized now for all our internal targets. And we have also started to use it for external projects. And we now have three different partnerships utilizing the brain transporter technology, including the recently signed deal with Novartis. Next slide, please. During the second quarter this year, we held our first capital markets day, and then we presented our ambitions for 2030. And I'm really pleased to say that we are already delivering on our ambitions. So if we start with the first one, Lekembe, to be an established treatment in Alzheimer's disease, I'm really happy to see how Lekembe's demand continues to grow. The second one is to have a balanced and broader pipeline with projects in all stages of development. And our pipeline is already broader and continue to increase and develop. The third one is additional successful global partnerships. And of course, we are very happy with the new collaboration with Novartis and we have more positive discussions ongoing. The fourth one is our aim to be profitable and to have recurring dividends in the future. And we expect to be highly profitable this year. And Anders will come back to this. Next slide, please. As I said, we are already delivering on our ambitions, and now I will go through a bit about how. We start with Lecambi, and I think now we are really well on our way to get Lecambi established as a treatment for Alzheimer's disease, a disease-modifying treatment affecting the underlying disease. Thanks to our partner, A-Size, their great work with Lecambi, it's now approved in 51 countries around the world. with Canada being the latest one. The iClick, the subcutaneous autoinjector, like a subcutaneous pen, was called iClick, was approved for maintenance dosing in the US during the quarter. And ASI has already initiated a rolling submission for initiation dosing as well. And launch has already started for maintenance dosing in the U.S. after the quarter. Next thing I want to say is about Europe. And there the launch has been initiated in Germany and Austria. And we're really happy to see that Finland has got the first patients that have been treated in a private clinic. Of course, this is great news from us from a Nordic perspective, since we are preparing for launch together with ASI in the Nordic countries. And Anna-Kaja will come back and talk more about this. Then there has been several presentations on Lekembe during the period and after the period. And those have shown that long-term data over four years treatment show continued increasing benefits over time. And also really reassuring to follow the real-world data coming for Lecambi when it's being used in clinical practice. And we have heard presentations both from the US, Japan and China. And the data have shown that the benefit and the safety profile are at least in line with the phase three results, which I think is great and encouraging. Subcutaneous administration data has also started to be presented and that supports this great further opportunity for patients to in a more easily way get the injection by an auto-injector and possible to do that at home in an easier way. Then I also want to mention that, of course, we follow with great interest the fantastic progress with the blood-based biomarkers. And the guidance was launched earlier or during the quarter about how to utilize the blood-based biomarkers. And they can now be used both for confirmation and for triaging. And we'll come back to that. If we then look at the second part of the pipeline, which is progressing really well and growing with new projects, I want to mention Exedavnamab, our alpha-s-nuclein antibody, currently in phase 2a, with a second part of the study ongoing in both Parkinson's disease patients and in multiple systemic atrophy patients. And I'm also really happy to be able to communicate that we're also now working on another misfolded protein target called Huntingtin for Huntington's disease. And here we are working with antibodies, but we are also broadening it into other modalities, utilizing our brain transporter technology. And Johanna will talk more about this in today's call. The third one is to have additional successful global partnerships. And as I said, we are very happy about the new collaboration with Novartis regarding an undisclosed target for neurodegenerative diseases. And we will re-engineer their antibody to include our brain-transported technology and enabling then a better penetration into the brain. I also want to mention the other brain-transporter collaborations that we have so far is one with ASI on Band 2802, where we're generating great data, and Band 2803, which we are completing now the tech transfer to Bristol Myers Squibb. It's also great to see that we have continued strong interest for our projects and for our brain transporter technology for antibodies, as well as for other modalities. The fourth part about the financials, we have strong financials and we are highly profitable this year with increasing royalties, as well as several milestones from ASI and upfront payments from Bristol Myers Squibb and Novartis. Next slide, please. If we think about the Alzheimer's field, it's evolving in a very nice way. And I want to highlight five different areas. The first one is that we see that we're getting easier and easier diagnosis by blood-based biomarkers. And I think this is important in helping to build the market in an easier way and to help to get the right patients to come to specialists to get a treatment initiated. The first tests are now available as confirmatory for specialists as well as for triaging for primary care. If we then look at the second one, we see more and more data that shows that earlier initiation of treatment of Lekembe shows better effect. So when we're looking at the earlier patients in the phase three Clarity 80 open labor extension study, where now 48 months data are available. we see that the majority of leucanumab-treated patients were stable or even improved after 48 months treatment. I think this is very encouraging. And I think it also further supports the ongoing AHEAD 345 study in pre-symptomatic individuals with amyloid pathology, but yet without symptoms. The third one is also really important, and that is the data that are being presented show the importance with maintenance treatment to maintain the treatment and the benefit of continued treatment with Lecambi, even after the plaques are cleared in order to continue to clear the toxic protofibers. And that's possible due to the mechanism of action and the low immunogenicity that we see with Lecambi. The fourth one is about more convenient dosing with Lecambi iClick, the subcutaneous autoinjector. And I think this is a really important next step for Lecambi. And it's making dosing so much easier for the patients and the care partners to handle the dosing at home. And we are also pleased to note that it was awarded as one of the top innovations for 2025 by Time Magazine. And the fifth one is that in the future, we expect to see more combination treatments for even better outcomes. And there is currently an ongoing study with leucanumab and A-sized tau antibody. And I think in the future, we will see more and more combination treatments. So to summarize, the key is to identify patients at an early stage, and here we can use the blood-based biomarkers, and we can start Lecambi treatment early and continue treatment with convenient dosing with Lecambi iClick. So great progress in this field for Lecambi. Next slide, please. So now we come to the R&D update, and I hand over to our chief R&D officer, Johanna Felting.

