Biogen, grappling with declining sales, slapped with DOJ subpoena over foreign operations

Biogen’s business has been in decline thanks to fierce multiple sclerosis competition and a botched Alzheimer’s drug launch. To make matters worse, the U.S. Department of Justice is looking into the company’s foreign operations.

Biogen has received a subpoena from the DOJ seeking information about its “business operations in several foreign countries,” the company disclosed in an annual filing. In addition, the company is providing information about its foreign businesses to the U.S. Securities and Exchange Commission (SEC), Biogen said.

It’s not clear which countries the DOJ and the SEC have set their sights on. Biogen is present in about 40 countries, including in Europe, China and Japan. A company spokesperson said Biogen doesn’t comment on government investigations.

The DOJ enforces the Foreign Corrupt Practices Act, which prohibits U.S. companies and their staffers from bribing foreign government officials. Many large biopharma companies, including Pfizer, Novartis, AstraZeneca’s Alexion, Teva and Bristol Myers Squibb, have faced investigations under the anti-foreign-corruption law in the past.

The subpoena follows a separate investigation by the SEC into Biogen’s Alzheimer’s disease drug Aduhelm and its launch. In parallel, a group of investors are suing Biogen and its former officers, alleging violations of federal securities laws.

After the intense controversy surrounding the Aduhelm approval and the drug's disastrous launch, Biogen two weeks ago decided to discontinue the medicine and recorded $60 million in close-out charges.

All these hurdles come as Biogen CEO Chris Viehbacher executes a pivotal turnaround plan, which is expected to save about $1 billion in gross operating costs by 2025.

Even as Biogen calls it quits on Aduhelm, its follow-up drug, Leqembi, hasn’t immediately become the star med it had promised to be. Eisai, which leads Leqembi commercialization, said last week that the drug will likely miss its goal of reaching 10,000 patients by March.

Meanwhile, Biogen’s bread-and-butter multiple sclerosis franchise saw sales drop 12% last year to $4.67 billion.