Leqembi® revenue totaled JPY 2.83 billion in the first quarter 2024
- Eisai reported JPY 2.83 billion in global revenue for Leqembi in Q1 2024.
- BioArctic received a royalty of about SEK 18 million from the sales.
- Eisai and Biogen co-commercialize Leqembi, with Eisai leading development and regulatory submissions globally.
- BioArctic holds commercialization rights for the Nordic region, pending European approval.
- BioArctic and Eisai are preparing for joint commercialization in the region.
- BioArctic's Q1 2024 report will be published on May 17, 2024.
- None.
Leqembi's sales figures, amounting to JPY 2.83 billion in Q1 2024, provide a direct window into the drug's market uptake and the financial health of the partnership between BioArctic, Eisai and Biogen. Royalty revenues for BioArctic of approximately SEK 18 million may seem modest, but they could indicate the beginning of a revenue stream that warrants attention. The drug's future potential largely hinges on regulatory approvals and the expansion of its commercial footprint.
An important aspect to consider is the commercial agreement structure, where Eisai has the lead on development and global submissions, sharing the commercialization with Biogen. This dynamic can impact the revenue distribution and strategic decision-making in the drug's lifecycle. BioArctic's position, with rights to commercialize in the Nordic region pending approval, places it in a potentially advantageous position to capitalize on local market knowledge.
From a financial perspective, the reported revenues are a key indicator of Leqembi's market performance. Investors should observe the percentage of total revenue that the royalty payments constitute for BioArctic. This will elucidate the drug's relative importance to the company's overall business. Another critical factor is the drug's reimbursement status and pricing strategy, as these will greatly affect its long-term commercial success and, by extension, the royalty stream to BioArctic.
Finally, the timing of the European approval is pivotal. Delays could significantly affect BioArctic's revenue projections, while timely approval could open up new streams of income as the company prepares for joint commercialization in the Nordic markets. The drug's performance in this new territory, often seen as a gateway to broader European markets, could serve as an indicator of its potential wider success.
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 currently Eisai and BioArctic are 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 April 24, 2024, at 12.45 p.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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