Alexion nears $25M settlement with SEC in FCPA probe

As previously disclosed, Alexion first received a subpoena in May 2015 concerning an investigation by the SEC’s Enforcement Division “requesting information related to our grant-making activities and compliance with the FCPA in various countries.” Additionally, Alexion received a request from the Department of Justice in October 2015 “for the voluntary production of documents and other information pertaining to Alexion’s compliance with the FCPA.”

The investigations focused on operations in various countries—including Brazil, Colombia, Japan, Russia, and Turkey—and Alexion’s compliance with the FCPA and other applicable laws, the regulatory filing stated. Both agencies also sought information “related to Alexion’s recalls of specific lots of SOLIRIS and related securities disclosures.”

In its latest regulatory filing, for the quarter ending March 31, 2020, Alexion said it has “reached an agreement in principle with the SEC Enforcement Division staff to settle the claims relating to the SEC investigation, pursuant to which we would pay an aggregate amount less than $25 million to resolve the investigation. As a result, we have accrued a liability in such amount in our financial statements for the quarter ended March 31, 2020.” Additionally, Alexion said it has recently been informed by the Department of Justice that “has closed its inquiry into these matters.”

Alexion said it is “committed to strengthening its compliance program and is currently enhancing and continuing to implement a comprehensive company-wide transformation plan that is designed to enhance our business processes, structures, controls, training, talent, and systems across Alexion’s global operations.”