Thank you so much, Gunilla. Next slide, please. As Gunilla mentioned, BioArctic is among the world's leading innovators in precision neurology, where we have two key platforms. The antibody platform with highly selective antibodies targeting aggregated forms of toxic proteins. These are intended to treat severe neurodegenerative diseases with high unmet medical need. such as Lekembe in Alzheimer's disease, Exedavnimab in synucleinopathies, Parkinson's or MSA, and also the TDP43 project for ALS. Bioarctic is also developing a brain transporter technology that facilitates the passage of antibodies and other drugs across the blood brain barrier. And the aim with this platform is to improve the brain exposure and distribution of the drug and thereby allow for lower dosing, improved convenience, reduced manufacturing costs and potentially also better efficacy. And in addition now, we're also further developing our brain transporter technology and expanding this into new modalities other than antibodies, such as enzyme proteins and even genetic medicines. And the development of the platform that will enable us to address different diseases by tailoring the modality target combination with the highest potential clinical benefit. Next slide, please. So this is an overview of our R&D portfolio with the two platform antibodies and brain transporters and the cross program synergies. The portfolio is the combination of fully funded projects run in partnership with global pharmaceutical companies, innovative in-house projects and technology platforms with significant market and out licensing potential. So far, our brain transporter platform has generated three collaborations with ASI, BMS and Novartis, and all of these collaborations are progressing really well. They are all with different targets, but importantly, the brain transporter technology is BioArchitect's own proprietary and has the potential to generate more collaborations in the future. You will also note a new brain transporter project in the portfolio, the HDBT4801 for Huntington's disease. And I will come back to this specific project later in the presentations. So to summarize, we are both advancing and broadening our R&D portfolio with new projects into new disease areas and with new collaborations. Next slide, please. Exidabnimab is an antibody that selectively targets the pathological alpha-synuclein aggregates while sparing the physiological monomers. EXIST is a Phase IIa study testing the safety and tolerability of Exidabnimab. In this study, we're also exploring a wide range of biomarkers, both biochemical and digital. And we have a quite unique approach in including the right patients in the study with a smell test that is an early sign of Parkinson's if you have an impaired smell, and also a CSF seeding amplification test to really make sure that we have the correctly diagnosed patients with the alpha-synuclein pathology in the study. The high-dose cohort is currently ongoing, both in Parkinson and multiple systemic atrophy, and the results are expected mid-2026. So following this success study, there are several potential possibilities for future development in different synucleinopathies, such as Parkinson, MSA, and DLB, and we're currently preparing for the next stage of development. Next slide, please. So this is very exciting to me that we are now expanding our portfolio into a new neurodegenerative disease, the Huntington's disease. And this is an inherited progressive neurological neuropsychiatric disorder that is caused by impaired function and degradation of nerve cells in specific areas of the brain. Huntington's disease is caused by a toxic mutant Huntingtin protein in the brain and the mutations in this gene results in a buildup of toxic aggregated Huntington protein causing Huntington's disease. The disease onset is between 30 and 50 years old of age and it's fatal within 10 to 30 years. Current treatments are only symptomatic and there is a large unmet medical need for better treatments. So next slide please. Targeting the Huntington protein in the Huntington's disease is an excellent strategic fit into our portfolio at BioArctic and with our capabilities. So this project is built on BioArctic's extensive experience in developing antibodies against misfolded aggregated toxic proteins and also our brain transporter platform that will enable us to increase the brain delivery of the drug. In this project, several modalities is being explored in parallel, antibodies as well as genetic medicine approaches. And since this is a brain target, we have of course also combined it with our brain transporter technology. So we are excited that we now expand our portfolio with yet another neurodegenerative disease in addition to Alzheimer's, alpha-synucleinopathies, ALS and Gaucher's, with the potential to bring hope for even more patients. Next slide, please. So with that I will hand over to our chief commercial officer Anna-Kaja Granblad for a commercial update.

