Leqembi® sales reaches €200 million - first sales milestone achieved

Rhea-AI Summary

BioArctic AB (Nasdaq Stockholm: BIOA B) announced that its partner Eisai has achieved the first sales milestone for Leqembi®, reaching €200 million in sales during Eisai's fiscal year 2024 (April 2024 - March 2025). This achievement triggers a €10 million milestone payment to BioArctic.

Leqembi, an antibody developed through collaboration between BioArctic and Eisai, originated from Professor Lars Lannfelt's research on the Arctic mutation in Alzheimer's disease. While Eisai manages clinical development, market approval applications, and global commercialization, BioArctic retains rights to commercialize Leqembi in the Nordic region jointly with Eisai, with preparations for regional commercialization currently underway.

Positive

• Achieved €200 million sales milestone for Leqembi
• Earned €10 million milestone payment
• Secured rights for Nordic region commercialization

Negative

• None.

Insights

Pharmaceutical Industry Analyst

The achievement of Leqembi's first sales milestone of €200 million represents a important inflection point for BioArctic, triggering a €10 million payment that strengthens their financial position. This milestone validates the commercial viability of Leqembi in the competitive Alzheimer's market and demonstrates strong market adoption.

The milestone payment structure is particularly significant for BioArctic's business model. These payments provide important non-dilutive capital that can fund ongoing research and development while reducing dependency on equity financing. The €10 million payment represents approximately 5% of the reported sales figure, suggesting a well-structured deal that allows BioArctic to benefit from Eisai's commercial success.

The joint commercialization rights in the Nordic region present a strategic opportunity for BioArctic to establish a commercial presence in their home market. This regional focus could provide additional revenue streams beyond milestone payments and serves as a potential blueprint for future commercial partnerships.

The timing of this milestone, achieved within Eisai's fiscal year 2024, indicates strong market uptake and successful positioning of Leqembi. This performance suggests potential for accelerated growth as market penetration increases and awareness grows among healthcare providers. The achievement of this first sales milestone could also accelerate the timeline for reaching subsequent milestones, providing additional catalysts for BioArctic's value creation.

STOCKHOLM, Feb. 18, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai has notified BioArctic that the first sales milestone according to the licensing agreement has been reached. The milestone was reached as sales of Leqembi reached €200 million in Eisai fiscal year 2024 (April 2024 - Match 2025). The event entitles BioArctic to a €10 million payment. 

Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and currently, the two companies are preparing for a joint commercialization in the region.  

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 person below, on February 18, 2025, at 08:00 CET.  

For further information, please contact:  
Oskar Bosson, VP Communications and IR 
E-mail:  oskar.bosson@bioarctic.se  
Phone: +46 70 410 71 80  

About lecanemab (Leqembi®) 
Lecanemab 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., Japan, China, Great Britain, and several other markets for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia. Lecanemab's approvals in these countries, as well as the CHMP's positive opinion in November 2024, were primarily based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. Eisai has also submitted applications for regulatory approval of lecanemab in several other countries and regions.

A supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing was approved by the U.S. Food and Drug Administration (FDA) in January 2025. In January 2025, the rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous auto injection formulation, which is being developed to enhance convenience for patients, was accepted in the U.S., with PDUFA date August 31, 2025. 

Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study 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 U.S, funded by the National Institute on Aging, part of the National Institutes of Health and Eisai. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. 

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 innovative 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.com. 

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Leqembi® sales reaches €200 million â€" first sales milestone achieved

 

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SOURCE BioArctic

FAQ

What sales milestone did Leqembi reach in February 2025 for BIOA?

Leqembi reached €200 million in sales during Eisai's fiscal year 2024 (April 2024 - March 2025).

How much is the milestone payment to BioArctic (BIOA) for Leqembi's sales achievement?

BioArctic will receive a €10 million milestone payment for reaching the sales target.

What are BioArctic's (BIOA) commercial rights for Leqembi in the Nordic region?

BioArctic has the right to commercialize Leqembi in the Nordic region jointly with Eisai, and both companies are preparing for joint commercialization in the region.

Who is responsible for Leqembi's global commercialization for BIOA?

Eisai is responsible for the clinical development, market approval applications, and global commercialization of Leqembi for Alzheimer's disease.