Leqembi revenue more than doubled - totaled JPY 6.3 billion in the second quarter 2024

Rhea-AI Summary

BioArctic AB's partner Eisai reported that Leqembi® revenue more than doubled in Q2 2024, reaching JPY 6.3 billion, a 120% increase from Q1 2024 (JPY 2.8 billion). This resulted in a royalty of approximately SEK 43 million for BioArctic. Eisai leads Leqembi's development and regulatory submissions globally, with Eisai and Biogen co-commercializing the product. BioArctic has commercialization rights in the Nordic region and is preparing for joint commercialization with Eisai pending European approval. BioArctic's Q2 2024 report will be published on August 29, 2024, at 08:00 a.m. CET.

Positive

• Leqembi revenue increased by 120% quarter-over-quarter to JPY 6.3 billion
• BioArctic received approximately SEK 43 million in royalties
• BioArctic has commercialization rights for Leqembi in the Nordic region

Negative

• None.

Insights

Financial Analyst

The substantial 120% quarter-over-quarter revenue growth for Leqembi is a significant positive indicator for BioArctic and its partners. With sales reaching JPY 6.3 billion in Q2 2024, up from JPY 2.8 billion in Q1, the drug's market penetration appears to be accelerating rapidly. This growth trajectory suggests strong market acceptance and potentially expanding patient access.

For BioArctic, this translates to a royalty of approximately SEK 43 million for the quarter. While the absolute figure may seem modest, it's important to consider the growth rate and future potential. If this growth pace continues, it could significantly impact BioArctic's financial health and valuation in the coming quarters.

The partnership structure with Eisai and Biogen is intriguing. BioArctic's right to commercialize lecanemab in the Nordic region, coupled with the pending European approval, could open up additional revenue streams. However, investors should closely monitor the progress of European regulatory approval and the subsequent commercialization efforts in the Nordic countries.

Looking ahead, key factors to watch include:

• Sustainability of this growth rate in subsequent quarters
• Expansion into new markets, particularly Europe
• Any changes in reimbursement policies that could affect patient access
• Competitive landscape in the Alzheimer's treatment market

While the news is undoubtedly positive, prudent investors should also consider potential risks such as regulatory challenges in new markets or unexpected safety concerns that could impact sales trajectory.

Medical Research Analyst

The rapid revenue growth of Leqembi (lecanemab) is a promising sign for the Alzheimer's disease treatment landscape. As an anti-amyloid beta (Aβ) protofibril antibody, Leqembi represents a new class of disease-modifying therapies for Alzheimer's. The significant quarter-over-quarter sales increase suggests growing physician confidence and patient acceptance of this novel treatment approach.

However, it's important to contextualize this growth within the broader Alzheimer's research field:

• Long-term efficacy data will be critical to sustain this growth trajectory
• Ongoing research into combination therapies or complementary approaches targeting other aspects of Alzheimer's pathology (e.g., tau proteins) could impact Leqembi's market position
• Real-world data on side effects and patient outcomes will be closely watched by the medical community

The pending European approval for Leqembi is a key milestone to monitor. European regulatory bodies often have different efficacy and safety thresholds compared to the FDA and their decision could influence global perception of the drug.

From a research perspective, Leqembi's commercial success could accelerate investment in similar approaches targeting early-stage Alzheimer's disease. This could potentially lead to a paradigm shift in Alzheimer's treatment, moving from symptom management to disease modification.

As the drug's use expands, researchers will be keen to observe its impact on long-term disease progression and quality of life measures. These real-world outcomes will be important in determining Leqembi's ultimate place in Alzheimer's treatment protocols.

STOCKHOLM, Aug. 1, 2024 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai today published the preliminary global revenue for Leqembi^® during the second quarter 2024, in conjunction with their partner Biogen's second quarter report. In total, sales of JPY 6.3 billion were recorded in the period, an increase of more than 120% compared to the previous quarter (Q1 2024: JPY 2.8 billion), resulting in a royalty to BioArctic amounting to approximately SEK 43 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 second quarter 2024 will be published on August 29 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 August 1, 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, brand name: 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, and Israel as treatment for early Alzheimer's disease (mild cognitive impairment and mild dementia due to Alzheimer's disease). (See full US prescribing information including boxed waring.)

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 12 other countries and regions, including the European Union (EU). A supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted to the U.S. Food and Drug Administration (FDA) in March 2024. The rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous injection formulation, which is being developed to enhance convenience for patients, was initiated in the U.S. under Fast Track status in May 2024. 

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 more than doubled â€" totaled JPY 6.3 billion in the second quarter 2024

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SOURCE BioArctic

FAQ

What was Leqembi's revenue in Q2 2024 for BioArctic's partner Eisai?

Leqembi's revenue for Q2 2024 was JPY 6.3 billion, more than doubling from the previous quarter.

How much did BioArctic (BIOA) receive in royalties from Leqembi sales in Q2 2024?

BioArctic received approximately SEK 43 million in royalties from Leqembi sales in Q2 2024.

When will BioArctic (BIOA) publish its Q2 2024 financial report?

BioArctic will publish its Q2 2024 financial report on August 29, 2024, at 08:00 a.m. CET.

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

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