Leqembi’s sales in the U.S. continue to underwhelm, overshadowed by its growth in international markets.
Eisai’s Biogen-partnered Alzheimer’s therapy Leqembi is “on track” to meet a fiscal year 2024 revenue goal of ¥42.5 billion ($279 million)—despite U.S. sales continuing to drag.
In the third quarter of Eisai’s 2024 fiscal year—which ran from October to December 2024—Leqembi made around ¥13.3 billion ($87.4 million), according to a Friday earnings announcement. U.S. revenue came to ¥7.7 billion ($51 million), representing approximately 30% quarter-on-quarter growth.
Analysts at Jefferies called Leqembi’s U.S. performance “steady” and “expected,” pointing to overseas sales as the main driver of Eisai’s growth in a Friday investor note. In Japan, the anti-amyloid antibody surged nearly 50% to bring in ¥4.1 billion ($27 million), while in the Chinese and other international markets, Leqembi sales jumped 33% to ¥1.5 billion ($9.9 million).
Leqembi “continues to be strong” overseas, according to the Jefferies analysts, adding that international sales also drove the asset’s beat last quarter.
Still, things seem to be looking up for Leqembi in the U.S. According to Eisai’s quarterly business report on Friday, there are currently around 13,500 patients on Leqembi, which falls “meaningfully ahead” of Jefferies’ expectations. Approximately 3,000 physicians are now prescribing the drug, while 1,200 medical institutions are purchasing it, which respectively represent 20% and 12% quarter-on-quarter growth.
Eisai also revealed that amyloid-beta PET testing has spiked 45% compared to the company’s second fiscal quarter, while its capacity to accommodate patients potentially eligible for treatment has expanded. The company also expects Leqembi uptake to “further accelerate” with the FDA’s recent approval of its once-monthly maintenance regimen.
All these factors, according to Eisai, contribute to Leqembi’s “steady progress” towards hitting its fiscal year 2024 worldwide revenue target of ¥42.5 billion ($279 million).
Eisai is also working on a subcutaneous formulation of Leqembi, which could “help reduce the burden on healthcare professionals and patients” by allowing at home administrations and by minimizing the number of visits needed.
The FDA last month accepted the application for subcutaneous Leqembi for maintenance dosing, with a target action date of August 31, 2025. Eisai plans to file its subcutaneous application for induction dosing after the verdict, aiming for an approval later this year or early next year, according to the company presentation.
Despite being the first anti-amyloid antibody for Alzheimer’s that won the FDA’s full approval, Leqembi’s uptake has been underwhelming. In November 2024, for instance, Eisai lowered its full-year sales forecast for the drug, citing a slow rollout in the U.S. Some have also raised doubts about Leqembi’s efficacy and safety, with the EU’s Committee for Medicinal Products for Human Use in July 2024 issuing a negative opinion for the treatment, noting that its benefits do not “counterbalance the risk of serious side events.”
Eli Lilly, which was the second company to get an anti-amyloid antibody approved for Alzheimer’s, has also reported slow uptake. The company’s Kisunla brought in $8 million in the fourth quarter, Lilly reported on Thursday. Anne White, president of Lilly Neuroscience, said on an earnings call that Kisunla has 800 prescribers so far.
“The true challenge here is health healthcare systems’ readiness,” White said, who added that Lilly learned lessons from “the first launch that went out there,” Leqembi.
