Mylan reports lower than expected earnings

Mylan has reported lower than expected full-year earnings and 2019 forecasts, thanks partly to delays in its generic Advair approval and continuing problems at its US manufacturing plant. Total revenues were $11.43 billion, down 4% compared to the prior year. North America segment net sales were down 18% to $4.10 billion, which the company said was partly driven by the restructuring and remediation activities at the Morgantown, West Virginia plant. In November the FDA warned Mylan about “significant” manufacturing violations at the plant, including “inadequate” cleaning of equipment and a failure to thoroughly investigate batches of medicines that did not meet specifications.
Shares in Mylan dropped more than 6% after the results were announced. CEO Heather Bresch, though, said the results were strong despite lower than expected uptake on generic Copaxone and the fact that the company did not receive approval for its generic Advair last year. The company’s version of GSK’s blockbuster inhaler finally got the green light from the FDA earlier this month and was launched at a 70% discount compared to the original drug. “Looking forward, I can confidently say, through leveraging the diversification across our commercial, operational and scientific platforms, we feel incredibly positive about our ability to deliver a strong top-line financial performance in 2019,” said Bresch.