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Mylan to delay launch of key products due to 'uncertain' regulatory environment

Mylan NV said it was lowering its full-year earnings guidance after electing to defer all major U.S. launches given the "region's ongoing challenges and the uncertain U.S. regulatory environment."

The pharmaceutical company now expects to post revenues of about $11.50 billion to $12.50 billion and adjusted EPS of between $4.30 and $4.70.

The company was previously targeting revenues of about $12.25 billion to $13.75 billion and adjusted EPS of between $5.15 to $5.55.

The decision to delay the launch of new key products, including the generic versions of pulmonary drug Advair and multiple sclerosis treatment Copaxone, also resulted in the company lowering its prior adjusted EPS guidance for 2018: from $6 to "at least $5.40."

The announcement was made in the company's second quarter earnings release. The pharmaceutical company booked second quarter adjusted net earnings of $589.9 million, or $1.10 per share, down from $592.4 million, or $1.16 per share, a year earlier.

The S&P Capital IQ normalized EPS consensus estimate for the quarter was $1.16.

Second-quarter 2017 revenues were up 16% year over year to $2.96 billion, driven by increased third party sales in Europe and the global segments thanks to the acquisitions of Meda AB and Renaissance Acquisition Holdings LLC.

On a GAAP basis, Mylan booked second quarter net earnings of $297 million, or 55 cents per share, up from $168.4 million, or 33 cents per share, in the prior-year period.