For evidence that a pricing scandal can translate into real lost sales for a pharmaceutical company, look no further than Mylan's third-quarter results. The now-infamous EpiPen took a $245 million hit to sales, partly on higher rebates required by a Justice Department settlement.
While Mylan didn't release its total EpiPen haul in the third quarter, Barclays analysts wrote in a note that they project its revenue fell to $184 million, down 57% versus last year.
On the company's third-quarter conference call, Mylan CEO Heather Bresch cited "accelerated deceleration" of EpiPen sales for some of the company's struggles in the U.S. during the period. The drugmaker is paying out higher governmental rebates as a result of its $465 million Department of Justice settlement—which focused on allegedly underpaid rebates to the government health program—and is seeing an overall contraction in the epinephrine injector market, she said.
Last summer, Mylan came under intense criticism for its repeated price hikes on EpiPen, which had taken the lifesaving injector's list price up several hundred percent over several years. In response, the company bolstered its patient access program and introduced a cheaper authorized generic that's now cannibalizing the brand.
Outside of the authorized generic, Richmond, Virginia's Kaléo Pharma launched Auvi-Q in response to the pricing firestorm, but some industry watchers felt that company did Mylan a favor with its $4,500 list price for a two-pack. CVS teamed up with Impax Laboratories to offer another much-discounted option, Adrenaclick, that's stealing market share.
Citing IMS Health data, Barclays analysts wrote that EpiPen and its authorized generic have ceded 30% of the market compared to 2016.
But price wasn't the company's only EpiPen problem over the last year.
The drugmaker recently settled a separate controversy relating to insufficient rebate payments to Medicaid. For years, EpiPen was incorrectly listed as a non-innovator med for rebating purposes, meaning Mylan allegedly paid out lower rebates for sales through the government program. The drugmaker finalized a $465 million settlement on the issue back in August and as a result, it's now paying larger rebates, according to the Monday earnings release. Mylan admitted no wrongdoing in the deal.
Altogether, the company's sales in North America fell 22% on the period. Mylan touted its new generic approval for Teva's multiple sclerosis med Copaxone and its performance outside of the U.S. as positive developments during the quarter.