5/20/2026

speaker
Gunilla Oswald
CEO

presentation for the first quarter of 2026. It has been a strong start of the year for Biotic following a transformative year of 2025 with record financial results. It shows that the growth era continues in a great way for Biotic. It's reassuring to see that more and more patients are getting access to Lekembe and we had more than 500 million euros of sales during our partner ASI's fiscal year. And that resulted in a commercial milestone to Biotic. Our projects and our brain transporter technology are also progressing really well. And we have increased focus on business development, which is based on great interest in brain transporter and in our projects. I'll talk more about that in today's presentation. Next slide, please. Biotic is listed at Nasdaq Stockholm large cap. This is our disclaimer. Next slide, please. So I'm Gunilla Oswald, 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 will start our presentation by giving some key highlights. Next slide, please. Biotic is focusing on two different platforms in precision neurology, and we are among the world-leading innovators in both areas. The first area is about creating highly selective antibodies, which is targeting aggregated, misfolded forms of toxic proteins. The most advanced program here is Lekanamab, LekanV, and we also have projects targeting alphasnuclein, TDP43, and Huntingtin. The second area is when we are utilizing our brain transporter platform in unique ways to deliver antibodies more efficiently into the brain. But we have now also broadened our scope and we are also working on other modalities like enzymes and also genetic medicine and small molecules to enable more efficient transportation of them also into the brain with innovative approaches. The innovations at Biotic continue to impress me deeply. They are unique and very competitive. Next slide, please. We are already delivering on our 2030 ambitions that we presented for our Capital Markets Day last year. And we have then stated that we have four areas of focus. The first one is to establish Lekembe as a disease-modifying treatment for Alzheimer's disease. And here we see a steady growth across geographies with sales that was more than 500 million euros the last 12 months. And we expect the subcutaneous autoinjector called iClick together with increasing use of blood-based biomarkers, that that together will contribute to continued strong growth. The second aspect here is that ASIC has also indicated in their guidance for 2026 that we are expecting sales of more than 900 million US dollars. So I think that Lekembe is well on its way to become a blockbuster with yearly sales more than 1 billion US dollars in not too long. The second area is to have a broader pipeline and more advanced with projects in all stages of development. And I'm happy to see that our pipeline has expanded last year and our projects are progressing really well. I want to highlight our Alphas Nuclein project, Exedavnema, where the Phase 2A study is fully recruited with the results expected later this year. And also the follow-up compound, BAM2238, with our brain transporter coupled to alpha-synuclein in an antibody. And there the ING activities are ongoing in order to take the compound into clinic next year. The third area is more partnerships. And last year we initiated partnerships with Bristol Myers Squibb and Novalis. And we're very pleased with both of those partnerships and really impressed with how the collaborations are progressing and delivering. We also see continued strong interest that we have in both our projects and in our Brain Transporter platform. Partnership discussions are complex and takes time. We are in a very strong position with our high quality projects and innovative technologies. The fourth aspect is strong financials. And our quarterly royalty revenues from the Cambys sales grew 68% compared to first quarter last year. And we have now more than 2 billion Swedish crowns in cash, which means that we can continue to invest in our projects and our innovations. And we have also the possibility to start to pay some dividends. Next slide, please. Our business model is built around partnerships. That is a key component behind our success. A-Sign has been a long-term successful collaboration all the way back since 2005. And now we are getting 9% royalties from global LeCambie sales. And we have just then passed our second commercial milestone and got another 20 million euros from ASI. And we have 34 million euros still remaining in milestones. For Bristol Myers Squibb, we have received 100 million US dollars so far and there is a substantial amount left. And Novartis, we have so far received 30 million US dollars. And also here is a substantial amount still to receive if it also continues well. We are grateful for AbbVie who has made us receive 30 million US dollars, which helped us build the company and also progressing the project further. And it's a project I strongly believe in and looking forward to more results. And we expect more partnerships to come. That is our business model, and we're working on that. And we cannot say exactly when time is, but we will let you know when we can discuss. Next slide, please. So by that, I hand over to our Chief R&D Officer, Johanna Helting. Thank you, Gunilla. Next slide, please.

