Looking ahead, we continue to have great confidence in our underlying business in every region and the opportunities we have for long-term growth. The difference can likely be attributed to generic price erosion and competition, among other factors, he said.
Rajiv Malik, president of the company, added that Mylan has the strength to manage any headwinds that come its way because of its global integrated platform.
Chad Landmon, an attorney who helps generic drugmakers gain FDA approval, said it has been a challenge for the FDA to prove generic versions of both Copaxone and Advair function the same as branded versions.
Mylan chief executive Heather Bresch said the entire healthcare sector is at an inflection point.
The challenges facing generic drugmakers broadly have also weighed on Mylan's shares.
Generic drugmakers in the U.S. were hit by weakening prices in the quarter, and Mylan said it expects mid-single digit generic drug price drops worldwide and high-single digit falls in North America.
Mylan's stock bounced back in midday trading Wednesday from lower-than-expected second quarter earnings after the company's management said its generic drug Advair is not being delayed by further FDA-required studies.
North America segment third party net sales of $1.28 billion were down 9%; and up around 4% excluding the decrease in sales of the EpiPen Auto-Injector of approximately $172 million.
Mylan's quarterly net earnings rose 76.4 percent to $297 million, or 55 cents per share, helped by demand for products it gained through the acquisition of Swedish drugmaker Meda a year ago.
As a result, the company said it now expected full-year revenues would fall somewhere in the range of US$11.5bn and US$12.5bn, while adjusted earnings per share (EPS) were seen clocking in at between US$4.30 and US$4.70.
The midpoint of revenue guidance was lowered by about $1 billion, an estimated $575 million of which was attributed to new launches, said EvercoreISI analyst Umer Raffat.
Shares closed at $32.08, up 29 cents, after opening 5.9% lower.
The company maintains a 70% share of the market, including the EpiPen and the EpiPen authorized generic, Mylan executives said on its earnings call, but the EpiPen is going to be less than 5% of the company's profit moving forward. That missed analysts' average estimate of $1.16.