After Mylan NV (MYL) on Thursday, Aug. 18, said it has finalized a $465 million settlement with the U.S. Department of Justice and other government agencies over the classification of its EpiPen auto injectors in the Medicaid Drug Rebate Program, attention turns back to dynamics in the generics business.
Mylan announced in October that it had agreed to the terms of the settlement, which resolves claims relating to the classification of EpiPen Auto-Injector and EpiPen Jr Auto-Injector for purposes of the Medicaid Drug Rebate Program. The settlement does not contain an admission or finding of wrongdoing.
EpiPen, which is used to treat life-threatening allergic reactions, has been classified with the Centers for Medicare and Medicaid Services as a non-innovator drug since before Mylan bought the drug in 2007. Mylan will reclassify EpiPen and pay the rebate applicable to innovator products effective as of April 1, 2017.
"While we think this weighs minimally on business fundamentals, the news should at least somewhat ease investor concerns that there could be further read-through from the issue," wrote Wilbur.
Shares of Mylan were trading at $30.88 on Friday, up 1%.
"With today's resolution, the bulk of focus can shift back to generic dynamics as it pertains to pricing and new product approvals," wrote Raymond James & Associates Inc. analyst Elliot Wilbur in a note Thursday.
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He maintained his bullish stance on the stock and noted that the negative commentary from both the industry and the company previously as well as regulatory issues suppressed expectation of expanding Mylan's product portfolio.
"Outside of the noise surrounding EpiPen pricing and reimbursement, we believe Mylan's business relatively outperformed in the generic environment, that is, until 2Q17 when the negative trifecta of lack of high-margin new product flow, accelerated base price pressure, and consolidation in downstream channels caught up with the company, resulting in a rather substantial guidance reset," wrote Wilbur.
"However, we continue to remain bullish, as we believe the aforementioned negativities have already been priced-in and Mylan's current share levels seem to reflect all but a doomsday scenario," added Wilbur, who has a strong buy rating on the stock.
Mylan on Aug. 9 revised its full-year 2017 revenue guidance to between $11.5 billion and $12.5 billion, from the previous range of $12.25 billion to $13.75 billion, and its adjusted EPS guidance to between $4.30 and $4.70, from the $5.15 to $5.55 range.
"Given the region's ongoing challenges and the uncertain U.S. regulatory environment, we have elected to defer all major U.S. launches from our full year 2017 financial guidance to 2018, including generic Advair and generic Copaxone," said Mylan CEO Heather Bresch in the earnings release.
Mylan reported second-quarter adjusted diluted earnings per ordinary share of $1.10, down 5% from the year-ago period. Total revenue rose 16% to $2.96 billion. Analysts had forecast, on average, non-GAAP EPS of $1.16 on revenue of $3.02 billion, according to FactSet.
-- Kinsey Grant contributed to this article
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Editors' pick: Originally published Aug. 18.