Core Insights - BioArctic reported a transformative year with record financial results, including an operating profit exceeding SEK 1.2 billion and a doubling of cash position [1][2] - The company proposed a dividend of SEK 2.00 per share for the financial year 2025, reflecting its strong financial position [2] Financial Summary - Cash and cash equivalents and short-term investments at the end of the period amounted to SEK 2,190.4 million, up from SEK 778.9 million [1] - Cash flow from operating activities was SEK 313.3 million, compared to a negative SEK 27.4 million in the previous year [1] - Earnings per share before and after dilution were SEK -0.10, improving from SEK -0.36 [1] - Profit for the period was SEK -8.8 million, an improvement from SEK -31.5 million [1] - Operating profit was SEK 33.2 million, compared to SEK -53.5 million in the previous year [1] - Net revenues reached SEK 184.0 million, up from SEK 101.2 million, with SEK 127.0 million in royalties from Leqembi [1] Product Development and Regulatory Updates - Leqembi was approved in over 50 markets, with sales growing each quarter; royalty revenues increased by 31% year-on-year despite currency impacts [1] - The subcutaneous version of Leqembi, Leqembi Iqlik, was launched for maintenance treatment in the US, allowing for home administration [1] - Regulatory reviews for Leqembi Iqlik are ongoing in the US, China, and Japan, with priority reviews granted by the FDA and EMA [1] - The company is working to broaden the availability of Leqembi in Nordic countries and is addressing regulatory challenges in Europe [1] Research and Development Initiatives - BioArctic has strengthened its project portfolio with new initiatives in Huntington's disease and Parkinson's disease, alongside advancing existing projects [1] - Candidate drugs for two projects are being prepared for clinical studies, including one in ALS and another in Parkinson-related disorders [1] - The company is investing in its BrainTransporter technology to enhance the delivery of treatments across the blood-brain barrier [1] - Strong interest in BioArctic's technology and projects has been noted, with opportunities for new strategic partnerships anticipated [1]

Core Viewpoint - BioArctic AB will release its fourth quarter report for October - December 2025 on February 18, 2026, at 08:00 a.m. CET, followed by a presentation for investors, analysts, and media at 09:30 a.m. CET [1][2]. Company Information - BioArctic AB is a Swedish biopharma company focused on innovative treatments for neurodegenerative diseases, including Alzheimer's disease [2]. - The company developed Leqembi® (lecanemab), the first drug proven to slow the progression of early Alzheimer's disease and reduce cognitive impairment [2]. - BioArctic has a diverse research portfolio, including antibodies targeting Parkinson's disease and ALS, as well as additional Alzheimer's projects [2]. - The company utilizes its proprietary BrainTransporter™ technology to enhance treatment efficacy by transporting antibodies across the blood-brain barrier [2]. Event Details - The presentation on the fourth quarter report will include comments from CEO Gunilla Osswald and CFO Anders Martin-Löf, followed by a Q&A session [1]. - Participants can join via webcast or teleconference, with options to submit questions during the event [1][2].

