KV Pharmaceutical Receives Letter From NYSE Regarding Delayed Filing of Its 2009 Annual Report on Form 10-K
22 June 2009 - 10:44PM
PR Newswire (US)
ST. LOUIS, June 22 /PRNewswire-FirstCall/ -- KV Pharmaceutical
Company (NYSE:KVa/KVb) (the "Company") today announced that it
received a letter from NYSE Regulation, Inc. (the "NYSE") on June
16, 2009 informing the Company that it is subject to certain
procedures as specified in Section 802.01E of the NYSE's Listed
Company Manual ("Section 802.01E") as a result of its failure to
timely file its Annual Report on Form 10-K for the fiscal year
ended March 31, 2009 (the "2009 Annual Report") with the Securities
and Exchange Commission (the "SEC"). Section 802.01E provides that
the NYSE will monitor the Company and the status of the Company's
filing of the 2009 Annual Report for a six-month period from the
filing due date for the 2009 Annual Report. If the 2009 Annual
Report is not filed with the SEC upon expiration of such six-month
period, the NYSE will, in its sole discretion, determine whether to
provide the Company with an additional six-month period in which to
file the 2009 Annual Report. The letter also states that,
regardless of the procedures specified in Section 802.01E and if
circumstances warrant, the NYSE could commence delisting procedures
at any time during any period that is available to complete the
filing of the 2009 Annual Report. As previously disclosed in its
Notification of Late Filing on Form 12b-25 filed with the SEC on
June 2, 2009, the Company has been unable to timely file the 2009
Annual Report due to an ongoing internal investigation being
conducted by the Audit Committee (the "Audit Committee") of the
Board of Directors of the Company. While the Audit Committee's
investigation has been substantially completed, the Audit Committee
has referred certain matters with a potential financial reporting
impact resulting from its investigation to management for
resolution. Until these matters can be resolved, the Company will
not be in a position to file the 2009 Annual Report with the SEC.
The Company expects these matters to be resolved before the end of
July 2009. In addition, the Company is continuing to evaluate the
financial statement implications of the provisions of the consent
decree the Company entered into with the U.S. Food and Drug
Administration (the "FDA") on March 2, 2009 and of the previously
disclosed actions to recall all of the products it manufactured,
suspend manufacturing and shipment of its products, substantially
reduce its workforce and realign its cost and organizational
structure. As a result of the investigation conducted by the Audit
Committee and the matters related thereto currently under
evaluation by management, the Company was unable to timely file its
2009 Annual Report with the SEC. The Company is in the process of
preparing the 2009 Annual Report but is unable, at this time, to
estimate when the 2009 Annual Report will be completed and filed.
About KV Pharmaceutical Company KV Pharmaceutical Company is a
fully integrated specialty pharmaceutical company that develops,
manufactures, markets, and acquires technology-distinguished
branded and generic/non-branded prescription pharmaceutical
products. The Company markets its technology distinguished products
through ETHEX Corporation, a subsidiary that competes with branded
products, and Ther-Rx Corporation, the company's branded drug
subsidiary. For further information about KV Pharmaceutical
Company, please visit the Company's corporate Web site at
http://www.kvpharmaceutical.com/. Cautionary Note Regarding
Forward-looking Statements The information in this press release
may contain various forward-looking statements within the meaning
of the United States Private Securities Litigation Reform Act of
1995 ("PSLRA") and which may be based on or include assumptions
concerning the operations, future results and prospects of the
Company. Such statements may be identified by the use of words like
"plan," "expect," "aim," "believe," "project," "anticipate,"
"commit," "intend," "estimate," "will," "should," "could" and other
expressions that indicate future events and trends. All statements
that address expectations or projections about the future,
including without limitation, product development, product
launches, regulatory approvals, market position, acquisitions, sale
of assets, revenues, expenditures, resumption of manufacturing and
distribution of products 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 "safe harbor" provisions, the
Company provides the following cautionary statements identifying
important economic, political and technological factors, which
among others, 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) the ability to continue as a
going concern; (2) changes in the current and future business
environment, including interest rates and capital and consumer
spending; (3) the difficulty of predicting FDA approvals, including
timing, and that any period of exclusivity may not be realized; (4)
the possibility of not obtaining FDA approvals or delay in
obtaining FDA approvals; (5) acceptance and demand for new
pharmaceutical products; (6) the introduction and impact of
competitive products and pricing, including as a result of
so-called authorized-generic drugs; (7) new product development and
launch, including the possibility that any product launch may be
delayed or that product acceptance may be less than anticipated;
(8) reliance on key strategic alliances; (9) the availability of
raw materials and/or products manufactured for the Company under
contract manufacturing arrangements with third parties; (10) the
