ST. LOUIS, June 29, 2012 /PRNewswire/ -- K-V
Pharmaceutical Company (NYSE: KVa/ KVb) ("the Company") today
announced that on June 26, 2012 it
was notified by the New York Stock Exchange Regulation, Inc., that
its Class A common shares is below criteria for the average closing
price of a security of less than $1.00 over a consecutive 30 day trading period.
This notification pertains to the Class A Common Stock but also
affects the Class B Common Stock. The Company will have a six-month
period from the date of the NYSE notification to cure this
deficiency.
Per NYSE procedures, K-V intends to notify the NYSE within 10
business days from the receipt of the NYSE notification of its
intent to cure this deficiency within the six-month cure period.
During this six-month cure period, the Company's shares will
continue to be listed and traded on the NYSE, subject to its
compliance with other NYSE continued listing standards. However,
starting on July 3, 2012 the
Company's Class A common shares and Class B common shares will
trade under the symbols "KVa.BC" and "KVb.BC," respectively.
About K-V Pharmaceutical Company
K-V Pharmaceutical Company is a specialty branded pharmaceutical
company with a primary focus in the area of women's
healthcare. As such, we are committed to advancing the
health of women across all the stages of their lives.
For further information about K-V Pharmaceutical Company, please
visit the Company's corporate Website at
www.kvpharmaceutical.com.
Cautionary Note Regarding Forward-looking Statements
This release contains various forward-looking statements within
the meaning of the United States Private Securities Litigation
Reform Act of 1995 (the "PSLRA") and which may be based on or
include assumptions concerning our operations, future results and
prospects. Such statements may be identified by the use of words
like "plan," "expect," "aim," "believe," "project," "anticipate,"
"commit," "intend," "estimate," "will," "should," "could,"
"potential" and other expressions that indicate future events and
trends.
All statements that address expectations or projections about
the future, including, without limitation, statements about product
launches, governmental and regulatory actions and proceedings,
market position, revenues, expenditures and the impact of the
recall and suspension of shipments on revenues, adjustments to the
financial statements, the filing of amended SEC filings and other
financial results, are forward-looking statements.
All forward-looking statements are based on current expectations
and are subject to risk and uncertainties. In connection with the
PSLRA's "safe harbor" provisions, we provide the following
cautionary statements identifying important economic, competitive,
political, regulatory and technological factors, among others, that
could cause actual results or events to differ materially from
those set forth or implied by the forward-looking statements and
related assumptions. Such factors include (but are not limited to)
the following:
(1) our ability to continue as a going
concern;
(2) the risk that the Company may be insolvent in the near
term, if it is not able to generate sufficient liquidity to satisfy
its upcoming payment obligations including $95.0 million of milestone payments owed to
Hologic beginning August 4, 2012 and
a $13.5 million interest payment owed
on its senior secured notes due on September
15, 2012;
(3) the risk that, if necessary, the Company will be
unsuccessful in attempts to restructure its existing capital
structure and operations;
(4) risks associated with the introduction and growth
strategy related to the Company's Makena® product,
including:
(a) the impact of competitive, commercial payor, governmental
(including Medicaid program), physician, patient, public or
political responses and reactions, and responses and reactions by
medical professional associations and advocacy groups, on the
Company's sales, marketing, product pricing, product access and
strategic efforts;
(b) the possibility that the benefit of any period of
exclusivity resulting from the designation of Makena® as an orphan
drug may not be realized as a result of U.S. Food and Drug
Administration's (the "FDA") decision announced on March 30, 2011 to decline to take enforcement
action with regards to compounded alternatives, as updated on
June 15, 2012;
(c) the Center for Medicare and Medicaid Services' ("CMS")
prior policy regarding Medicaid reimbursement for Makena®, as
updated on June 15, 2012, and the
resulting coverage decisions for Makena® by various state Medicaid
and commercial payors;
(d) the statements made on June 15,
2012 by FDA and CMS may not lead to state Medicaid and other
payers making Makena® easily accessible to patients, that
unreasonable policies and conditions may continue to be imposed and
compounding of hydroxyprogesterone caproate could continue to
exceed the scope of traditional pharmacy compounding;
(e) the satisfaction or waiver of the terms and conditions
for our continued ownership of the full U.S. and worldwide rights
to Makena® set forth in the previously disclosed Makena®
acquisition agreement;
(f) the number of preterm birth risk pregnancies for which
Makena® may be prescribed, its safety and side effects profiles and
acceptance of pricing;
(g) the risk that, if needed, future modifications or
amendments to the agreement with Cytyc Prenatal Products Corp. and
Hologic, Inc. (Cytyc Prenatal Products Corp. and Hologic, Inc. are
referred to collectively as "Hologic") may be unsuccessful;