speaker
Johanna Felting
Chief R&D Officer

So as Gunilla talked to, our R&D portfolio is built on two platforms, antibodies and brain transporter, providing both depth and scalability in neurodegenerative diseases. We combine fully funded partnerships with leading pharma such as ACI, BMS and Novartis with proprietary programs that offer further out licensing potential. Progress in the portfolio remains strong. All brain-transporter collaborations are on track, and key milestones have been reached for our internal programs, including the start of ING-enabling activities for BAN 2238 and BAN 3014. Overall, we are advancing a diverse partner-validated pipeline and growing scientific, strategic, and commercial options. Next slide, please. So our alpha-synuclein portfolio continues to advance and expand, offering multiple opportunities across alpha-synucleinopathies. Our lead program, Exidavnimav, is progressing well. The phase two EXIST study in Parkinson's disease and multiple systemic atrophy is now fully recruited, and we have held key regulatory and key opinion leader interactions to prepare for the next stage of development. Next generation assets in the portfolio are progressing as well, with BAN 2238 in ING enabling phase and PDBD 2278 in discovery. And together, this builds a strong expanding office of nuclear pipeline from clinical stage to future innovation. Next slide, please. So our brain transporter platform addresses one of the most fundamental challenges in neuroscience, efficient delivery across the blood brain barrier of therapeutics. And this is enabled by active transport of biopharmaceuticals into the brain via the transparent brain receptor. And this enhanced delivery can translate into higher, faster, and deeper brain exposure with improved clinical outcomes, improved patient convenience, safety, and lower cost for manufacturing. So the brain transporter, therefore, plays a critical role in unlocking the full potential of CMNS therapies. Next slide, please. So our next generation alpha-synuclein antibody, the BAM2238, demonstrates strong preclinical performance, both with enhanced brain exposure and favorable safety profile. So by combining the alpha-synuclein targeting with our brain transporter technology, BAM2238 achieves significant increase in brain exposure in preclinical models. And that is what you see in the middle picture here. And importantly, This enhanced delivery is achieved without compromising safety so we observe no signs of anemia or reduction of reticulocytes while maintaining a full effective function of the protein and that's the data shown to you right. So otherwise reduction in reticulocytes is a commonly reported side effect targeting the transferrin receptor for brain delivery. Overall, the band 2238 highlights how the brain transporter has the potential to both improve target engagement and reduce development risk, strengthening the value of our next generation pipeline. Next slide, please. So as Camilla also mentioned, we are also now broadening our brain transporter platform beyond antibodies and enzymes and also include additional modalities such as genetic medicines and small molecules, significantly increasing the scope of the platform. So the data in the picture here clearly shows how the brain-transporter-coupled modalities deliver superior brain resolution compared to a standard therapy. So in the top picture, you see a standard therapy, and in the lower pictures, in green, you see an antibody, in yellow, you see an enzyme, and in red, you see a small modality. And all of them have very, very much higher brain exposure when coupled to the brain-transporter platform. So across the platform, delivery of antibodies are preclinically validated and advancing. Enzymes are progressing with our first internal program, the G-Case program for Gaucher's disease. And small modalities represent a new important growth area for us. So overall, the Brain Transporter is evolving into a versatile platform with particular future value drivers across CNS discovery disorders. Next slide, please. So then I will hand over to our chief commercial officer, Anna-Kaja Björnblad.

speaker
Anna-Kaja Grönblad
Chief Commercial Officer

Thank you, Johanna. So I will continue with an update on Lecambi and I will start with the stating that the global sales of Lecambi amounted to around 580 million US dollars in a size fiscal year 2025 so that is almost a doubling versus the previous fiscal year and we can see a good growth across the line and the can be continues to be the global market leader of the anti-amyloid antibodies A couple of the driving factors are that the market for blood biomarker continues to grow, and there has been approximately a 12-fold increase over the last two years, with the number actually doubling every six months since January 2024. last year cms also formally included the blood-based biomarkers as a beta confirmatory diagnosis and today it is estimated that approximately 15 of the diagnoses were done by these blood-based biomarkers and these will continue to increase as more tests are expected to be approved this year Another factor is that more and more patients received continued treatment after the Lecambi maintenance dosing was approved, first for the IV and then for the subcutaneous formulation, the autoinjector iClick, which was approved in August last year. According to ASI, iClick also seems to have led to an increase in new patients initiating treatment with Lecambi IV. So going forward, we see even more expansion possibilities with the potential approval of the subcutaneous initiation treatment, both in the US with the set PDUFA in August, 24th of August, and with an expected approval also in Japan in quarter three this year and in China in quarter one next year. So this is a huge advantage for patients, the caregivers and less of a bottleneck for hospitals and obviously also a competitive edge for Lecambi. So in Europe, the IV maintenance dosing is under regulatory review at EMA since February. And in parallel, the negotiations for pricing and reimbursements are ongoing in the EU. And so today it's available in Germany and Austria, as well as out of pocket in UK, Finland and Portugal. So next slide, please. So as the Nordic countries are a bioptics home market, I thought I would also comment on the recent negative recommendation for Leukemia by the new therapies council in Sweden. As we have seen in other European countries, it is a challenge to get immediate access. And we knew that the dialogue would be challenging also in Sweden based on the assessment report issued in December last year by the TLV, the Dental and Pharmaceutical Benefits Agency. So in which some of the assumptions in the health economic modeling were extremely conservative in our opinion. Although ASA was very solution oriented in the negotiations, the expectations from the anti-cancer were impossible to meet at this point. But both ASI and Bioarctic, we are very committed to securing patient access in Sweden and across Nordics. And the ENTI Council has stated that there is a possibility to reopen the dialogue, for example, if and when we have the IV maintenance dosing approved by EMA. And we could also try to find another innovative ways of securing the structured introduction. We are also evaluating a resubmission in Denmark, and in the coming months, we're expecting to see assessment reports coming out of Norway and Finland. But in the meantime, though, we see that there is a private market in Finland. Four clinics have now started Leukemia treatment, and we are approached by other private clinics across the Nordics who are looking into this possibility as well. So in parallel, our neuroscience account managers, as well as our medical affairs team are working every day with the education on the site readiness activities in the preparations for a broader reimbursement across the Nordics. So next slide, please. Finally, I would like to conclude by showing a few highlights from the ADPD Congress in March in Copenhagen, where four-year follow-up data were presented for the EU-approved population, meaning the ApoE4 non-carriers or heterocycloids. This data show that long-term continuation of treatment is essential, and that four years treatment with Leukemia saves between 10 to 14 months of time in the mildest stage of the disease, if you compare to matched controls in two large data betas, the pre-specified ADNI cohort and the matched cohort of the Swedish BioFinder. At the conference, it was also highlighted that starting treatment as early as possible as it seems to result in even better results. Also, as usage increases across the world, more and more hospitals present real-world data from clinical practice in these congresses at ADPD, specifically from countries such as the US, Japan, China, and South Korea. And to the right, you can see, for example, the graph showing that there is also a high treatment persistence in initially 371 patients at a US clinic starting in 2023. It was 78% at 18 months, and after two years, it was 67% persistence of the treatment. So more and more data, further strengthen the cannabis efficacy and safety profile, and we are already looking forward to attending next Congress coming up, the AAIC in London in July. So next slide, and I will thereby hand over to our chief CFO, Anders Martin Lapp.

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