Mylan has been dealing with increased competition from less expensive generic drugs amid the expiration of patent protections on its proprietary drugs.
Continued delays in launching the two high-profile generics, however, means there is little to distract investors from a tightening price environment in the U.S. Mylan expects prices to decline by mid-single digits globally and by high-single digits in the U.S.
The FDA failed to approve Mylan's generic Advair in late March.
This is providing investors an opportunity to differentiate between pharmaceutical companies focused exclusively on generics and/or specialty medicines and those capable of delivering a broad and diverse portfolio across multiple channels in various geographies, which remains Mylan's strategy.
Over the past year, "there's been challenges in the industry, but Mylan had been able continue to absorb those challenges and that volatility", Chief Executive Heather Bresch said on a conference call following the release of quarterly results. Company president Rajiv Malik said on Wednesday's earnings call that the FDA will not require any further clinical or device-related studies for the Advair copy - a comment likely behind Mylan stock's recovery from early morning losses.
Borderlands Developer Gearbox Software Reveals New Game
Those interested in throwing their name in the hat for technical test consideration can sign up over on the Project 1v1 website . A "short" closed technical test is scheduled for this summer, and Gearbox has opened sign-ups for the beta on its website .
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 executives said Wednesday that the company planned to submit a response to the FDA's concerns regarding Advair in the next few weeks. The company said North American sales for its EpiPen Auto-Injector fell more than expected in the most recent quarter as cheaper generic versions launched.
Mylan said its second-quarter net earnings rose 76.4 percent to $297 million, or 55 cents per share, mostly due to revenue from its purchase of Swedish drugmaker Meda a year ago. Mylan also cut its 2018 earnings per share target from $6 to at least $5.40. The company also lowered its forecast for adjusted earnings per share to about $4.30 to $4.70 per share, down from $5.15 to $5.75 as previously predicted.
Umer Raffat, a senior analyst with Evercore ISI, estimated in a research note that half of the revenue revision came from the delay of new launches, while the rest stemmed from increased price erosion and competition.
Shares closed at $32.08, up 29 cents, after opening 5.9% lower.
Excluding one-time items, the company earned $1.10 per share, missing analysts' average estimate by 6 cents, according to Thomson Reuters I/B/E/S.