Core Viewpoint - BioArctic AB's partner Eisai has received Priority Review from the U.S. FDA for the supplemental Biologics License Application (sBLA) for Leqembi Iqlik, a subcutaneous autoinjector for Alzheimer's disease treatment, with a PDUFA action date set for May 24, 2026 [1] Group 1: Product Details - Leqembi Iqlik is indicated for treating Alzheimer's disease in patients with Mild Cognitive Impairment (MCI) or mild dementia, representing early Alzheimer's disease [1] - If approved, Leqembi Iqlik would be the first anti-amyloid treatment allowing at-home injections for both initiation and maintenance dosing [1] - The sBLA is supported by data showing that the 500 mg subcutaneous dosing regimen achieves equivalent exposure to the current bi-weekly intravenous dosing, with similar clinical benefits [3] Group 2: Administration and Benefits - The autoinjector allows for a once-weekly starting dose, providing an alternative to the current bi-weekly intravenous administration [2] - Each injection takes approximately 15 seconds, potentially reducing healthcare resource utilization associated with intravenous dosing [2] - The safety profile of subcutaneous administration is comparable to intravenous administration, with less than 2% incidence of systemic injection or infusion-related reactions [3] Group 3: Clinical and Regulatory Context - Lecanemab, the active ingredient in Leqembi, is a humanized monoclonal antibody targeting both protofibrils and amyloid plaques, which are key factors in Alzheimer's disease [4][6] - Lecanemab is already approved in 53 countries and is under regulatory review in 7 additional countries, with various dosing regimens established [7] - Ongoing clinical studies, such as the AHEAD 3-45 study, are exploring the efficacy of lecanemab in preclinical Alzheimer's disease [9] Group 4: Collaboration and Company Background - BioArctic has a long-term collaboration with Eisai for the development and commercialization of Alzheimer's disease treatments, including lecanemab [10] - BioArctic retains rights to commercialize lecanemab in the Nordic region and has no development costs associated with it, receiving milestone payments and royalties on global sales [10] - BioArctic focuses on innovative treatments for neurodegenerative diseases and has a broad research portfolio, including projects targeting Parkinson's disease and ALS [11]

Core Viewpoint - BioArctic AB's partner Eisai announced that Leqembi® (lecanemab) has been included in China's "Commercial Insurance Innovative Drug List," enhancing access to early Alzheimer's Disease treatment in China [1][2]. Group 1: Drug Inclusion and Impact - The inclusion of Leqembi in the Commercial Insurance Innovative Drug List is a significant step towards improving access to innovative medicines for Alzheimer's Disease in China [2]. - The list aims to bridge the coverage gap between the National Reimbursement Drug List and innovative medicines addressing significant unmet needs [2]. Group 2: Market Context and Patient Demographics - Eisai estimates that there were 17 million patients with mild cognitive impairment or mild dementia due to Alzheimer's disease in China in 2024, a number expected to rise with the aging population [3]. - Leqembi was launched in China in June 2024 and has been delivered in the private market [3]. Group 3: Collaboration and Development - Leqembi is a product of a long-term collaboration between BioArctic and Eisai, with BioArctic originally developing the antibody based on Professor Lars Lannfelt's discovery [4]. - Eisai is responsible for the clinical development, market approval applications, and commercialization of Leqembi, while BioArctic retains commercialization rights in the Nordic region [4][9]. Group 4: Regulatory Status and Clinical Trials - Lecanemab is approved in 51 countries and is under regulatory review in 9 countries, with various dosing regimens approved in multiple regions [7]. - Ongoing clinical studies, such as the AHEAD 3-45 study, are exploring lecanemab's efficacy in preclinical Alzheimer's disease [8]. Group 5: Company Overview - BioArctic AB is a Swedish biopharma company focused on innovative treatments for neurodegenerative diseases, including Alzheimer's disease [10]. - The company has a broad research portfolio, including projects against Parkinson's disease and ALS, utilizing proprietary technology to enhance treatment efficacy [10].

Core Insights - BioArctic AB's partner Eisai will present new findings on lecanemab (Leqembi®) at the Clinical Trials on Alzheimer's Disease (CTAD) conference, focusing on long-term treatment benefits, safety, and subcutaneous administration [1][5][9] Presentation Highlights - Key presentations will include data on long-term treatment effects and estimated time savings over 10 years, as well as safety and benefits of subcutaneous dosing for initiation [1][5] - Real-world clinical practice insights will be shared, including findings from the US ALZ-NET registry [1][5] Poster Presentations - A poster session will cover various studies, including baseline characteristics and safety findings from the ALZ-NET registry [3] - Additional topics include enrollment patterns in preclinical trials, stability and improvement in early Alzheimer's disease, and patient acceptability of the autoinjector for subcutaneous delivery [4] Continued Treatment Analysis - New analyses will be presented on the benefits of continued lecanemab therapy and estimated time savings based on Phase 3 clinical data [5][7] - A late-breaking symposium will discuss the potential benefits of subcutaneous initiation dosing and related pharmacokinetic findings [5] Mechanism and Clinical Outcomes - Presentations will review the effects of lecanemab on soluble amyloid-beta protofibrils and clinical outcomes from subcutaneous administration [6][7] - A societal cost comparison between subcutaneous and intravenous lecanemab will also be discussed [7] Collaboration and Development - Lecanemab is a result of a long-term collaboration between BioArctic and Eisai, with BioArctic holding commercialization rights in the Nordic region [7][11] - The drug is approved in 51 countries and under review in 9, with a focus on subcutaneous dosing in the U.S. [9][11]

