WASHINGTON, Oct. 7, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced that its subsidiary, Mylan
Inc., has agreed to the terms of a $465
million settlement with the U.S. Department of Justice
("DOJ") and other government agencies that will resolve questions
that have been raised about the classification of EpiPen®
Auto-Injector and EpiPen Jr® Auto-Injector (collectively, "EpiPen
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 Inc. 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 ("CMS") 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. 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.
Mylan CEO Heather Bresch
commented, "This agreement is another important step in Mylan's
efforts to move forward and bring resolution to all EpiPen
Auto-Injector related matters. The agreement is in addition to the
significant steps Mylan has taken in relation to EpiPen
Auto-Injector over the past several weeks, including the
unprecedented, pending launch of a generic version of EpiPen
Auto-Injector and expansion of our patient access programs for this
product. Entering into this settlement is the right course of
action at this time for the Company, its stakeholders and the
Medicaid program."
Mylan will include a pre-tax charge of approximately
$465 million in the quarter ended
Sept. 30, 2016 as a result of this
settlement.
2016 Earnings Guidance Update
Mylan also announced it expects full year 2016 adjusted diluted
earnings per ordinary share ("EPS") to be between $4.70 - $4.90, as compared to the previously
communicated full year guidance range of $4.85 - $5.15. The majority of this change in
full year 2016 adjusted EPS guidance is the result of the
previously announced changes in EpiPen Auto-Injector access
programs and the upcoming launch of the generic to EpiPen
Auto-Injector. These initiatives seek to further enhance access to,
and affordability of, EpiPen Auto-Injector. Much of the impact of
this guidance change will occur in the third quarter.
Mylan remains committed to its target of at least $6.00 in adjusted EPS in 2018.
Mylan is not providing forward looking guidance for full year
2016 U.S. GAAP EPS guidance or a reconciliation of full year 2016
adjusted EPS to U.S. GAAP EPS because Mylan is unable to predict
with reasonable certainty the ultimate outcome of certain
significant items without unreasonable effort. These items include,
but are not limited to, acquisition-related expenses including
those related to the recently closed Meda transaction,
restructuring expenses, asset impairments, litigation settlements,
changes to contingent consideration and certain other gains or
losses. These items are uncertain, depend on various factors, and
could have a material impact on U.S. GAAP EPS for the guidance
period.
Mylan to Report Third Quarter 2016 Financial Results on
Nov. 9, 2016
Mylan will host a conference call and live webcast, on
Wednesday, Nov. 9, 2016 at
4:30 p.m. ET, to review the Company's
financial results for the third quarter ended Sept. 30, 2016. Mylan will release its financial
results on Nov. 9 after the close of
the U.S. financial markets.
The dial-in number to access the earnings call
is 800.514.4861 or 678.809.2405 for
international callers. To access the live webcast, please log on to
Mylan's website, mylan.com, at least 15 minutes before the event is
scheduled to begin to register and download or install any
necessary software. A replay of the webcast will be available at
mylan.com/investors, for a limited time.
Mylan now intends to hold its investor day in conjunction with
the release of its fourth quarter results.
Forward-Looking Statements
This press release includes statements that constitute
"forward-looking statements," including with regard to the
agreement on terms of a settlement and the expected payment, the
full year 2016 adjusted EPS guidance and Mylan's commitment
to its target of at least $6.00 in
adjusted EPS in 2018. These statements are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. Because such statements inherently involve risks and
uncertainties, actual future results may differ materially from
those expressed or implied by such forward-looking statements.