Thank you, Johanna. You can go to the next slide, please. I will go back to Lecambi again. I'll start with the regulatory update for all of you. Since the last quarterly report, Lecambi IV has now been approved in three additional countries. That is in India, Australia, and in end October also in Canada. So in total, Lecambi is approved in 51 countries and territories. And as of October, in addition to the US, the IV maintenance treatment, meaning once every four weeks, is also approved in China, in Qatar, United Arab Emirates and India. So Anders will soon present the sales numbers. But in short, I would say that the Lekembe growth really continues steadily. So in Q3 versus Q2, when you adjust to China's actual demand, the growth was 14%. And we have seen recent launches in Mexico and Saudi Arabia. And as of August and September, as Gunilla mentioned, Lekembe was launched also in the EU, in Austria and Germany, where patients have started treatment. And what we hear is that within the first two months, it's around 350 centers were registered in the system for the controlled access program. And as educational activities is being rolled out, In the two countries, registrations and prescriptions continue to increase at major specialist clinics. And finally, in the Nordics, of course, as Gunilla mentioned, there is a private clinic in Finland offering Lekembe treatment to patients willing to pay out of pocket. And we know that a few patients have received treatment in October. So this is an important milestone for us in our ambition to increase but also becoming a fully fledged pharmaceutical company. So in the meantime, the price and reimbursement and the dialogue continues with all the Nordic countries and we aim to launch gradually throughout 2026. So next slide, please. So additionally, I would like to spend a few minutes again on the Lecambi iClick, the subcutaneous autoinjector, which was approved in the US in August and launched as of early October. And as Alzheimer's disease is a progressive disease where neurodegeneration and cognitive decline continues, even after plaque removal, it is important to offer both health care professionals and patients the possibility to choose between continuing on once monthly infusions in the hospitals or to switch to once weekly at home injections after the 18 months treatment. So this obviously could be a benefit for the patient who might want to travel and feel less bound to the hospital, but also to healthcare providers in reducing the resources related to the infusions. Reimbursement for the ICLIC is expected to be included on formulary in the beginning of 2027, but individuals can seek insurance coverage via the medical exception process, which is something that is quite common in the US. And ASI staff is providing information on this process, and nurse educators provide support on dosing and demonstration kits, etc., So this is truly a major step in the treatment of Alzheimer's disease patients. And recently, Lekembe iClick was selected by Time as one of the best inventions in the medical and healthcare category. In addition, ASA has also a rolling SPLA ongoing, also for the weekly initiation treatment in the US since September, which is planned to be completed in the last quarter of this year. So potential approval may be in Q2 or Q3 next year. And finally, submissions for the subcutaneous weekly initiation treatment is also planned for Japan before the end of this year. Next slide, please. So moving on to my final slide, this is to highlight again the true advancements we are seeing with the Lecambia iClick and with the parallel development in the usage of diagnostic blood tests. If you remember, US clinical guidelines were presented at the ADPD Congress in July this summer, saying that blood-based biomarker tests showing more than 90% sensitivity and specificity can be used for confirmatory diagnosis in patients with cognitive impairment. And the first blood-based confirmatory tests are available in several countries, in the US and China, for instance. And for Gerabio's test, Lumipulse, for instance, has been granted IBD clearance and C2N is another company that has submitted for regulatory filing in the U.S. for their confirmatory test. And meanwhile, Roche Phosphatau 181 blood test was granted IVD clearance from the FDA for use in the primary care test as a triage test. So more tests will be done. 350,000 tests are expected to be used in 2025. And a new CMS payment rate is coming up from January next year. And of course, as more patients are being tested, more patients will receive a diagnosis. So as we see, these advancements will contribute significantly to the leukemic growth going forward, especially in the US, China and Japan. So that's all from me. And with that, I will now hand over to our CFO, Anders Martin Lööf.

