Aegerion Pharmaceuticals Inc., maker of the drug Juxtapid for a rare cholesterol disorder, received a subpoena from the U.S. Department of Justice requesting documents on its marketing and sale of the medicine.
Aegerion said it intends to cooperate with the government’s investigation and didn’t provide further details in a statement yesterday. The Cambridge, Massachusetts-based company said it “is committed to complying with all applicable laws, rules and regulations.”
Chief Executive Officer Marc Beer received a warning letter from the Food and Drug Administration in November about comments in an interview on CNBC. The FDA said Beer’s statements “provide evidence that Juxtapid is intended for new uses, for which it lacks approval and for which its labeling does not provide adequate directions for use.”
Aegerion dropped 11 percent to $65.77 at the close in New York in the shares’ biggest single-day decline since Nov. 18. The stock has more than doubled in the last 12 months.
The company doesn’t know the origin of the investigation or whether it’s related to the FDA warning letter, Amanda Murphy, a spokeswoman, said today in a telephone interview.
“We don’t expect so, but we don’t know for sure,” she said of a relation to the FDA warning letter. “We feel really confident in the compliance processes and practices that we’ve had in place since launch. We’re operating as we have been because we feel so good about our compliance processes.”
Beer has told analysts and investors that, based on the experience of others and outside counsel, it may take a few months to several years to resolve, she said.
“With a small company with one product and a small sales force, we hope there could be the potential to come to some resolution of the situation more efficiently,” Murphy said.
Aegerion also forecast 2014 sales of $190 million to $210 million compared with the $204.1 million average of 10 analysts’ estimates compiled by Bloomberg. Revenue last year was $48 million to $49 million while the average of the analysts’ estimates was $49.8 million.
“Some may have been hoping for numbers higher than the current sell-side consensus, especially given that there was a 5.5 percent price increase for Juxtapid on January 1st,” Cory Kasimov, an analyst with JPMorgan Chase & Co., wrote in a research note yesterday. In addition, he said, the “subpoena from the U.S. Department of Justice introduces fear of the unknown and appears to have spooked investors.”