BioArctic AB

Good morning and welcome to Biotic's presentation for the fourth quarter and for the full year of 2025. It has been a fantastic year for Biotic. In 2025 we entered into a new era that we call the growth era. And we can conclude that we have a transformative year behind us with record financial results. We are making our science accessible to more and more patients than ever before. And I think it's great and reassuring to see that more and more patients are getting access to Lecambi. We are accelerating our innovations. Our portfolio is progressing really well and has been further expanded. And our brain transporter technology is further evolving with new innovations. We have increased focus on business development. We are broadening our collaborations and utilizing our brain transporter technology. And we'll talk more about all this in today's presentation. Next slide, please. Biotic is listed at Nasdaq Stockholm large cap, and this is our disclaimer. Next slide, please. I'm Gunilla Åsvall, and I'm the CEO of Biotic. 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. I'll start our presentation by giving some key highlights. Next slide, please. I'm proud to state that Biotic is among the world leading innovators in precision neurology. We have two key platforms, where the first one is innovation and generation and development of highly selective antibodies that are targeting aggregated, misfolded forms of toxic proteins like leucanumab. And we also have projects targeting alphasnuclein, TDP43 and Huntingtin. The second area is the brain transporter platform, where we have an innovative way to deliver antibodies. And I want to highlight that we are broadening the platform to enable more efficient transportation of other modalities into the brain with new innovative approaches. I'll talk more about that in today's presentation. Next slide, please. Last year, we held our first Capital Markets Day, where we presented our ambitions for 2030. And I'm so happy to see that we are already clearly delivering on our ambitions. If we start with the first one, Lecambi, to be established treatment in Alzheimer's disease, Lecambi demand continues to grow to more and more patients, and we are now having global sales above 500 million US dollars. I think it looks bright with the blood-based biomarkers and the subcutaneous administration coming. The second aspect is balanced and broader pipeline with projects in all stages of development. And the pipeline is already broader with new projects added last year for both Parkinson related diseases as well as Huntington's disease. The third one is additional successful global partnerships, and we are very pleased with ASI and our two new collaborations since last year, Bristol Myers Squibb and Novartis. We are also really happy with the further discussions that are ongoing. The fourth one is about our finances. Our aim is to be profitable and have recurring dividends in the future. We were highly profitable in 2025. Our strong financial position allows us to continue to invest heavily in our business. At the same time, give something back to our shareholders. There is a proposal by the Board of Dividends of two Swedish crowns per share. Next slide, please. So I just want to comment on some of the latest highlights towards delivering on our ambitions. So we start with Lekembe. And I would like to start by thanking, thanks to our partner, ASI's great work. Lekembe is now approved in 53 countries around the world. The subcutaneous autoinjector that is called iClick in the US has been launched for maintenance dosing in the US. The next important step is approvals of subcutaneous initiation dosing. And it was great to see that both the authorities in the US and in China has granted priority review. And I think this points to how important the subcutaneous opportunity is for the patients. And we are very much looking forward to the PDUFA date that FDA has set by the 24th of May this year. It's also reassuring to notice that all data being presented at congresses, including long-term data and real-world evidence data, are very encouraging for Lecambi. If we then turn to the pipeline, it's progressing really well and we are growing the pipeline and they are advancing. If we look at our alpha-synuclein portfolio and start with Exidabnema, which is our antibody which currently is in phase 2a, the second part of the study with both Parkinson's disease and the multiple systemic atrophy patients will be finalized this year. And we are actively preparing for phase 2b. We can also communicate that we have nominated two new candidate drugs and we are preparing for INDs. And we have also further expanded our portfolio. And as you know, I'm very excited about our brain transporter technology platform, where we have further innovations for different modalities, including our brain transporter technology, utilizing our brain transporter technology. And Johanna will talk more about this and show some nice new data. The third one is about our partnerships. And as I said, I'm really happy with all three partners, ASI, Bristol Myers Squibb and Novartis. All three programs looks great. And it's also happy to notice that we were very busy during JP Morgan in January this year. And it's great to see that we have continued strong interest for our projects and for our brain transporter technology, both for antibodies as well as other modalities. The fourth aspect is about our financials. They are strong. We were highly profitable in 2025- with record full-year results of 1.2 billion Swedish crowns. The royalties for Lekemby are steadily increasing. And during 2025, we received several milestones also, both from ASI and upfront payments from Bristol-Myers Squibb and Novartis. And that led to that we have a strong cash position of 2.2 billion Swedish crowns. And Anders will talk more about this. Next slide, please. So by that, I will now hand over to our chief R&D officer Johanna Felting for an update from R&D.