Thank you, Anna-Kaja. If we start to look at the Likambi numbers, the global Q3 sales came in at 18 billion yen, or roughly $121 million. And at first glance, that looks quite negative since there was a 22% decrease from the second quarter of 2025. But that is all due to a large stockpiling effect in China in this second quarter. So ASI calculated what the growth would have been from the second to the third quarter without the stockpiling effect. And then the growth would have been 14%. We recorded royalty of 117.2 million Swedish. That's also down from 162.5 million Swedish in the second quarter. But we have also estimated what the royalty would have been without the stockpiling effect. And then we would have been around 125 million Swedish in the second quarter and 135 in this quarter. So I think that's a better reflection of the actual development of the Lycambi sales in the world. Turning down to China, so actual recorded sales for 0.2 billion yen or 0.6 million dollars, so a 97% decrease from the second quarter. Basically, the clinics in China are receiving They can be from inventory right now in the third quarter. The actual demand was roughly $18 million, and that's a 10% increase from $16 million in the second quarter. But all in all, this means that there is still quite a significant inventory left in China. So we expect very low sales in China also during the fourth quarter, and that was reported by ASAP. Turning to the US, the sales are increasing well. They were up to 10.2 billion yen, or roughly $69 billion, representing a 12% increase from the second quarter. And here, ASI is really trying to leverage the developments that Anakaya was talking about with the blood-based biomarkers that are now being used more and more, and the acceptance of iClick for maintenance therapy this year and for induction next year. But to really get the full effect of this, you have to target the primary care practitioners. So that is what ASA is doing now. They're targeting roughly 3,500 primary care practitioners. They're running very big educational programs and running large awareness campaigns straight to the patients. So they're really building momentum now to start to see an impact from from iClick and PubBase biomarkers starting probably more from next year, but they're really starting to do the groundwork now. And here, you can say that they're mimicking Japan a little bit. Japan is the market that has come the furthest along in the demand expansion phase. Sales here were $42 million representing a 13% increase from the second quarter. And here they have really succeeded in setting up a good treatment chain where roughly 4,200 doctors are referring to 800 initial treatment centers and there the patients stay for a while and then they are moved over to follow-up facilities. So that's a system that has worked incredibly well and that is what they're trying to achieve now in the US as well. I think it's also really interesting to see that the disease awareness campaigns that are running for mild cognitive impairment in Japan are significantly increasing the recognition rates. Because we all know that mild cognitive impairment, which is the earliest phase of the disease, It's really where you want to treat the patients. With the disease-modifying therapy, you can have the most effect if you start as early as possible. But today, those patients aren't really diagnosed to a large extent. So these awareness campaigns can really start to build momentum for more patients getting the drug when they really should have it. And then, as Anna-Kaja mentioned, the EU launch has been initiated in Austria and Germany. It's really exciting to see that that is starting well. However, it will take some time before you see any significant impact in our royalties from EU, which is a slightly slower market than the US and Japan. If we then turn to the Lecambi global sales forecast, they have a forecast of 76.5 billion yen for their fiscal year 2025 for Lecambi. And if you look on the right hand side of the graph, you see that they have already in the first two quarters of that fiscal year achieved 48% of the forecast in the US and 49% in Japan and already 83% in China. So all in all, if you also include the other countries, they have achieved roughly 52% of the overall annual forecast in the first two quarters of that period. And since they are growing, we have a very high confidence that they would reach the forecast for the year. So everything is looking really, really good for Lecambi, and it seems to reach their forecast with some margin. If we then turn to our own numbers, you see that the Q3 net revenues were 133 million. And this quarter, that was mainly based on the recurring revenues, with royalties of 117 million and co-promotion revenues of 5 million. So it's exciting to see that we're becoming more and more like a normal company with recurring revenues that make up a larger share of our revenue base. We also recorded some revenues from the new Novartis agreement. As you know, we got $30 million upfront when we started that collaboration, and now we recorded $9 million out of that in the third quarter, and we will record the rest during the remainder of that collaboration. Looking at our operating expenses, they increased to 150 million this quarter compared to 95 a year ago. And this time around, that was basically just normal cost. We have had large currency effects in the previous two quarters, but not this quarter. So the underlying operating costs were 146 million. And that's slightly over than our recurring revenues. So we have operating costs that are 24 million higher than our recurring revenues. But we are approaching a point where we will have recurring revenues that are larger than our operating expenses. So we are getting closer and closer to long-term profitability. If we then look at our costs for the remainder of the year, we expect them to keep increasing since we have a more mature project portfolio and we have built up our commercial organization. I have previously stated that I expect our full year costs to be roughly 50 to 70% higher than the cost of last year. Now we think we will be in the lower range of that interval. So I would say roughly 50 to 60% higher than the cost of last year. And then on the right hand side, you see that operating loss was 29 million for the third quarter. We expect something similar in the fourth quarter. So the operating profit for the year should be well above 1 billion Swedish. On the next slide, you see our net result on the left. It's then, of course, a bigger loss than the operating loss, and that's mainly explained by the crude taxes of 65 million, but we have a positive financial net of 8 million, so that ameliorates a little bit. And then the operating cash flow, you typically see one very big bar, and that's the payment of the $100 million upfront payment that we received from Bristol Myers Squibb in the second quarter. The $30 million upfront payment, $30 million, I should say, from Novartis had not been received in the third quarter. It was received in October. So the bar you see on the left-hand side with our cash balance right now of 1.9 billion Swedish does not include the Novartis payments. So our financial position will continue to be strengthened in the fourth quarter. So we are going to end the year with a very, very solid position. I think that was all for me. And now I hand back to Gunilla for some closing remarks.

