KV PHARMACEUTICAL CO 
By ST. LOUIS, Feb. 9, 2012 /PRNewswire/ -- K-V Pharmaceutical Company (the "Company") (NYSE: KVa/KVb) today reported updated performance metrics for Makena®.
Makena® was launched during March of 2011. From its launch date through January 31, 2012:
-- Approximately 7,900 vials have been shipped to Ther-Rx customers of
which approximately 6,500 vials have been distributed to doctors and
patients. This is an increase of approximately 600 vials shipped to
customers and 1,600 vials shipped to doctors and patients since November
2011;
-- As part of Ther-Rx's commitment to patient access, we have also provided
approximately 1,200 additional vials at little or no patient
out-of-pocket cost through our patient assistance program for use by
patients who have demonstrated financial need;
-- Approximately 6,000 patient referrals from over 3,500 prescribers have
been made to the Makena Care Connection®, an increase of approximately
1,200 patients and 500 prescribers since November 2011;
-- Approximately 3,700 patients have either initiated treatment, are in the
enrollment phase or are pending insurance approval and treatment
initiation, an increase of more than 900 patients since November 2011;
-- Over 250 payers, both commercial and Medicaid, have reimbursed Makena®
and at least 19 states have reimbursed Makena®; and
-- Current data indicates patient co-pays are averaging approximately $10
per injection, the same or less cost than those typically associated
with compounded 17P formulations.
"We continue to advance our commercialization strategy for Makena® by actively engaging the medical and payer communities on the differences between FDA-approved Makena® and unapproved compounded 17P formulations," said Greg Divis, President and CEO of K-V Pharmaceutical and President of Ther-Rx. "Our efforts are driving improved performance metrics and we are intensely focused on continuing to grow our market share."
Fiscal 2012 Form 10-Q and Investor Conference Call
The Company will be filing its fiscal 2012 third quarter Form 10-Q with the U.S. Securities & Exchange Commission (SEC) after the close of market today. The Company will host an investor conference call on Friday, February 10, 2012 at 8:30 a.m. EST to discuss the information contained in the Form 10-Q 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 4088697. 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 10009958. 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 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
September 30, 2011;
(2) risks associated with
the introduction and
growth strategy
related to the
Company's Makena(R)
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(R) 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(R),
and the resulting coverage decisions
for Makena(R) 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(R) set forth
in the previously disclosed Makena(R)
acquisition agreement, as amended from
time to time, including $107.5 million
of remaining scheduled payments by us
for those rights as of December 31,
2011; and
(e) the number of preterm births for which
Makena(R) 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(R) and
Gynazole-1(R) 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
September 30, 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
September 30, 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
September 30, 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 September 30, 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 this Report, 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 Report. 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
