ST. LOUIS, May 25, 2012 /PRNewswire/ -- K-V
Pharmaceutical Company (the "Company") (NYSE: KVa/KVb) today
announced that in view of the unusual market activity in the
Company's common stock, the NYSE has contacted the Company in
accordance with its usual practice. K-V's policy is not to comment
on unusual market activity.
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 press 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, 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, as discussed in Note 3—"Going Concern and
Liquidity Considerations" in the Notes to the Consolidated
Financial Statements (Unaudited) included in Part I, Item 1 of our
Quarterly Report on Form 10-Q for the fiscal quarter ended
December 31, 2011;
(2) 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 to decline to take
enforcement action with regards to compounded alternatives;
(c) the Center for Medicare and
Medicaid Services' ("CMS") policy regarding Medicaid reimbursement
for Makena®, and the resulting coverage decisions for Makena® by
various state Medicaid and commercial payors;
(d) 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, as amended from time to time,
including $95.0 million of remaining
scheduled payments by us for those rights; and
(e) the number of preterm births for which
Makena® may be prescribed, its safety and side effects profiles and
acceptance of pricing;
(3) the possibility of delay or inability
to obtain FDA approvals of Clindesse® and Gynazole-1® and the
possibility that any product relaunch may be delayed or
unsuccessful;
(4) risks related to compliance with
various agreements and settlements with governmental entities
including those discussed in Item 1 (b)— "Discontinuation of
Manufacturing and Distribution; Product Recalls; and the FDA
Consent Decree" in the Company's Form 10-K/A for the fiscal year
ended March 31, 2011 (the "Fiscal
2011 Form 10-K/A) or in our Quarterly Report on Form 10-Q for the
fiscal quarter ended December 31,
2011, 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 healthcare
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; and
(d) our ability to comply with the
Settlement Agreement dated December 7,
2011 with the United States
resolving certain claims under the Qui Tam provisions of the False
Claims Act, which could result in significant penalties including
exclusion from participation in federal healthcare
programs;
(5) the availability of raw materials and/or
products manufactured for the Company under contract manufacturing
agreements with third parties;
(6) 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,
litigation discussed in Note 16—"Commitments and
Contingencies—Litigation and Governmental Inquiries" of the Notes
to the Consolidated Financial Statements (Unaudited) in Part I,
Item 1 of our Quarterly Report on Form 10-Q for the fiscal quarter
ended December 31, 2011,
including:
(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;
(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;
(7) the possibility that our current
estimates of the financial effect of previously announced product
recalls could prove to be incorrect;
(8) risks related to the Company's highly
leveraged capital structure discussed in Part I, Item 2—
"Management's Discussion and Analysis of Financial Condition and
Results of Operations—Liquidity and Capital Resources" of our
Quarterly Report on Form 10-Q for the fiscal quarter ended
December 31, 2011, including:
(a) the risk that the maturities of our debt
obligations may be accelerated due to our inability to comply with
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; and
(c) risks that future changes in the Board of
Directors may lead to an acceleration of the maturities of the
Company's debt;
(9) 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
(10) the risks detailed from time to time in the
Company's filings with the Securities and Exchange Commission
("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/A for the fiscal year ended March
31, 2011, and Part II, Item 1A—"Risk Factors," and Part I,
Item 2—"Management's Discussion and Analysis of Financial Condition
and Results of Operations" of our Quarterly Report on Form
10-Q for the fiscal quarter ended December
31, 2011, 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 2011 Form 10-K/A for the fiscal
year ended March 31, 2011, and Part
II, Item 1A—"Risk Factors" in our Quarterly Report on Form 10-Q for
the fiscal quarter ended December 31,
2011, as supplemented by our subsequent SEC filings.
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