Thank you so much, Anders. We are coming towards the end of today's presentation with some upcoming news flow and some closing remarks. So next slide, please. So we are now in the fourth quarter of 2025, and I think it's great to see that more and more patients are getting access to Lecambi around the globe. And also really pleased to see that we're also starting, even if it's small. So we're starting in the Nordics. We see continued regulatory processes on lecanumab with the Canada approval. And I think it's great to see the ICLIC being approved for maintenance dosing in the US. And our partner ACI are working hard to conclude the supplementary BLA filing for Lecambia ICLIC in the US for initiation dose. And also to file in Japan for both initiation and maintenance dosing with ICLIC. We are, of course, looking forward to the next Alzheimer's Congress. It's CITAD in San Diego in the beginning of December. And there we note several presentations on leucanumab, including subcutaneous data and more real-world evidence data from, for example, U.S. registered. So this is something I'm really looking forward to. So come to next slide. So the key takeaways from today's presentation is that Biotic is now in our new era and we see great progress both on Lekembe as well as the rest of our portfolio and the brain transporter technology. We have already started to deliver on our 2030 ambitions. Lecambi is well on track to become an established treatment for Alzheimer's disease. Sales continue to show increasing demand on a global level. Further regulator approvals, launches, reassuring data from long-term treatment and real-world evidence. Our portfolio has increased, and we have initiated programs for Huntington's disease with different modalities. Our business development efforts continue to deliver with a third brain-transporter collaboration now having been initiated during the third quarter. And this was the first of its kind, and it shows that we are also expanding to becoming also a platform company. And the last point is that we have strong financials, as Anders described, with great cash flow, with milestones and record royalties during this year, growing more than 180% year on year. So I think the future looks very bright for Biotic, and it's bringing hope for many patients. Next slide, please. So by that, we say thank you so much for your attention, and we're 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 Joseph Hedden from RX Securities. Please go ahead.

Good morning. Thanks for taking my questions. Firstly, on the Canby IGLIC, do you have any visibility on when regulatory findings might be made in Europe or China, or the strategy there is. And then secondly, it's great to see a Huntington project just on the brain transporter technology. I know that first program is an antibody, and you've mentioned genetic medicine. Is brain transporter capable of, for instance, using an AAV vector like, I mean, Huntington's, the Unicure therapy made a lot of noise recently. Is there anything

Thank you so much, Josef. Excellent questions. So I think the first question can be iClick in Europe and China. We cannot comment on that. I mean, right now we are really happy about the progress in the US and Japan. And then we know our partner is doing everything they can to help as many patients as possible around the world. So we'll come back to that. Then your question with regard to Huntington's disease and where we are also really happy to see the brain transporter. So I didn't understand any specific question. I think I can take it. But if I just end and then I hand over to you, Johanna. And then for the brain transporter, I think it's really, really good to see that we can utilize that for several different modalities and definitely help to get different modalities better into the brain. And I think it's important to point out that brain transporter is not one thing. It's a platform with many different tailor-made ways to handle, depending on what kind of target and what kind of modality. We have several different approaches that we utilize, depending on if it's an extracellular target, intracellular target, or what kind of modality we have. And then I hand over to Johanna, who I understand the question I missed.

