The generic drugmaker said it was no longer including any major US product launches in its forecast for this year, pushing them back to 2018 due to the uncertain USA regulatory environment.
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 difference can likely be attributed to generic price erosion and competition, among other factors, he said. But Mylan President Rajiv Malik told investors Wednesday that the FDA seems more focused on quickly approving subsequent versions of generics. She said the agency is continuing to expedite the review of potential first generics. "This is clear evidence that generic challenges are being faced by all".
Mylan chief executive Heather Bresch said the entire healthcare sector is at an inflection point.
"[Teva] experienced ... greater competition as a result of an increase in generic drug approvals by the U.S. FDA", Peterburg said in the earnings release.
Sales of its signature EpiPen autoinjector, used to treat anaphylaxis, fell 9 percent in the second quarter of 2017 as generic versions came on the market, even though the market segment saw a 4 percent increase in sales.
Acquisitions boosted net sales in the region by $151 million during the period but lower generic prices and stepped-up competition to Mylan's flagship EpiPen Auto-Injector more than offset the inclusion of new businesses.
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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.
Mylan lowered its 2017 earnings per share estimate by 5% from $5.17 to $4.93 and its 2018 estimate by 10% from $5.78 to $5.21.
The company now expects 2017 revenue of $11.5 billion to $12.5 billion, compared with the FactSet consensus of $12.4 billion, and 2017 adjusted earnings-per-share of $4.30 to $4.70, below the FactSet consensus of $5.13.
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 past year.
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.
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.