Eisai projects Leqembi® revenue to total JPY 56.5 billion for fiscal year 2024 (April 2024 - March 2025)
BioArctic's partner, Eisai, projects Leqembi® sales to reach JPY 56.5 billion (approx. SEK 4 billion) for FY 2024 (April 2024 - March 2025), generating SEK 360 million in net royalties for BioArctic. For FY 2023, Leqembi sales were JPY 4.3 billion, resulting in SEK 28.2 million in royalties. BioArctic holds commercialization rights for lecanemab in the Nordic region, pending European approval. The first-quarter report for 2024 will be released on May 17, 2024. The disclosed information complies with the EU Market Abuse Regulation.
- Eisai projects Leqembi sales to reach JPY 56.5 billion for FY 2024.
- BioArctic is expected to receive approximately SEK 360 million in net royalties from Leqembi sales for FY 2024.
- Significant increase in projected royalties for FY 2024 compared to SEK 28.2 million in FY 2023.
- BioArctic holds commercialization rights for lecanemab in the Nordic region pending European approval.
- Eisai and BioArctic are preparing for joint commercialization in the Nordic region.
- Leqembi sales for FY 2023 were only JPY 4.3 billion, significantly lower than the projected sales for FY 2024.
- BioArctic's royalty revenue for FY 2023 was to SEK 28.2 million.
- Commercialization in the Nordic region is still pending European approval, adding regulatory uncertainty.
Insights
Eisai's projected revenue for Leqembi® of JPY 56.5 billion for FY2024 represents a significant increase from the JPY 4.3 billion in FY2023. This dramatic rise in revenue reflects strong market adoption and potential growth in the neurological treatment sector. For BioArctic, the projected net royalty of approximately SEK 360 million is notable when compared to the SEK 28.2 million earned in FY2023. This suggests a substantial positive impact on BioArctic's financials, providing a strong revenue stream that could fuel further R&D and operational activities.
From a financial perspective, such a boost is likely to attract investor interest, potentially driving up BioArctic's stock price. However, this is highly dependent on the realization of these projections and any unforeseen market or regulatory changes.
Short-term, investors might see a positive response in stock prices due to the optimistic projection. Long-term, sustained revenue growth will depend on Leqembi's market acceptance, competition and clinical efficacy.
The anticipated growth in Leqembi sales indicates a strong market demand for neurological treatments, particularly in Alzheimer's. This suggests that Eisai's marketing strategies and product positioning are resonating well with the target market. Moreover, BioArctic's role in the Nordic commercialization, pending European approval, could open new revenue streams and expand market reach.
The collaboration between Eisai and Biogen in co-commercializing Leqembi allows for a robust market entry strategy. Investors should note the potential for increased market share in the competitive neurology space.
Market dynamics around Leqembi will also be influenced by regulatory approvals, reimbursement policies and the competitive landscape, factors that are important for sustaining long-term growth and market positioning.
Leqembi's projected revenue surge highlights its clinical acceptance and efficacy in treating Alzheimer's disease. This increase suggests that the drug is meeting a critical medical need, potentially offering significant clinical benefits to patients.
The regulatory landscape, particularly the pending European approval, will be essential in determining the drug's future market success. Any delays or challenges in this approval process could affect revenue projections and market confidence.
For investors, it’s important to monitor ongoing clinical trial results and post-market surveillance data, which will provide further insights into Leqembi's long-term viability and safety profile in a real-world setting.
Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and Eisai and BioArctic are currently preparing for a joint commercialization in the region.
BioArctic's report for the first quarter 2024 will be published on May 17 at 08.00 a.m. CET.
This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons below, on May 15, 2024, at 05.45 a.m. CET.
For further information, please contact:
Oskar Bosson, VP Communications and IR
E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80
Jiang Millington, Director Corporate Communication and Social Media
E-mail: jiang.millington@bioarctic.se
Phone: +46 79 33 99 166
About lecanemab (generic name,
Lecanemab (Leqembi) is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab is approved in the
U.S. : For the treatment of Alzheimer's disease (AD). It should be initiated in patients with mild cognitive impairment or mild dementia stage of disease. See full US prescribing information.Japan : For slowing progression of mild cognitive impairment (MCI) and mild dementia due to AD.China : For the treatment of MCI due to AD and mild AD dementia.
Lecanemab approvals were based on the large global Phase 3 Clarity AD study. In the Clarity AD study, lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.
Eisai has also submitted applications for approval of lecanemab in 14 countries and regions, including the European Union (EU).
Eisai has completed a lecanemab subcutaneous bioavailability study, and subcutaneous dosing is currently being evaluated in the Clarity AD (Study 301) open-label extension (OLE) study. A maintenance dosing regimen has been evaluated as part of the Phase 2b study (Study 201).
Since July 2020 Eisai's Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the
About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.se.
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SOURCE BioArctic
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