Accelerated competition is harming the company's base business, executives said on Wednesday, but the FDA also isn't moving fast enough to approve Mylan's generics for asthma medication Advair and multiple sclerosis drug Copaxone.
On a call with investors, the company blamed the delays on restructuring at the FDA and said that it didn't expect the agency to require any more clinical or device-related studies.
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.
An FDA spokeswoman said the agency is already implementing a plan to streamline the generic drug review process and expects to approve a record number of generics by the end of the year.
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.
GlaxoSmithKline plc's Advair (fluticasone/salmeterol) and Teva Pharmaceutical Industries Ltd.'s Copaxone (glatiramer acetate) are major drug franchises, each earning billions a year despite competition in both therapeutic areas.
The company's stock price has dropped almost 20 percent since last week as generic drugmakers like Teva and Endo International Plc have said they are facing weakening prices in the United States. Mr. Landmon, who doesn't work with Mylan, said this is especially true with Advair because it is administered through an inhaler.
Mylan chief executive Heather Bresch said the entire healthcare sector is at an inflection point.
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. The stock was down 5.8% to $29.94 at 9:41 am. Revenue jumped 16% to $2.96 billion.
In all for the latest quarter, Mylan missed views, reporting earnings of $297 million, or 55 cents a share, up from $168.4 million or 33 cents a share a year earlier.
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. The 2017 revenue estimate was lowered by 2% from $12.29 billion to $12.06 billion and the 2018 estimate was cut by 4% from $13 billion to $12.4 billion. 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.
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 past year. That missed analysts' average estimate of $1.16.
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