Thank you so much, Josef, for that excellent question. And we are, of course, following the competitive landscape very well, and we understand and we have seen the Unicure data. I think it's excellent data. But that's a treatment that is not for everyone. It's a quite invasive treatment, and you actually need maybe a 15-hour surgery for one patient to administer that drug, and you do it with intrathecal administration and injections in different sites in the brain right now. So our approach is a bit different, and I can't speak too much of it today before we have the patents in place and so, but we have another approach. and we are not primarily targeting AAV with our brain-transported technology.

Okay, thank you very much.

I hope that responded to your question. Thank you, Johanna.

Yes, thank you. The next question comes from Susanna Quekborner from Handelsbanken. Please go ahead.

Hello. I'd like to ask a question regarding Lecambi sub-Q. So listening to the ESAI conference call, there was talk about the iClick being listed in formularies only by 2027. There seems to be a medical exemption program which would address something like 80% of patients. To me, it sounds like there's likely to be more paperwork associated with that. which sounded like it was going to be limited or access was going to be limited at least until 2027. Maybe you can just sort of explain that to me and then also how does that impact your competitive advantage versus Eli Lilly's from Turniturg which is also expected to read out data in 2026 and they have the sub-Q formulation as well.

We start with your question on ICLIC. The process in the US with the reimbursement agency or CMS is that it's certain times of the year that you need to submit in order to come into the next year. That's the reason for why we expect ICLIC to be on the formulary from January 2027. Right now, just as you said, Susanna, there is a possibility to utilize the medical exemption program, which I think many of these physicians are used to do for other treatments. And what we have understood from ASI is that it's not overwhelming paperwork. It's a fairly easy process that can help most patients to already be reimbursed right now. And I'll also go on the differentiation part a little bit and then hand over to Anna-Kaja. So I think, I mean, we see then the iClick as a really good differentiator versus competitors. And then we will follow with great interest when also return comes with some efficacy data. We haven't seen much yet. So I think each compound has to show itself before we can comment too much. And we haven't seen much of it yet. But I think, meanwhile, we're really happy for LeCambi iClick, which all the data we have seen so far looks really, really promising. And more data is expected to be shown at CITAD. So I don't know, Anna-K, if you want to add something.

No, not really. I think, again, I think it's, we haven't seen that much data on renternitog yet, so I think it's too early to say anything about it. But we, of course, understand that they also see the need of a subcutaneous autoinjector, because we think that this will be a key driver and for patients also being, having an easier treatment. So we see the need from the Eli Lilly as well. They see us, this is a

If I can have a follow-up question. Also, I saw that Takeda discontinued their alpha-synuclein antibody, which they reported they had, say, two results on. Maybe you can talk about the differentiation to your alpha-synuclein antibody.

Yeah, I think it's really important to understand that every antibody is different from each other. And we think that we have a clearly superior antibody, much more selective, the most selective antibody that we know for alphas nuclein between the pathological forms and the physiological forms. We have more than 100,000 fold selectivity, which is a huge difference from competitors. And also, I think it's important to see the design of the clinical studies that we also think that we are designing better studies for the future. But I will hand over to Johanna.

Thank you, Gunilla. No, I totally agree. And thank you for the question. Of course, it's always sad when a clinical study that brings hope the patient does not read out. But I think that we have a differentiated profile, both in terms of the selectivity for what we believe is the toxic species, the aggregated species, and a very high affinity for those species. And we also have a superior human PK profile as compared to the AstraZeneca Takeda, It was also a fairly small, I would say, phase two clinical trial. And I think that we can have a clear differentiation with this, both in terms of human PK, study design and selectivity for the toxic species.

So not much read over, I would say. Absolutely not.

Okay, thank you.

The next question comes from Natalia Webster from RBC. Please go ahead.

