Despite a somewhat ambling launch, Biogen’s Eisai-partnered Alzheimer’s disease drug Leqembi continues to grow. But to truly unlock the amyloid-busting antibody’s potential, the company will need to keep pushing for simpler delivery formats and work to dismantle barriers related to testing and more, Biogen executives said on an analyst call Wednesday.
On the “anniversary” of Leqembi’s broader launch last fall, Biogen CEO Chris Viehbacher said the company has already learned a great deal about what it will take for Leqembi to succeed, as well as where Biogen and Eisai need to improve.
Chief among those plans are Biogen and Eisai’s efforts to win approvals for more convenient formulations of the antibody, including designs on a subcutaneous maintenance dose and an under-the-skin formulation patients could use to initiate treatment.
“We add prescribers every week, and we see more sales every week,” Viehbacher said. “I think that’s the way it’s going to progress—probably until we get subcutaneous [Leqembi] for induction. I think that could be quite a game changer.”
Biogen and Eisai have already initiated a rolling review for subcutaneous Leqembi for maintenance dosing, where the partners expect to receive a regulatory verdict next year. But the companies are still generating data on the optimal dose for an under-the-skin initiation formulation and don’t anticipate a regulatory decision around that product presentation until the first quarter of 2026, Biogen’s development chief, Priya Singhal, M.D., said on the call.
Biogen’s CEO also acknowledged the difficulties in pinpointing eligible patients, citing the need for PET scans, lumbar punctures and MRIs. Viehbacher suggested a transition to more blood-based diagnostics rather than PET scans could ease the onboarding process.
All told, third-quarter U.S. Leqembi sales grew 33% over the prior quarter to $39 million, falling short of consensus estimates, analysts at Mizuho Securities wrote in a note to clients Wednesday.
Globally, the antibody brought home sales of roughly $67 million, marking a 66% increase over the second quarter.
Behind the scenes, there was a 40% uptick in the number of new prescribers writing prescriptions for Leqembi in the third quarter versus Q2, Alicia Alaimo, Biogen’s president and head of North America, added during the call.
Still, as was the case at the beginning of Leqembi’s launch, Alaimo said the biggest burden to uptake continues to be “infrastructure challenges.”
Alaimo also acknowledged Biogen’s boots-on-the-ground sales efforts.
Earlier this year, Biogen unveiled plans to boost its U.S. sales force by 30%, which included plans to hire a customer-facing field team that would join Eisai on the partners’ Leqembi push.
“Now the teams have been out there for several weeks,” Alaimo explained, adding that the partners are starting to see “a little bit more accelerated growth than what you do see in the rest of the nation,” specifically in areas where Biogen and Eisai’s commercial efforts are overlapping.
The Biogen executives’ comments came as the company reported total third-quarter revenue of around $2.5 billion, which was down 3% from the sum the company generated during the same period in 2023.
While multiple sclerosis products continued to be the top earners for Biogen with collective sales of roughly $1.1 billion, the business was down 9% from 2023’s third quarter, which Biogen’s chief financial officer, Michael McDonnell, attributed primarily to competition and channel dynamics.
In an effort to reassure investors, McDonnell pointed to a recent decision from the European Patent Office to uphold a Tecfidera patent concerning dimethyl fumarate dosing set to expire in 2028.
“However,” he warned, “generics are challenging this patent, and we do anticipate further challenges.”
The situation was better in the rare disease arena, where Biogen saw third-quarter sales increase 10% year-over-year to $495 million. McDonnell credited that boost in large part to the company’s Friedreich’s ataxia drug Skyclarys, which delivered 8% quarter-over-quarter revenue growth to $82 million thanks to increased patient demand.
Overall, the drug is now generating sales in 15 countries and reeled in $102 million worldwide in Q3, McDonnell said.
In light of the modest quarter, Biogen is sticking to its previous prediction that revenue will decline by a low single-digit percentage in 2024.
But, in a silver lining for investors, the company is raising its earnings per share forecast from a prior range between $15.75 and $16.25 to a new $16.10–$16.60 ballpark.