ST. LOUIS, June 13, 2011 /PRNewswire/ -- K-V Pharmaceutical
Company (the "Company") (NYSE: KVa/KVb) today announced that it has
filed its form 10-K for the fiscal year ended March 31, 2011 with the U.S. Securities and
Exchange Commission.
The Company will be holding an investor conference call today at
4:30 p.m. EDT to discuss the Form
10-K as well as provide a general update on other company matters.
Participants can listen to the conference call by dialing
866-843-0890 and providing code 2667800. To access the live web
cast of the conference call, please go to the investor relations
portion of the Company's website under "Conference Calls" at
www.kvpharmaceutical.com. Please log-in or dial-in at least 10
minutes prior to the start time to ensure a connection.
A replay of the call will also be available for seven days by
calling 877-344-7529 and providing code 445162. An archived version
of the webcast will be accessible for 30 days at
www.kvpharmaceutical.com.
About K-V Pharmaceutical Company
K-V Pharmaceutical Company is a fully-integrated specialty
pharmaceutical company that develops, manufactures, markets, and
acquires technology-distinguished branded prescription
pharmaceutical products. The Company markets its
technology-distinguished products through Ther-Rx Corporation, its
branded drug subsidiary.
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 that 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," "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
development, product launches, regulatory approvals, governmental
and regulatory actions and proceedings, 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
PSLRA's "safe harbor" provisions, the Company provides 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:
- our ability to continue as a going concern;
- the impact of competitive, commercial, payor, governmental,
physician, patient, public or political responses and reactions,
and responses and reactions by medical professional associations
and advocacy groups, to the Company’s sales, marketing, product
pricing, product access and strategic efforts with respect to
Makena™, and its other products, including introduction or
potential introduction of generic or competing products, or
competition from unapproved therapies or compounded drugs, against
products sold by the Company and its subsidiaries, including
Makena™, and including competitive or responsive pricing
changes;
- the possibility of not obtaining U.S. Food and Drug
Administration (“FDA”)approvals or delay in obtaining FDA
approvals;
- new product development and launch, including the possibility
that any product launch may be delayed or unsuccessful, including
with respect to Makena™;
- acceptance of and demand for the Company’s new pharmaceutical
products, including Makena™, and for our current products upon
their return to the marketplace, as well as the number of preterm
births for which Makena™ may be prescribed and its safety profile
and side effects profile and acceptance of the degree of patient
access to, and pricing for, Makena™;
- the possibility that any period of exclusivity may not be
realized, including with respect to Makena™, a designated Orphan
Drug;
- the satisfaction or waiver of the terms and conditions for the
continued ownership of the full U.S. and worldwide rights to
Makena™ set forth in the previously disclosed Makena™ acquisition
agreement, as amended;
- the consent decree between the Company and the FDA and the
Company’s suspension of the production and shipment of all of the
products that it manufactures (other than the Potassium Chloride ER
Capsule products that are the subject of the FDA letter received
September 8, 2010 allowing the return
of those products to the marketplace) and the related nationwide
recall affecting all of the other products that it manufactures, as
well as the related material adverse effect on its revenue, assets
and liquidity and capital resources, as more fully described in
Item—2 “Management’s Discussion and Analysis of Financial Condition
and Results of Operations—Discontinuation of Manufacturing and
Distribution; Product Recalls; and the FDA Consent Decree” in the
Company’s Form 10-Q for the quarter ended December 31, 2010;
- the two agreements between the Company and the Office of
Inspector General of the U.S. Department of Health and Human
Services (“HHS OIG”) pertaining to the exclusion of our former
chief executive officer from participation in federal healthcare
programs and pertaining to the dissolution of our ETHEX subsidiary,
in order to resolve the risk of potential exclusion of our Company,
as more fully described in Note 1—“Description of Business—Changes
in Management” in the Notes to the Consolidated Financial
Statements included in Part I of the Company’s Form 10-Q for the
quarter ended December 31, 2010;
- the plea agreement between the Company and the U.S. Department
of Justice and the Company’s obligations therewith, as well as the
related material adverse effect, if any, on its revenue, assets and
liquidity and capital resources, as more fully described in Note
1—“Description of Business—Plea Agreement with the U.S. Department
of Justice” in the Notes to the Consolidated Financial Statements
included in Part I of the Company’s Form 10-Q for the quarter ended