Factors that could cause or contribute to such differences include,
but are not limited to: the inability or unwillingness on
the part of any of the parties to agree to a final settlement;
any legal or regulatory challenges to the settlement; any
failure by third parties to comply with their contractual
obligations; any changes in or difficulties with our
inventory of, and our ability to manufacture and distribute, the
EpiPen® Auto-Injector; the potential impact of any change in
patient access and the introduction of a generic version of the
EpiPen Auto-Injector; the effect of any changes in our customer and
supplier relationships and customer purchasing patterns; other
changes in third-party relationships; the possibility that Mylan
may be unable to achieve expected synergies and operating
efficiencies in connection with Mylan's acquisition of Meda AB
(publ.) ("Meda") by Mylan within the expected time-frames or at all
and to successfully integrate Meda; the impact of competition;
changes in the economic and financial conditions of the businesses
of the Company; the scope, timing, and outcome of any ongoing legal
proceedings and the impact of any such proceedings on our business;
any regulatory, legal, or other impediments to our ability to bring
our products to market; actions and decisions of healthcare and
pharmaceutical regulators, and changes in healthcare and
pharmaceutical laws and regulations, in the United States and abroad; our ability to
protect our intellectual property and preserve intellectual
property rights; expected or targeted future financial and
operating performance and results; inherent uncertainties involved
in the estimates and judgments used in the preparation of financial
statements, and the providing of estimates of financial measures,
in accordance with U.S. GAAP and related standards or on an
adjusted basis; other uncertainties and matters beyond the control
of management; and the other risks detailed in the Company's
filings with the Securities and Exchange Commission. Mylan
undertakes no obligation to update these statements for revisions
or changes after the date of this release.
Non-GAAP Financial Measures: Full year 2016 adjusted EPS
guidance and target of at least $6.00
in adjusted EPS in 2018
This press release includes the presentation and discussion
of certain financial information that differs from what is reported
under accounting principles generally accepted in the United States ("U.S. GAAP").
Adjusted EPS is a non-GAAP financial measure calculated as
U.S. GAAP EPS, adjusted for
various items, including acquisition related amortization;
litigation settlements, net; non-cash accretion of contingent
consideration liability; certain R&D milestone payments; clean
energy investments pre-tax losses; acquisition related costs;
restructuring and other special items; and the tax effect of these
items. This non-GAAP financial measure is presented in
order to supplement investors' and other readers' understanding and
assessment of the financial performance of Mylan N.V. ("Mylan" or
the "Company"). Management uses this measure internally for
forecasting, budgeting, measuring its operating performance, and
incentive-based awards. Mylan believes that this non-GAAP financial
measure is useful supplemental information for its investors and
when considered together with its U.S. GAAP financial measure and
the reconciliation to the most directly comparable U.S. GAAP
financial measure, provides a more complete understanding of the
factors and trends affecting its operations. The financial
performance of the Company is measured by senior management, in
part, using adjusted EPS, along with other performance metrics.
Management's annual incentive compensation is derived, in part,
based on the adjusted EPS metric. In addition, primarily due to
acquisitions, Mylan believes that an evaluation of its ongoing
operations (and comparisons of its current operations with
historical and future operations) would be difficult if the
disclosure of its financial results were limited to financial
measures prepared only in accordance with U.S. GAAP. Investors and
other readers should consider non-GAAP measures only as supplements
to, not as substitutes for or as superior measures to, the measures
of financial performance prepared in accordance with U.S. GAAP. For
additional information regarding the components and uses of
non-GAAP financial measures refer to Management's Discussion and
Analysis of Financial Condition and Results of Operations-- Use of
Non-GAAP Financial Measures section of Mylan's Quarterly Report on
Form 10-Q for the quarter ended June 30,
2016. With respect to the target of at least $6.00 in adjusted EPS in 2018, the Company is not
providing a U.S. GAAP target or reconciliation because the
Company has not quantified all future amounts, including U.S. GAAP
amounts, related to this target and it does not represent Company
guidance.
Mylan is a global pharmaceutical company committed to setting
new standards in healthcare. Working together around the world to
provide 7 billion people access to high quality medicine, we
innovate to satisfy unmet needs; make reliability and service
excellence a habit; do what's right, not what's easy; and impact
the future through passionate global leadership. We offer a growing
portfolio of more than 2,700 generic and branded pharmaceuticals,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS worldwide depend. We market our
products in more than 165 countries and territories. Our global
R&D and manufacturing platform includes more than 50
facilities, and we are one of the world's largest producers of
active pharmaceutical ingredients. Every member of our more than
40,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at mylan.com.
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SOURCE Mylan N.V.