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MYL

Mylan

$35.94

-0.9 (-2.44%)

17:12
10/07/16
10/07
17:12
10/07/16
17:12

Mylan: EpiPen Auto-Injector to be classified as 'innovator drug' on April 1

Mylan said the following in a regulatory filing: Item 2.02 of this report is incorporated by reference into this Item 7.01. The press release also announced that Mylan had agreed to the terms of a $465M settlement with the U.S. Department of Justice and other government agencies that will resolve questions that have been raised about the classification of the EpiPen Auto-Injector and EpiPen Jr Auto-Injector for purposes of the Medicaid Drug Rebate Program.The terms of the settlement do not provide for any finding of wrongdoing on the part of Mylan or any of its affiliated entities or personnel. The question in the underlying matter was whether EpiPen Auto-Injector was properly classified with the Centers for Medicaid and Medicare Services as a non-innovator drug under the applicable definition in the Medicaid Rebate statute and subject to the formula that is used to calculate rebates to Medicaid for such drugs. EpiPen Auto-Injector has been classified with CMS as a non-innovator drug since before Mylan acquired the product in 2007 based on longstanding written guidance from the federal government. The settlement terms provide for resolution of all potential rebate liability claims by federal and state governments as to whether the product should have been classified as an innovator drug for CMS purposes, and subject to a higher rebate formula. Consistent with the recent CMS rule regarding the classification of drugs for rebate purposes, EpiPen Auto-Injector will begin being classified as an innovator drug on April 1, 2017. In connection with the settlement, Mylan expects to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. Mylan will continue to work with the government to finalize the settlement. Also on October 7, Mylan received a document request from the Division of Enforcement at the Securities and Exchange Commission seeking communications with the CMS and documents concerning Mylan products sold and related to the Medicaid Drug Rebate Program, and any related complaints. Mylan intends to fully cooperate with the SEC's investigation.

  • 07

    Oct

  • 28

    Mar

MYL Mylan
$35.94

-0.9 (-2.44%)

09/22/16
ARGS
09/22/16
NO CHANGE
ARGS
Mylan weakness creates good entry point, says Argus
After Mylan's stock fell 17% over the last month, Argus analyst Jacob Kilstein thinks that the stock has reached an attractive entry point, He says that the company's new generic EpiPen will cannibalize branded sales but should help it beat upcoming generic competitors. He thinks that the stock is undervalued and keeps a Buy rating on the stock.
09/23/16
BERN
09/23/16
NO CHANGE
BERN
Mylan generic Epipen to lower EPS by about 10%, says Bernstein
Bernstein analyst Aaron Gal estimates that Mylan's decision to introduce a generic version of its EpiPen will create a drag of about 10% on its EPS. After viewing the Congressional hearings on the device, Gal continues to believe that a competitor to EpiPen will hit the market before the end of 2018. He keeps a $60 price target and Outperform rating on Mylan.
09/30/16
LEER
09/30/16
NO CHANGE
Target $45
LEER
Outperform
Mylan price target cut to $45 on lower EpiPen estimates at Leerink
Leerink analyst Jason Gerberry lowered his EpiPen sales forecasts by 33-45% from 2017-2021 in light of recent company updates, including its plan to launch an authorized generic of the emergency treatment later this year. While Mylan "appears on the right side of the law" regarding the latest Medicaid rebate controversy, Gerberry believes investors should consider the risk of a future settlement related to the issue. He cut his price target on Mylan shares to $45 from $55, but keeps an Outperform rating on the stock as he sees cash flows being sufficient to justify the current price.
10/04/16
JPMS
10/04/16
NO CHANGE
Target $52
JPMS
Overweight
Mylan price target lowered to $52 from $62 at JPMorgan
JPMorgan analyst Chris Schott lowered his price target for Mylan to $52 saying he remains cautious on the shares over the near-term given the ongoing Epipen controversy. The analyst, however, views the stock as "very inexpensive" and keeps an Overweight rating on the name. Schott sees a limited long-term impact to his thesis from the Epipen controversy and believes Mylan's generics business is underappreciated. He maintains an Overweight rating on the shares.

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