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 greenlight 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.

She added that the company now expects to generate total revenues of between $11.5 billion and $12.5 billion in 2019, and earnings per share in the range of $3.80 to $4.80.

This is lower than analysts’ average predictions of $5.04 earnings per share and sales of $11.9 billion.

“We are putting a highly disciplined financial lens to unlock latent value from the assets we've integrated as we transition to a business model that is predominantly driven by organic growth," Bresch added

Mylan president Rajiv Malik said: "We anticipate growth of more than $1 billion in new launches, nearly all of which have already been approved, and which reflects a heavier weighting on specialty and complex generic products aligned with the evolution of the pharmaceutical industry."

Last year Mylan became the fifth company to launch a generic version of AbbVie’s blockbuster Humira, in collaboration with Fujifilm.