Dive Brief:
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Mylan reported Nov. 9 a third-quarter loss just shy of $120 million, resulting mainly from a previously announced $465 million settlement for overcharging the federal government on EpiPens (epinephrine auto-injectors) for Medicaid patients. The company had reported a profit of $429 million a year earlier.
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The drugmaker also disclosed in its quarterly regulatory filing that the company is being targeted in several federal generic-pricing probes. Information in the filing also showed Mylan had received a subpoena from the Department of Justice concerning the misclassification of EpiPen back in November 2014.
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Mylan said it intends to launch a $300 generic version of EpiPen, half the branded product's price, during the first half of December. (In late August, the company said it anticipated offering the generic within several weeks.)
Dive Insight:
Mylan, which acquired EpiPen in 2007, has hiked the price more than 400% since 2012, sparking public outrage, congressional scrutiny and the federal settlement fine.
And amid the still-heightened attention to drug pricing, the U.S. Department of Justice has continued a sweeping investigation of multiple generic-drug makers, including Mylan, for alleged price-fixing and collusion.
During an earnings call with analysts, CEO Heather Bresch tried to downplay the situation. She said she wished Mylan had better anticipated “the magnitude and acceleration of the rising out-of-pocket costs for a growing minority of patients who may have ended up paying full WAC [wholesale acquisition cost] or more when they went to the pharmacy counter."
In response, she said Mylan took the “swift and unprecedented actions” of increasing its savings card program to $300 from $100, doubling eligibility for its patient assistance program and preparing the generic version of EpiPen.
After numerous analyst questions about EpiPen, Bresch stressed during the earnings call that Mylan is “much more than any one product,” though the company has heavily promoted EpiPen. Indeed, strong marketing and some luck have turned EpiPen into Mylan's first $1 billion product.
While Mylan's total quarterly revenue climbed 13% year over year to $3.06 billion, growth fell below Wall Street expectations. Its generics business netted about $2.6 billion in third-quarter sales, up 17% over Q3 2015, the company said.
But revenues from "special segment third party net sales," a classification which includes sales of EpiPen, fell 4% year over year to $419 million. Mylan attributed the drop primarily to wholesalers making fewer EpiPen purchases in anticipation of the generic's imminent launch, noting that prescriptions actually increased in the third quarter.