Mylan's Q3 revenue drops 2 percent, as US sales hit by launch of EpiPen authorised generic

Mylan said Monday that third-quarter sales fell 2 percent year-over-year to just under $3 billion, missing analyst forecasts of $3.1 billion, as revenue in the US was hit partly by the introduction of an authorised generic version of EpiPen. Sales in North America plunged 22 percent to $1.2 billion, as revenue from EpiPen declined by $245.1 million.

Mylan specifically attributed the decline in EpiPen revenue to the launch of its authorised generic version of the drug, higher governmental rebates following a $465-million settlement with the US Department of Justice regarding the classification of the product under Medicaid and increased competition. Earlier this year, Kaléo re-introduced its epinephrine auto-injector Auvi-Q, while CVS announced that it would offer Impax Laboratories' Adrenaclick at an 80-percent discount to the list price of EpiPen. Additionally, the FDA cleared Adamis Pharmaceuticals' epinephrine auto-injector Symjepi in June.

In other markets, Mylan's sales in Europe jumped 24 percent to $1 billion, as revenue in the rest of the world climbed 9 percent versus the prior-year period to $743.3 million. The drugmaker noted that  revenue was boosted by its 2016 purchase of Meda, which added about $163.6 million, including $117.2 million in Europe. Mylan added that profit in the quarter reached $88.3 million, up from a loss of $119.8 million in the same period of 2016.

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CEO Heather Bresch said the results "were especially strong considering the ongoing challenges we experienced in the US, including accelerated deceleration of EpiPen sales - both from our launch of an authorised generic as well as the contraction of the overall epinephrine auto-injector market."

Commenting on the results, Capital Markets analyst Randall Stanicky remarked "the question for Mylan will be whether its higher barrier pipeline can help deliver through continued erosion headwinds," adding "it could have been worse."

Mylan noted that mainly due to the recent US approval of generic versions of Teva's Copaxone, in both 20-mcg and 40-mcg strengths, it is increasing the midpoint of its annual earnings per share guidance to a range of $4.45 to $4.70, with the lower end lifted from $4.30 per share. Sales for the full year are estimated to be between $11.75 billion and $12.5 billion, with the bottom end of the range increased from $11.5 billion.

For related analysis, see ViewPoints: Mylan confirms feeling the pain but not gain of generics peers.

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