Thank you so much Gunilla. Next slide, please. So this slide provides an overview of our R&D portfolio, featuring the two main platforms that Gunilla talked about, the antibodies and the brain transporter platform, and also the highlighted cross-program synergies. So the portfolio includes fully funded projects partnered with major global pharmaceutical companies, such as ACI, Bristol-Myers Squibb, and Novartis. And we also have several in-house projects and technology platforms with substantial market and licensing opportunities. All collaborations involving the Brain Transporter Platform are advancing well and as planned. And since the last quarterly update, we have also achieved important milestones within the portfolio, including the nomination of two candidate drugs, BAN 2238 for alpha-synuclein disease and BAN 3014 for TDP-related proteinopathies such as ALS. Additionally, you will notice a new project in the brain transporter portfolio, the PDBT2278, and this is targeting the alpha-synuclein disease. So next slide, please. So both BAN20-38 and BAN30-14 were recently nominated at Candidate Drugs and have now advanced from research into preclinical development. BAN20-38 is targeting toxic aggregated alpha-synuclein such as oligomers, protofibrils and aggregates. And this is combined with the brain transporter technology. It offers opportunities in several different nucleopaties, such as Parkinson's disease, MSA and dementia with Lewy body. And for BAM3014, this antibody targets toxic aggregated TDP43 proteins, such as oligomers, protofibrils and aggregates, and it offers opportunity for several of the TDP43 proteinopathies, such as ALS and frontal temporal lobe dementia. So both of these programmes, we have now initiated IND enabling activities and they are being prepared for clinical studies. So the next slide, please. So alpha-synuclein misfolding and aggregation is central to alpha-synuclein disease development. And our alpha-synuclein portfolio offers opportunity in several of these new synucleinopathies, such as Parkinson and dementia with Lewy body and multiple systemic atrophy. Exedamnibab is most advanced and is currently being tested in the EXIST study, a phase 2A study for safety and tolerability. And in parallel to this, we are preparing for the next stage of development into phase 2B. 2238, that I just talked about, is the newly nominated alpha-synuclein antibody combined with the brain transporter technology for better efficacy and better brain uptake. And BAN 2238 is an alpha-synuclein antibody combined with the brain transporter, also representing an additional advancement in the brain transporter portfolio, for which further details will not be disclosed at this time. Next slide, please. So I'm very excited to share some new data today on our brain transport platform. So we know that the blood brain barrier that represents a significant challenge for neuroscience. And if we can improve the delivery to the brain of our drugs, that represents an enormous opportunity for increased, of course, exposure in the brain. enhanced clinical efficacy, greater patient convenience by lowering the dose and offering other routes of administration, potentially better safety and lower manufacturing costs. So we are investing very heavily in the brain transporter technology to deliver different types of biopharmaceuticals beyond antibodies and enzymes that we talked about in the past. So we have developed this technology further now to enable delivery of small drug modalities to the brain. So this is a very innovative and flexible system that aims to transport various types of drugs, such as genetic medicines and small molecules into the central nervous system. Next slide, please. So here I'm very happy to show you some new data and this image here compares the brain distribution of a standard antibody up to your upper left corner in green with a BT coupled antibody in green below. And you can appreciate the hope that the great increase of the green fluorescent color, which represent the antibody present in the brain. And this is the same dose in the same time frame and the same antibodies just with and without the brain transporter technology. So antibodies we have worked with for quite some time, but we have also now shown you data with the distribution in the brain of an enzyme and also a small modality. So this BT coupled approach significantly improves the brain distribution of our drug modalities. And for the BTA, the antibodies, this is a technology now that is fully implemented and validated both in mice and in non-human primates. And here we have both internal and external candidates at various stage of development. And then the BTE, the enzyme platform. We have our first internal program, the BTG case for Gaucher's disease, and this is progressing very well. It's an orphan indication that offers market potential for bioarchitecture and a project that we can drive longer into the clinic. And I think that this enzyme project, it really sets the foundation for future enzyme-based projects coming along in the portfolio. And then what's new and presented here today is the BT-S, the BT small modalities. And this is a novel and very flexible system that enables efficient brain delivery of genetic medicines such as ASOS or siRNA. It could be degraders, it could be small molecule approaches or anything that you want to deliver into the brain basically. And here some key data is now being generated showing the utility of the system and what is shown here is then the brain distribution. And I think that there's been a really strong interest in our brain transporter technology at the JP Morgan Health Conference in January in San Francisco. And we are very excited about the future further development of this platform and hope that we will be able to show you some more data in the coming year. So next slide, please. So with this, I will hand over to our chief commercial officer, Anna-Kaja Granblad, for a commercial update.

