The Department of Justice is seeking more information regarding Biogen’s overseas operations, while the Securities and Exchange Commission is looking into the launch of the now-defunct Alzheimer’s disease therapy Aduhelm.
Pictured: Biogen’s office and lab buildings in Cambridge, Massachusetts/iStock, hapabapa
Biogen has disclosed in a Wednesday Securities and Exchange Commission filing that it has been served a subpoena by the U.S. Department of Justice, which is seeking more information regarding the company’s overseas operations.
The Securities and Exchange Commission (SEC) has also issued subpoenas to Biogen, asking for additional information regarding the launch of its abandoned Alzheimer’s disease therapy Aduhelm (aducanumab), the company reported.
In connection with the Department of Justice subpoena, Biogen is “providing information relating to our business operations in several foreign countries to the SEC,” it noted in Wednesday’ filing.
Outside the U.S., Biogen has established a presence in more than 40 territories, according to its website. These include Australia, Canada, China, Japan and several European countries. Biogen’s international headquarters is in Switzerland.
BioSpace reached out to Biogen for comment on the U.S. government investigations but the company was not immediately available.
The news of the subpoenas come one day after Biogen reported its fourth-quarter and full-year financial results, posting disappointing sales figures and plotting a bleak forecast for 2024. In the fourth quarter of 2023, the pharma made over $2.3 billion in revenue, a 5% decline from the same period the prior year.
Its multiple sclerosis business, anchored by Fampyra (fampridine), Tecfidera (dimethyl fumarate) and Vumerity (diroximel fumarate), suffered an 8% sales hit, bringing in only $1.1 billion in the most recent quarter. Tecfidera contributed heavily to Biogen’s poor financial performance, with its revenues tanking 17.8% in the fourth quarter.
Though relatively small, Biogen also absorbed $60 million in close-out costs associated with Aduhelm. Late last month, the pharma announced that it would discontinue the development and commercialization of the controversial Alzheimer’s therapy and instead channel its resources and energy into Leqembi (lecanemab).
CEO Chris Viehbacher called this decision “difficult” on Tuesday, but one that represents the most efficient use of the company’s capital. “By the time Aduhelm would get its confirmatory data we just felt that Leqembi would be so far ahead and there are going to be other agents.”
Leqembi’s launch, however, has been slow. Eisai—Biogen’s development and commercialization partner for the Alzheimer’s therapy—reported last week that it will likely miss its March 2024 goal of treating 10,000 patients. Since winning the FDA’s full approval in July 2023, Leqembi has only reached around 2,000 patients so far, with about 8,000 more on waitlists.
In the face of these compounding problems, Biogen CFO Mike McDonald said during the investor call on Tuesday that the company is expecting a low-to-mid-single-digit percentage drop in revenue in 2024, while its core revenue from products would be relatively flat.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