Hi there. Thanks for taking my questions. Firstly, I was wondering on EZI's four-year Lakembi guidance to March. This is implying a slowdown in growth for Lakembi sales for calendar Q4 into Q1 26. So, Just curious to hear if you think this is conservative, appreciating that there may be some further impact from the China inventory adjustment in Q4. And then my second question is on the European launch. I appreciate it's early days and it could take some time to see a more meaningful contribution here, but are you able to provide a bit more feedback on how this is progressing? And if you're accounting any of the initial challenges that you saw in the US around capacity or otherwise? And then finally, just on profit, you've maintained your long-term ambition for sustainable profitability. I was wondering if you're able to touch on any key considerations for cost phasing in 2026, and if you're able to confirm that you still expect to reach sustainable profitability from 2026 as well. Thank you.

So I think it's Anders who should start. Right.

So if you look at the ASI forecast, I think you're specifically asking whether they will be for China. Well, all in all, they are already at 52 percent of the full year forecast after two quarters, 87 percent in China. I think it's correct that the Chinese sales would be very low in the next quarter as well. But then I think more or less the inventory should be used up. So they should have a strong first quarter of next year. So we remain very confident that they will reach their forecast for the full years, and so are they. That's what they communicated on their call. As for the profit for next year, we will not comment on our cost for next year until we finish the years. So you'll hear more about that in February when we communicate our year-end results.

And then there was a question for Anna-Kaja.

Yes, regarding the EU launches. And what I can say is that, of course, I mean, the EU consists of 27 countries and all of these countries have their national market access processes on price and reimbursement. So I would say that after Germany and Austria, typically being the early launch countries, it takes quite some more time before each country has gone through this process. So I would say that We can be cautious when it comes to the sales coming from Europe next year. I think we are, let's say, infrastructurally wise in a better situation than in the USA. But still, I mean, this is a new treatment paradigm also that is being implemented. So each clinic has to really go through and have a checklist on what to have in place in order to start the treatment. treatments on patients. So I think we should be kind of cautious and understanding of the changes that needs to be in place in the clinic. So it will be rolled out gradually throughout Europe next year.

And I just want to remind also that we have said all the time that Europe is a small, small proportion out of the global sales. Especially, I mean, the coming two years, but also long term. It's really US, Japan, China and other parts of Asia and other parts of the world that also contributes a lot.

Great, thank you.

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

Yes, hi. Thanks for taking my question. So yeah, one first on financials. So I just wondered how we should think about the Novartis upfront payment being recognized over 21 months. Will this be in a linear fashion or how should we think about the revenue contribution of that part going forward? Thank you.

Short answer is yes.

Linear.

So, yes, linear. It's very hard. We are delivering, as we have communicated, we are working on a Novartis compound that we are modifying and we'll deliver it back to them. And that will take some time. And it's really hard to estimate how large a share of that work has been done. So you typically do that in a linear fashion over the expected time course of the collaboration. So linear.

Okay, thank you. And also, I had a question on your competitive position or ASI's competitive position versus Kisumla. You know, looking at the curve, it seems that they are accelerating sales. I guess ASI has done a lot of the groundwork already to prepare for that. But I just wonder, on your discussions with ASI, Why are some patients choosing Kizunda over Lecambi or why are some patients choosing Lecambi over Kizunda? What's your feedback here so far in the launch? Thank you.

Would you like to take it, Annika? Yes, I mean, of course, it can be still the number one disease-modifying treatment for Alzheimer's in the U.S. as well. But as you say, I mean, of course, Kisunda is having some advantage as being a front-runner in establishing these kind of treatments on the market. But what we can see is that, and what ASA reports is that, It's not kind of reducing the Le Camber market, but it's growing the kind of total market as such. Of course, I mean, there is a difference in the... They have once monthly today and we have twice monthly in the 18 months treatment phase. And then you can choose to go to once monthly or iClick. So, of course, every patient is an individual and has to kind of decide what works best for that patient. But otherwise, I think Lekembe is still showing a strong growth and driving. And so in total, it's growing the total market.

Okay, thank you very much.

The next question comes from Sebastian van der Schuyt from Kempen. Please go ahead.

Hi, team. Congrats on the progress and thank you for taking my question. Just one from our side. Could you maybe give some color on what would be your goal or non-goal decision for further development of the Parkinson's program? What type of signals do you want to see against placebo to push the development forward? And what could next steps for the program look like? Thank you.