Core Viewpoint - BioArctic AB's partner Eisai has received approval for Leqembi (lecanemab) for once every four weeks intravenous maintenance dosing for early Alzheimer's disease in the UK [1][15]. Group 1: Approval and Treatment Regimen - Leqembi was previously approved in August 2024 for treating mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease in specific patient groups in the UK [2]. - The new maintenance dosing allows patients to transition from an 18-month regimen of 10 mg/kg every two weeks to either 10 mg/kg every four weeks or continue with the bi-weekly regimen [2]. Group 2: Market Context and Demographics - Approximately 982,000 individuals in the UK are living with dementia, with Alzheimer's disease accounting for 60-70% of these cases, a number expected to rise with an aging population [3]. Group 3: Collaboration and Development - Leqembi is a product of a long-term collaboration between BioArctic and Eisai, with BioArctic having rights to commercialize the drug in the Nordic region [4][10]. - Eisai is responsible for clinical development, market approval applications, and commercialization globally, while BioArctic incurs no development costs for lecanemab [10]. Group 4: Regulatory Approvals and Clinical Trials - Lecanemab has been approved in 51 countries, including the US, Japan, China, and the EU, for early Alzheimer's disease treatment, with ongoing regulatory reviews in nine additional countries [6]. - The approvals were based on Phase 3 data from the Clarity AD clinical trial, which met its primary and key secondary endpoints with statistically significant results [7]. Group 5: Ongoing Research and Future Studies - Eisai's ongoing Phase 3 clinical study (AHEAD 3-45) involves individuals with preclinical Alzheimer's disease and is fully recruited as of October 2024 [8]. - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) is also ongoing and includes lecanemab as a key therapy [8].

Core Insights - Health Canada has granted a Notice of Compliance with Conditions for Leqembi® (lecanemab), marking it as the first treatment for early Alzheimer's disease authorized in Canada targeting the underlying cause of the disease [1][18] - Leqembi has shown significant efficacy in reducing disease progression and cognitive decline in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease [2][7] Company Overview - BioArctic AB and Eisai have a long-standing collaboration since 2005, focusing on the development and commercialization of Alzheimer's disease treatments, with Eisai responsible for clinical development and market applications [5][11] - BioArctic retains commercialization rights for Leqembi in the Nordic region and is preparing for joint commercialization with Eisai [5][11] Clinical Data - The approval of Leqembi is based on the Phase 3 Clarity AD study, which demonstrated statistically significant results in meeting primary and secondary endpoints [3][7] - The Clarity AD study involved 1,795 patients with early Alzheimer's disease, confirming the presence of amyloid pathology, and utilized a bi-weekly dosing regimen of 10 mg/kg for 18 months [7][8] Market Context - Alzheimer's disease accounts for 60 to 80% of all dementia cases, with over 771,000 dementia patients in Canada as of January 1, 2025, projected to rise to approximately 1 million by 2030 [4] - The annual care provided by family and friends for dementia patients is equivalent to 290,000 full-time jobs, expected to increase to 690,000 by 2050 [4] Product Information - Leqembi selectively binds to both soluble and insoluble amyloid-beta aggregates, reducing their presence in the brain, which is crucial for slowing cognitive decline [2][16] - The drug is approved in 51 countries, including the U.S., Japan, and the EU, and is under review in 9 additional countries [2][8]

