Eisai Revises Leqembi Sales Outlook for FY 2024

Eisai Co., Ltd., a leading global pharmaceutical company, has recently updated its revenue outlook for Leqembi, its innovative treatment for early Alzheimer's disease. In a recent announcement, Eisai revised its sales forecast for the fiscal year 2024 (April 2024 - March 2025) to JPY 42.5 billion, down from the previously announced JPY 56.5 billion. This article explores the factors contributing to the revision and the potential implications for Eisai and its partners.

Market dynamics and competition have played a significant role in the revision of Leqembi's sales outlook. Eisai's initial forecast was ambitious, given the competitive landscape in Alzheimer's disease treatments. With rivals like Biogen's Aduhelm facing pricing challenges and safety concerns, Eisai may have adjusted expectations to better align with market realities. Additionally, the ongoing Phase 3 clinical study (AHEAD 3-45) for preclinical AD and the Tau NexGen clinical study for Dominantly Inherited AD (DIAD) may have influenced the outlook, as Eisai awaits further data to validate Leqembi's long-term potential.

Regulatory changes and approval processes have also impacted Leqembi's sales projections for fiscal year 2024. Eisai initially projected sales of JPY 56.5 billion but revised it down to JPY 42.5 billion in November 2024. This revision may be attributed to the ongoing Phase 3 clinical study (AHEAD 3-45) for preclinical AD, which started in July 2020, and the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), initiated in January 2022. These studies, conducted as public-private partnerships, may have delayed the regulatory approval process, affecting sales projections. Additionally, Eisai's submission of a supplemental Biologics License Application (sBLA) for intravenous (IV) maintenance dosing in March 2024, with a PDUFA action date set for January 25, 2025, might have contributed to the revised sales outlook.



Pricing strategies and reimbursement policies significantly impact Leqembi's sales outlook. Eisai's updated sales forecast of JPY 42.5 billion for FY2024 reflects market dynamics influenced by these factors. Leqembi's approval in multiple countries, including the U.S., Japan, and China, exposes it to diverse pricing and reimbursement landscapes. In the U.S., Medicare Part B reimbursement rates, which are tied to Average Sales Price (ASP), affect Leqembi's affordability and uptake. Lower ASPs can lead to reduced reimbursement, potentially impacting sales. In Japan, Eisai has implemented a tiered pricing strategy, offering discounts to hospitals based on the volume of Leqembi administered, which may boost sales. Meanwhile, China's reimbursement policies, such as the National Reimbursement Drug List (NRDL), can influence Leqembi's market penetration. Eisai's strategic pricing and reimbursement negotiations are crucial for maximizing Leqembi's sales potential.



Clinical trial results, particularly from Eisai's global Clarity AD trial, played a significant role in the revision of Leqembi's sales projections. The trial demonstrated that Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results, leading to its approval in several countries. Real-world evidence from post-approval use has also contributed to the positive outlook, as Leqembi has shown promising results in treating mild cognitive impairment (MCI) due to AD and mild AD dementia.

In conclusion, Eisai's revision of Leqembi's sales outlook reflects market dynamics, competition, regulatory changes, and pricing strategies. Despite the downward revision, the updated forecast of JPY 42.5 billion for FY2024 still represents a significant opportunity for Eisai and its partners. As Leqembi continues to demonstrate its potential in treating early Alzheimer's disease, investors should monitor its progress and consider the strategic adjustments Eisai may make to optimize its commercialization and market penetration.