As Mylan reported a quarterly loss due to a recent settlement with the federal government, its CEO gave a clearer timeline for releasing a generic EpiPen, and said the company has advanced efforts to increase the device's shelf life.
The British drugmaker will release the much-anticipated generic version of the EpiPen in the first half of December, CEO Heather Bresch said during the conference call. Following public backlash over EpiPen price hikes, the company said in late August that the generic device would be available "within weeks," but it has yet to be released.
Bresch also said the company has filed an application with the Food and Drug Administration to extend the device's shelf life. She had previously told members of Congress that the drugmaker has been working to extend the device's shelf life from 18 months to 24 months, but it was unclear how Mylan had changed the product to extend its expiration period.
The company also reported a $119.8 million loss in the third quarter, down significantly from $428.6 million in profits reported the same time the year before. Mylan said the loss was primarily due to its $465 million settlement with the U.S. Justice Department regarding its classification of the EpiPen under the Medicare Drug Rebate Program.
Mylan was accused by legislators and regulators of misclassifying the brand name EpiPen as a generic, which would allow it to pay lower rebates to Medicare. The company didn't admit any wrongdoing, but said the settlement "will resolve questions raised about the classification” of the EpiPen under the program.
The loss came even as global revenue remained strong at $3 billion, up 13% thanks to sales from recent acquisitions, and to a lesser extent, sales of new products. Prescriptions for the EpiPen grew year-over-year despite the pricing backlash.
However, the company did note that specialty sales, which include the EpiPen, were down 4% as wholesalers change their purchasing patterns in anticipation of the generic product.
Bresch didn't directly comment on the election of Republican Donald Trump in her initial remarks, except to say that Mylan is committed to its mission even as the "world may be filled with uncertainty and the future of the U.S. health system may be unclear."
President-elect Trump favors casting light on the factors behind high healthcare costs, wants to import drugs from other countries and allow Medicare to directly negotiate on drug prices. Those are all measures that are generally opposed by drugmakers.