and
(h) our ability to generate sufficient capital to satisfy the
$95.0 million of remaining milestone
payments to Hologic related to the purchase of Makena®, which are
due beginning August 4, 2012;
(5) the possibility of further delay or inability to obtain
FDA approvals to relaunch Clindesse® and Gynazole-1® and the
possibility that any other product relaunch may be delayed or
unsuccessful;
(6) risks related to compliance with various agreements and
settlements with governmental entities including,
including:
(a) the consent decree between the Company and the FDA and
the Company's suspension in 2008 and 2009 of the production and
shipment and the nationwide recall of all of the products that it
formerly manufactured, as well as the related material adverse
effect on our revenue, assets, liquidity and capital
resources;
(b) the agreement between the Company and the Office of
Inspector General of the U.S. Department of Health and Human
Services ("HHS OIG") to resolve the risk of potential exclusion of
the Company from participation in federal health care
programs;
(c) our ability to comply with the plea agreement between a
now-dissolved subsidiary of the Company and the U.S. Department of
Justice, including the remaining payments owed under the plea
agreement; and
(d) our ability to comply with the Settlement Agreement dated
December 6, 2011 with the Department
of Justice, the United States
Attorney's Office for the District of Massachusetts, the Office of Inspector General
of the Department of Health and Human Services and the TRICARE
Management Activity (collectively the "Parties") resolving certain
claims under the qui tam provisions of the False Claims Act,
including the remaining payments owed under the Settlement
Agreement, which could result in significant penalties including
exclusion from participation in federal health care
programs;
(7) the availability of raw materials and/or products
manufactured for the Company under contract manufacturing
agreements with third parties;
(8) risks that the Company may not ultimately prevail in, or
that insurance proceeds, if any, will be insufficient to cover
potential losses that may arise from:
(a) the series of putative class action lawsuits alleging
violations of the federal securities laws by the Company and
certain individuals;
(b) product liability lawsuits, including the possibility
that our current estimates of the financial effects of ongoing
product liability claims and lawsuits could prove to be
incorrect;
(c) lawsuits pertaining to indemnification and employment
agreement obligations involving the Company and its former Chief
Executive Officer; and
(d) challenges to our intellectual property rights by actual
or potential competitors and challenges to other companies'
introduction or potential introduction of generic or competing
products by third parties against products sold by the
Company;
(9) the possibility that our current estimates of the
financial effect of previously announced product recalls could
prove to be incorrect;
(10) risks related to the Company's highly leveraged capital
structure, including:
(a) the risk that the maturities of our debt obligations may
be accelerated due to our inability to comply with scheduled
interest and principal payments, covenants and restrictions
contained in our loan agreements;
(b) restrictions on the ability to increase our revenues
through certain transactions, including the acquisition or
in-licensing of products or relaunch of certain of our
products;
(c) the risk that, if required, efforts to negotiate
amendments to, modification or restructuring of our existing debt
obligations may not be successful; and
(d) risks that future changes in the Board of Directors may
lead to an acceleration of the maturities of the Company's
debt;
(11) the risk that we may not be able to satisfy the
quantitative listing standards of the New York Stock Exchange,
including with respect to minimum share price and public float;
and
(12) the risks detailed from time to time in the Company's
filings with the Securities and Exchange Commission (the
"SEC").
This discussion is not exhaustive, but is designed to highlight
important factors that may impact our forward-looking
statements.
Because the factors referred to above, as well as the statements
included in Part I, Item 1A -- "Risk Factors," of our Annual Report
on Form 10-K for the fiscal year ended March
31, 2012 could cause actual results or outcomes to differ
materially from those expressed in any forward-looking statements
made by us or on our behalf, you should not place undue reliance on
any forward-looking statements. All forward-looking statements
attributable to us are expressly qualified in their entirety by the
cautionary statements in this "Cautionary Note Regarding
Forward-Looking Statements" and the risk factors that are included
under Part I, Item 1A of the Fiscal 2012 Form 10-K. Further, any
forward-looking statement speaks only as of the date on which it is
made and we are under no obligation to update any of the
forward-looking statements after the date of this release. New
factors emerge from time to time, and it is not possible for us to
predict which factors will arise, when they will arise and/or their
effects. In addition, we cannot assess the impact of each factor on
our future business or financial condition or the extent to which
any factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statements.
SOURCE K-V Pharmaceutical Company