Thank you, Johanna. I will go back to Lecambi for a while. I will start by just reminding everyone on the many recent and upcoming regulatory and development steps for Lecambi that really increases the treatment options for patients, but also drives the sales growth around the world. As Gunilla mentioned, the IV formulation is now approved in 53 countries, of which the latest ones were Canada, Brazil and Malaysia. And the IV maintenance treatment once every four weeks is approved in seven countries. And in the EU, the EMA accepted ACI submission for the IV maintenance earlier this year. When it comes to the subcutaneous autoinjector, the weekly maintenance treatment was launched, as Gunilla mentioned, in the US in October last year. And the SPLA for the weekly induction treatment was granted priority review by the FDA. And we're looking forward to the PDUFA date set for May the 24th. In Japan, the application for the subcutaneous induction treatment was submitted in November last year, and ASA expects a launch later in 2026. And then finally, ASI also sent an application for the subcutaneous autoinjector also in China last month, where it was granted priority review and ASI expects a launch in 2027. So many advancements and this will drive the leukemia growth even further. The game changer being really the subcutaneous autoinjector, where the induction treatment is given as two injections of 250 milligram each, where each injection only takes 15 seconds. So next slide, please. So also with regards to the real world evidence, Lecambi continues really to deliver more data. At the most recent Alzheimer's Congress, CTAD, in December last year in San Diego, there was a lot of presentations on Lecambi. So real world evidence coming from US and Japan shows really consistent results in terms of efficacy and safety with findings from the clinical trials. Additional data presented indicated that earlier initiation may be associated with greater benefit and that continued Lekembe treatment may provide a benefit compared with stopping therapy. So finally, data also presented at CETER verified that the subcutaneous formulation offers a convenient option with comparable exposure and safety to IV. And this can really reduce treatment burden for patients and their care partners and healthcare, of course. So this was really, really encouraging to see all this data in December last year. So next slide, please. So what are the trends on the key markets for Lakembi? Anders will soon show you the bioarctic royalty based on the Lakembi sales, but we can conclude that Lakembi sold for more than 500 million US dollars in the calendar year of 2025. That's a nice milestone. uh the global anti-amyloid market has more than doubled in 2025 and this is driven by mainly three things i would say first the use of blood-based biomarkers both for triaging and for confirmatory confirmatory diagnosis is increasing china has been really in the forefront but also in the us it is steadily increasing and it is estimated that approximately 10 of confirmatory diagnosis in clinical practice in the US are done by blood-based biomarkers. Secondly, more physicians are prescribing Lekembe. In Japan, more than 800 facilities are now starting initial treatment, and 1,700 centers are focusing on the follow-up after six months onwards. And in the US, there is an enhanced coordination between the primary care physicians and neurologists. On the slide, you can see the targeted direct-to-consumer information campaigns that EISA has been rolling out in the US and in Japan. And the second one is to address really the awareness of mild cognitive impairment. The fact that Lekembe was included in the commercial insurance innovative drug list in China in December will gradually give more physicians and patients access to Lekembe from the second half of the year, it is estimated. Thirdly, the subcutaneous water injector that I mentioned was launched in the US for maintenance in October, also drives growth. It is estimated that 80% of the patients on Lakembi want to continue treatment after 18 months. The insurance coverage through the medical exception process is increasing, and the pay approval rate is estimated to be over 80% in the US. And finally, in Europe, the launches in Austria and Germany are ongoing since September last year, whereas the reimbursement discussions are ongoing in other countries. And finally, the first private clinic in the Nordics started treating patients in Finland in October last year. And what we hear from the market is that there are several other private clinics that are about to start. And we also hear that there are private patients traveling to Finland, also from Sweden, for example. Also since April, our team in the Nordics has gradually been out visiting memory clinics every day, educating on the Lekembe data and on the infrastructure that needs to be in place. We are active at national and regional specialist meetings, visiting regional healthcare decision makers, and we're increasing our digital communication on Lekembe. There is really a big interest and willingness to learn more and to make sure that all relevant staff at the clinics are educated. So next slide. So finally, this is my last slide, and I know it's a busy one, but there was a question sent to us before, Harald, on the progress with governments regarding Lecambi reimbursement in the Nordics. And as you probably know, EISA is responsible for reimbursement and pricing. But this slide shows an overall picture of the different steps and the parties involved in the process and what the completed steps are for Lecambi in blue, which you can also find publicly available. It is the ambition for both ASI and us to secure patient access to Leukemia in all Nordic countries. And as you might know, in red there, you see that in Denmark, the Danish Medicines Council came out with a negative recommendation in December. So here ASI is considering the next steps and will be in dialogue with the authorities regarding potential next steps. In Sweden, the TLV published their health economic evaluation in December. The next step is to negotiate with the county council. And in Finland, the assessment report from Fimea has been recently published. And in Norway, the assessment is still ongoing, the Norwegian Medicines Agency. So there's no official set timelines on how long these processes are. But EISA is working very closely in dialogue with the authorities to answer any potential questions or other requests. And clearly, the ambition is to finalize these different steps during the year. So you can go to the next slide and by that I leave the word to our CFO Anders Barton Lööf.