One of the developers behind the Alzheimer’s disease drug Leqembi has set new revenue expectations that some analysts see as more practical than previous guidance.
On Wednesday, Japan-based Eisai predicted revenue from the drug would hit 56.5 billion yen, or roughly $361 million, during the company’s 2024 fiscal year, which runs through the end of next March. To meet that mark, sales would have to increase significantly, as they totaled around $19 million over the first three months of this year.
Yet, according to Jefferies analyst Michael Yee, there are reasons to believe in Eisai’s forecast. For example, third-party sales data indicates Leqembi is on pace to generate about $30 million this quarter. If that momentum continues or accelerates, sales could meet or beat Wall Street’s consensus forecast for this year, which currently stands at $218 million.
Yee also noted how, on a Wednesday call with investors, Eisai executives appeared confident they’ll meet their revenue estimate, given Leqembi’s performance this year and recent week-over-week sales growth. The forecast “seems in-line with the consensus numbers we’ve been tracking and looks more realistic and achievable than previous soft guidance or long-term projections,” Yee wrote in a note to clients.
Leqembi received full approval in the U.S. last July, marking a major milestone in Alzheimer’s treatment. Eisai and its development partner, Biogen, expected the approval would lead to far greater sales and use of their therapy. So far, though, Leqembi’s launch has been more challenging than either company anticipated.
Eisai had previously hoped 10,000 U.S. patients would be on Leqembi before the end of March. But that goal proved lofty. By the final week in January, just 2,000 patients were taking the drug, with another 8,000 or so on a waiting list.
“This was always going to be a gradual launch,” Chris Viehbacher, Biogen’s CEO, said in November. “Obviously, sales will be expected to ramp at some point. But it has always been a difficult product to forecast because there’s just no real good analogs here.”
More recently, Biogen and Eisai have signaled that the storm clouds may be parting. Biogen said the estimated number of patients on Leqembi more than doubled between the final three months of last year and the first three months of this year. Order volume also tripled at 100 “integrated delivery networks” that the company deems high priority because they treat so many patients.
“I’m extremely encouraged by the progress that has occurred,” Viehbacher said during the company’s last earnings call.
With that progress in mind, Biogen has said it plans to increase the number of salespeople selling Leqembi by 30%.
Biogen and Eisai hope a more convenient version of Leqembi that they’ve been developing will further aid sales and uptake. The companies said Wednesday they’ve begun submitting an approval application to the Food and Drug Administration for an injectable form of the therapy, which is currently given as an intravenous infusion.
Eisai estimates this “rolling submission” could be complete by October. If the FDA agrees to grant the application priority review — a type of regulatory fast pass given to medicines that can offer “significant improvements” in the treatment of serious conditions — an approval decision could come in mid-2025.
Notably, the application covers the use of injectable Leqembi as a “weekly maintenance dose” for patients who have already completed an initiation phase with the intravenous version. Yee wrote that such an approval would be “nice to have,” but, at least for investors, the “real focus” is getting injectable Leqembi approved as an induction therapy.
That would “ramp sales growth given the convenience factor and reduce healthcare burden,” according to Yee.