Yeah, so I will start and just say that Exidavnamab, which is currently in a phase two A study, and the main task for this study is to look at safety tolerability. And we have two doses. We have had first a lower dose where we have a safety review that supported us to go into the higher dose part in exactly the way that we had planned and wanted. And then we have also broadened it, not only for Parkinson's disease, but also for multiple systemic atrophy, where we also have got orphan drug destination. So I think, I mean, we are doing a lot of biomarkers, but that's really in order to prepare also for next step for phase 2b. So I think it's really important to see that the expectation here is really to look at safety tolerability for this program. And so far, what we have seen, it looks really good. But the readout there will be just after summer next year is what we expect. The study is ongoing and still recruiting, so it's a little hard to say exactly when it happened, but the best estimate is a little bit after summer next year. And then there is a lot of opportunities for this asset. And as we have described before, it can be Parkinson's disease dementia, it can be Lewy body dementia, it can be different parts of Parkinson's disease, it can be MSA. So there is a lot of opportunities and at the moment we are evaluating different of those kind of indications and preparing for the next step. So I think this is a very interesting asset, very exciting with a lot of opportunities.

I don't know if you want to add something, Johanna. No, I have nothing to add to that. Just to echo what Gunilla said, this is a quite small study and a short study, so not too much should be expected in terms of biomarker readouts. It's a safety and tolerability study. It's three months, and that's a bit too short to see efficacy on biomarkers related to disease modification. That should be the next study.

Got it. Thank you, guys.

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

So there doesn't seem to be any people in the phone queue right now, but we have some written questions that have been posted during the call, so I'll read them out loud and then Gunilla can direct who should take the question, although I think the first one is maybe Anders' one. But it's from Peter, who wonders, looking forward, when we start to record sales in the Nordic countries, how are we going to report that going forward?

So in our profit and loss statement, you have our total revenues, and then in the notes, we will have our different revenues split up by line, and we already do, actually. So the revenues from the Nordics form can be seen straight away. They are part of what is called co-promotion revenue, which is...

reimbursement we get from from a side for a profit sharing but over time yes i think we will uh comment on how things are going in the mornings i hope that answers the question thank you and then follow-up question from peter as well regarding opex and the difference in opex if you compare q1 and q2 it's down uh in in q3 and he wonders uh what were the reasons for this and then going forward also what is the level that we can expect anything you can say there

Right, no, so our costs are quite lumpy. So if you deduct the other operating expenses, which is mostly currencies, yes, our costs were down a little bit in the third quarter, but we expect them to go up again in the fourth quarter and then we'll see what happens next year, especially what happens after the XIST trial if we enter into significant larger clinical trials with With Exedamnum up, you should expect increasing R&D spending next year. But it's too early to tell exactly what that would look like. But of course, with a maturing R&D portfolio, you incur larger costs, which is a great thing for a company like ours.

Thank you. Then we had a question for Fredrik, but I think we answered that because it came from somebody else as well. And then... Eric from Carnegie has a question regarding the EVOKE trials that are coming up soon, in just the next couple of weeks, the expectations on results for the EVOKE trial where semaglutide is tested in early AD in EVOKE and EVOKE+. What's our thoughts on that, if that study is positive and how that could potentially impact or not impact the Camby-Ganila?

Yeah, so I think I'm really looking forward to seeing the results. And it's quite imminent now. I think it's two well-designed clinical trials in phase three. They did not have a proper phase two. So it's very hard to say anything about what to expect here, I think. But if positive, then I think that it's a compliment to Lecambi. I don't see this as a competitive treatment. I see it's a complementing treatment because it has a completely different mechanism of action and potentially then could help patients together with Lecambi.

Okay, thank you. And I think the last one about the risk regarding China, you touched upon it, Anders, but maybe you want to clarify once again what we think about the stocking effect in China and how long that's going to last and when we can expect more new sales coming in in China.

Yes. So the stockpile that was built up in Q2, I expect it to run out during the fourth quarter. So you should see an effect of that on the sales in the fourth quarter, but not beyond that. That would be my estimate.

Yes. Thank you. Those were all questions in the queue. I don't believe, operator, that we have any more questions waiting in line either. And if so, I think that concludes today's call. Thank you so much for listening, and we'll see you back in a quarter from now. Thank you so much. Thank you. Have a good day.