regulatory environment, including regulatory agency and judicial
actions and changes in applicable law or regulations; (11)
fluctuations in revenues; (12) the difficulty of predicting
international regulatory approvals, including timing; (13) the
difficulty of predicting the pattern of inventory movements by the
Company's customers; (14) the impact of competitive response to the
Company's sales, marketing and strategic efforts, including the
introduction or potential introduction of generic or competing
products against products sold by the Company and its subsidiaries;
(15) risks that the Company may not ultimately prevail in
litigation, including challenges to the Company's intellectual
property rights by actual or potential competitors or to the
Company's ability to market generic products due to brand company
patents and challenges to other companies' introduction or
potential introduction of generic or competing products by third
parties against products sold by the Company or its subsidiaries,
including without limitation the litigation and claims referred to
in Note 16 of the Notes to the Consolidated Financial Statements in
the Company's Quarterly Report on Form 10-Q for the quarter ended
June 30, 2008 and under the heading "Certain Other Matters" in the
Company's Form 8-K filed with the SEC on April 30, 2009; (16) the
possibility that the Company's current estimates of the financial
effect of certain announced product recalls could prove to be
incorrect; (17) whether any product recalls or product
introductions result in litigation, agency action or material
damages; (18) the possibility that the findings of the Audit
Committee inquiry referenced in the Company's Form 10-Q for the
quarter ended June 30, 2008, Form 12b-25 filed with the SEC on
November 13, 2008, Form 12b-25 filed with the SEC on February 2,
2009, Form 12b-25 filed with the SEC on June 6, 2009, as well as
certain other of the Company's SEC filings, could have a material
impact on the Company's financial results; (19) the satisfaction or
waiver of the other closing conditions in the previously disclosed
Gestiva(TM) acquisition agreement; (20) the possibility that the
auction rate securities held by the Company may not return to
liquidity at their face value or at all; (21) the consent decree
between the Company and the FDA and the Company's suspension of the
production and shipment of substantially all of the products that
the Company manufactures and the related nationwide recall
affecting substantially all of the products that the Company
manufactures, as well as the expected material adverse effect on
the Company's revenue, assets and liquidity and capital resources,
all as more fully described in the Company's Form 8-K filed with
the SEC on January 26, 2009, the Company's Form 8-K filed with the
SEC on February 26, 2009, the Company's Form 8-K filed with the SEC
on March 3, 2009 and the Company's Form 8-K filed with the SEC on
April 30, 2009; (22) the series of putative class action lawsuits
alleging violations of the federal securities laws by the Company
and certain individuals, all as more fully described in the
Company's Form 8-K filed with the SEC on January 26, 2009, the
Company's Form 8-K filed with the SEC on February 26, 2009 and the
Company's Form 8-K filed with the SEC on April 30, 2009, as well as
certain other of the Company's SEC filings; (23) the possibility
that insurance proceeds are insufficient to cover potential losses
that may arise from litigation, including with respect to product
liability or securities litigation; (24) the informal inquiry
initiated by the SEC and any related or additional governmental
investigative or enforcement proceedings, including actions by the
FDA and the U.S. Department of Justice, all as more fully described
in the Company's Form 8-K filed with the SEC on January 26, 2009,
the Company's Form 8-K filed with the SEC on February 26, 2009 and
the Company's Form 8-K filed with the SEC on February 30, 2009;
(25) delays in returning certain or many of the Company's products
to market, including loss of market share as a result of the
suspension of shipments, and related costs; (26) sale or licensing
of certain assets; (27) the ability to monetize the auction rate
securities (ARS) currently held by the Company, the amount of
proceeds to be received from such monetization and the timing of
receipt of proceeds by the Company; (28) the timing and ability to
realize and receive expected tax refunds, the actual refund amount
to be received by the Company subject to any challenges or
otherwise and the timing of receipt of the refund by the Company;
(29) the possibility that default on one type or class of the
Company's indebtedness could result in cross default under, and the
acceleration of, other indebtedness of the Company; and (30) the
risks detailed from time-to-time in the Company's filings with the
SEC. This discussion is not exhaustive, but is designed to
highlight important factors that may impact the Company's
forward-looking statements. The Company is under no obligation to
update any of the forward-looking statements after the date of this
press release. All forward-looking statements attributable to the
Company 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 the
heading "Item 1A--Risk Factors" in the Company's Annual Report on
Form 10-K for the year ended March 31, 2008, as supplemented by the
Company's subsequent SEC filings. DATASOURCE: KV Pharmaceutical
Company CONTACT: Michael Anderson of KV Pharmaceutical Company,
+1-314-645-6600 Web Site: http://www.kvpharmaceutical.com/
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