Leqembi® revenue totaled JPY 10 billion in the third quarter 2024

Rhea-AI Summary

BioArctic AB's partner Eisai reported Leqembi® global revenue of JPY 10 billion for Q3 2024, marking a 60% increase from Q2 2024's JPY 6.3 billion. This resulted in a royalty payment of approximately SEK 70 million to BioArctic. Eisai leads Leqembi's development and regulatory submissions globally, with Biogen co-commercializing the product. BioArctic maintains commercialization rights in the Nordic region and is preparing for joint commercialization with Eisai pending European approval.

Positive

• Leqembi revenue increased 60% quarter-over-quarter to JPY 10 billion
• BioArctic received approximately SEK 70 million in royalties
• Potential market expansion with pending European approval

Negative

• None.

Insights

Financial Analyst

The JPY 10 billion ($67 million) Leqembi revenue represents significant quarter-over-quarter growth of 60%, indicating strong market penetration for this Alzheimer's treatment. BioArctic's royalty of SEK 70 million ($6.3 million) demonstrates meaningful revenue contribution from their partnership with Eisai. The sequential growth trajectory suggests positive market acceptance and improving reimbursement landscape. The pending European approval and Nordic commercialization rights could unlock additional revenue streams for BioArctic, though market dynamics may differ from the US. The revenue ramp-up appears to be gaining momentum, which is important for BioArctic given their relatively modest market cap of $900 million. The royalty structure provides a steady income stream while limiting operational costs and risks typically associated with direct commercialization.

STOCKHOLM, Oct. 30, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today published the preliminary global revenue for Leqembi during the third quarter 2024, in conjunction with their partner Biogen's quarterly report. In total, sales of JPY 10 billion were recorded in the quarter, an increase of approximately 60% compared to the previous quarter (Q2 2024: JPY 6.3 billion), resulting in a royalty to BioArctic amounting to approximately SEK 70 million.

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 and pending European approval Eisai and BioArctic are preparing for a joint commercialization in the region.

BioArctic's report for the third quarter 2024 will be published on November 14 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 person below, on October 30, 2024, at 11.45 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

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, South Korea, Hong Kong, Israel, UAE and Great Britain for the treatment of MCI due to AD and mild AD dementia. Lecanemab's approvals in these countries 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. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

Lecanemab marketed in the U.S., Japan and China. Eisai has also submitted applications for approval of lecanemab in 10 countries and regions, including the European Union.

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 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® revenue totaled JPY 10 billion in the third quarter 2024

 

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SOURCE BioArctic

FAQ

What was Leqembi's revenue in Q3 2024 for BioArctic (BIOA)?

Leqembi generated JPY 10 billion in global revenue during Q3 2024, resulting in approximately SEK 70 million in royalties for BioArctic.

How much did Leqembi sales grow in Q3 2024 compared to Q2 2024?

Leqembi sales increased by 60% from JPY 6.3 billion in Q2 2024 to JPY 10 billion in Q3 2024.

What are BioArctic's (BIOA) commercial rights for Leqembi?

BioArctic has commercialization rights for Leqembi in the Nordic region and is preparing for joint commercialization with Eisai pending European approval.