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Mylan (MYL) Launches Authorized Generic EpiPen at $300

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Mylan N.V. announced the launch of the first generic version of its life-saving allergy treatment, EpiPen auto-injector, at more than 50% discount on the branded product’s price. The generic EpiPen will have a list price of $300 for a pack of two and will reach pharmacies beginning this week.

We note that Mylan made it to the headlines in Aug 2016 for the massive price hike of EpiPen. As per lawmakers, as of May 2016, Mylan had hiked the price of EpiPen by more than 480% in the U.S. – from $103.50 for a set of two in 2009 to the present level of $608.61. Note that Mylan had purchased EpiPen in 2007.

The pricing controversy even led to a congressional hearing and drew immense criticism from former U.S. presidential candidate Hillary Clinton.

Along with the generic launch announcement, the company said it is offering a savings card for eligible patients with commercial health insurance, which provides up to $25 off the out-of-pocket cost for the authorized generic. Introduction of the authorized generic was one of several initiatives announced by the company in its efforts to counter negative publicity related to the price hike issue, which also included changes in EpiPen access programs like raising the savings card program from $100 to $300, and doubling the eligibility of the patient assistance programs.

However, these initiatives have seemingly failed to mitigate the situation. The launch of an authorized generic version didn’t go down well with Senator Bernie Sanders either, who even posted a tweet, saying “At $300 generic EpiPens will still cost 3 times more than they did in 2007. This isn't a discount. It's a PR move.”

Interestingly, the recent move comes a day after 20 U.S. states filed a federal lawsuit against several generic drug makers including Mylan and Teva Pharmaceutical Industries Limited (TEVA - Free Report) among others. According to the lawsuit, the companies were indulging in a widespread illegal conspiracy to reduce competition, and artificially hiking and manipulating prices of generic prescription drugs. These concerned drugs include doxycycline hyclate delayed release (an antibiotic used for a range of conditions including respiratory tract infections), and glyburide, an oral diabetes medicine (Read more: 20 States Sue Teva, Mylan & Other Drug Companies for Price Fixing).

However, there seems to be no end to Mylan’s woes. The company again drew flak for misclassifying EpiPen as a generic product in the Medicaid Drug Rebate Program, which revealed that the company had been largely underpaying rebates to Medicaid for the drug for a long time than it would have if the drug was classified as a branded one.

As a result, in the third quarter of 2016, the company booked a $465 million charge related to a settlement with the U.S. Department of Justice (DoJ) and other government agencies to resolve disputes related to the misclassification of EpiPen, which led to weaker-than-expected results.

The company has also received subpoenas from the DoJ, seeking additional information related to the marketing, pricing and sale of its four generic products.

Despite these challenges, shares of the company have outperformed the Zacks categorized Medical-Generic Drugs industry. In fact, the company has lost 19.1% since Aug 2016, while the industry witnessed a decline of 25.7%. Note that the entire industry is under immense pressure of late, with several generic drugmakers like Impax Laboratories, Inc. getting involved in drug pricing issues.

Meanwhile, earlier this month, Mylan announced restructuring programs in certain locations in an attempt to streamline its operations globally as it focuses on the integration of acquired businesses. The company expects to cut less than 10% of its global workforce, marking the first step in a series of actions.

MYLAN NV Price and Consensus

 

Mylan currently carries a Zacks Rank #3 (Hold).

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