Pharmaceutical maker Mylan NV announced it would not launch any new medications to the USA market in 2017.
Mylan N.V. no longer expects to launch generic copies of the blockbuster asthma drug Advair or multiple sclerosis medicine Copaxone this year, a delay which led the specialty pharma to cut its revenue forecasts for 2017.
Mylan would be the first company to bring a generic version of Advair to the market and one of the first to bring a generic version of Copaxone.
Those companies said customers consolidating to negotiate lower prices and regulators that have approved more versions of drugs to increase competition are hurting their bottom lines. 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. She said the agency is continuing to expedite the review of potential first generics.
The challenges facing generic drugmakers broadly have also weighed on Mylan's shares.
Mylan executives said Wednesday that the company planned to submit a response to the FDA's concerns regarding Advair in the next few weeks.
Declining sales of EpiPen, driven by competition and the launch of Mylan's authorized generic, present another challenge, even as the company continues to face scrutiny for steeply increasing the allergic reaction med's price.
Following the scandal, and under new leadership, the Food and Drug Administration announced a plan to facilitate prescription drug competition, especially for branded drugs that had no generics, or limited ones, available.
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, the maker of the EpiPen allergy treatment, said its 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 past year. It cut its forecast for earnings per share to a range of $4.30 to $4.70, from $5.15 to $5.55 previously.
The company reported total revenue of $2.96 billion and earnings per share of $1.10, missing estimates of $3.03 billion in revenues and EPS of $1.16, according to analysts surveyed by Thomson Reuters.
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. Sales were helped by recent acquisitions, including Meda and Renaissance Acquisition that contributed about $633 million in net sales during the quarter. On an adjusted basis, earnings fell to $1.10 a share from $1.16 a share.