Current Report
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to
Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report
(Date of earliest event reported): November 1, 2005
King
Pharmaceuticals, Inc.
(Exact
name of
registrant as specified in its charter)
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Tennessee
(State
or
other jurisdiction
of
incorporation)
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0—24425
(Commission
File
Number)
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54-1684963
(IRS
Employer
Identification
Number)
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501
Fifth Street, Bristol, Tennessee
(Address
of
principal executive offices)
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37620
(Zip
Code)
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Registrant’s
telephone number, including area code: 423-989-8000
Not
Applicable
(Former
name or
former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
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Item 1.01
Entry into a Material Definitive Agreement.
On
October 31,
2005, King Pharmaceuticals, Inc. (the “Company”) entered into (i) a
definitive settlement agreement with the United States of America, acting
through the United States Department of Justice and the United States Attorney’s
Office for the Eastern District of Pennsylvania and on behalf of the Offices
of
Inspectors General of the Department of Health and Human Services (HHS/OIG)
and
the Department of Veterans Affairs to resolve the previously-disclosed
governmental investigations related to the Company’s underpayment of rebates
owed to Medicaid and other governmental pricing programs during the period
from
1994 to 2002 (the “Federal Settlement Agreement”), and (ii) similar
settlement agreements with 48
States
and the District of
Columbia (collectively, the “State Settlement Agreements”). Some of the matters
addressed by the settlement agreements were subject to a court seal, which
was
lifted on November 1, 2005.
Pursuant
to the
Federal Settlement Agreement, the Company will make a payment of approximately
$124.1 million, plus interest accruing at the rate of 3.75% from July 1, 2005.
This amount includes $62.1 million representing the entire amount of
underpayments to Medicaid and other governmental pricing programs from 1994
to
2002 and an equal amount to cover interest, costs, and penalties. A total of
approximately $50.6 million of the $124.1 million resolution amount has been
earmarked for payment to 49 states and the District of Columbia. To date, the
Company has received signed State Settlement Agreements from 48 states and
the
District of Columbia, which in the aggregate have been allocated $50.4 million
of the resolution amount. As more fully described in Exhibit 10.2 hereto, the
State Settlement Agreements are substantially identical to the Federal
Settlement Agreement.
In
addition, the Company has entered into a five-year corporate integrity agreement
with HHS/OIG (the “Corporate Integrity Agreement”) pursuant to which the Company
is required, among other things, to keep in place its current compliance
program, to provide periodic reports to HHS/OIG and to submit to audits relating
to its Medicaid rebate calculations.
As
previously reported, the SEC has also been conducting an investigation relating
to the Company’s underpayments to governmental programs, as well as into the
Company’s previously disclosed errors relating to reserves for product returns.
While the SEC’s investigation is continuing with respect to the product returns
issue, the Staff of the SEC has advised the Company that it has determined
not
to recommend enforcement action against the Company with respect to the
aforementioned governmental pricing matter. The Staff of the SEC notified the
Company of this determination pursuant to the final paragraph of Securities
Act
Release 5310. Although the SEC could still consider charges against individuals
in connection with the governmental pricing matter, the Company does not believe
that any governmental unit with authority to assert criminal charges is
considering any charges of that kind.
Consummation
of the
Federal Settlement Agreement and some State Settlement Agreements is subject
to
court approval. The federal action against the Company was filed under seal
in
the United States District Court for the Eastern District of Pennsylvania by
an
individual purportedly acting as a “relator” pursuant to the federal False
Claims Act. The Company understands that the relator objects to the resolution
provided in the Federal Settlement Agreement and that he may assert his right
to
a “fairness hearing”, which might not take place before mid-2006. The Company
believes that the relator will not object to the amount of the settlement,
but
instead will argue that he should be awarded a larger share of the proceeds
than
the government believes is appropriate. The relator’s share, if any, would be
paid solely by the government and would not affect the amount the Company is
required to pay to resolve the matter.