December 31, 2010;
- changes in the current and future business environment,
including interest rates and capital and consumer spending;
- the availability of raw materials and/or products, including
Makena™ and Evamist®, manufactured for the Company under contract
manufacturing agreements with third parties;
- the regulatory environment, including regulatory agency and
judicial actions and changes in applicable laws or regulations,
including the risk of obtaining necessary state licenses in a
timely manner;
- fluctuations in revenues;
- the difficulty of predicting the pattern of inventory movements
by the Company’s customers;
- risks that the Company may not ultimately prevail in
litigation, including product liability lawsuits and challenges to
its intellectual property rights by actual or potential competitors
or to its 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—“Commitments and Contingencies” of the Notes to the
Consolidated Financial Statements in Part I of the Company’s Form
10-Q for the quarter ended December 31,
2010, and that any adverse judgments or settlements of such
litigation, including product liability lawsuits, may be material
to the Company;
- the possibility that our current estimates of the financial
effect of certain announced product recalls could prove to be
incorrect;
- whether any product recalls or product introductions result in
litigation, agency action or material damages;
- failure to supply claims by certain of the Company’s customers,
including CVS Pharmacy, Inc. and Caremark CVS Corporation, that,
despite the formal discontinuation action by the Company of its
products, the Company should compensate such customers for any
additional costs they allegedly incurred for procuring products the
Company did not supply;
- the series of putative class action lawsuits alleging
violations of the federal securities laws by the Company and
certain individuals, as more fully described in Note
16—“Commitments and Contingencies—Litigation and Governmental
Inquiries” of the Notes to the Consolidated Financial Statements in
Part I of the Company’s Form 10-Q for the quarter ended
December 31, 2010;
- 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;
- the informal inquiries initiated by the SEC and any related or
additional government investigation or enforcement proceedings as
more fully described in Note 16—“Commitments and
Contingencies—Litigation and Governmental Inquiries” of the Notes
to the Consolidated Financial Statements in Part I of the Company’s
Form 10-Q for the quarter ended December 31,
2010;
- the possibility that the pending investigation by the HHS OIG
into potential false claims under the Title 42 of the U.S. Code as
more fully described in Note 16—“Commitments and
Contingencies—Litigation and Governmental Inquiries” of the Notes
to the Consolidated Financial Statements in Part I of the Company’s
Form 10-Q for the quarter ended December 31,
2010 could result in significant civil fines or penalties,
including exclusion from participation in federal healthcare
programs such as Medicare and Medicaid;
- delays in returning, or failure to return, certain or many of
the Company’s approved products to market, including loss of market
share as a result of the suspension of shipments, and related
costs;
- the ability to sell or license certain assets, and the purchase
prices, milestones, terms and conditions of such transactions;
- the possibility that default on one type or class of the
Company’s indebtedness could result in cross default under, and the
acceleration of, its other indebtedness;
- the risks that present or future changes in the Board of
Directors or management may lead to an acceleration of the
Company’s bonds or to adverse actions by government agencies or our
auditors;
- the risk that even though the price and 30-day average price of
the Company’s Class A Common Stock and Class B Common Stock
currently satisfy the quantitative listing standards of the New
York Stock Exchange, including with respect to minimum share price
and public float, the Company can provide no assurance that they
will remain at such levels thereafter;
- compliance with debt covenants; and
- 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. Because the factors referred to above, as well as
the statements included under the captions Part I, Item 1A—"Risk
Factors," Part II, Item 7—"Management's Discussion and Analysis of
Financial Condition and Results of Operations" and elsewhere in the
Company's most recent Form 10-K, could cause actual results or
outcomes to differ materially from those expressed in any
forward-looking statements made by the Company or on the Company's
behalf, you should not place undue reliance on any forward-looking
statements.
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 Part I, Item 1A – "Risks
Factors" in the Company's most recent Form 10-K, as supplemented by
the Company's subsequent SEC filings. Further, any
forward-looking statement speaks only as of the date on which it is
made and the Company is 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
the Company to predict which factors will arise, when they will
arise and/or their effects. In addition, the Company cannot assess
the impact of each factor on its 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