FDA adds EpiPen to drug shortage list as lower sales of product bring Mylan's North American revenue down 19 percent

Mylan reported Wednesday that first-quarter sales in North America plunged 19 percent year-over-year to $985.3 million, which the drugmaker partially attributed to lower sales of branded products including EpiPen. The financial results came as the FDA added EpiPen to its drug shortage list, noting that the product has "intermittent supply constraints due to manufacturing delays from the manufacturing partner."  

Earlier this week, an advocacy group warned of growing EpiPen shortages in the US, which follows similar reports in Canada and the UK. The FDA said Wednesday that EpiPen, as well as a lower-dose version called EpiPen Jr, and Mylan's own generic versions of those products, are currently available, but that "supply levels may vary across wholesalers and pharmacies."  

Shortages of the drug come after Mylan announced last April that Pfizer's Meridian Medical Technologies unit, which manufactures the EpiPen auto-injector, had expanded a recall of the device to include the US and other markets after previously recalling 81 000 units distributed in Australia, New Zealand, Europe and Japan following reports of defects. Later in the year, the FDA issued a warning letter to Meridian over violations related to the manufacturing of the device.  

The FDA also disclosed Wednesday that supplies of Impax Laboratories epinephrine auto-injector Adrenaclick are limited due to manufacturing issues, while Kaléo has available supply of Auvi-Q. Kaléo re-launched Auvi-Q in 2017 after the device had previously been removed from the market after the discovery of defects in the injection mechanism.  

In response to the news, Mylan noted that it is receiving "continual" supply from Meridian, with CEO Heather Bresch calling it a case of "intermittent supply." Bresch added "ironically, [the FDA] have to put that on the shortage list, to say there's not a shortage."

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In the first quarter, Mylan posted about $2.7 billion in total revenue, down 1 percent versus the year-ago quarter and slightly below forecasts of about $2.8 billion. The company noted that sales of branded products, including EpiPen, in North America decreased $108.7 million, in addition to the loss of exclusivity on blood-pressure drug olmesartan. Net profit for the three-month period declined 1 percent to $495.6 million.  

Mylan noted that quarterly net sales in Europe jumped 19 percent to $1 billion, which the drugmaker principally attributed to favourable currency effects. In addition, revenue in the rest of the world rose by 8 percent to $626.7 million, in part due to new product sales in emerging markets.  

Mylan CEO Heather Bresch stated "Mylan's first quarter demonstrates continued execution on our long-term plan," continuing "our diversity and durability are what allow us to absorb evolving industry dynamics and natural market volatility, while at the same time accelerate our mission of providing access to high quality medicine.  

Commenting on the results, RBC Capital Markets analyst Randall Stanicky said "this was a challenging quarter that had already been tempered."

For the full year, Mylan affirmed its guidance of earnings in the range of $5.20 per share to $5.60 per share, on $11.75 billion to $13.25 billion in revenue.

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