Core Insights - BioArctic AB's partner Eisai has initiated a rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. FDA for Leqembi Iqlik (lecanemab-irmb) as a subcutaneous autoinjector, following the FDA granting Fast Track Status [1][15] - Leqembi Iqlik, if approved, would be the first anti-amyloid treatment allowing at-home injection from the start, enhancing treatment accessibility for Alzheimer's disease patients [1][2] Company Overview - BioArctic AB is a Swedish biopharma company focused on innovative treatments for neurodegenerative diseases, having developed Leqembi, the first drug proven to slow Alzheimer's disease progression [11] - The collaboration between BioArctic and Eisai dates back to 2005, with Eisai responsible for clinical development and commercialization, while BioArctic retains rights for commercialization in the Nordic region [4][10] Product Details - Leqembi is indicated for treating Alzheimer's disease in patients with Mild Cognitive Impairment (MCI) or mild dementia, and is currently approved in 48 countries, with regulatory reviews ongoing in 10 countries [2][7] - The sBLA submission is based on Phase 3 clinical studies evaluating subcutaneous administration of lecanemab, which could offer a weekly starting dose as an alternative to bi-weekly intravenous dosing [2][3] Clinical Development - Eisai's ongoing Phase 3 clinical study (AHEAD 3-45) involves individuals with preclinical Alzheimer's disease and aims to assess the efficacy of lecanemab [9] - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) is also ongoing, incorporating lecanemab as a key anti-amyloid therapy [9] Treatment Mechanism - Leqembi targets both amyloid plaque and protofibrils, which are believed to contribute to cognitive decline in Alzheimer's disease [3][14] - The subcutaneous formulation of Leqembi has the potential to reduce healthcare resource utilization associated with intravenous dosing, streamlining the treatment pathway for Alzheimer's disease [2]

Core Insights - BioArctic AB's partner Eisai presented significant findings on lecanemab (Leqembi®) at the Alzheimer's Association International Conference, highlighting its clinical efficacy and safety profile over four years of treatment [1] Group 1: Clinical Efficacy - Four years of lecanemab treatment helped patients remain in the early stage of Alzheimer's disease longer compared to the natural disease course, with a 27% slowing of clinical decline as measured by the CDR-SB scale [2] - Among patients who completed the core study, 95% chose to continue in the open-label extension study, demonstrating a 1.01-point less decline over three years and a 1.75-point less decline after four years compared to expected decline in other cohorts [3] - In a tau PET sub-study, 69% of participants with low tau levels showed improvement or no decline after four years of treatment, indicating sustained long-term benefits [4] Group 2: Safety Profile - No new safety findings were observed in the open-label extension study, with rates of amyloid-related imaging abnormalities (ARIA) decreasing after the first 12 months and remaining consistent throughout four years [5] - Interim real-world data indicated that 84% of patients on lecanemab either remained stable or clinically improved, with a safety profile consistent with phase 3 data [6] Group 3: Treatment Administration - Subcutaneous dosing of lecanemab is being explored as a new treatment option, with a weekly maintenance dose of 360 mg showing comparable clinical and biomarker benefits to intravenous administration [9][10] - The safety profile of the 360 mg weekly subcutaneous maintenance dose was consistent with intravenous therapy, with systemic injection reactions occurring in less than 1% of patients [11] - Subcutaneous dosing allows for easier home administration, potentially reducing the need for infusion center visits and enhancing patient compliance [12] Group 4: Commercialization and Collaboration - Eisai leads the global development and regulatory submissions for Leqembi, with BioArctic holding rights for commercialization in the Nordic region [13][17] - BioArctic has no development costs for lecanemab and is entitled to payments related to regulatory approvals and sales milestones [17] - The collaboration between BioArctic and Eisai has been ongoing since 2005, focusing on the development and commercialization of Alzheimer's disease treatments [16]