The
relator has
also filed claims in the United States District Court for the Eastern District
of Pennsylvania against the Company purportedly on behalf of 13 states pursuant
to the laws of those states. The Company believes that the relator will also
object to the Company’s settlement with those states, as well as to the proposed
settlements with the other states, because of disagreements over the relator’s
share of the states’ proceeds. Resolution of the relator’s claim for a share is
not expected to increase the Company’s settlement cost, but could delay
consummation of some or all State Settlement Agreements until a hearing can
be
held, which might not take place before mid-2006.
The
Company
understands that the relator has filed a motion for preliminary injunction
in
the United States Court for the Eastern District of Pennsylvania seeking to
require that the Company’s payments under the settlement agreements be held in
the registry of the court pending a determination of the relator’s share. The
Company will vigorously oppose this motion. The Company expects that the federal
government, and possibly some of the states, will also oppose the motion. The
Company believes it is likely that the court will decide the relator’s motion
before year-end. If the court were to grant the relator’s motion for preliminary
injunction or uphold any fairness objections raised by the relator, the affected
governmental parties would not be required to consummate their settlement
agreements. In that event, the Company believes that it is likely that most
or
all of the parties would enter into new agreements with the Company
on
substantially
the same financial terms as the existing agreements, but can provide no
assurance that they would do so.
The
relator has
also filed a claim in the United Sates District Court for the Eastern District
of Pennsylvania seeking damages from the Company because of allegations that
the
Company improperly retaliated against the relator. The Company denies the
allegations and will vigorously contest this action. Resolution of this claim
will not delay consummation of the settlements and is not expected to have
a
material adverse effect on the Company.
The
Company accrued
in prior years a total of $130.4 million in respect of its estimated
underpayments to Medicaid and other governmental pricing programs and estimated
settlement costs with all relevant governmental parties, which sum is classified
as restricted cash and an accrued expense on the Company’s balance sheet. The
Company believes that the existing accrual is sufficient to cover the full
costs
of all sums owed the federal and state governments, together with related
obligations to reimburse the expenses of some of the parties.
The
agreements
described above will not resolve any of the previously disclosed civil suits
that are pending against the Company and related individuals and
entities.
The
foregoing
description of the Federal Settlement Agreement, the State Settlement Agreements
and the Corporate Integrity Agreement is qualified in its entirety by the text
of the Federal Settlements Agreements, the State Settlement Agreements, and
the
CIA, which are attached hereto as Exhibits 10.1, 10.2, and 10.3, respectively,
and incorporated herein by reference.
Item 7.01
Regulation FD Disclosure.
On
November 1, 2005, King Pharmaceuticals, Inc. issued a issued a press release,
a
copy of which is furnished as Exhibit 99.1, announcing the entering into the
settlement agreements resolving the governmental pricing
investigation.
In
accordance with general instruction B.2 of Form 8-K, this information, including
Exhibit 99.1, shall not be deemed filed for the purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, or otherwise subject to the
liability of that section, nor shall it be deemed incorporated by reference
in
any filing under the Securities Act of 1933, as amended, or the Securities
Exchange Act of 1934, as amended, except as we may specifically state in any
such filing.
Exhibits:
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Exhibit
Number
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Description
of Exhibit
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10.1
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Settlement
Agreement, dated as of October 31, 2005, among the United States
of
America acting through the entities named therein, King Pharmaceuticals,
Inc. and Monarch Pharmaceuticals, Inc.
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10.2
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Settlement
Agreement, dated as of October 31, 2005, among the state of Massachusetts,
King Pharmaceuticals, Inc. and Monarch Pharmaceuticals, Inc. and
general
description of the other state settlement agreements
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10.3 |
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Corporate
Integrity Agreement, dated as of October 31, 2005, between the Office
of
Inspector General of the |
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Department
of
Health and Human Services and King Pharmaceuticals,
Inc.
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99.1
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Press
Release
of King Pharmaceuticals, Inc. dated November 1,
2005.
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SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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Date:
November 4, 2005
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KING
PHARMACEUTICALS, INC.
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By:
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/s/
Brian A.
Markison
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Brian
A.
Markison
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President
and
Chief Executive Officer
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